BIS and FCO Standards for Bio-fertilizer productions, CIB registration procedures for Bio-control agents..pptx

KSNUAHS-SHIVAMOGGA
COLLEGE OF AGRICULTURE, NAVILE,
SHIVAMOGGA.
Topic: BIS and FCO Standards for Bio-fertilizer productions,
CIB registration procedures for Bio-control agents.
Course: Bio-fertilizer Technology
MICRO-511 (2+1)
Presented by:
Gururaj Dasannavar
1st
PhD (Agronomy)
PA1TBD0173
KSNUAHS, SHIVAMOGGA.
Presented to:
Dr. Divya M
Assistant Professor
Dept of Agri’l Microbiology
CoA, KSNUAHS,
SHIVAMOGGA-577412.

Introduction
As synthetic fertilizers have numerous environmental hazards, it is important to reduce their usage in
agriculture without affecting crop yield. The introduction of Microbial biofertilizers is a viable and
economical option for better crop production in sustainable agriculture.
Biofertilizers are the microorganisms in single or consortia that increase the nutrient uptake of plants by
rhizospheric interactions. Plant growth-promoting rhizobacteria (PGPR); enhance the growth of plants
and their products through various mechanisms such as phosphorus solubilization, production of plant
growth hormones, nutrient and mineral uptake and fixing of atmospheric nitrogen (Bashan et al.1990;
Okon and Labandera-Gonzalez 1994; De Freitas et al.1997; Bashan 1998; Goldstein et al.1999).
Microbial biofertilizers usage is predicted to be increased in the nearby future due to numerous reasons
such as more fertilizer demand because of increasing food demand, limited feedstock/ fossil fuels, high
fertilizer cost, soil depletion, and many environmental hazards posing threat to agriculture.
Microbial biofertilizers are the when applies to the soil, plant surfaces, and seed, cause various
rhizospheric interactions which result in better supply, uptake, and availability of nutrients to plant. They
are easily accessible to small and marginal farmers. Biofertilizers involves a group of microorganisms
such as algae, fungi, cyanobacteria, and bacteria having symbiotic relationship with host plants.
Biofertiliser Newsletter, Vol. 29(1) :
June 2021

1. Nitrogen-Fixing Microorganisms
a) Free-living Nitrogen-fixing bacteria
b) Symbiotic and endophytic associations
c) Associative microbes in the rhizosphere
2. Phosphorus - Solubilizing Microorganisms
3. Mycorrhizal Biofertilizers
4. Other Mineral-Solubilizing Biofertilizers
5. Plant Growth-Promoting Microorganisms
Microbial biofertilizers are:

Steps involved in the biofertilizer production
Strain Selection Criteria:
Preparation of Biofertilizer:
Biofertilizers Production through Fermentation
Production of N2
-Fixing Biofertilizers
Production of Rhizobium Biofertilizers
Production of Azotobacter Biofertilizers
Production of Azospirillum Biofertilizers
Production of Phosphate-Solubilizing Biofertilizers

Biofertilizers Production/Application
 The production of carrier-based biofertilizers is the most effective and inexpensive method for better crop production.
 The large scale production involves major steps such as
1.Isolation of efficient microbial strains
2. Preparation of carrier material
3. Mixing of culture with sterilized carrier material, and packing.
 The carrier material should ideally have the following properties such as
1. Locally available 5. Easy to process
2. Inexpensive 6. High water-holding capacity
3. Readily available 7. Organic
4. Non-toxic 8. Carry high cell population
9. Should be able to support microbial survivability for a long time.
 The commonly used carrier material such as vermiculite, peat soil/lignite, press mud, charcoal, soil mixture, and farmyard manure is generally
neutralized. But, they have certain limitations such as
1. Temperature sensitivity 3. It become less effective by low cell counts
2. Possessing lower shelf-life 4. Being contamination free.
Thus, there was a need for the development of liquid formulations for Azospirillum, Rhizobium, Acetobacter, and Azotobacter, though it is a costlier
method, but has advantages of having higher cell counts, easier production, longer shelf-life, no contamination, storage up to 45 degree C and
greater competence in soil (Ngampimol and Kunathigan 2008). However, the application method of biofertilizers involves seedling root dipping,
seed treatment, and soil application.

Seed Treatment
Seed treatment is the most common, effective, and cost-effective method for all types of
microbial strains (Sethi et al.2014). The seeds are uniformly mixed and coated in a
slurry, shade-dried and then sown within 24 h.
The seed treatment can be done for many plants by using Rhizobium in case of pulses,
for, Azotobacter for cereals and grasses like sudangrass, bermudagrass, para grass,
Napier grass, star grass, etc.), and Azospirillum or phosphorus-solubilizing bacteria
(maize, rice, and sorghum) (Taylor and Harman 1990).
Seedling Root Dipping
This application is used for crops like vegetables, cereals, trees, fruits, sugarcane, grapes,
cotton, banana, and tobacco. Where seedling roots are dipped in a water suspension of
microbial inoculants (nitrogen-fixing Azotobacter or Azospirillum and phosphorus-
solubilizing microbial biofertilizer) for sufficient time. The treatment time varies for
different crops.
20–30 min for vegetable crops and 8-12 hrs for paddy before transplantation (Barea
and Brown 1974).

