DRAFT -- 5/15/00
THE FDA BIOTECH HEARINGS:
AN ANALYSIS AND
Federal Focus, Inc.
11 Dupont Circle, N.W.,
Washington, D.C. 20036
THE FDA BIOTECH HEARINGS:
AN ANALYSIS AND
By Federal Focus, Inc.
TABLE OF CONTENTS
About Federal Focus and Its Agri-Biotech
Purpose of the Paper
II. Current Regulatory Structure
The Federal Regulatory Framework for
Agricultural Biotechnology Generally
A. United States Department
of Agriculture (USDA) 4
B. Food and Drug
Administration (FDA) 5
C. Environmental Protection
Agency (EPA) 8
D. The Clinton
Administration’s New Food and Agricultural Biotechnology Initiatives
III. Public Concerns Over Agri-Biotechnology
A. Introduction 13
B. Transparency of the
Regulatory Process 14
C. Food Safety and Human
Health Concerns 18
D. Environmental Safety
E. Other Concerns 21
IV. Federal Focus Recommendations
for Improving the
1. Executive Order
Interagency Committee on Biotechnology
2. Development of a Unified
Listing for Biotechnology Regulation 23
3. Establishment of a
Biotechnology Website 24
4. Expansion of OMB Circular
to Address Data Quality 25
5. Interagency FACA
Committee for Biotechnology 26
6. Outreach Programs 27
About Federal Focus
• Federal Focus, Inc. is a
private, non-profit 501(c)(3) educational foundation dedicated to
research and education on science policy issues, particularly those
impacting federal regulation. It was incorporated in the District of
Columbia in 1986.
• Federal Focus specializes in
the analysis of issues dealing with federal agencies, including research
projects involving public policy issues in a number of substantive
fields. Examples of the organization’s work include:
– Symposia on Budget
Training for federal employees.
– Numerous publications on
risk assessment and epidemiology.
– Co-sponsorship of a data
access symposium with the American Association for the Advancement
of Science (AAAS).
– Partnership with the
Navy Kids mentoring program to sponsor conferences on effective
methods to conduct Internet-based mentoring for public grade school
– Coordination of the U.S.
exhibit on environmentally-friendly technologies as part of the Rio
Environmental Summit in 1992.
The Federal Focus Symposium on the
Regulation of Agricultural Biotechnology
• Federal Focus will convene a
symposium on regulation of agricultural biotechnology on October 24,
2000. The meeting will be held at the Georgetown University Conference
Center in Washington, D.C.
• The symposium will provide
federal officials with the opportunity to:
– Evaluate the current
U.S. regulatory regime for agricultural biotechnology.
– Discuss what, if any,
changes to the process should be considered to ensure protection of
consumers and to enhance consumer confidence in biotech regulation.
Federal Focus White Paper on
• Federal Focus has prepared
this paper to bolster support for the basic regulatory structure for
genetically-modified food products and to stimulate discussion of how to
improve transparency and increase public confidence in biotech products
-- The paper will be vetted
in advance of the October symposium (including posting on the
Federal Focus website) and will serve as a basis for discussion at
paper concludes that the existing legal framework provides a workable
system for agri-biotech regulation and that no major regulatory reform
is necessary. However, there is a need for greater transparency in the
• The White Paper includes
specific measures for increasing the transparency of the process.
• The paper consists of three
(1) An overview of the
existing regulatory framework, focusing on the roles of FDA, USDA,
(2) Key concerns over agri-biotech
products that were raised at FDA public meetings in late 1999. These
(a) Transparency in the
regulatory process and outcome, including product labeling and
other right-to-know issues;
(b) Food safety and
human health concerns; and
(3) Recommendations on how
the agencies can increase transparency in their decision making to
address the concerns raised by the interested public.
Federal Focus Recommendations for
Improving the Agri-Biotechnology Regulatory Structure
• While the current regulatory
structure for the development, testing, and marketing of agricultural
biotechnology products is basically sound, Federal Focus believes that
the federal government should consider the following specific
recommendations to increase the transparency of the regulatory process
for biotechnology. These recommendations include:
Order Establishing Federal Interagency Committee on Biotechnology
-- Federal Focus
recommends that the Administration issue an Executive Order to
codify the existing regulatory review process for biotechnology.
-- A key element of the
Executive Order would be the establishment of a federal
interagency committee on biotechnology. The core of the
committee would be drawn from officials at FDA, USDA, and EPA,
although additional representation would come from various other
federal departments including the Department of State and the
Office of the U.S. Trade Representative.
-- The Executive Order
and the interagency committee would provide a structural unity
to the regulatory process for biotechnology. It would make the
process more transparent to the public and demonstrate a greater
sense of permanence to the process. At the same time, the
process would maintain its flexibility and focus on safety of
the products under consideration.
