Regulating Foods Derived From Genetically Engineered Crops
by Donald L. Uchtmann (1)
This article describes key federal policies and statutes, and
the role of the Food and Drug Administration, in assuring that foods derived from
genetically engineered crops are as safe as other foods in the United States.
The article concludes that the regulatory system is remarkably healthy, but can
be improved even further. Also described in the article are the plans announced
May 3, 2000 to strengthen the system of science based regulation and consumer
access to information.
offers much promise. (2) Perceived benefits arising
from its application to agriculture and the food industry include:
- Cheaper and more abundant food
- New foods of higher quality and greater utility for the consumer
- Reduced food production costs for the farmer
- Reduced use of chemical pesticides and the accompanying reduction in environmental
- Job creation, especially in countries at the leading edge of biotechnology
research and commercialization
- Staving off a world food crisis potentially arising from world population
Associated with these perceived
benefits is an array of risks (3) and societal
- Known food safety, agricultural, or environmental risks, e.g., allergies,
a new bacteria resistant to antibiotics, or a new "super" weed
- Unknown food safety, agricultural, or environmental hazards
- Concerns about biotechnology's impact on the structure of agriculture and
the number of "family" farms
- Concerns about biotechnology's impact on corporate mergers and the accompanying
concentration of economic power
- Ethical and religious concerns, about patenting genes and about both using
a technology to move genes among organisms which do not naturally mate and repressing
a technology that offers the potential for significant humanitarian benefits.
The opportunity to glean significant
benefits from genetic engineering, coupled with some risks and societal concerns,
causes genetic engineering and its products to be both controversial and subject
to governmental regulation. (4) This article focuses
on the federal regulatory scheme intended to assure that foods derived from genetically
engineered plants are just as safe to consumers as other foods consumed in the
United States. (5) The foundation for that regulatory
scheme is found in the Federal Food, Drug, and Cosmetic Act and two significant
pubic policy statements, all three of which are described below.
II. Genetic Engineering and Food-safety: Key Federal Policies and Statutes
The 1986 Coordinated
Framework for the Regulation of Biotechnology
Biotechnology products, including
foods derived from genetically engineered crops, are regulated pursuant to a coordinated
framework announced in1986 by the White House Office of Science and Technology
Policy. Relying on existing federal laws, the coordinated framework assigns lead
regulatory responsibility to one federal agency for each category of product use.
(6) For example, the Food and Drug Administration (within the Department
of Health and Human Services) is the lead regulatory agency for genetically engineered
products in the category of "food and food additives" even though the Food Safety
and Inspection Service (within the Department of Agriculture) has jurisdiction
over meat and poultry products. Where agency responsibilities or authorities adjoin
or overlap under existing laws, the coordinated framework sets out principles
for coordinated and cooperative reviews. (7)
Some background: In the mid 1980s numerous
federal agencies had already amassed considerable experience regulating agricultural,
pharmaceutical, and other products developed by traditional genetic manipulation
techniques such as selective breeding. In the Spring of 1984 the Reagan Administration
formed an interagency working group to consider the adequacy of the existing regulatory
framework as the basis for regulating new products of biotechnology. This working
group "sought to achieve a balance between regulation adequate to ensure health
and environmental safety while maintaining sufficient regulatory flexibility to
avoid impeding the growth of an infant industry." (8)
The working group published Notice of its Proposal for a Coordinated Framework
in December, 1984, and announced its regulatory policy in June, 1986. Present
in both the 1984 and 1986 Notices is the working group's conclusion that existing
laws as currently administered by existing agencies would adequately meet the
regulatory needs for products of the newer biotechnologies, for the most part.
Under the coordinated framework,
selected categories of products potentially produced by biotechnology processes
and the specific agencies given primary responsibility for approving their commercial
use under existing laws are: (9)
- plants, seeds, plant pests, and certain genetically engineered organisms
containing genetic material from plant pests: regulated by the Animal
and Plant Health Inspection Service (APHIS) of the US Department of Agriculture.
