Annotated
Bibliography Entry
Reference:
US NRC 2000
Title: Genetically Modified Pest-Protected Plants:
Science and Regulation
Authors: National Research Council
Publisher: The National Academies Press, 2101 Constitution Avenue, NW, Washington DC
20418 USA
Publication details: 2000. 292p.
Context
Protecting Plants from Pests
Commercial Cultivation of Transgenic Crops
Terms of Reference
Terminology
Findings & Recommendations
Striving for the Ideal Regulatory Framework
Table of Contents
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SUMMARY
Context
A
revolution has been taking place in the life sciences, sparked by striking
advances in our fundamental understanding of living systems.
These advances have led to the development of powerful molecular
techniques, which can help society to conquer human disease, improve food
production, and better protect the environment. As with all new scientific developments, however, potential
risks need to be carefully evaluated and dealt with appropriately.
The National Academies are committed to bringing together experts to
discuss and comment on the scientific issues surrounding the application of
biotechnology to important modern-day problems.
In
1987 the National Academy of Sciences issued a white paper on the Introduction
of Recombinant DNA-Engineered Organisms into the Environment, which dealt
with general principles concerning potential ecological risks in field testing.
In 1989, the National Research Council issued the report, Field
Testing Genetically Modified Organisms: Framework for Decisions, which
addressed the ecological risks of small-scale field testing of engineered
organisms. Neither potential human
health risks, nor issues raised by large-scale commercial planting, were
addressed in that study that considered scientific issues primarily, not
regulatory policy. These two
reports reflected the best judgment of two highly expert groups of scientists,
and they were based on the scientific evidence available to them at the time.
These reports from the National Academies are available at www.nap.edu.
Utilizing
information gained over the past decade, the National Research Council is
releasing this report on genetically modified pest-protected plants.
It provides timely advice to researchers, developers, and regulatory
agencies involved in reviewing the science surrounding the regulation of
genetically modifies pest-protected crops.
The report addresses only one aspect of the ongoing revolution in the
life sciences and agriculture, and it is careful to point out where more
research and scientific information is needed to answer remaining questions.
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Protecting
Plants from Pests
Agriculture
has been suffering from pest and disease infestation since its inception,
causing enormous, unpredictable losses in food production.
Genetic engineering of plants for resistance to pests and disease,
creating transgenic pest-protected plants, is one of the many tools for
increasing food security. It is
embedded within the long-standing science of conventional breeding for plant
improvement. The use of chemicals
to control pests* can be abated and perhaps someday eliminated by the
appropriate use of transgenic methods, combined with conventional breeding and
other techniques of sustainable agriculture.
Many
valuable technologies will form the basis for future plant protection.
The appropriate balance among them will be pest and situation-specific.
This report provides an overview of the use of transgenic techniques to
enhance the pest resistance of crops, with a focus on the regulatory system that
oversees the introduction of transgenic pest-protected plants. It is but one contribution to the larger and complex system
of pest management, as well as to the broader issues surrounding the often
virulent debate about using modern biotechnology to improve agricultural
production.
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Commercial
Cultivation of Transgenic Crops
Transgenic
crops were first commercially planted in the United States in 1995.
Since then the acreage planted to transgenic crops had increased rapidly
with some 70 million acres being grown in the United States, and 98.6 globally
in 1999. Of this acreage, a large
percentage (for example, 30 million acres in the US in 1999) is planted with
transgenic pest-protected crop varieties containing the Bacillus
thuringiensis (Bt) gene that confers protection to certain insect pests and
with varieties that are herbicide-tolerant.
In 1998, about 25% of the US cotton acreage and 21% of the corn acreage
was planted with varieties containing Bt genes.
This
increase in acreage planted in transgenic crops has largely resulted because of
benefits produced to farmers. Many
farmers are growing transgenic crops because they either produce more effective
control of serious pests than conventional chemical treatments, or they provide
control at lower costs than conventional treatments, or both. The growing of some Bt crops has been accompanied by a
reduction in the amounts of chemical pesticides previously used on these crops.
This has produced a side benefit in terms of reducing exposure of humans
and other non-target organisms to these toxic chemicals and lessening the
contamination of air and water.