Soil Application
In soil application, the biofertilizer is applied directly to the soil either alone or in
combination. The mixture of phosphate solubilizer, rock phosphate, and cow dung is
kept in shade overnight while maintaining its moisture content at 50% and then applied
to the soil (Pindi and Satyanarayana 2012). For example Azotobacter (for coffee, tea,
rubber, all fruit/agroforestry plants for fuelwood, fruits coconuts, gum, fodder, leaves,
spice, nuts, flowers, and seeds) and Rhizobium (for leguminous plants or trees) (Zahran
1999; Hayat et al.2010).
A good carrier should have the following properties such as
1. Good moisture absorption capacity 5. Easily available
2. Non-toxicity, easy to sterilize 6. Good buffering capacity
3. Free of lump forming material
4. Inexpensive for maintaining the survivability of selected microbial strain.

Microbial Biofertilizers available in the market
In the market, there are numerous microbial biofertilizers available in the form of dried or
liquid cultures under different trade names, that can be used for various purposes such as soil
fertility and plant growth enhancement. For example, the rhizobium biofertilizers can
maintains soil fertility, fix 50–300 kg N ha-1
which increases crop yield by 10–35%, and leaves
residual nitrogen for subsequent crops (Davis 1996; Chen 2006).
The Azotobacter biofertilizer can maintains soil fertility, fix 20–40 mg N g-1
of carbon source
that causes up to crop 15% increase in yield and produces plants growth-promoting substances
such as indole acetic acid, vitamin B complexes, and gibberellic acid; and also control plant
diseases by killing some of the plant pathogens (Abd El-Lattief 2016; Kurrey et al.2018).
The phosphorus-solubilizing bacterial biofertilizers are nonspecific and can be used for all
crops, produce enzymes that mineralize the insoluble organic phosphorus into a soluble form,
thereby increasing crop yield by 10–30% (Sharma et al.2013).

Limitations of Microbial Biofertilizers
Though biofertilizer technology is environmentally friendly and has many advantages,
there are certain limitations associated with this technology that causes doubt among
stakeholders about its application.
The main disadvantages related with biofertilizers which need immediate attention by
extensive research as well as proper planning involves lower nutrient density (thus, are
required in bulk to be made available for most crops), plant specificity, the difficulty of
storage, requirement of separate machinery and skill for production and
application than that used for chemical fertilizers.
More importantly insufficient awareness about their use, application and benefits
among farmers (Malusà et al.2016). Also, there are certain limitations about
biofertilizers application which affect the technology at stages of production,
marketing, or usage (Jangid et al.2012).

BIS and FCO Standards for Bio-fertilizer productions.
BIS standards for two species viz. Rhizobium (IS: 8268-1976) and Azotobacter (IS: 9138-1979), there is no systematic quality
certification system and monitoring mechanism. It is entirely an internal arrangement and voluntary system as of now. As the
products being living microorganisms, the quality checkup, certification batch-wise is highly essential. Each unit should have
lab infrastructure and plans/arrangements for the same. Each unit, therefore should have the following facilities:
 Adequate microbiological lab and qualified microbiologist.
 Sampling and testing at various stages of production, including the quality of raw materials.
 Specify on the packets all the contents and cell counts. The source of mother culture and the strain name should also be
mentioned.
 The unit should fix their quality certificate and batch number, pack the products in proper packing material.
 Store the products in cooler places till they are sold to farmers.
 Ensure to have aseptic conditions, cleanliness and contamination free production lines and housing.
 Preferably use automatic and closed systems.
 As per BSI specifications, certain tests are required to be conducted, like no. of cells, colony character, reaction etc. Cell
number at the time of manufacture should not be less than 108 and 107 per gram of carrier material, respectively for Rhizobium
and Azotobacter. Similarly, the number of cell count and permissible contamination at expiry dates are also specified.
 As certification arrangements are not in place at present, legislation for quality monitoring and accredited labs for testing may
be needed in future to ensure proper quality and promote these products.

Biofertilizers and Organic Fertilizers Covered in
Fertilizer (Control) Order, 1985
(Amendments - March 2006, November, 2009 and June 2012)
General Rules
Ministry of Agriculture, Department of Agriculture and Cooperation,Government
of India, New Delhi, vide their order Dated 24th March, 2006 included
biofertilizers and organic fertilizers under section 3 of the Essential Commodities
Act, 1955 (10 of 1955), in Fertilizer (Control) Order, 1985. These rules were
further amended in respect of applicability, specifications and testing protocols
vide Gazette notification 3 November, 2009.
National Centre of Organic Farming- Ghaziabad-
UP

Schedule-III
[Clause 2(h) and (q)]
PART – A
Specification of Biofertilizers
Ministry of Agriculture, Department of Agriculture and
Cooperation, Government of India, New Delhi,