- pesticides and other toxic substances: regulated by the US
Environmental Protection Agency (EPA),
- food additives and food: regulated by the Food and Drug Administration
(FDA) of the US Department of Health and Human Services (FDA actually
regulates all food other than meat and poultry products, the Food Safety Inspection
Service of USDA has jurisdiction for domestic livestock and poultry products,
and EPA sets "tolerances" for pesticide residues in food; but FDA is the lead
agency for all food and food additives).
Example: New Bt corn varieties
(plants genetically engineered to produce a protein toxic to European Corn Borer)
have fallen under the regulatory jurisdiction of all three agencies - USDA, EPA,
and FDA. For a particular line of Bt corn to be commercially grown in
the United States, it needed to be approved by USDA-APHIS (e.g., a petition for
"nonregulated status" needed to be approved) which would consider whether the
plant would be a "plant pest" and prepare an environmental assessment. The USDA
approval is intended to assure that the crop would not be harmful to agriculture
considering both its benefits (effective control of European Corn Borer) and its
shortcomings (possibly speeding the development of Bt-resistant pests).
Because Bt corn plants contain their own toxic protein, it was also regulated
by EPA which has responsibility to assure the safety of pesticides. Since the
Bt corn is intended to be fed to livestock, processed into corn syrup
(a sweetener) for use in soft drinks, or made into corn flakes, FDA also had regulatory
jurisdiction. To summarize: A company bringing a particular variety of Bt
corn to the marketplace needed to approach USDA, EPA, and FDA and meet all their
regulatory requirements; USDA would determine that it was safe to grow, EPA that
it was safe for the environment, and FDA that it was as safe to eat as other foods
(although FDA would not automatically review and formally approve the product
before it entered the marketplace). Not all genetically engineered crops would
fall within the jurisdiction of all three agencies, but Bt corn is one
The 1938 Federal Food,
Drug, and Cosmetic Act
Regarding the safety of all food,
including food developed from biotechnology, the key legislation is the 1938 Federal
Food, Drug, and Cosmetic Act (hereafter, FDCA or Act). (10)
The following provisions of the Act, as amended, are especially significant:
- Act § 402. Adulterated Foods. Summary: The adulteration of food and the introduction
into interstate commerce of adulterated food is prohibited by the Act.
(11) Foods are deemed adulterated, for example, if they contain any
poisonous or deleterious substance in a quantity that ordinarily renders the food
injurious to health. (12) The Act provides criminal
sanctions for violation of its prohibited acts, (13)
and perhaps more significantly, by criminalizing conduct the Act provides a foundation
for civil liability. Section 402 is also the statutory basis of FDA's "post-market"
authority to remove food from the market that has been found, through experience
or otherwise, to be unsafe.
- Act § 409. (Unsafe) Food Additives. Summary: The addition of an "unsafe" food
additive to food, or the introduction into interstate commerce of food with an
"unsafe" food additive, is prohibited. (14) Food
additives are "unsafe" unless, for example, the additive and its use are in conformity
with a federal regulation prescribing the conditions for safe use.
(15) Substances that are "generally recognized as safe" (GRAS) by scientists
are excluded from the definition of "food additives" and, therefore, cannot be
a § 409 (Unsafe) Food Additive. (16) Importantly,
Section 409 is the basis for FDA's only "pre-market" approval requirements
for genetically engineered food or any other food.
- Act § 343. Misbranded food. Summary: The misbranding of food or introducing
misbranded food into interstate commerce is prohibited.
(17) Foods are misbranded if, for example, the label is false or misleading.
- Act § 701. Regulations and Hearings. General authority to promulgate regulations
for the enforcement of the Federal Food, Drug, and Cosmetic Act is delegated to
the Secretary of Health and Human Services (the "departmental home" for FDA).
- Act § 408a. Pesticide Tolerances. Summary: Foods containing "unsafe" levels
of pesticide residues are brought within the meaning of § 402 Adulterated Foods,
thus making their sale unlawful. Unsafe levels of residues include those exceeding
the "tolerances" established by EPA. The Administrator of EPA is given the authority
to issue regulations which establish, modify, or revoke tolerances for particular
pesticide residues. Such tolerances must be "safe," meaning generally that "there
is a reasonable certainty that no harm will result from aggregate exposure ...."