Given
the rapid increase in plantings of transgenic varieties, concerns have been
raised about the ecological and human health risks that might be posed by these
crops. Although these risks might
not in principle differ in type from those associated with other conventionally
bred pest-resistant varieties or chemical pesticides, they nevertheless have
become a focus of attention by several groups who are concerned by potential
risks that might be posed by transgenic breeding methods. This concern has been magnified in Europe and other parts of
the world where consumer resistance has been increasing against food products
produced from transgenic plants.
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Terms of Reference
Concerns
about the risks posed by transgenic plants have led some to question the safety
review they receive in the United States under the Coordinated Regulatory
Framework. Some believe that human
health and environmental risks are not properly assessed.
Others believe the risks are minimal, that benefits outweigh risks, and
the current regulatory scheme is too onerous.
This debate has intensified in recent months given the international
climate and impending regulatory decisions in the United States where new
regulations for transgenic plants are being considered.
Several
professional societies, members of Congress, and other groups have expressed
concern over the regulation of transgenic crops, citing the need for on
impartial review of the present and proposed process. The National Research Council responded to this need by
commissioning and funding the present study that was initiated in March 1999.
The committee was charged with the following task:
The
committee will investigate risks and benefits of genetically modified
pest-protected (GMPP) plants and the coordinated Regulatory Framework for
Regulation of Biotechnology affecting the use of these plants. The study will:
(1)
Review the principles in the NAS Council’s white paper, Introduction of
DNA-Engineered Organisms into the Environment (1987), for their continued
scientific validity and assess their appropriateness for current decisions
regarding GMPP plants;
(2)
Review scientific data which
addresses the risks and benefits of GMPP plants;
(3)
Examine the existing and
proposed regulations to qualitatively assess their consequences for research,
development, and commercialization of GMPP plants; and
(4)
Provide recommendations to
address the identified risk/benefits, and, if warranted, for the existing and
proposed regulation of GMPP plants.
The
report is composed of four chapters and an Executive Summary. Chapter 1 is an introductory chapter that discusses issues
that led to the initiation of the present study, current EPA, USDA, and FDA
policies, the task given to the committee by the NRC, and role of this report.
Chapter 2 deals with the potential environmental and human health impacts
of pest-protected with risks and benefits being among the issues discussed.
Chapter 3 provides several case studies related to the commercial
production of transgenic genetically modified pest-protected crops, analyzes the
1994 and 1997 rules proposed by EPA for the regulation of plant-pesticides, and
identifies several research needs. Chapter
4 provides an overview of the current regulation of plant products under the
coordinated framework for the regulation of biotechnology by EPA, FDA, and USDA
and provides recommendations that the committee believes will improve this
process. The Executive Summary
summarizes the key finding, conclusions, and recommendations of the report.
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Terminology
Genetically
Modified Plants
Plant
breeders use a variety of genetic techniques to enhance the ability of plants to
protect themselves from plant pests. Regardless
of the technique used, the committee considers these plants to be genetically
modified. Although the committee
recognizes that there is no strict dichotomy between the products of
conventional and transgenic technologies, in this report it has used the
following terms:
·
pest-protected plant or genetically modified
pest-protected (GMPP) plant: refers to any plant
that has been genetically modified to express a pesticidal trail*, regardless of
the technique used*;
·
transgenic
pest-protected plant: refers to any plant that has
been genetically modified with modern molecular techniques (rDNA technology,
commonly referred to as genetic engineering) to express a pesticidal trait;
·
conventional
pest-protected plant: refers to any plant that has
been genetically modified by classical or cellular plant breeding techniques
(such as hybridization or tissue culture) to express a pesticidal trait.
·
many
plants have evolved a natural protection against pests without any type of
genetic modification done by humans. This
report refers to those plants as naturally pest-protected plants.
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Findings and Recommendations
Review of the 1987
National Academy of Sciences Principles
The
committee reviewed the 1987 NAS white paper, Introduction of Recombinant
DNA-Engineered Organisms into the Environment: Key Issues.
The 1987 paper focused on the safety of rDNA techniques and on ecological
issues associated with the potential spread of transgenic organisms or genes
associated with transgenic organisms, and it provided the following conclusions:
·
Point 1 “There is no evidence that unique
hazards exist either in the use of rDNA techniques or in the movement of genes
between unrelated organisms.”
·
Point 2
“The risks associated with the introduction of rDNA-engineered organisms are
the same in kind as those associated with the introduction of unmodified
organisms and organisms modified by other methods.”