BIS and FCO Standards for Bio-fertilizer productions, CIB registration procedures for Bio-control agents..pptx

PRINCIPLES FOR REGISTRATION OF BIOFERTILIZERS
To ensure that circulation of such products for research or commercial purposes has been
authorised and that they are safe, efficacious, and effective as per label claims.
The purpose of this registration guideline is to provide a general framework for the registration
of biofertilizers on a regionally harmonised or country basis with common data
requirements and equivalent registration systems. It is assumed that there is already a
regulatory framework in use or being drafted for fertilizers in general or conventional
(chemical) fertilizers.
Together with recommendations for legislative action in case there is no existing framework or
the framework is deficient in some respects. This will ensure that the regulatory bodies and the
product proponents have the same understanding of bio-fertilizer registration requirements. As
such, the product proponents could develop their business plan accordingly.
Why Register Biofertilizers?
Purpose of Registration Guidelines

Objectives of registration framework for Biofertilizers
To ensure that only registered biofertilizers are placed on the market and made available for use by
farmers.
To ensure that only biofertilizers that are demonstrated to be safe and effective for intended use may be
registered.
To ensure that registered biofertilizers are used correctly and safely.
 To ensure that registration of a biofertilizer may be re-evaluated if new data becomes available
following registration.
To ensure that registration procedures take account of the lower inherent toxicity of biofertilizers.
To ensure that the registration procedures adopted by a national authority for biofertilizers follow a
harmonised regional approach so that evaluation of an application for registration might utilise data
from equivalent biofertilizers in other countries in the region and reduce testing requirements (fast
tracking)
To facilitate inter-national/inter-regional trade in biofertilizers.
To ensure marketplace monitoring/surveillance once a given biofertilizer has been registered.

Scope of registration system
Microbial biofertilizers: The guideline limits itself to only biofertilizers or biofertilizers
containing carrier based (solid or liquid) living microorganisms which colonize the rhizosphere
or the interior of the plant and promotes growth by increasing the supply or availability of
primary nutrient and/or growth stimulus to the target crop, when applied to seed, plant
surfaces, or soil. Throughout the guideline, biofertilizers will refer to microbial biofertilizers.
What formulation is to be registered?
Biofertilizers of any kind may be in circulation for research or for commercial purposes. All
available products should be registered.
Registration by national registration authority for approval of a biofertilizer in that
specific country. This is the main focus of these guidelines.
Joint reviews by two or more countries of submitted data whereby responsibilities for
evaluating applications are shared. For example, one country might lead on efficacy and
another leads on toxicity. Alternatively if one country has carried out an evaluation, another
can accept the data.

Regionally harmonised system where there is one regional level committee
making decisions on behalf of all the member countries. But each country has the
right to refuse to register a given pesticide, or modify the conditions of
registration.
Each participating country has the right to refuse admission of regionally
registered product into national lists if the intended uses are inappropriate or if
there are special risk factors.
There must be common data requirements but not necessarily equivalent
registration because each participating country could make independent decisions.
Biofertilizers from Genetically Modified Organisms (GMOs)
There is a regulatory mechanism for approving the production, importation and
use ('release into the environment') of GMOs (e.g. a Biosafety Act or Law).
Therefore, GMOs will be out of the scope of this guideline.

Identity and ownership of biofertilizers
The key to safeguards for small, resource-poor farmers and consumers is the legal
concept of identity of the registered product. Identity of any fertilizer is
determined by its composition
Details and concentration of active ingredients/active agents
Details and concentration of formulants
Details and concentration of impurities
And any other details as determined by regulators usually on a case-by case basis
according to the nature of the biofertilizer proposed for registration.
Identity

Ownership of a biofertilizer being registered
Biofertilizers being considered for registration may be either public goods,
having been developed in publicly funded institutions for the benefit of farmers
and other users at low cost or on a cost recovery basis; or they may be private
goods owned by a company in a commercially oriented enterprise.
It is important to note that even if a biofertilizer is public goods, it is still likely
to have a trade name as a form of intellectual property protection. Conversely,
generic biofertilisers marketed for commercial purposes do not have a trade name.
Irrespective of whether a particular product is public or private goods, it should be
recognised that the registration is affected because the biofertilizer is to be used
and generally there will be some economic or commercial activities attached to its
use. The legal or natural person in whose name the biofertilizer is registered
(registrant) must be prepared to take on responsibility for the registered product
post registration as part of product stewardship.

Registration is aimed at coping with any of the following developments:
Commercial organisations offering alternative products for the same active agent
Generics marketed without a trade name
Small-Medium Enterprisers and local communities developing biofertilizers for local use.
The need for registration here is to give users assurances of genuine, good quality products.
It is important to remember that even if a given biofertilizer to be registered is considered as
“public goods”, the registrant should still either be the originator of the data required or have
a right to use that data. In some cases the data may be in the public domain so the second
criterion will be satisfied. Additionally, even with public goods, the biofertilizer product will
have a trade name.
Confidential data

The data that are “commercial in confidence”. Confidential data could include
data on identity but also accompanying manufacturing data that provide an
explanation of the composition and the origin of impurities.
Analytical data from an independent accredited laboratory to back up the
assertions on identity and the required certificate of composition limits are not
confidential, nor are data on efficacy and toxicology/other adverse effects.
The separate submission of confidential data (by secure means electronically or in
sealed envelope) should be accompanied by a Disclosure Declaration detailing the
extent to which the confidential data may be shared with other official regulatory
bodies.