Whole foods, such as fruits, vegetables,
and grains, generally are not subject to pre-market approval under Act § 409 (Food
Additives) because such foods are generally recognized as safe (GRAS).
(21) But should a genetically engineered whole food be subject to strict
pre-market review and approval by FDA? FDA gained insight into this question when
it chose to conduct a pre-market extensive review of the Flavr Savr tomato, utilizing
an evaluation process open to public comments and a decision process open to public
scrutiny. (22) The rationale for the pre-market
extensive review was the uncertainty about whether the genetically engineered
Flavr Savr tomato was "substantially equivalent" to existing tomatoes, which are
recognized as safe. If it was not substantially equivalent to existing tomatoes,
its transgenic food components would be a "food additive" (i.e. not GRAS) and
the food would be required to undergo pre-market review and approval under § 409.
(23) FDA's conclusion was that the Flavr Savr tomato was "substantially
equivalent" to its non-genetically engineered tomato counterparts. More importantly,
the experience gained in the Flavr Savr considerations contributed to the development
of FDA's 1992 Policy Statement regarding foods derived from new plant varieties.
FDA's 1992 Policy Statement:
Foods Derived from New Plant Varieties
FDA's 1992 policy statement clarified
FDA's legal and regulatory framework for foods derived from new plant varieties,
including new varieties developed through genetic engineering. It established
a "standard of care" for the developers of new crop varieties regarding the testing
necessary to assure that foods arising from the new plant varieties would be as
safe as other foods. It provided guidance as to when a new plant variety would
trigger the pre-market approval requirements of Sec. 409. And it provided guidance
to producers regarding when they should voluntarily consult with FDA regarding
various issues. Under this framework, foods derived from genetically engineered
crop varieties are regulated using an approach identical in principle to that
applied to foods derived from conventionally developed new varieties.
Under FDA's 1992 policy the safety
of food and its regulatory status (is pre-market approval required or not?) depends
on specific characteristics of the food and its intended use, irrespective of
the method by which the plant variety was developed. In other words . . .
- if a new plant variety (for example, a new Bt variety of corn) is
intended to be used as a food, the safety of that new variety is generally determined
by examining the likely presence of toxicants or allergens in the food and any
changes in nutritional value;
- the mere presence of trans-genetic material (nucleic acids) in the food does
not trigger the pre-market FDA review and approval required by Sec. 409 (the genetic
material is GRAS);
- but if the new genetic material expresses itself in the food as a
new protein, carbohydrate, fatty acid, oil, or other substance that differs
significantly from those currently found in existing foods, then (a) the
food is not substantially equivalent (25) to foods
already on the market, (b) the "new" proteins, etc., will not be GRAS, and (c)
the food with "new" proteins, etc., is subject to the pre-market review and approval
requirements of Sec. 409 (unsafe food additives).
For example, if the genes in a new
plant variety express themselves in food as a novel protein sweetener,
that sweetener would trigger the submission of a § 409 food additive petition
by the company and mandatory pre-market approval by FDA. But the mere presence
of rDNA in the food, by itself, would not trigger the pre-market approval apparatus.
A company could easily have questions
about food from its new plant variety. For example, is the food substantially
equivalent to existing foods and thereby generally recognized as safe (GRAS)?
Or is pre-market approval required? The 1992 policy statement provided guidance
on when the company should voluntarily consult with FDA on scientific issues,
the design of appropriate test protocols, whether a food additive petition under
Sec. 409 would be required, and the requirements for labeling. Although the consultations
are technically voluntary, they have become part of the standard of care expected
of industry and are relevant in determining civil liability in cases involving
unsafe food. As a practical matter, the voluntary consultations are tantamount
to being mandatory. (27) A list of completed consultations
can be found on the World Wide Web. (28) A helpful
explanation of when a company should consult with FDA, and a decision diagram
showing the critical points when consultation should occur, can be found in a
1992 issue of Science. (29)
FDA's 1992 policy also addressed
labeling of foods derived from new plant varieties, including plants developed
by genetic engineering. The FDCA defines the information that must be disclosed
in labeling. The Act also requires that all labeling be truthful and not misleading,
but it does not require disclosure in labeling of information solely on the basis
of consumers' desire to know.