Development of a
Unified Regulatory Agenda Listing for Biotechnology Regulation
-- As part of its
duties, the interagency committee on biotechnology should
prepare a joint statement of planned regulatory actions in the
field of agricultural biotechnology as part of the Unified
Agenda of Federal Regulatory and Deregulatory Actions.
-- A core part of this
Unified Agenda listing should include a separate Regulatory
Calendar for Biotechnology, including a commitment to holding
periodic public meetings to air biotechnology issues.
-- The Unified Agenda
listing and the Regulatory Calendar for Biotechnology would
contain a schedule of all regulatory actions related to
agricultural biotechnology, including:
• New final rules
and proposed rules under consideration
• Notices of
advisory committee meetings
• Notices of
Reduction Act clearances of forms related to biotechnology
guidance under development
Establishment of a
Coordinated Federal Biotechnology Website
-- In order to promote
transparency in the existing regulatory process and to increase
public understanding, Federal Focus recommends the creation of a
single comprehensive federal Internet site for agricultural
biotechnology. Such a website could be maintained by the
interagency committee for biotechnology established under the
-- In clear and
understandable terms, the website would discuss the current
federal regulatory regime for agricultural biotechnology and the
division of responsibilities among agencies. The website would
also contain the biotechnology listing in the Unified Agenda, as
-- Coverage under the
website would be broad. For example, the biotech website would
also serve as an interactive point of reference for consumers.
The government could post information on new initiatives and
procedures, and the public could voice their concerns, including
views on the adequacy of new government measures in this field.
Meeting announcements and the availability of reports could also
of OMB Circular A-130 to Address Data Quality
-- Particularly as
regards federal website listings with information on
biotechnology, there should be a mechanism to ensure data
quality and to allow for the correction of information lacking
in quality, objectivity, utility, or integrity. In line with OMB’s
recommendation, OMB Circular A-130 (Management of Federal
Information Resources) could serve such a data quality function.
-- Federal Focus
believes that through the interagency committee on
biotechnology, the relevant agencies should formulate and adopt
clear procedures based upon OMB Circular A-130 to allow for the
public to seek correction of information related to
biotechnology either on website or disseminated via other means.
Committee for Biotechnology
-- The federal
government should consider the establishment of a single FACA
committee for agricultural biotechnology. This would be a
standing committee devoted to these issues which would have
jurisdiction over the entirety of the three-agency regulatory
process for biotechnology.
-- The committee could
meet at set intervals to discuss issues brought to it by FDA,
USDA, or EPA. Federal Focus recommends that the FACA Committee
be permitted to consider and offer advice on biotechnology
issues which the committee deems important, in addition
to reacting to specific questions and charges brought forward by
-- As an alternative to
this unitary FACA approach, Federal Focus would support
broadening existing FACA committee membership at FDA, USDA, and
EPA to include scientists with specific expertise in
-- The federal
government should, therefore, consider adoption of a
comprehensive public education plan related to agricultural
biotechnology. Such efforts might include:
presentations to a variety of consumers groups.
• Workshops on
biotechnology for scientists, public interest
representatives, and professionals from the public health
• Publication of a
periodic biotechnology newsletter for interested parties.
"town meetings" on biotechnology to allow
regulators direct interface with concerned members of the
THE FDA BIOTECH HEARINGS:
AN ANALYSIS AND
By Federal Focus, Inc.
About Federal Focus and Its Agri-Biotech
Federal Focus, a non-profit 501(c)(3)
research foundation devoted to the advancement of scientific principles in
public policy, has prepared the following discussion paper in connection with
our upcoming symposium, "The Regulation of Agricultural
Biotechnology". The Federal Focus symposium, which will feature
presentations by prominent federal regulatory officials involved in this field,
will be held at the Georgetown University Conference Center in Washington, D.C.,
on October 24, 2000.
Much has been said and written in recent
months on the subject of agri-biotechnology, including concerns over alleged
risks to food safety and/or the environment and the asserted need for additional
regulation of this developing industry. Concerned citizens, nutritional experts,
industry representatives, environmental activists, and other interest groups
have weighed in forcefully, even emotionally, for or against certain regulatory
proposals in the media and elsewhere. Examples of these activities related to
agricultural biotechnology include:
• Agencies have assembled
hundreds of pages of transcripts from public meetings at which comments
• Culminating a year-long
study, the National Academy of Sciences released a 280-page report on
regulation of genetically modified plants on April 5, 2000. The title of
the report is "Genetically Modified Pest-Protected Plants: Science
and Regulation." Some of the key conclusions of the NAS report
– "...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." (p. 6 (emphasis in original))
– "The committee is
not aware of any evidence that foods on the market are unsafe to eat
as a result of genetic modification." (p. 9 (original in bold))
– "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." (p. 15)
• Countless articles have
appeared in professional journals and the trade press, as well as in the
• Most recently, the White
House issued a press release on May 3rd announcing new
"Food and Agricultural Biotechnology Initiatives: Strengthening
Science-Based Regulation and Consumer Access to Information."
