Good Manufacturing Practices (GMPs) for the 21st Century -

Food Processing
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Table of Contents
Executive Summary

Section One   Current Food Good Manufacturing Practices

1. 1.1 The Development of Food GMPs

2. 1.2 Key Provisions of Food GMPs

1. 1.2.1 General Provisions (Subpart A)

2. 1.2.2 Buildings and Facilities (Subpart B)

3. 1.2.3 Equipment (Subpart C)

4. 1.2.4 Production and Process Controls (Subpart E)

5. 1.2.5 Defect Action Levels (Subpart G)

 6. References

Section Two   Literature Review of Common Food Safety Problems and Applicable Controls
1. 2.1 Microbiological Safety

2. 2.2 Chemical Safety

3. 2.3 Physical Safety

4. 2.4 Other Considerations

5. References

Section Three   Previous Surveys of Manufacturing Practices in the Food Industry

1. 3.1 Meat and Poultry Listeria Reassessment Survey

2. 3.2 Listeria Reassessment-Evaluation Report

3. 3.3 Food Processing Magazine's Annual Manufacturing Trends Survey

4. 3.4 Food Engineering Magazine's Annual Best Manufacturing Practices Survey

5. 3.5 A Survey of Control System Validation Practices in the Food Industry

6. 3.6 Automation Practices in the Food Industry

7. 3.7 Survey on the Use of Computer-Integrated Manufacturing in Food Processing Companies

8. 3.8 FDA HACCP Survey

9. 3.9 Survey of Maryland Cider Producer Practices

10. References
 Section Four   Common Food Safety Problems in the U.S. Food Processing Industry: A Delphi Study
1. 4.1 Methodology

2. 4.2 Results
1. 4.2.1 Round 1 Results

2. 4.2.2 Round 2 Results

3. 4.2.3 Round 3 Results

4. 4.2.4 Post-Study Discussions with Select Experts

1. 4.2.4.1 Additional Resources Recommended

2. 4.2.4.2 Current Government Programs of Potential Interest

3. References

Appendix A   Annotated Bibliography on Food Safety Problems and Recommended Preventive Controls

Appendix B   Definitions of Food Safety Problems

Appendix C   Examples of Preventive Controls and/or Corrective Actions for the Top Ten Food Safety Problems

Appendix D   Exploratory Factor Analysis

Appendix E   Comparison of Food GMPs to Quality Systems and Other GMPs

 
 Executive Summary
Since the last revision of food Good Manufacturing Practices (GMPs) almost 20 years ago, the food manufacturing industry has seen many changes,
including newly recognized pathogens, more sophisticated technologies, and increased automation. While GMPs can control for many food safety
problems, it is not clear that current GMPs adequately address these new developments. The food safety literature reviewed for this study shows that
there continue to be food safety problems. The Food and Drug Administration (FDA) is currently evaluating its food GMPs regulations to ensure that
they take today's technologies and food safety hazards into account.

Under contract to FDA, Eastern Research Group, Inc. (ERG) undertook this study comprising an extensive literature review and an expert elicitation of
current food safety problems and the range of preventive controls needed to address them. The expert elicitation identified the most significant food
safety problems, foods at high risk for these problems, and other major areas of concern. Based on the number of votes by experts who participated in
the elicitation, "deficient employee training," "contamination of raw materials," "poor plant and equipment sanitation," and "poor plant design and
construction" were ranked as the top four food safety problems faced by food manufacturers today. Results from the study also indicated that
refrigerated and dairy foods have the highest general risk of food safety problems compared to other food categories. Baked and refrigerated foods
pose the highest risk in terms of allergen hazards. The expert elicitation also showed that the needs of small and medium-sized food processors likely
vary from larger processors, with smaller facilities generating higher risk scores than large facilities across all food safety problems and sectors
considered.

The food safety experts who participated in the study recommended a range of preventive controls that could address most of the food safety
problems faced by the food processing industry today. They did not, however, differentiate these preventive control recommendations by facility size
despite the higher risk rankings of smaller facilities. The most frequently mentioned preventive controls with broad applicability across sectors and food
safety problems included:

 Training -- Ongoing and targeted training on issues ranging from allergen control, cleaning and sanitation procedures, incoming ingredient
receipt protocol, and monitoring for employees, management, as well as suppliers,

 Audits -- Periodic audits and inspections of facility and raw material suppliers either in-house or by third-party firms,
 Documentation -- Documentation of training activities, raw material handling policies and activities, cleaning and sanitation, receiving records,
and use of sign-off logs, and

 Validation/Evaluation -- Evaluation of training effectiveness and establishment of accountability; validation of cleaning through testing (i.e.,
swabs, organoleptic evaluations, and bioluminescence tests)

Post-study follow-up discussions with four of the experts also generated additional recommendations. While most experts agreed that food GMPs
could be improved, opinions on how this should be done varied widely. Some experts indicated that GMPs were lacking in some areas, whereas
others noted that the food GMPs should remain as written and that other approaches should be taken to encourage greater compliance.
Recommendations made included:
 Revision of food GMPs in key areas, such as training,

 Addition of new requirements, including components of HACCP, allergen control, and record keeping,

 Issuance of a guidance document that would clarify GMPs and its expectations, and

 Institution of positive incentive programs, such as reduced inspections for select facilities that meet certain requirements.

Finally, ERG's literature review and comparative analysis of other GMPs (i.e., for pharmaceutical/biologic products and medical devices) and quality
system programs revealed that the majority of preventive control recommendations echo the principles of these other GMPs regulations and quality
systems. All of the programs reviewed, including International Organization for Standardization (ISO) 9001: 2000, American Society for Quality (ASQ)
Q9004-3-1993 (Quality Management and Quality System Elements -- Guidelines for Processed Materials), pharmaceutical GMPs, and medical device
GMPs, have similar key provisions on training, audits, documentation, and evaluation/validation. A thorough comparison of the elements of food GMPs
to these systems (see Appendix E) might aid FDA in its food GMPs modernization effort.

Current Good Manufacturing Practices (CGMPs)

Page Last Updated: 12/23/2014 

 GMPs - Section One: Current Food Good Manufacturing
Practices
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Current food good manufacturing practices (GMPs) are published in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110). GMPs
describe the methods, equipment, facilities, and controls for producing processed food. As the minimum sanitary and processing requirements for
producing safe and wholesome food, they are an important part of regulatory control over the safety of the nation's food supply. GMPs also serve as
one basis for FDA inspections.

The current GMPs are the result of an extended rulemaking process that spanned decades. The following section (Section 1.1) describes when, why,
and how the food GMPs were developed and some of the obstacles that were overcome. Table 1-1 summarizes the major events that led to the
development of GMPs as they are today. Section 1.2 provides a detailed discussion of the requirements in each of the five subparts of the GMP
regulation, and concludes with a table (Table 1-2) outlining the main requirements.

1.1   The Development of Food GMPs

Food safety has been regulated since the mid-1800s and was mostly the responsibility of local and state regulators. However, the Pure Food and
Drugs Act, passed by Congress in 1906, marked the first major federal consumer protection law with respect to food processing. The 1906 law
prevented interstate and foreign commerce in misbranded or adulterated foods, drinks, or drugs. The intent of the Act was to prevent poisoning and
consumer fraud. As more food products were manufactured in subsequent years, however, poor-quality food products and deceptive packaging
continued to be produced due to loopholes in the law. Consumers were often unaware of what they were buying until products were opened.
Therefore, in 1933, the FDA decided to overhaul the 1906 Act.

In 1938, after a battle about USDA jurisdictions with respect to the Act's enforcement, the Food Drug, and Cosmetic Act (FDCA) replaced the 1906
Act. The FDCA provided the necessary identity and quality standards to protect consumers from fraud. The FDCA provides the regulatory basis for
today's food GMPs. Two sections of the FDCA are directly related to conditions in a facility where food has been manufactured.

 Section 402 (a)(3) specifies that food has been manufactured under such conditions that it is unfit for consumption.

 Section 402 (a)(4) considers that food may be adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have
become contaminated with filth or rendered injurious to health.
These provisions are unlike other parts of Section 402, in that they relate to the conditions of a facility where food is produced or stored. Thus, instead
of having to prove that the food is adulterated, insanitary conditions are considered sufficient to show that the food might have become adulterated.

Given the FDCA's vagueness in establishing violations and thus, the difficulty of enforcing it, FDA began working on draft GMP regulations by the mid-
1960s (although others had made the suggestion to do so as early as 1948). The objective of the GMP regulations was to describe general rules for
maintaining sanitary conditions that must be followed by all food processing facilities to ensure that the statutory requirements of Section 402(a)(3) and
(4) were met. After much industry involvement, including much debate about FDA's authority to adopt rules to carry out the provisions of the FDCA, the
GMP regulations for food processing facilities were finally proposed in 1968 (see Table 1-1).

Three broad categories of interrelated issues arose during the development of the GMPs (Dunkelberger, 1995):

 Concern that the regulations were unduly stringent and especially burdensome for small food companies without necessarily improving the
quality or safety of foods.

 Contention that the GMP regulations must prescribe conditions that "reasonably" relate to insanitary conditions that may contaminate food and
render it injurious to health.

 Assertions that the regulations did not have the force of law.

These first two issues were resolved mostly through the use of more general terms, such as "adequate," "sufficient," and "suitable," rather than hard-
line standards. FDA also used "shall" when the agency felt compliance was necessary and "should" when practices in the rule were less obviously
related to the statutory requirements of the Act. The third issue became inconsequential when it was proved that FDA did have the statutory authority
to promulgate the GMP regulations. The GMP regulations were finalized in April of 1969 and published as Part 128 of the Code of Federal Regulations
(CFR). In 1977, Part 128 was recodified and published as Part 110 of the CFR.

The final GMP regulations were very broad, not specifying what exactly a facility must do to comply. This naturally created enforcement problems for
the FDA. To address the ambiguity created by the umbrella GMPs, FDA next tried to develop industry-specific GMPs through the mid-1970s. By the
late 1970s, however, FDA decided to improve the umbrella GMPs rather than adopting industry-specific GMPs. The revisions were finalized in 1986
and printed in 21 CFR 110. Specific GMPs were also included and printed in 21 CFR Parts 100 through 169 for:

 Quality control procedures for nutrient content of infant formula (21 CFR 106).

 Thermally processed low-acid canned foods in hermetically sealed containers (21 CFR 113).

 Acidified foods (21 CFR 114).

 Bottled drinking water (21 CFR 129).

In July of 2002, FDA formed a Food GMP Modernization Working Group to examine the effectiveness of current food GMPs given the many changes
that have occurred in the food industry since 1986. The Working Group has been researching the impact of food GMPs on food safety, as well as on
the impact (including economic consequences) of revised regulations. Part of the group's current effort, as of June 2004, is to find out which elements
of the food GMPs are critical to retain and which should be improved. FDA is now holding public meetings to obtain the public comments to assist in
this effort.

 Table 1-1: Food GMP Development Timeline

Date Milestone
1906 The Bureau of Chemistry passes the 1906 Pure Food and Drugs Act, prohibiting interstate commerce in
misbranded and adulterated foods, drinks, and drugs
1933 FDA recommends revising the 1906 Pure Food and Drugs Act
1938 FDA passes the 1938 Federal Food, Drugs, and Cosmetics Act, which provides identity and quality standards
for food
Mid FDA decides to clarify the FDCA through GMP regulations
1960s
1968 FDA proposes food GMP regulations
1969 FDA finalizes food GMP regulations
Early FDA considers promulgating industry-specific regulations
1970s
Late- FDA decides to revise the general GMPs rather than adopting industry-specific GMPs
 1970s
1986 FDA publishes revised food GMPs
2002 FDA forms Food GMP Modernization Working Group
2004 FDA announces effort to modernize food GMPs
Source: Dunkelberger, 1995; FDA, 1981b.
1.2   Key Provisions of Food GMPs

The current GMPs consist of seven subparts, two of which are reserved. The requirements are purposely general to allow individual variation by
manufacturers to implement the requirements in a manner that best suit their needs. Table 1-2 summarizes the five written subparts, which are
discussed in further detail below.

1.2.1   General Provisions (Subpart A)

The general provisions in Subpart A of the food GMPs are divided into four sections. The first section defines much of the terminology used in
describing GMPs. The terms "shall" and "should" are also defined to differentiate between when compliance is necessary ("shall") and when
procedures and practices are not directly related to insanitary conditions as specified in Section 402(4)(a) ("should").

The section on personnel delineates plant and employee responsibilities with regard to personal hygiene. For example, personnel with diseases or
other conditions that could contaminate food are to be excluded from manufacturing operations. The section also outlines expectations with respect to
personal hygiene and cleanliness, clothing, removal of jewelry and other unsecured objects, glove maintenance, use of hair restraints, appropriate
storage of personal items, and restrictions on various activities, such as eating and smoking. The section discusses the need for appropriate food
safety education and training in very general terms. The subpart further mandates the assignment of supervisory personnel to ensure compliance.

Currently, establishments that only harvest, store, or distribute raw agricultural commodities are exempt from the requirements of Subpart A, although
FDA reserves the right to issue special regulations to address this sector.

1.2.2   Buildings and Facilities (Subpart B)

Subpart B of the food GMPs outlines requirements for the maintenance, layout, and operations of food processing facilities.

Section 110.20 outlines the requirements for adequate maintenance of the grounds, including litter control, waste removal and treatment, and grounds
maintenance and drainage. The subpart requires that plants be designed and built to reduce the potential for contamination. Some detail is provided
on how to achieve this, but the requirements are largely focused on the end result of a sanitary facility rather than specific practices. The language also
includes many general terms to allow flexible implementation of the requirements.

Section 110.35 describes sanitary operations. Physical facilities, equipment, and utensils are to be sanitized in a way that protects against food
contamination. Storage of cleaning materials and toxic materials permitted are outlined to prevent contamination with chemicals. The section also
briefly addresses pest control and cleaning of various food contact surfaces, as well as the frequency of cleaning.

Section 110.37 describes the requirements for adequate sanitary facilities and controls, including the water supply, plumbing, toilet and hand-washing
facilities, and rubbish and offal disposal.

Some of the requirements of the section are fairly specific, such as the requirement of self-closing doors for toilet facilities, whereas others remain
general, such as plumbing of adequate size and design.

1.2.3   Equipment (Subpart C)

Subpart C describes the requirements and expectations for the design, construction, and maintenance of equipment and utensils so as to ensure
sanitary conditions. It also adds a specific requirement; an automatic control for regulating temperature or an alarm system to alert employees to a
significant change in temperature. Other requirements of the subpart are fairly general and intended to prevent contamination from any source.

1.2.4   Production and Process Controls (Subpart E)

The first section of Subpart E lists the general sanitation processes and controls necessary to ensure that food is suitable for human consumption. It
uses more general words (e.g., "adequate," "reasonable," etc.) and covers many aspects not discussed in previous subparts. This section also
addresses the monitoring of physical factors (critical control points), such as time, temperature, humidity, pH, flow rate, and acidification.

The second section outlines very general requirements for warehousing and distribution. The section requires finished foods to be stored and
distributed under conditions that protect against physical, chemical, and microbial contamination. The container and the food must also be protected
from deterioration.

1.2.5   Defect Action Levels (DALs) (Subpart G)

The last subpart of the food GMPs allows FDA to define maximum defect action levels (DALs) for a defect that is natural or unavoidable even when
foods are produced under GMPs as set out in the other subparts of the regulations. Generally, these defects are not hazardous to health at low levels;
they include rodent filth, insects, or mold. The DALs are defined for individual commodities and may be obtained by request from FDA, which produces
a Handbook on Defect Action Levels for Food. They are also available from the FDA Web site Defect Action Levels handbook. Table 1-3 provides
examples of the maximum DALs for select food products. Manufacturers are expected to use quality control operations that reduce the level of the
defect to the lowest possible levels. Those exceeding maximum DALs will be considered in violation of Section 402 (3)(a) of the FDCA.

The section bans blending of food with a defect level above a maximum DAL with other food. It also stresses that compliance with DALs does not
excuse violations of Section 402(4)(a) of the FDCA or that of the other subparts of 21 CFR 110.

Table 1-2:  Summary of 21 CFR Part 110: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding
Human Food
Subpart A. General Section Definitions Definitions of:
Provisions 110.3  Acid foods/acidified foods
 Adequate

 Batter
  Blanching

 Critical control point

 Food

 Food-contact surfaces

 Lot

 Microorganisms

 Pest

 Plant

 Quality control operation

 Rework

 Safe-moisture level

 Sanitize

 Shall

 Should

 Water activity

Section Current good  Criteria for determining adulteration

110.5 manufacturing
 Food covered by specific GMPs is also covered by
practice
umbrella GMPs

Section Personnel Requirements for:

110.10  Disease control
  Cleanliness

 Education and training

 Supervision of personnel with regards to these

requirements

Section Exclusions  Excluded operations (raw agricultural

110.19 commodities)
 FDA can issue special regulations to cover
excluded operations

Subpart B. Buildings Section Plant and Grounds  Description of adequate maintenance of grounds
and Facilities 110.20
 Plant construction and design to facilitate
sanitary operations and maintenance

Section Sanitary Operations Requirements for:

110.35  Cleaning/sanitizing of physical facilities, utensils,
and equipment
 Storage of cleaning and sanitizing substances

 Pest control

 Sanitation of food contact surfaces

 Storage and handling of cleaned portable

equipment and utensils

Section Sanitary Facilities and Requirements for:

110.20 Controls  Water supply
 Plumbing

 Sewage disposal
  Toilet facilities

 Hand-washing facilities

 Rubbish and offal disposal

Subpart C. Equipment Section Equipment and  Requirements for the design, construction, and
110.40 Utensils maintenance of equipment and utensils
Subpart E. Production Section Processes and controls Delineates processes and controls for:
and Process Controls 110.80  Raw materials and other ingredients
 Manufacturing operations

Section Warehousing and Storage and transportation of food must protect against
110.93 distribution contamination and deterioration of the food and its
container
Subpart G. Defect Section    FDA has established maximum defect action
Action Levels 110.10 levels (DALs) for some natural or unavoidable defects
 Compliance with DALs does not excuse violation
of 402 (a)(4)

 Food containing defects above DALs may not be

mixed with other foods

Source: Federal Register 51, 1986.

Table 1-3: Maximum Defect Action Levels for Selected Food Products
Food Product Maximum Defect Action Level
Allspice (ground)  Average of 30 or more insect fragments per 10 grams
 Average of 1 or more rodent hairs per 10 grams

Broccoli (frozen)  Average of 60 or more aphids, thrips, and/or mites per 100 grams
Cocoa beans  More than 4% of beans by count are moldy
  More than 4% of beans by count are insect-infested or insect-damaged

 More than 6% of beans by count are insect-infested or moldy (NOTE: Level differs when
both filth and mold are present)

 Average of 10 mg or more mammalian excreta per pound

Pitted olives  Average of 1.3 percent or more by count of olives with whole pits and/or pit fragments
2 mm or longer measured in the longest dimension
Pineapple juice  Average mold count of 15% or more
 Mold count of any 1 subsample is 40% or more

Tomatoes (canned)  Average of 10 or more fly eggs per 500 grams

 5 or more fly eggs and 1 or more maggots per 500 grams

 2 or more maggots per 500 grams

Source: FDA, 2004.

References
Dunkelberger, Edward. 1995. The statutory basis for the FDA's food safety assurance programs: From GMP, to emergency permit control, to
HACCP. Food and Drug Law Journal 50. 357-383.

Federal Register 51. 1986. Part 110--Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. Federal Register 51.
June 19.

Food and Drug Administration (FDA). 1981a. The Story of the Laws Behind the Labels Part I: 1906 Food and Drugs Act . FDA Consumer. June.

Food and Drug Administration (FDA). 1981b. The Story of the Laws Behind the Labels Part II: 1938 Federal Food, Drugs, and Cosmetics Act. FDA
Consumer. June.
 Food and Drug Administration (FDA). 1999. Milestones in U.S. Food and Drug Law History. FDA Backgrounder. May 3.

FDA. 2004. The Food Defect Action Levels. Center for Food Safety and Applied Nutrition. Revised May 1998.

Gould, Wilbur A. 1994. CGMPS/Food Plant Sanitation. CTI Publications, Inc: Baltimore, MD.

Junod, Suzanne White. 1999. The Rise and Fall of Federal Food Standards in the United States: the Case of the Peanut Butter and Jelly Sandwich.
Society for the Social History of Medicine. Spring Conference. April 9.

Current Good Manufacturing Practices (CGMPs)

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GMPs - Section Two: Literature Review of Common Food Safety

Problems and Applicable Controls
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This section presents ERG's literature review of preventive controls for microbiological, chemical, and physical food safety problems in the food
processing industry. Microbiological safety hazards cause most of the foodborne illnesses and include pathogenic bacteria, viruses, and parasites.
Historically, pathogenic bacteria have been the most prevalent food safety hazard, with viral cases following closely behind according to the most
recent CDC report on the etiology of foodborne illness (CDC, 2004). Chemical food safety hazards vary widely, but the most common problems cited
in the literature include contamination with pesticides, allergens, and natural toxins, including scrombotoxins found in fish and mycotoxins found in
crops. Foreign objects, or physical safety hazards, are the least likely to affect large numbers of people and usually are easily recognized.

Many of the microbiological food safety problems discussed in the literature can potentially be addressed by good manufacturing practices (GMPs)
codified in 21 CFR 110, such as proper employee hygiene, adequate training, and effective cleaning and sanitizing of the manufacturing equipment
and environment. For example, niche environments, which are sites within the manufacturing environment that can harbor bacteria, are a significant
cause of post-processing contamination but difficult to reach with average cleaning and sanitizing procedures. Food plants that put in a greater than
average effort must identify and eliminate niches by taking apart equipment in order to minimize the risk of post-processing contamination from niche
environments. Others take an even more stringent approach by applying a post-package pasteurization method, virtually eliminating the risk of post-
processing contamination due to niche environments.

Many chemical food safety problems are also addressed by following good manufacturing practices, such as pest control and proper storage. The rigor
of the controls in place varies by plant, however. Further, some food safety problems, such as allergen control, may be better addressed by a Hazard
Analysis and Critical Control Point (HACCP) plan in addition to GMPs. Physical hazards may also be better controlled by a HACCP plan. Controls may
include foreign body detection systems, such as metal detectors, in addition to putting preventive measures in place.

Table 2-1 summarizes the range of problems associated with each type of hazard as identified in the literature. The following three sections provide a
more detailed overview of each hazard and the preventive controls to address each problem, as noted in the literature. Each section also includes a
summary flowchart that highlights the potential problems, the relevant CFR section or guidance that addresses each problem, the industry/product
covered, and the types of preventive controls typically recommended to eliminate or minimize the type of food safety hazard risk posed. Finally,
Section 2.4 discusses other issues to consider when evaluating food safety controls, in addition to GMPs.

2.1 Microbiological Safety

The microbiological safety hazards include pathogenic bacteria, viruses, and parasites. Some of the problems that lead to the contamination of food
with these microorganisms at the processor level can be easily remedied with improved employee training programs and effective hygienic practices.
Others are more difficult to control, such as post-processing contamination with Listeria monocytogenes, a pathogen that is ubiquitous in the
processing environment.

Inefficient hygienic practices among employees. Employee hygiene is paramount to plant sanitation and is one of the leading causes of food
contamination (Higgins, 2002). One of the challenges that food processors have to overcome is how to motivate employees to comply with hygienic
practices. Training is one step in the process, but is often not enough to ensure employee compliance. Companies have adopted several aids to
ensure employee compliance. For example, Atlanta's Buckhead Beef Company requires workers to key in their Social Security Numbers to activate
the hand sanitizer dispensers on the plant floor. The company then uses the collected data to impose financial reprisals on employees found to be
deficient in hand-sanitizing practices. Other controls include a sensor-equipped towel that prevents the cross-contamination that can occur with hand
cranks. These units also count the number of towels dispensed. A signal dispenser that beeps when users have washed their hands sufficiently is also
available to ensure adequate hand-washing time.

Language barriers. Current training programs, even those that include Spanish signage and instructional manuals, can be inadequate if the first
language of plant employees is one other than English or Spanish. Even Spanish training materials can be problematic due to dialectical differences in
translations. Some industry experts therefore recommend a picture-and-symbol approach to training to overcome language barriers (Higgins, 2002).

Table 2-1. Range of Processor-Level Problems by Type of Food Safety Hazard Posed
Microbiological Safety Inefficient employee hygiene practices
Language barriers
Ineffective training of employees
 Biofilms
Niche environments
Plant renovations
Ineffective use of cleaning agents/disinfectants
Lack of sanitary equipment design
Reactive instead of routine maintenance
Ineffective application of sanitation principles
Internalization of pathogens in fruit
Contamination of raw materials
Post-processing contamination
Chemical Safety Raw material contamination with pesticides
Indiscriminate spraying of facilities against pests
Mistaken identity of pesticides
Spillage of pesticides
Adding too much of an approved ingredient
Raw material contamination with an allergen
In-line cross-contamination with an allergen
Contamination by utilization of rework
Cross-contamination from maintenance tools
Cross-contamination from conveyor belts
Incorrect labeling or packaging
Older equipment (more difficult to clean)
Raw material contamination with natural toxins
Mycotoxin infestation due to drought
Mycotoxin infestation due to insect damage
Mycotoxin infestation due to delayed harvesting
Mycotoxin infestation due to mechanical damage
Mycotoxin infestation due to moisture/heat
Patulin production in apples
Corrosion of metal containers/equipment/utensils
Contamination with cleaner/sanitizer residue
 Adding too much of an approved ingredient
Physical Safety Foreign matter in raw materials
Poorly maintained equipment/lines
Light fixture breakage
Foreign matter introduction during storage
Ineffective training of employees. Although effective training is crucial to ensuring that sanitation standards are met, it is not clear that current training
methods are sufficient. In the third Annual Best Manufacturing Practices Survey conducted by the Food Engineering magazine in 2002, a panel of food
manufacturing professionals rated employee training as the lowest among all food safety measures in terms of effectiveness (Gregerson, 2002).
Employee training that companies conduct may be too generic. For example, external consultants may not be familiar enough with a plant's operations
and requirements to give effective advice. Other impediments to effective training might include training the wrong people, not training enough people,
or not providing enough training (Blackburn and McClure, 2002).

 Biofilms. Biofilms occur when bacteria form a slime layer upon a surface and provide an environment for pathogens to proliferate. The adhesion of
pathogenic bacteria to a biofilm is a food safety hazard because the biofilm can detach and become a significant source of food contamination.
Cleaning to remove biofilms prior to sanitation is often sufficient to prevent this problem. However, studies have shown that attached bacteria may
survive conventional cleaning methods (Austin and Berferon, as cited in Stopforth et al, 2002). Adequate cleaning prior to sanitizing is therefore
paramount to controlling this problem. Further, coating drains and equipment parts with antimicrobial material can counteract biofilms although it does
not eliminate the need for proper cleaning and sanitizing (Higgins, 2003).

 Niche environments. Niche environments are sites within the manufacturing environment where bacteria can get established, multiply, and
contaminate the food processed. These sites may be impossible to reach and clean with normal cleaning and sanitizing procedures. Examples include
hollow rollers on conveyors, cracked tubular support rods, the space between close-fitting metal-to-metal or metal-to-plastic parts, worn or cracked
rubber seals around doors, and on-off valves and switches (Tompkin, 2002). Tompkin (2002) provides an extensive list of potential niches.
Manufacturers must identify and eliminate niches. Microbiological sampling of the environment and equipment can detect a niche. Third-party
validation of test results might be useful to further establish confidence in environmental sampling results. Further, sanitary equipment design can help
prevent niches (AMI, 2003). Proper maintenance to keep equipment parts from providing potential niches is also essential.
 Plant renovations. Outbreaks of listeriosis have been linked to environmental contamination of food caused by plant renovations (FDA/CFSAN,
2001a). While no data were identified in the literature on this issue, plant renovations are likely to require revisions in standard operating procedures
(SOPs) to prevent contamination due to changes in processes.

 Ineffective use of cleaning agents and disinfectants. Different cleaning agents vary in their ability to remove different soil types (Blackburn and
McClure, 2002). Thus, the correct choice of cleaning agent is essential to ensure effective cleaning in a food processing facility. The efficacy of
disinfectants is dependent on microbial species, pH, presence of biofilms, temperature, concentration, and contact time (Stopforth et al., 2002;
Blackburn and McClure, 2002). Stopforth et al. (2002) found that commonly used disinfectants were not as effective as desired, possibly due to
inadequate pre-cleaning steps. While there were no examples in the literature of plants having problems with this issue, the potential for ineffective
sanitation is clearly present. Food manufacturers should always confirm the efficacy of their cleaning and disinfection programs with tests from the
supplying companies or in-house trials (Blackburn and McClure, 2002).

 Lack of sanitary equipment design. Good hygienic design of equipment prevents or minimizes microbiological contamination of food. The materials
used for food processing equipment should be easily cleanable. As noted earlier, niche environments are known sources of pathogens; surfaces also
deteriorate with age, and this abrasion makes cleaning more difficult (Blackburn and McClure, 2002). For cleaning and sanitation to be effective, all
parts of the equipment should be readily accessible. Another way to improve equipment hygiene is to use antimicrobial coatings on equipment parts
(Higgins, 2003).

 Reactive rather than routine/predictive maintenance. In the Best Manufacturing Practices Survey conducted by Food Engineering magazine in 2001,
56 percent of respondents reported having routine preventive programs (Gregerson, 2002). Only 8.5 percent of respondents noted having predictive
maintenance programs; the remaining respondents described their programs as reactive in nature, i.e., "run it 'til it breaks." Reactive maintenance can
result in food contamination before a failure is identified. Niches can develop or controls can become defective in processing equipment that is not
routinely maintained. For example, in 1994, a Listeria monocytogenes outbreak was linked to the use of defective processing equipment in the
production of chocolate milk (FDA/CFSAN, 2001a).
 Ineffective application of sanitation principles. It may be difficult for a food processor to apply sanitation principles consistently and effectively to each
batch of product. Food processors have found that improving the effectiveness of sanitation principles is dependent on using redundant processing
controls (FDA/CFSAN, 1999c). Validation of cleaning processes may also be necessary. Automation that makes it unnecessary for humans to conduct
the cleaning, such as robotic spray washers, may also improve sanitation. The extent to which these practices are used in the industry is unclear and
should be explored with industry experts.

Internalization of pathogens in fruit. Fruit is usually contaminated by direct or indirect contact with animal feces. Studies have shown that pathogens
can infiltrate fruit through damaged or decayed areas or through the flower end of the fruit (FDA/CFSAN, 1999a; FDA/CFSAN, 1999b; FDA/CFSAN,
1999c). While employing best control practices--such as not using dropped fruit, removing damaged fruit, and washing/brushing fruit prior to
processing--minimizes these risks, the problem can only be controlled with some certainty by a kill step, such as pasteurization. Other possible
controls are listed in the FDA Report of 1997 Inspections of Fresh, Unpasteurized Apple Cider Manufacturers and listed again in the annotated
bibliography.

Contamination of raw materials. Many pathogens, like E. coli and Salmonella, enter the food processing environment via raw materials contaminated
with those pathogens. A number of studies have shown that methods currently in place to prevent this are not sufficient (FDA/CFSAN, 1999a;

FDA/CFSAN, 1999b; FDA/CFSAN, 1999c; Riordan et al., 2001; Tilden et al., 2002). Raw material contamination can affect any industry, but is more
common in industries that use animal-derived products or products at risk of cross-contamination by animal feces. There are numerous preventive
controls available to address the hazard. Some controls minimize the risks of raw material contamination (i.e., ensuring that raw material suppliers
comply with good agricultural practices) and others (i.e., irradiation, pasteurization) involve a kill-step to eliminate any pathogens.

Post-processing contamination. Products can also be contaminated if the post-processing environment, utensils, or equipment have been
contaminated with a pathogen. This issue is especially relevant to the pathogen Listeria monocytogenes, due to its hardiness and pervasiveness in the
environment. Effective controls against post-process contamination include eliminating the pathogen from the post-processing environment by using
environmental sampling to eliminate niches, effective sanitation, and various in-package pasteurization methods. Use of preservatives, such as nisin,
to slow down the growth ofListeria monocytogene are also becoming more common.
 

Figure 2-1: Microbiological Safety Problems, Related CFR Section or Guidance, Industries
Affected, and Sample Preventive Controls Suggested
Microbiological Food Safety Problem Relevant CFR Section/Guidance Industries Affected Sample Controls
Efficacy of hygienic practices
→ Subpart A. 110.10 Personnel → All → Keypad controls
(b) Hygienic practices Sensor equipped paper towels

Language barriers
→ Subpart A. 110.10 Personnel → All → Bilingual training
(c) Education and Training
→ Subpart B. Buildings and → All → Bilingual/picture posters and
  Facilities signs
110.35 Sanitary Facilities and
Controls

Ineffective training
→ Subpart A. 110.10 Personnel → All → In-house training
(c) Education and Training Training enough employees

Biofilms
→ Subpart B. Buildings and → Mostly RTE → Test drains
Facilities foods Scrub surfaces prior to sanitizing
110.35 Sanitary Operations

Niche environments
→ Subpart B. Buildings and → All → Environmental sampling
 Facilities Cleaning areas prone to niches
110.35 Sanitary Operations

Plant renovations
→ Subpart B. Buildings and → All → Not identified
Facilities
110.20 Plant and Grounds

Ineffective use of cleaning agents and disinfectants

→ Subpart B. Buildings and → All → Efficacy tests
Facilities
110.35 Sanitary Operations

Lack of sanitary equipment design

→ Subpart C. Equipment → All → Sanitary equipment design
110.40 Equipment and Utensils

Reactive maintenance
→ Subpart C. Equipment → All → Preventive maintenance plans
110.40 Equipment and Utensils

Lack of effectiveness and consistency in application of

→ Subpart E. 110.80 Processes and → All → Redundancy of sanitation
sanitation principles Controls processes
Cleaning validation
Automation

Internalization of pathogens in fruit

→ Subpart E. 110.80 Processes and → Juice Processing → HACCP (washing, culling, etc.)
Controls Pasteurization
(a) Raw Material and Other
Ingredients

Contamination of raw materials

→ Subpart E. 110.80 Processes and → All → Supplier audits
Controls Raw material or product testing
(a) Raw Material and Other Supplier compliance with GAPs
Ingredients Sanitation
Irradiation
HACCP
→ Meat/Poultry → Chilling
Spray-washing/warm water wash
Steam vacuuming/pasteurization
 Feed ingredient control
Spraying chicks
Use of starter culture
Trimming
→ Dairy → Pasteurization
→ Produce → Chlorine wash
Brushing
Culling
Ozone treatment
→ Eggs → Shell pasteurization/washing
  Spraying chicks
Feed ingredient control
Use of salmonella-free
chicks/pullets

Post-processing contamination
→ NA → All → HACCP
Environmental sampling
In-package steam/hot water
Pasteurization
Sanitation
Vacuum-steam-vacuum
technology
Irradiation
Preservatives
2.2 Chemical Safety

Chemical safety hazards include intentionally added chemicals (e.g., allergens), unintentionally added chemicals (e.g., cleaners and solvents), and
natural toxins (e.g., mycotoxins). Chemicals can also contaminate food through corrosion of metal processing equipment/utensils and residues of
cleaning chemicals left on processing equipment. Further, adding too much of an approved ingredient, such as a vitamin in vitamin-fortified products,
may compromise the safety of foods.
Raw material contamination with pesticides. FDA has found that roughly 1 percent of sampled domestic produce has pesticide residue in violation of
EPA standards (FDA/CFSAN, 2002). While the incidence of contamination is low, consumers remain concerned about pesticide residues. Aside from
washing and testing the produce, manufacturers can select produce from organic suppliers to avoid raw material contaminated with pesticides. Other
alternative farming systems, such as low-input sustainable agriculture (LISA) and integrated pest management, are also control options at the farm
level (Moulton, 1992). These systems, which use much less pesticide than conventional agricultural systems, rely on biological, chemical, cultural, and
physical principles and tools to control pests throughout the farming operation. Other preventive control options may include genetic engineering with
resistance against pests or developing safer chemicals (Moulton, 1992).

Indiscriminate spraying of facilities against pests. Chemicals can contaminate food if pesticides against insects and rodents are used indiscriminately
in a processing facility. Therefore, food experts generally recommend that pest control be performed only by professionals to avoid residues in food
(Folks, 2001).

Mistaken identity of pesticides. Food can become contaminated with pesticides if pesticide container labels are misread or when products are stored in
containers that have had another use. The best way to control the risk of mistaken identity is to store pesticides away from food ingredients, keep an
inventory of pesticides, and store the products in their original containers (Tybor, 1990; Folks, 2001; Bryan, 1997).

Spillage of pesticides or other chemicals. Pesticides should be handled like poisons to avoid potential spillage. Storing chemicals away from food and
packaging materials will minimize accidental spillage of pesticides and other chemicals (Tybor, 1990). Further, processors should only use food-grade
lubricants and greases in manufacturing.

Corrosion of metal containers/equipment/utensils. Metal poisoning can occur when heavy metals leach into food from equipment, containers, or
utensils. When highly acidic foods (e.g., citrus fruits, fruit drinks, fruit pie fillings, tomato products, sauerkraut, or carbonated beverages) come into
contact with potentially corrosive materials, the metals can leach into the food (Tybor, 1990). One solution to the problem is to use appropriate, non-
corrosive materials in food processing.
Residue from cleaning and sanitizing. If equipment and other food handling materials are not rinsed well, then residue from detergents, cleaning
compounds, drain cleaners, polishers, and sanitizers can contaminate a food product. This problem can best be controlled by properly training
personnel about cleaning and sanitizing (Folks, 2001; Tybor, 1990).

Accidentally adding too much of an approved ingredient. Some substances, such as preservatives, nutritional additives, color additives, and flavor
enhancers, are intentionally added to food products. But adding an approved ingredient in inordinate amounts by accident--such as adding too much
nitrite to cured meat--can result in a toxic product (Bryan et al., 1997). Thus, Tybor (1990) recommends that nitrite be stored in a locked cabinet and
weighed and bagged separately before being added to any product. Nutritional safety issues can also arise when product labels' nutrition information
is incorrect. Thus, it can be dangerous to public health when too little or too much of a specified nutrient is added. For example, malnutrition can occur
if infant formula does not deliver the expected nutrient content during its shelf life. Due to the risk involved, infant formula quality control procedures
and labeling requirements are addressed outside of GMPs in 21 CFR 106 and 107, respectively. There are also many examples of nutritional food
safety issues arising when too much of a nutrient gets added to a product unintentionally. For example, some vitamins that are added to fortified foods
(such as Vitamin A) are known to be toxic at high doses. And iron, a necessary dietary component, can cause severe illness and death if too much is
ingested. Controlling chemicals by keeping an inventory of additives minimizes the occurrence of this type of contamination (Folks, 2001).

Natural toxins. Food can be contaminated with naturally occurring chemicals that cause disease. Toxins such as mycotoxins (discussed further below)
and marine toxins are naturally produced under certain conditions. Given that these toxins generally occur in raw materials, especially crops and
seafood, manufacturers should require suppliers to certify hat the products they purchase are free from natural toxins.

Cross-contamination with allergens on production lines. A product can become cross- contaminated with allergens on the production line. To minimize
the risk of cross-contamination, equipment must be cleaned and sanitized to remove all traces of allergens when the next run includes product that
should not contain allergens (Minnesota Department of Agriculture, 2003). Wash-down techniques may need adjustment to ensure that they remove
allergens as well as pathogens (Higgins, 2000). Rinsing with water only or only cleaning at the end of the day is not adequate (FDA/CFSAN, 2001a).
Some equipment may need to be disassembled to be cleaned. The cleaning process should be verified by visual inspection. Enzyme-linked
immunosorbent assay (ELISA) tests can also help verify cleaning procedures (Deibel et al., 1997; Morris, 2002). Manufacturers may choose to
physically separate lines for allergen- and nonallergen-containing products (Morris, 2002). This may be too costly for most plants; scheduling longer
production runs to minimize changeovers, with allergen-containing product runs scheduled at the end of the day, may be a more suitable alternative
(Deibel et al., 1997; FDA/CFSAN, 2001b; Floyd, 2000; Gregerson, 2003; Minnesota Department of Agriculture, 2003; Morris, 2002). Crossover points
on production lines, including conveyor belts that transport products, should be enclosed to prevent cross-contamination. Physical detachments and
lockouts can be used for equipment common to allergen- and nonallergen-containing foods (Deibel et al., 1997). Maintenance tools should be color-
coded to prevent cross-contamination (FDA/CFSAN, 2001b; Morris, 2002). Allergenic materials should be stored separately from nonallergenic
materials, with dedicated utensils and containers. Putting all of the ingredients for a specific batch on a pallet before taking them to the processing
area, or "staging," will also minimize the risk of cross-contamination. Line clearance, such as removing all the ingredients from the production area and
checking for cleanliness, can also help prevent cross-contamination (Floyd, 2000). Product can also be tested for the presence of allergens, although
this does not appear to be a common industry practice (FDA/CFSAN, 2001a). Finally, allergens should be evaluated as part of a hazard analysis, and
a HACCP plan or similar approach can be taken to identify process areas that are at high risk for contamination with allergens (Morris, 2002).