FDA requires special labeling if
the composition of the GM food differs significantly from its conventional counterpart.
For example, if a food contains a major new sweetener as a result of genetic modification,
a new common name or other labeling may be required. (30)
Similarly, if a new food contains a protein derived from a food that commonly
causes allergic reactions (and the developer cannot demonstrate that the protein
is not an allergen), labeling would be necessary to alert sensitive consumers.
Regarding the need to label a food just because it is from a genetically engineered
plant variety, FDA does not require foods produced from GM crops to be specially
labeled. (31) FDA's rationale is that it has no
basis to distinguish genetically engineered foods as a class from foods developed
through other methods of plant breeding.
III. Genetic Engineering and Food-safety: Some Key Regulatory Issues
The use of foods derived from genetic
engineering has been controversial. (32) In the
United States, the FDA has addressed this controversy by holding a series of public
meetings in late 1999 titled "Biotechnology in the Year 2000 and Beyond." These
meetings, held in Chicago, Washington, D.C., and Oakland, have served as a forum
for the airing of views from experts and lay citizens regarding the current regulation
of foods derived from genetically modified plants. A sampling of these issues
appears below and transcripts from these meetings can be obtained from the FDA's
internet site. (33)
New Technology and a Patchwork of
Old Laws: Does the patchwork of older legislation provide an adequate statutory
basis for the regulation of new risks associated with products at the cutting
edge of technological innovation? The Coordinated Framework relies on a patchwork
of laws such as the 1938 Federal Food, Drug, and Cosmetic Act as the statutory
basis for biotechnology regulation. Critics argue that these laws were not enacted
to regulate biotechnology and have been stretched beyond their original regulatory
intent. Others argue that the laws are sufficient to identify the broad agricultural,
environmental, and food-safety concerns related to biotechnology and to assign
regulatory oversight to appropriate agencies, and that the laws have been amended
as necessary to fix outdated provisions. Furthermore, the broad concepts present
in the laws provide flexibility to agencies as they promulgate rules and regulations
which are the heart of the regulatory effort.
Regulating the Product, not the
Process: Should GM foods be subject to a separate regulatory scheme because they
are derived from a genetic engineering process, or should they be regulated like
all other foods where the focus is on the characteristics of the product?
Consistent with the Coordinated Framework, FDA currently focuses on the characteristics
of the food product, not the fact that it may have been produced from a plant
produced from the process of genetic engineering, in determining how it is regulated.
For example, foods derived from Bt corn or Roundup Ready soybeans are
not subject to a separate, mandatory regulatory scheme. However, they are subject
to a voluntary consultation process. Critics argue that the process of creating
plants through genetic engineering makes GM foods inherently different, creates
inherently different risks, and should be subject to a strict regulatory scheme
applied to all foods derived from genetically engineered plants.
Pre-market Approval and Substantial
Equivalence: Should all foods derived from genetically modified plants be subject
to mandatory pre-market approval, even food thought to be "substantially equivalent"
to its non-GM counterpart? Most foods have not been tested and approved by
FDA before coming to market. Under current laws and regulations the only foods
subject to FDA pre-market approval (FDCA, Sec. 409 - Food Additives) are foods
containing added substances. Under its 1992 policy statement, FDA does not generally
require pre-market approval for genetically modified foods - it views the GM food
as GRAS unless there is a significant difference in its proteins, carbohydrates,
etc., compared to the food's non-GM counterpart. Only if there are significant
differences, is pre-market approval required. To date, most of the GM foods reviewed
by FDA under its voluntary consultation procedures have not been viewed as significantly
different, so most GM foods have not been formally reviewed and approved by FDA
before entering the market. Critics argue that no GM foods are exactly equivalent
to their non-GM counterparts; therefore, all should be subject to the existing
pre-market approval requirements applying to food additives.
Voluntary Consultations: Should
the voluntary consultative procedure described in FDA's 1992 Policy Statement
be made mandatory? Although technically voluntary, the threat of civil liability
makes the consultations tantamount to mandatory in the eyes of the companies.