BIOFERTILIZER REGISTRATION PROCEDURES
A pre-submission consultation meeting is proposed to serve as communication tools and
provide guidance and advice to registrants prior to submitting an application package for
biofertilizers. To ensure that the pre-submission consultations follow a standardized process,
and the information provided by both the registry and the registrant is recorded and maintained,
face to face meeting, usually requested for by a registrant is proposed. During this meeting, the
following information is supplied:
Details of the identity of the bio-fertilizer
List of active agents
Deposition of culture in a nationally recognised culture collection (when applicable)
Disclosure of any non- active ingredients
Proof of ownership of the biofertilizer to be registered
Type of registration to be requested when full application made:(Amended registration (e.g.
modified use, emergence of adverse effects) is not likely to apply to this situation)
Pre-submission Consultation

Registration for experimental use
Temporary (when applicable)or full registration
Safety information
Short summary of the bio-fertilizer safety to human, animals, plants and the environment
a list specifying contents of the proposed product, including active ingredient and formulants, impurities
and metabolites.
manufacturing methods, information regarding any potential health or environmental
analysis report with certification of limits by an approved lab
Efficacy information (when available)
short summaries of available data regarding efficacy,
Mode of action of active ingredient (if known)
In general, the pre-submission consultation meeting should take place within 10 working days following
request by a registrant.
Label information

Providing feedback to registrant
 After the pre-submission consultation, the registration authority should respond within a
specified timeframe 15 working days either with a request for clarification of any outstanding
issues OR with a letter with the following information:
 Confirmation that the applicant is a suitable registrant as being the owner of the biofertilizer
or in a suitable relationship with the owner. The registration authority may also wish to verify
that the applicant has the capacity for product stewardship and is not just a ‘post office box’
for a ‘real’ registrant outside the country that might be difficult to contact in case of problems.
 Confirmation that full submission may proceed for the product registration
 A comprehensive list of the safety, efficacy, and labelling requirements
 Confirmation of data waivers when applicable
 Confirmation of the handling of confidential business information
 Confirmation of the fee to be paid along with submission
 Other administrative requirements

Multiple registration authorities
If multiple registration authorities are involved, e.g. for joint reviews of data, the procedures involved
should be modified appropriately.
Processing an application for registration of a biofertilizer follows these steps:
Administrative requirements
The administrative requirements are meant to provide product proponents with enough information to
prepare the registration package based on regulatory requirements and procedures. A checklist will be
included so that the interested stakeholders could verify whether they have put together all the necessary
documents to support product registration.
Minimum information need to be included in the application file for product registration as well as other
administrative requirements such as the applicable fees. A check list to be used to verify whether or the
requirements are met is recommended. The regulatory body reserves its right to seek for additional
information if it is deemed necessary to complete the safety and efficacy reviews or conform the validity
of the information on the product label.
Letter of intention: When submitting an application for product registration, an intention letter should
be included to outline the purpose of the application. It will include a brief description of the
manufacturing company such as his vision, and mission. The letter of intention should not exceed two
pages. Should indicate whether the product has been used elsewhere in agricultural production. If it has
not been used elsewhere.

Application form
Product proponents will be required to complete an application form to be filled out so as
to provide a summary of the information about the product such as the
type of the product
constituent materials
source and proportion
well-documented physical-chemical-biological properties
the applicant and his/her contact information including the address
the signature of the authorized representative
fees paid for the file analysis when applicable.
Registration fees
The registration fee includes fees for label, efficacy data, and safety data reviews to be
paid to the regulatory body. however, the efficacy and quality data should be generated by
a party approved by the regulatory body. The registration fee is fixed amount + applicable
taxes.

Authorized representative
To ensure that confidential business information is not released to unauthorized
individuals, the product proponents should provide in writing a list of maximum
three persons authorized to request information on the product file. Details on the
individuals including their contact information and their relationship with the
product proponent should be specified.
Any person external to the regulatory body that is not included in the list should
not have access to information in the product file. A product proponent could
modify the list anytime in writing; however, the regulatory body won’t be
responsible for any damage that may occur during the transition period i.e. from
the initial list to the revised list of authorized individuals.
Hence, he/she will have to make sure that the regulatory body receives the
information on time and confirm with the regulatory body the reception of the
amended list. Once the amended list is received the regulatory body should
immediately implement the change.

Declaration of country agent
When a product proponent is not a citizen of the country where he wants to register the
product, he/she must have a citizen of the country as country or local agent.
An official letter signed by the product proponent and countersigned by the country
agent should be submitted to the regulatory body. The country agent must be included in
the list of authorized representative(s).
Product label
The authorized representative should provide a tentative product label that meets the
requirements in the registration guideline. The mandatory sections of a product label
should be considered. Additional information could be added, but will be subject to the
approval of the regulatory body to include it on the commercial label. The commercial
label will have to include a registration number granted by the regulatory body as a seal
of approval.