Raw material contamination with allergens. When controlling a production process for allergens, manufacturers must maintain a close working
relationship with suppliers of raw materials. The ingredient specification should provide assurance that the product is allergen free (Deibel et al., 1997;
FDA/CFSAN, 2001c). Manufacturers should also obtain full ingredient lists from their suppliers (Deibel et al., 1997; Gregerson, 2003). Reconditioned
ingredients and oils should not be purchased (Minnesota Department of Agriculture, 2003). The manufacturer should also audit suppliers each year to
determine other products that are run on the same production line, whether any allergenic processing aids or rework have been used in the product,
and whether any contamination from other common equipment could have occurred (Gregerson, 2003). A training program may be necessary to
educate suppliers about allergen control, especially if suppliers have not implemented an allergen control plan (Deibel et al., 1997, Minnesota
Department of Agriculture, 2003).

Contamination with allergens by utilization of rework. Proper use of rework is essential to prevent contamination of product with allergens. A
documented rework plan should be available. Rework areas, equipment, and containers must be clearly identified and documented, as well as the
rework itself (Deibel et al., 1997; Gregerson, 2003). This can be done through the use of color tags, plastic liners, or bar coding.

Not declaring an allergen on labeling. Unavoidable product contamination with allergens may occur if it is impossible to verify that all residue has been
removed from a line or if other controls cannot be put in place (Floyd, 2000). A good manufacturing practice includes reviewing the labeling to ensure
that the allergen is declared. However, a study of inspections conducted by FDA/ CFSAN (2001a) indicated that many firms do not have label review
policies. Further, a large percentage of these manufacturers had undeclared allergens in their products. Controls to prevent this problem can include
removing old label and packaging inventories from plants, verifying labels by scanning bar codes, and conducting label audits (FDA/CFSAN, 2001b;
FDA/CFSAN, 2001c; Minnesota Department of Agriculture, 2003).

Older equipment. Effective cleaning is paramount to controlling allergen contamination. Older equipment, however, may not be designed to verify
cleaning with a visual inspection (Deibel et al., 1997). As noted in the section on microbiological issues and controls, all parts of the equipment should
be readily accessible and visible for cleaning and sanitation to be effective. Further, equipment surfaces should not harbor allergens. Gregerson (2003)
reports one such case in which cross-contamination with allergens occurred due to the surface nicks on the processing table. Thus, sanitary
equipment design is necessary to ensure proper removal of allergens from equipment.

Infestation of mycotoxins due to drought. Toxigenic fungi, or mycotoxins, are found primarily in foods of plant origin, although they can also pass
through the food chain in milk and meat. Drought can encourage the growth of mycotoxins in certain crops. For example, drought stress can cause
aflatoxin, a type of mycotoxin, to grow in corn and treenuts (Moss, 2002). Drought can be minimized through adequate irrigation schedules (Park et al.,
1999). Thermal and chemical treatments are also available for use on crop that is already affected by mycotoxins (Park et al., 1999). Thermal
inactivation, however, is not effective on certain types of mycotoxins, such as aflatoxin. Chemical treatments, such as ammoniation and activated
carbons and clays, are other possible controls (Boutrif, 1999; Horne et al., 1989; Park et al., 1999; Suttajit, 1989).

Infestation of mycotoxins due to damage. Insect damage is associated with high levels of mycotoxin infection, as is mechanical damage from
harvesters (Boutrif, 1999; Moss, 2002; Park et al., 1999). Diseases, such as ear rot in corn, also cause damage that leaves the crop susceptible to
mycotoxin infestation (Moss, 2002). Delayed harvesting can also make crops more susceptible to disease due to higher moisture levels (Park et al.,
1999). Damage to the product, whether through insect feeding or mechanical harvesters, provides a potential entry point for the mold that produces
the mycotoxin. Controls available include pest management to prevent insect damage, breeding cultivars that are resistant to pest damage, timely
harvesting, hand picking or electronic sorting to remove damaged crops, and thermal or chemical treatment as noted above (Boutrif, 1999; Moss,
2002; Park et al., 1999; Suttajit, 1989). Possible biological control of insects and diseases in the field is also being investigated (Moss, 2002).
Infestation of mycotoxins due to moisture/heat during storage. Post-harvest storage that protects the product from heat and moisture is essential to
prevent mycotoxin infestation (Boutrif, 1999). Grains should be dried as soon as feasible, and storage under modified atmospheric conditions is
desirable (GASCA/CTA, 1997). Products should be dried rapidly to less than 10 percent moisture (Park et al., 1999). Products can also be sampled for
mycotoxins during storage (Boutrif, 1999). Methods include visual inspection with black light, ELISA tests, and complex laboratory analysis using high-
pressure liquid chromatography (Horne et al., 1989). While prevention with proper storage conditions is the best way to control mycotoxin infestation,
thermal and chemical inactivation, as described earlier, can control any mycotoxins that do form under storage.

Patulin production in apples. Patulin is a mycotoxin that is produced by a number of molds associated with fruit spoilage (Bisessur et al., 2001). Control
methods often used in the production of apple juice include using tree-picked apples, culling apples, washing apples, charcoal treatment, chemical
preservation using sulfur dioxide, gamma radiation, fermentation, trimming of fungus-infected apples, and clarification methods (Bisessur et al., 2001;
Jackson, et al., 2003).

Figure 2-2: Chemical Safety Problems, Related CFR Section or Guidance, Industries Affected, and
Sample
Preventive Controls Suggested
Chemical Food Safety Problem Relevant CFR Section/Guidance Industries Sample Controls
Affected
Pesticides: Raw material
→ Subpart E 110.80 Processes and → All → Organic production systems
contamination with pesticides Controls Integrated pest management
(a)(1) Raw materials and other Low-input sustainable agriculture
Development of safer chemicals
Genetically engineered pest-resistant
plants
Washing and testing produce

Pesticides: Indiscriminate spraying of

→ Subpart B 110.35 Sanitary Operations → All → Professional pest control
facilities against pests (c) Pest control
Pesticides: Mistaken identity of
→ Subpart B 110.35 Sanitary Operations → All → Maintain pesticides in original containers
pesticides (b) (2) Storage of toxic chemicals Keep inventory of pesticides in a secure,
supervised area, separated from food

Pesticides: Spillage of pesticides

→ Subpart B 110.35 Sanitary Operations → All → Store pesticides away from
(b)(2) Storage of toxic chemicals food/packaging
Handle like poison
Use only food-grade greases and
lubricants

Metals: Corrosion of
→ Subpart E 110.80 Processes and → All → Use equipment that does not corrode
containers/equipment/utensils Controls with
(b)(7) Manufacturing operations acidic foods

Cleaning chemicals: Residue from

→ Subpart B 110.35 Sanitary Operations → All → Train personnel about cleaning and
cleaning and sanitizing (a) General maintenance sanitizing

Approved ingredients: Accidentally

→ Subpart E 110.80 Processes and → All → Keep an inventory of additives
adding too much of an approved Controls
ingredient

Toxins: Natural toxins

→ Subpart E 110.80 Processes and → Various crops and → Certification of product by supplier
Controls seafood
(a)(3) Raw materials and other
ingredients

Allergens: Cross-contamination with

→ Federal Food, Drug and Cosmetics Act → All → All Adequate cleaning and sanitizing
allergens on production line Section 402 (a)(4) Insanitary conditions Separate production lines
Run allergen-containing product at end
of
day
Long production runs
Verification of cleaning
Physical lockouts or detachments
Staging areas
Line clearance
 Color code maintenance tools
Employee training
Crossover points should be contained
HACCP

Allergens: Raw material contamination

→ Federal Food, Drug and Cosmetics Act → All → Maintain close working relationship with
with allergen Section 402 (a)(4) Insanitary conditions supplier
On-site audits of material suppliers
Allergen training for suppliers
Ensure that suppliers have implemented
documented an allergen prevention plan
Do not purchase reconditioned
ingredients
HACCP
 

Allergens: Contamination by
→ Federal Food, Drug and Cosmetics Act → All → Clearly identify and document rework
utilization of rework Section 402 (a)(4) Insanitary conditions Documented rework plan
HACCP

Allergens: Incorrect labeling or

→ Federal Food, Drug and Cosmetics Act → All → Verify labels and packaging with bar
packaging Section 402 (a)(4) Insanitary conditions code
scanners
Discard old labels and packaging
Conduct label audits
HACCP
Label verification policies and
procedures

Allergens: Older equipment harder to

→ Federal Food, Drug and Cosmetics Act → All → Sanitary equipment design
clean Section 402 (a)(4) Insanitary conditions

Mycotoxins: Infestation due to drought

→ Subpart E 110.80 Processes and → Various crops → Adequate irrigation schedules
Controls (mostly grains, Chemical/thermal inactivation
(a)(3) Raw materials and other corn,
ingredients peanuts, treenuts)
  

Mycotoxins: Infestation due to insect

→ Subpart E 110.80 Processes and → Various crops → Pest management
damage Controls (mostly grains, Breed cultivars resistant to pest damage
(a)(3) Raw materials and other corn, Electronic sorting
ingredients peanuts, treenuts) Handpicking
Chemical/thermal inactivation
Biological control in the field
Timely harvesting

Mycotoxins: Infestation due to

→ Subpart E 110.80 Processes and → Various crops → Controlled atmospheric storage
moisture/heat during storage Controls (mostly grains, Dry grain as soon as possible
(a)(3) Raw materials and other corn, Chemical/thermal inactivation
ingredients peanuts, treenuts) Testing/sampling for mycotoxins

Mycotoxins: Patulin production in

→ Subpart E 110.80 Processes and → Apple juice → Charcoal treatment
apples Controls Sulfur dioxide treatment
(a)(3) Raw materials and other Gamma irradiation
ingredients Fermentation
Clarification methods (pressing,
centrifugation, fining, enzyme
treatment, and filtration)
Use tree-picked and culled apples
2.3      Physical Safety

Materials that do not belong in food, like glass or metal, cause physical safety hazards. A physical safety hazard is any extraneous object or foreign
matter in food that can cause injury or illness in the person consuming the product (Folks, 2001). Rocks, metal, wood, and other objects are
sometimes found in raw ingredients. Further, contamination can occur during transport, processing, and distribution of foods due to equipment failure,
accidents, or negligence (Institute of Medicine/National Research Council, 1998). Separation equipment should be used to separate the foreign bodies
from the product. Detection methods include metal detectors, x-ray machines, and optical systems (Wallin and Haycock, 1998).
Foreign matter in raw materials. Sources of foreign matter in raw materials can include nails from pallets and boxes, ingested metal from animals,
harvesting machinery parts, elements from the field, veterinary instruments, caps, lids, closures, and more (Wallin and Haycock, 1998). Mechanical
harvesters will often collect more than the product. Processors can include separation equipment, such as destoners, air cleaners, magnets, screens,
sieves, traps, scalpers, and washers as part of their production lines. For example, grain processors use four screens to remove foreign materials
(Stier, 2001). Foreign matter in raw materials can be controlled with raw material inspections and vendor certifications or guarantees from suppliers. X-
ray technology is also available to examine incoming material (Folks, 2001).

Poorly maintained equipment and lines. Pieces of equipment can break off and enter food products during processing if equipment is poorly
maintained. Routine or preventive maintenance and other periodic checks of equipment can minimize the risk from this safety issue. Risk is further
minimized with the use of metal detectors and x-ray machinery. Proper calibration of equipment and minimizing contact between pieces of machinery
is also helpful (Folks, 2001; Stier, 2001).

Lighting fixture/other glass breakage. Glass can be controlled by having a glass breakage policy, such as throwing away all food and containers within
10 feet of the incident (Stier, 2001). Light fixtures can be protected so that if they break, the glass does not spill out (Folks, 2001). Other controls
include examining of empty glass containers visually or cleaning a container with water or compressed air and inverting the container to remove any
shards. Capping equipment should be properly calibrated and lines should be monitored for evidence of glass breakage. X-ray technology can also be
helpful in identifying glass pieces in food (Olson, 2002).

Human factors. Production line workers can be a major source of contamination. For example, jewelry can fall off or break, fingernails can break, and
pens can fall into food. Jewelry removal is required under GMPs. If pens are metallic, a metal detector can detect them. Production workers' fingernails
should be cut short and gloves should be worn under certain processing conditions.

Introduction of foreign matter during storage. Pests can enter products during storage, leaving remnants behind. Effective pest control is the solution. It
can include preventive measures such as filling in all non-functional openings in a building; fully sealing doors, windows, and vents; protecting intake
points with filters or grills; and protecting drains and other facility intakes and exits. Professional extermination is needed once pests have established.
UV light traps can also be used, although they need to be designed to prevent further contamination from the tray that collects the insect remains
(Wallin and Haycock, 1998).

Figure 2-3. Physical Safety Problems, Related CFR Section or Guidance, Industries Affected, and
Sample
Preventive Controls Suggested
Physical Food Safety Problem Relevant CFR Section/Guidance Industries Sample Controls
Affected
Foreign matter in raw materials
→ Subpart E 110.80 Processes and Controls → All → Raw material inspection and specification
(b)(8) Measures against extraneous material Vendor certification/letters of guarantee
GAPs Destoners
Magnets
Screens
Washers
X-ray technology

Poorly maintained equipment and lines

→ Subpart E 110.80 Processes and Controls → All → Metal detectors
(b)(8) Measures against extraneous material X-ray technology
Subpart E 110.40 Equipment and Utensils Proper maintenance and calibration of
(a) Maintenance detection equipment
Controlling contact between pieces of
machinery
Passing product through separation
equipment
 Light fixture or other glass breakage
→ Subpart E 110.80 Processes and Controls → All → Shield light
(b)(8) Measures against extraneous material Glass breakage policy
Subpart E 110.20 Plant and Grounds Glass scanners
(5) Lighting Monitoring lines for glass breakage
Proper adjustment of capping equipment
Visual examination of containers
Cleaning containers with
water/compressed air and inverting
X-ray technology

Introduction of foreign matter during

→ Subpart B 110.35 Sanitary Operations → All → Pest control
storage (c) Pest Control
2.4      Other Considerations

There is a wide range of issues related to the safety and wholesomeness of food in addition to GMPs. These should be considered in addition to the
problems identified at the food processing level when evaluating the effectiveness of food GMPs. They include the following and are discussed in more
detail below:

 New trends contributing to foodborne illness,

 Most common causes of foodborne illness,

 High-risk foods, and

 Role of market incentives

New trends contributing to foodborne illness. A number of recent trends contribute to the incidence of foodborne illness. For example, in recent years,
there has been an increase in consumer purchases of ready-to-eat (RTE) foods, made popular by the busy lifestyles of people today. Many cases of
foodborne illness are caused by RTE foods that were cross contaminated with pathogenic bacteria. Since RTE foods are generally not cooked prior to
consumption, the likelihood of foodborne illness is high when these products are contaminated.
Another alerting trend is the increase in new and drug-resistant infectious foodborne agents since the GMPs were last revised. Listeria
monocytogenes andCryptosporidium are examples of newly recognized agents that has been of great concern in the last few years. Some pathogens
have also shown antimicrobial resistance, such as Campylobacter jejuni and Salmonella typhimurium DT104. There is also evidence of well-known
viruses, such as hepatitis A and Salmonella entertidis, appearing in new foods like produce (Institute of Medicine/National Research Council, 1998).
The evolution of these new agents and new vehicles transmitting known pathogens makes prevention of food contamination a moving target for those
in charge of ensuring food safety.

The aging population in the United States is another trend of concern: this group is at higher risk for developing illness from contaminated food. As the
baby boomer generation enters their retirement years, one can expect this trend to become even more pronounced. These and other changes over
time significantly increase the risk of contracting foodborne illness, necessitating a new look at food GMPs in light of these factors.

Most common causes of foodborne illness. Pathogenic bacteria are the most commonly reported agents of foodborne illness, closely followed by
viruses (CDC, 2004). Further, most reported cases of foodborne illness are attributable to poor handling at the home or at retail food establishments
rather than failures at the food processing level (CDC, 2000). It is not possible to determine (with certainty) the cause of foodborne illness in roughly 50
percent of all foodborne illness cases. Moreover, many foodborne illness cases go unreported.

High-risk foods. The level of risk to public health varies by type of food. Some food products, such as refrigerated RTE foods, have a higher risk of
being contaminated by pathogenic bacteria (e.g., Listeria monocytogenes) than others, such as frozen RTE products (NFPA, undated). Further,
FDA/CFSAN (2001a) has also shown in their Listeria monocytogenes risk assessment that the level of risk varies for different types of RTE foods.
Therefore, from a risk perspective, indiscriminate application and/or recommendation of controls and policies may unduly burden manufacturers as
well as the FDA and in some cases lead to inadvertent outcomes. For example, under the current zero-tolerance policy of the Food Safety and
Inspection Service (FSIS) for Listeria monocytogenes, when a plant's testing program detects Listeria monocytogenes on plant equipment, the plant is
required to recall all product produced on that line during the period of contamination. FSIS may also obtain test data if a plant has a suspected
problem with Listeria monocytogenes. While there is a consensus in the industry that aggressive environmental monitoring is essential to
controlling Listeria monocytogenes, Tompkin (2002) argues that the zero-tolerance policy discourages, rather than encourages, the RTE food industry
from confirming the presence of Listeria monocytogenes in their environmental sampling programs. Many companies may conduct less (rather than
more) aggressive environmental monitoring and product testing to avoid regulatory conflict.

Role of market incentives. FSIS is required to inspect meat and poultry slaughtering and processing plants carcass by carcass. As a result of the
continuous inspection requirements, FSIS's inspection budget is four times that of FDA (Institute of Medicine/National Research Council, 1998). The
lack of inspection resources may contribute to less enforcement of food safety statutes under FDA's jurisdiction. Given the lack of resources, it is
important to evaluate the role of other, non-regulatory incentives that encourage food safety. For example, food safety problems can be a major liability
for manufacturers of brand name products. If food is said to be unsafe, these manufacturers can face a huge public relations crisis that will negatively
affect their bottom line (Ballenger and Ollinger, 2003). Consumers may also shun an entire category of food (Institute of Medicine/National Research
Council, 1998). Most producers of branded products, therefore, invest more to ensure the safety of the food they produce. Grocery stores and
wholesalers also require strict food safety controls from their suppliers to protect their reputations. For example, USDA's Economic Research Service
(ERS) researchers recently surveyed 1,000 slaughtering plants and found that contractual agreements covering food safety standards result in higher
levels of food safety with regards to equipment, testing, dehiding, sanitation, and operating procedures (Ballenger and Ollinger, 2003). A similar study
for FDA-regulated products may yield comparable results.

References

American Meat Institute (AMI). 2003. Sanitary Equipment Design. AMI Fact Sheet. March.

Ballenger, Nicole, and Michael Ollinger. 2003. Weighing Incentives for Food Safety in Meat and Poultry. Amber Waves. USDA/ERS, Washington, DC.
April.

Bissessur, J., K. Permaul, and B. Odhav. 2001. Reduction of Patulin During Apple Juice Clarification. Journal of Food Protection. Vol. 64, No. 8.

Blackburn, Clive de W., and Peter J. McClure. 2002. Foodborne Pathogens: Hazards, Risk Analysis, and Control. CRC Press, Washington, DC.

Boutrif, Ezzeddine. 1999. Minimizing Mycotoxin Risks Using HACCP - The Cracker. International Tree Nut Council. September.
Bryan, Frank L., John J. Guzewich, and Ewen C.D. Todd. 1997. Surveillance of Foodborne Disease III. Summary and Presentation of Data on
Vehicles and Contributory Factors; Their Value and Limitation. Journal of Food Protection. Vol. 60, No. 6: 701-714.

CDC. 2004. 2002 Summary Statistics: The Total Number of Foodborne Disease Outbreaks by Etiology. Foodborne Outbreak Response and
Surveillance Unit. http://www.cdc.gov/foodborneoutbreaks/us_outb/fbo2002/summary02.htm.

CDC. 2000. Surveillance for Foodborne Disease Outbreaks--United States, 1993--1997. MMWR Surveillance Summaries. Vol. 49 (SS01):1-51. March
17.

Deibel, Kurt, Tom Trautman, Tom DeBoom, William H. Sveum, George Dunaif, Virginia N. Scott, and Dane T. Bernard. 1997. A Comprehensive
Approach to Reducing the Risk of Allergens in Food. Journal of Food Protection. Vol. 60, No. 4: 436-441.

FDA/CFSAN. 2002. Food and Drug Administration Pesticide Program: Residue Monitoring 2000. Washington, DC. May.

FDA/CFSAN. 2001a. Draft Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of
Ready-to-Eat Foods. January.

FDA/CFSAN. 2001b. Seafood HACCP Alliance HACCP Training Curriculum Manual: Hazards -- Biological, Chemical, and Physical (Chapter 2).
November.

FDA/CFSAN. 2001c. Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh
and Fresh-cut Produce. September 30.

FDA/CFSAN. 1999a. Potential for Infiltration, Survival, and Growth of Human Pathogens within Fruits and Vegetables. November.

FDA/CFSAN. 1999b. Preliminary Studies on the Potential for Infiltration, Growth, and Survival of Salmonella enterica Hartford and Escherichia coli
O157:H7 Within Oranges. November.
FDA/CFSAN. 1999c. Report of 1997 Inspections of Fresh, Unpasteurized Apple Cider Manufacturers. January.

Floyd, Bruce M. 2000. Battling Allergen Contamination. Food Product Design. December.

Folks, Heather, and Dennis Burson. 2001. Food Safety: Chemical Hazards. University of Nebraska Cooperative Extension.

GASGA/CTA. 1997. Mycotoxins in Grains. Technical Leaflet. No. 3. June.

Gregerson, John. 2003. Plain Talk About Allergen Management. Food Processing. January 29.

Gregerson, John. 2002. Third Annual Best Manufacturing Practices Survey. Food Engineering. February.

Gould, William A. 1994. CGMP's/Food Plant Sanitation. CTI Publications, Inc., Timonium, MD.

Higgins, Kevin T. 2003. Food Safety: Say Goodbye to the Burn. Food Engineering. January.

Higgins, Kevin T. 2002. The Culture of Clean. Dairy Foods. November.

Higgins, Kevin T. 2000. A Practical Approach to Allergen Control. Food Engineering. July.

Horne, C.W., L.L. Boleman, C.G. Coffman, J.H. Denton, and D.B. Lawhorn. 1989. Mycotoxins in Feed and Food Producing Crops. U.S. National Dairy
Database. http://www.mda.state.mn.us/dairyfood/mfgallergens.htm.

Institute of Medicine. 2001. Food Safety Policy, Science, and Risk Assessment: Strengthening the Connection. Food Forum Workshop
Proceedings.National Academy Press, Washington, DC.

Institute of Medicine/National Research Council. 1998. Ensuring Safe Food. National Academy Press, Washington, DC.
Jackson, Lauren S.,, Tina Beacham-Bowden, Susanne E. Keller, Chaitali Adhikari, Kirk T. Taylor, Stewart J. Chirtel, and Robert I. Merker. 2003. Apple
Quality, Storage, and Washing Treatments Affect Patulin Levels in Apple Cider. Journal of Food Protection. Vol. 66, No. 4.

Minnesota Department of Agriculture. 2003. Managing Food Allergen Risks. http://www.mda.state.mn.us/dairyfood/mfgallergens.htm.

Morris, Charles E. 2002. Best Practices for Allergen Control. Food Engineering. March.

Moss, Maurice. 2002. Toxigenic Fungi. In Foodborne Pathogens: Hazards, Risk Analysis and Control edited by Clive de W. Blackburn and Peter J.
McClure. Woodhead Publishing Limited and CRC Press LLC. Boca Raton, FL.

Moulton, Curtis J. 1992. Reducing Pesticide Residues in Food. Food Safety and Quality. June.

Muth, Mary K., Shawn A. Karns, and Donald W. Anderson. 2001. Analysis of Hazard Analysis Critical Control Point (HACCP) Survey Data. RTI.
Prepared for FDA Center for Food Safety and Applied Nutrition. May.

NFPA/AMI/NTF/NCC/NMA/NAMP/SMA/AAMP. 2000. Meat and Poultry Listeria Reassessment Survey. Presentation provided to ERG by Jenny Scott,
Senior Director, Food Safety Programs, National Food Processors Association, on May 27, 2003.

National Food Processors Association (NFPA). Undated. Industry Position on Control of Listeria Monocytogenes, With Emphasis on Meat and Poultry
Products. National Food Processors Association. www.nfpa-food.org.

Olson, Alan R. 2002. Hard or Sharp Objects. Compendium of Fish, Fishery Product Processes, Hazards, and Controls. October.

Park, Douglas L., Henry Njapau, and E. Boutrif. 1999. Minimizing Risks Posed by Mycotoxins Utilizing the HACCP Concept. Food, Nutrition, and
Agriculture.No. 23.

Riordan, D. C. R., G. M. Sapers, T. R. Hankinson, M. Magee, A. M. Mattrazzo, and B. A. Annous. 2001. A Study of U.S. Orchards To Identify Potential
Sources of Escherichia coli O157:H7. Journal of Food Protection. Vol. 64, No. 9: 1320-1327.
Stier, Richard F. 2001. Foreign Materials in Foods: Are They Really Dangerous? Market Pulse.

Stopforth, J.D., J. Samelis, J. N. Sofos, P. A. Kendall , and G. C. Smith.. 2002. Biofilm Formation by Acid-Adapted and Nonadapted Listeria
monocytogenesin Fresh Beef Decontamination Washings and Its Subsequent Inactivation with Sanitizers. Journal of Food Protection. Vol. 65, No. 11:
1717-1727.

Suttajit, Maitree. 1989. Prevention and Control of Mycotoxins. Mycotoxin Prevention and Control in Foodgrains.

Tilden, John Jr., Wallace Young, Ann-Marie McNamara, Carl Custer, Barbara Boesel, Mary Ann Lambert-Fair, Jesse Majkowski, Dur Vaga, S. B.
Werner, Jill Hollingsworth, and J. Glenn Morris. 2002. A New Route of Transmission for Escherichia coli: Infection from Dry Fermented
Salami. American Journal of Public Health. Vol. 85, No. 8: 1142-1145.

Tompkin, R.B. 2002. Control of Listeria monocytogenes in the Food Processing Environment. Journal of Food Protection. Vol. 65, No. 4: 709-725.

Tybor, Phillip T., William C. Hurst, A. Estes Reynolds, and George A. Schuler. 1990. Preventing Chemical Foodborne Illness. The University of
Georgia College of Agricultural and Environmental Sciences Cooperative Extension Service. November. http://www.ces.uga.edu/pubcd/b1042-w.html.

Wallin, P., and P. Haycock. 1998. Good Manufacturing Practice (GMP). In Foreign Body Prevention, Detection, and Control. Blackie Academic and
Professional, London.

Page Last Updated: 09/27/2015 

 GMPs - Section Three: Previous Surveys of Manufacturing
Practices in the Food Industry
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In the last few years, a number of surveys have evaluated the state of current manufacturing practices in the food industry. Although most of these
surveys are limited in scope, the combined data may assist FDA in identifying various areas of concern and in supporting its own findings regarding
food safety practices of the industry. For example, results from several of the surveys indicate that small manufacturers are less likely to have certain
food safety practices in place than larger manufacturers. The importance of employee training also appears to be a common theme in some of the
survey results.

Table 3-1 summarizes the characteristics of eight industry surveys identified, including survey mode, sample size, and response rate. The following
sections discuss the findings of each survey in more detail.

3.1 Meat and Poultry Listeria Reassessment Survey

The Meat and Poultry Listeria Reassessment Survey was designed to determine the industry response to a 1999 Federal Register (FR) Notice
requesting that meat and poultry plants reassess their Hazard Analysis and Critical Control Point (HACCP) plans for Listeria monocytogenes (Lm)
contamination control (Federal Register 64, 1999). The survey was sponsored by the American Association of Meat Processors (AMI), National
Chicken Council (NCI), National Meat Association (NMA), North American Meat Processors (NAMP), American Meat Institute (AMI), National Food
Processors Association (NFPA), and National Turkey Federation (NTF), whose members answered a three-page questionnaire on their response to
the 1999 FR Notice. Survey respondents included mostly small or very small establishments. Only one-third of the survey respondents were large
establishments.

Survey results showed that almost all establishments (98 percent) responded to the 1999 FR notice with a reassessment of their HACCP plans
for Lm contamination control. More than a third of the responding plants indicated adding critical control points. In addition, roughly two-thirds of plants
reported having end-product testing programs for Lm and almost all plants (90 percent) reported using environmental testing. Among all responding
plants, very small plants conducted the least testing.
 Table 3-1: Industry Surveys of Manufacturing Practices

  Response
Year Mode Sample Frame Rate

Meat and Poultry Listeria Reassessment Survey 2000 Mail Trade group member companies 91%
(NFPA et al., 2000) (277/303)

Evaluation Report Listeria  Reassessment 2000 Email 30 Randomly selected large and NA

(USDA/FSIS, 2000) small food plants

Food Processing 2002 Manufacturing Trends 2002 Email Readers NA

Survey (Ennen, 2002) l

Food Processing 2003 Manufacturing Trends 2003 Email Readers NA

Survey (Ennen, 2003)

Food Processing 2004 Manufacturing Trends 2004 Email 149 Readers from circulation list NA
Survey (Fusaro, 2004)

3  Annual Best Manufacturing Practices Survey

rd
2002 Mail Readers 13%
(Gregerson, 2002) (130/1,000)

2  Annual Best Manufacturing Practices Survey

nd
2001 Mail Readers 13%
(Morris, 2001b) (132/1,000)
 Table 3-1: Industry Surveys of Manufacturing Practices

  Response
Year Mode Sample Frame Rate

1  Annual Best Manufacturing Practices Survey

st
2000 Mail Readers 11%
(Morris, 2000a) (112/1,000)

A Survey of Automation Practices in the Food 2001 Mail U.S. food manufacturers (as well 54% (27/50)
Industry (Ilyukhin et al., 2001a) as system integrators and
equipment suppliers)

A Survey of Control System Validation Practices in 2001 Mail U.S. food manufacturers (as well 54% (27/50)
the Food Industry (Ilyukhin et al., 2001b) as system integrators and
equipment suppliers)

A Survey on the Use of Computer-Integrated 1989 Mail Food processing companies in 32% (31/98)
Manufacturing in Food Processing Companies (Aly, central California
1989)

FDA HACCP Survey (Muth et al., 2001) 2001 Mail/phon U.S. food manufacturers and 32%
e repackagers (595/1,142)

Survey of Practices of Maryland Cider Producers 1999 Mail U.S. cider producers 100%
(Senkel et al., 1999) (11/11)
Survey results also showed that the majority of plants respond in some way when environmental testing limits are exceeded, most commonly by
intensifying sanitation. Overall, while most manufacturers had appropriate programs in place prior to the reassessment, many refined their programs
as part of reassessment.

3.2 Listeria Reassessment--Evaluation Report

The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) also conducted a short study of 30 randomly
selected large and small plants to investigate activities undertaken in response to the 1999 FR Notice. For the study, FSIS supervisory inspection
personnel were questioned by email regarding the actions of plants they inspected.

All 30 of the large and small establishments sampled reviewed their HACCP plans in response to the notice, discussed the notice with plant personnel,
and documented their reassessment in their hazard analyses. Approximately three-fourths of the establishments modified their HACCP plans. Of
these, half of the plants added or modified critical control points in their HACCP plans, a third added or modified verification activities, and one-fourth
added or modified corrective actions. Establishments also viewed Lm as a sanitation issue, with about two-thirds of the establishments reviewing their
sanitation standard operating procedures (SSOP) programs.

Outside of HACCP and SSOP plans, almost half of plants had taken actions in response to the 1999 FR Notice, such as training, product or
environmental testing, adding sanitizers, developing abatement programs, adding floor foamers and citric acid, modifying packaging rooms, adding
footbaths, increasing handwashing, providing special clothes, conducting repairs to improve sanitation, doing new construction, and increasing anti-
microbial additives. According to the survey, approximately two-thirds of the establishments conduct some form of environmental testing at a minimum
on a weekly basis. Fewer than two-thirds typically conduct product testing once per quarter.

3.3 Food Processing Magazine's Annual Manufacturing Trends Survey

Each year, Food Processing magazine surveys food manufacturing professionals regarding their beliefs about important upcoming issues in the
industry and plans for the following year. We reviewed the last three surveys available.
In the 2002 and 2003 surveys, food safety was the top and growing concern, with the events of September 11 having accelerated these concerns. The
2002 survey did not cover many food safety practices, but reported that many of the respondents were increasing security at their plants by securing
physical facilities and improving employee identification and surveillance. In 2003, improving security was also a top concern, with 78 percent intent on
improving facility security. Roughly half of those surveyed have added surveillance initiatives and increased background checks during that year. In
addition, while the majority of respondents reported responding to the current food safety concern with employee training, roughly three-quarters
indicated an intent to either institute a HACCP plan or modify their existing HACCP plan. More than half of the respondents indicated that their
companies planned to improve pest control and that they have augmented or will be augmenting, sanitation equipment.

In the 2004 survey, food safety continued to be the top concern for manufacturers. Almost all respondents reported that they would take additional
steps to improve food safety, with the majority of respondents mentioning training as the most important factor in improving sanitation. Many
respondents also mentioned HACCP programs and improved pest control. Sanitary equipment and rapid microbial detection systems were mentioned
less frequently, but many manufacturers use them. Other steps undertaken by food processors to improve food safety included reevaluation of HACCP
programs (6.8 percent), improved traceback to suppliers (3.5 percent), bioterrorism training (3.4 percent), and more metal detection (2.7 percent).

3.4 Food Engineering Magazine's Annual Best Manufacturing Practices Surveys

Each year, Food Engineering magazine surveys its readership to determine current best manufacturing practices. We reviewed the last three surveys
available.

Overall, survey results were very similar from year to year. An analysis of survey responses showed that supervised on-the-job training is the most
widely used training method in the industry. Other popular methods included onsite classroom training, vendor training programs, and cross-training in
various skills. The number of plants practicing reactive maintenance is relatively high across all survey years, oscillating between slightly less than and
somewhat more than one-third from year to year. In all years, however, the majority of plants surveyed applied preventive or predictive maintenance
programs. In 2000, survey results indicate that HACCP has been voluntarily implemented in more than two-thirds of plants in each industry segment
other than meat and poultry, in which HACCP is mandated. However, fewer than 10 percent of plants with HACCP programs had people appointed to
manage the HACCP plans; half the plants that did have such managers were meat processors.
The 2002 survey also asked respondents to comment on the efficacy of the practices in use, in addition to providing information on best practices. As
might be expected, most respondents (84 percent) characterized their reactive maintenance programs as inefficient. Meanwhile, more than half (56
percent) of those practicing routine preventive maintenance considered their programs efficient. While anti-microbial treatments and rapid microbial
detection systems were not frequently used, plants that used these systems rated them very highly. HACCP programs were rated as very useful,
although less so than anti-microbial treatments and rapid microbial detection systems. Few of those employing voluntary HACCP programs expressed
disappointment with the programs (2 percent compared to 14 percent of those that implemented mandated HACCP programs). Contrary to other
findings, training was only found to be very useful by one-third of plants using it to improve food safety. On the other hand, sanitary equipment was
found to be very useful by more than half of plants that recently added such equipment to their locations.

3.5 A Survey of Control System Validation Practices in the Food Industry

Digital control systems, which have increased in use in recent years, require proper validation to prevent serious failures. Ilyukin et al. (2001a)
attempted to determine who conducts control system validation at food manufacturing plants and how it is done with an industry survey.

While validation of control systems should be part of a good manufacturing practice program, less than a third of food plants responding to the survey
considered themselves responsible for control system validation. The majority of food plants surveyed delegated this responsibility to a third party,
such as an equipment supplier, system integrator, or consulting firm. While most food plants that reported not having validation plans would like to
establish such plans, up to a quarter indicated that they would never develop them.

Moreover, less than a fifth of food plants reported requesting validation records from the third-party who conducted the validation. Most equipment
suppliers and system integrators reported keeping these records and could provide them to their customers. Slightly more than 10 percent of food
manufacturers generated and kept validation records themselves. Training on control systems was conducted either by manufacturers (29 percent) or
by third-party firms. Roughly one-third of plants surveyed had formal control system maintenance plans in place, and the rest had informal plans.

3.6 Automation Practices in the Food Industry

Ilyukhin et al. (2001b) conducted a survey of food manufacturers, system integrators, and equipment suppliers to determine the state of automation
practices in the food industry. The majority (59 percent) of food manufacturers reported that their plants were mostly automated. Ilyukhin (2001b) found
that the level of automation was correlated with annual production. Almost all plants with smaller annual production volumes reported a desire to
increase automation. The biggest obstacles to automation reported were time and cost.

The level of automation varied by operation. Among the responding plants, processing was automated at 94 percent of food manufacturing operations
and packaging was automated at 82 percent. Automation was used in less than half of the plants surveyed for raw material processing, post process
handling and inspection, and warehousing and storage. The type of automation used (type of processor, software, sensors, transmission technology,
etc.) varied widely. Almost a quarter of food manufacturing plants used computer integrated manufacturing for HACCP.

3.7 Survey on the Use of Computer-Integrated Manufacturing in Food Processing Companies

Aly (1989) conducted a survey of 98 food processing companies located between Sacramento and Fresno in central California. The questions in the
survey addressed eight key computer-integrated manufacturing (CIM) functions, namely accounting, production planning, distribution management,
computer-aided manufacturing, quality control, materials handling, maintenance scheduling, and design.

Of the CIM functions surveyed, the three most commonly used were accounting (98.6 percent), production planning (77.4 percent), and distribution
management (45.2 percent; this category includes such functions as order processing, sales inventory, shipping, and invoicing). Computer-aided
manufacturing was used by less than half of companies, with most using it to monitor package weights. A very small number used robots. Further,
while the percentage using CIM in quality control was small, more use of this CIM function is expected in this area in the future due to current
emphasis on quality. Only a small minority use the other CIM functions surveyed. Aside from the eight functions addressed in the survey, CIM
functions used by a small number of survey participants included engineering, scheduling, and process control. Survey results also indicated that 66.7
percent of companies not currently using CIM in their plants are considering use of CIM in the future. Cost has been an obstacle for the majority of
companies.

3.8 FDA HACCP Survey

In 1998, FDA conducted an industry survey to determine HACCP practices of food manufacturing facilities in six FDA-regulated industries. For the
survey, each of the six industries was further stratified into large and small plants. Plants were contacted by phone and asked questions about their
HACCP plans (including training, planning, and implementation), the level of documentation of sanitation practices and procedures, performance of
microbiological testing and other monitoring practices, and verification of specific sanitation procedures such as pasteurization.

The survey found significant differences between small and large plants. In general, large plants were more likely to have HACCP practices, sanitation
processes, or other food safety procedures in place than small plants. HACCP training was also more likely in large plants. In plants that conduct
HACCP training, managers and quality control personnel were the most often trained, but production workers were also trained in over half of plants.
Training was most often administered by an industry trade group. Surveys results also indicated that large plants are more likely to be familiar with
HACCP than small ones. At the time the survey was conducted (1998), more than half of the plants surveyed had not implemented HACCP and had
no intention to do so if not required by FDA. Overall, about 76 percent of plants had written sanitation programs and 78 percent had written records
that verified sanitation inspections. Small plants were unlikely to have these systems in place.

3.9 Survey of Maryland Cider Producer Practices

In 1999, Senkel et al. (1999) conducted a survey to evaluate the manufacturing practices of Maryland cider producers. Eleven cider producers were
mailed a survey, which included questions about raw material sourcing and sanitation controls. Cider producers were then invited to a training program
focused on E. coli contamination, HACCP, sanitation procedures, and GMPs.

The survey indicated that the majority of cider producers purchase some or all of their apples from neighboring states. A few make use of windfall
apples, using only washers/scrubbers to clean them. While many (7 out of 11 producers) reported washing and brushing apples only prior to milling, a
few also reported sanitizing apples after cleaning and before milling. Most producers reported using the traditional hydraulic press with rack and cloths.
A few producers use preservatives, but only one reported pasteurizing the cider. None allow fermentation of the cider before distribution or sale and
almost all refrigerate the finished product at temperatures between 0.6 and 7.2 Celsius. While all producers reported washing and sanitizing
equipment, a few did not always sanitize equipment between uses.
Evaluation after the training program indicated that producers implemented controls from the HACCP plans, but did not adapt any GMPs, or SSOPs,
or keep any monitoring records. While none of the major pathogens were found in in-line samples, generic E. coli was found. Given that the generic E.
coli was not found on the raw materials, in-plant processing contamination likely occurred, indicating a need for GMPs and SSOPs in addition to
HACCP controls to ensure product safety.