·
Point 3
“Assessment of the risks of introducing rDNA-engineered organisms into the
environment should be based on the nature of the organism and the environment
into which it is introduced, not on the method by which it was produced.”
The
committee discussed the above principles in light of its knowledge of the
underlying scientific processes involved in conventional and transgenic methods.
It is important to point out that the committee is not aware of
controlled field studies which directly compare the ecological effects of
transgenic and conventional pest-protected plants bred for the same pesticidal
traits. Therefore, the
committee’s conclusions about the 1987 NAS principles are not based on data
for such comparisons, but on mechanistic knowledge and scientific information
about the resulting genetically modified plants.
For example, conventional breeding often involves the transfer of traits
which are controlled by several interacting genes and often occurs without
specific knowledge of which genes and gene products are involved.
Therefore, some of the plants produced by this method could have
unanticipated properties. With transgenic methods, there is often more knowledge
about the genes and gene products being transferred, but diverse traits and
genes from unrelated organisms can be transferred so some specific products
could have unique properties. Because both methods have potential to produce organisms of
high or low risk, the committee agrees that the properties of a
genetically modified organism should be the focus of risk assessments, not the process
by which it was produced (point 3).
The
committee also agrees with points 1 and 2 in the sense that the potential
hazards and risks associated with the organisms produced by conventional and
transgenic methods fall into the same general categories.
As this report discusses, toxicity, allergenicity, effects of gene flow,
development of resistant pests, and effects on non-target species are concerns
for both conventional and transgenic pest-protected plants.
In this regard, the committee found no strict dichotomy between or new
categories of the health and environmental risks that might be posed by
transgenic and conventional pest-protected plants (points 1 and 2), and
recognizes that the magnitude of risk varies on a product by product basis
(point 3).
The
present committee found the three general principles to be valid within the
scope of issues considered by the 1987 paper, and the present report further
clarifies and expands on these principles.
This
report expands on the 1987 principles by describing various methods of both
conventional and transgenic plant breeding, and their potential consequences.
Potential
Health and Ecological Impacts and Research Needs
Conventional
pest-protected plants have substantially improved plant health and agricultural
productivity and have often lessened the need for chemical pesticides.
Transgenic pest-protected plants have the potential to make similar
contributions, as has already been documented with transgenic pest-protected
cotton (section 1.5.5). Human health and environmental benefits could arise from
reductions in the application of chemical pesticides resulting from the
commercial production of certain transgenic pest-protected plants.
However, the relative risks and benefits will depend on the particular
transgenic pest-protected plant in question.
Historically,
pest-protected plants have rarely caused obvious health or environmental
problems, but there is a potential for undesirable effects.
Therefore, a major goal for further research and development of
transgenic and conventional pest-protected plants should be to enhance
agricultural productivity in ways that also foster more sustainable agricultural
practices, enhance the preservation of biodiversity, and decrease the potential
for health problems that could be associated with some types of pest-protected
plants. Although the committee
focused its discussions on transgenic pest-protected plants, many of the
following recommendations for research and development also apply to
conventional pest-protected plants.
Health Impacts and Research Needs
Health
impacts that the committee considered fall into three general categories:
allergenicity, toxicity, and pleiotropic effects of genetic modifications.
The
potential for allergenic responses to novel gene products was considered.
Such responses have not been documented for commercialized transgenic
pest-protected plants, although one incident has been documented at the research
stage. Several indirect tests for
allergenicity are available. For
novel proteins, the most common methods involve analyzing the protein for its
digestibility, estimating the level of protein expression and consumption, and
assessing homology to know allergens. While
these indirect tests can be good indicators of potential allergenicity, the
development of more direct tests is highly desirable.
Therefore, the committee recommends that
Priority
should be given to the development of improved methods for identifying
potential allergens in pest-protected plants, specifically, the development of
tests with human immune-system endpoints and of more reliable animal models.
The
committee reviewed data concerning toxicity testing and potential pleiotropic or
secondary effects of genetic modification.
The committee concluded that monitoring for pleiotropic changes in plant
physiology and biochemistry during the development of pest-protected plants
should be an important element of health-safety reviews, in addition to testing
the toxicity of the introduced gene products.