Sampling requirements
Sampling standard operational procedures (SOPs) are meant to ensure consistence
of product sampling including representative samples.
This specification shows the manner in which samples are taken to prevent
contamination. The registration authority will check that information provided
shows consistency.
This is particularly important when the sample is to be used for legal decision like
product registration, detention, or cancelation of the registration, etc.
The sampling SOP should be communicated to the regulatory officers such as
inspectors, but also the product proponents to prevent unnecessary challenges.
The following outlines the recommended sampling SOPs that will be
implemented by the participating regulatory bodies to ensure adequate
marketplace monitoring or surveillance from product registration/importation to
the end of lifetime in the marketplace.

General requirements for sampling
Precautions and directions must be observed when drawing, preparing, and handling samples
intended for quality control
To ensure that representative samples are taken, sampling must be carried out by a qualified,
trained, and experienced person
For packaged products, unopened packets should be sampled and send to the laboratory using
appropriate equipment to prevent possible contamination of samples during handling
Samples must be taken in the presence of the product proponent and/or his/her authorized
representative
Collected samples should not show any visible sign of potential contamination or have been
exposed to a well-established contaminant
For quality control, samples should be tested from each lot separately to determine whether a
material meets the regulatory requirements with respect to prescribed standards or
specifications

Drawing samples
The number of sample-packets to be taken from a lot will depend on the size of the lot. The samples
should be randomly selected using a well-established randomization tool or software when applicable.
The inspector or any other authorized staff shall take 3 sample-packets for the same batch based on the
batch number. The sample should be taken in the presence of the product proponent or his/her authorized
representative; the latter should sign on the sampling form of the inspector. When analysing samples,
each packet should be taken separately.
The inspector or any other authorized staff should carry with him/her appropriate sampling forms on
which to consign information about the sample and the sampling procedures. Hence, each sample should
be sealed in cloth bags or any approved containers using the inspector seal after having put inside the
sampling-form filled out by himself/herself
When the product proponent or her/his authorized representative wants to send samples to independent
lab(s) for potential cross-validation of the results; the inspector or the authorized staff should randomly
selected additional 3 sample-packets for each independent lab. The samples should be handled similarly
to the legal samples.
The total number of lots to be sampled will depend on how many there are. When the total number of
lots is lower than or equal to 5, each of them will be sampled. When it is higher than 5, 5 randomly
selected lots will be sampled.

Number of randomly selected samples to be drawn from a lot
 Efficacy requirements
In addition to the product label and safety information, the application package should
include efficacy data generated by an institution/organization approved by the regulatory
body. The efficacy data should include quality data (i.e. guarantee analysis, level of
biological contaminant at specified dilution level), and performance data generated based
on the registration guideline i.e. guideline for efficacy testing. A summary of the efficacy
data should be submitted alongside the supporting data.

Good experimental practices
It is recommended that efficacy trials be conducted using Good Experimental Practices
(GEP)1. The primary goal of GEP is to ensure that all efficacy trials conducted are of a
high quality and the results derived are reliable and can be used by different registration
authorities for comparison in verifying product efficacy. This is particularly important
in the context of mutual recognition across countries. An external audit to verify proper
use of the GEP should be conducted at the discretion of the applicable regulatory
bodies. Hence, the approval duration of the organizations/institutions/institutes and
research scientists should be subject to renewal.
Location of efficacy testing and site selection
The location of efficacy testing should be recommended by applicable regulatory
bodies. Hence, the regulatory body should determine the minimum number of agro-
ecological zones (AEZ) where a given biofertilizer should be tested when a product is
recommended for several AEZ.

Minimum number of trials
The minimum number of trials required to support product efficacy will vary depending
for instance on the intended usage pattern, intended crops, and label claims. For
example, a product intended for soil application, to be used on a single crop with the
claim of increased yield would generally require a low number of trials. However, when
the same product is also intended for foliar application (on the same product label), and
for several crops, and claims yield increases and improved root biomass, the minimum
number of trials may significantly increase.
Spatial and temporal distribution of the Minimum number of trials
In general, the minimum number of trials should be conducted in more than one
growing seasons (temporal variability) and in different locations (spatial variability). The
minimum number of growing seasons to be considered should be determined by the
appropriate regulatory body.

Representative crops
When several crops are considered for the same biofertilizer the minimum number of
trials may increase drastically to the extent that it is no longer affordable or scientifically
relevant given the potential similarity across crops. In the case where the similarities
between crops is supported by scientific evidence in terms of physiology and production
patterns, the crops could be grouped together based on similarities and the efficacy
testing conducted using a representative crop from each group. The grouping should be
validated by the regulatory body before the beginning of the trials to prevent
misunderstanding. The grouping won t be considered in the case of a few crops (e.g. <3
‟
crops).