References

Aly, Nael A. 1989. A Survey on the Use of Computer-Integrated Manufacturing in Food Processing Companies. Food Technology. March 1989.

Ennen, Steve. 2002. Food Security. Food Processing. February 2002.

Ennen, Steve. 2003. Safety Tops Concerns for Coming Year. Food Processing. January 1.

Federal Register 64. 1999. 9 CFR Parts 416 and 417: Listeria Monocytogenes Contamination of Ready to Eat Products. Food Safety and Inspection
Service, U.S. Department of Agriculture. Federal Register 64 (101). May 26, Wednesday.

Fusaro, Dave. 2004. Annual Manufacturing Trends Survey: Manufacturing Concerns for a Scary New World. Food Processing. January 12.

Ilyukhin, Sasha V., Timothy A. Haley, and Rakesh K. Singh. 2001a. A Survey of Automation Practices in the Food Industry. Food Control.Vol. 12: 285-
296.

Ilyukhin, Sasha V., Timothy A. Haley, and Rakesh K. Singh. 2001b. A Survey of Control System Validation Practices in the Food Industry.Food
Control. Vol. 12: 297-304.

Morris, Charles E. 2002. 3rd Annual Best Manufacturing Practices Survey. Food Engineering. February 2.
Morris, Charles E. 2000. Best Manufacturing Practices. Food Engineering. February 1.

Morris, Charles E. 2001. Best Manufacturing Practices. Food Engineering. February.

Muth, Mary K., Shawn A. Karns, and Donald W. Anderson. 2001. Analysis of Hazard Analysis Critical Control Point (HACCP) Survey Data. RTI.
Prepared for FDA Center for Food Safety and Applied Nutrition. July.

NFPA/AMI/NTF/NCC/NMA/NAMP/SMA/AAMP. 2000. Meat and Poultry Listeria Reassessment Survey. Presentation provided to ERG by Jenny Scott,
Senior Director, Food Safety Programs, National Food Processors Association (NFPA) on May 27, 2003.

Senkel, I. Arthur, Robin A. Henderson, Beverly Jolbitado, and Jianghong Meng. 1999. Use of Hazard Analysis Critical Control Point and Alternative
Treatments in the Production of Apple Cider. Journal of Food Protection. Vol. 62: 778-785.

USDA/FSIS. 2000. Evaluation Report Listeria Reassessment. http://www.fsis.usda.gov/OPPDE/PEIS/Reports/OPPDE/Listeria_Re.htm.

Current Good Manufacturing Practices (CGMPs)

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 GMPs - Section Four: Common Food Safety Problems in the U.S.
Food Processing Industry: A Delphi Study
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To improve understanding of the current state of food safety hazards at food processing facilities, ERG conducted an expert elicitation. The study had
two primary objectives:
1. To identify the main problems that pose microbiological (i.e., pathogenic bacteria, viruses, and parasites), chemical (i.e., allergens, cleaners
and solvents, and mycotoxins), and/or physical (i.e., foreign objects such as glass and metal) safety hazards to food at the processor level, and

2. To determine the preventive controls and/or corrective actions that food manufacturers should implement to address each of the problems
identified.

Such information helps identify those sectors where the processor-level problems are of high importance for public health. Further, the information on
the effectiveness of preventive controls may help identify the most effective GMP requirements.

4.1      Methodology

The study objectives posited above require gathering current data not accurately known or available. Moreover, they do not easily lend themselves to
more precise analytical techniques, such as an industry survey designed to yield statistically valid estimates of population parameters. The necessary
information, however, can be gathered using the subjective judgments of experts on a collective basis (Linstone and Turoff, 2002). Thus, this study
uses a modified three-round Delphi technique widely applied in the forecasting and policy arenas.

A successful application of the technique requires assembling a panel, preferably consisting of 15 or more individuals who are considered "experts" in
the given field of investigation. Thus, with guidance from the CFSAN Working Group, ERG assembled a 15-member panel comprising nationally
recognized experts in food safety, HACCP, food plant sanitation, quality systems, process optimization, GMP compliance, and food microbiology (see
Table 4-1).[1] On average, each individual panel member possessed over 30 years of food industry experience in various sectors, such as canned
foods, fresh produce, meat and poultry products, and seafood. Further, most of these individuals have served and/or are currently serving on
numerous national committees related to food safety, HACCP, and GMPs.

4.2      Results
Like most Delphi studies, our study consisted of three Delphi rounds in which the collective responses of the panel were revealed to each individual
prior to the commencement of the next round. The following sections summarize the findings from each of the Delphi rounds, highlighting key findings.
As a modified fourth round, ERG and FDA also conducted two post-study discussions with select experts from the panel to review the findings of the
study and obtain recommendations for the effort to modernize food GMPs. Section 4.2.4 summarizes the results from these discussions.

4.2.1   Round 1 Results

In the initial Delphi round, we provided our expert panel with a list of food safety problems previously identified through our literature review and
through discussions with the FDA Food GMP Modernization Working Group and select expert panel members. We then asked each panel member (1)
to indicate the food sectors to which the listed problem is mainly applicable and (2) to add to the food safety problem list if necessary. Only one
individual expanded our list of food safety problems, adding "lack of chemical control programs" and "lack of allergen control programs." This lends
support to the comprehensiveness of our original food safety problem list. Other main findings (see Table 4-2) based on the tabulation of responses to
this question (Q1) include the following:

 Refrigerated and meat and poultry products are the two main sectors to which the majority of the food safety problems are applicable.

 While some problems, such as "deficient employee training," "poor plant and equipment sanitation," "contamination of raw materials," and
"poor plant design and construction," are applicable to all food sectors, other problems, such as "biofilms," "condensate on pipes and other
equipment," and "stagnant water due to dead ends in plumbing," are more sector-specific. For example, biofilms are more of a concern for the
refrigerated, frozen, and dairy sectors.

 The relative importance of a given food safety problem (measured by the number of votes received) varies by sector. The top-rated food safety
problems by sector include (see Table 4-2, highlighted cells):
o "Incorrect labeling or packaging" and "poor plant and equipment sanitation" for baked goods;

o "Deficient employee training" and "biofilms" for dairy products;

o "Deficient employee training" and "poor plant and equipment sanitation" for frozen products;
 o "Deficient employee training" and "condensate on pipes and other equipment" for refrigerated products;

o "Poor plant and equipment sanitation" for shelf-stable foods;

o "Poor plant and equipment sanitation" for meat and poultry products.

In this round, we also asked experts to select from the list provided (Q2) the ten most important food safety problems facing food manufacturers today
based on the frequency and severity of the problems. Experts were directed not to include those problems that (1) are solely applicable to meat and
poultry or (2) might be applicable to other food categories but whose importance is mainly driven by their frequency and severity in meat and poultry.
Table 4-3 presents the ranking of food safety problems by number of votes. Interestingly, those problems identified as having broad applicability
across all food sectors (i.e., "deficient employee training," "contamination of raw materials," "poor plant and equipment sanitation," and "poor plant
design and construction") in the previous question ranked at the top of our top ten food safety problems list. The finding affirms, at least partially, the
internal validity of our Delphi design. [2]

4.2.2   Round 2 Results

The objective of the second Delphi round (Q3) was to determine whether each of the top ten problems identified in the previous round posed a
sufficiently different food safety risk for a particular food item (e.g., pies) within a major food category (e.g., baked goods) than the risk for the major
food category as a whole.[3] Thus, we asked the expert panel members to indicate whether a separate risk score is more appropriate for a listed food
item within a major food category for each of the ten food safety problems. To ensure consistency of responses and also make it possible to use
related data, such as unit sales, we included a list of IRI product categories for each food sector from which experts were asked to select. [4] An all-
capture subcategory titled "All other" was also included within each food sector to ensure comprehensiveness.

Table 4-4 provides the list of food items (by food sector and food safety problem) that the panel members indicated as requiring separate risk scores.
Overall, the number of food subsectors selected across the food sectors was lowest for shelf-stable foods. The refrigerated, frozen, and dairy sectors,
however, had the highest number of subsectors selected for scoring in the next round. Overall, given the different areas of expertise of individual panel
members, the number of food items (i.e., subsectors) within each food sector identified as meriting a separate risk score was extensive. The total
number of categories for the panel members to score for "general" as well as "allergen" risks by facility size ranged from 70 to over 100 across the ten
food safety problems. This substantially increased the respondent burden in the subsequent round.

4.2.3   Round 3 Results

The primary objectives of the third Delphi round were (1) to assess the risk posed by each of the top ten food safety problems by food sector and
facility size and (2) to determine the types of preventive controls and/or corrective actions necessary to address each of these problems by food sector
and facility size. Therefore, we asked our expert panel members to assign a "general" as well as an "allergen" risk score from 1 to 4 based on the
problem's frequency and severity by food sector and facility size (Q4). We further instructed our panel that:

 The "general" risk score assigned should reflect the risk of the food safety problem with respect to all hazards (i.e., microbiological, physical,
and chemical) except for allergens

 The "allergen" score should reflect the risk of the food safety problem with respect to allergens only.

To ensure consistency of responses, we requested that risk scores be assigned according to the scheme outlined in Table 4-5 below. Thus, each
individual expert first had to assess whether the problem occurred at a high or low frequency in the specified food sector (i.e., how widespread the
problem is) and then to evaluate whether the probability that food could be rendered unsafe due to the problem was high or low (i.e., assess the
severity of potential consequences of the problem) given the typical practices of a manufacturer that experiences the problem. We also directed the
panel members to skip those categories to which they thought the food safety problem did not apply or that were not relevant to "general" or "allergen"
hazards.[5]

Table 4-5: Risk Scoring Grid

Frequency Severity
High Low
High 4 2
Low 3 1
Because of the number of food sectors that individuals had to score, data generated from this question were voluminous (over 77,000 observations). A
cursory analysis of the risk score data leads to the following observations:
 Overall, the general and allergen risk scores for small and medium-sized facilities are higher than those of large ones across all problems and
food sectors.

 Problems that have received the highest general risk scores (2.75 or higher) include "deficient employee training," "poor plant and equipment
sanitation," "difficult-to-clean equipment," "poor employee hygiene," and "contamination of raw materials." The majority of these problems also have
been identified as having broad applicability across sectors in the initial round.

 The problems that have received the highest allergen scores are "incorrect labeling or packaging," followed by "deficient employee training,"
and "difficult-to-clean equipment."

 The general risk scores assigned to the refrigerated food categories tend to be higher than those of other food categories across all problems.
The next highest general risk scores are assigned to frozen and dairy food categories.

Given the degree of overlap among various food safety problems, we expect that some underlying factors, which are smaller than the number of
variables, are mainly responsible for the covariance among our variables. Therefore, we performed an exploratory factor analysis to determine how
many underlying dimensions there are for the risk score data collected. In a nutshell, factor analysis enables one to detect structure in the relationships
between variables as a means of exploring the data for possible data reduction. The method also enables one to test specific hypotheses regarding
the number of underlying dimensions and whether certain variables belong to a given dimension while others belong to another (Kim and Mueller,
1978). A more detailed discussion of factor analysis can be found in Appendix D.

In performing the factor analysis, ERG separated the general risk scores from the allergen risk scores. Next, for each of the ten risk problems, we
calculated an average risk score for each subsector, taking the average over the experts' scores. This reduced the data to 396 observations
(subsectors) for both the general and allergen risk categories, with a total of ten variables (i.e., the average risk scores for each problem). ERG
performed a factor analysis on these two datasets (general and allergen risks) to determine how the information contained in the ten risk problems
could be combined to provide summary information.
The factor analysis technique allows us to generate an overall risk score that combines the information in all of the ten problems. The mean values by
sector for overall risk are presented in Tables 4-6 and 4-7. The mean for all sectors (and subsectors) is centered at zero. Thus, stratifying the average
by sector provides an indication of the relative risk of these sectors. A value that exceeds zero indicates that overall risk in the relevant sector is
greater than average risk.

The overall risk score reflects the results from using a one-factor analysis model. That is, we calculated the relationship between all of the variables
and one underlying factor that we call "overall risk." Factor analysis can also separate the variables into more than one factor. ERG performed a set of
preliminary analyses and determined that both general and allergen risks are best described by a four-factor model. That is, the ten variables can best
be described by four underlying factors.[6] The four factors, however, differ slightly between the general and allergen categories. We named the four
factors in the general category as:

 Process-related contamination risk,

 Equipment risk,

 Quality control risk, and

 Input-related risk.

The four factors in the allergen category were named:

 In-process contamination risk,

 Quality control risk,

 Other contamination risk, and

 Equipment risk.

The names of factors are derived from those variables that contribute the most to the factor values. [7] For example, the "process-related contamination
risk" factor gets its name from the fact that the variables that contribute the most to it are "contamination during processing," "contamination of raw
materials," and "poor employee hygiene." The average scores by sector are presented in Tables 4-6 and 4-7 for each of the four factors. Once again,
values that exceed zero indicate above-average risk.

For comparison's sake, we have also generated the average scores (in standardized form) for each of the ten risk problems presented to the experts
by sector. These are presented in Tables 4-8 and 4-9. We present these as standardized values (i.e., mean centered and zero with a standard
deviation of one) to be comparable to the values presented in Tables 4-6 and 4-7. [8] Once again, values that exceed zero indicate above-average risk.

One way to see the information in Tables 4-6 to 4-9 is as three sets of summaries of risk. The least aggregated form is that of the standardized
average scores presented in Tables 4-8 and 4-9 for the ten risk problems. The four factors presented in Tables 4-6 and 4-7 aggregate the information
from the ten risk problems to four summary measures. Finally, the overall risk factor summarizes the four risk factors, or the ten risk problems, into one
measure for each sector. The data on the ten risk problems generate a broad picture of the problems in each sector. The one- and four-factor models,
however, account for correlations among the ten risk problem scores to generate summary measures.

After the assignment of risk scores, we asked our expert panel to consider the types of preventive controls and/or corrective actions that food
processors need to address each of the ten food safety problems by facility size (Q5). [9] While large food processors might have the capital to invest in
more sophisticated technologies, small processors are likely to face resource constraints, making such technologies infeasible. Therefore, we
instructed our experts to take account of cost-effectiveness when making recommendations on the types of controls/actions by size of food processor
and main food sector (i.e., baked goods, dairy, frozen, refrigerated, and shelf-stable). [10]

Although the experts interviewed for the pilot indicated the need for size-specific preventive controls, a review of responses indicates that the majority
did not, in fact, differentiate by facility size in their preventive control recommendations. Some even explicitly noted that facility size should not be a
factor. Additionally, for some problems, experts did not feel that it was important to differentiate by food sector, hence applying the same set of
preventive controls to all major food sectors for the problem in question. A minority of experts assigned different preventive controls to a minority of
food subsectors.
Table 4-10 provides the complete set of preventive control recommendations for the top four food safety problems with broad applicability across all
food sectors, mainly "deficient employee training," "contamination of raw materials," "poor plant and equipment sanitation," and "poor plant design and
construction." Some of the recurring themes from the table are:

 Ongoing and targeted training on issues such as allergen control, cleaning and sanitation procedures, incoming ingredient receipt protocol, and
monitoring,

 Training of employees, management, and suppliers,

 Evaluation of training effectiveness and establishment of accountability,

 Validation of cleaning through testing (e.g., swabs, organoleptic evaluations, and bioluminescence tests),

 Periodic audits and inspections of facility and raw material suppliers either in-house or by third-party firms, and

 Documentation of training activities, raw material handling policies and activities, cleaning and sanitation, receiving records, and use of sign-off
logs.

Tables 4-11 through 4-12 present the preventive control recommendations for the remaining six food safety problems, "contamination during
processing," "poor employee hygiene," "difficult-to-clean equipment," "post-process contamination at manufacturing plant," "incorrect labeling and
packaging," and "no preventive maintenance." Interestingly, for majority of these problems, some experts indicated implementing GMPs and/or
HACCP. The finding indicates that there are two dimensions to some of the processor-level problems, such as "contamination during processing,"
"poor employee hygiene," and "difficult-to-clean equipment." Food safety hazards may arise due to the lack of GMPs (i.e., plain noncompliance),
through ineffective application of GMPs (i.e., deficient employee training programs), or through a combination of both.

Some experts also indicated a need for clearly defined GMP expectations for such problems as "incorrect labeling and packaging," "poor plant design
and construction," and "no preventive maintenance." Ambiguities in the definitions in the food GMPs may lead to ill-defined expectations at the
processor level. The same issue was also brought up during our discussions with select experts during the study pilot, as well as post-study
discussions.
Across the ten food safety problems, the most frequently mentioned preventive controls include training (in-house or by outside consultants) and third-
party or in-house audits of GMPs, HACCP, SSOPs, and quality programs, and implementation of HACCP and SSOPs (see Table 4-13). Other
commonly noted problem-specific preventive controls were:

 Supplier audits and supplier certification programs for raw material contamination problems,

 Plant design reconfiguration and use of outside consultants for plant design, better sanitation, and improved flow and access to equipment for
poor plant design and construction problems,

 SSOPs and environmental sampling and other monitoring for difficult-to-clean equipment problems,

 Use of preventive maintenance programs and documentation for deficiencies in preventive maintenance and assignment of accountability for
contamination during processing problems,

 Environmental sampling, proper implementation of SSOPs, institution of HACCP, and product and process flow controls for post-process
contamination problems, and

Label review and verification for incorrect labeling or packaging problems.

As noted previously, institution of certain types of records, such as training activities, raw material handling policies and activities, cleaning and
sanitation, and receiving records, is one of the recurring themes in the preventive control recommendations of experts. Table 4-14 presents the
frequency of the various types of records recommended as preventive controls. As the table shows, the most frequently mentioned record types
include cleaning and sanitation related records (87 percent) and equipment maintenance records (73 percent), followed by supplier audit records (67
percent) and personnel records (60 percent). Other types of records indicated by some experts as preventive controls include raw material/ingredient
records, labeling and packaging records, warehousing/inventory/storage records, and corrective action documentation.
4.2.4   Post-Study Discussions with Select Experts
To review the findings of the Delphi study and discuss suggestions for improvements with respect to food GMPs, ERG and FDA conducted two post-
study meetings with four experts from the panel. The meetings were held on May 5 th and May 26th, 2004, at FDA's Center for Food Safety and Applied
Nutrition in College Park, Maryland.

Charlie Cook and Cameron Hackney were the food safety experts invited to the May 5 th meeting. Cook is an independent consultant who has served in
the food industry for 55 years. Throughout these years in the food industry, he has directed product and process development, quality management,
regulatory compliance, food safety, and product crisis activities. Hackney is Dean of the Davis College of Agriculture, Forestry, and Consumer
Sciences at West Virginia University and has extensive experience in food microbiology, dairy processing, and food toxicology.

C. Dee Clingman and Donn Ward were the food safety experts invited to the May 26 th meeting. Clingman is President of CDC Global Quality and
Safety and was the Vice President of Quality Assurance of Darden Restaurants for 21 years. Ward is the Associate Head of the Science Department
at North Carolina State University and has served in various organizations striving for improvements in food safety, including the Seafood HACCP
Alliance Curriculum Development Committee and the NSF International Food Safety Advisory Council.

While many issues relevant to food GMPs were covered during the two meetings, some main themes emerged from these discussions. Most experts
agreed that the food GMP modernization effort should not be sector-specific and should be focused on addressing a few important issues. These
included the following:

 Improved, documented training with a minimum set of universal requirements,

 Recordkeeping in a few important areas, especially process control,

 Allergen control, with documented allergen control programs, including training and label review,

 Use of a guidance document to achieve compliance,

 Adding components of HACCP, such as controls, verification, and corrective action, and
 Positive incentive programs to encourage compliance.

These topics, as well as other points that were raised during the meetings, are discussed in detail below.

Training. The most frequently discussed topic during both meetings was training. All experts thought that training should be improved at food facilities.
Most also concurred that training tends to be worse at small facilities. Nonetheless, Clingman noted management at large facilities are under the
impression that there is nothing new to learn, which is problematic as well. Opinion on the length and frequency of training varied, but experts agreed
that it should be tailored to the job of the employee. Cook suggested a one-time training session of 6 to 8 hours and 20 minutes of continuous training
on a weekly basis. Hackney considered 2 days of training sufficient. Other specific recommendations for training mentioned by several experts
included:

 Developing a minimum set of requirements (e.g., Ward mentioned identifying the important areas for training, those that have a direct impact
on food safety) without being overly prescriptive or trying to differentiate by sector,

 Requiring documentation that shows that training took place,

 Requiring trainer certification,

 Requiring written SOPs for training (for consistency and inspection purposes), and

 Requiring training in allergens (only mentioned during first meeting).

Although some of the experts recommended manager training, Cook felt that top-level management would not have the time to commit to training.
Cook emphasized that training needs to be highly visual, live, and ongoing. Clingman also mentioned the effectiveness of pocket-sized 3x5 cards in
training, which can serve as constant reminders of key principles. While experts noted that these are effective methods, the consensus was that
training should be adapted to the needs of each company and left to the manufacturer to customize. For example, Clingman noted that small plants
would require different training from large plants. Certification of training programs by FDA was also mentioned as a possible option during the first
meeting.
Recordkeeping. Another theme at both meetings was the importance of recordkeeping. Experts agreed that records are important in ensuring food
safety outcomes, especially with respect to ensuring that the documented activities actually took place. These records include SOPs and
documentation that SOPs were followed. Ward also noted the importance of SOPs in ensuring consistency of training.

Cook mentioned the importance of risk-based records. In his experience, when plants are overwhelmed by paperwork, they are more likely to fabricate
records. He added that while SOPs are needed, they should not be punitive. In other words, firms should not be fined if they do not adhere to SOPs
exactly as written. He also noted that the most critical records are process control records (e.g., water temperature).

Clingman mentioned the importance of records that are produced at the time of the activity versus those created after the activity has taken place. He
noted that such post-activity records are not effective for ensuring that the activity occurs as intended.

Allergen control. Allergen training was discussed in detail in the first meeting. Cook and Hackney agreed that allergens are a very important issue and
that training in this area is severely lacking. Records found to be critical for allergen control include label review records, letters of guarantee for raw
materials, and a documented allergen control program, with training as the main component..

Both experts felt that a label review process would increase food safety, especially with respect to allergens. A requirement for a label review could be
added to the processes and controls section of the food GMPs; it would detail how to match up the formula of the product to the ingredients stated on
the label. Both experts emphasized that the label review process must be managed internally. According to Cook, medium to large plants currently
conduct label reviews, whereas small plants typically do not. Hackney briefly discussed rework as another issue that should be addressed in GMPs
with respect to allergen control.

Development of a guidance document. There was discussion at both meetings about the development of a guidance document to supplement and
help explain the concepts in the food GMPs. Cook emphasized that manufacturers need clearly defined expectations, which the current food GMPs
are lacking. These, he said, could be provided in a guidance document. Some experts would prefer a guidance document to a regulation because the
former could provide detail not currently available in the food GMPs without becoming too prescriptive. Hackney used the example of the Seafood
Hazard Guide (http://www.cfsan.fda.gov/~comm/haccp4.html) to show that some guidance documents are like regulations in their impact on
manufacturer behavior. Creating a guidance document would not address the issue of enforceability, some meeting participants noted; others argued
that a good guidance document might achieve a better food safety outcome with less resistance from industry. Cook suggested trying a guidance
document first and then developing metrics based on the results, as he thinks there will be major resistance from industry to changing Part 110,
especially with respect to recordkeeping.

Role of HACCP. HACCP was mentioned frequently by experts as being an effective way to ensure food safety. Cook and Clingman both noted that the
increase in the use of HACCP in food manufacturing has increased because large, influential customers require it. Its role in the food GMP
modernization effort is, however, debatable. A few experts liked the idea of a HACCP-based approach to food GMP modernization. During the May
26th meeting, Clingman and Ward suggested taking important pieces of HACCP and incorporating them into a new regulation. Clingman recommended
taking the principles of controls, verification, and corrective action and renaming them as something other than HACCP for the GMP modernization
effort. Both Hackney and Cook noted that GMPs are needed as a base for HACCP, however, and that HACCP cannot substitute for GMPs.

Positive incentive programs. During the second meeting, Clingman brought up the concept of motivating food manufacturers with positive incentives to
improve their practices beyond those dictated by GMPs. He recommended that FDA reward excellent performance instead of standard performance.
As an example, he proposed allowing manufacturers to do self-audits after they have shown exemplary performance for a given period of time. FDA's
own audits of such facilities could be reduced.

Clingman also suggested that FDA could certify an employee at a food manufacturing plant with a role in QA or food safety as an FDA inspector. This
individual could then conduct official FDA inspections and provide documentation to FDA, and the plant could get reevaluated periodically for re-
certification. Certified inspectors might be required to attend an annual meeting for continuing education and other updates. Eventually these
individuals might be asked to conduct inspections in other food manufacturing facilities as well, once their reputation is well established.      Along with
these recommendations, Clingman also mentioned a similar program run by the National Marine Fisheries Services (NMFS) program for certifying
seafood inspectors.

Other topics of discussion. Apart from the above, a few other topics were briefly addressed at these meetings. Pest management briefly came up at
the end of the first meeting. Cook mentioned that manufacturers need to verify that their facilities are pest- and rodent-free and that this should be
specified in a guidance document.
Internal audits and validation were brought up during discussions about recordkeeping in the first meeting. During the second meeting, audits were
discussed in the context of providing a supervisory review. Section 4.2.4.1 provides the experts' recommendations on good examples of minimum
standards.

During both meetings, the effectiveness of FDA inspections was discussed. Suggestions included training inspectors better and ensuring that the
same training is provided to all. All experts noted that small manufacturers have more food safety problems than large manufacturers, with a few
exceptions.

Given the difficulty of managing someone's personal hygiene, Clingman discussed solutions such as special soaps and gloves.

The issue of microbial testing was briefly raised during the second meeting. Ward commented that microbial testing would not be productive given the
number of microbes and viruses that are of concern and the length of time it takes to obtain test results. He also noted that environmental sampling is
conducted at large plants but generally not at small plants due to the expertise and financial investment required. Both Clingman and Ward agreed,
however, that a plant that is visually clean generally does not require environmental testing. Ward commented that environmental testing usually
verifies what you already suspect upon visual inspection. Clingman added that environmental testing is more relevant for certain food sectors than
others.

Imports were raised as issues of concern by Clingman and Cook. No provision on how to modernize food GMPs to address this issue was discussed,
however.

4.2.4.1      Additional Resources Recommended

A few experts recommend further reading for clarification and specifics on some of the topics discussed during the meetings. Most of these are
described or available on the Internet, or were handed out during the meeting, as listed below:
 Basic Standards:
o Supplier Food Safety Guidelines by C. Dee Clingman (handout at 5/26 meeting)
 Training Requirements:
o Seafood HACCP

o Servsafe http://www.nraef.org/servsafe/?flag=lcd&level1_id=6&level2_id=1

o NSF International manual on food safety and quality

expectations http://www.cookandthurber.com/2004_Expectations_Processing_Manual.pdf

 Audits:
o NFPA internal audit document http://www.nfpa-safe.org/docs/NFPA-SAFE_Policies-and-Procedures-Manual.pdf

o Silliker third-party audits http://www.silliker.com/html/auditing_gmps.php

o Pizza Hut third-party audits

 Allergen Control Programs:

o General Mills' and Kraft's SSOP documents for allergen control

4.2.4.2      Current Government Programs of Potential Interest

There are a number of existing government programs that FDA could study while preparing to modernize food GMPs. One type of program uses third
party inspections, thus increasing the oversight of the governing body without incurring additional costs in most cases. An existing program of this
nature is the FDA Center for Devices and Radiological Health Third Party Review Program. Under this program, FDA has accredited persons who are
authorized to review 510(k)s--pre-market notifications for medical devices. Accredited persons conduct these reviews and forward them onto FDA,
which makes a final determination on each application within 30 days. This program has been very successful, speeding up 510(k) reviews by 29
percent. The program has recently been extended to Class II medical devices. More information on the program can be found at Third Party Review .

CDRH has also established a third-party inspection program, which allows accredited persons to inspect eligible manufacturers of Class I or II medical
devices. The manufacturers must meet certain conditions in order to be inspected by an accredited person. More information on this program can be
found at Accredited Persons Inspection Program.
Positive incentive programs were mentioned by Clingman as a potential method for encouraging greater compliance. As noted earlier, NMFS runs one
such program. The Occupational Safety and Health Administration (OSHA) also runs a positive incentive program, called the Voluntary Protection
Program (VPP). Employers have to apply to the program and if they meet VPP requirements, they may join the program. Employers in the program
are inspected regularly to ensure they continue to meet VPP requirements. The frequency of these inspections is reduced the longer the employer
remains in the program, depending on which level of participation they have reached (Star, Merit, or Demonstration). Annual self-evaluations are
required, the results of which are shared with OSHA. More information on the program can be found
at http://www.osha.gov/dcsp/vpp/anniversary.html.

Similar programs are likely to be found at other government agencies. The ones noted above have shown great success and might be of special
interest to FDA.

References

Kim, Jae-on, and Charles W. Mueller. 1978. Introduction to Factor Analysis: What It Is and How to Do It. Sage Publications: Beverly Hills, CA.

Linstone, Harold A., and Murray Turoff. 2002. The Delphi Method: Techniques and Applications. Addison-Wesley: Reading, MA.

 Table 4-1: Expert Panel Members

Expert Name Areas of Expertise
C. Dee Clingman  Provides assistance with HACCP analysis, quality improvement, identifying hazards, and internal training
 Product inspection, product safety, sanitation training and certification, supplier inspections, and quality
assurance audits for restaurants

 Registered Sanitarian
  President of CDC Global Quality & Safety

Peter Cocotas  Developed HACCP plans for fast food restaurants, catering, meat, seafood, canned goods, fresh produce,
beverages, and other products
 Certified as a third party auditor by the NFPA (National Food Processor’s Association) SAFE Program

 Recognized as 3  party auditor by Kroger, Albertson’s, ConAgra, Campbell Soup, C.K.E. Enterprises,
rd

International Packaged Ice Association, Association of Food Industries, McDonald’s, and others

Clifford M. Coles  Contract testing and process assistance for major food companies
 Has several technical publications relating to microbiological and quality control issues in the food industry

Char les Cook  55 years in the food industry

 Directed product and process development, quality management, regulatory compliance, food safety, and
product crisis activities

 Expert witness support in numerous food safety related litigation

 Chaired the AMI-HACCP Task Force

 Currently Adjunct Professor in the Department of Meat and Animal Science at the University of Wisconsin,
Madison, Wisconsin

Cameron Ray  Food microbiology, dairy processing, and food toxicology

Hackney
 Chair of the National Academy of Sciences’ Committee on Use of Scientific Criteria and Performance
Standards for Safe Food

 Several publications on microbiology especially focusing on the seafood industry

 Dean of the Davis College of Agriculture, Forestry and Consumer Sciences, West Virginia University

John Manoush  Low-acid canned foods, such as baked beans

 Provides customized training and technical assistance to food manufacturers implementing HACCP programs
  Assists in design of experiments, statistical process control, vendor and co-packer auditing, sanitation, and
employee training

 Thoroughly knowledgeable in FDA GMPs, low-acid regulations, and AIB guidelines for sanitation and pest
control

 27 years as Manager of Quality and R&D for B&M Baked Beans

 Private consultant

Nancy Nagle  Specializes in produce food safety and good agricultural practices
 Provides expertise in Good Agricultural Practices, HACCP, and processing for the fresh produce industry

 Food Safety Advisor to the California Strawberry Commission

 Co-chair of the scientific task force that developed the "Voluntary Guidelines for Fresh Produce" for the
Western Growers Association and the International Fresh-Cut Produce Association

 Adjunct professor and member of the Industry Advisory Committee for Chapman University, Food Science
Department

Robert Price  Extensive experience in implementing HACCP programs for the seafood industry
 Established the first successful statewide seafood technology program, the Seafood Technology Extension
Program at the University of California Cooperative Extension at Davis

 Helped to implement the first set of federal food regulations geared specifically for the seafood industry;
drafted the strategy for educating industry and inspectors on how to meet the new rules

 Led hundreds of workshops and training courses to educate consumers, industry workers, regulators and
academics about seafood safety and safe seafood processing and handling techniques

 Created the Seafood Network Information Center (SeafoodNIC) at http://seafood.ucdavis.edu, a

clearinghouse of information on seafood research, marketing, product development, news, and more that
receives more than 6,300 hits a month from 40 countries
William Sanders  28 years of experience in the food industry devoted to technical management
 Development of quality control systems, training programs, and gap assessment processes

 Dry cereal, infant foods, frozen foods, low- and high-acid canned foods, milk, milk powders, acidified foods,
pet foods, refrigerated foods, and beverages

 Currently Vice President of Quality Management and Regulatory Affairs at Nestle

Robert Savage  Development of microbiological methods, QC sampling plans, thermal process schedules for low-acid canned
foods, and troubleshooting microbiological problems
 While with FDA, active in the implementation of the first HACCP-based, low-acid canned food regulations,
investigations of botulism outbreaks, product recalls and evaluations and audits of firms’ compliance with FDA
regulations both domestically and overseas

 Leading expert in thermal processing technology

 President, HACCP Consulting Group

Tommy L.  Over 40 years of food safety experience

Shannon
 Led the development of process control, HACCP and auditing as proactive management processes for
quality, food safety, and manufacturing reliability at Campbell Soup Company

 Recognized leader in HACCP development; worked with USDA, FDA, and various trade associations in HACCP
protocol development and implementation

 Participated in HACCP Pilot Plant programs and in training programs for regulatory officials

 Retired as Vice President of Quality Assurance, Campbell Soup Company

 Owns a food safety and quality management consulting practice

William Sperber  Over 30 years of experience in food microbiology

 Member of the National Advisory Committee on Microbiological Criteria for Foods
  Has worked with a number of other committees and associations in the field of food microbiology

 Industry advisor to the U.S. Delegation to the United Nations Codex Committee on Food Hygiene; member of
the Conference for Food Protection, Council III; past chairman and executive committee member of the Food
Microbiology Research Conference

 Senior Corporate Microbiologist at Cargill, Inc.

Richrd Stier  International experience in food safety (HACCP), food plant sanitation, quality systems, process optimization,
GMP compliance, and food microbiology
 Canning, freezing, dehydration, deep-fat frying, aseptic systems, and seafood processing

Donn Ward  Vice chair of the Seafood HACCP Alliance Curriculum Development Committee since 1995
 From 1994 through 2000, vice chair of NSF International’s Food Safety Advisory Council and from 1992
through 1998, member of the National Advisory Committee on Microbiological Criteria in Foods

 Served on the U.S. Delegation to Codex Alimentarius Commission’s Food Hygiene Committee

 Associate Head of the Food Science Department, North Carolina State University

Edmund A.  Extensive industry and consulting experience in food safety, food microbiology, microbial control in food
Zottola processing, sanitation, GMPs, and HACCP
 Published over 100 research articles in refereed J=journals, as well as another 100 general interest
publications including extension bulletins, pamphlets, fact sheets, and articles in trade journals

 Involved with HACCP since 1971, and with GMPs since 1972

 Presented short courses and seminars on research topics given above, food safety, food regulations, HACCP
and GMPs

 Professor emeritus, food microbiology, Department of Food Science and Nutrition, University of Minnesota

 President of Lansi Bay consulting company

  Table 4-2: Summary of Q1 Responses: Applicability of Food Safety Problem by Sector
Food Safety Not a Baked Dairy Frozen Refrigerated Shelf-Stable Meat and Total # of
Problem problem goods poultry Votes w/o
Meat &
Poultry
Poor plant 0 (0%) 10 (63%) 11 (69%) 12 (75%) 14 (88%) 8 (50%) 14 (88%) 55
design and
construction
Deficient 0 (0%) 11 (69%) 13 (81%) 15 (94%) 15 (94%) 11 (69%) 14 (88%) 65
employee
training
Poor employee 0 (0%) 10 (63%) 12 (75%) 13 (81%) 13 (81%) 7 (44%) 13 (81%) 55
hygiene
Difficult-to-clean 0 (0%) 8 (50%) 11 (69%) 10 (63%) 13 (81%) 8 (50%) 13 (81%) 50
equipment
No preventive 1 (6%) 9 (56%) 10 (63%) 10 (63%) 12 (75%) 9 (56%) 11 (69%) 50
maintenance
Contamination 0 (0%) 12 (75%) 11 (69%) 14 (88%) 14 (88%) 10 (63%) 14 (88%) 61
of raw materials
Contamination 0 (0%) 9 (56%) 11 (69%) 13 (81%) 13 (81%) 10 (63%) 13 (81%) 56
during
processing
Post-process 0 (0%) 9 (56%) 10 (63%) 9 (56%) 13 (81%) 9 (56%) 13 (81%) 50
contamination
at
manufacturing
plant
Contamination 1 (6%) 6 (38%) 9 (56%) 7 (44%) 11 (69%) 6 (38%) 12 (75%) 39
by reworked
product
Lack of 7 (44%) 7 (44%) 6 (38%) 7 (44%) 7 (44%) 7 (44%) 8 (50%) 34
equipment parts
reconciliation
after repairs
Lack of crisis 3 (19%) 12 (75%) 12 (75%) 12 (75%) 12 (75%) 12 (75%) 12 (75%) 60
management
protocol
Lack of 4 (25%) 2 (13%) 8 (50%) 4 (25%) 7 (44%) 5 (31%) 7 (44%) 26
knowledge of
welding
standards
Poor pest 2 (13%) 11 (69%) 9 (56%) 10 (63%) 12 (75%) 10 (63%) 10 (63%) 52
control
Lack of 2 (13%) 10 (63%) 9 (56%) 12 (75%) 11 (69%) 11 (69%) 9 (56%) 53
equipment
knowledge
Inadequate 0 (0%) 2 (13%) 10 (63%) 8 (50%) 13 (81%) 4 (25%) 11 (69%) 37
cooling
Biofilms 0 (0%) 4 (25%) 13 (81%) 10 (63%) 12 (75%) 6 (38%) 14 (88%) 45
Use of 6 (38%) 6 (38%) 7 (44%) 5 (31%) 7 (44%) 6 (38%) 7 (44%) 31
unpotable water
Stagnant water 1 (6%) 5 (31%) 12 (75%) 8 (50%) 11 (69%) 10 (63%) 9 (56%) 46
due to dead
ends in
plumbing
Condensate on 0 (0%) 7 (44%) 10 (63%) 11 (69%) 15 (94%) 6 (38%) 12 (75%) 49
pipes and other
equipment
Poor plant and 0 (0%) 13 (81%) 12 (75%) 15 (94%) 14 (88%) 14 (88%) 15 (94%) 68
equipment
sanitation
Inadequate glass 4 (25%) 7 (44%) 8 (50%) 8 (50%) 10 (63%) 11 (69%) 8 (50%) 44
cleanup policy
Lack of product 3 (19%) 11 (69%) 10 (63%) 11 (69%) 11 (69%) 10 (63%) 11 (69%) 53
recovery
protocol
Incorrect 1 (6%) 13 (81%) 9 (56%) 12 (75%) 13 (81%) 11 (69%) 10 (63%) 58
labeling or
packaging
Lack of chemical 0 (0%) 1 (6%) 1 (6%) 1 (6%) 1 (6%) 1 (6%) 1 (6%) 5
control
programs
Lack of allergen 0 (0%) 1 (6%) 1 (6%) 1 (6%) 1 (6%) 1 (6%) 1 (6%) 5
control
programs
Total number of 35   196   235   238   275   203   262   1,147
votes

 Table 4-3: Number of Votes by Food Safety Problem

Food Safety Problem Number of Votes
Deficient employee training 15 (94%)
Contamination of raw materials 12 (75%)
Poor plant and equipment sanitation 12 (75%)
Poor plant design and construction 12 (75%)
No preventive maintenance 11 (69%)
Difficult-to-clean equipment 10 (63%)
Post-process contamination at manufacturing plant 10 (63%)
Contamination during processing 9 (56%)
Poor employee hygiene 9 (56%)
Incorrect labeling or packaging 7 (44%)
Contamination by reworked product 5 (31%)
Inadequate cooling 5 (31%)
Biofilms 4 (25%)
Lack of equipment knowledge 4 (25%)
Not selected 4 (25%)
Poor pest control 4 (25%)
Stagnant water due to dead ends in plumbing 4 (25%)
Condensate on pipes and other equipment 3 (19%)
Lack of crisis management protocol 3 (19%)
Lack of knowledge of welding standards 2 (13%)
Lack of product recovery protocol 2 (13%)
Lack of allergen control programs 1 (6%)
Lack of equipment parts reconciliation after repairs 1 (6%)
Use of unpotable water 1 (6%)