And FDA believes all companies that have brought genetically engineered foods
to market so far have participated in the voluntary consultations. The results
of those consultations are available to consumers under the Freedom of Information
Act, and FDA has asked the public for advice about how it might make the consultation
data available in a more user friendly manner. Critics argue that the voluntary
nature of the consultation, on its face, erodes consumer confidence and, in a
procedural sense, doesn't provide the kind of "sunshine" on the decision making
process that a mandatory consultative process would provide.
Labeling and Allergies: By not labeling
all genetically engineered foods, is FDA putting the public at greater risk of
ingesting a new allergen and suffering an allergic reaction? FDA does not
believe that a GM food is any more likely to cause an allergic reaction than a
non-GM food. It notes that about 90 % of all food allergies in the U.S. are caused
by cow's milk, eggs, fish and shellfish, tree nuts, wheat, and legumes (especially
peanuts and soybeans). Under existing policy, companies must generally tell consumers
on the food label when the food contains a gene from one of these common allergy
causing foods. FDA also indicates it has no scientific evidence to indicate that
any of the new proteins introduced into food by GM foods will cause allergies.
And, in the unlikely circumstance that the GM food does cause allergic reactions,
FDA can exercise its post-market authority to remove the food from stores, just
as it would with unsafe foods resulting from other remote risks. Critics argue
that a new protein in a GM food could theoretically be a new allergen and there
is no known test that can assure it is not; therefore, consumers who wish to choose
non-GM foods as a way of avoiding a "new allergen" risk can't tell which foods
might be genetically engineered.
Consumer Choice and Labeling: Should
genetically engineered foods be labeled to allow consumers to choose? The
issue is more complex than it would first appear. Should foods containing some
threshold of GM ingredients be subject to mandatory labeling or should the labeling
policy simply allow (as it currently allows) the food industry to segregate, label
as "GM Free," and supply foods that are below an established threshold for GM
free? How do we best use the limited amount of "label space" available? How do
you label genetically engineered foods without misleading the public?
Getting Maximum Bang for the Regulatory
Buck: If FDA were given new funding to improve the safety of food, would it make
sense to invest those new dollars in combating the risks of genetically engineered
food or combating other food safety risks? Microbial spoilage and food contaminants
(substances like lead or dioxins) probably pose much greater risks to the safety
of the food supply than genetic engineering. So should new funds be invested in
new programs to combat food spoilage and contamination, or in expanding FDA's
capacity to conduct pre-market reviews and approvals of all foods derived from
genetically engineered foods?
Narrow Regulatory Mandates: Do the
narrow statutory mandates to agencies prevent them from considering ethical and
religious dimensions of biotech-related issues? The regulatory jurisdiction
of FDA, for example, is statutorily focused on food safety and labeling issues.
FDA has no statutory authority to ban GM foods because of ethical or religious-based
concerns about genetic engineering. Some who hold such views believe the statutes
should empower the agencies to look beyond their current scope of authority. Others
believe that such ethical and religious views are entirely proper as a basis for
individual actions, e.g.,consumer boycotts. They argue, however, that agencies
shouldn't be enforcers of ethics or religion because such a role would raise the
issues of "whose ethics" and "whose religion;" instead, such issues should be
deferred to the political arena, subject to constitutional limits on the role
of government and protections of individual freedoms. It should be noted that
the narrow mandates of biotech regulators and the current labeling void for genetically
engineered foods creates a dilemma for those who object to biotechnology on religious
or ethical grounds. They are either forced to recast their objections as concerns
about health and environmental risks (if they are to have any impact on agency
rule-making), or they must resort to public protests and civil disobedience (if
they are to otherwise "live" their beliefs). If it were possible, through some
resolution of the labeling issue, to empower these people to "live" their beliefs
through consumer choice, such a resolution might bring greater clarity to the
arguments about health and environmental risks and defuse some of the public protests
about genetically engineered foods.