Mutual recognition
When data conducted elsewhere are found to be relevant in another country based
on the similarity of the agro-climatic conditions, the applicable regulatory bodies
may recommend a reduce number of trials to confirm the efficacy of the product
in the local conditions. Generally, the required minimum number of trials is
reduced to a half and the temporal variability is automatically waived. The mutual
recognition will be granted based on the merit of the rationale and evidence
provided to support the similarity of the agro-climatic conditions and also based
on the existence of precedence.
Shelf life for bio-fertilizers and bio-pesticides
As microbiological inoculant products contain viable microorganisms or other
active ingredients subject to degradation or loss of viability over time, such
products must display an expiry date on their labels to indicate the date after
which the required minimum number of viable cells can no longer be guaranteed.

Measurable parameters
During assessment of product efficacy, considerations should be made prior to, after
treatment and after harvest as follows:
Prior to treatment: To ensure that product efficacy is evaluated in appropriate
conditions, the initial soil fertility level should be evaluated prior to the establishment
of the trials. Soil analysis prior to treatment should include: soil texture, pH, cation-
exchange capacity, organic matter content, availability of selected plant nutrients,
functional microorganisms in the case of microbiological products, soil-borne diseases
in the case of bio-pesticides, etc. This information should be collected regardless of the
label claims.
After treatment: After the application of the treatment, minimum weather data
including the ambient temperature, humidity and rainfall should be collected. In
addition to the initial soil testing, information on weather conditions could also be used
to explain any spatial or temporal variability. Other measureable parameters will be
based on the label claims2.

After harvest:
considerations for
Tissue analysis for nutrient uptake (i.e. major, secondary and micro- nutrients depending on the
product of interest).
Crop yields (grain yield, haulms, husks, etc)
Quality of the crop yields when applicable (based on label claim)
functional microorganisms for microbiological products,
Soil-borne diseases in the case bio-pesticides
Data analysis
The data should be statistically analyzed including descriptive statistics and analysis of variance
(ANOVA) using accepted software (e.g., SAS, R). The method of statistical analysis should be
considered prior to conducting the trial. The level of significance and the mean separation
techniques should be the ones that are commonly used in the field of interest (e.g. 5% and the
least significant difference i.e. LSD). All label claims must be adequately supported by
scientific data that has been statistically analyzed and demonstrates a statistically significant
benefit. The statistical analysis should be consistent across AEZ for the same product and
treatments.

Safety requirements
A package of safety data should be prepared In addition to the supporting
document, a rationale not exceeding 5 pages to substantiate the safety of the
product should be provided. Basically, the product proponent should demonstrate
that each ingredient in the product formulation is present at level expected to be
safe to human, animal, plants, and the environment. Also,
The safety of the formulation when all the ingredients are mixed together should
be demonstrated i.e. mixing the ingredients results in a product equally safe. In the
case of bio-fertilizers the level of non-guaranteed micro-organisms should not be
higher than the tolerance prescribed in this registration guideline.

Labeling and packaging requirements
Labels must not have any incorrect or misleading information or mark or brand or name that would
tend to deceive or mislead a purchaser with respect to the composition or utility of the product.
Existing Regulations may specify what must be on the label of biofertilizer in both general and
specific terms. The approved and registered product label must match the label being used in the
marketplace.
The main panel of the label is considered to be the "principal display panel". This panel must
display at least the product name, the product weight and the name and address of the registrant or
the manufacturer. The label should also as specified by the regulations have a complete address. If
an address stated on the label refers to the place of manufacture of the container, this must be clearly
indicated ("bags manufactured by"). If the product is packaged outside the country, contains a
country’s address on the label, and is imported for resale in the country, the words "imported by" or
"imported for" must precede the country’s address, unless the geographic origin of the pre-packaged
product is also stated on the label.
All information on the label must be printed conspicuously, legibly and indelibly. All information
must be printed in a font size that would be legible from a normal distance without the aid of
magnifying devices. This information must in the country’s official languages as required by law.

Quality requirements
Quality requirements
Quality of biofertilizers is one of the most important factors resulting in their success or
failure; acceptance or rejection by end-user, the farmers. Quality is about specifications
for physical and chemical properties in quantitative terms for maintaining quality. This
includes things like moisture content, particle size and the permissible limits of
undesirable constituents as well as specifications for quality checks of fertilizer samples.
In other terms, the microorganisms in the active form per gram or millilitre biofertilizer
and maintained over the period of the products lifetime. Thus a description of quality
may contain parameters like the microbial density at the time of manufacture, microbial
density at the time of expiry, the expiry period, the permissible contamination, the pH,
the moisture, the microbial strain, and the carrier. Quality has to be controlled at various
stage of production (during mother culture stage, carrier selection, broth culture stage,
mixing of broth and culture, packing and storage).