Details of this announcement are discussed in section II.D below.
Purpose of the Paper
The purpose of this paper is to focus
this vast discussion in a way that federal officials may find useful in
finalizing and implementing their resulting policy decisions.
First, the paper provides a brief
overview of the current regulatory structure, focusing on the key
responsibilities and policies of the three lead federal agencies. Our analysis
summarizes the legal framework under which these agencies operate and identifies
important policy documents that clarify the agencies’ role in biotech
regulation. The paper concludes
that the existing legal framework provides a workable system for agri-biotech
regulation and that no major regulatory reform is necessary. However, there is a
need for greater transparency in the three-agency process.
Second, the paper sets forth a list of
the principal concerns that have been raised with respect to the current
regulatory regime. In preparing this list, Federal Focus has reviewed the
transcripts from the three public meetings that FDA sponsored in
November-December, 1999, as well as numerous other sources. The list does not
catalogue all, or even most, of the comments received, but focuses instead on
the critical areas we believe regulators should address in enunciating and
supporting their policies.
Finally, a series of discrete
improvements to the system are suggested. Foremost among Federal Focus’s
recommendations is that transparency in the process be increased. We have,
therefore, offered specific, program-level suggestions to bolster transparency
and increase the confidence of consumers in the effectiveness of agri-biotech
II. CURRENT REGULATORY STRUCTURE
The Federal Regulatory Framework for
Agricultural Biotechnology Generally
The U.S. government does not currently
have a unified regulatory regime for agricultural biotechnology products. In
1985 the White House Office of Science and Technology Policy prepared a concise
matrix of the numerous laws, regulations, and guidelines applicable to
biotechnology products at some point in their research, development, marketing,
shipment, use and/or disposal. See 50 Fed. Reg. 47174 (Nov. 14, 1985).
Executive Office officials used this legal matrix in connection with their
issuance of a 1986 document, Coordinated Framework for Regulation of
Biotechnology. 51 Fed. Reg. 23302 (June 26, 1986). The 1986 policy document,
while providing a description of the regulatory policies for the affected
federal agencies, expressly contemplated that changes to the framework would
likely be needed in the future.
Regulatory jurisdiction over
agricultural biotechnology is split among three principal agencies: USDA, EPA,
and FDA. There is substantial consultation among these agencies on biotechnology
issues. However, in many instances, there is also overlapping jurisdiction, and
approval by multiple agencies for a proposed product is required.
The intended use of a proposed genetic
modification largely determines which agencies are involved. For example, a
genetic modification intended to create an herbicide tolerance in a food crop
would undergo review and approval by USDA, EPA, and FDA. However, if a similar
modification were undertaken for an ornamental plant (no human consumption), FDA
review would not be required. If a genetic modification was intended to change
only the ornamental characteristic of an ornamental plant, without changing
herbicide tolerance or viral resistance (such as creating a new color flower),
only USDA approval would be needed.
The following discussion outlines the
regulatory framework for agricultural biotechnology in place at each of the
three key agencies.
States Department of Agriculture
USDA’s Animal and Plant Health
Inspection Service (APHIS) is the lead office within the agency for
biotechnology regulation. APHIS is responsible for regulating the field testing
of genetically-modified plants. In addition to field testing, APHIS approval is
required for interstate or international movement of genetically engineered
APHIS has developed a streamlined
process for allowing field testing of genetically-modified plants. Under this
process, companies or other institutions provide APHIS with prior notification
of intent to field test the plant. APHIS then has 30 days to object or the test
may go forward. This is permission only for the field test, however, not general
permission to commercialize the plant.
In considering applications for field
testing, APHIS requires certain information about the plant, including a
description of new genes in the plant, the purpose of the test, the test
protocol, and precautions to prevent inadvertent escape of plants/pollen into
the environment. APHIS has the right to inspect the test area before, during
and/or after the test.
Permission to Commercialize
To obtain permission to commercialize a
genetically-modified plant, companies are required to petition APHIS for a
"determination of non-regulated status". This petition requires
submission of detailed genetic information, information about indirect effects
on other plants, and field test results. Petitioners are also required to
include information which may be unfavorable to the petition. Petitions are
published in the Federal Register, and the public is afforded the
opportunity to comment. APHIS grants the petition if it determines that the
plant presents no significant risks to other plants and is as safe as
non-modified varieties. It should be noted that "non-regulated status"
refers to APHIS regulation only, not to EPA or FDA regulation.
Other USDA Involvement in
Other offices at USDA besides APHIS also
play a role in agri-biotech regulation. The Foreign Agricultural Service, for
example, is responsible for monitoring foreign regulations and restrictions on
genetically-modified plants. The Agricultural Research Service conducts
agricultural biotechnology research, and the Economic Research Service conducts
studies on the economic impact of agricultural biotechnology.