Although results of tests for changes in the level of certain endogenous
plant toxicants are presented during consultation with FDA, there is a lack of
an extensive database on the natural levels of such compounds in both transgenic
and conventional pest-protected plants. The committee recognizes the challenges
associated with detecting changes in those compounds given insufficient
analytical information, and therefore, recommends research to
Assess
and enhance data on the baseline concentrations of plant compounds of
potential dietary or other toxicological concern, and determine how
concentrations of these compounds may vary depending on the genetic background
of the plant and environmental conditions.
In
addition to the above research, the committee recommends that
The
EPA, FDA, and USDA collaborate on the establishment of a database for natural
plant compounds of potential dietary or other toxicological concern.
The
committee recognizes that a significant amount of time and resources will be
needed to establish such a database, given the complexity of these plant
compounds.
For
some novel pest-protectants developed for future commercialization, long term
toxicity testing may be warranted. Tests
that involve feeding of large quantities of pest-protected plants to animals
have limitations, and the results can be difficult to interpret especially when
the animal’s natural diet does not consist of the type and quantities of the
plant being tested. Therefore, the committee recommends research to
Examine
whether long term feeding of transgenic pest-protected plants to animals whose
natural diets consist of the quantities and type of plant material being
tested (for example, grain or forage crops fed to livestock) could be a useful
method for assessing potential human health impacts.
In
conclusion, although there is the potential for the adverse health effects
discussed in this section,
The
committee is not aware of any evidence that foods on the market are unsafe to
eat as a result of genetic modification.
Ecological
Impacts and Research Needs
Three
major ecological impacts were considered by the committee: effects on nontarget
species, effects of gene flow, and evolution of pest resistance to
pest-protected plants.
The
committee reviewed studies concerning non target effects. The committee found that both conventional and transgenic
pest-protected crops could have effects on non target species, but these
potential effects are generally expected to be smaller that the effects of
broad-spectrum synthetic insecticides.
Therefore, the use of pest-protected crops could lead to greater
biodiversity in agroecosystems where they replace the use of those insecticides.
The use of transgenic pest-protected plants should also be compared with
sustainable agriculture methods for crop protection.
The committee recommends research to
Determine
the impacts of specific pest-protected crops on non target organisms, compared
with impacts of standard and alternative agricultural practices through
rigorous field evaluations.
Gene
flow between cultivated crops and wild relatives was the second ecological
impact considered by the committee. On
the basis of the literature, the committee found that pollen dispersal can lead
to gene flow among cultivated crops and from cultivated crops to wild relatives
but that only trace amounts of pollen are typically dispersed further than a few
hundred feet. The committee found
that the transfer of either conventionally bred or transgenic resistance traits
to weedy relatives potentially could exacerbate weed problems, but such problems have not been observed or
adequately studied. Therefore, the committee
recommends further research to
Assess
gene flow and its potential consequences: develop a list of plants with wild
or weedy relatives in the United States; identify key factors that regulate
weed populations; assess rates at which pest resistance genes from the crop
would be likely to spread among weed populations; and evaluate the impact of
specific, novel resistance traits on the weed abundance.
Develop
transgenic or other techniques that decrease potential for the spread of
transgenes into wild populations.
Evolution
of pest resistance to
pest-protected plants was the third major ecological impact addressed by the
committee. The committee concluded that pest resistance to
pest-protected plants could have a number of potential environmental and health
impacts such as a return to the use of more harmful chemicals or replacement of
an existing pest-protected variety with novel varieties for which there is less
information available about health and environmental impacts. The committee recommends that
If
a pest-protectant or its functional equivalent is providing effective pest
control, and if growing a new transgenic pest-protected plant variety
threatens the utility of existing uses of the pest-protectant or its
functional equivalent, implementation of resistance management practices for
all uses should be encouraged (for example, Bt proteins used both in microbial
sprays and in transgenic pest-protected plants).
In
addition to the above recommendation, the committee recommends general ecological
research to
Improve
our understanding of the molecular basis of pest-plant interaction and of the
population ecology and genetics of target pests so that more ecologically and
evolutionarily sustainable approaches to the use of pest-protected plants can
be developed.
Develop
more specific expression systems for transgenes in ways that lessen nontarget
exposure and delay pest adaptation (for example, use of promoters that would
limit expression to certain tissues).
Monitor
ecological impacts of pest-protected crops on a long term basis to ensure the
detection of impacts that may not be predicted from tests conducted during the
regulatory approval process.
