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Biosafety Guidelines

The document outlines Pakistan's national biosafety guidelines for work with genetically modified plants. It establishes three categories of risk for regulated work, with category 1 posing minimal risk, category 2 posing low risk, and category 3 posing considerable risk. It provides containment guidelines for field work with GM plants based on their risk categories and history of safe use. The guidelines aim to evaluate and mitigate any ecological, environmental or health risks posed by experimental GM plants.

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Waseem Hayat Haider
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35 views13 pages

Biosafety Guidelines

The document outlines Pakistan's national biosafety guidelines for work with genetically modified plants. It establishes three categories of risk for regulated work, with category 1 posing minimal risk, category 2 posing low risk, and category 3 posing considerable risk. It provides containment guidelines for field work with GM plants based on their risk categories and history of safe use. The guidelines aim to evaluate and mitigate any ecological, environmental or health risks posed by experimental GM plants.

Uploaded by

Waseem Hayat Haider
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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NATIONAL BIOSAFETY GUIDELINES

Government of Pakistan
Pakistan Environmental Protection Agency
(Ministry of Environment)
(May 2005)
Genetic transfer of traits in transgenic
plants by recombinant DNA technology
oHigh vitamin contents as in golden rice

oImproved amino acid profile as in QPM

oImproved fiber in case of fiber crops

oIncreased shelf life as in flavr savr tomatoes

oInsect pest resistance as in case of Bt-cotton

oImproved oil contents and lipids as in different oil crops


Genetic transfer of traits in transgenic
plants by recombinant DNA technology
oReduced toxicity like Erucic acid in brassica and gossypol
contents in cotton

oHerbicide resistance in crops like maize

oProduct quality improvements

oMale sterility traits

oOthers (production of metabolites/ chemicals, improvement of


nutritional traits, incorporation of marker genes, stress
resistance properties etc.)
REASONS FOR CONCERNS
• Changes in ecological roles:

• Changes in genetic relationships:

• Changes in allergenicity, toxicity, or nutritional composition of


foods:

• Indirect effects:

• Ethical and social Issues:


BASIS OF BIOSAFETY GUIDELINES

• All regulated works are classified according to level of


anticipated risk and safety, into three categories:

• A) Work bearing minimal risk,

• B) Work bearing low risk,

• C) Work bearing considerable level of risk.


Risk Category 1

• Experiments characterized as risk Category 1 include:

A. Tests involving organisms that naturally exchange genetic


material, provided that the donor and the recipient are of the
same species or that the donor species is capable of
exchanging genetic material with the recipient species under
natural circumstances.
RISK CATEGORY 2 WORK
• Work with previously approved host/vector systems
but in which the genetic material inserted exhibits one
or more of the following properties.

• codes for proteins regulating cellular metabolism, growth


or division.

• represents a pathogenic determinant.

• represents an uncharacterized DNA or RNA sequence


derived from microorganisms which cause diseases in
humans, plants or animals.
RISK CATEGORY 3 WORK

• Application of genes determining pathogenicity in microorganisms


other than the approved host microorganisms

• Transfer of whole viral genomes, viroids or genetic fragments


known to initiate infection in humans, plants or animals.

• Application of genetically manipulated DNA sequences coding for


proteins known to regulate cell growth or to be toxic to human
cells.
GUIDELINES FOR FIELD WORK
GENETICALLY MODIFIED PLANTS
• For experimental plants considered to have a history of safe
use in the field

• Those plants are considered to have safe history that have


been modified by,

• A. conventional breeding practices (e.g. selective breeding,


mutagenesis, protoplast fusion or embryo rescue) and/or
having inherent characteristics typical of modified plants from
conventional breeding practices,

• B. the introduction of genetic inserts that are known to be


harmless and nonhazardous to the environment.
• For experimental plants which do not meet the previous
conditions, work may proceed under appropriate containment
level.

• The said measures of containment must observe any one or more


of the following conditions:

A. There is no cross-hybridization.

B. There are arrangements to contain the dispersal of plants and


plant materials.

C. Introduced gene expression is stable, and does not fluctuate


with changing environmental conditions.
• In the case of those plants which do not have a history of safe use in
the field, work may proceed with a preliminary risk assessment to
determine:

A. Effects on the ecology of the trial site.


• Increased resistance to diseases and pests.
• Propensity for weediness.
• Effects on other target and non-target organisms.

B. Effects on the ecology in the open environment


• Potential for cross-hybridization.
• Promotion of and stimulus for the growth and development of
weeds.
• Invasion of wild populations beyond the trial site.

• C. Effects on other elements in the surroundings.


REGULATIONS AND CONTAINMENT DURING
FIELD TESTS
Considering the risks involved with untested
experimental plants, measures for the control and
containment of field trial must set aside provisions for
the following:

A. Contained tests may be conducted in plant glass houses, on site.


The scale and period of contained cultivation is appropriate to
both the nature of the investigation, and the nature of the
particular plant.

B. The site chosen is suitable to the particular plant under study.


Test plots are fenced in and isolated from feral populations. "No
Entry" signs are put up atregular intervals around the perimeter.
REGULATIONS AND CONTAINMENT DURING
FIELD TESTS
C. Arrangements are made to collect, burn and destroy
experimental plants and plant materials at the conclusion of
work.

• D. The cultivation of plants is surveyed and directed by the IBC


(Institutional Biosafety Committees), at regular intervals, as
appropriate to the growth or developmental patterns of the
particular plant.

• E. Other interests, which the NBC (National Biosafety


• Committee) or IBC deems suitable.

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