Along with its other research
activities, USDA's Cooperative State Research, Education and Extension Service (CSREES)
administers the Biotechnology Risk Assessment Research Grants Program. This
program funds research to assist federal regulatory agencies in making
science-based decisions on the safety of genetically engineered organisms. The
CSREES received approximately $1.5 million in funding for FY 2000 and solicited
competitive research proposals earlier this year. See 65 Fed. Reg.
11706 (March 3, 2000).
and Drug Administration
The FDA relies primarily on two
sections of the Federal Food Drug and Cosmetics Act (FFDCA) in regulating
human and animal foods, including genetically engineered foods. Under
section 402(a)(1), a food is deemed "adulterated" (and thus
unlawful) if it bears or contains an added poisonous or deleterious
substance that may render the food injurious to health, or a
naturally-occurring substance that is ordinarily injurious. Section
402(a)(1) imposes a legal duty on those who introduce food into the
marketplace, including foods derived from new crop varieties, to ensure that
the food satisfies the applicable safety standard (i.e., "reasonable
certainty of no harm").
The second primary section FDA
relies on is section 409, which was added as an amendment to the Act in
1956. Section 409 requires pre-market approval for "food
additives" -- substances intentionally added to food -- unless the
substance is generally recognized as safe (GRAS). Food additives are subject
to review and approval by FDA before they may be used in food. Generally,
whole foods such as fruits, vegetables, and grains, are not subject to
FDA applies the same standards to
biotechnology products as to non-biotech products.
Substances produced through biotechnology that are added to foods are
considered as food additives for regulatory purposes if, but only if, they
differ significantly from substances currently found in food in terms of
structure, function, and/or quantity.
In that many genetically-modified
food crops do not differ significantly from non-bioengineered versions, FDA
pre-market approval is generally not required. For the past several years,
FDA has followed a program of premarket "consultation" for new
bioengineered products and strongly encourages companies developing such
products to participate in these consultations. This premarket consultation
process would become mandatory under the Clinton Administration’s new food
and agricultural biotechnology initiatives. (See section II.D, infra).
Scientists and policy-makers within
the Office of Policy, Planning and Strategic Initiatives and the Office of
Premarket Approval at FDA’s Center for Food Safety and Applied Nutrition (CFSAN)
are the primary FDA regulators of food biotechnology. CFSAN shares duties
with the Center for Veterinary Medicine, which deals with matters pertaining
to animal feed and food-animals.
1992 FDA Statement of Policy:
Foods Derived From New Plant Varieties
In1992, FDA published a policy
document in the Federal Register showing how the agency interprets
the Act with respect to foods derived from new plant varieties. 57 Fed.
Reg. 22984 (May 29, 1992).
The 1992 policy requires that
genetically engineered foods meet the same rigorous safety standards
required of all other foods. The linchpin of the 1992 policy is a
comprehensive "guidance to industry" section that establishes a
"standard of care" for developers to ensure food safety. The
statement contains detailed scientific guidance for developers of new plant
varieties, complete with flow charts, to help plant developers to both
ensure food safety in genetically engineered products and to understand the
issues FDA considers important. The policy explains, for example, that
safety assessments of foods derived from new plant varieties include
• Purpose or intended
technical effect of the genetic modification
• Source, function and
stable incorporation of introduced genetic material
• Analytical studies to
determine whether the genetic modification had any effects on the
composition of the food (such as the levels of important nutrients
and naturally-occurring toxins)
• Safety of new or
modified substances in food (for example, proteins, carbohydrates,
fats, or oils).
FDA is the only agency with
authority to require labeling of food products. FDA's policy has been to
require labeling only if the composition of a food product derived through
genetic engineering differs significantly from its conventional counterpart.
Companies must tell consumers on the food label when a product includes a
gene from one of the common allergy-causing foods (cow’s milk, fish or
shellfish, eggs, tree nuts, wheat, and certain legumes, especially peanuts
and soybeans), unless the company can show that the protein produced by the
added gene does not make the food cause allergies.
For example, if a food product were
to be engineered to contain a protein that may cause allergic reactions,
labeling would be appropriate. If the potential allergic reactions from the
genetically-added component were serious enough (such as peanut proteins),
FDA could consider whether marketing of the product should be disallowed.
To date, FDA has not concluded that
there are reasons that would cause genetically-modified foods, as a class,
to be distinguished from foods developed by other plant breeding mechanisms.
Likewise, FDA has taken the position that the Federal Food Drug and
Cosmetics Act does not require informational labeling based solely on
consumers' desire to know. Under the Administration’s new initiative, FDA
will develop guidelines to further clarify this voluntary labeling regime.
(See section II.D, infra).
Environmental Protection Agency
Congress has delegated to EPA
significant regulatory authority over biotechnology products under three
statutes: the Toxic Substances Control Act (TSCA), 15 U.S.C. § 2601, et
seq.; the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7
U.S.C. § 136, et seq., and Section 408 of the Federal Food, Drug and
Cosmetics Act, 21 U.S.C. § 346a.