Making a decision on registration
Modes of registration
 The application will include the mode of registration applied for such as:
 Provisional/full
 Experimental
 Renewal (when applicable; in that case the frequency at which the registration should be renewed has to be defined)
 A decision must be based on whether to grant registration according to the completeness of the data and a satisfactory outcome
of assessments. In the case of an application for Full Registration, the registration authority may decide to grant provisional
approval if further data are required. This situation may arise with a new product where there is insufficient experience of field
use.
 The next step is to record a registration number and details of registration in the official Register and issue a
corresponding Certificate of Registration. The Register and the Certificate will record the Conditions of Registration such as
post-registration controls, major use categories, restrictions or cautions on use permitted off-label and minor uses, and any
observations or directions on submitted plans for labelling and advertising.
 The registration authority should reserve the right to revoke, suspend or modify registration on its own initiative subject to
emergence of data post-registration. See later.
 When a registrant is not satisfied by a decision made by the regulatory body, he/she would normally have the right of appeal
to a higher authority in the first instance, and ultimately to the courts based on the provisions in fertilizers Act and/or
regulations or in administrative law (judicial review).

Certificate of Registration
A form should be produced for the Certificate of Registration to bear all the important details
of registration including:
Registration number/previous registration status and No.
Type of registration
Period of validity
Registrant’s details
Emergency contact
Details of Biofertilizer
Conditions of registration
Type of biofertilizer
Restrictions and cautions.

Register of biofertilizers
The Register of bio-fertilizers may be provided in paper and or electronic form. If a national registration
system is being considered but there is a relevant regional body looking towards harmonisation of
(bio-)fertilizer registration, then it is recommended that the Register be shared with the regional body with
a view to making the register available to other countries in the region.
Schedule of fees
The fees for different categories of registration should be transparent. It is preferable if fees are announced
in secondary legislation rather than in primary law so that fees established previously do not become out-
dated through inflation. It is recommended that fee levels should be subject to stakeholder consultation. If
there is a regional dimension to registration, there should be coordination between the regulators in order
to avoid forum shopping by registrants. Fees proposal should be made for the following:
 New or Temporary registration
Safety data review
Efficacy data review
Quality review
Handling and processing
Amendment to registration

Due process in registration
The registration authority has a duty to provide a good service to registrants, ensuring
that registration applications are treated fairly, without prejudice and bias and in a timely
manner. Presumed to be in the primary are provisions for:
Transparency in application process, data requirements and evaluation
Time limit for evaluation and decision-making
Giving reasons for refusal
Complaints and appeals procedures
Most importantly, it is reasonable that an indicative time limit should be given for a
decision on registration. If the evaluation cannot be completed within the allotted time,
the registrant should be informed as to the reasons.

Post-registration controls – product stewardship
Post-registration controls will mainly take the form of market surveillance to
ensuring that the quality standards are maintained throughout the marketing
chain of the bio-fertilizers based on the prescribed specification. If it is
discovered that standards have to be modified based on emerging concerns, the
registration guidelines will be amended accordingly.

REFERENCES
AATF [African Agricultural Technology Foundation].2013. A Guide to the Development of Regulatory Frameworks
for Biopesticides in Sub-Saharan Africa. Nairobi: African Agricultural Technology Foundation
Abd El-Fattah DA, Eweda WE, Zayed MS (2013) Effect of carrier materials, sterilization method, and storage
temperature on survival and biological activities of Azotobacter chroococcum inoculants. Ann Agric Sci
58(2):111–118
Ansori A, Gholami A (2015) Improved nutrient uptake and growth of maize in response to inoculation with
Thiobacillus and mycorrhiza on an alkaline soil. Commun Soil Sci Plant Anal 46:2111–2126
Barea JM, Brown ME (1974) Effects on plant growth produced by Azotobacter paspali related to synthesis of plant
growth regulating substances. J Appl Microbiol 37:583–593
Bashan Y, Ream Y, Levanony H, Sade A (1989) Non-specific responses in plant growth, yield, and root colonization
of noncereal crop plants to inoculation with Azospirillum brasilense Cd. Can J Bot 67:1317–1324
Bhattacharyya, P. and Tandon, H.L.S. (2012). Biofertilizer Handbook – research – production – application. Fertilizer
Development and Consultation Organization 204-204A Bhanot Corner, Pamposh Enclave, New Dehli 110048
(India)
Boddey RM, de Oliveira OC, Urquiaga S, Reis VM, Olivares FL, Baldani VLD, Döbereiner J (1995) Biological
nitrogen fixation associated with sugar cane and rice: contributions and prospects for improvement. Plant Soil
174:195–209
CFIA (1997). T-4-114 - Sampling Procedures for Fertilizers. Canadian Food Inspection Agency.