 Table 4-4: Food Subsectors Identified for Risk Scoring by Food Safety Problem
Food Food Subsector Food Safety Problem
Sector Defici Contamin Poor Poor No Difficult- Post- Contamin Poor Incorr
ent ation of Plant Plant Preventi to-Clean Process ation Emplo ect
Emplo Raw and Design ve Equipme Contam During yee Labeli
yee Materials Equip and Mainten nt ination Processin Hygie ng or
Traini ment Constru ance at g ne Packa
ng Sanita ction Manufa ging
tion cturing
Plant
Baked Bakery snacks 1 1     1 1 1 1 1 1
goods English muffins         1          
Fresh bread and 1   1   1 1        
rolls
Pastry/donuts 1 1 1 1 1 1 1 1 1  
Pies/cakes 1 1 1 1 1 1 1 1 1 1
All other 1 1 1 1 1 1 1 1 1 1
Dairy Butter 1     1           1
Cheese 1 1 1 1 1 1 1 1 1 1
Cottage cheese 1 1 1 1 1 1 1 1 1 1
Creams/creamers 1 1 1 1 1 1 1 1   1
Milk 1 1 1 1 1 1 1 1 1 1
Sour cream 1   1 1 1 1 1 1   1
Yogurt 1 1 1 1 1 1 1 1 1 1
All other 1 1 1 1 1 1 1 1 1 1
Frozen Frozen 1 1 1 1 1 1 1 1 1 1
appetizers/snack
rolls
Frozen baked 1 1 1 1 1 1 1 1   1
goods
Frozen breakfast 1 1 1 1 1 1 1 1   1
food
Frozen coffee 1 1 1 1 1 1 1 1    
creamer
Frozen cookies 1 1 1 1 1 1 1 1   1
Frozen corn on       1 1          
the cob
Frozen 1 1 1   1 1   1 1  
desserts/topping
s
Frozen 1 1 1 1 1 1 1 1 1 1
dinners/entrees
Frozen dough 1 1 1 1 1 1 1 1    
 Frozen fruit 1 1 1 1 1 1 1 1    
Frozen novelties 1 1 1 1 1 1 1 1 1 1
Frozen pasta 1 1 1 1 1 1 1 1    
Frozen pies 1 1   1 1 1 1 1 1 1
Frozen pizza 1 1 1   1 1 1 1 1 1
Frozen plain   1 1 1 1 1 1 1    
vegetables
Frozen pot pies 1 1 1 1 1 1 1 1 1 1
Frozen 1   1 1 1          
potatoes/onions
Frozen prepared 1 1 1 1 1 1 1 1 1  
vegetables
Frozen seafood 1 1 1 1 1 1 1 1 1 1
Frozen side 1 1 1 1 1 1 1 1 1 1
dishes
Ice 1 1 1 1 1 1 1 1 1 1
cream/sherbet
Frozen juices 1 1 1 1 1 1 1 1 1  
All other 1 1 1 1 1 1 1 1 1 1
Refriger Baked goods 1 1 1 1 1 1 1 1 1 1
ated Cheesecakes 1 1 1 1 1 1 1 1 1 1
Deli-salads 1 1 1 1 1 1 1 1 1 1
Desserts 1 1 1   1 1 1 1 1 1
Dough/biscuit 1 1 1 1 1 1 1 1 1 1
dough
Egg substitutes 1 1 1 1 1 1 1 1 1 1
Entrée/side 1 1 1 1 1 1 1 1 1 1
dishes
Fresh cut fruits 1 1 1 1 1 1 1 1 1 1
and vegetables
Juice/beverage 1 1 1 1 1 1 1 1 1 1
Juice/drink 1 1 1 1 1 1 1 1 1 1
 concentrate
Lard 1 1 1 1 1   1 1   1
Lunches 1 1 1 1 1 1 1 1 1 1
Margarine/sprea 1 1 1 1 1   1 1   1
ds/butter blend
Pasta 1 1 1 1 1 1 1 1 1 1
Pickles/relish 1 1 1 1 1 1 1 1 1 1
Pizza 1 1 1 1 1 1 1 1 1 1
Refrigerated dips 1 1 1 1 1 1 1 1 1 1
Tortilla/eggroll/w 1 1 1 1 1 1 1 1 1 1
onton wrap
Salad dressing 1 1 1 1 1 1 1 1 1 1
Seafood - 1 1 1 1 1 1 1 1 1 1
packaged
Seafood - 1 1 1 1 1 1 1 1 1 1
unpackaged
Spreads 1 1 1 1 1 1 1 1 1 1
All other 1 1 1 1 1 1 1 1 1 1
Shelf- Aseptic juices 1 1 1 1 1 1 1 1 1  
stable Baked beans           1 1      
Baking mixes   1 1 1 1   1 1   1
Baking needs               1   1
Baking nuts   1     1 1   1 1 1
Bottled juices 1 1 1     1 1 1 1  
Bottled water 1 1 1 1   1 1 1    
Breadcrumbs/ba 1 1 1       1 1    
tters
Canned juices 1 1 1     1 1 1 1  
Canned/bottled 1   1     1 1   1  
fruit
Caramel/taffy                    
apple kits
Carbonated                 1  
beverages
Chocolate candy   1 1 1 1 1 1 1   1
Cocktail mixes                 1  
Cocoa mixes   1         1 1 1  
Coffee                    
Coffee creamer 1 1 1   1 1 1 1 1 1
Cold cereal     1 1   1 1 1   1
Cookies 1           1 1 1 1
Crackers             1 1 1  
Croutons 1           1 1 1 1
Dessert toppings 1 1     1         1
Dinners 1 1 1   1 1 1 1 1 1
Dip 1 1 1   1 1 1 1 1  
Dried fruit   1 1 1   1 1 1 1 1
Drink mixes   1   1 1 1 1 1 1  
Dry   1 1       1     1
beans/vegetables
Dry fruit snacks   1           1 1 1
Evaporated/cond 1   1 1 1 1 1      
ensed milk
Flour/meal   1       1        
Frosting   1           1   1
Gelatin/pudding     1     1 1 1    
mixes
Gravy/sauce 1 1 1 1 1 1 1     1
mixes
Gum                    
Hot cereal                    
Ice cream 1 1   1           1
cones/mixes
Instant potatoes 1         1 1 1    
Isotonics 1           1      
Jellies/jams/hone   1 1 1 1     1   1
y
Juice/drink   1   1 1       1  
concentrate
Marshmallows                    
Mayonnaise 1 1 1   1 1        
Mexican foods 1   1 1 1 1 1 1   1
Mexican sauce       1 1   1      
Milk   1 1       1 1   1
flavoring/drink
mixes
Mustard and                    
ketchup
Non-chocolate     1             1
candy
Non-fruit drinks     1              
Oriental food 1   1 1   1 1 1   1
Pancake mixes         1     1   1
Pasta           1 1 1    
Peanut butter   1           1   1
Pickles/relish/oliv       1         1  
es
Pizza products 1 1     1 1 1 1    
Popcorn/popcorn     1 1            
oil
Powdered milk 1 1 1 1 1 1 1 1 1  
Rice   1                
Rice/popcorn   1           1 1  
cakes
Salad dressings 1   1   1 1 1 1   1
Salad toppings   1           1 1  
 Salty snacks                   1
Sauce 1 1     1 1 1      
Seafood 1 1 1 1 1 1 1 1 1 1
Shortening and     1 1            
oil
Snack   1           1 1 1
bars/granola bars
Snack nuts/seeds   1           1   1
Soup 1   1 1   1 1     1
Spaghetti/Italian     1 1            
sauce
Spices/seasoning   1 1         1    
s
Stuffing mixes   1           1    
Sugar                    
Sugar substitutes                    
Syrup/molasses                    
Tea  bags/loose   1 1              
Tea  instant tea   1         1 1    
mixes
Tea  ready-to-               1    
drink
Tomato products                    
Vegetables 1 1         1 1 1  
Vinegar                 1  
Weight   1 1 1       1   1
control/nutrition
liquid/powder
Weigh control     1         1   1
candy/tablets
All other 1 1   1 1 1 1 1 1 1
Note: "1" indicates that the sector has been selected for individual risk scoring by one or more experts.
 Table 4-6: Overall Risk Scores and Factor Risk Scores By Sector, General Risk Category
Risk Factors Food Sectors
Baked Goods Dairy Frozen Refrigerated Shelf-Stable
Overall risk -0.058 0.837 0.232 1.098 -0.513
Process-related contamination [a] -0.376 0.665 0.128 0.518 -0.249
Equipment [b] -0.084 0.254 0.259 0.848 -0.375
Quality control [c] -0.037 0.670 -0.087 0.182 -0.102
Input-related contamination [d] 0.542 0.078 0.206 0.668 -0.333
[a] The process-related contamination risk factor loads highly on "contamination during processing," "contamination of raw materials," and
"poor employee hygiene."
[b] The equipment risk factor loads highly on "poor plant design and construction," "difficult-to-clean equipment," and "poor plant and
equipment sanitation."
[c] The quality control risk factor loads highly on "post-process contamination at plant," "no preventative maintenance," and "deficient
employee training."
[d] The input-related contamination risk factor loads highly on "poor employee hygiene," "difficult-to-clean equipment," and "contamination
of raw materials."

Table 4-7: Overall Risk Scores and Factor Risk Scores By Sector, Allergen Risk Category
Risk Factors Food Sectors
Baked Goods Dairy Frozen Refrigerated Shelf-
Stable
Overall risk 0.707 0.107 0.453 0.975 -0.527
 
In-process contamination [a] 0.197 -0.102 0.250 0.551 -0.261
Quality control [b] 0.434 0.391 0.228 0.364 -0.269
Other contamination [c] -0.007 0.017 0.301 0.272 -0.184
Equipment [d] 0.470 -0.005 0.222 0.756 -0.351
[a] The in-process risk factor loads very highly on "contamination during processing," and moderately high on "incorrect labeling or packaging."
[b] The quality control risk factor loads highly on "no preventative maintenance," "deficient employee training," and "post-process contamination at plant."
[c] The other contamination risk factor loads highly on "contamination or raw materials" and "poor employee hygiene."
[d] The equipment risk factor loads highly on "poor plant design and construction," "poor plant and equipment sanitation," and "difficult-to-clean equipment."

Table 4-8: Average Standardized Scores for the Ten Risk Problems By Sector, General Risk Category
Risk Problem Food Sectors
Baked Goods Dairy Frozen Refrigerated Shelf-Stable
Poor plant design and construction -0.218 0.608 0.239 1.041 -0.458
Deficient employee training 0.000 0.671 0.177 1.088 -0.479
Poor employee hygiene 0.460 0.474 0.128 1.134 -0.494
Difficult-to-clean equipment 0.458 0.756 0.394 1.021 -0.574
No preventive maintenance 0.068 0.783 0.147 0.579 -0.325
Contamination of raw materials -0.415 0.660 0.218 0.849 -0.380
Contamination during processing -0.268 0.900 0.188 0.865 -0.414
Post-process contamination at plant -0.242 0.955 -0.152 0.483 -0.192
Poor plant and equipment sanitation -0.266 0.731 0.315 1.027 -0.488
Incorrect labeling or packaging -0.311 0.358 -0.071 0.900 -0.279
Note: The numbers reported in this table reflect standardized scores. ERG standardized the values for these variables to be consistent
with the values reported for the factor analysis.

Table 4-9: Average Standardized Scores for the Ten Risk Problems By Sector, Allergen Risk Category
Risk Problem Food Sectors
Baked Goods Dairy Frozen Refrigerated Shelf-Stable
Poor plant design and construction 0.214 0.165 0.245 1.173 -0.489
Deficient employee training 1.425 0.157 0.469 0.648 -0.493
Poor employee hygiene 0.181 0.337 0.204 0.773 -0.365
Difficult-to-clean equipment 0.984 -0.187 0.600 0.834 -0.520
No preventive maintenance 0.286 0.585 0.346 0.626 -0.399
Contamination of raw materials 0.042 -0.147 0.378 0.451 -0.252
Contamination during processing 0.365 -0.016 0.380 0.794 -0.404
Post-process contamination at plant -0.260 -0.376 -0.180 0.528 -0.048
Poor plant and equipment sanitation 0.660 0.150 0.387 0.776 -0.443
Incorrect labeling or packaging 0.047 -0.222 0.107 0.567 -0.194
Note: The numbers reported in this table reflect standardized scores. ERG standardized the values for these variables to be consistent
with the values reported for the factor analysis.

Table 4-10: List of Preventive Controls Recommended for the Top Four Food Safety Problems
Deficient Employee Training Contamination of Raw Materials Poor Plant and Equipment Poor Plant Design and
Sanitation Construction
3x5 pocket-sized cards to remind Document all activities Assign accountability for plant A sanitary design control
employees of a few vital hazards and equipment sanitation program
Conduct audits (in-house, by third All transport carriers and Audit of outside cleaning Better overall flow to
party, of GMPs, or not specified warehouses should be inspected companies prevent cross-
contamination
Base training efforts on Antibiotic testing Awareness of new sanitation Better understanding of
Vulnerability Assessment Report technologies such as ozone process flow concepts
and chlorine dioxide
Improve training on process control Self inspection (by department or County extension programs Building, construction, and
and pathogen monitoring individual) that offer consulting services equipment companies and
engineers need to be
trained in sanitary design
criteria
Better use of chemical supplier Audit and inspection emphasis Conduct cross-department Clearly defined expectations
expertise should be placed on offshore- inspections
sourced raw materials
Bilingual training (in-house or not Better controls on raw Dedicated cleanup crew Conduct audits (internal or
specified) agricultural practices, e.g., foreign third-party, GMP, of plant
object control design, construction, and
grounds, to correct
 deficiencies, twice a year, or
not specified)
Conduct brief training sessions Better overall pest management Develop SSOPs for all Consultants (use for advice
periodically equipment or not specified)
Make use of county and IFT Certificates of analysis/supplier Documentation (of hygiene Contract out the fix, with
extension programs guarantees and sanitation activities, firms that specialize in food
procedure, sign-offs on plant design, or not
SSOPs, signed and verified specified
records of activities, or not
specified)
Develop in-house training programs Change suppliers if needed Documented bilingual Control condensation
(for new employees, using input procedures
from employees and QA team, or
not specified)
Develop monthly meetings with Clean/decontaminate raw Efficacy of sanitation process Develop "Mr. Clean"
employees to train (short duration materials when possible should be quantitatively attitude in personnel
or not specified) measured by pre-op and op
micro counts, organoleptic
evaluations, by
bioluminescence, swabs, or
ATP)
Directed, work-area or product- Color code according to risks Use performance as criteria in Develop plant
specific training, with input from employee review upgrades/expansion plans
and approved by plant operations to reduce this problem
management
Hold discussion groups on training Develop specifications for all Employee training Develop priority list for
issues products and make sure specs are areas needing revision
achieved outside GMP audit at and/or specific operational
least yearly practices necessary due to
design issues
Documentation of training activities Documented handling policies Reduce employee turnover Develop programs for short
and long-term fixes
Use performance as criteria in Employee training on what to Environmental sampling Develop understanding of
employee review look for when receiving incoming (involving QC lab, daily GMPs in all employees
ingredients sanitation tests, or not including the boss; clean up
specified) plant so that it complies
with GMPs
Employee mentoring programs Ensure that the storage areas are Formal sanitation program Evaluate design issues and
(e.g., match employees with same clean and maintained with clear-cut responsibilities potential effects on food
language/ethnicity) appropriately defined safety
Evaluate effectiveness of training Establish criteria for prevention GMP audits (internal or Greater sanitation
of contamination of raw materials external, monthly or annually,
or not specified)
Food safety reminders on paystubs FDA Website for recalls Hand washing facilities in Head of maintenance has
and websites processing area (sensors or had training in sanitary
not specified) design
Food safety training of all new GMP audits (internal or external; Have personnel sign off when Implement programs
employees with minimum quarterly of storage areas, monthly with SSOPs completed designed to compensate for
refresher response from management, or the design flaws, e.g., more
not specified) frequent cleanup, more
people on the line
Formal training policy GMPs Improved worker training Improved flow and
better/easier access to
equipment
GMPs Greater frequency of port In-house audits of sanitation Inspection by certified third
inspection party
Good orientation programs Implement programs within the In-house training (by outside Limit condensation
plant to prevent contamination of consultants or not specified)
products with materials from the
outside of packaging.
HACCP Improved monitoring of incoming Interactive training Limit downtime
raw materials
Handwashing Incoming inspection and approval Keypad controls Limit splash
programs
Training in temperature control, Sampling and testing (in-house, Make sure there is sufficient Monthly meetings to discuss
monitoring equipment, hygiene, more frequent, periodic, or not time to clean problems and how to make
GMP, and overall food safety risk specified) corrections, involving all
personnel including
management and
maintenance
Improved thermal process focus Metal detectors or filters (in bulk Management commitment New equipment if needed
transfer operations or not and involvement
specified)
Improved training on pathogen Mandatory handwashing or glove More involvement by the Obtain input from buyers
monitoring use chemical suppliers for training and their
and education (e.g., teaching QA/sanitation/food safety
programs) people
Industry affiliation training Multiple tanks for bulk liquids to Ongoing cleaning (sweeping, Owner/operator must
programs ensure separation of lots etc.) during production address
operations
In-house training (specific or Provide segregated storage Outside training of personnel Reconfigure, correct, repair,
general, by insurance carrier, (separate raw materials from responsible for monitoring or fix problems
consultant, or not specified) finished products)
Use of broad range of training Review past audits of suppliers More effective pathogen Relocate to a less risk area
materials and learning aids, such as monitoring schemes and or move concerned area
CD-ROM, online learning, more pathogen monitoring
equipment labeling, food safety
icons
Make training a part of supervisor's Personal hygiene training (see Pay and other incentives for Review by technically
performance rating training for detail) employees to practice good competent and experienced
sanitation resource to identify problem
areas and construction
constraints
Management Program for rotation and code Improve definition of Sanitation records
commitment/responsibility tracking of raw materials sanitation expectations and
process: define "clean"
Training on monitoring equipment Proper cleaning and sanitizing of Provide proper tools and Sign off on corrections
bulk carriers supplies for adequate
sanitation
Seminars (monthly, by specialist Proper in-house storage Routine cleaning and SSOPs
from outside company, or not sanitizing of refrigerators,
specified) coiling coils, and compressors
Use outside consultants who Purchasing of fresh produce from Make sanitation a core Stricter in-process controls
understand adult education growers utilizing GAPs programs corporate value can be used to help
compensate
Ongoing verbal exampling and Conduct random microbiological Signed and verified records The sanitary design criteria
reinforcement of training concepts verification of lots must be implemented
Outside training courses Raw material specifications (and SSOPs (written, for each piece Training
product specifications of processing equipment and
appropriate to the product) processing areas, with signoff
logs, or not specified)
Posters and use of reminder icons Maintain receiving records Tech group training in University extension
in critical areas of plant auditing and evaluation of services
sanitation effectiveness
Provision of learning aids, such as Sanitation at farms and milking Employ technical staff Use professionals on all
video and other visuals (NFPA and operations redesigns
other professional organization
video programs)
Training refresher courses Separate or designated Third-party auditing/training Weld (when possible or not
employees for tasks of tech and management specified)
group.
Repetition in training of concepts Separate personnel by job Audits (third-party or in-  
taught function (raw vs. processed) house)
Review and update in-house Separate raw ingredients and Train employees (in-house  
training programs quarterly finished product and processing and by outside consultants,
entirely in-house,
interactively, verbally, or not
specified)
Set up plant training committee, Supplier audits Training programs for  
with guidance from HR or training management supervision and
department and plant operations as cleaning personnel with focus
coordinators on cleaning technique,
cleaning and sanitation
compounds, and how to
evaluate performance
Training on specific allergen Supplier training Use contract cleaners  
controls and specific cleaning and
sanitation procedures
Test all employees, including Third-party audits of raw Use detergent  
management, for understanding materials
and proficiency
Training based on show and tell Training Use sanitizers in condensate  
examples of basic food safety pans
practices, with use of graphics and
icons
Training booklets, USDA Use of irradiated or pasteurized Use video film for training  
publications ingredients
Training in learning to read and Use of processed materials vs. Validate the procedures being  
write English raw material where appropriate used to clean and sanitize the
plant
Training in specific dairy issues Use pre-process treatments to Visual daily inspections  
prevent contamination from raw
materials
Training tailored to management Use risk assessment to identify Weekly sanitation tests  
personnel above and beyond potential hazards
operational employees
(managers/supervisors)--trained in
GMPs, sanitation, HACCP, allergens
Written training guidelines Vendor qualification/supplier Written cleaning and  
certification, especially for sanitation procedures that
 specific pathogen and chemical are developed by corporate
sensitive raw materials (based on staff or preferably by the
third-party or in-house audit, companies that supply the
conduct FOIA inquiries, call cleaning/sanitation chemicals
current customers) and systems.

 Table 4-11: List of Preventive Controls Recommended for the Next Three Food Safety Problems
No Preventive Maintenance Difficult-to-Clean Equipment Post-Process Contamination at
Manufacturing Plant
Assign accountability (to individual or not specified) A sanitary design control Adequate design of the process flow to take
program the product most effectively from the end
of the "process" into packaging
Assign to a department Additional of kill-step at end of Allergen controls
processing
Assign to a position description All equipment should be Avoid all human contact with finished goods
certified as acceptable for use
in food plants
At minimum, apply preventive maintenance program Apply in-depth evaluation of Better overall understanding of post-retort
to food contact or processing equipment cleaning practices until repairs handling of cans/bottles
made
Clearly defined expectations Assign accountability to Conduct audits (GMP, in-house or third-
department party, or not specified, of controls or
processes)
Comprehensive maintenance program is essential to Assign accountability to Configure product flow to prevent cross-
food processing plants (large or small) individual contamination
Conduct audits (third-party, GMP, of facility, of Better process control schools Control traffic patterns
maintenance plan, of processing equipment, or not
specified)
Develop program and stick to it Bilingual training if needed Dedicated equipment
Documentation Cleaning areas prone to niches Denial of pest access and proper pest
monitoring and control programs
Emergency maintenance logs Conduct audits (in-house or Develop management controls to prevent
 third-party, GMP, of plant and post-processing contamination
grounds, SSOPs, or not
specified)
Equipment manufacturer develop programs and Conduct regularly scheduled Documented handling policies
training for maintenance personnel cleaning
Establish a preventive maintenance program (on Consulting with manufacturer Documented sanitation programs
critical equipment, critical infrastructure, internal, or before purchase
not specified)
Having production sign that they accept the repaired Contract out cleaning Employee awareness through education
equipment back into service or sign off when repairs and training
are completed
Identification of repairs needed Document training Environmental and processing area
sampling
Identify critical equipment parameters and initiate Effectiveness of cleaning is Finished product inspection program
monitoring programs verified and pre-operational
inspections are done
Maintenance plan Employee training (new hires, GMPs
cleanup crew, equipment
specific, in-house programs, or
not specified)
Maintenance request systems Environmental sampling and HACCP (establish, utilize to identify
testing (increase frequency, for potential hazards, reassess)
pathogens, or not specified)
Management review Examine equipment & develop Immediate final packaging of finished goods
plans to upgrade hard to clean
units
Monitoring and documentation of preventive Extra cleaning during breaks Improve raw and cooked process flow
maintenance process
Monthly inspections General ease of equipment Improved pathogen monitoring on dry dairy
cleaning needs to be improved products
Parts reconciliation program GMPs Incubation program (for aseptic or retorted
only)
Planned and documented maintenance programs HACCP Involvement of sanitation chemical
suppliers
Records (of emergency and routine repairs/services, Head of maintenance has had Limit personnel access
maintenance activities, or not specified) training in sanitary design
Repair trending and tracking Identify better equipment Maintain equipment
designs for future purchases
Signed and verified records Identify via competent and Maintenance of air handling systems
experienced resource--develop
specific cleaning procedures
Terminate ongoing employee offender Implement a monitoring Microbiological monitoring or sampling of
program to assess the actual finished and packaged product
risks
Training Improve expectations relative Ozone air fogging of environment during off
to materials and design hours
Use a third party to evaluate Improvement of CIP capabilities Package must be intact
(better line flow design for
equipment or not specified)
Use of metrics to evaluate efficacy of preventive Installations conducted by Packaging inspection program
maintenance equipment manufacturer
Utilize computer preventive maintenance program Knowledge of the equipment Positive filtered air pressure in packaging
(such as MP2 system; other software is available) harborage sites areas
  Label equipment with proper Product sampling
cleaning instructions
  Management responsibility, Proper cleaning and sanitizing and
review, and follow-up documentation of valving and design
  Meetings (monthly training Proper environmental controls
meetings or short duration
meetings)
  Microbial sampling Proper seaming/sealing of containers and
routine monitoring of same
  Design or purchase easier-to- Proper storage
clean equipment
  Purchase the right equipment Proper valving and design to ensure
for the task pasteurized milk is not contaminated on
cold side
  Repair, replace, or return Rewards for good job
equipment to manufacturer
  Review and update training Routine cleaning of refrigeration systems
programs quarterly such as compressors, fans, and condensate
collectors
  Rewards for doing good job Sanitation practices (for packaging and
sealing areas, product contact surfaces and
equipment, or not specified)
  Sanitation tests (daily or Segregate all raw and finished goods
weekly)
  Signed and verified records SSOPs (written with signed and verified
records or not specified)
  Sign-off on cleaning Sufficient monitoring programs for
environmental conditions
  SSOPs (for equipment, difficult Temperature control must be appropriate
cleaning, written, or not for product
specified)
  Surface sampling Terminal kill-step in process
  Taking equipment apart to Trash handling and product handling
clean systems and personnel for unprocessed and
processed areas of the production
  Use video tapes for training and Warehouses and transport carriers must
other visuals meet GMP expectations
  Utilize suppliers who provide  
support services
  Verification of efficacy of  
cleaning using swabs or ATP
tests
 Table 4-12: List of Preventive Controls Recommended for the Remaining Three Food Safety Problems
Contamination During Processing Poor Employee Hygiene Incorrect Labeling or Packaging
Allergen control program (with 3x5 pocket-sized cards to remind employees of a few vital Two approvers for in-process label
process scheduling or not specified) hazards and packaging changes
Integrated Pest Management Adequate restroom facilities and equipment (based on Adherence to approved formulas
the number of employees, including handwashing and and suppliers
sanitizing stations, clean locker rooms and showers,
centralized handwashing, warm water at handwashing
stations, or not specified)
Assign department for self- Automated handwashing stations/keypad controls and All labeling material should be pre-
inspection sensor-equipped towel dispensers approved by third party
Assign individual for self-inspection Base training efforts on Vulnerability Assessment Report Allergen control programs such as
production scheduling, proper
cleaning, and ingredient handling
Clearly defined expectations, i.e., Clearly define expectations Allergen identification system for all
food code inbound ingredients
Color code risks Communication Batching programs and record
keeping
Condensate control through proper Conduct audits (include operating personnel, Careful inventory and verification of
air circulation management, and maintenance, third-party GMP review, label status
internal audits, or not specified)
Conduct audits (in-house, third Define minimum standards Check labels and product daily--all
party, GMP, of systems and shifts
processing lines and areas, or not
specified)
Configure product flow to prevent Develop training materials and procedures internally, COA for all inbound raw materials
cross-contamination using input from employees and QA team
Define process capability Develop training programs that emphasize the Conduct audits (third-party, of label
importance of employee hygiene compliance or performance, or not
specified)
Develop appropriate control Directed, work-area-specific training, with input from and Define expectations as to ingredient
measures to prevent contamination approved by plant operations management declaration
Develop preventive maintenance Disciplinary actions Define when cleanup is needed to
program prevent carryover into non-allergen
product
Training (improved existing training, Discuss personal hygiene during monthly meetings Develop control programs for
temperature control training, scheduling formulations without
personnel hygiene training, or not allergens first in production day
specified)
Employment of certified food safety Discussion groups Develop label management control
manager on issuing, storing, and disposition of
obsolete labels
Environmental monitoring and Documentation of training or written training guidelines Develop label review process with at
control least two persons involved
Environmental sampling Emphasize personnel hygiene when hiring Develop label/product
documentation at beginning of shift
and checks on each new container
Equipment maintenance (routine, Employee mentoring (by matching employees with same Development of labeling
preventative, or not specified) language/ethnicity or not specified) expectations
Facility equipment layout Employee supervision Eliminate potential cross-
contamination during processing
Glass breakage procedures Employee training (new employees, in-house, outside, on Employee training (proper labels,
personal sanitation and hygiene, on food safety, or not label/formulation control,
specified) importance of using appropriate
labeling, or not specified)
GMPs Enforce employee hygiene work rules Formal process for approval of labels
and printed packaging
HACCP (utilization, establishment, Food safety reminders on paystubs and websites HACCP (establishment of CCP, risk
implementation, reassessment, or assessment review, and
not specified) reassessment)
Handling practices Formal training policy Inspection and documentation of all
labels used in production
Improved CIP capability GMPs Isolated storage for all allergen-
 containing ingredients
Improved equipment design Good orientation programs Label development critical, involve
management, quality control,
production, warehouse personnel
Limit personnel access Hand wash signs posted Label inventory control system
Mandatory handwashing or glove Impress on the employees the need to keep clean Labeling allergens is most critical
use protection and protocol personally, as well as keep plant clean
Metal detection (with magnets and Laboratory testing Mandatory sample label attachment
screens or not specified) to production records
Microbial sampling Management commitment Monitor as part of packaging CCP
Monthly meetings for management Managers set good examples Off-shore-produced product of great
and employees concern
More reliance on prerequisite Monitor efficacy--develop metrics Packaging engineering
programs
Plant management to do self- Monitoring of employees (including handwashing Preoperations label review and
inspection stations) documentation before production
can begin
Positive filtered air pressure in Provide ongoing verbal examples and Programs to approve all labels
packaging areas reinforcement/repetition of training concepts
Pre-operational inspections of Policy that all personnel will adhere to hygiene codes QC label monitoring program during
processing lines/equipment production
Prevent crossover of personnel from Posters (bilingual or not specified) Records
raw to finished products
Preventive maintenance Prepare demonstrations of the effects of poor hygiene Removal of outdated/old/obsolete
labels (removal program or not
specified)
Process awareness Provide aprons or coats (for critical employees) and Review finished packaging
uniform and shoes
Proper cleaning and sanitation of Regular re-training of existing employees Review and verify labels (when new
equipment and product contact supplier, by routine inspections,
surfaces upon receipt, at time of use, or not
specified)
Proper cleaning and system design Seminars Review process (internal, of label
and construction and on-line packing, or not specified)
Properly designed and documented Set up plant training committee, with guidance from HR Scanning bar codes or using on-line
cleaning and sanitizing programs or training department and plant operations as bar code scanners
coordinators
Record logs Signed and verified records SSOPs
Sampling SSOPs (written or not specified) Third-party marketplace compliance
verification
Sanitary design program State Public Health training handouts Independent technical review of all
labels
Segregation of processes, Supervision Verify labels and maintain records
operations, products, product line,
staging areas, and storage for raw
and finished products
Separate or designated employees Training based on show and tell examples of basic food  
for tasks safety practices, with use of graphics and icons
Sign off to make sure task is Training in reading and writing English  
completed
SSOPs (operational, written with Training with supervision on floor responsible for  
signed and verified records, or not performance, not QA
specified)
Traffic control between processed, Understanding needs  
WIP, and raw material
Use follow-up operational Use of broad range of training materials, such as video  
management training tapes, CD-ROM, online learning, equipment
labeling, booklets, food safety icons (in critical areas of
plant or not specified)
Use covers on open food Visible handwashing checks  
containers/equipment
  Vulnerability Assessment Report by outside food safety  
expert
 Table 4-13: Top Five Commonly Mentioned Preventive Controls by Food Safety Problem
Food Safety Problem Most Frequently Mentioned Controls Count [a]
Deficient employee training Audits (third-party or in-house) 6
In-house training 6
Bilingual training 6
Use video tapes for training and other visuals 4
Documentation of training activities 3
Contamination of raw materials Supplier audits 8
Supplier qualification/certification 7
Raw material and product specifications 6
Testing or inspecting raw materials 5
Segregation of storage 4
Poor plant and equipment Training 9
sanitation Audits (third-party or in-house) 7
SSOPs 6
Documentation of sanitation activities and procedures 5
Sanitation evaluation and monitoring 4
Poor plant design and construction Audits (third-party or in-house) 7
Fix problems and reconfigure plant design 2
Use outside consultants or others specialized in plant 2
design
Contract out repair and design work 2
Correct, reconfigure, or repair equipment 2
No preventive maintenance Preventive maintenance programs 9
Audits (third-party or in-house) 5
Records/documentation of maintenance 4
Assign accountability 2
Sign off on repaired equipment 2
Difficult-to-clean equipment SSOPs 8
Training 7
Environmental sampling and testing 5
 Audits (third-party or in-house) 5
Repair, replace, or return equipment 3
Post-process contamination at Audits (third-party or in-house) 6
manufacturing plant Environmental sampling 4
SSOPs 4
Training 3
Sanitation practices 3
Contamination during processing Audits (third-party or in-house) 10
Training 7
Segregation or processes, products, and storage 6
HACCP 4
Equipment maintenance 4
Poor employee hygiene Training 9
Audits (third-party or in-house) 7
Adequate facilities and equipment 5
Automated handwashing and towel dispensers 4
Broad range of training media and materials 4
Incorrect labeling or packaging Label review/verification 8
Audits (third-party or in-house) 5
Training 5
HACCP 3
Removal of outdated labels 3
[a] Total number of experts that included the control in question in their list of preventive controls for the food safety problem.

Table 4-14: Types of Records Recommended as Preventive Controls

Record Type [a] Count Percent
Cleaning and sanitation 13 87%
Corrective action documentation 1 7%
Equipment maintenance records 11 73%
Labeling and packaging 5 33%
Personnel records 9 60%
 Receipts of incoming ingredients, raw materials 3 20%
Supplier audits 10 67%
Warehousing/inventory/storage records 2 13%

[1]
 Although our original expert panel had 17 members, we only received responses to all three Delphi rounds from 15 individuals.

[2]
 Note that the initial question asks the respondent to evaluate the food safety problem according to one dimension, "applicability," within each food
sector. The second question, however, asks the respondent to consider the food safety problem with regards to two dimensions, "frequency" and
"severity."

[3]
 The need for this round was determined during the study pilot, in which some experts indicated that certain subsectors within each main food sector
(baked goods, dairy, frozen, etc.) merit different risk scores.

[4]
 "IRI" refers to the InfoScan® Custom Store Tracking database provided by Information Resources, Inc. (IRI). The database consists of scanner data
collected weekly from more than 32,000 supermarket, drug, and mass merchandiser outlets across the United States and is current as of January 2,
2000--the version available to FDA under its contract with IRI at the time this study was conducted. The database provides detailed information on
average unit prices, sales volumes, and other measures at the product, brand, and Universal Product Code (UPC) levels.

[5]
 This, in effect, results in censored score data, which might be analyzed using applicable econometric methods, such as Tobit.

[6]
 This does not imply that each variable is assigned to specific factor. Variables can (and will) be related to more than one factor.

[7]
 The name of a factor is subjective.

[8]
 Factor analysis uses and generates standardized values.
 [9]
 Although the terminology "corrective actions" was included in input received during the study pilot, none of the recommendations fell into this
category.

[10]
 Given the large number of food subsectors identified for risk scoring in round 2, we only asked experts to provide preventive control
recommendations for the main food sectors and note any additional controls that might be needed for a subcategory, if any.