VI. Conclusions and Recent Developments
How Healthy Is the Food-safety
How healthy is the regulatory scheme
for genetically engineered food? There is considerable evidence that the regulatory
system's vital signs are surprisingly healthy. (34)
The system has appropriate checks and balances, overall responsibility is shared
between governmental and private entities, and decision making generally takes
place "in the sunlight" of public scrutiny. It provides opportunities for the
public and scientific experts to be heard, and for both the regulated (the researchers
& companies) and the intended beneficiaries of regulation (the consumer and
the public) to fully participate. It generally operates in a manner that instills
public confidence. It is dynamic and undoubtedly will continue to evolve. It has
been tested by controversial issues in the past and has managed to evolve and
adapt successfully to changing scientific discoveries and political realities.
It is difficult to imagine that a truly erroneous regulatory decision regarding
biotechnology would be made, or stand very long if it were made. Either consumers,
scientists, the public at large, the courts, the legislature, or the increasingly
important international community would find a way to effectively intervene.
Food-safety Regulation Be Improved?
Our system of regulating biotechnology
is not a perfect system. (35) We should continue
to evaluate both the regulatory system and its specific regulatory actions. And
we should continue to work diligently to identify where improvements can be made.
For example, regarding the system of biotech regulation, should there be some
rearrangement or consolidation in the agency roles outlined in the Coordinated
Framework? Does the system strike the appropriate balance between formal governmental
regulation and the less formal regulation of consumer choice exercised through
the marketplace? Has the system struck the correct balance between our society's
insatiable desire for safety and its insatiable demand for innovation and new
products, such as those resulting form genetic engineering? To what extent should
our domestic regulatory scheme be in harmony with the schemes of trading partners
or defer to international trading rules?
Regarding specific agency actions, can
FDA find some resolution of the labeling issue (perhaps some guidance for voluntary
labeling as was developed for organic foods)? Should FDA make its 1992 voluntary
consultation procedures mandatory? Can the food testing and risk analysis data
developed in those consultations be more readily available to consumers who want
that information, perhaps through "Food Safety Assessments" that would be available
on the internet and functionally analogous to the Environmental Assessments of
agency actions required by the National Environmental Policy Act? Are there other
approaches to these and other issues that would better serve the public interest?
In a Press Release issued May 3, 2000,
the White House announced plans to strengthen science-based regulation of biotechnology
and consumer access to information. (36) More
specifically, the plans call for the following steps regarding food safety:
- The Food and Drug Administration (FDA) will take steps to ensure that it is
informed at least 120 days before new agricultural biotechnology crops or products
are introduced into the food supply and will propose that submitted information
and the agency's conclusion be made available to the public.
- The U.S. Dept. of Agriculture (USDA), FDA, and the Environmental Protection
Agency (EPA) will support an expanded program of competitively awarded, peer-reviewed
research focusing on current & future safety issues.
- FDA will develop guidelines for voluntary efforts to label food products under
their authority as containing or not containing bioengineered ingredients in a
truthful and straightforward manner, consistent with the requirements of the Federal
Food, Drug, and Cosmetic Act.
- USDA, FDA, EPA, and the State Department will enhance domestic and foreign
public education and outreach activities to improve understanding of the nature
and strength of our regulatory process.
On their face, these initiatives
seem to be a reasoned response intended to improve a regulatory scheme that is
currently serving U.S. consumers quite well. But the details will be important
and they have yet to be developed.
1. Uchtmann is a Professor of Agricultural Law in the Department
of Agricultural and Consumer Economics, University of Illinois at Urbana-Champaign.
B.S. 1968, University of Illinois; M.A. The University of Leeds, England, 1972;
J.D. 1974, Cleveland State University. He is a former President of the American
Agricultural Law Association.
2. See, e.g., Food and Drug Administration, Genetic
Engineering: Fast Forwarding To Future Foods (article revised February 1998
and visited May 16, 2000) <http://www.fda.gov/bbs/topics/CONSUMER/geneng.html>.
3. See Gerald C. Nelson et al, The Economics
and Politics of Genetically Modified Organisms in Agriculture: Implications for
WTO 2000, at 32 (1999) (Bulletin 809, November 1999, Office of Research, College
of ACES, U. of Illinois at Urbana-Champaign).