TSCA regulation applies only to
bioengineered microbes. Thus, this portion of EPA biotechnology regulation
may be considered as outside agriculture, although some of the microbes may
be used for agricultural purposes. TSCA regulation is administered by the
Office of Pollution, Prevention and Toxics within the Office of Prevention,
Pesticides and Toxic Substances (OPPTS).
EPA issued its TSCA regulation on
biotechnology in 1997. See 62 Fed. Reg. 17909 (April 11, 1997)
("Microbial Products of Biotechnology; Final Regulation Under the Toxic
Substances Control Act"). This rule established procedures for the
premanufacture review of certain new microbial products of biotechnology
comparable to those for traditional chemical substances, but which were
tailored to address the specific characteristics of these microorganisms.
The primary focus of FIFRA was to
provide federal control of pesticide distribution, sale, and use. EPA was
given authority under FIFRA to study consequences of pesticide usage and to
require certain users to register when purchasing pesticides.
Under FIFRA, EPA regulates the
testing, distribution, sale and use of plants and microbes that produce
pesticidal substances. The BioPesticides and Pollution Prevention Division
of the Office of Pollution Prevention of OPPTS is responsible for FIFRA
biotechnology regulation. Technically, EPA does not regulate whole plants
but rather the pesticide produced by the plant and the genetic
material that produces the pesticide.
EPA has not yet promulgated final
FIFRA regulations on bioengineered "plant pesticides." The agency
has held extensive regulatory proceedings, however, including at least three
public hearings on the proposed rule. Using guidelines that are already in
place, the BioPesticides and Pollution Prevention Division is currently
providing a two stage process for biopesticide registration: 1) Experimental
Use Permit (EUP); and 2) full commercial approval (also known as Section 3
registration). The EUP study data is used to support full registration. EPA
looks at data in four categories: 1) product characterization; 2)
toxicology; 3) non-target organisms effects; and 4) exposure and
environmental fate. EPA may consult with USDA and FDA in the review process.
To date, EPA has registered several
plant-pesticide active ingredients, mostly Bt delta endotoxins.
EPA is willing to discuss
biotechnology regulatory issues with interested parties, including the types
of waivers that may be granted. EPA will provide a written determination on
whether a product would be exempted by the proposed rule.
Federal Food, Drug and Cosmetics
Under FFDCA, EPA sets tolerance
limits for pesticides used on food and animal feed. EPA is also able to
waive the requirement for a tolerance. FFDCA is administered by the Office
of Pollution Prevention. EPA is encouraging registrants (under FIFRA) to
apply for tolerance exemptions.
Office of Science Coordination and
The Office of Science Coordination
and Policy within the Office of Prevention, Pesticides and Toxic Substances
(OPPTS) is the central point of coordination within EPA for biotechnology
Clinton Administration’s New Food and Agricultural Biotechnology
On May 3, 2000, the Clinton
Administration issued a White House press release designed to strengthen
existing science-based regulation of agricultural biotechnology and to provide
additional information to consumers. The document reaffirms the Administration’s
support of this new scientific field, which it believes holds great promise to
improve the world food supply. Thus, the initiative primarily involves
confidence-building measures designed to reassure growers and the public
regarding the safety of these products.
The initiative will be accomplished
through a variety of means, including formulation of certain new regulations.
The following are the primary elements envisioned under the new initiative, as
quoted from the press release.
Reinforce the Strength &
Transparency of Science-Based Regulation
• The Council on Environmental
Quality (CEQ) and the Office of Science and Technology Policy (OSTP)
will conduct a 6 month interagency assessment of Federal environmental
regulations pertaining to agricultural biotechnology and, if
appropriate, make recommendations to improve them.
– This effort will involve
preparation of case studies to identify strengths and areas for
improvement in the current regulatory structure. The focus will be
on domestic environmental issues. FDA, USDA, EPA, the Department of
the Interior, and other agencies will be asked to participate, as
• 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 conclusions
be made available to the public.
– Under this element, FDA
will prepare a proposed rule requiring companies to notify FDA of
their intention to market a new biotech food. This process would
make mandatory the existing voluntary consultation process. After
reviewing a company’s submission, FDA will issue a letter stating
its conclusions about the safety and regulatory status of the
– FDA plans to make the
relevant information available on its agency website.
– FDA has said that it
also plans to supplement its veterinary medicine and food advisory
committees with additional scientists with agricultural
biotechnology expertise. The agency will then rely on these
committees to resolve some of its overarching questions related to
• USDA, FDA, and EPA will
support an expanded program of competitively awarded, peer-reviewed
research focusing on current & future safety issues.