Page Last Updated: 09/27/2015 

GMPs - Appendix A: Annotated Bibliography on Food Safety

Problems and Recommended Controls
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August 9,2004

Return to Good Manufacturing Practices (GMPs) for the 21st Century - Food Processing

Table A-1: Summary of Literature Findings on Microbiological Safety Issues and Preventive Controls
Source Industry/Products Problem/Risk Preventive Controls Suggested
AMI, 2003 Meat and poultry Manufacturing equipment design The processing equipment should be
of sanitary design.
 It must be cleanable down
to the microbiological level
 It must be made of
compatible materials

 It must be accessible for

inspection, maintenance,
cleaning, and sanitation

 It must be self-draining (i.e.,

does not allow for product or
liquid collection)

 It must have its hollow areas

hermetically sealed

 It must be free of niches

 It must have sanitary

operational performance

 It must have its

maintenance enclosures
hygienically designed

 It must be hygienically
compatible with other plant
systems

 It must have a validated

cleaning and sanitizing protocol

BBC News, Prepared foods Cooks and chefs with long and/or Short and clean finger nails
2002 artificial finger nails
Beauchat Fresh produce Pathogen contamination through  Treatment of produce with
and Ryu,  Contact with soil, raw or chlorinated water (may not
1997 improperly composted manure, eliminate pathogens completely)
irrigation water containing
 Control of potential points
untreated sewage, or
of contamination in the field,
contaminated wash water
during harvesting, processing and
 Contact with animals, distribution, retail markets, at
insects, unpasteurized products food-service facilities, and at
of animal origin, and home
contaminated surfaces

Bell and Not specified Not specified  Effective hygiene

Kyriakides,
 Routine pathogen
2002a
monitoring

 Steam pasteurization

 GAPs

 Microbiological testing

 Chlorine washing

 Challenge studies to
determine the critical control
points

 Segregation of raw materials

from in-process and finished
products

 Effective cleaning and

disinfection
Bell and Not specified Not specified  Controlling the feed of food
Kyriakides, animals and poultry
2002b
 Effective hygiene

 Routine pathogen
monitoring

 Steam pasteurization

 GAPs

 Microbiological testing

 Chlorine washing

 Challenge studies to
determine the critical control
points

 Segregation of raw materials

from in-process and finished
products

 Effective cleaning and

disinfection

Bell and Raw and processed foods  Product manufactured with  Monitoring and testing the
Kyriakides, no processing stage to kill the product
2002c organism
 Washing produce with
 Product with few or no chlorine
preservatives
 Segregation of raw and
 Post-process contamination processed materials

 Poor personnel handling  Effective cleaning and

 practices sanitation

 Environmental sampling and

cleaning

 Routine monitoring of
cleaning efficiency

Belluck and Lettuce  Open shed Not specified

Drew, 1998
 Unchlorinated wash water

 Unsanitary employee
practices

Berne, 1997 All foods Not specified  Good employee hygiene

 Ensurance of adequate hand
washing through the use of
automated hand washing
systems

 Use of color-coded cleaning

materials

 Use of pathogen detection

and cleaning validation testing
systems

Best, 2000 Meat and eggs In-plant construction activities  Avoidance of sample
compositing during testing
 Testing during operations to
reflect true-life conditions

 Nonrandomized testing
  Vaccination

 Competitive exclusion

 In-the-shell pasteurization

Brandt, 1999 Hot dogs Risk of post-processing  Revised plant procedures

contamination withListeria
 Packaging innovations
monocytogenes
 Addition of key ingredients,
such as sodium nitrite, sodium
lactate, sodium diacetate,
polyphosphates, organic acids,
smoke flavoring, and
bacteriocins, such as nisin and
pediocin

Bryan et al., Processed foods  Raw product/ingredient No specific controls suggested

1997 contaminated by pathogens
 Cross-contamination from
raw ingredient of animal origin

 Bare-hand contact by food

handler

 Handling by an intestinal
carrier of enteric pathogens

 Inadequate cleaning of
processing or preparation
equipment

 Storage in contaminated
environment
Calicioglu et Soudjouk-style sausage Natural fermentation may not Use of a starter culture
al., 2002 eradicate E. Coliin the absence of
controlled fermentation, post-
fermentation cooking, and/or
ambient-storage processing step
Chmielewski Processed foods  Biofilm formation  Biofilm development control
and Frank, via nutrient and water limitation,
 Infrequent cleaning of
2003 equipment design, and
environmental surfaces, such as
temperature control
storage tank and pump exteriors,
and walls and ceilings  Use of chemical and physical
force combination during
cleaning

 Appropriate sanitizer
selection

 Microbial load monitoring

with plating of swabbing solution,
contact plates, and the dipstick
technique

Cliver, 1999 Fruits and  Human errors in handling  Cold storage and
vegetablesGrainsDairy appropriate selection of
 Pests and rodents
productsMeatPoultryFish packaging for fruits and
 Temperature abuse during vegetables
handling  Pasteurization for milk

 Irradiation and dipping in a

trisodium phosphate solution for
poultry

 Proper handling and routine

monitoring for toxins for fish
Cramer, Processed foods  Microbiological (pathogens)  Adherence to the basic
2003 hazards elements of sanitary design,
including facility site selection,
 Physical (glass, metal
grounds and dust control, pest
shavings, wood) hazards
control, basic facility flow, plant
 Chemical (allergen cross materials, and equipment
contamination) hazards  Cross-functional training of
staff in sanitary facility and
equipment design

Curiel, 2003 Processed foods Increased probability of microbial Sanitary equipment design
contamination due to mild
preservation technologies
Deibel, 2001 Not specified Biofilm formation  Effective cleaning and
sanitation that combines physical
and chemical methods
 Use of peroxide and
peroxide-containing sanitizers
instead of chlorine, iodophors,
and most quaternary ammonium
compounds

Donnelly, Smoked seafoodRTE meat  Listeria contamination due  Use of advanced chemical
2002/2003 and poultrysoft to niche environments sanitizers to clean and sanitize
cheesesraw milkMexican- surfaces
 Improper placement of
style cheeses
drains  Rotation of chemical
sanitizers

 Employee-gowning
protocols

 Easily cleanable boots

  Segregation of raw materials
and food production areas

 Use of foot baths

 Foaming sanitizers and

hand-washing systems

 Product reformulation

 Electronic pasteurization

 High-pressure processing
(HPP)

Doyle E., Meat and poultry Listeria  Use of organic acids, other
1999 preservations, or bacteriocins in
product formulation
 Application of additional
process steps, such as thermal
process, irradiation, high
pressure, pulsed electric fields,
electrolyzed oxidizing water,
ultraviolet light, and ultrasound

 Use of modified atmosphere

packaging (MAP)

Doyle, 2000 Foods of animal and plant  Animals and animal manure  Education of producers
origin used for foods are a leading
 Implementation of HACCP
source of food borne pathogens
systems at the point of
 Imported foods production

Drew and Apple juice  Use of decayed apples  HACCP

Belluck, possibly have been in contact
 Pasteurization
1998 with deer feces
 Inadequate quality control

Ennen, 2003 Processed foods Not specified  HACCP training and

implementation of
date/lot/batch coding, metal
detection and x-ray machines
 Audit programs

 Process control and plant

improvements training

 Locking of milk tankers for

security

 Increased production line

sampling and improved clean-out
procedures

 Intervention processes for

carcass beef, E. Coli test and hold
programs

 HACCP/FDA inspections/AIB
audits

 Research and development

 Personnel training

Erickson, Mayonnaise and  Use of unpasteurized eggs  Use of pasteurized eggs

1995 mayonnaise dressing
 Wet environmental areas  GMPs
  Good hygienic practices

ERS, 2001a Meat and poultry Not specified  Animal or meat testing for
pathogens,
 Knife sterilization and
temperature, airflow, and other
process controls

 Improved evisceration and

hide, hair, and feather removal
techniques

 Employee work methods

and empowerment for food
safety decisions

 Production line layouts that

minimize cross-contamination

 Pathogen testing of
equipment and plant
environment

 Use of labor-saving
equipment that reduces cross-
contamination

 Rate at which workers'

hands, tools, and equipment are
sterilized

 Management strategies, like

the Hazard Analysis and Critical
Control Points (HACCP) system
  Steam pasteurization and/or
vacuuming

 Hot water sprays

 Use of Chlorinated water

and other sanitizers to disinfect
product, work surfaces, and
equipment

 Competitive exclusion
(poultry)

 Automation of manual
processes

ERS, 2001b Meat and poultry Pathogens Irradiation

FDA/CFSAN, Selected RTE foods  Plant renovations Maintenance of food safety controls
2001a and strengthening of existing
 Use of defective processing
controls
equipment

 Inadequate pasteurization

FDA/CFSAN, Seafood  Bacteria (sporeformers and  Good personal hygiene

2001b nonsporeformers)
 Elimination of insufficiently
 Viruses due to poor hygienic treated sewage to fertilize crops
practices
 Freezing (parasite control)
 Worms and protozoa

FDA/CFSAN, Fresh and fresh-cut  Manure and biosolids  Temperature control

2001c produce
 Water for agricultural uses  Physical removal of
microorganisms
  Improper postharvest  Use of effective GRAS
packing, cooling, and storage cleaning agents
practices
 Ozone treatment

 Irradiation

 Biocontrol

FDA/CFSAN, Fruits and vegetables and  Contamination of No specific controls recommended in

1999a juices damaged/decayed sites on the the study
rind of fruits that pathogens may
infiltrate via insects and birds or
immersion in cold contaminated
water
 Equipment cross
contamination during processing

FDA/CFSAN, Oranges Salmonella Enterica Hartford and E. Refrigeration reduces the

1999b ColiO157:H7 can be internalized in survivability of E. Coli but not of S.
the fruit at infiltration levels of 3 Hartford
percent or higher
FDA/CFSAN, Fresh unpasteurized apple  Contamination through  Culling
1999c cider direct/indirect contact with
 Initial washing
animal feces during growing and
harvesting of apples  Prompt processing or
 Pathogen migration through refrigerated holding
the flower end or breaks in the  Final culling, washing, and
apple skin brushing

 A closed processing system

 Equipment sanitation
 Environmental sanitation

 Employee hygiene

 Implementation of HACCP

 Pasteurization

 UV treatment

 High pressure sterilization

 Electric resistance heating

 Aseptic packaging

 Ultrafiltration

 Pulsed electric field

 Electromagnetic fields

 Pulsed light

 Ozone treatment

 Hot water rinses

 Irradiation

 Freezing and thawing

 Redundant processing
controls

 Use of sanitizer dips and

sprays and preservatives
  Microbiological testing of
products

Floyd, 1999 RTE foods and some  Areas with standing water  Testing of areas that have a
microwaveable products potential to contaminate the
 Drains and floors
processing/packaging areas or
 Dry-cleaned operations adjacent spaces
 Environmental testing

 Equipment testing to
validate the cleaning process

 Monitoring of the
effectiveness of clean-up and
sanitizing procedures

 Validation of changes to
cleaning procedures

 Swabbing of dry-cleaned
operations areas

 Testing of packaging
material and packaging area

Food Quality Not specified Inadequate sanitation Automated handwashing stations

Magazine, with boot dips
1997
Gagliardi et Melons Contaminated wash water Focusing on water quality as an
al., 2003 important control point at the farm
and at processing and packing
facilities
Gregerson, Processed foods Not specified  On-the-job training of
2002 employees
  Cross training of employees

 Bonus programs, including

benefits packages (medical,
dental) and good work conditions

 Routine preventive and/or

predictive maintenance
schedules

 Antimicrobial treatments

 Rapid microbial detection

systems

The Shell eggs Not specified  Voluntary quality assurance

Hartford, programs, including cleaning and
1999 disinfecting hen houses between
flocks, strict rodent control,
washing of eggs, refrigeration
between transport and storage,
biosecurity measures, mortality
monitoring, use of salmonella-
free chicks and pullets
 In-shell pasteurization

 Irradiation

 Spraying of hatched
chickens with Preempt

 Implementing HACCP

Hegenbart, Dairy foodsFruits and  Pathogenic bacteria  Sanitation of the milking

1996 vegetablesGrainsFish and facility (dairy)
 seafood
 Toxins and carcinogens  Cleaning of the cows' udders
prior to milking (dairy)
 Mycotoxins
 Thermostatic control of milk
 Parasites and viruses holding tanks (dairy)

 Frequent changing of the

bedding materials in holding pens
(poultry)

 Feed testing (poultry)

 Competitive exclusion
(poultry)

 Use of herbicides and

pesticides (plants)

 Adequate irrigation and pest

protection (crops)

 Post harvest cooking and/or

freezing (seafood)

Higgins, Food and beverages Post-processing contamination  In-package sterilization

2003
 Steam vacuuming

 Organic acid sprays

 Washes and Rinses

 Thermal pasteurization

 Irradiation

 Ultra high pressure

 pasteurization

 Coating drains or equipment

parts with antimicrobial agents

 Cleaning and sanitizing

surfaces

Higgins, Dairy products  Language barriers among  Bilingual training

2002 plant employees
 Picture- and symbol-based
 Ineffective employee approach to training and
training instruction

 Poor hygienic practices  Keypad controls on hand

among employees sanitizers that enable the
collection of data on
handwashing practices of
employees

 Sensor-equipped paper
towel dispensers to replace hand
cranks

 Contour mapping and/or

spatial analysis to identify any
infestation hot spots in the plant

Higgins, Processed foods  Reactive maintenance  Institution of a workable

2001 maintenance plan where
 Lack of integration between
predictive maintenance is applied
operations and maintenance
to the most critical assets
 Lack of integration among  Integration of CMMS,
CMMS, condition-based monitoring, and enterprise asset
monitoring, and enterprise asset
 management systems management systems

Hoffman et Raw and smoked fish L. monocytogenes strains may persist Regular L. monocytogenes testing of
al., 2002 in a plant for years. Thus, drains and molecular subtyping of
environmental contamination is isolates obtained
separate from that of incoming raw
materials.
Holah and Not specified  Ovens designed to drain into  Separation of processing
Thorpe, high-risk areas areas from non-processing areas
2002 and high-risk from low-risk areas
 Leakage of sumps under
ovens into high-risk areas  Monitoring and controlling
cleaning and disinfection
programs to prevent biofilms

 Intensive periodic cleaning

in addition to routine cleaning

 Use of multiple cleaning

products for specific operations

 Monitoring the efficacy of

cleaning and disinfecting agents

 Microbiological testing

Ilyukhin et All processed foods Control system failures as a result of Formal and comprehensive training
al., 2001 inadequate control system validation and maintenance programs for
measures manufacturing equipment and
control system
Jahncke and Cold-smoked finfish  Improper refrigeration  Properly storing fish so that
Herman, controls their internal temperature is less
2001 than 40 degrees Fahrenheit
 Listeria
monocytogenes and C.  Thawing frozen fish under
 botulinumspores present on fish sanitary conditions

 Cross-contamination with L.  Temperature control of the

monocytogenes during slicing and brine solution during brining
cutting
 Removal of thick and large
parts

 Strict adherence to SSOPs

and GMPs

Keller et al., Apple cider  Certain processing areas, No specific controls recommended in
2002 such as apple mills and tubing for the study
pomace, and juice transfer, may
harbor contaminants even after
cleaning and sanitation
 Use of poor quality
ingredients

 Poor sanitation

 Reuse of uncleaned press

cloths

Kindle, 2001 Not specified  Wood-covered door frames Doors made of corrosion-resistant
that corrode over time material
 Doors that unnecessarily
remain open

Krysinki, Not specified  Effectiveness of sanitizers  Clean surfaces prior to

1992 depends upon the surface being sanitization for complete biofilm
cleaned; polyester/polyurethane removal
is most difficult to sanitize
 Combine GMPs with HACCP
  Effectiveness of biofilm
removal with cleaners depends
on the surface being cleaned;
polyester/polyurethane is most
difficult to clean

Kuhn, 1995 Not specified  Inadequate hand washing  Automated hand-washing

practices machines
 Lack of cleaning validation  ATP bioluminescence
monitoring

 Portable sanitation
equipment

Kuntz, 1992 Not specified  Molds  Prevention of contamination

by proper cleaning of
 Yeast
manufacturing equipment,
 Viruses  Removal of microorganisms
 Bacteria by washing, trimming,
centrifuging, and filtration

 Removal of oxygen by
applying a vacuum, or the
replacement of oxygen by gases,
such as nitrogen or carbon
dioxide

 High or low temperature

treatments depending on the
type of food product

 PH control

 Control of water activity

 levels via cooking, baking, or
dehydration

 Use of preservatives or
inhibitory substances that have
Generally Recognized as Safe
(GRAS) status

 Irradiation

Morris, Processed foods Not specified  Routine preventive and/or

2000a predictive maintenance
schedules
 HACCP

 Pay-for-skills programs
where the responsibility goes to
the workers

 On-line standard plate count

(SPC)

 Automated batch control

Morris, Processed foods  Weak prerequisite No specific controls recommended in

2000b programs, including SSOPs, the study
GMPs, QA programs, consumer
complaint monitoring,
environmental monitoring,
vendor certification, and allergen
management
 Half-way HACCP programs
due to lack of upper-
 management commitment

 Release of product despite

CCP violations

 Inclusions of quality
components in HACCP that dilute
its effectiveness

 Weak CCP validations and

hazard analyses

 Inadequate/inefficient
documentation

 Inadequate training

 Lack of continuous
improvement

Mortimore, Not specified  Wrong perception of the  Education about food borne
2003 value and complexity of HACCP illness and trends
implementation
 Education on how HACCP is
 Traditional and/or a minimal system that ensures
hierarchical organizational maximum control
structure
 Education on how HACCP
 Lack of expertise in hazard can help reduce sanitation costs
analysis and risk evaluation and down time, lengthen shelf
life, improve efficiency, and
 Lack of motivation and reduce waste
failure to develop the right
attitude and skills for system
maintenance
Murphy et Fully-cooked vacuum- Existence of Listeria monocytogenes  In-package steam
al., 2003 packed chicken breast pasteurization
meat
 In-package hot water
pasteurization

Neff, 1999 Frozen vegetables Ineffectiveness of chlorine (widely  Peroxyacetic acid

used to decontaminate process
 Ozone
water) under certain circumstances
 Ultraviolet radiation

NFPA, RTE foods Listeria monocytogenes  Applying a validated

undated listericidal process where
appropriate,
 Purchasing from suppliers
with a Listeria control program,

 Minimizing the potential for

recontamination,

 Adopting new technologies

as soon as they are available, and

 Implementing an
environmental monitoring
program forListeria spp. to verify
that the control program is
effective.

 In-package pasteurization

 Ionizing radiation

 Product reformulation
with L. monocytogenes inhibitors
Paulson, Not specified  Gloves with poor barrier  Washing hands prior to
1996 characteristics donning gloves
 Ineffective hand washing  Ongoing employee training
among employees and education

 Hand contact with  Institution of a quality

contaminative surfaces, such as control program
mucous, blood, soil, urine, or
feces  Environmental
disinfection/sanitation program

 Restriction of tasks among

employees to prevent cross
contamination

Raloff, 1998 Pasteurized egg Listeria Addition of bacteriocins to the food

productsHot dogsPoultry monocytogenes and Clostridium product
summer sausageMeat
products
Riordan et Fresh fruit Internalization of microflora in the  Exclude dropped or
al., 2001 fruit, especially in those that have damaged fruit from those that
been dropped and/or damaged are designated for the production
of unpasteurized juice or for the
fresh or fresh-cut market
 Locate orchards away from
potential sources of
contamination, such as pastures

Rushing and Acidified foods Not specified Maintenance of an adequately low

Fleming, pH of 4.6 or below throughout the
1999 food
Senkel et al., Apple cider  Lack of specific GMP,  Ensuring conformance to
1999 sanitation standard operating GMP and sanitation procedures
 procedures, and sanitation
 Ensuring conformance to
monitoring records
HACCP
 Lack of adherence to GMPs
and HACCP

Siddiqi, 2001 Not specified Pathogen transmitting pests, such as  An integrated pest
rodents, roaches, and flies management program that relies
on inspection, monitoring,
establishing action threshold
levels, and implementing first
non-chemical and then chemical
measures
 Communication and
education

 Computer-aided monitoring

 Nonvolatile nonrepellant
insecticide formulations

Snowdon Honey  Yeasts and spore-forming Routine microbiological testing,

and Cliver, bacteria including standard plate counts,
1996 yeast counts, bacterial spore-former
 Coliforms
assays, and coliform counts
 Cross-contamination

 Insanitary equipment and

buildings

Sommers et Ham Existence of Listeria innocua  Vacuum-steam-vacuum

al., 2002 technology
 Ionizing radiation
Stier, 2002 Not specified  Construction projects Evaluation of how changes affect
one's operation and taking steps to
 Increases in production
ensure that food safety is not
volume
compromised in the process
Stopforth et Fresh beef Biofilms on equipment surfaces to Correct sanitizer selection as each
al., 2002 whichListeria monocytogenes cells sanitizer has an optimal working
can attach and persist despite environment in which it is most
washing and sanitizing effective
Thimothe et Raw, whole, and Presence of Listeria  Heat treatment during
al., 2002 processed crawfish monocytogenes  andListeria ssp. in processing
drains and some employee contact
 Practices preventing post-
surfaces
processing contamination (not
specified)

Thomas et Cooked potato products Bacillus and Clostridium Addition of nisin to the product

al., 2002 formulation
Tilden et al., Dry fermented salami Presence of E. Coli O1576:H7 on raw Not specified
2002 meat used in manufacturing salami
Tompkin et RTE processed foods  Product testing is insufficient  Environmental and
al., 2002 to indicate the mode of equipment testing to detect
contamination niches
 Errors in food handling  Inclusion of sampling sites
that are good indicators of
 Establishment of a pathogen control, such as food contact
in a niche which is impossible to surfaces
reach and clean with normal
cleaning and sanitizing  Weekly or more frequent
procedures sampling of the food processing
environment

 Improvements in equipment
design to make cleaning more
 effective and to minimize
breakdowns and repairs

 Increased use of post-

packaging pasteurization with
irradiation, hot water, steam, and
high pressure

USDA/FSIS, Beef Cattle is an important reservoir for E.  Post-slaughter antimicrobial

2002 ColiO157:H7 decontamination methods,
including spray-washing, steam-
vacuuming, steam pasteurization,
warm water wash, trimming,
lactic acid decontamination
 Chilling and temperature
control for finished product
storage

USDA/FSIS, Meat and poultry  Food contact surface  Dry cleaning

2001 contamination between the
 Pre-rinsing equipment
cooking and packaging steps
 Cross contamination  Foaming and scrubbing

 Reservoirs of L.  Rinsing

monocytogenes, including floors  Visual inspection of
and drains, standing water, equipment
ceilings and overhead pipes,
refrigeration condensation units,  Cleaning walls and floors
recess or hollow material, air
filters, and open bearings  Sanitizing

 Drying

 Environmental and contact

 surface testing to determine the
effectiveness of cleaning and to
identify potential sources of
contamination

 Rotating sanitizers
periodically

 Alternating between alkaline

and acid-based detergents to
avoid soapstone or hard water
buildups and formation of
biofilms

 Plant design to eliminate

traffic flow between RTE and raw
product areas

 Use of dehumidifiers and

drip pans in RTE areas

 Smooth, sealed, and

moisture-free ceilings and walls

 Filtered air supply

 Light fixtures that do not

harbor dirt or moisture

 Environmental testing of
non-food contact surfaces, food
contact surface testing, and
product testing

 Regular validation of test

 results by a third party

Walker et Not specified Lack of hygiene knowledge among Not specified

al., 2003 food handlers
Young, 2003 Not specified Equipment that is not designed to be  Automated sanitation
cleaned with the help of automation systems
 Transfer of sanitation duties
from the third to second or first
shifts and to better-trained
employees

 Use of ozone (instead of

chlorine) as disinfectant

 Table A-2: Summary of Literature Findings on General Chemical Safety Issues and Preventive Controls
Source Industry/Products Problem/Risk Preventive Controls Suggested
Bryan et al., All foods  Natural toxins No specific controls recommended
1997
 Spillage of chemicals

 Indiscriminate spraying of
chemicals

 Misreading labels

 Adding too much of an

approved ingredient

 Leaching of toxic containers

or pipelines due to acidic foods

FDA/CFSAN, All foods Chemical hazards occur: No specific controls recommended

2001  Naturally (e.g., mycotoxins,
allergens, and marine toxins)
 From intentionally added
chemicals (e.g., preservatives,
and nutritional and color
additives)

 From unintentionally added

chemicals (e.g., pesticides,
veterinary drugs, toxic elements,
and cleaning/sanitizing
chemicals)

Folks and All foods Raw materials may be contaminated  Store chemicals separately
Burson, with: from food and packaging
2001a  Pesticides materials
 Antibiotics  Thoroughly rinse cleaning
agents and sanitizers from
 Hormones equipment
 Toxins  Only use USDA-approved
 Fertilizers chemicals

 Fungicides  Pest control should be

performed by professionals
 Heavy metals
 Pest control residues in food
 PCBs should be controlled
During processing, contamination  Inventory should be kept of
can occur with: chemicals, colorings, and
 Preservatives additives
 Flavor enhancers  Conduct audits of chemicals
  Color additives used

 Peeling aids  Train employees adequately

about chemical use
 Defoaming agents
 Test product in-house for
 Pesticides residues
 Cleaners/sanitizers

Jahncke and Cold-smoked fish  Temperature abuse of  Certification of proper time

Herman, Scrombotoxin-susceptible fish and temperature handling on
2001 vessel
 Sensory evaluation

 Analytical testing

 Refrigerated at 40 F or less

 Rapid cooling of the product

after cold-smoking process

Moulton, All food  Pesticide residue  Organic production systems

1992
 Integrated pest
management

 Low input sustainable

agriculture (LISA)

 Development of safer
chemicals

 Genetically-engineered,
pest-resistant plants

Tybor et al., Various  Metal poisoning from food  Use equipment and utensils
1990 handling equipment and utensils that do not corrode with citrus
due to corrosion fruits, fruit drinks, fruit pie
fillings, tomato products,
 Pesticide spills
sauerkraut, and carbonated
 Indiscriminate spraying of beverages
facilities with pesticide  Store and secure pesticides
 Improper storage or away from food products
mistaken identity of pesticides  Handle pesticides like
 Incomplete washing of poisons
produce  Avoid indiscriminate
 Adding too much of application of pesticides
intentional food additives  Use trained and certified
 Unintentional food additives personnel in application of
pesticides

 Avoid use of empty cleaning

chemical containers for food
storage

 Properly train personnel

about cleaning and sanitizing

 Use only approved food

grade lubricants and greases

 Maintain chemicals in
original containers

 Read and follow instructions

on labels

 Keep inventory of chemicals

 in a secure, supervised area

Table A-3: Summary of Literature Findings on Allergen-related Chemical Safety Issues and Preventive Controls
Source Industry/Products Problem/Risk Preventive Controls Suggested
CSPI, 2001 Processed foods  Modification of product  Cross-checking ingredients
recipe without changing the on labels
label
 Separate production runs
 Not separating
production runs  Clean machinery properly

 Not cleaning machines

properly between runs

Deibel et al., Processed foods  Raw material An allergen prevention plan that
1997 contamination includes:
 A close working
 Allergen contamination
relationship with material
from products containing
suppliers
allergens run on same
production line  On-site audits of material
suppliers
 Improper use of rework
 Allergen training for
 Cross-contamination suppliers
from maintenance tools
 Longer run times that
 Incorrect labeling or minimize changing products
packaging
 Scheduling the allergen-
 Cross-contamination containing product at the end of
from conveyor belts the run
 Inadequate cleaning  Covering transport belts to
between allergen-containing
 product run and nonallergen- prevent ingredients from falling
containing product runs
 Identifying and
 Older equipment documenting rework
difficult to clean
 Color coding maintenance
 Lack of employee tools or specifying proper
training cleaning procedures

 Verifying labels and

packaging (e.g., with bar code
scanners)

 Physical detachments or
lockouts for equipment with
high-contamination risk

 Enclosure of line crossover

points

 Verification of cleaning
between allergen and
nonallergen runs

 ELISA tests

 Employee training

FDA/CFSAN, Ice cream, bakery, and  Omittance of raw  Effective label review
2001d candy ingredients that are potential policies
allergens from label
 Scheduling production of
 Failure of label review allergen-containing products at
policies the end of production runs

 Contamination of
 product by utilization of  Proper use of rework
rework
 Equipment and system
 Use of common utensils design considerations
 Allergen and  Thorough cleaning of lines
nonallergen runs were not after running allergen-
scheduled or sequenced containing products
 No dedicated equipment  Effective management of
for allergen runs label inventory
 Inadequate cleaning of  Control of ingredients from
lines (rinsing with water only suppliers
or cleaning at end of day
only)  Training of employees in
allergen control
 Lack of training in
allergen control

FDA/CFSAN, All foods Food allergens enter food by  Minimize equipment

2001e means of: exposure to allergens
 Misformulation
 Designate and label
 Improper scheduling equipment for use with specific
products
 Use of rework
 Enclose equipment
 Improper sanitation
 Avoid crossovers of
 Cross-contamination production lines

 Add allergens near the end

of a process
  Schedule longer run times

 Run nonallergen-containing
products before allergen-
containing products

 Produce allergen-
containing products on a
separate day than other
products

 Adequate control on
rework

 Discarding old labels and

packaging materials

 Conduct label audits

 Appropriate sanitation

 Training on allergens and

sanitation

FDA/CFSAN, Fish and fisheries products Food and color allergens in foods  Declare the presence of an
2001f allergen
 Test for residue of an
allergen

 Require supplier
certification

 Review label of raw

materials
Floyd, 2000 All foods  Lack of product  Employee training
scheduling
 Scheduling of production
 Lines are not separated runs

 Raw material  Separation of allergenic

contamination may be and nonallergenic products,
beyond a manufacturer's with dedicated bins, scoops, and
control weighing buckets

 Poor equipment design  Staging areas (putting all

ingredients for a specific batch
 Lack of employee on a pallet before processing)
training
 Line clearance after
allergen processing

 Verification with test kits

 Design plant to avoid dust

carryover

 Improved equipment
design

 Add warning to label as last

resort

Gregerson, 2003 All foods  Poor sanitation  Obtain full ingredient list
from suppliers
 Use of common utensils
 Investigate whether any
 Reuse of baking allergenic processing
parchments aids/rework has been
 Use of table with surface incorporated into the product
nicks that caused cross-  Investigate possible
 contamination product carryover from
common equipment
 Raw material
contamination  Replacement of non-
functioning or non-
 Lack of dedicated lines characterizing allergens
or allergenic product
scheduling at end of day  Allergenic products should
be run on dedicated lines or
 Lack of proper scheduled at end of day
identification of materials
 Long run times for
allergenic products to minimize
product carryover

 Rework areas, equipment,

and containers should be clearly
identified through use of color
tags, bar codes, etc.

 Equipment should be made

of sanitation friendly material,
like stainless steel

 ELISA tests

Higgins, 2000 All foods  Inadequate washdown  Proper washdown

techniques
 Too many changeovers,
 Longer production runs
 Scheduling allergen-
containing products before  Scheduling allergen-
non-allergen containing containing products for the end
products of the day
  Poor equipment design  Sanitary equipment design

 Products shipped in  UPC scanners to ensure

wrong package correct packaging

 Lack of line separation  Add allergens at the end of

the line

 Focus on 8 common
allergens

 Validate allergen-control
program with testing kits of in-
process and finished foods

Minnesota Processed foods  Poor equipment design  HACCP

Department of
 Crossover of conveyor  Consider non-allergenic
Agriculture, 2003
lines substitutes

 Allergen addition point  Add allergenic ingredients

not isolated on line at end of process

 Re-feed systems are not  Sanitary equipment design

dedicated
 Allergen addition point of
 Raw material line should be isolated
contamination
 Re-feed systems should be
 Product lines are not dedicated
dedicated or allergenic
products are not run last  Product should be
contained on line
 Inadequate sanitation
 Eliminate crossover of
 Incorrect labeling or conveyor lines
 packaging  Ensure suppliers have
implemented and documented
 Contaminated an allergen plan
maintenance tools
 Products with allergens
 Lack of employee should be run at one time or at
education the end of a production run

 Adequate cleanup is
required between runs

 All rework should be clearly

labeled

 Labels should be verified

 Outdated packaging
material should be removed
from plant

 Sanitation practices should

be validated using sight,
bioluminescence, and ELISA
tests

 Check maintenance tools

for cross-contamination

 Employee training

Morris, 2002 All products  Lack of dedicated lines  Eliminate allergens if

or not adding allergenic possible
product at end of process
 Add allergenic ingredient at
 Crossover of conveyor end of process
 lines  Dedicate production line to
allergenic products
 Contaminated
maintenance tools  Cover conveyors
 Too many changeovers  Seal off allergen addition
points on line
 Poor sanitation
 Color code maintenance
 Lack of employee tools
training
 Audits and documentation
should be required of raw
material suppliers

 Longer production runs

with minimal changeovers for
high-volume products

 When changeovers are

necessary, products containing
allergens can be scheduled last
in the production cycle

 Discard old packaging

 ELISA tests

 HACCP

 Employee training

 Table A-4: Summary of Literature Findings on Mycotoxin-related Chemical Safety Issues and Preventive Controls
Source Industry/Products Problem/Risk Preventive Controls Suggested
Moss, 2002 Cereals, legumes, oilseeds,  Insect damage For preventing aflatoxin
 treenuts, milk, meat, contamination:
 Drought
coffee, cocoa, fruits, spices  Preventing insect damage
 High water activity  Alleviating drought stress
 Mold growth  Reducing water activity in
product
For preventing ochratoxin A
contamination:
 Prevention of mold growth
at every stage of production
 For preventing patulin
contamination:

 Removal of moldy apples

 Treatment with charcoal or

sulfur dioxide
For preventing fumosin
contamination:
 Breed cultivars resistant to
insect damage and ear rot
 Biological control in the
field

Bissessur et al., Apple juice Production of patulin in apple  Charcoal treatment

2001 juice
 Chemical preservation
using sulfur dioxide

 Gamma irradiation

 Fermentation
  Trimming of fungus-
infected apples

 Clarification methods
(including pressing,
centrifugation, fining, enzyme
treatment, and filtration)

Boutrif, 1999 Tree nuts  Drought  Timely harvesting

 Insect infestation  Pesticides

 Delayed harvesting  Minimize mechanical

damage
 Mechanical damage
 Electronic sorting to
 Moisture and heat remove immature, damaged, or
during storage mold infested kernels
 Immature kernels  Handpicking to remove
immature, damaged, or mold
infested kernels

 Chemical/heat inactivation
of mycotoxins

 Proper storage to protect

from moisture and heat

GASGA/CTA, Grains  Insect damage For field fungi:

1997  Protection from insect
 Temperature stress
damage
 High water activity  Protection from
temperature stress
 For storage fungi:
 Dry grain as soon as
feasible
 Store under modified
atmospheric conditions

 Protect from damage and

insects

 Sample for fungi

Horne et al., Grains  Droughts  Detect mycotoxin with

1989 black light
 Temporary storage
conditions  ELISA tests

 High moisture storage  Other screening programs

conditions
 Storage facilities with 13
 Immature or broken percent moisture content
kernels
 Anhydrous ammonia
treatment

 Shaking out immature or

broken kernels

Jackson, et al, Apple cider  Damaged fruit  Use tree-picked apples

2003
 Dropped apples  Cull apples

 Washing inadequate for  Washing (not for high

high levels of contamination levels of contamination)

Park et al, 1999 Crops  Insect damage  Effective insect control

 Adequate irrigation
  Drought schedules

 Lack of timely harvesting  Timely harvesting

 High moisture storage  Minimize mechanical

damage during harvesting
 High temperature during
storage  Removal of extraneous
material
 Physical damage during
processing  Dry products to under 10
percent moisture

 Storage on dry, clean

surface

 Clean up and separation of

product

 Thermal inactivation of
mycotoxins

 Chemical inactivation of
mycotoxins

 Ammoniation

 Activated carbons and clays

Suttajit, 1989 Peanuts and corn  High temperature  Drying to less than 9
percent moisture for peanut
 High humidity
and less than 13.5 percent
 Insect damage moisture for corn
 Maintenance of warehouse
at low temperature
  Effective insect control

 Chemical treatment

 Handpicking

 Organic solvents

 Heating and cooking

 Ionizing radiation

USDA/ARS, 2002 Wheat, barley, peanuts,  Aflatoxin and  Future: gallic acid
corn, cottonseed, tree nuts, deoxynivalenol production
 Humidity control
and figs
 High humidity and
rainfall

Table A-5: Summary of Literature Findings on Physical Safety Issues and Preventive Controls
Source Industry/Products Problem/Risk Preventive Controls Suggested
Folks and All foods Any extraneous object or foreign matter in  Raw material inspection and
Burson, food, sources include: specification
2001  raw materials
 Vendor certification and
 poorly maintained equipment letters of guarantee

 improper production procedures  Metal detectors

 poor employee practices  X-ray technology

 Effective pest control

 Preventative equipment
maintenance

 Proper sanitation
 procedures

 Proper maintenance and

calibration of detection
equipment

 Appropriate handling of
packaging material

 Proper shipping, receiving,

and storage practices

 Tamper-proof or tamper-
evident packaging

 Employee education

 Protecting light fixtures

 Controlling contact between

pieces of machinery

Olson, 2002 All foods Hard or sharp objects are food safety hazards,  Periodic checks of metal
further classified into metallic and non- equipment
metallic objects. Sources include:
 Metal detectors
 Processing equipment
 Glass containers  Passing product through
separation equipment

 Visual examination of empty

glass containers or containing
transparent product

 Cleaning with water or

compressed air and inverting
 glass containers

 Monitoring lines for glass

breakage

 Proper adjustment of
capping equipment

 X-ray systems

Stier, 2001 All foods  Mechanical harvesters that collect  Plant audits that evaluate
more than just the product systems
 Improperly maintained equipment  Destoners
and lines
 Magnets
 Packages infested by rodents or
insects  Screens

 Not shielding lights  Washers

 Lack of policies about glass breakage  Proper equipment

maintenance
 Struvite
 Tamper-proof packaging

 Insect/rodent control

 Employee education

 Glass breakage policies

 Scanners for glass

 Metal detectors

American Meat Institute (AMI). 2003. Sanitary Equipment Design. AMI Fact Sheet. March.
The AMI Equipment Design Task Force (EDTF) is comprised of representatives from ten meat and poultry processing companies. The EDTF has
developed operational and equipment guidelines to minimize the spread of Listeria in meat processing plants. The EDTF has identified the critical
nature of equipment design in reducing the risk of contamination of food products by Listeria monocytogenes. The 10 principles of sanitary design
published by the EDTF include; (1) cleanability to a microbiological level, (2) made of compatible materials, (3) accessibility for inspection,
maintenance, cleaning, and sanitation, (4) self-draining that does not allow for product or liquid collection, (5) hermetically-sealed hollow areas, (6)
niche-free parts, (7) sanitary operational performance, (8) hygienic design of maintenance enclosures, (9) hygienic compatibility with other plant
systems, and (10) validated cleaning and sanitizing protocols.
Keywords: meat processing, poultry processing, Listeria, equipment, cleaning, sanitation

BBC News. 2002. Finger Nails Hide Nasty Food Bugs. BBC News. Newssearch.bbc.co.uk/1/hi/health/2148501.stm. July 24.

The study, conducted by Michael Doyle and colleagues at the University of Georgia, indicates that cooks and chefs with long finger nails are more
likely to pass on food bugs, such as E. Coli, to consumers. Further, long and artificial nails are a breeding ground for potentially harmful bacteria. Even
after thorough washing and brushing, pathogens, such as E. Coli, can remain under finger nails and can be passed on to consumers.
Keywords: E. Coli, risk assessment

Beauchat, Larry R. and Jee-Hoon Ryu. 1997. Produce Handling and Processing Practices. Emerging Infectious Diseases. Vol. 3, No. 4.

Contamination of fresh produce with pathogens is not rare. Contamination can occur through contact with soil, raw or improperly composted manure,
irrigation water containing untreated sewage, or contaminated wash water. Contact with mammals, reptiles, fowl, insects, unpasteurized products of
animal origin, and contaminated surfaces (including human hands) are other potential points of contamination. Treatment of produce with chlorinated
water reduces pathogenic and other microorganisms on fresh produce but does not eliminate them. Potential points of contamination need to be
controlled in the field, during harvesting, processing and distribution, in retail markets, at food-service facilities, and at home.
Keywords: fresh produce, pathogens, handling, processing, controls

Bell, Chris and Alec Kyriakides. 2002a. Pathogenic Escherichia Coli. In Foodborne Pathogens: Hazards, Risk Analysis and Controledited by
Clive de W. Blackburn and Peter J. McClure. Woodhead Publishing Limited and CRC Press LLC. Boca Raton, FL.
Controls that can reduce introduction of fecal pathogens into raw milk include effective hygiene and routine monitoring for pathogens. Meat
contamination can be minimized by effective animal husbandry and proper hygiene. The inability to eliminate the pathogen has resulted in the
introduction of steam pasteurization that decontaminates the surface of the meat while retaining the raw meat quality and appearance. Good
agricultural practices (GAPs), microbiological testing, and chlorine washing can minimize contamination of produce. E. Coli can survive fermentation
and therefore products made with this process should be examined with challenge studies to determine the critical control points that require effective
control to minimize contamination. Washing efficacy is dependent on good contact between the contaminant and the microbial agent and agitation
assists in this process. Sprouting processes (alfalfa seeds) have also been implicated inE. Coli contamination. Testing is essential to achieve some
control over this form of contamination. Segregation, effective cleaning, and disinfection are key to preventing post-process contamination.
Keywords: E. Coli, good agricultural practices, risk analysis, pasteurization, controls, testing

Bell, Chris and Alec Kyriakides. 2002b. Salmonella. In Foodborne Pathogens: Hazards, Risk Analysis and Control edited by Clive de W.
Blackburn and Peter J. McClure. Woodhead Publishing Limited and CRC Press LLC. Boca Raton, FL.

Salmonella can be reduced by controlling the feed of food animals and poultry. Birds can also be vaccinated against infection. Animal husbandry
practices also influence the spread of Salmonella. The same practices outlined for E. Coli can be used to prevent contamination of raw milk, raw meat
and poultry, eggs, and produce.
Keywords: Salmonella, controls,risk analysis, animal husbandry

Bell, Chris and Alec Kyriakides. 2002c. Listeria Monocytogenes. In Foodborne Pathogens: Hazards, Risk Analysis and Controledited by
Clive de W. Blackburn and Peter J. McClure. Woodhead Publishing Limited and CRC Press LLC. Boca Raton, FL.

L. monocytogenes is widespread in the environment and occurs in all raw food materials from time to time. The factors that contribute include raw
material or product exposed to contamination, product manufactured with no processing stage to kill the organism, product with few or no
preservatives, and product exposed to post-process contamination. The pathogen can grow at very low temperatures in foods. Control of Listeria is
dependent on preventing contamination of or growth in raw materials, destroying or reducing it if present in raw materials, preventing recontamination
in the factory by the environment, equipment or personnel. Monitoring and testing the product can be appropriate in some products, such as raw milk
or smoked fish. Washing produce with chlorine also reduces contamination with Listeria. With respect to post-process contamination, there is probably
no bacterial pathogen that exploits the food processing environment better than Listeria. The organisms are transferred either from the environment to
the product or via product contact surfaces from aerosols or poor personnel handling practices. The best way to control Listeria is to eliminate it from
the post-processing environment by segregating raw materials and processed materials and by practicing effective cleaning and sanitation. In addition
to food product contact surfaces, the environment should be checked and cleaned, including reservoirs where Listeria can quickly grow to high levels.
Cleaning practices themselves can also spread the organism and should be controlled. Routine monitoring of cleaning efficacy by means of sampling
is also essential.
Keywords: Listeria, risk analysis, controls, handling, post-processing, segregation, cleaning, sanitation

Belluck, Pam and Christopher Drew. 1998. From a Farm in California to Outbreak of Food Poisoning in the East. The New York Times.
January 5.

In July 1996, a small Californian lettuce company was identified as the source of an E. Coli O157:H7 bacteria outbreak. The organic farm did not use
any chemicals to wash lettuce and operated in a barn next to a small cattle pen. The processing shed was completely open on one side, exposing the
large stainless steel tub where the leaves of lettuce were washed before being mixed and shipped in three-pound boxes. Because the cattle were less
than 100 feet away, cow feces could be blown into the shed by wind, washed in by rain, and tracked in on workers' boots, by animals or by the birds
seen flying into the barn. Further, dust from the trucks and cars driving in and out of the parking area and debris from the field were blown into the
wash tank and wash area. In the wash tank, lettuce was swished around by employees, some of whom did not wear gloves, and who had no
acceptable place to sanitize their hands. The company also had no quality control procedures in place. No chlorine, which can be used on organic
foods to kill bacteria, was added to the wash water and no bacterial testing was done.
Keywords: fresh produce (lettuce), organic production, E. Coli, risk assessment 

Berne, Steve. 1997. Simplifying Sanitation. Prepared Foods. March.

Sanitation and good employee hygiene practices are of high importance in ensuring food safety in a plant. Whether making sure employees keep good
hygiene or checking the efficacy of sanitized equipment, keeping the procedure simple will more likely result in employees actually performing the
required tasks. There are a number of systems on the market to ensure hygienic practices among employees and to check for the effectiveness of
equipment sanitation. Meritech's CleanTech® system is a no-touch hand-washing system. The system provides a low-volume warm water wash
followed by an antimicrobial solution spray. It also has a cycle counter so the frequency of hand and glove washing can be monitored. Color-coded
cleaning materials are another way to simplify training and assure proper application. The colors and shapes ensure proper selection, ease
identification and monitoring, simplify training and SSOP understanding. IDEXX has a new Salmonella detection system called Bind® which enables
the manufacturer to test for the existence of Salmonella easily. There also are ATP bioluminescence cleaning validation systems for detection of food
residue, yeast, mold, and bacteria on production surfaces.
Keywords: sanitation, employee hygiene, cleaning, equipment

Best, Daniel. 2000. Chicken or Egg - It's Safety First. Food Processing. April 2.