The
Coordinated Framework for Regulation
Background and History
In
1986, the Coordinated Framework for the Regulation of Biotechnology apportioned
jurisdiction over transgenic products by using existing legislation: for
example, plants came under the jurisdiction of the Federal Plant Pest Act (FPPA)
administered by the USDA; food and feed under the jurisdiction of the Federal
Food, Drug, and Cosmetic Act (FFDCA) administered by the FDA; and microorganisms
and substances used for pest control under the jurisdiction of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and parts of FFDCA,
administered by the EPA. Transgenic
pest-protected plants were not addressed in the original framework document.
USDA
published its policy under the coordinated framework providing for field testing
permits for transgenic plants in 1987 and field testing notifications in 1993
and 1995. In 1993, it finalized its
policy for determining when certain plants would no longer be regulated
articles. In 1992, FDA published
its policy for foods derived form new plant varieties based on its role under
FFDCA. In 1994, EPA proposed a rule
to regulate the pesticidal substances in pest-protected plants as
plant-pesticides under FIFRA and FFDCA. Several
groups opposed that statutory interpretation on both legal and scientific
grounds; others supported the EPA’s oversight of transgenic pest-protected
plants, given the agency’s mission to address environmental concerns.
In the last few years, there have been concerns expressed by several
professional societies and other groups over the broad scope of the proposed EPA
rule and opposite concerns expressed by consumer and environmental groups that
the EPA rule does not adequately cover all of the risk issues.
Overall
Approach
The
committee recognizes that
There
is an urgency to complete the regulatory framework for transgenic
pest-protected plant products because of the potential diversity of novel
traits that could be introduced by transgenic methods and because of the rapid
rate of adoption of and public controversy regarding transgenic crops.
Accordingly,
the committee has chosen to take EPA’s proposed rule and the overarching
coordinated framework as given and as designed for transgenic products, and to
examine ways in which this current regulatory approach and its use of scientific
information might be improved. In
doing so, the committee does not suggest that this is the only possible approach
to regulating these products. It is beyond this committee’s scope to determine
which of the three federal agencies (USDA, EPA, or FDA) is best suited to
regulate pesticidal substances expressed in transgenic plants.
EPA’s
current proposal for regulating pesticidal substances in pest-protected plants
claims broad jurisdiction over such products in all seeds and plants sold with
claims of pest-protection, but it grants a generic exemption from registration
to those bred by conventional means. The
committee agrees with EPA’s proposed exemption of pesticidal substances in
conventionally bred plants, because the committee recognizes that there are
practical reasons for exempting those substances based in part on historical
experience of safe use of, and the benefits provided by these crops.
However, the committee questions the scientific basis used by EPA
for this exemption because there appears to be no strict dichotomy between the
risks to health and the environment that might be posed by conventional and
transgenic pest-protected plants.
The
committee found that, in some cases, the use of conventional pest-protected
crops might have the potential to lead to human and animal health impacts;
therefore
There
is a need to significantly increase research aimed at assessing the potential
risks posed by conventional pest-protected plants, and make improvements of
conventional breeding procedures, if found appropriate.
Scientific Basis for the 1994 Proposed EPA Rule
Consistent
with the coordinated framework and its statutory mandates, EPA has asserted
jurisdiction over pesticidal substances in transgenic pest-protected plants in
its 1994 proposed rule. The
committee reviewed the scientific basis of EPA’s 1994 proposed rule and the
exemption of certain categories of transgenic pest-protected plants under
this rule. The committee found most
of the criteria used by EPA for assessing transgenic pest-protected
products to be scientifically valid, but there were some exceptions.
EPA
proposed to exempt all plant-pesticides where the structural gene for producing
the plant-pesticide is derived from a sexually compatible plant.
The committee found that the current EPA rule would exempt transgenic
pest-protectants if the structural gene came from a sexually compatible plant,
regardless of the source of the promoter for expression of the gene. This
categorical exemption of transgenic pest-protectants derived from transgenes
from sexually compatible plants could result in no EPA regulation of genetically
engineered products that contain higher levels of toxicants.
The committee agrees that, in many cases, exemptions for certain sexually
compatible transgenic pest-protectants will be warranted; however, it questions
the categorical exemption of these products.
The committee recommends that
Given
that transfer and manipulation of genes between sexually compatible plants
could potentially result in adverse effects in some cases (for example,
modulation of a pathway that increases the concentration of a toxicant), and
given the public controversy regarding transgenic products, EPA should
reconsider its categorical exemption of transgenic pest-protectants
derived from sexually compatible plants.