– The three lead agencies
will coordinate their research programs for biotechnology and expand
them to the extent funds are available. USDA’s Initiative for
Future Agriculture and Food Systems is supposed to "...provide
a strong core of competitively funded risk assessment
Enhance Information for Consumers
• 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
not misleading manner, consistent with the requirements of the Federal
Food, Drug, and Cosmetic Act.
– The labeling guidelines
will be developed through the use of focus groups. The draft
guidelines will then be published for public comment in order to
maximize consumer input before they are finalized.
• USDA will work with farmers
and industry to facilitate the creation of reliable testing procedures
and quality assurance programs for differentiating non-bioengineered
commodities to better meet the needs of the market.
– USDA will prepare an
Advanced Notice of Proposed Rulemaking (ANPR) with input from
scientists, industry, and consumers. The ANPR will seek input on
current market practices, and the desirability and feasibility of
various quality assurance programs.
• 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.
– The federal government
will proactively seek to build a shared understanding of the safety
and benefits of biotechnology.
• USDA will provide farmers
with reliable information on markets to inform planting decisions and
with best farming practices for new crop varieties.
III. PUBLIC CONCERNS OVER AGRI-BIOTECHNOLOGY
PRODUCTS AND REGULATION
The coordinated oversight of
biotechnology by FDA, USDA, and EPA needs to be strengthened by the
contrib-utions of scientists and industries, healthcare professionals
and educators, consumer organizations and others into a concerted
national information initiative. No one group – not government or
industry, not scientists or consumer advocates – can successfully
address the information and trust gaps developing around biotechnology.
But together, each can play to their strengths in support of a safe,
nutritious and consumer-valued food system.
-- Dr. Mildred Cody,
Georgia State University
FDA Public Meeting,
Washington, D.C., Nov. 30, 1999
In late November and early December,
1999, FDA sponsored a series of three public meetings on regulation of
agricultural biotechnology. One purpose of these meetings was to elicit public
comment on the regulation of genetically modified or genetically engineered food
plants and the steps that federal officials are taking to ensure the safety of
these products to the public and the environment.
The concerns raised involved both
substantive health and environmental issues as well as concerns with the federal
regulatory process. While the merits of the alleged problems are open to debate,
the meetings clearly demonstrate that biotechnology is facing a growing crisis
in terms of consumer confidence. Therefore, as the above quotation articulately
states, educational efforts, and perhaps certain process refinements, may be
required to reassure the public of the safety of biotechnology and the merits of
the current regulatory regime.
The following is a brief discussion of
some of the key criticisms voiced at the FDA meetings from late 1999. Federal
Focus has not attempted to catalogue the entire universe of concerns here, but
merely to highlight -- without attribution -- the most common criticisms raised
and to distill these for purposes of discussion. The concerns fall into three
(1) Transparency in the
regulatory process and outcome, including product labeling and other
(2) Food safety and human
(3) Environmental safety
of the Regulatory Process
One of the main objections to the
federal regulatory process for agricultural biotechnology has been that it is
not sufficiently transparent. Such criticisms generally involve both the level
of information made available to the public as well as the ability to discern
all of the key aspects of the agencies’ decision making processes.
Transparency can also involve the perceived independence and objectivity of the
regulatory decision makers. The following points illustrate these concerns.
• There have been allegations
that federal regulators have been too sensitive to the needs of the
biotechnology industry. The biotechnology issue has become politicized
to the point where regulators’ judgment has become clouded.
– Politicians and trade
officials have made repeated statements about maintaining U.S.
leadership in the field of biotechnology.
-- Heavy lobbying efforts on
the part of agri-biotech companies have prevented legislative
measures (including labeling requirements) from imposing additional
safeguards on the biotechnology industry.
– Since biotechnology is
largely the product of U.S. scientific efforts, there is a
perception that American scientists, both inside and outside of
government, may be less objective on these issues than their
– There have also been
charges of conflict of interest, due to the "revolving
door" of employment between government regulators and industry
– The U.S. media has also
tended to take a positive view of biotechnology, based upon the
favorable statements of government officials and industry
representatives. Thus, this outlet for public information has
arguably been compromised. By contrast, the European media has taken
a more analytical and critical approach to biotechnology.
– It has been suggested
that FDA has used its strong institutional reputation for consumer
safety to dampen public fears in the biotechnology area.
However, it has been alleged that internal agency documents
(produced in the course of litigation) show that FDA scientists
have expressed strong reservations about the safety of
genetically-modified products. Such concerns were allegedly
concealed, as they were inconsistent with FDA policy.
• A major process criticism
has been that the agencies have not been following the letter of the law
in regard to genetically-modified food products. Under the Federal Food,
Drug, and Cosmetics Act (FFDCA), FDA has a duty to ensure a
"reasonable certainty of no harm" when reviewing food
products. However, FDA has allegedly not required the appropriate
testing to meet that standard. Critics say that if the agency desires a
different standard, it should be open about it and seek a change in the
– Specifically, critics
charge that the agencies have failed to establish a system for
premarket safety testing and have likewise failed to demonstrate
that these products are useful or necessary.