In-plant construction activities are a major culprit in food borne illness outbreaks in meat plants. Construction activity results in the dissipation of dust
and, with it, microorganisms throughout a plant environment. Some of the control procedures include: avoidance of sample compositing during testing
to detect contamination patterns, testing during operations to reflect true-life conditions in the plant, and nonrandomized testing. For egg producers,
the control of Salmonella hinges on the adoption of multiple controls. Some of these controls include vaccination, competitive exclusion, and in-the-
shell pasteurization. In the U.S., the United Egg Producers Association promotes the adoption of its Five Star program among its members that
combines vaccination with sanitation, pest controls, washing and refrigeration controls.
Keywords: meat processing, construction, risk assessment, controls, eggs, pasteurization, Salmonella

Bissessur, J., K. Permaul, and B. Odhav. 2001. Reduction of Patulin During Apple Juice Clarification. Journal of Food Protection.Vol. 64, No.
8.

Patulin is a mycotoxin produced by a number of molds involved in fruit spoilage. Various methods are currently used to reduce the levels of patulin in
apple juice, including charcoal treatment, chemical preservation using sulfur dioxide, gamma irradiation, fermentation, and trimming of fungus-infected
apples. Many of these processes are expensive and time-consuming. This study found that clarification methods, including pressing, centrifugation,
fining, enzyme treatment, and filtration, were successful in reducing patulin levels in apple juice. However, the process resulted in high levels of patulin
in the pressed pulp after filtration and centrifugation, and this could be harmful if used for animal feed.
Keywords: patulin, mycotoxin, juice, controls  

Boutrif, Ezzeddine. 1999. Minimizing Mycotoxin Risks Using HACCP - The Cracker. International Tree Nut Council. September.

Pre-harvest drought, insect infestation and delayed harvesting are important external factors that contribute to mycotoxin formation. Some of these are
difficult to control, but good agricultural practices (GAPs), such as timely harvesting and use of pesticides are controls that can reduce mycotoxin
infestation. During harvest, mechanical damage should be minimized to prevent subsequent contamination. Crops should also be harvested in a timely
manner to prevent mycotoxin formation due to high moisture levels. While prevention through pre-harvest management is best, should contamination
persist or occur at a later time, processing and storage controls should be in place as well. Processing may involve removal of parts of the commodity,
making it more susceptible to mold formation. Mycotoxins may be eliminated through physical separation or chemical/heat inactivation. Electronic
sorting and handpicking can remove damaged, immature, or mold infested kernels and remove a significant amount of aflatoxins in shelled nuts.
Proper storage is critical, as moisture, heat, and physical damage greatly increases the potential for mycotoxings to form.  Stored products must be
stored under dry and cool conditions that would prevent mold growth.
Keywords: mycotoxins, good agricultural practices, HACCP, risk assessment, controls, separation, storage

Brandt, Laura A. 1999. Hot Dog Days. Prepared Foods. August.

Listeria monocytogenes can grow at refrigerated temperatures if it gets on a product before packaging. Proper heating of hot dogs and meats can,
however, reduce the risk of listeriosis, which affects mostly pregnant women, the elderly and the immunocompromised. Food manufacturers are trying
to control such pathogens through revised plant procedures, packaging innovations, and by adding key ingredients. Some of the preservatives that are
formulated into hot dogs and other processed meats to control the growth of pathogens include sodium nitrite, sodium lactate, sodium diacetate,
polyphosphates, organic acids, smoke flavoring, and bacteriocins, such as nisin and pediocin.
Keywords: meat processing, Listeria, risk analysis, controls, preservatives

Bryan, Frank L., John J. Guzewich, and Ewen C.D. Todd. 1997. Surveillance of Foodborne Disease III. Summary and Presentation of Data on
Vehicles and Contributory Factors; Their Value and Limitation. Journal of Food Protection. Vol. 60, No. 6:  701-714.
Factors that contribute to food borne illness outbreaks are identified in this paper, based on collection of food borne disease outbreak data from
various sources. The contributory factors are situations or operations that allow contamination of foods and survival and/or proliferation of the etiologic
agents in the foods. Contamination can occur with natural toxins, which are toxic elements found in animal or plant substances. Mushrooms are the
most common example. Chemicals can enter foods through spillage or indiscriminate spraying. Misreading labels can also result in accidentally or
incidentally adding poisonous substances to food. An approved ingredient can also be added in excessive quantities by accident, such as too much
nitrite in cured meat or too much ginger powder in gingersnaps. Toxic substances in containers or pipelines can leach into food by contact with highly
acidic foods. Raw ingredient can be contaminated or foods can be obtained from polluted sources. Foods that are not heated and are processed on or
in equipment used previously with raw foods without proper cleaning can become cross-contaminated. Cross-contamination can also occur through
workers who do not wash their hands, through cleaning aids, such as sponges that are not disinfected, or when raw foods touch or drip onto other
foods. Inadequate hygiene on the part of food handlers and inadequate cleaning of equipment and utensils can also result in contamination. Storage of
dry foods in an environment where overhead drippage, back siphonage, airborne contamination, and access for insects and rodents are likely are also
situations conducive to contamination. Other contributory factors are those that allow survival or fail to inactivate the contaminant, such as insufficient
cooking time or temperature or inadequate acidification. Factors that allow proliferation of contaminants include inadequate refrigeration, insufficient
acidification, inadequate fermentation, modified atmosphere packaging (MAP), and more. Data on these factors can suggest preventive measures to
be adopted as practices.
Keywords: outbreaks, contributory factors, risk assessment, cleaning, cross-contamination  

Calicioglu , Mehmet, Nancy G. Faith, Dennis R. Buege, and John B. Luchansky. 2002. Viability of Escherichia coli O157:H7 during
Manufacturing and Storage of a Fermented, Semidry Soudjouk-Style Sausage. Journal of Food Protection. Vol. 65, No. 10:  1541-1544.

This study evaluated the manufacturing process for soudjouk-style sausage on the viability of E. coli O157:H7. Natural fermentation and drying
processes were found to be less effective than the use of a starter culture in reducing levels of E. coli O157:H7. These results indicate that naturally
fermented old-country-type sausage may allow the survival of E. coli O157:H7 in the absence of controlled fermentation, post-fermentation cooking,
and/or an ambient-storage processing step. These results provide a framework for small-scale producers of "old-world" sausage to modify their current
manufacturing processes to enhance product safety with regard to E. coli O157:H7.
Keywords: meat  processing, E. Coli, risk assessment
Chmielewski, R.A.N. and J.F. Frank. 2003. Biofilm Formation and Control in Food Processing Facilities. Comprehensive Reviews in Food
Science and Food Safety. Vol. 2: 22-32.

Microorganisms within biofilms are protected from sanitizers increasing the likelihood of survival and subsequent contamination of food. The type of
food contact surface and topography play a significant role in the inability to decontaminate a surface. Abraded surfaces accumulate soil and are more
difficult to clean than smooth surfaces. In most food processing plants, food contact surfaces are cleaned and sanitized daily. However, many
environmental surfaces, such as storage tank and pump exteriors, walls, and ceilings, are cleaned infrequently. This infrequent cleaning provides the
opportunity for biofilm formation if moisture is present. Nutrient and water limitation, equipment design, and temperature control are important in biofilm
control. Cleaning can be accomplished by using chemicals or combination of chemical and physical force (water turbulence or scrubbing). Sanitizer
selection should be based on whether or not a biofilm is likely to be present and the organic load likely associated with the biofilm. Manufacturing
equipment must be fabricated using appropriate materials. Plants should monitor the microbial load on surfaces with plating of swabbing solution,
contact plates, and the dipstick technique.
Keywords: food processing, biofilms, cleaning, sanitation, controls

Cliver, Dean O. 1999. Eating Safely: Avoiding Foodborne Illness. Prepared for the American Council on Science and Health. June.

Most food borne disease hazards are caused, not by additives or pesticides, but by microbes. Poor sanitation and preparation practices are more
common in food-service operations and in the home than they are in food processing. The scientific knowledge necessary to eliminate pathogens at
the farm level does not yet exist. The main sources of food contamination include human errors in handling, pests and rodents, and temperature abuse
during handling. Prevention or minimization of human error is possible via the enforcement of good sanitary practices, such as thorough hand washing
and glove wear for various cases. There are additional considerations for different categories of foods, such as fruits and vegetables, grains, milk and
dairy products, meat, poultry, fish, egg products, and other food products, such as ethnic foods, spices, honey, mayonnaise and dressings. Some of
these include cold storage and appropriate selection of packaging for fruits and vegetables, pasteurization for milk, irradiation and dipping in a
trisodium phosphate solution for poultry, and proper handling and routine monitoring for toxins for fish.
Keywords: food service, handling, sanitation, risk analysis, controls
Cramer, Michael M. 2003. Building the Self-cleaning Food Plant: Six Steps to Effective Sanitary Design for the Food Plant. Food Safety
Magazine. February/March.

Incorporation of sanitary design into your facility can prevent development of microbiological niches, facilitate cleaning and sanitation, maintain or
increase product shelf life and improve product safety by reducing potential of food borne illness, injury or recall. Food safety hazards that must be
controlled include microbiological (pathogens), physical (glass, metal shavings, wood) and chemical (allergen cross contamination), while preventing
product exposure to sources of filth (dust, rodent excrement). For cooked, ready-to-eat (RTE) products, the study recommends adhering to the
following six basic elements of sanitary design:

 Facility site selection,

 Grounds and dust control - grading grounds for drainage and paving driveway and parking areas,

 Pest control - landscaping design to prevent pest harborage, adequate door seals, use of insect electrocuters,

 Basic facility flow - separate entrance for employees, isolation of lunchrooms, lockers, and restrooms, and use of captive shoes,

 Plant materials - use of easily cleanable materials for floors, walls, and ceilings, caulk-sealed seams, flush doorjambs, no sewage lines running
over production or storage areas, and positive airflow in RTE areas, and

 Equipment - sanitary equipment design and third-party review of equipment design.

The study also recommends cross-functional training of staff in sanitary facility and equipment design to evaluate existing structure and plant
equipment or to facilitate expansion and improvements. This can be accomplished through the use of available literature, or more effectively, through
training courses offered by experts in the field.
Keywords: facility design, equipment, cleaning, sanitation, ready-to-eat, pest control, employee training

CSPI. 2001. FDA Inspections Find Undisclosed Allergens in Processed Food. April 3.

An unpublished government report found that many processed foods are contaminated with peanut or egg allergens but labeling does not disclose
these substances. In an FDA survey of 85 small, medium, and large food plants, FDA and state inspectors found that only half of the firms were cross-
checking ingredients on the labels with ingredients used in manufacturing the product. Some companies modified the product recipe without changing
the label. Others were using contaminated equipment. In another study of cross-contamination issues, companies did not separate production runs or
clean their machinery properly. HACCP has been recommended by CSPI to ensure food does not become contaminated with allergens.
Keywords: allergens, labeling, risk analysis, cross-contamination, HACCP

Curiel, Roy. 2003. Building the Self-cleaning Food Plant: Hygienic Design of Equipment in Food Processing. Food Safety Magazine.
February/March.

As a result of the development and application of increasingly mild preservation technologies, processed foods become more sensitive to microbial
contamination, requiring greater control of the manufacturing process. One way to achieve this added control is to "build in" hygiene into the equipment
used in the food manufacturing facility from the start. Selected criteria and basic requirements for a variety of hygienic equipment characteristics
provide a fundamental overview of areas that can be addressed by food manufacturers. These include:

 Materials of construction. Product-contact materials must be inert to the product under operating conditions, as well as to detergents and
antimicrobial chemicals (sanitizers) under conditions of use.

 Surface roughness. Product contact surfaces should be smooth enough to be easily cleanable. To achieve this quality of surface, polishing or
other surface treatment may be required.

 Crevices. Crevices cannot be cleaned, and as such, will retain product residues that may effectively protect microorganisms against
inactivation. The presence of slide bearings should be considered when writing procedures for cleaning and disinfection. These procedures may
require instructions for both partial or total dismantling of equipment, or for increased cleaning times.

 Screw threads. The use of screw threads and bolts in the product area should be avoided. Where unavoidable, the crevices created should be
sealed, at minimum.
 Sharp corners. Sharp corners in the product area should be avoided. Exceptions are constructions where the sharp corner is continually swept,
such as in lobe pumps. Welds should not be made in corners, but on the flat surfaces, and must be smooth.

 Dead areas. There is a significantly reduced transfer of energy to the food residues (soil) in dead areas in process equipment that is placed
outside of the main flow of cleaning liquids than there is to the soil in the main flow.

 Drainability of equipment and process lines. To make it possible to remove all chemicals from process equipment, the equipment must be
designed to be self-drainable.

 Top rims of equipment. The design of the top rims of product-containing equipment must avoid ledges, where product can lodge and that are
difficult to clean.

 Mandoor covers. Mandoor covers intended to protect the food products may accumulate dirt, which will enter the product in the vessel when
the lid is opened. Policy should specify that no tank is opened during production unless absolutely necessary.

 Shaft passages and seals. Shaft passages and seals may leak product to the outside of the line. Microorganisms may then multiply in the
product and grow back to the product side. Reciprocating shafts should be sealed by means of flexible diaphragms or bellows. To prevent the
ingress of microorganisms in rotating shafts, double seals with microbiocidal barrier liquids should be used.

Keywords: equipment, facility design, cleaning, sanitation, controls

Deibel, Virginia. 2001. Biofilms. Brain Wave Technologies: Thought for Food. Vol. I. No. 1. May.

Chlorine, iodophors, and most quaternary ammonium compounds are ineffective against removing biofilms. The best method of controlling biofilms is
to prevent their development in the manufacturing environment. Effective cleaning and sanitation, which combines physical and chemical methods
within the program, will often prevent the accumulation of food product residues and bacterial cells on equipment surfaces. Cleaning by brushing,
scrubbing, and scraping surfaces is often necessary because once a bacterial cell is released from the protection of a biofilm, it is much less resistant
to subsequent sanitizers. Acid cleaners can be used to remove inorganic soil or material, such as rust, and using soft water for cleaning aids in the
effectiveness of cleaning chemicals. Further, peroxide and peroxide containing sanitizers have been found to be highly effective in removal of biofilms.
Keywords: biofilms, cleaning, sanitation

Deibel, Kurt, Tom Trautman, Tom DeBoom, William H. Sveum, George Dunaif, Virginia N. Scott, and Dane T. Bernard. 1997. A
Comprehensive Approach to Reducing the Risk of Allergens in Food. Journal of Food Protection. Vol. 60, No. 4: 436-441.

The control of food allergens in a food processing plant requires an allergen prevention plan that determines the potential sources of contaminating
allergens and appropriate controls to prevent their introduction into products. A close working relationship with suppliers is important. The ingredient
specification should warrant that the product is free of foreign material, including allergens. An on-site audit is recommended. The supplier should also
provide a list of other products with allergens used on the processing line on which the manufacturer's ingredient is produced. It may be necessary to
raise awareness of suppliers through a training program. Longer run times that minimize changing products and scheduling the allergen-containing
product at the end of a run reduce the chance of allergen contamination. Belts that run materials from one place to another should be covered to
prevent ingredients from falling onto other belts and airflow should be considered. Rework must be clearly identified and documented. Maintenance
tools should be color coded for specific areas or proper cleaning procedures should be specified. A process control check to verify that known
allergens are listed on the ingredient label is essential. It is also important to verify that the food product is placed in the appropriately labeled package
and that the appropriate label is placed on the product. Bar code scanners are sometimes used for this. The design of new lines or equipment must
minimize the potential for human error. It is necessary to use physical detachments or lockouts of high-risk equipment if lines are used for both
allergen and nonallergen containing foods. Crossover points should be enclosed. Verification of cleaning between allergen and non-allergen containing
product runs is essential. Some equipment may need to be disassembled and manually cleaned. ELISA tests are being developed for allergens that
could help verify the cleaning procedures, which is currently limited to visual inspection. A major problem is that older equipment may not be designed
to verify visual cleaning. Employee training programs have proven to be one of the most effective tools for preventing inadvertent contamination with
allergens.
Keywords: allergens, controls, prevention, suppliers, equipment, labeling, cleaning, employee training

Donnelly, Catherine W. 2002/2003. Inside Microbiology: Getting a Handle on Listeria. Food Safety Magazine. December 2002/January 2003.
Listeria is a very common pathogen that can be found almost anywhere in the environment. Some of the  high risk foods for Listeriacontamination
include smoked seafood, ready-to-eat (RTE) meat and poultry products, soft cheeses, raw milk and Mexican-style cheeses, especially products not
commercially prepared. The main control mechanism that the food industry has in place for protecting products like RTE meat and poultry
from Listeria contamination is to clean and sanitize to eliminate the pathogen and then to conduct environmental testing and monitoring to verify that
sanitation efforts have been successful. Listeria establishes niches in food processing plant environments and unless there is absolutely rigorously
focused sanitation, it can persist for months or years within food plant environments. Further, most food processing plants in the U.S. were not
designed with control of this pathogen in mind. For example, drains may have been placed in undesirable high-traffic floor areas where cross-
contamination can easily occur. One of the responses to the Listeria crisis in the mid-1980s in the dairy industry was major plant redesign activities,
including redesign of floors and drains so they could be effectively cleaned and sanitized and increased protection of the filling equipment from air
contamination. There are many interventions used as part of the sanitation program in food companies, including the use of advanced chemical
sanitizers to clean and sanitize surfaces and the rotation of those chemical sanitizers so that organisms do not have a chance to develop resistance
over time, employee gowning protocols, easily cleanable boots, segregation of raw materials and food production areas, use of foot baths, foaming
sanitizers and handwashing systems. Another intervention strategy involves making changes within the products themselves. Kraft Foods, for
instance, has developed a potassium lactate and sodium diacetate preservative system that, when used in the formulation of products like hot dogs,
creates a good chemical barrier to the growth of Listeria. Additional control technologies include electronic pasteurization, especially when done in the
package, irradiation, other non-thermal processing intervention technologies, such as high pressure processing (HPP). Because the greatest risk
of Listeria growth is through process contamination, however, it is very important that the intervention is applied in final package with any of these
technologies.
Keywords: Listeria, cleaning, sanitation, facility design, intervention, controls

Doyle, Ellin M. 1999. Literature Survey of the Various Techniques Used in Listeria Intervention. FRI Briefings. Food Research Institute,
University of Wisconsin. November.

Recalls, illnesses, and deaths associated with Listeria in food products have been reported over the past years. These incidences indicate that
additional techniques may be needed for controlling Listeria in food processing plants and especially in those processing ready-to-eat (RTE) products.
In response to the Listeria issue, on March 8, 1999, the Food Safety and Inspection Service (FSIS) of the USDA amended the Federal meat and
poultry inspection regulations of certain RTE meat and poultry products. The new performance standards indicate the objective level of food safety
performance that establishments must meet. The amended regulations, however, allow establishments to develop and implement processing
procedures customized to the nature and volume of their production. The techniques covered in the literature survey include the use of organic acids,
other preservatives, and bacteriocins in product formulations, application of additional process steps, such as thermal processes, irradiation, high
pressure, pulsed electric field pasteurization, electrolyzed oxidizing water, ultraviolet light, and ultrasound, and use of modified atmosphere packaging
(MAP) to suppress growth of food borne pathogens.
Keywords: ready-to-eat, Listeria, intervention, regulation

Doyle, Michael P. 2000. Food Safety Issues Arising at Food Production in a Global Market. Journal of Agribusiness. Vol. 18, No. 1:  129-133.

Food borne illness is a major public health concern in the United States, with an estimated 76 million cases occurring annually. More than 90 percent
of food borne illnesses of known cause are of microbial origin. Animals used for foods and their manure are leading sources of food borne pathogens.
Recent advances in the investigation of food borne outbreaks using genetic fingerprinting techniques enable epidemiologists to identify outbreaks and
sources of implicated foods that heretofore were undetected. Tracebacks of outbreaks to the point of production place greater liability and
responsibility on food producers. Implementation of Hazard Analysis Critical Control Point (HACCP) systems at the point of production is essential to
increasing the safety of foods of animal and plant origin.
Keywords: outbreaks, tracking, HACCP 

Drew, Christopher and Pam Belluck. 1998. Deadly Bacteria a New Threat to Fruit and Produce in U.S. The New York Times. January 4.

Several outbreaks of deadly bacteria in juice and produce have occurred in recent years.  Lettuce from a small producer caused an outbreak of E.
Coli O175:H7  in three states and sickened at least 61 people.  The producer operated under unsanitary conditions, with the lettuce being washed and
packaged less than a hundred feet from a cattle pen.

In mid-1995, orange juice served at Walt Disney World was contaminated with Salmonella.  The contamination was believed to be caused by a toad
that crawled onto the juice processing equipment.  In response, the state of Florida drafted rules that required a two-step cleaning process of fruit,
including an acid-based detergent and chlorine and that prevented the use of split or decayed fruit. 
In late 1996, 70 people became sick after consuming Odwalla's fresh-squeezed apple juice.  Odwalla's juice was not pasteurized at the time and thus
required additional controls, like sorting out damaged fruit and washing the remaining fruit with sanitizers. Documents show, however,  that in the
weeks before the outbreak, Odwalla began relaxing its standards on accepting blemished fruit. Apples with defect rates of 25 to 30 percent were used,
compared to the 5 percent that was normally acceptable to Odwalla in the past. Furthermore, a QA manager's recommendation to add a chlorine rinse
to the acid rinse already being used was not implemented because another executive feared it would affect the taste of the juice (the brand of acid
wash Odwalla was using was only able to kill all the E. Coli O175:H7 in 8 percent of lab tests and should not have been used without chlorine). 
Another quality assurance manager suggested testing for Listeria monocytogenes again, which had been found in orange and apple juice in 1995, but
dropped the plan after resistance from upper management.  In the outbreak case, the company was accused of using a batch of rotten apples, some
with worms in them. Odwalla denied that the company took any such risks, but recognized that their safety systems failed. As a result of the outbreak,
Odwalla hired safety consultants and voluntarily implemented a Hazard Analysis Critical Control Point (HACCP) plan. Odwalla also started using
pasteurization to kill all pathogenic bacteria in its apple juice given that the skin gets mashed into the juice.  Odwalla decided not to pasteurize orange
juice given that the juice can be extracted without touching the rind. 
Keywords: outbreaks, juice, fresh produce (apples), E. Coli, HACCP, pasteurization

Economic Research Service (ERS). 2001a. Industry Food Safety Actions: Conventional Practices and Technologies. U.S. Department of
Agriculture, Economic Research Service. February 12. www.ers.usda.gov/briefing/IndustryFood Safety/convenprac/.

In meat and poultry processing, the primary means of preventing the spread of pathogens is with conventional work practices, such as effective
sanitation programs and the use of work programs that minimize opportunities for product contamination. Some of the most effective work practices as
identified by food safety experts and plant managers include:

 Animal or meat testing for pathogens,

 Knife sterilization and temperature, airflow, and other process controls,

 Improved evisceration and hide, hair, and feather removal techniques,

 Employee work methods and empowerment for food safety decisions,

 Production line layouts that minimize cross-contamination,

 Pathogen testing of equipment and plant environment,

 Use of labor-saving equipment that reduces cross-contamination,

 Rate at which workers' hands, tools, and equipment are sterilized, and

 Management strategies, like the Hazard Analysis and Critical Control Points (HACCP) system.

These methods may be particularly important for small plants that may not have the resources to buy expensive technologies, such as automated
carcass steam pasteurizers or irradiation equipment. Some of the conventional technologies available to meat and poultry processors include (1)
steam pasteurization and/or vacuuming systems, (2) hot water sprays, (3) use of chlorinated water and other sanitizers to sanitize the product, work
surfaces, and equipment, (4) competitive exclusion (applicable to poultry), and (5) automation of manual processes.
Keywords: meat processing, poultry processing, controls, sanitation, testing, work practices, HACCP

Economic Research Service (ERS). 2001b. Industry Food Safety Actions: Unconventional Technologies/Irradiation. U.S. Department of
Agriculture, Economic Research Service. February 22. www.ers.usda.gov/briefing/IndustryFood Safety/unconventech/.

Food processing firms, universities, and the USDA are conducting research on many new technologies to control pathogens. One of these
technologies commonly accepted as a tool to kill all pathogens is irradiation. Depending on the type of food and radiation dosage, irradiation can be
used to sterilize packaged food for storage at room temperature, eliminate or reduce pathogens, delay spoilage, control insect infestations, delay
ripening, and inhibit sprouting. The capital costs of food irradiation equipment depend primarily on the irradiation source, food product, plant volume,
and facility design. Further, there are substantial economies of scale involved in food irradiation with the cost per pound of irradiated meat decreasing
by increases in annual volume.
Keywords: pathogens, irradiation, costs

Ennen, Steve. 2003. Safety Tops Concerns for Coming Year. Food Processing. January 1.
According to Food Processing's 2003 Manufacturing Survey, food safety is one of the most important issues facing the food industry today. The
majority (64 percent) of respondents indicated that their companies have either implemented new food safety and sanitation initiatives or intend to do
so. Among these respondents, 84 percent noted that their companies will address food safety with employee training. Another 73 percent indicated
that their companies have plans to tweak or implement HACCP plans. Meanwhile, 60 percent of respondents said that their companies plan to improve
pest control, while 55 percent said that plans to augment sanitation equipment are underway or completed. Among the many scientific safety initiatives
cited were improved E. Coli testing, stronger biosecurity measures, audits, access restrictions, implementation of date/lot/batch coding, metal
detection, and x-ray machines. Overall, 22 percent of respondents indicated that their companies had no plans to improve safety this year but no
reasons were given for their decision.
Keywords: food safety initiatives, sanitation, employee training, HACCP, pest control

Erickson, J.P. 1995. An Assessment of Escherichia coli O157:H7 Contamination Risks in Commercial Mayonnaise From Pasteurized Eggs
and Environmental Sources, and Behavior in Low-pH Dressings. Journal of Food Protection. Vol. 58, No. 10: 1059-1064. [only have abstract]

This study evaluated E. Coli contamination risk during commercial mayonnaise and mayonnaise dressing production, and E. Coli behavior in low-pH
dressings. Two potential contamination sources, pasteurized liquid eggs and wet environmental areas were observed for 4 months in 3 processing
plants. The study concluded that if plants use pasteurized eggs and GMPs, plants are unlikely to harbor E. Coli. Further, stringent hygienic practices
by consumers and food-service workers can prevent microbial pathogen contamination during preparation, handling, and storage of mayonnaise-
ingredient recipes, such as chilled perishable salads and salad-bar dressings.
Keywords: risk assessment, E. Coli, dressing (mayonnaise), eggs, employee hygiene

FDA/CFSAN. 2001a. Draft Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected
Categories of Ready-to-Eat Foods. January.

This risk assessment includes analysis of available scientific information and data in the development of exposure assessment and dose-response
models to predict the public health impact of Listeria monocytogenes from 20 RTE food categories. Outbreaks often are due to a breakdown in food
safety controls that have been put in place to prevent such occurrences. Outbreaks of listeriosis have been linked to plant renovations, use of defective
processing equipment, and inadequate pasteurization. Maintenance of food safety controls and strengthening of existing controls is therefore
paramount.
Keywords: ready-to-eat, risk assessment, Listeria, outbreaks, controls

FDA/CFSAN. 2001b. Seafood HACCP Alliance HACCP Training Curriculum Manual: Hazards - Biological, Chemical, and Physical (Chapter
2). November.

Food safety hazards are typically categorized into three classes: biological, chemical, and physical. Biological hazards include harmful bacteria,
viruses or parasites, such as Salmonella, Hepatitis A, and Trichinella. Chemical hazards include compounds that can cause illness or injury due to
immediate or long-term exposure. Chemical hazards can be subdivided into naturally occurring chemicals (mycotoxins, allergens, marine toxins),
intentionally added chemicals (preservatives, nutritional additives, color additives), and unintentionally added chemicals (pesticides, veterinary drugs,
toxic elements, food processing plant chemicals such as cleaners). Risks increase when chemicals are not controlled or the recommended treatment
rates are exceeded. Physical hazards, on the other hand, include foreign objects in food that can cause harm when ingested, such as metal or glass
fragments.
Keywords: seafood processing, HACCP, biological hazards, chemical hazards, physical hazards

FDA/CFSAN. 2001c. Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial
Hazards on Fresh and Fresh-cut Produce. September 30.

The extensive study identifies the various production practices that may influence the risk of contamination and exposure to pathogens in fresh and
fresh-cut produce. Key areas of concern are practices related to prior land use, adjacent land use, field slope and drainage, soil properties, crop inputs
and soil fertility management, water quality and use practices, equipment and container sanitation, worker hygiene and sanitary facilities, harvest
implement and surface sanitation, pest and vermin control, effects of domesticated animal and wildlife on the crop itself or packing area, post-harvest
water quality and use practices, post-harvest handling, transportation and distribution, and documentation and recordkeeping. Some of the control
measures recommended include temperature control, physical removal of microorganisms, use of cleaning agents, such as chlorine, chlorine dioxide,
bromine, iodine, quaternary ammonium compounds, acidic compounds with or without fatty acid surfactants, alkaline compounds, peracetic acid,
hydrogen peroxide, and additional/new processing technologies, such as ozone, irradiation, and biocontrol.
Keywords: fresh produce, risk analysis, controls

FDA/CFSAN. 2001d. Food Allergen Partnership. January.

In October of 1998, FDA formed a partnership with the Minnesota Department of Agriculture (MDA) and the Wisconsin Department of Agriculture,
Trade, and Consumer Protection (WDATCP). One of the goals of the partnership was to obtain current information on allergen awareness and to
provide training and information to the industry about effective control measures. Three ice cream, 31 bakery, and six candy manufacturers were
inspected in Minnesota and 10 ice cream, 23 bakery, and 12 candy manufacturers were inspected in Wisconsin . A questionnaire was used to assess
industry practices. Routine regular inspections were conducted. Six establishments in Minnesota and ten establishments in Wisconsin had written
recall procedures addressing allergens. In 25 percent of establishments inspected, raw ingredients, such as nuts or artificial colors were omitted from
the label. Of firms that felt they had adequate label review policies, 15 percent were found to have discrepancies. Further, 38 percent of the Minnesota
and 64 percent of Wisconsin firms without label verification procedures were found to have undeclared allergen residues in their products. Most firms
discarded labels after formulation changes. Further, of the 37 of 85 firms that utilized rework, roughly half had product that tested positive for allergens.
Only four percent of establishments inspected used analytical testing to verify the effectiveness of cleaning and sanitation procedures. In Minnesota,
10 of the 40 firms had SSOPs that were proven effective and followed. In many establishments, common utensils were used in the production of
allergen and nonallergen-containing products. Cross-contamination also occurred when baking sheets were reused without cleaning. Production was
frequently not scheduled or sequenced for allergen control. Many firms also did not have dedicated equipment for allergen and nonallergen production.
Cleaning of these lines was found to be inadequate, rinsing with water only or cleaning only at the end of the day. Further, only three of the 85
Minnesota and Wisconsin firms utilized personnel that were trained and dedicated to allergen control. When product was tested, a number of samples
were positive for allergen residue. Many establishments changed operating procedures as a result of the findings from these inspections, including
many sanitation changes. A number of establishments also did not make changes, however. In sum, industry awareness is essential in the control of
potential allergen residue risk. Possible controls include scheduling production of allergen-containing products at the end of manufacturing runs,
appropriate labeling, proper use of rework, equipment and system design considerations, thorough cleaning of lines after running allergen-containing
products, effective management of label inventories, control of ingredients from suppliers and training of employees.
Keywords: allergens, industry practices, labeling, testing, sanitation, cross-contamination, cleaning, employee training, controls
FDA/CFSAN. 2001e. Food Allergen Monitoring. January.

Food allergens can become part of food unintentionally by means of misformulation, improper scheduling, use of rework, improper sanitation, and
cross-contamination. Controls include good manufacturing practices (GMPs), minimizing equipment exposure to the allergen, designating and labeling
equipment for use with specific products, enclosing equipment and avoiding crossovers, adding allergens near the end of a process, scheduling longer
run times, running non-allergen products before products with allergens, producing allergen products on a separate day from non-allergen products,
color coding tools for allergen and non-allergen products, adequate controls on rework, discarding old labels and packaging materials, conducting label
audits, appropriate sanitation, and training on allergens and proper sanitation.
Keywords: allergens, risk assessment, controls

FDA/CFSAN. 2001f. Chapter 19:  Allergens, Food Intolerance Substances and Prohibited Food and Color Additives. Fish and Fisheries
Products Hazards and Controls Guidance. June.

Some food and color additives can cause an allergic-type reaction in consumers. Sulfiting agents and FD&C Yellow #5 are additives used on fish and
fisheries products that can cause such reactions. A number of foods also contain allergenic proteins. Possible preventive measures include declaring
the presence of the allergen, testing for residue, requiring supplier certification that the product is allergen free, and reviewing labeling of raw materials.
Keywords: allergens, prevention, testing, labeling

FDA/CFSAN. 1999a. Potential for Infiltration, Survival, and Growth of Human Pathogens within Fruits and Vegetables. November.

Water, insects, and birds may serve as vectors resulting in contamination of damaged or decayed sites on the rind of fruits and vegetables. Under
certain conditions, pathogens can infiltrate and become internalized in the fruit or vegetable. Fruit can also become contaminated if immersed in cold,
contaminated water or if vulnerable external points of fruit are immersed in contaminated water. Equipment may also cross contaminate both fresh
apple and orange juice during processing. Despite their natural acidity, pathogens are able to survive in these fruit juices. Thus, sanitation is extremely
important in juice processing.
Keywords: fresh produce, risk analysis, juice, sanitation 
FDA/CFSAN. 1999b. Preliminary Studies on the Potential for Infiltration, Growth, and Survival of Salmonella enterica Hartford and
Escherichia coli O157:H7 Within Oranges. November.

Study indicated that infiltration of pathogens into oranges can occur. This study found that oranges can internalize pathogen at an uptake frequency of
3 percent. Observed infiltration levels may be conservative because intact fruit was used as well as a decontamination step. Cold storage reduced
survivability of E. Coli but not of S. Hartford. These findings indicate that refrigeration cannot be used to ensure reduction of microbial pathogens.
Further study is required to determine factors that lead to contamination and infiltration, with respect to cultivation, harvesting, transport, storage, and
processing.
Keywords: fresh produce (oranges), E. Coli, Salmonella, cold storage

FDA/CFSAN. 1999c. Report of 1997 Inspections of Fresh, Unpasteurized Apple Cider Manufacturers. January.

Contamination of apple cider likely occurs during the growing and harvesting phase, through direct or indirect contact with animal feces. Washing
apples may reduce surface contamination, but studies also report pathogens can migrate into the tissue of the apple through the flower end or breaks
in the skin of the apple. Best practices include culling; initial washing; prompt processing or refrigerated holding; final culling, washing, and brushing; a
closed processing system; equipment sanitation; environmental sanitation; and employee hygiene. Applying these best practices does not guarantee
pathogen-free cider, but when applied along with HACCP, will substantially reduce the likelihood of contamination. Other possible control methods
include pasteurization, UV treatment, high pressure sterilization, electric resistance heating, aseptic packaging, ultrafiltration, pulsed electric field,
electromagnetic fields, pulsed light, ozone treatment, hot water rinses, irradiation, and freezing and thawing. Studies are needed to assess the
effectiveness of some of these treatments and others (such as pasteurization) have been proven effective. Redundant processing controls, such as
duplicating culling and washing/brushing steps at several points during the chain and use of sanitizer dips and sprays and preservatives, have also
proven effective in other segments of the food industry. However, the inspection indicated that these practices are largely absent in the cider industry.
Microbiological testing of products and the environment would also be helpful in assessing effectiveness of the controls in place.
Keywords: cider, fresh produce (apples), best practices, HACCP, controls, pasteurization, testing

Floyd, Bruce M. 2000. Battling Allergen Contamination. Food Product Design. December.

Companies must review their products to determine whether it contains any of the known 160 allergens. The people reviewing the products must
receive training to recognize problematic families of foods. Other controls include scheduling, separation of products, staging areas, line clearance,
and verification. Nonallergenic products should be scheduled first, preceded by a thorough cleaning of the line. Allergenic materials and nonallergenic
materials should be stored separately, with dedicated bins, scoops and weighing buckets. Dust control is also essential and required by GMPs.
Staging (putting all of the ingredients for a specific batch on a pallet prior to taking them to the processing area) will also eliminate errors before they
occur. Removing all the ingredients from the weighing and production areas of a line and checking for cleanliness are also helpful in avoiding
contamination. Test kits are also available that can detect the presence of peanut, egg, and milk at very low levels. These kits have to be applied by a
technically experienced person who will need additional training. However, random, inadvertent contamination will be difficult to detect with testing. A
good system builds preventative efforts into earlier components of the production process. Unavoidable contamination can occur if it is impossible to
verify that all allergen residue has been removed from equipment or if plant design prevents separation of lines, increasing the likelihood of dust
carryover. Furthermore, contamination of raw materials may be beyond a manufacturer's control. In these cases, companies may need to redesign the
plant or add warnings to the label, although these should be a last resort since they eliminate potential customers. Allergen contamination prevention
boils down to improved equipment design, plant layout, material handling within the plant, supplier control and verification, and employee training. If
allergen contamination still cannot be avoided, warnings should be put on the label.
Keywords: allergens, product review, prevention, controls, separation, facility design, equipment, employee training, handling, labeling

Floyd, Bruce M. 1999. Testing for Foodborne Pathogens. Food Product Design. July.

The article addresses pathogen-testing procedures for products that are minimally cooked by the consumer, including all RTE products, as well as
microwaveable products that may not receive sufficient heating to kill the bacteria in question. Pathogen testing involves environmental testing,
equipment swabbing and product testing of raw materials and finished product. If the product is not cooked in its packaging material, packaging should
be tested as well. The quantity and type of testing depends on the product. GMPs must be in place and have been validated before designing a testing
program. Traffic patterns need to be examined and environmental testing should occur in areas that have the potential to contaminate processing and
packaging areas and their surrounding space. The particular organisms tested for will be those that are a problem in the given industry. Processes
without a cook step and products that the consumer minimally processes, have a much greater need for testing on the raw material side. Under such a
testing program, breaches will be detected before they reach crisis proportions.
Keywords: pathogens, testing, packaging, good manufacturing practices

Folks, Heather and Dennis Burson. 2001a. Food Safety: Chemical Hazards. University of Nebraska Cooperative Extension. 

Raw materials can be contaminated with pesticides, antibiotics, hormones, toxins, fertilizers, fungicides, heavy metals, and PCBs. During processing,
contamination can occur with food additives, preservatives like nitrite, flavor enhancers, color additives, peeling aids, and defoaming agents.
Lubricants, paints, and coatings from buildings and equipment can also contaminate food. Further, pesticides, cleaners, and sanitizers can
contaminate products. Chemical hazards can be controlled by storing them separately from food and packaging materials. Cleaning agents and
sanitizers should be thoroughly rinsed from equipment during cleanup. Only USDA-approved chemicals should be used. Pest control should be
performed by professionals and chemical residues in incoming food products should be controlled. An inventory should be kept of all chemicals,
colorings, and additives. Audits should be conducted of chemicals used, employees should be trained adequately, and in-house testing of product
should be conducted.
Keywords: chemical hazards, risk assessment, controls, separation, cleaning, pest control

Folks, Heather and Dennis Burson. 2001b. Food Safety: Physical Hazards. University of Nebraska Cooperative Extension.

A physical hazard is any extraneous object or foreign matter in a food item, which can cause illness or injury to a person consuming the product.
Sources for such contaminants include raw materials, badly maintained equipment, improper production procedures, and poor employee practices.
Controls include raw material inspection and specification, vendor certification and letters of guarantee, metal detectors, x-ray technology, effective
pest control, preventative equipment maintenance, proper sanitation procedures, proper maintenance and calibration of detection equipment,
appropriate handling of packaging material, proper shipping, receiving and storage practices, tamper-proof or tamper-evident packaging, and
employee education. Less obvious measures, such as protected lighting fixtures and controlling contact between pieces of machinery, should also be
considered.
Keywords: physical hazards, risk assessment, controls

Food Quality Magazine. 1997. Did You Wash Your Hands? Food Quality Magazine. March.
Good sanitation is one of the most important aspect of working in a food processing plant. To ensure good sanitation, Haagen-Dazs has installed
automatic washing systems at various locations in its processing area. The system is claimed to be 60 percent more effective in removing pathogenic
bacteria from hands than manual hand washing. New versions of the automatic handwashing system also incorporate a boot dip for washing boots
and an air curtain for drying hands.
Keywords: sanitation, cleaning, employee hygiene

Gagliardi, J.V., P.D. Millner, G. Lester, and D. Ingram. 2003. On-Farm and Postharvest Processing Sources of Bacterial Contamination to
Melon Rinds. Journal of Food Protection. Vol. 66, No. 1:  82-87.