4. For an excellent, brief discussion of the contemporary
setting of biotechnology, science, government regulation, and public concern,
see the Preface to National Research Council, Genetically Modified Pest-Protected
Plants: Science and Regulation (2000). This publication is available from National
Academy Press and is on the Internet (visited May 16, 2000) at <http://books.nap.edu/catalog/9795.html>.
5. Regarding the safety of bioengineered foods generally,
see U.S. Food and Drug Admin., Are Bioengineered Foods Safe?, FDA Consumer Magazine
Jan.-Feb. 2000 (visited Jan. 31, 2000) <http://www.fda.gov/fdac/features/2000/100_bio.html>.
6. In addition to federal regulation, agencies of each
of the fifty states may regulate the use of biotechnology products within the
particular state, under either independent state laws (for example, a state seed
certification law) or authority delegated by a federal agency. Michael J. Malinowski,
Biotechnology, Law, Business, and Regulation § 11.06[A] (1999).
7. See Coordinated Framework for Regulation of
Biotechnology, 51 Fed. Reg. 23302 (June 26, 1986).
8. Coordinated Framework for Regulation of Biotechnology,
51 Fed. Reg. 23302, 23303 (June 26, 1986). The dual goals of promoting health
and safety and promoting the U.S. biotech industry are readily apparent when one
reads the Proposed Coordinated Framework. Proposal for a Coordinated Framework
for Regulation of Biotechnology; Notice, 49 Fed. Reg. 50856 (December 31, 1984).
Also, see United States Regulatory Oversight in Biotechnology (visited
October 26, 1999) <http://www.aphis.usda.gov/biotech/OECD/usregs.htm>.
9. Michael J. Malinowski, Biotechnology, Law, Business,
and Regulation § 11.06[A], at p. 11-87 (1999). Also see Chart I in the Coordinated
Framework, 51 Fed. Reg. 23302, 23304 (June 26, 1986) and U.S. Regulatory Oversight
of Biotechnology (visited Feb. 15, 2000) <http://www.aphis.usda.gov/biotech/OECD/usregs.htm>.
10. 21 U.S.C.A. § 303 (West 1999).
11. 21 U.S.C.A. § 331 (West 1999).
12. 21 U.S.C.A. § 342(a) (West 1999). Food is also adulterated
if it contains an unsafe pesticide chemical residue, i.e., a residue exceeding
a tolerance or exemption established by the Administrator of the Environmental
Protection Agency. 21 U.S.C.A. § 346a (West 1999).
13. 21 U.S.C.A. § 333 (West 1999). The criminal penalties
cannot exceed three years in prison and a $10,000 fine.
14. 21 U.S.C.A. § 342(a) (West 1999).
15. 21 U.S.C.A. § 348(a)(2) (West 1999).
16. 21 U.S.C.A. § 321(s) (West 1999). Food additives used
prior to 1958 can also be "generally recognized as safe" because of the experience
based on their common use in food.
17. 21 U.S.C.A. § 331 (a) and (b) (West 1999).
18. 21 U.S.C.A. § 343(a) (West 1999).
19. 21 U.S.C.A. § 371(a) (West 1999).
20. See 21 U.S.C.A. § 346a. The quoted language
comes from § 346a(b)(2)(a)(ii). The EPA has addressed the issue of tolerances
for pesticides produced by Bt corn, for example. In the case of MON 810,
the EPA concluded that no tolerance was necessary and exempted the active ingredient.
See Pesticide Fact Sheet (visited Feb. 14, 2000) <http://www.epa.gov/docs/fedrgstr/EPA-PEST/1997/September/Day-10/cry.htm>.
21. To reduce regulatory burden, FDA exercises minimal
oversight of products that are Generally Recognized as Safe (GRAS). Such foods
are subject to FDA's Sec. 402 broad post-market authority to remove unsafe foods
from the marketplace, but exempt from the far more rigorous and resource demanding
pre-market review of Sec. 409 (unsafe food additives).
22. FDA looked explicitly at both food and feed use of
products containing the "antibiotic marker gene" introduced into the Flavr Savr
tomato by genetic engineering, both for the likelihood of inactivation of therapeutic
antibiotics (the gene didn't inhibit the use of existing antibiotics in people)
and for the potential of genetic flow to microorganisms (nor did it contribute
substantially to bacteria developing resistence). FDA concluded that the gene
was safe. See FDA's review document at <http://vm.cfsan.fda.gov/~dms/OPA-ARMG.HTML#1>
(Visited September 23, 1999).