– Critics have also
challenged the notion that genetically-modified products are
substantially equivalent to other food products, when at the same
time, they are considered sufficiently unique to warrant patent
– It has actually been
argued that FDA approvals of genetically-modified foods are less
stringent than other food approvals, with additives only receiving a
full review where there are believed to be grounds for concern. The
inference is that all genetic changes should be considered additives
(and not "generally recognized as safe"), and the burden
should be placed upon the industry to demonstrate safety.
• There have been calls for
better coordination of regulatory activities by the three key agencies
– USDA, FDA, and EPA.
• Critics have charged that
FDA has been too concerned with the potential drain on its resources to
conduct a proper review of genetically-modified products. This casts a
cloud over the entire regulatory program.
• The current FDA consultation
process for genetically-modified foods is perceived as being outside the
regulatory system and therefore not subject to public scrutiny. Critics
have argued that there should be an open and mandatory consultation
process for all genetically-modified foods, which is seen as
justified because of the newness of this technology. Transparency in
this regard will prevent companies from cutting corners in the future as
they develop and market genetically-modified products.
• Some have argued that the
agencies, particularly USDA, have relied on "unsupported
claims" and "shoddy studies" supplied by agri-biotech
companies in making regulatory decisions.
• To increase transparency and
public support, there is a need for enhanced public education efforts
related to agricultural biotechnology.
– The public needs more
and better information which is easily accessible. Mere reference to
technical scientific literature is insufficient to meet this need.
– There also needs to be
better communication between regulators and the press, science
writers, and educators who are involved with public communications
on the biotechnology issue.
• A frequently voiced concern
regarding a lack of transparency in biotechnology products involves
calls for labeling of genetically-modified products. The primary
motivations behind this movement are right-to-know principles and
consumer choice. Regulators have noted that some groups appear to desire
genetically-modified labeling information not necessarily because of any
identifiable substantive concern, such as food safety or the
environment, but because the information is there to be had. These
critics simply assert their rights as Americans to be able to make
A number of subissues surrounding
these calls for labeling of genetically-modified products include:
– What form should a
genetically-modified labeling requirement take? Opportunity costs in
placing additional information on food labels must be considered, as
studies have shown that consumers tend to absorb only a certain
amount of information.
– Labeling must be
meaningful and standardized, but how much information should be
provided, and exactly what do consumers want to know?
– If a product is labeled
a "GM product" or "GM-free," does this imply a
"quality" message to the consumer? Is that appropriate?
– At what point is a
product deemed to be "GM-free"? Certain food products may
contain a de minimis amount of genetically-modified
materials. These materials may be ubiquitous at this point, and
genetically-modified components may be difficult to detect in highly
processed foods such as oils.
– The organic food
industry fears that unless there is mandatory labeling, organic food
producers will not be able to choose non-GM component ingredients
for their products. This is above and beyond their concerns about
contamination in the field (e.g. creation of superweeds).
– Some have argued that a
product labeled "organic" may lead consumers to believe
that such products are GM-free. Not all GM-free foods can meet the
definition of organic, however, and consumers will still be
uncertain regarding the status of the non-organic products they may
– Some have suggested that
if companies oppose labeling of genetically-modified products or are
unwilling to incur the additional cost, there will be a public
perception that they have something to hide. This perception would
diminish consumer confidence in genetically-modified crops.
• Critics have also called for
greater transparency in biotechnology regulation based upon instances of
past failures of the regulatory system, such as approval of the
prescription diet drug phen-fen, the delay in approval of claims linking
folic acid to the prevention of birth defects, and problems associated
with silicone breast implants.
Safety and Human Health Concerns
Although regulators have determined that
all genetically-modified food products marketed to the public thus far to be
substantially equivalent to their non-genetically-modified cousins, critics
question this finding of equivalency. This is especially so since biotechnology
now allows for transgenic crosses, something that was impossible using previous
plant breeding techniques. While gene splicing may be more precise in terms of
the DNA segments that are transferred, the long-term effects of this genetic
material transfer are less clear. Depending where the gene sequences land in
plant chromosomes, different pleiotropic effects may be possible. Such
unexpected effects have been observed in certain genetically-modified flowers,
and it is not clear what other unintended consequences could manifest.
Critics therefore argue that
bioengineered foods could present a number of potential human health concerns.
Commenters at the FDA public meetings and elsewhere have raised the following
points concerning potential health effects of genetically-modified crops:
• There is a great concern
about the potential of genetically-modified foods to transfer food
allergens to new crops, particularly where such transfers would not be
suspected by susceptible individuals.
Food allergies affect
approximately 2.5 to 5 million Americans (roughly 1-2% of adults and
4-6% of children), with effects ranging from mild discomfort to
potential fatality. Since most known food allergens are proteins,
proteins added via genetic modification could cause allergic reactions.