This study assessed the sources and extent of melon rind contamination in production fields and at processing and packing facilities. In the spring of
1999, cantaloupe sampled from two sites in the Rio Grande River Valley showed that postharvest-processed melon rinds often had greater plate
counts of bacterial contaminants than field-fresh melons. Sources of coliforms and enterococci were at high levels in melon production soils, especially
in furrows that were flood irrigated, in standing water at one field, and in irrigation water at both sites. At one processing facility, wash water pumped
from the Rio Grande River may not have been sufficiently disinfected prior to use. Because soil, irrigation water, and process water were potential
sources of bacterial contamination, monitoring and management on-farm and at processing and packing facilities should focus on water quality as an
important control point for growers and packers to reduce bacterial contamination on melon rinds.
Keywords: fresh produce (melons), production, processing, risk analysis, water quality

GASGA/CTA. 1997. Mycotoxins in Grains. Technical Leaflet. No. 3. June.

There are five types of mycotoxins that occur often in food: deoxynivalenol, zearalenone, ochratoxin, fumonism, and aflatotoxin. There are those that
invade before harvest, called field fungi, and those that occur after harvest, called storage fungi. The primary factors influencing the growth of field
fungi are insect damage and temperature stress. For storage fungi, these are moisture content and temperature. To prevent growth in stored grain, the
grain should be dried as soon as feasible. Storage under modified atmosphere conditions is desirable. The grain should be protected from damage
and insects. Under storage, the grain can be sampled for fungi. [Note: Article is written in an international tone and thus, may be less applicable to U.S.
operations.]
Keywords: mycotoxins, fungi, prevention, grains, storage

Gregerson, John. 2003. Plain Talk About Allergen Management. Food Processing. January 29.

Manufacturers are sometimes using a "may contain" statement on labeling that critics argue is regarded as a substitute for GMPs. Problems have
been uncovered by FDA inspections that include conveyors handling both allergen and non-allergen containing products which were only washed
once a year, use of common utensils with both types of products and reusage of baking parchments. Another case included an ideal operation in terms
of best practices, with the exception that a table contained surface knicks that caused cross-contamination. Many processors have begun to include
allergens as part of their HACCP plan. Manufacturers should obtain full ingredient lists from their suppliers as well as investigate whether any
allergenic processing aids or rework have been incorporated into the product, or whether product carryover from common equipment might have
occurred. During product development, manufacturers should consider whether any non-functional or non-characterizing allergens can be replaced.
Allergenic and non-allergenic runs should be done on dedicated lines, or otherwise scheduled at the end of the day and followed by a complete clean
up. Allergens should be made in successive batches and runs should be longer to further minimize potential carryover. Rework areas, equipment and
containers should be clearly identified, as well as the rework itself, through use of color tags, containers, plastic liners or bar coding. Equipment should
be made of sanitation-friendly material, like stainless steel. ELISA tests can also be conducted.
Keywords: allergens, labeling, equipment, sanitation, HACCP

Gregerson, John. 2002. Third Annual Best Manufacturing Practices Survey. Food Engineering. February.

Food Engineering conducts an annual survey of best manufacturing practices in the food industry by interviewing a panel consisting of more than 400
food manufacturing professionals in top management, production management, engineering, quality control, packaging, and purchasing across every
segment of the food industry. More than 80 percent of survey respondents work at plants with 249 employees or less. When asked about
maintenance, 25 percent of respondents said they will run equipment until it breaks, while nearly 56 percent indicated that their plant maintains routine
preventive maintenance schedules. Only 2.6 percent are employed in plants where condition monitoring tools are used and 8.5 percent have a
predictive maintenance program. Employee training and HACCP programs continue to dominate efforts to improve food safety. Anti-microbial and
rapid microbial detection systems are not as prevalent but 53 percent of respondents who use them rate them as very useful, compared to 40 percent
of plants that use HACCP (either voluntarily or as mandated). Only 2 percent of respondents involved in voluntary HACCP programs rated them as not
useful, compared to 14 percent involved in government-mandated HACCP programs. Employee training rated lowest among all food safety measures
implemented. About one-third of those whose plants emphasized employee training in food safety rated it as "very useful." Half of the plants that
added sanitary equipment rated their results as very useful, compared to 41 percent whose plants improved employee training to improve sanitation.
Keywords: best practices, HACCP, employee training, equipment, maintenance, sanitation

The Hartford. 1999. Food Processing: Salmonella. The Hartford Loss Control Department Technical Information Paper Series.

A number of states, along with the United Egg Producers, have established voluntary quality assurance programs for egg producers. Participants
agree to follow certain practices, including cleaning and disinfecting hen houses between flocks, adopting strict rodent control measures, washing eggs
properly, refrigerating eggs between transport and storage, putting in place biosecurity measures, monitoring mortality of chickens, using salmonella-
free chicks and pullets. Newer technologies are currently being explored, including in-shell pasteurization, irradiation, spraying newly hatched chickens
with Preempt (a biotechnology product, approved by FDA, that contain bacteria that reduce Salmonella colonization of chicks' intestines). The risk
management control that can have the greatest effect in controllingSalmonella is the implementation of HACCP at all levels of food processing.
Keywords: eggs, Salmonella, animal husbandry, controls, HACCP

Hegenbart, Scott. 1996. Reinforcing the Links in the Food Safety Chain. Food Product Design. March.

In 1989, the Council for Agricultural Science and Technology (CAST), Ames, IA, created a task force to determine the state of knowledge about U.S.
food borne disease risks. The task force's findings were released in a 1994 report entitled "Food Borne Pathogens: Risks and Consequences." Among
the report findings are that the application of Hazard Analysis Critical Control Point (HACCP) systems can reduce the likelihood of foodborne illness.
By designing hurdles along the entire length of this chain, the reduction of incidence and prevention of contamination would contribute to the overall
safety. Pathogenic bacteria are usually the first targets of any food safety discussion because they are behind 90 percent of all food safety outbreaks.
In dairy farming, the sanitation of the milking facility, cleaning of the cows' udders prior to milking, and careful thermostatic control of milk holding tanks
are among the contributors to microbial control. Keeping Salmonella in check in poultry involves controls, such as more frequent changing of the
bedding materials in holding pens, testing of feed, and competitive exclusion. Fruits and vegetables contain naturally occurring toxins most of which
are destroyed or inactivated by processing and cooking. Because consumers are eating more fresh vegetables raw, however, it becomes important to
control/minimize naturally occurring toxins. Eliminating the stress through the use of herbicides, pesticides, etc., can help reduce the natural toxins a
plant produces. Controlling weeds is also critical because they may contain toxins and they could be harvested along with the crop. Mycotoxins that
are produced by certain types of mold also pose a public health risk. Thus, controlling mold growth early in the food chain is critical since many
mycotoxins are stable to the heat of subsequent processing. Fields must be given adequate moisture (through irrigation) and pest protection because
drought and blight leave plants more susceptible to mold. Preliminary research is further revealing that specific soil conditions may reduce the plant's
tendency toward mold growth. Fish and seafood commonly contain parasites. Because these foods are still primarily harvested rather than farmed,
less control over the source is possible. Instead, more attention is given to post-harvest seafood handling because most parasites can be destroyed by
processing/cooking heat and by freezing. Viruses also are readily destroyed by heat. The ones of greatest concern are Hepatitis A and Norwalk virus,
which do not enter the food chain at this early stage and are usually the result of contamination by handlers. In the early links of the food chain, most
viral food safety risks come from seafood.
Keywords: food chain, pathogens, risk analysis, HACCP, controls, good agricultural practices

Higgins, Kevin T. 2003. Food Safety:  Say Goodbye to the Burn. Food Engineering. January.

Food and beverage processors have to determine which food safety initiatives give them the greatest return on investment. In-package sterilization is
the solution to post-processing contamination associated with Listeria and is slowly gaining more acceptance in terms of irradiation of meat. Brawley
Beef in California employs multiple food safety interventions, including steam vacuuming, organic acid sprays, washes and rinses, thermal
pasteurization, and irradiation. Ultra high pressure pasteurization can also be applied in package, as is done by Avomex, Inc. Coating drains or
equipment parts with antimicrobials are other applications that help keep facilities clean and safe, although they do not eliminate the need for cleaning
and sanitizing surfaces. Given that the economic payoff of these investments is not clear, processors have to do a qualitative assessment of the
technologies available to help them meet their food-safety objectives.
Keywords: food processing, post-processing, packaging, pasteurization, cleaning, sanitation, costs

Higgins, Kevin T. 2002. The Culture of Clean. Dairy Foods. November.

The key to keeping food plants safe is to develop the right strategies to make sure that sanitation standards are met. Effective training is essential and
language may be a barrier. Bilingual signage manuals and instructional manuals can fall short when multiple languages are spoken. A picture and
symbol based approach can be an affordable and effective solution. Experts can be helpful in motivating employees to comply with fundamental
sanitation principles. Various aids, like keypad controls on hand sanitizers and sensor-equipped paper towels are also available. Contour mapping and
spatial analysis can be used to proactively manage pest control. Overall, numerous technologies are available to sanitize a plant, but they are only
effective if supported by plant employees.
Keywords: sanitation, employee hygiene, employee training

Higgins, Kevin T. 2001. Are Maintenance Needs Predictable? Food Engineering. May.

Predictive maintenance is scarce among food processors. Further, firms, who have reportedly adopted predictive maintenance, typically monitor some
critical equipment while continuing preventive schedules and reactive maintenance on less important assets. A survey by Entek IRD suggests that only
5 percent of plant maintenance is predictive in nature. Another 25 percent is preventive and at least half of that work is unnecessary. Most of the rest is
corrective despite the fact that it costs more than three times as much as predictive steps would have cost. In a food processing facility, the key to a
workable maintenance plan is to prioritize the assets and to apply predictive maintenance to the most critical units. It is also important to integrate the
control systems at a plant for predictive maintenance to work.
Keywords: food processing, maintenance, equipment, costs

Higgins, Kevin T. 2000. A Practical Approach to Allergen Control. Food Engineering. July.

Food processors have made a lot of progress on the issue of allergens, but a lot of work remains to be done. Good manufacturing practices (GMPs),
HACCP, and sanitation are at the heart of any allergen control program. Wash-down techniques may need adjustment to ensure that sanitarians are
removing allergen proteins as well as pathogens from equipment surfaces. Longer production runs to minimize changeovers and scheduling allergen-
containing products on a line at the end of the day are also good control strategies. Thermal treatment is ineffective in ridding equipment of proteins
that are the basis of food allergens. Sanitary equipment design is also very helpful to minimize the presence of allergens. UPC scanners can minimize
the chance that allergen-containing products get shipped in the wrong package. Separation of lines will prevent cross-contamination. Adding allergens
at the end of the line also simplifies cleanup. One of the problems is that any food that has a protein has the potential to be allergenic, but a
manufacturer cannot control for all. Currently, the focus is on the eight most common allergens. There is also a lack of consensus on the acceptable
trace levels of an allergen. Testing kits of in-process and finished foods and of equipment will help manufacturers validate their allergen-control
programs.
Keywords: food processing, allergens, good manufacturing practices, separation, HACCP, sanitation, controls

Hoffman, Adam D. , Kenneth L. Gall, Dawn M. Norton, Martin Wiedmann. 2002. Listeria monocytogenes Contamination Patterns for the
Smoked Fish Processing Environment and for Raw Fish. Journal of Food Protection. Vol. 66, No. 11:  52-60.

Environmental samples and raw fish from two smoked fish processing facilities were screened for L. monocytogenes, and all isolates were subtyped
by automated ribotyping to examine the relationship between L. monocytogenes contamination from raw materials and that from environmental sites.
Results indicate a disparity between the subtypes found on raw fish and those found in the processing environment. This study indicates that
environmental contamination is separate from that of incoming raw materials and includes strains persisting, possibly for years, within the plant.
Operational and sanitation procedures appear to have a significant impact on environmental contamination, with both plants having similar prevalence
values for raw materials but different contamination prevalence values for the environmental sites. Plant A, which had a higher environmental
contamination prevalence value, may have more potential reservoirs for L. monocytogenes, as it has a larger production volume, is housed in an older
facility, and used continuous running water as part of processing. This study concludes that regular L. monocytogenes testing of drains, combined with
molecular subtyping of the isolates obtained, allows for efficient monitoring of persistent L. monocytogenes contamination in a processing plant.
Keywords: seafood processing, Listeria, controls, environmental sampling

Holah, John and Richard Thorpe. 2002. Hygienic Plant Design and Sanitation. In Foodborne Pathogens: Hazards, Risk Analysis and
Control edited by Clive de W. Blackburn and Peter J. McClure. Woodhead Publishing Limited and CRC Press LLC. Boca Raton, FL.

The primary objective of a hygienic plant design is to set up effective barriers to microbial and other contamination. Level 1 is the factory site. Issues at
Level 1 include rodent control (bait), bird control (clean up spillage), insect control (screens, lighting), and avoidance of dust (good landscaping). Level
2 is the factory building. Issues at Level 2 include external environment protection and internal microbiological, chemical, and physical protection. In
some factories, drainage and subsequent contamination has occurred through leakage from floors above due to floor defects and badly maintained
drains. Level 3 is the internal barriers separating manufacturing processes. Processing areas should be separated from non-processing areas and
high-risk areas should be separated from low-risk areas. Some ovens have been designed to drain into high-risk areas, which presents a
contamination risk. Problems have also occurred with leakage of sumps under ovens, into the high-risk area. Boot baths and washes have been
shown to inadequately disinfect low-risk footwear, so different boots should be worn in high-risk areas. Providing an environment in which the
formation of biofilms is limited, undertaking cleaning and disinfection programs as required, and monitoring and controlling these programs to ensure
their success can control the formation of biofilms. Routine cleaning operations are never 100 percent and intensive periodic cleans are required to
remove the soil accumulation over time. These can include increased cleaning time, higher temperatures, alternative chemicals, and manual
scrubbing. For the majority of food operations, it is necessary to use multiple cleaning products for specific operations. The efficacy of disinfectants is
controlled by interfering substances, pH, temperature, concentration, and contact time. Of the acceptable chemicals, the ones most often used are
chlorine-releasing components, quaternary ammonium compounds (QAC), amphoterics, and quaternary ammonium/amphoteric mixtures. Efficacy
tests can be conducted to test cleaning and disinfecting agents. Cleaning equipment is prone to contamination with Listeria and should be specific to
high-risk area and disinfected after use. Microbiological sampling can be used to assess the effectiveness of a sanitation program.
Keywords: facility design, food processing, separation, equipment, risk assessment, controls, cleaning, sanitation

Horne, C.W., L.L. Boleman, C.G. Coffman, J.H. Denton, and D.B. Lawhorn. 1989. Mycotoxins in Feed and Food Producing Crops.U.S National
Dairy Database. http://www.mda.state.mn.us/dairyfood/mfgallergens.htm on April 23, 2003.

Methods for detecting mycotoxin range from visual inspection made with black light to ELISA tests to complex laboratory analysis using high-pressure
liquid chromatography. Aflatoxin is a major toxin group. Properly designed and operated storage facilities can prevent aflatotoxin development but field
conditions, such as droughts, often cannot be altered. Grains should be removed from temporary storage as soon as possible. The major influences
on growth and reproduction of mycotoxins in grains are moisture content, temperature, oxygen supply, pH, and condition of the grain. Grains should
not be stored under high moisture conditions. The long-term safe storage moisture content is generally accepted to be 13 percent. Many U.S.
processors have established vigorous screening programs for aflatoxins and other mycotoxins in their raw materials. Treatment with anhydrous
ammonia, which breaks the bond of the aflatotoxin molecule and reduces its destructive potential, has not received full approval of the FDA but has
been used in several states to treat contaminated commodities. It also has a number of disadvantages, including discoloration of the grain. Shaking
out immature or broken kernels is also done.
Keywords: mycotoxin, storage, grains

Ilyukhin, Sasha V., Timothy A. Haley, and Rakesh K. Singh. 2001. A Survey of Control System Validation Practices in the Food
Industry. Food Control. Vol. 12. No. 5: 297-304. [only have abstract]

Over the last decade, there has been a significant increase in the use of digital control systems in the food manufacturing industry. The additional
tasks with which digital controllers are burdened make their function much more complex than the electro-pneumatic-mechanical systems they
replace. Potential control system failures can affect operator and process safety. Proper control system validation measures can prevent such
potentially tragic failures. A nationwide scientific survey of US food manufacturers was conducted to generate information regarding the validation
practices within the food manufacturing industry. This survey also included system integrators and equipment suppliers that sell goods and services to
the US food manufacturers. It has been determined that the majority of food manufacturers delegate the responsibility for control system validation to a
third-party, such as equipment supplier, system integrator or a consulting firm, with little understanding of the validation process and its importance.
Only a few food manufacturing companies utilize validation resources available from equipment suppliers and system integrators. Equipment suppliers
and system integrators should combine their efforts to provide the food industry with formal and comprehensive training and maintenance programs for
the equipment as well as the system that controls it.
Keywords: validation, equipment, suppliers

Jackson, Lauren S.,, Tina Beacham-Bowden, Susanne E. Keller, Chaitali Adhikari, Kirk T. Taylor, Stewart J. Chirtel, and Robert I. Merker.
2003. Apple Quality, Storage, and Washing Treatments Affect Patulin Levels in Apple Cider. Journal of Food Protection.Vol. 66, No. 4.

Patulin is a mycotoxin produced primarily by Penicillin expansum, a mold responsible for rot in apples and other fruits. The growth of this fungus and
the production of patulin are common in fruit that has been damaged. However, patulin can also be detected in sound fruit. This study found that
dropped apples contained patulin, while tree-picked apples did not. Patulin was also discovered in unculled tree-picked apples stored at 0 to 2 degrees
Celsius for 4 to 6 weeks, whereas none was found in culled tree-picked apples. Further, washing apples reduced patulin levels by 10 to 100 percent,
depending on the initial patulin levels and the type of wash solution used. This study indicates that the avoidance of using dropped apples and the
careful culling of apples are good methods for reducing patulin levels in apples. Washing is also useful, however, when apples are highly contaminated
with patulin, washing treatments are not able to reduce patulin levels to less than 50 micrograms per liter, the FDA action level for the toxin.
Keywords: patulin, mycotoxin, fresh produce (apples), risk assessment, controls

Jahncke, Michael L. and Daniel Herman. 2001. Control of Food Safety Hazards During Cold-smoked Fish Processing. Journal of Food
Science. Vol. 66 No. 7: 1104-1112.

Waters where finfish are harvested may contain bacteria or spores that may be pathogenic to humans, such as Clostridium botulinum andListeria
monocytogenes. Fish may also come in contact with pathogenic microorganisms during harvesting, handling on board, and off-loading and
transportation to a smoking facility. In general, good sanitation procedures should be applied throughout harvest, transportation, storage, and
postharvest handling. In the U.S., direct treatment of finfish to reduce microbial load is permitted after harvest and before processing. Chlorine solution
dips, which require intense management to avoid recontamination, have been replaced by chlorine solution rinses or sprays that are followed by a
rinse with potable water. The following constitute some of the potential hazards and the applicable controls for cold-smoked finfish processing:

 Incoming fish may harbor parasites and contain unsafe levels of biogenic amines. All lots of fish directly received from the harvest vessel
should be accompanied by documentation certifying proper time and temperature handling of the fish.

 Contamination of the raw material or outgrowth of pathogenic microorganisms may occur if the fish is not maintained in a sanitary facility with
proper refrigeration controls. Thus, fish should be stored so that their internal temperature is less than 40 degrees Fahrenheit.

 Frozen raw fish should be thawed under sanitary conditions.

 Listeria monocytogenes and C. botulinum spores present on a single fish could contaminate an entire batch within the brine solution. Thus, to
minimize microbial growth and cross-contamination, temperature control of the brine solution during brining is recommended.

 Presence of sufficient salt in the fish is essential to inhibit the outgrowth of Clostridia species and to prevent the formation of toxins. Portions
that are too thick or too large should be removed and cut to the proper size.
 Cross-contamination with L. monocytogenes can occur during slicing and cutting. Strict adherence to SSOPs and GMPs is essential. In
particular, effective SSOPs can be used to minimize or prevent cross contamination with L. monocytogenes.

Keywords: seafood processing, sanitation, risk assessment, controls, cross-contamination

Keller, Susanne E., Robert I. Merker, Kirk T. Taylor, Hsu Ling Tan, Cathy D. Melvin, Stuart J. Chirtel, and Arthur J. Miller. 2002. Efficacy of
Sanitation and Cleaning Methods in a Small Apple Cider Mill. Journal of Food Protection. Vol. 65, No. 6:  911-917.

The efficacy of cleaning and sanitation in a small apple cider processing plant was evaluated by surface swab methods as well as microbiological
examination of incoming raw ingredients and of the final product. Surface swabs revealed that hard-to-clean areas, such as apple mills or tubing for
pomace and juice transfer may continue to harbor contaminants even after cleaning and sanitation. Use of poor quality ingredients and poor sanitation
led to an increase of approximately 2 logs in aerobic plate counts of the final product. Reuse of uncleaned press cloths contributed to increased
microbiological counts in the finished juice. Finally, using apples inoculated with Escherichia coli K-12 in the plant resulted in an established population
within the plant that was not removed during normal cleaning and sanitation. The data presented in this study suggest that current sanitary practices
within a typical small cider facility are insufficient to remove potential pathogens.
Keywords: cleaning, sanitation, cider, testing,, risk analysis, fresh produce (apples)

Kindle, Lauryn. 2001. Opening Doors to Food Safety and Sanitation. Food Processing. May 22.

In a recent study, it was found that doors have a significant effect on room air distribution. Food processing doors should be of corrosion-resistant
materials and remain shut as much as possible to minimize the transfer of food pathogens. Most door frames are wood covered and are vulnerable to
microbial contamination over time as the wood corrodes with repeated cleaning. One control developed by The Rytec Corp. of Jackson, WI is a
stainless steel high-speed roll door.
Keywords: sanitation, food processing, facility design, control

Krysinki, E.P. 1992. Effect of Cleaners and Sanitizers on Listeria monocytogenes Attached to Product Contact Surfaces. Journal of Food
Protection. Vol. 55, No. 4:  246-251. [only have abstract]
A variety of chemical cleaning and sanitizing compounds were evaluated for their ability to remove and/or inactivate surface adherentListeria
monocytogenes. Resistance of adherent cells to sanitizers was dependent upon the surface studied, being greatest on polyester/polyurethane,
followed by polyester, and stainless steel. Biofilm removal with cleaners followed the same pattern, with polyester/polyurethane the most difficult to
clean. Complete biofilm removal/inactivation was obtained in many cases where a surface was cleaned prior to sanitization. Listeria biofilms should be
controllable by combining GMPs with HACCP.
Keywords: cleaning, sanitation, Listeria, biofilms, HACCP, good manufacturing practices

Kuhn, Mary Ellen. 1995. Getting Lathered up About Plant Sanitation. Food Processing. June.

Elimination of bacterial contamination not only improves food safety but also aids in increasing product shelf life. Thus, food processors have started
giving serious consideration to how equipment should be cleaned and sanitized during the design stage. National Sanitation Foundation (NSF) has
developed standards to assure that equipment can be quickly disassembled for cleaning and does not have difficult-to-clean features, such as screws
or rough surfaces. Further, an increasing number of food manufacturers are looking to standardize their cleaning operations so that they can better
control the end results. Some of the technologies food plants are adopting for this purpose include automated hand-washing systems, ATP
bioluminescence monitoring for detection of soil or bacteria on plant surfaces, and portable sanitation equipment.
Keywords: food processing, sanitation, equipment, facility design, cleaning

Kuntz, Lynn A. 1992. Keeping Microorganisms in Control. Food Product Design. August.

Molds, yeast, viruses, and bacteria can cause food spoilage and more importantly food borne illness when ingested. Controlling these constitutes the
most important challenge to food manufacturers. Some of the basic preventative controls that should be in place in food processing plants to control
for these food safety hazards include:

 Prevention of contamination by proper cleaning of manufacturing equipment,

 Removal of microorganisms by washing, trimming, centrifuging, and filtration,

 Removal of oxygen by applying a vacuum, or the replacement of oxygen by gases, such as nitrogen or carbon dioxide,
 High or low temperature treatments depending on the type of food product,

 pH control,

 Control of water activity levels via cooking, baking, or dehydration,

 Use of preservatives or inhibitory substances that have Generally Recognized as Safe (GRAS) status, and

 Irradiation.

Keywords: food processing, cleaning, sanitation, irradiation, controls

Minnesota Department of Agriculture. 2003. Managing Food Allergen Risks.http://www.mda.state.mn.us/dairyfood/mfgallergens.htm.

Food manufacturers need to evaluate their operations and develop plans to control unidentified allergens. Evaluation of allergen hazards should be
part of a HACCP plan. Non-allergenic ingredients should be considered as substitutes. Allergenic ingredients should be added at the end of a process.
Equipment should be easy to clean, inspect, and maintain. Production lines should be designed to isolate allergen addition point, dedicate re-feed
systems, ensure product containment, and eliminate crossover of conveyor lines. Manufacturers should ensure that suppliers have implemented and
documented an allergen plan. Reconditioned ingredients and oils should not be purchased. Proper sanitation or dedicated use should be ensured
regarding transportation of bulk ingredients/shipping containers that are reused. Specifications/ingredient statements should be reviewed before
substituting raw materials. Production systems should be dedicated or products with allergens should be run at one time or at the end of a production
run. Adequate clean up should be performed between runs. A documented rework plan should be available. All rework should be clearly labeled.
Labels on incoming ingredients should be checked. Label accuracy should be verified. The use of "may contain" labeling in lieu of GMPs should be
limited. Outdated packaging materials should be removed from plants. Product traceability systems should be in place and verified. Sanitation
practices should be validated using sight, bioluminescence testing, and ELISA testing. Maintenance tools should be checked to make sure that they
are not potential vectors for cross-contamination. Employee practices for sanitation should be specified and employees should receive good training
and education about allergens.
Keywords: allergens, HACCP, controls, equipment, facility design, suppliers, sanitation, labeling, packaging, maintenance
Morris, Charles E. 2002. Best Practices for Allergen Control. Food Engineering. March.

The basic allergen control strategy is similar at many companies. The big eight allergens include peanuts, tree nuts, milk, eggs, soybeans, finfish,
shellfish, and wheat. The first step in formulating a product is to eliminate allergens if possible or add them in towards the end of the process.
Dedicated production lines are also a preferred strategy while a portion of a given line can also be dedicated. Many food plants were not designed with
allergen control in mind, such as where a product on an upper conveyor can drop on a product on the conveyor below. Covering the conveyors can
solve this problem. "Hang-ups", where product residues can collect to be swept up in a later production run, can be contained by cleaning, isolating, or
sealing off allergen-addition points on the line. Color coding maintenance tools can prevent cross-contamination. Full ingredient lists should be
obtained from raw material suppliers and audits should be conducted to help assure that allergens are properly identified in raw materials and
ingredients. Best practices can also include longer production runs with minimal changeovers for high-volume products. Where changeovers are
necessary, products containing allergens can be scheduled last in the production cycle to minimize cross-contamination and cleanup. To prevent
packaging mix-ups, old packaging should be discarded and a tracking system should be used. ELISA (enzyme-linked immunoabsorbent assays) tests,
developed by FARRP and Neogen, can validate the effectiveness of an allergen cleaning program. A HACCP-like approach and employee training are
also important. Allergens should be evaluated with a HACCP-like approach, with process areas identified as high-risk considered as critical control
points. Employee training is also very important to the success of allergen control.
Keywords: allergens, best practices, facility design, equipment, packaging, cleaning, testing, HACCP, employee training

Morris, Charles E. 2000a. Best Manufacturing Practices. Food Engineering. February.

Food Engineering conducted a survey of an Executive Advisory Panel, consisting of more than 400 food-manufacturing professionals in various roles
in the industry, to share manufacturing improvements implemented in the past five years and how they achieved these improvements. HACCP
programs were established by 75 percent of panelists and 79 percent have improved employee training in plant sanitation and food safety. More than
65 percent of panelists regularly review and document GMPs, SOPs, and SSOPs, while 62 percent conduct independent audits or inspections, to
better assure plant sanitation and food safety. Forty-five percent added equipment of sanitary design and 39 percent replaced equipment with new
equipment with a more sanitary design. Thirty-eight percent increased lab testing and 32 increased QA staff. One-third of panelists implemented or
increased use of microbial detection systems. Only 9 percent of the panelists reported that their plants had appointed a HACCP coordinator with no
other responsibilities and of those, half were meat processors. When asked about maintenance, 71 percent of panelists apply preventive maintenance,
but 28 percent practice reactive maintenance.
Keywords: best practices, HACCP, sanitation, good manufacturing practices, facility design, equipment, maintenance

Morris, Charles E. 2000b. HACCP Under the Microscope. Food Engineering. October.

According to the 2000 Food Engineering's Best Manufacturing Practices Survey, 75 percent of respondents have established HACCP programs in
their plants. More than two-thirds of respondents in every industry outside of meat, poultry, and seafood, have voluntarily implemented HACCP.
HACCP has gained acceptance in industries where it is not required, but compliance and enforcement problems have arisen in industries that do
require it. Compliance failures include weak prerequisite programs (SSOPs, GMPs, QA programs, consumer complaint monitoring, environmental
monitoring, vendor certification, and allergen management), "half-way" HACCP programs due to lack of upper-management commitment, product
releases despite CCP violations, inclusions of quality components in HACCP that dilute its effectiveness, weak CCP validations and hazard analyses,
inadequate/inefficient documentation, inadequate training, and a lack of continuous improvement.
Keywords: best practices, HACCP, compliance

Mortimore, Sara. 2003. Problems Encountered Applying the HACCP Approach to Food Safety: If HACCP can Work so Well, Then Why do so
Many Businesses Have Problems With It? FoodInfo Online Features. IFIS Publishing. January 27. www.foodsciencecentral.com.

HACCP can be seen as an unnecessarily burdensome and bureaucratic activity among food manufacturers. Implementation of an effective HACCP
plan requires education on (1) food borne illness and trends, (2) why HACCP is a minimalist system that ensures maximum control, and (3) how it can
help reduce sanitation costs and down time, and lengthen shelf life, improve efficiency, and reduce waste. The cause of many of the problems of
implementation can be traced back to the decision to adopt HACCP and the reasons why it was chosen. While it seems that the best HACCP systems
are developed by businesses that are driven to self-improvement, the prompt may also come from regulators and customers. The lack of
understanding of the HACCP concept or methods, as well as a lack of appropriate microbiological and toxicological knowledge, often leads to over-
reliance on advice from many quarters, and can result in over-complex HACCP systems. This is further confounded by reliance on "off-the-shelf"
HACCP packages, inadequate or improperly deployed generic plans and consultant plans that do not fit the business. This is particularly relevant for
small and medium-sized enterprises (SMEs) but also for many larger companies. In the industry, there is a shift towards second generation HACCP
models that allow greater flexibility and that emphasize prior development of effective prerequisite hygiene programs. Another prime requirement for
effective implementation of HACCP programs is having an understanding of the people that will be responsible for operating the system and providing
adequate training. [Note: Article is based on the U.K experience of HACCP implementation. Thus, the findings may not be fully applicable to the U.S.]
Keywords: HACCP, implementation, sanitation, employee training

Moss, Maurice. 2002. Toxigenic Fungi. In Foodborne Pathogens: Hazards, Risk Analysis and Control edited by Clive de W. Blackburn and
Peter J. McClure. Woodhead Publishing Limited and CRC Press LLC. Boca Raton , FL.

Toxigenic fungi are found primarily in foods of plant origin, such as cereals, legumes, oilseeds, and treenuts. They may also pass through food in chain
in milk and meat. Controls for aflatotoxin (occurring in corn and treenuts) include preventing insect damage, alleviating drought stress, and reducing
water activity in the product. Controls for ochratoxin A (occurring in coffee, cocoa, vine fruits, spices, cereals) include prevention of mold growth at
every stage of the production process. Removing moldy apples, conversion to cider, treatment with activated charcoal or sulfur dioxide can control
Patulin (occurring in apple juice). Fumosin (occurring in corn) elimination is difficult. Ear rot and insect damage are associated with high levels of
infection. The breeding of cultivars resistant to such damage is a possible control strategy. The possibility of biological control in the field is also being
investigated.
Keywords: fungi, risk analysis, controls

Moulton, Curtis J. 1992. Reducing Pesticide Residues in Food. Food Safety and Quality. June.

While FDA reports that 96 percent of all foods have safe levels of pesticide residue or none, consumers remain concerned. Pesticide residues can be
controlled by reducing dependence on them through organic production systems, integrated pest management, and low input sustainable agriculture
(LISA). Other farm industry efforts include development of safer chemicals and genetically engineered, pest-resistant plants.
Keywords: pest control, organic production, chemical hazard, risk assessment
Murphy, R.Y., L.K. Duncan, K.H. Driscoll, B.L. Beard, M.B. Berang, and J.A. Marcy. 2003. Determination of Thermal Lethality ofListeria
monocytogenes in Fully Cooked Chicken Breast Fillets and Strips during Postcook In-package Pasteurization. Journal of Food
Protection. Vol. 66, No. 4: 578-583.

The presence of Listeria monocytogenes in processing environments renders meat or poultry products at risk for contamination after cooking and
before packaging. This study evaluates the post-cook in-package pasteurization on eliminating Listeria monocytogenes from three types of vacuum-
packaged fully cooked chicken breast meat products that were treated with continuous pilot scale steam or hot water cooker. Results indicate that both
steam and hot water pasteurization are effective for the inactivation of Listeria monocytogenes in fully cooked and vacuum-packaged chicken breast
meat products.
Keywords: meat processing, poultry processing, Listeria, packaging, pasteurization, controls

National Food Processors Association (NFPA). Undated. Industry Position on Control of Listeria Monocytogenes, With Emphasis on Meat
and Poultry Products. National Food Processors Association. www.nfpa-food.org.

Listeriosis is a serious disease that is primarily transmitted through a limited number of foods. Specifically, it appears that foods that support the growth
of pathogenic Listeria monocytogenes over the shelf life of the product, especially foods given a listericidal process which have become
recontaminated, pose the greatest risk to consumers. Control of L. monocytogenes has proven to be a difficult challenge in food processing
establishments that manufacture RTE products that are not treated in their final package to eliminate this organism. In 1999, the food industry
reviewed and revised suggested programs designed to minimize the presence, survival, and multiplication of L. monocytogenes in foods. These
programs include:

 Applying a validated listericidal process where appropriate,

 Purchasing from suppliers with a Listeria control program,

 Minimizing the potential for recontamination,

 Adopting new technologies as soon as they are available, and

 Implementing an environmental monitoring program for Listeria spp. to verify that the control program is effective.

In addition to modifying in-plant practices and upgrading verification programs, many in industry are also seeking long term and more dependable
solutions to this problem, such as in-package pasteurization with heat or ionizing radiation, use of ionizing radiation, and product reformulation to
retard or preclude growth of L. monocytogenes.
Keywords: food processing, Listeria, ready-to-eat, controls, suppliers, packaging, pasteurization

Neff, Jack. 1999. Beyond Chlorine. Food Processing. January 1.

Chlorine has been the disinfectant of choice for the food and beverage manufacturing industry for years. Despite its widespread use, chlorine usage is
not problem free. In water with high levels of organic residue, chlorine dissipates quickly. Using too much chlorine to compensate, however, can lead
to the formation of excessive hypochlorous acid that causes chlorine to volatize more rapidly creating fumes that can pose hazards to plant workers.
Further, one food processor found chlorine to be ineffective in sunlight or if it has warmed up significantly above room temperature. Thus, it is difficult
to find the right level of chlorine needed to kill all the microorganisms without leaving too much chlorine or volatile fumes behind. An alternative to
chlorine is peroxyacetic acid that one frozen vegetable processing facility is currently using. Although it costs 50 to 100 percent more than chlorine, the
agent reportedly provides improved microbial control and safety. Other emerging disinfecting technologies include ozone and ultraviolet radiation.
Keywords: food processing, disinfectant

Olson, Alan R. 2002. Hard or Sharp Objects. Compendium of Fish, Fishery Product Processes, Hazards, and Controls. October.

Foreign objects can be broadly classified as food safety hazards (e.g., glass) and food non-safety hazards (e.g., filth). Foreign objects that are physical
hazards are referred to as hard or sharp objects. Hard or sharp objects are further divided into metallic objects, which are divided into ferrous and non-
ferrous metals, and non-metallic objects. Controls for metal inclusion can include periodic checks of metal equipment and passing the product through
metal detectors or separation equipment. Glass can be controlled by visual examination of empty glass containers containing transparent product,
cleaning with water or compressed air and inverting empty glass containers, periodically monitoring lines for glass breakage, proper adjustment of
capping equipment, and passing the product through an x-ray system. Non-metallic objects can also be detected by an x-ray system.
Keywords: seafood processing, physical hazards, risk analysis, controls
Park, Douglas L., Henry Njapau, and E. Boutrif. 1999. Minimizing Risks Posed by Mycotoxins Utilizing the HACCP Concept. Food, Nutrition,
and Agriculture. No. 23.

Prevention through pre-harvest management, such as enforcing effective insect control programs and maintaining adequate irrigation schedules, is the
best way to control mycotoxin formation. Field crops should be harvested in a timely manner and damage kept to a minimum during harvesting to
prevent infestation of mycotoxins. Extraneous material should be removed and products should be dried rapidly to under 10 percent moisture. In the
post-harvest phase, storage and processing are the major areas where contamination can be prevented. An accumulation of moisture and heat and/or
physical damage can increase the likelihood of mycotoxins. Appropriate packaging or general hygiene are generally useful in minimizing damage from
insect infestation. Product should be stored on a dry, clean surface. During processing, mycotoxins can be intentionally eliminated or introduced.
Control procedures that can be employed include clean up and separation, thermal inactivation, and chemical inactivation. For example, electronic
sorting and hand-picking can remove a significant proportion of aflatoxins in shelled peanuts. Complete separation of all contaminated particles may
not be achieved, however, and other procedures have to be used to manage contamination in the final product. Thermal inactivation is a good
alternative, although aflatoxins and deoxynivalenol are resistant to heat. Other potential control processes include ammoniation and activated carbons
and clays.
Keywords: mycotoxins, HACCP, prevention, risk assessment, separation, controls

Paulson, Daryl S. 1996. To Glove or to Wash: A Current Controversy. Food Quality. June/July.

Both hand washing and using gloves have their adherents and detractors. The article argues that using these in tandem may be the most effective
solution, combined with vigorous enforcement and employee training, and an environmental sanitation program. An intact glove provides adequate
protection from microbial transmission of hand-contaminating microorganisms. However, some food-grade gloves may have existing pinhole punctures
and/or can be easily ripped, torn, or punctured during use. While hand washing, on the other hand, can be very effective in removing microorganisms,
ensuring that food workers perform effective hand washes is difficult. Thus, the study recommends (1) donning of gloves to be preceded by an
effective hand wash, (2) ongoing employee training and education, (3) high personal hygiene requirements, and (4) institution of a quality control
program to monitor and enforce hand washing and gloving sanitation practices. Further, to reduce disease transmission by contaminated objects, the
study suggests an effective environmental and sanitation program and restriction of tasks among workers to prevent contamination in addition to the
previously noted four controls.
Keywords: employee training, employee hygiene, sanitation, controls

Raloff, Janet. 1998. Staging Germ Warfare in Foods. Science News. Vol. 153. No. 6. February 7.

Many bacteria generate small proteins known as bacteriocins. Bacteriocins function as unusual, narrow-spectrum antibiotics. They tend to harm only
microbes that closely resemble the bacteria that manufactured them. In many cases, bacteriocins attack potentially fatal food-poisoning germs, such
as Listeria monocytogenes or the Clostridium responsible for botulism. A number of studies on foods ranging from pasteurized egg products, hot dogs,
poultry summer sausage to meat products, have shown promising results where the bacteriocins added were effective in killing certain types of
pathogens.
Keywords: pathogens, control, bacteriocins

Riordan, D. C. R., G. M. Sapers, T. R. Hankinson, M. Magee, A. M. Mattrazzo, and B. A. Annous. 2001. A Study of U.S. Orchards To Identify
Potential Sources of Escherichia coli O157:H7.Journal of Food Protection. Vol. 64, No. 9:  1320-1327.

Fourteen U.S. orchards were surveyed in autumn 1999 to determine the incidence and prevalence of E. Coli O157:H7, E. Coli, total aerobic microflora,
and yeasts and molds. Fruit was also tested for internalization of microflora by aseptically removing the core, stem, and calyx areas, and the individual
sections were assessed for the categories of microflora listed above. Findings suggest that dropped or damaged fruit should not be included in fruit
designated for the production of unpasteurized juice or for the fresh or fresh-cut market. In addition, orchards should be located away from potential
sources of contamination, such as pastures.
Keywords: fresh produce, E. Coli, risk analysis

Rushing, J.E. and H.P. Fleming. 1999. Scheduled Processes. Department of Food Science, Food Processing. FSE 99-21.