23. Because the objective of most modifications is to effect
some kind of change in composition no matter how small, one could argue that a
genetically engineered food cannot be exactly equivalent. This is largely the
argument of those who question the safety of any GM food. In practice, there is
an iterative consultation process between developers and FDA through which it
is decided by mutual consensus whether pre-market approval should or should not
be required. FDA provides guidance to the developer on a case-by-case basis. Personal
communication from Dr. Bruce Chassy, Professor and Head, Department of Food Science
and Human Nutrition, UIUC.
24. Statement of Policy, Foods Derived From New Plant Varieties,
57 Fed. Reg. 22983 (1992)
25. The concept of substantial equivalence as applied to
GM foods was first used in an OECD publication, "Safety Evaluation of Foods Derived
by Modern Biotechnology: Concepts and Principles," 1993, available at <http://www.oecd.org//dsti/sti/s_t/biotech/prod/MODERN.pdf>,
accessed October 10, 1999. It is a report of a group of 60 experts from 19 countries,
nominated by their governments. An October 7, 1999, article in Nature,
challenging the validity of using substantial equivalence to evaluate the safety
of GM foods has drawn quick rebuttals. See <http://www.biotechknowledge.com/showlib_us.php3?2167>,
accessed October 10, 1999.
26. See Statement of Policy, Foods Derived From
New Plant Varieties, 57 Fed. Reg. 22983 (1992).
27. See Statement of Policy, Foods Derived From
New Plant Varieties, 57 Fed. Reg. 22983, 22991 (1992).
28. U.S. Food and Drug Administration, Foods Derived from
New Plant Varieties Derived through Recombinant DNA Technology - Final Consultations
under FDA's 1992 Policy (visited Jan. 31, 2000) <http://vm.cfsan.fda.gov/~lrd/biocon.html>.
29. David A. Kessler, Michael R. Taylor, James H. Maryanski,
Eric L. Flamm, Linda S. Kahl, The Safety of Foods Developed by Biotechnology,
256 Science 1747, 1749 (1992).
30. FDA did not require special labeling for the Flavr
Savr tomato because the new tomato was not significantly different from the range
of commercial varieties referred to by that name. However, Calgene (the developer
of the Flavr Savr tomato) decided to provide special labeling, including point-of-sale
information, to inform consumers that the new tomato has been developed through
31. The agency has not required labeling for other methods
of plant breeding such as chemical- or radiation-induced mutagenesis, somaclonal
variation, or cell culture. For example, there is no requirement to label hybrid
sweet corn because it was developed through cross-hybridization.
32. See, e.g., Greenpeace, The Sound of Unsound
Science: EPA and EU Regulation of Bt Crops and Effects on Non-Target Insects
(visited May 16, 2000) <http://www.greenpeace.org/~geneng/>.
33. See Food and Drug Administration, Bioengineered
Foods (visited May 16, 2000) <http://www.fda.gov/oc/biotech/default.htm>.
34. See, e.g., National Research Council, Genetically Modified
Pest-Protected Plants: Science and Regulation, at Chapter 4: Strengths and Weaknesses
of the Current Regulatory Framework, p. 143 - 180 (2000). This publication is
available from National Academy Press and is on the Internet (visited May 16,
2000) at <http://books.nap.edu/catalog/9795.html>.
36. The White House Office of the Press Secretary, Clinton
Administration Agencies Announce Food and Agricultural Biotechnology Initiatives:
Strengthening Science Based Regulation and Consumer Access to Information (visited
May 9, 2000), <http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/2000/5/4/10.text.1>.
(This FACT SHEET can be accessed through the web site for White House Electronic
and searching for Fact Sheets issued May 3, 2000). See also, Food and
Drug Administration, FDA to Strengthen Pre-market Review of Bioengineered
Foods (visited May 16, 2000) <http://www.fda.gov/bbs/topics/NEWS/NEW00726.html>.