The
committee also examined EPA’s proposed exemption for viral coat proteins
expressed in transgenic pest-protected plants.
Viral coat proteins in transgenic pest-protected plants are not expected
to jeopardize human health, inasmuch as consumers already ingest these
substances in nontransgenic food, so the committee agrees with the exemption of
these proteins from EPA jurisdiction under FFDCA. However, the committee
questions the EPA’s categorical exemption of all viral coat proteins
under FIFRA due to concerns about the potential for outcrossing with weedy
relatives. The committee agrees
that exemption of particular viral coat proteins in certain plant species will
be warranted. However, the
committee suggests that
EPA
should not categorically exempt viral coat proteins from regulation
under FIFRA.
Scientific Data Used by the Agencies in the Regulatory Process
The
committee reviewed examples of data submitted by applicants to the regulatory
agencies for currently commercialized transgenic pest-protected plant products
(that is, products with BT and viral coat proteins).
The federal agencies already address most of the categories of scientific
concerns presented in this report (see table 4.3).
However, the committee found some areas where the risk assessment process
for transgenic pest-protected plants could be improved.
In
reviewing toxicity testing relevant to human health, the committee found that,
When
the active ingredient of a transgenic pest-protected plant is a protein and
when the health effects data are required, both short-term oral toxicity and
potential for allergenicity should be tested.
Additional categories of health effects testing (such as for
carcinogenicity) should not be required unless justified.
Additional
categories of toxicity testing do not appear justified for currently
commercialized products such as many Bt proteins (Cry1A and Cry3A) and viral
coat proteins. However, it is
important that the tests that are performed be rigorous, logical, and
scientifically sound. Novel or less
familiar plant-pesticides (that is, in comparison to viral coat proteins and Bt
toxins) may require additional categories of toxicity testing.
Although
the committee realizes that it is often difficult to obtain enough
plant-expressed protein for toxicological testing; tests should be conducted
whenever possible using the protein as it is expressed in the plant. The committee recommends that
The
EPA should provide clear, scientifically justifiable criteria for establishing
biochemical and functional equivalency when registrants request permission to
test non plant-expressed proteins in lieu of plant-expressed proteins.
In
addition to human health toxicity testing, allergenicity testing is very
important. The committee recognizes
that the FDA has developed preliminary information on the assessment of
potential food allergens that could be helpful to applicants as they evaluate
potential products and develop product-specific data to address questions
concerning allergenicity. The
committee recommends that
FDA
should put a high priority on finalizing and releasing preliminary guidance on
the assessment of potential food allergens, while cautioning that further
research is needed in this area.
The
committee found some room for improvement in the procedures used in USDA’s
review of outcrossing or gene flow for virus-resistant squash (section 3.1.4).
USDA’s commercialization of the squash was controversial because the
transgenic squash potentially could transfer its acquired virus-resistance genes
via pollination to wild squash (Cucurbita pepo), which is an agricultural
weed in some parts of the southern United States.
USDA’s assumption that transgenic resistance to viruses will not affect
the weediness of wild relatives
might be correct, but longer-term empirical studies are needed to determine
whether this is true. The committee
recommends that
USDA
should require original data to support agency decision-making concerning
transgenic crops when published data are insufficient.
Operational
Aspects and Impacts of the Coordinated Framework
Elements of an Effective
Regulatory Framework
The
committee finds that, operating under the coordinated framework, EPA, USDA, and
FDA have successfully applied existing statutes to address the introduction of
transgenic pest-protected plant products, but concludes that there is room for
improvement. In particular, those
agencies have achieved a significant degree of coordination in their oversight
of transgenic pest-protected plants, but certain aspects of this coordination
could be enhanced. Only through
effective coordination can the three lead agencies minimize duplication, avoid
inconsistent regulatory decisions, address potential gaps in oversight, and
ensure that regulations evolve with experience and scientific advancements.
Ultimately, the credibility of the regulatory process and acceptance of
the products of biotechnology depends heavily on the public’s ability to
understand the process and the key scientific principles on which it is based.
The
committee identified five elements of an effective regulatory system which
support the objectives of the coordinated framework (Box 1).
New Genetics, Food &
Agriculture: Scientific Discoveries - Societal Dilemmas