A scheduled process is a process selected by a processor as adequate for use under the conditions of manufacture for a food in achieving and
maintaining a food product that will not permit the growth of microorganisms having public health significance. A scheduled process must be
established by a qualified person or a competent process authority, with expert knowledge acquired through appropriate training and experience in the
acidification and processing of acidified foods. The key to safe preservation of acidified foods is the maintenance of an adequately low pH in the
finished product to prevent growth and toxin production by the Clostridium botulinum bacterium. Acidified foods must have a finished equilibrium pH of
4.6 or lower. While a pH of 4.6 or lower is adequate to prevent growth and toxin production byClostridium botulinum, it may not be adequate to prevent
growth of other microbiological pathogens. Thus, acidified foods must be thermally processed to an extent that is sufficient to destroy the vegetative
cells of microbes of public health significance and those of non-health significance that can grow in the product under the conditions in which it is
stored, distributed, and held by the consumer.
Keywords: scheduled process, acidified foods

Senkel, I. Arthur, Robin A. Henderson, Beverly Jolbitado, and Jianghong Meng. 1999. Use of Hazard Analysis Critical Control Point and
Alternative Treatments in the Production of Apple Cider. Journal of Food Protection. Vol. 62, No. 7:  778-785.

The purpose of this study was to evaluate the practices of Maryland cider producers and determine whether implementing hazard analysis control
point (HACCP) would reduce the microbial contamination of cider. Cider producers were surveyed to determine existing manufacturing practices and
sanitation. A training program was then conducted to inform operators of safety issues, including contamination with Escherichiacoli O157:H7, and
teach HACCP concepts and principles, sanitation procedures, and good manufacturing practice (GMP). Although all operators used a control strategy
from one of the model HACCP plans provided, only one developed a written HACCP plan. None developed specific GMP, sanitation standard
operating procedures, or sanitation monitoring records. Six operators changed or added production controls, including the exclusion of windfall apples,
sanitizing apples chemically and by hot dip, and cider treatment with UV light or pasteurization. Facility inspections indicated improved sanitation and
hazard control but identified ongoing problems. Microbiological evaluations of bottled cider before and after training, in-line apples, pomace, cider, and
inoculated apples was conducted. E. Coli O157:H7,Salmonella, or Staphylococcus aureus were not found in samples of in-line apple, pomace, and
cider, or bottled cider. Generic E. Coli was not isolated on incoming apples but was found in 4 of 32 (13%) in-line samples and 3 of 17 (18%) bottled
fresh cider samples, suggesting that E. Coli was introduced during in-plant processing. To produce pathogen-free cider, operators must strictly
conform to GMPs and sanitation procedures in addition to HACCP controls. Controls aimed at preventing or eliminating pathogens on source apples
are critical but alone may not be sufficient for product safety.
Keywords: cider, E. Coli, HACCP, sanitation, fresh produce (apples), risk assessment, controls
Siddiqi, Zia. 2001. New Technologies in Pest Management Prevent Pathogen Spread. Food Processing. February 21.

Because of their behavior, biology, and morphology, insect and rodent pests serve as exceptional disease vehicles for harboring and rapidly
transporting diseases. In the food handling environment, the three main pests that have been known to transmit pathogens are rodents, roaches, and
flies. An integrated pest management program (IPM) is necessary to eliminate insect and rodent pests and hence the spread of pathogens from these
sources. IPM relies on inspection, monitoring, establishing action threshold levels, and implementing first non-chemical and then chemical measures.
IPM also involves communication and education. Some of the newer technologies, such as computer-aided monitoring and nonvolatile nonrepellant
insecticide formulations, enable the placement of control agents in precise locations thereby eliminating the possibility of pathogen spread.
Keywords: pest control, handling, pathogens

Snowdon, J.A. and D.O. Cliver. 1996. Microorganisms in Honey. International Journal of Food Microbiology. Vol. 31. No. 1-3: 1-26. [only have
abstract]

Microbes of concern in post-harvest handling are those that are commonly found in honey (i.e., yeasts and sporeforming bacteria), those that indicate
the sanitary or commercial quality of honey (i.e., coliforms and yeasts), and those that under certain conditions could cause human illness. Primary
sources of microbial contamination are likely to include pollen, the digestive tracts of honey bees, dust, air, earth, and nectar, which are very difficult to
control sources. The same secondary (after-harvest) sources that influence any food product are also sources of contamination for honey. These
include air, food handlers, cross-contamination, equipment, and buildings. Secondary sources of contamination are controlled by good manufacturing
practices (GMPs). Routine microbiological testing of honey is necessary to control for microorganisms. The testing might include standard plate counts
for general information, specialized tests (such as yeast counts and an assay for bacterial spore formers), and coliform counts for checking sanitary
quality.
Keywords: honey, risk assessment, controls, handling, testing

Sommers, Christopher, Michael Kozempel, Xuetong Fan, and E. Richard Radewonuk. 2002. Use of Vacuum-Steam-Vacuum and Ionizing
Radiation To Eliminate Listeria innocua from Ham. Journal of Food Protection. Vol. 65, No. 12: 1981-1983.
Vacuum-steam-vacuum (VSV) technology is known to successfully to eliminate Listeria innocua from hot dogs and ionizing radiation has been used to
eliminate Listeria spp. from RTE meats. The application of these technologies can cause changes in product quality. This study investigated the ability
of VSV and ionizing radiation, together, to eliminate Listeria innocua from ham meat and skin. The use of both treatments resulted in an additive
reduction of L. innocua on ham. The combination treatment did not cause statistically significant changes in product quality.
Keywords: meat processing, Listeria, controls

Stier, Richard F. 2002. Validating Safety in Your Plant. Food Engineering. September.

The root cause of most food borne illness is often a breakdown in plant sanitation. Changes in operations can have profound and often devastating
effects on the plant sanitation system. Construction projects and increases in production volume have the potential to adversely affect safety. For
example, Listeria contamination resulting from construction operations has been cited as a cause of one of the largest recalls of processed meats in
recent history. Plants need to ensure that changes are undertaken in an orderly and controlled fashion to ensure food safety.
Keywords: sanitation, validation, construction, risk analysis

Stier, Richard F. 2001. Foreign Materials in Foods: Are They Really Dangerous?  Market Pulse.

Sources of foreign materials include inadvertent materials from the field (e.g., stones, metal, insects, undesirable vegetable matter, dirt, or small
animals), inadvertent results from processing and handling (e.g., bone, glass, metal, wood, nuts, bolts, screening, cloth, grease, paint chips), materials
entered during distribution (e.g., insects, metal, dirt, stones), materials intentionally placed in food (employee sabotage), and miscellaneous sources
(e.g., struvite). Mechanical harvesters often collect more than just the product and so processors include destoners, air cleaners, magnets, screens
and washers as part of their lines. Grain processors and manufacturers used four screens to remove foreign materials. Preventive maintenance is
important in preventing foreign materials from entering the processing operation and is considered a HACCP prerequisite. Properly maintained
equipment and lines usually do not cause problems. All packages should be designed to prevent tampering after the container is sealed. Packages
should be examined for insect or rodent infestation that came from the exterior. The greatest concern with contamination during distribution and
storage is bulk products. Employee sabotage is difficult to monitor. Controls include good management and proper employee education. A good QA
system and good line workers are essential. Struvite, a hard crystalline material that can be formed in canned proteinaceous seafoods, is also hard to
control. It resembles glass and can break a tooth, but will not cut like glass. Stone and wood, based on the author's experience, are usually foreign
materials that are controlled by HACCP and are not common. Glass can be controlled by policies that require throwing away all containers within 10
feet of the breakage and shielding lights. Scanning for glass on-line is possible too, although expensive. Metal is a common industry concern and best
addressed by preventive maintenance. Ferrous materials can be removed by magnets. Metal detectors are also becoming more common, especially in
the meat sector. In sum, the following practices should be followed: plant audits that evaluate systems for pest control, foreign object removal, plant
condition, shipping and receiving practices, and plant maintenance procedures; a review of packaging materials and container/package handling
procedures; a review of agricultural practices; a review of personnel practices; package evaluation to ensure it is tamper proof; a review of consumer
complaints to see whether foreign materials are an issue. These steps should be part of a HACCP program.
Keywords: physical hazards, HACCP, maintenance, equipment, packaging, controls

Stopforth, J.D., J. Samelis, J. N. Sofos, P. A. Kendall , and G. C. Smith.. 2002. Biofilm Formation by Acid-Adapted and NonadaptedListeria
monocytogenes in Fresh Beef Decontamination Washings and Its Subsequent Inactivation with Sanitizers. Journal of Food Protection. Vol.
65, No. 11:  1717-1727.

Despite conventional cleaning methods, such as washing and sanitizing, pathogenic bacteria can remain on equipment surfaces and contaminate
food. This study investigated the effect of various sanitizers on Listeria monocytogenes cells in suspension and those attached to a surface by means
of a biofilm (slime layer to which pathogenic bacteria can attach and grow). The study results indicate that attached cells are more resistant than cells
in suspension to the effects of sanitizers. Further, the study indicates that each sanitizer has an optimal working environment in which it is most
effective.
Keywords: sanitation, biofilms, Listeria

Suttajit, Maitree. 1989. Prevention and Control of Mycotoxins. Mycotoxin Prevention and Control in Foodgrains. 

The inhibition of fungal growth can be achieved by physical, chemical, and biological treatment. This includes drying (less than 9 percent moisture for
peanut and less than 13.5 percent moisture for corn) and proper storage after harvest, such as maintenance of the container/warehouse at low
temperature and humidity and keeping insects out. Various chemical treatments have been used and are the most effective means to remove
mycotoxins from contaminated commodities as compared to hand picking, organic solvents, heating and cooking, or ionizing radiation.
Keywords: mycotoxins, prevention, controls

Thimothe, Joanne, Jonathan Walker, Voranuch Suvanich, Ken L. Gall, Michael W. Moody, Martin Wiedmann. 2002. Detection of Listeria in
Crawfish Processing Plants and in Raw, Whole Crawfish and Processed Crawfish (Procambarus spp.). Journal of Food Protection. Vol. 65,
No. 11:  1735-1739.

This study monitored the presence of L. monocytogenes and other Listeria spp. in the processing environment, in raw, whole crawfish, and in cooked
crawfish meat from two processing plants. Although Listeria innocua was the predominant Listeria spp. found (20 samples), four samples were positive
for L. monocytogenes. L. monocytogenes was detected in three raw material samples and in one environmental sample. Listeria spp. were found in
29.5% of raw, whole crawfish (n = 78) and in 4.4% of environmental samples (n = 181) but in none of the finished product samples. Among the
environmental samples, Listeria spp. were found in 15.4% of the drains (n = 39) and in 5.1% of the employee contact surfaces (gloves and aprons)
(n = 39) but in none of the samples from food contact surfaces. Even though a high prevalence of Listeria spp. was detected on raw materials, it
appears that the heat treatment during the processing of crawfish and the practices preventing post-processing recontamination can significantly
reduce Listeria contamination of RTE crawfish meat.
Keywords: seafood processing, Listeria, risk assessment

Thomas, Ingram, Bevis, Davies, Milne, and DelvesBroughton. 2002. Effective Use of Nisin to Control Bacillus and Clostridium Spoilage of a
Pasteurized Mashed Potato Product. Journal of Food Protection. Vol. 65. No. 10: 1580-1585. [only have abstract]

Heat-resistant spore-forming bacteria, such as Bacillus and Clostridium, can survive and grow in cooked potato products. The natural food
preservative nisin is used in heat-treated foods to prevent the growth of such bacteria. The study shows that nisin remains at effective levels after
pasteurization and extends shelf life of the product by at least 30 days. The ingredients and the preservatives, however, must be well mixed to ensure
nisin efficacy.
Keywords: bacteria, pasteurization, cooked product (potatoes), controls
Tilden, John Jr., Wallace Young, Ann-Marie McNamara, Carl Custer, Barbara Boesel, Mary Ann Lambert-Fair, Jesse Majkowski, Dur Vaga, S.
B. Werner, Jill Hollingsworth, and J. Glenn Morris. 2002. A New Route of Transmission for Escherichia coli: Infection from Dry Fermented
Salami. American Journal of Public Health. Vol. 85, No. 8:  1142-1145.

This study evaluated the production of dry fermented salami associated with an outbreak of Escherichia coli O157:H7 infection in Washington State
and California. Facility inspections, review of plant monitoring data, food handler interviews, and microbiological testing of salami products were
conducted. Production methods complied with or exceeded federal requirements and industry-developed good manufacturing practices. No evidence
suggested that post-processing contamination occurred. This study suggests that E. Coli O157:H7 may have been present on raw meat and
subsequently survived the currently accepted processing methods.
Keywords: meat processing, E. Coli, risk analysis, post-processing

Tompkin, R.B. 2002. Control of Listeria monocytogenes in the Food Processing Environment. Journal of Food Protection. Vol. 65, No. 4: 
709-725.

Recontamination is the primary source of Listeria monocytogenes in many commercially prepared ready-to-eat processed foods. Product testing will
not indicate the mode of contamination or how to prevent further occurrences. Environmental testing is better and more cost-effective in detecting the
mode of contamination and enabling timely corrections. Listeriosis can occur in isolated cases or as a cluster of cases due to a contaminated lot of
food, both of which are generally due to errors in food handling. Outbreaks of a few to several hundred cases that are scattered with regards to time
and location are typically due to the establishment of the pathogen in a niche, which is a site within the manufacturing environment in which Listeria
monocytogenes becomes established and multiplies. These niches may be impossible to reach and clean with normal cleaning and sanitizing
procedures and continue to contaminate food during processing operations. Environmental and equipment testing is necessary to detect niches. The
sampling sites should include areas that are good indicators of control, like food contact surfaces. The food processing environment should be
sampled at least weekly. It should be noted that while Listeria monocytogenes can be reduced, it cannot be eliminated from the environment.
Continued improvements in equipment design are necessary to make cleaning more effective and to minimize breakdowns and repairs. There will be
increased use of post-packaging pasteurization with irradiation, hot water, steam, and high pressure in the future.
Keywords: food processing, Listeria, ready-to-eat, testing, risk analysis, controls
Tybor, Phillip T., William C. Hurst, A. Estes Reynolds, and George A. Schuler. 1990. Preventing Chemical Foodborne Illness. The University
of Georgia College of Agricultural and Environmental Sciences Cooperative Extension Service. November.
http://www.ces.uga.edu/pubcd/b1042-w.html.

Chemical hazards include metals, pesticides, intentional food additives, and other chemical residues. The residues, if consumed in large enough
quantities, can be harmful to humans. Some agents implicated in chemical foodborne illness are beneficial and essential in the diet as nutrients, others
preserve food and others are part of food plant sanitation. Chemical foodborne illness is usually the result of human error. With regards to metal
poisoning outbreaks, the source is primarily food handling equipment and utensils made of inappropriate materials. When high-acid foods come into
contact with the equipment or utensil, corrosion occurs and is leached into the food. This can occur with citrus fruits, fruit drinks, fruit pie fillings, tomato
products, sauerkraut, and carbonated beverages. Pesticide contamination can occur due to spills, indiscriminate spraying of food-handling facilities or
equipment, improper storage of pesticides or mistaken identity, and incomplete washing of fruits and vegetables. Possible controls include storing and
securing pesticides away from food products, maintaining the chemical in its original container, reading and following instructions on the label, handling
pesticides like poisons, avoiding indiscriminate application of pesticides, and using trained and certified personnel for pesticide application. Some food
additives can cause health problems in sensitive individuals. FDA requires declaration on labels of sulfites at 10 ppm or higher. Sodium nitrite, a
controlled additive, must be stored in a locked cabinet and weighed and bagged separately before addition to any product. Unintentional food
additives, such as detergents, cleaning compounds, drain cleaners, polishers, and sanitizers can best be controlled by properly training personnel
about cleaning and sanitizing, reading and following label instructions, storing chemicals away from food, maintaining chemicals in their original
containers, avoiding use of empty cleaning chemical containers for food storage, using only approved food grade lubricants and greases, and keeping
an inventory of these chemicals in a secure, supervised area.
Keywords: chemical hazards, equipment, risk assessment, controls, storage, employee training

USDA/ARS. 2002. Food Safety:  National Program Annual Report FY 2002.

Aflatoxin is found in peanuts, corn, cottonseed, tree nuts and figs. Fumosins are found in corn and deoxynivalenol is found in wheat and barley.
Scientists have demonstrated that gallic acid is an inhibitor of aflatotoxin in some tree nuts. High humidity and rainfall were found to stimulate
aflatotoxin production in cottonseed. Providing improved management recommendations may prevent the occurrence of aflatotoxin in cottonseed.
Keywords: mycotoxins, control, prevention 

USDA/FSIS. 2002. Guidance for Minimizing the Risk of Escherichia coli O157:H7 and Salmonella in Beef Slaughter Operations. September.

Despite good slaughter practices, which are also detailed in this guidance, contamination of carcasses can still occur. Post-slaughter antimicrobial
decontamination methods can be used to address this issue, including spray-washing, steam-vacuuming, steam pasteurization, warm water wash,
trimming, lactic acid decontamination. Chilling and finished product storage at temperatures that preclude pathogen growth are also post-slaughter
processes that aid in minimizing contamination risks.
Keywords: meat processing, E. Coli, risk analysis, controls

USDA/FSIS. 2001. Controlling Listeria monocytogenes in Small and Very Small Meat and Poultry Plants. September.

Contamination of foods with Listeria monocytogenes most frequently occurs when a product or food contact surface is contaminated between the
cooking and packaging steps. Control methods include the following sanitation steps: dry cleaning, pre-rinsing equipment, foaming and scrubbing,
rinsing, visual inspection of equipment, cleaning walls and floors, sanitizing, and drying. Also, environmental and contact surface testing should be
done to determine the effectiveness of cleaning and identify potential sources of contamination. Sanitizers that have proven most effective include
quaternary ammonia compounds, chlorine solutions and products containing peracetic acid. Rotating sanitizers periodically is a good practice as it is
more effective against Listeria monocytogenes and other bacteria. Alternating between alkaline and acid based detergents also helps to avoid
soapstone or hard water buildups and the formation of biofilms and to alter the pH of the environment to prevent adaptation of the bacteria. Plants
must be designed to eliminate traffic flow between RTE and raw product areas. RTE areas should have dehumidifiers and drip pans that are sanitized
regularly. Ceilings, floors, and walls should be smooth, sealed, and moisture free. Air supply should be filtered. Light fixtures should be designed so
that they do not harbor dirt or moisture. Environmental testing of non-food contact surface, food contact surface testing, and product testing can be
conducted in-house by an establishment. Results, however, should be validated on a regular basis by a third party.
Keywords: meat processing, poultry processing, Listeria, controls, sanitation, testing, facility design, ready-to-eat
Walker, Elizabeth, Catherine Pritchard, and Stephen Forsythe. 2003. Food Handlers' Hygiene Knowledge in Small Food Businesses. Food
Control. Vol. 14. No. 5: 339-343. [only have abstract]

Personal interviews were conducted with 444 food handlers in 104 small food businesses regarding their knowledge of food hygiene. The study
reports that 57 percent of food handlers thought that they could tell if food was contaminated with food poisoning bacteria by sight, smell, and taste.
Roughly, 25 percent of the interviewees thought that bacteria readily multiplied at -10, 75, or 120 degrees Celsius. Around 16 percent thought that the
correct temperature of a refrigerator was -18 degrees Celsius or below. The study demonstrated that the basic lack of hygiene knowledge and
understanding could prove to be a major barrier to the effective implementation of HACCP in small food businesses in the U.K.
Keywords: employee hygiene, handling, HACCP, implementation

Young, Renee. 2003. Rethinking Sanitation. Food Engineering. March 29.

Manufacturers must adopt a holistic view of plant sanitation from how ingredients are delivered to the shipment of finished goods. This includes not
only rethinking the sanitation of processing systems but of all the building systems, including electrical fixtures and duct work. With the advent of PLC,
PC and CIP systems that measure the temperature, cleaning fluid mix, and pressure used in a cleaning session, operators can correct the problem
immediately. In the majority of smaller plants, equipment is not designed to be cleaned with the help of automation. Plants have different types of
equipment that range in age and design, making it virtually impossible to set up a spray pattern that will automatically and effectively clean each or
provide accurate measurements. In such plants, manufacturers are placing more emphasis on the employees. Many companies are transferring
sanitation from the third shift to the first or second and staffing those shifts with better-trained employees. Other plants are working to fully automate
their sanitation systems, eliminating the possibility of human error. Further, concern over the use of toxic chemicals in sanitation procedures and the
cost associated with their handling and disposal has many manufacturers looking for safer alternatives. Ozone is making strides as a safe alternative
and a powerful oxidant that destroys microbes. For example, salad maker, Sandridge Food Corp., uses aqueous ozone to disinfect celery and its
associated equipment. Plumrose USA Inc., a processor of ham, turkey, chicken, and deli meats, uses ozonated water to sanitize work areas and
processing equipment used for slicing and packaging and to rinse its stainless steel transportation racks.
Keywords: sanitation, facility design, equipment, employee training
 Current Good Manufacturing Practices (CGMPs)

Page Last Updated: 06/16/2015 

 GMPs - Appendix B: Definitions of Food Safety Problems
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Return to Good Manufacturing Practices (GMPs) for the 21st Century - Food Processing

Biofilms. A slime layer formed by bacteria on a surface, which provides an environment for pathogens to proliferate. Food contamination can result
when biofilms detach from their substrate and enter food products/ingredients.

Condensate on pipes and other equipment. When cold pipes come in contact with humid air in a food processing plant, condensate will form, which
can drip and contaminate food.

Contamination by reworked product. When food contamination results from using reworked product originating from one product line in another
product line.

Contamination during processing. The adulteration of a product during processing (with pathogens, chemicals, allergens, or foreign objects) so that
it is no longer wholesome and safe, therefore potentially rendering the finished product unsafe to eat. While contamination during processing can be
caused by other problems listed in the questionnaire (e.g., inadequate glass cleanup policy), contamination during processing, as defined here, is
meant to capture those problems not listed in the questionnaire that result in contamination during processing.

Contamination of raw materials. The adulteration of a product ingredient (with pathogens, chemicals, allergens, or foreign objects) so that it is no
longer wholesome and safe, therefore potentially rendering the finished product unsafe to eat. The problem encompasses those instances where the
incoming raw materials arrive contaminated as well as those where raw material contamination occurs at the plant. While the contamination of raw
materials can be caused by other problems listed in the questionnaire (e.g., use of unpotable water to wash food ingredients), contamination of raw
materials, as defined here, is meant to capture those problems not listed in the questionnaire that result in the contamination of raw materials.

Deficient employee training. Training that does not meet the following minimum requirements is considered deficient. Training, at a minimum, must
include a written policy covering GMPs, personal hygiene, plant sanitation policies and procedures, food safety and quality control policies, and
product tampering awareness and consequences. Training must be presented in a language that can be understood by all employees. Training
programs should be updated annually and records should be kept of training sessions. All new employees must be provided with initial training that
covers the minimum requirements and refresher courses should be provided quarterly. Operational deficiencies should result in additional training.

Difficult-to-clean equipment.  When food production and packaging equipment is not designed and installed in such a way as to produce a
wholesome product (e.g., the equipment is difficult to access for cleaning or the equipment is not operating properly).

Inadequate cooling. Not using the proper temperature during storage or processing of food ingredients or food products, especially refrigerated or
frozen foods.

Inadequate glass cleanup policy. If a glass cleanup policy, which should include properly cleaning glass containers, providing shielding in the event
of glass breakage during productions, and the proper cleanup of glass in nonproduction areas (glass should not be used in or near processing or
storage areas), does not exist or is not comprehensive.

Incorrect labeling or packaging. Products can be packaged from old or other products or placed in the wrong packaging.  In other cases, allergens
might not be declared on the label when they should be.
Lack of allergen control programs. Not available. Added by one expert.

Lack of chemical control programs. Not available. Added by one expert.

Lack of crisis management protocol. No written procedures or training on how to manage crises at the facility.

Lack of equipment knowledge. Poor understanding by employees who operate equipment on how to keep equipment clean and prevent equipment
maintenance tasks, such as lubrication of machinery, from contaminating food.

Lack of equipment parts reconciliation after repairs. No written procedures or training to ensure that all equipment parts are accounted for after a
repair.

Lack of knowledge of welding standards. No written standards or training on how to properly conduct welding in a food-processing environment.

Lack of product recovery protocol. No coding, traceability, or recall systems.

No preventive maintenance. When no documented plan of regularly scheduled inspections exists that identifies and corrects facility and equipment
problems before they become a food safety hazard.

Poor employee hygiene. Employee hygiene is considered poor if it could result in unsafe food or increases the likelihood of unsafe food
manufactured at the plant. This could be attributable to inadequate employee hygiene policies and procedures, lack of monitoring and compliance
verification, and other causes.

Poor pest control. Absence of a detailed pest management policy and program that is documented and conducted under the supervision of a
licensed pest control contractor.
Poor plant and equipment sanitation. Plant and equipment sanitation is considered poor if it could result in unsafe food or increase the likelihood of
unsafe food manufactured at the plant. This could be attributable to lack of adequate sanitation procedures, ineffective application of sanitation
policies, inadequate or lack of monitoring and verification of cleanliness, and/or other causes.

Poor plant design and construction. When the construction and design of the facility increase the likelihood of food contamination (e.g., cross-over
of flow paths of raw and finished products, contacts between walls or floors and food ingredient or finished food product, and poorly drained floors).

Post-process contamination at manufacturing plant. The adulteration of a finished food product after processing (with pathogens, chemicals,
allergens, or foreign objects) at the manufacturing facility so that it is no longer wholesome and safe, therefore rendering the finished product unsafe to
eat. The post-processing contamination might occur between the lethality treatment and packaging or post packaging at the manufacturing plant.
While post-processing contamination can be caused by other problems listed in the questionnaire (e.g., inadequate pest control), post-processing
contamination, as defined here, is meant to capture those problems not listed in the questionnaire that result in post-processing contamination.

Stagnant water due to dead-ends in plumbing. When plumbing connections do not have a drain into other areas and thus result in sitting water that
can contaminate food.

Use of unpotable water. Use of water that does not meet local health requirements, at a minimum.

Current Good Manufacturing Practices (CGMPs)

Page Last Updated: 06/16/2015 

 GMPs - Appendix C: Examples of Preventive Controls and/or
Corrective Actions for the Top Ten Food Safety Problems
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Contamination during processing. Separation of production lines, use of physical detachments and lockouts, use of staging areas, routine
maintenance of manufacturing equipment, and properly conducted, unbiased, third party audit of GMPs.

Contamination of raw materials. Supplier audits, raw material testing and verification, supplier training, pre-processing treatments (i.e.,
pasteurization, irradiation, washing, culling, etc.), documentation from suppliers certifying safety of materials, and properly conducted, unbiased, third-
party audit of GMPs.

Deficient employee training. Provision of training specific to the employees' duties, bilingual training, provision of learning aids, such as newsletters,
posters, and videos, seminars and employee reviews, evaluation of the effectiveness of training, training refresher courses, in-house training (versus
consultants), and properly conducted, unbiased, third-party audit of GMPs.
Difficult-to-clean equipment. Environmental sampling, cleaning areas prone to niches, SSOPs, taking equipment apart to clean, addition of a kill-step
at the end of processing (i.e., pasteurization, irradiation, etc.), and properly conducted, unbiased, third-party audit of GMPs.

Incorrect labeling or packaging. Institution of label review policies, removal of old label and packaging inventories from the manufacturing site,
verification of labels by scanning barcodes, label audits, training and properly conducted, unbiased, third-party audit of GMPs.

No preventive maintenance. Preventive maintenance plan, documentation of repairs and servicing, and properly conducted, unbiased, third party
audit of GMPs.

Poor employee hygiene. Use of sensor-equipped towel dispensers, keypad controls for hand washing, automated hand washing stations, and
properly conducted, unbiased, third party audit of GMPs.

Poor plant and equipment sanitation. Keypad controls that keep track of hand washing, sensor-equipped hand towels, pay incentives, beeping
dispenser to ensure adequate hand-washing time, documentation of hygiene activities (i.e., logs), SSOPs, and properly conducted, unbiased, third-
party audit of GMPs.

Poor plant design and construction. Properly conducted, unbiased, third party audit of GMPs.

Post-process contamination at manufacturing plant. Environmental sampling, inclusion of a kill-step at the end of processing (i.e., pasteurization,
irradiation, etc.), use of preservatives, SSOPs, and properly conducted, unbiased, third-party audit of GMPs.

Current Good Manufacturing Practices (CGMPs)

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 GMPs - Appendix D: Exploratory Factor Analysis
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Factor analysis is a data reduction technique that reduces the number of variables used in an analysis by creating new variables (called factors) that
combine redundancy in the data. The factor analysis conducted for this report reduced the number of variables from ten to four factors. The underlying
theory behind factor analysis is that a set of multivariate observations stem from a lesser number of underlying factors. For example, data on students'
test scores in math, science, art, and literature might reflect two underlying factors: one for "technical ability" and one for "creativeness." A student's
"technical ability" will probably be better reflected in math and science test scores, while a student's "creativity" should be reflected in art and literature
test scores. The factors are meant to reflect some underlying abstract dimension or concept. The measured variables are imperfect measures of those
dimensions or concepts.

A factor analysis looks for trends in correlations among the variables. Given that the factors are unmeasured, it is necessary to use numerical
algorithms to solve a factor analysis. The first step in a factor analysis is to determine the number of relevant factors. Many algorithms used to solve
factor analyses have methods of determining an appropriate number of factors, but it is also possible to specify (fix) a number of factors. For the
analysis in this report, we allowed the algorithm to determine the number of factors.
The output from the factor analysis will generate a table that relates each variable to each factor and assigns a numerical value between -1 and 1 to
each relationship. The numerical values are referred to as factor loadings and reflect the strength of relationship between the factors and the variables.
Variables that are closely related to one another should all load highly on the same factor. This is the essence of factor analysis: combining redundant
variation in the data.

The factors generated in a factor analysis do not have a straightforward interpretation. In fact, it is up to the researcher to determine how a factor
should be named. For the most part, theoretical considerations can guide in naming a factor. Nevertheless, developing appropriate names for factors
is an important aspect of factor analysis.

Once a factor analysis has been performed, a mathematical operation called rotation is performed. The purpose of rotation is to make each factor
distinct (in terms of factor loadings) from the other factors. Most raw factor loadings require rotation. The term rotation stems from the technique
involved: the axes are literally rotated around the score to generate new axes and thus new factor scores. From a mathematical perspective, this
transformation is justified since the factor loadings are only unique up to a multiplicative constant. Thus, rotation need only preserve the order of the
loadings to be consistent.

Scoring is the process of generating values for the factors for each observation in the data. For example, a factor analysis that reduces a set of 20
variables to six factors might be based on 1,000 observations on those 20 variables. The factor analysis only generates 120 factor loadings (20
variables x six factors). Although each observation has a value for each variable, none of the observations has a value for the six factors (at this point).
Scoring assigns a value to each observation for each factor. Once again, because the factors are unobserved, it is necessary to use numerical
algorithms to solve the equations used to score the factors.

Current Good Manufacturing Practices (CGMPs)

Page Last Updated: 06/16/2015 

 GMPs - Appendix E: Comparison of Food GMPs to Quality
Systems and Other GMPs
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 Table E-1: Comparison of Pharmaceutical GMPs, Medical Device GMPs, ISO 9001:2000, and ASQ Quality System to Food GMPs
  Food GMPs ISO 9001:2000 ASQ Quality System Medical Device GMPs Pharmaceutical
GMPs
Key  Personnel  Manageme  Management  QS Requirements  Organizati
Provisions o - nt responsibility responsibility o - on and
Disease o - Management responsi Personnel
 Marketing
control Managemen bility o -
o -
t  Specification o -Quality
Responsibili
commitmen and design ties of
Cleanliness audit
t quality
o -  Procurement o -Personnel control unit
o -
Education
 and Customer  Production  Design Control o -
training, focus and production Personnel
supervision control  Document Controls qualification
o -
 Purchasing Controls s and
 Plants and Quality  Product responsibili
grounds policy verification  Identification and ties
o - o -  Measuring Traceability
 Buildings
Grounds Planning and test  Production and and facilities
equipment process Controls
o - o - o -
Plant Responsibilit  Nonconformi  Acceptance Activities Design &
design and y, authority, ty construction
constructio and  Nonconforming
n communica  Corrective Product o -
tion action Sanitation &
 Sanitary  Corrective and maintenanc
operations o -  Handling and Preventative Action e
Managemen post-production
o -  Labeling and  Equipment
t review  Documentati
General Packaging
maintenanc  Resource on and records o -
e  Handling, Storage, Design, size,
management  Personnel Distribution, and & location
o - o - Installation
 Product
Substances Provision of o -
safety and liability  Records
used for resources Constructio
cleaning  Quality n, cleaning,
o -  Servicing
methods &
o - Human  Statistical Techniques maintenanc
Pest resources e
control
o -  Control of
o - Infrastructur components
Sanitation e and drug
 of food- o - product
contact Work containers and
surfaces environmen closures
t
o -  Production
Storage  Product & process
and realization controls
handling.
o - o -
 Sanitary Planning of Written
facilities and product procedures,
controls realization deviations
o - o - o -
Water Customer- Change in
supply related components
processes
o - o -
Plumbing o - Equipment
Design and identificatio
o - n
developmen
Sewage t
disposal o -
o - Sampling
o - and testing
Purchasing
Toilet of in-
facilities o - process
Production materials
o -
and service and drug
Hand- provision
washing products
facilities o - o -
Control of Control of
o -
monitoring microbiologi
Rubbish and
 and offal measuring cal
disposal devices contaminati
on
 Equipmen  Measurem
t and utensils ent, analysis, o -
and Reprocessin
 Processes improvement g
and controls
o -  Packaging
o - Monitoring and labeling
Raw and control
materials measureme
nt  Holding &
o -
distribution
Manufactur o -
ing Control of  Laboratory
operations nonconform controls
 ing product
Warehous  -Testing
ing & o - and release for
distribution Analysis of distribution
data
 -Stability
o - testing
Improveme
 Records
nt
and reports
 Quality
 Returned
management
& salvaged drug
system
products
o -
Documenta
tion
requirement
 s
Training  Appropria  Personnel  Training all  Management  Training in
te training for training levels of responsibility to define the regulations
food handlers necessary to personnel within training needs for applicable to
and meet the organization: personnel each employee
supervisors in organization Selection &
 Training in current  Additional
proper food needs; training of
GMP regulation and how training for
handling identification of recruited
individual job functions supervisory
techniques and training needs personnel &
relate to the overall personnel to
food through a gap personnel
quality system ensure the
protection analysis transferred to
safety, identity,
principles.
 Appropriat
new assignments  Training for strength,
 Training e level of  Training of temporary work under quality, and
should ensure training in executive special environmental purity of the
awareness of hygiene management in conditions product
the dangers of practices by job quality system
poor personal function (basic- operation and  Personnel
hygiene and level and criteria for who provides
insanitary advanced-level evaluating the training must
practices. training) effectiveness of be qualified to
the system do so
 Training in
sensory  Training of
evaluation and technical
identification of personnel
hazards and (including
associated marketing,
controls procurement, and
product & process
 Training of engineering
personnel in personnel) in 
appropriate statistical
hygienic
 practices techniques,
process capability
 Training studies, statistical
and sampling, data
reevaluation of collection &
testing analysis, problem
personnel identification,
problem analysis,
and corrective
action

 Training of
supervisors and
workers in their
respective tasks,
such as
equipment
operation,
reading &
understanding of
documentation
provided

 Formal
qualification of
personnel
performing
specialized
operations

 Motivation
and quality
awareness
  Measuring
quality
achievements and
recognition of
good
performance

Audits Audits are not Internal audits at  Internal  Management needs  Audits are
explicitly specified planned intervals audits of the to establish procedures not explicitly
to determine quality system at for quality audits of its specified but
whether the quality regular intervals documented quality are embodied
management to evaluate the system and ensure that within the
system (1) effectiveness of they are performed required record
conforms to the the various review process.
 Only those records
planned quality system
that demonstrate the  Annual
arrangements and elements
quality auditing system record review
(2) is effectively
 Audit needs are to be made available to evaluate the
implemented and
to have a plan to an FDA inspector. FDA applicability of
maintainedSelectio
with a clearly does not have access to quality
n of auditors
defined scope and the actual audit reports standards, need
should ensure
reason (i.e., for changes in
objectivity and
routine specifications,
impartiality
verification, manufacturing
(auditors should
organizational processes, or
not audit their own
change, consumer control
work)Internal
complaints, etc.) procedures.
audits of
management  To avoid
system records, conflict of
hygiene, interest, auditors
housekeeping, and should not audit
other their own work
functionsManagem
 Audit results
ent review of
should be
internal audit
documented with
results
specific examples
of deficiencies
and
noncompliance
and suggestions
of
corrective/preven
tive actions

 Review and
evaluation of the
quality system by
company
management
members,
customers, or
qualified
independent
auditors

 Quality
system audits
should consist of 
(1) specific
findings, (2)
overall
effectiveness of
the quality system
in achieving
quality objectives,
 and (3)
considerations for
updating the
quality system
with changes
brought about by
new technologies,
quality concepts,
market strategies,
customer
requirements, etc.

Documentati No documentation  Records of  Sufficient Explicitly requires that all of Explicitly requires
on requirements quality documentation of the following records be that all of the
explicitly specified, management achievement of readily available to FDA following records
except for supplier system reviews required product inspectors be readily available
certification for quality and food  Device master to FDA inspectors
 Personnel
cleaning safety record: device, production  Equipment
records
compounds and process, quality cleaning & use
 A method for
raw materials.  Product removing and
assurance, packaging and log: Must
realization labeling, and installation contain dates,
disposing of
process records specifications. times,
documents that
products, lot
 Records of are out of date  Device history
numbers, and
customer- record: date of
 Documents manufacture, quantity
signatures
related product include:
requirement manufactured, quantity  Componen
specifications, distributed, acceptance t, drug product
reviews test procedures, records (of DMR), container,
 Records of inspection identification label and closure, and
design and instructions, work control numbers. labeling
development instructions, records:
inputs, outputs, operational  Quality system Supplier names,
 reviews, procedures, record: procedures and lot numbers,
verification, and quality manuals, documentation of receiving codes,
validation laboratory activities test results,
procedures, and individual
 Design and quality assurance  Complaint files: inventory
development procedures compliant files to records,
changes and determine if investigation documentation
reviews  Records needed. If so, record of of labeling
including should be for investigation examination,
control process verification of and records of 
changes operation of rejected
quality system materials
 Supplier
selection  Examples of  Master
evaluation records include: production &
records inspection control records:
reports, test data, Prepared,
 Production qualification
process dated and 
reports, validation signed by one
validation reports, audit
records where individual and
reports, checked by
verification is calibration data,
not possible another
and regulatory
 Monitoring inspection  Batch
and measuring reports. production and
device control records:
calibration and documentation
verification of completion
records of each
significant step
 Internal in
audit records manufacturing
  Records of  Laboratory
production records: All
inspection and data, test
tests method
modification
 Records of records,
nonconforming stability testing
products results
 Corrective  Distributio
and preventive n records: Date
action records. and quantity
shipped

 Complaint
files

Evaluation/ There are no  Evaluation  Process and  Verification of  Process

Validation evaluation/validati of information product design product design, i.e., validation
on requirements relating to qualification and testing to determine
 Evaluation
to determine customer validation whether the design
of product and
whether a perceptions of involving periodic output meets the
process
performed activity whether the evaluation of the functional and operational
deviations
is achieving its organization design at requirements of design
goal. Only for raw has met its significant stages inputs  Verificatio
materials, the customer n of yield
 Validation of  Design validation
facility is to requirements calculations and
the process and with lab testing of
"verify" component
 Evaluation product design prototypes
compliance using charge-ins by
of the through small-
supplier
effectiveness of scale trial and  Process validation different
certification or and revalidation in case of people
the actions sample tests
some other changes or process
taken, such as
method.
training and  Periodic
 education reevaluation and deviations
requalification of
 Evaluation the product to  Validation of
of the ability of ensure that it computer software when
results of meets all it is used as part of
design and specified production or the quality
development to requirements system
meet
requirements  Product  Evaluation of the
verification need for an investigation
 Physical, of a nonconforming
chemical,  Evaluation of product
microbiological, training
shelf-life, and effectiveness  Retesting and
sensory reevaluation of the
evaluations nonconforming product
after it has been reworked
 Evaluation
of design and
development
changes on
constituent
parts and
product already
delivered

 Reevaluati
on of testing
personnel

 Quality
system
effectiveness
 evaluation

 Evaluation
of the need for
action to
prevent
occurrence of
nonconformitie
s

 Validation
of product
shelf-life
through market
research and
transit tests

 Ensuring
that the
product meets
customer
requirements
through specific
target user
groups or test
marketing

 Design and
development
validation,
revalidation
upon design
and
development
 changes

 Process
validation

 Test
method
validation
Page Last Updated: 06/16/2015