CFIA (2010). Guide to the Canadian Federal Regulatory Requirements for Fertilizers and Supplements. Crop Inputs
Division; Plant Health and Biosecurity Directorate; Canadian Food Inspection Agency
Davis RD (1996) The impact of EU and UK environmental pressures on the future of sludge treatment and disposal.
Water Environ J 10:65–69
Diagne N, Arumugam K, Ngom M, Nambiar-Veetil M, Franche C, Narayanan K, Laplaze L (2013) Use of Frankia
and actinorhizal plants for degraded lands reclamation. Biomed Res Int 2013
Gutierez-Mañero FJ, Ramos-Solano B, Probanza A, Mehouachi J, Tadeo FR, Talon M (2001) The plant-growth-
promoting rhizobacteria Bacillus pumilus and Bacillus licheniformis produce high amounts of physiologically
active gibberellins. Physiol Plant 111:206–211
Idris EE, Iglesias DJ, Talon M, Borriss R (2007) Tryptophan-dependent production of indole-3-acetic acid (IAA)
affects level of plant growth promotion by Bacillus amyloliquefaciens FZB42.MPMI 20:619–626
James EK (2000) Nitrogen fixation in endophytic and associative symbiosis. Field Crops Res 65:197–209
Jangid MK, Khan IM, Singh S (2012) Constraints faced by the organic and conventional farmers in adoption of
organic farming practices. Indian Res J Ext Educ Spec Issue II:28–32
Kannaiyan S (ed) (2002) Biotechnology of biofertilizers. Alpha Science Int’l Ltd
Lugtenberg B, Kamilova F (2009) Plant-growth-promoting rhizobacteria. Annu Rev Microbiol 63:541–556
Malusà E, Pinzari F, Canfora L (2016) Efficacy of biofertilizers: challenges to improve crop production. In: Singh DP
et al (eds) Microbial inoculants in sustainable agricultural productivity.Springer, New Delhi
Meena VS, Maurya BR, Verma JP (2014) Does a rhizospheric microorganism enhance K+ availability in agricultural
soils? Microbiol Res 169:337–347

Ngampimol H, Kunathigan V (2008) The study of shelf life for liquid biofertilizer from vegetable waste. Au J T
11:204–208
Pindi PK, Satyanarayana SDV (2012) Liquid microbial consortium – a potential tool
Polyanskaya LM, Vedina OT, Lysak LV, Zvyagintsev DG (2002) The growth-promoting effects of Beijerinckia
mobilis and Clostridium sp. cultures on some agricultural crops. Microbiologyproduction. In: Singh DP et al
(eds) Microbial inoculants in sustainable agricultural productivity. Springer, New Delhi
Richardson AE (2001) Prospects for using soil microorganisms to improve the acquisition of phosphorus by plants.
Aust J Plant Physiol 28:897–906
Schachtman DP, Reid RJ, Ayling SM (1998) Phosphorus uptake by plants: from soil to cell. Plant Physiol 116:447–
453
Sethi SK, Sahu JK, Adhikary SP (2014) Microbial biofertilizers and their pilot-scale production. Microbial
Biotechnol Progr Trends 297
Sharma SB, Sayyed RZ, Trivedi MH, Gobi TA (2013) Phosphate solubilizing microbes: sustainable approach for
managing phosphorus deficiency in agricultural soils. Springerplus 2:587
Simiyu–Wafukho S., Cargele Masso;. Nang ayo N., 2013. Guidelines for Registration of Biofertilizers in Sub
‟
Saharan Africa 2013, The African Agricultural Technology Foundation (AATF).XX pp. ISBN XXX-XXXX-
XXSimiyu–Wafukho S., Cargele Masso;. Nang ayo N., 2013. Guidelines for Registration of Biofertilizers in
‟
Sub Saharan Africa 2013, The African Agricultural Technology Foundation (AATF).XX pp. ISBN XXX-
XXXX-XX.

Singh I, Giri B (2017) Arbuscular mycorrhiza mediated control of plant pathogens. In: Mycorrhiza – Nutrient
uptake, biocontrol, ecorestoration. Springer, Cham, pp 131–160
Smith SE, Read DJ (1997) Mycorrhizal symbiosis. Academic Press, London
Stephens JHG, Rask HM (2000) Inoculant production and formulation. Field Crops Res 65:249–258
Sundara B, Natarajan V, Hari K (2002) Influence of phosphorus solubilizing bacteria on the changes in soil
available phosphorus and sugar cane and sugar yields. Field Crops Res 77:43–49
Taylor AG, Harman GE (1990) Concepts and technologies of selected seed treatments. Annu Rev Phytopathol
28:321–339
The Fertilizer Association of India (2010). The Fertiliser (control) order 1985 (as amencdded up to June 2010).
Ensuring food security. New Delhi
Unkovich MJ, Pate JS (2000) An appraisal of recent field measurements of symbiotic N2 fixation by annual
legumes. Field Crops Res 65:211–228
Wall LG (2000) The actinorhizal symbiosis. J Plant Growth Regul 19:167–182
Zahran HH (1999) Rhizobium-legume symbiosis and nitrogen fixation under severe conditions and in an arid
climate. Microbiol Mol Biol Rev 63:968–989

BIS and FCO Standards for Bio-fertilizer productions, CIB registration procedures for Bio-control agents..pptx

More Related Content

Similar to BIS and FCO Standards for Bio-fertilizer productions, CIB registration procedures for Bio-control agents..pptx (20)

More from AkhilKanukula2 (20)

Recently uploaded (20)

BIS and FCO Standards for Bio-fertilizer productions, CIB registration procedures for Bio-control agents..pptx