As noted above in the discussion of labeling, allergenicity is of
particular concern where the added protein is not normally associated
with that type of food (e.g., peanut proteins added to another type of
– For foods to which
people are commonly allergic, testing methods are available.
However, for foods not commonly allergenic, or for non-food sources
such as bacteria, there are no tests for allergenicity.
– Screening mechanisms
currently exist for biochemical characteristics of proteins to see
if they are consistent with characteristics of allergens, but the
effectiveness of this approach in protecting public health is
– FDA has been criticized
for not having invested the resources to develop industry guidance
on allergenicity testing for proteins. The agency has also been
called upon to develop protocols for such testing itself.
– Labeling of
genetically-modified products has also been advocated as a way to
help potentially allergic consumers avoid products to which they
might be susceptible.
– Despite these concerns,
an October 1999 survey by the International Food Information Council
indicated that seven out of ten Americans support the current FDA
policy on labeling foods produced using biotechnology. As discussed
above, the FDA policy in recent years has required special labeling
only when the food has been significantly changed or when a
potential safety concern such as an unexpected food allergen has
• There have also been
concerns that genetic modification in foods could somehow alter products’
• There is concern that
recombinant DNA techniques could produce unexpected toxins or
carcinogens to a different degree or in an unexpected manner from
• Agencies have been accused
of relying on inadequate toxicological testing and other inferences in
trying to demonstrate a "reasonable certainty of no harm"
consistent with the FFDCA.
– It is argued that the
only way to attain the reasonable certainty of no harm standard for
genetically-modified foods is through long-term animal feeding
studies, followed by clinical and human feeding studies.
• There may be a latency
period associated with health effects related to genetically-modified
foods. This could be comparable with Creutzfeldt-Jakob Disease (the
human variant of mad cow disease) which takes 12 to 15 years to
• Critics have also raised
concerns about immunosuppression and antibiotic resistance associated
with antibiotic markers used in biotechnology. These critics warn that,
ultimately, genetically-modified products could make people more
susceptible to bacterial and other infections.
• As in traditional
agriculture, farm workers are considered a key susceptible subpopulation
when examining the health effects of genetically-modified products. A
case in point would be plants bioengineered to tolerate higher doses of
herbicides. Such crops would likely tend to receive greater doses of
these chemicals, thereby increasing the exposure of farm workers.
Critics suggest that environmental
impacts of genetically-modified crops are even less well understood than human
health impacts. The following points highlight some of the environmental safety
concerns associated with genetically-modified products.
• Perhaps the most frequently
cited concern is the likelihood of horizontal spread of introduced genes
to other plant populations, perhaps creating so-called "superweeds"
that are resistant to known herbicides.
• Critics claim that studies
are needed to determine the effects cross-pollination could have on soil
ecology and water supplies.
• There are concerns that
genetically-modified plants could be a threat to biodiversity, both in
terms of competition with other plant species and as potential threats
to various fauna.
-- For example, studies have
suggested that monarch butterflies and other beneficial insects are
highly susceptible to toxins in Bt corn and other
• Some commenters have called
for mandatory environmental reviews of genetically-modified products
before production and marketing approval.
Commenters at the FDA public meetings
and elsewhere have raised a number of other concerns with respect to
agricultural biotechnology, some of which may have no clear scientific answer.
• Ethical issues regarding
alteration of existing life forms trouble some commenters.
• Some critics have raised
objections to biotechnology on religious grounds.
• Others fear monopolies
associated with the patenting of living organisms.
• As FDA Commissioner Henney
has noted, some commenters have raised concerns over possible adverse
societal impacts on developing countries, which see genetically-modified
foods as an inexpensive alternative to chemical pesticides and
IV. FEDERAL FOCUS RECOMMENDATIONS
FOR IMPROVING THE AGRI-BIOTECHNOLOGY REGULATORY STRUCTURE
Federal Focus believes that the current
federal regulatory structure for the development, testing, and marketing of
agricultural biotechnology products is basically sound. As HHS Secretary Shalala
has noted, the U.S. food supply is the safest in the world. The three agencies
charged with overseeing bioengineered food products should work within the
existing structure to maintain this supply of safe, affordable food.
A fundamental goal of U.S. regulatory
law is to ensure transparency in government. Closely aligned with this goal is
the desire to foster confidence in government by increasing the public’s
participation in regulatory decision making. The recent Administration
Initiative for Biotechnology has both of these aims clearly in mind.
Therefore, Federal Focus believes that
the agencies must advance agri-biotech policy within the paradigm established by
existing U.S. regulatory laws, including strict compliance with the
Administrative Procedure Act, the Paperwork Reduction Act, the Regulatory
Flexibility Act, Executive Order 12866, and other laws designed to promote
transparency and public participation and confidence.
Federal Focus believes that the federal
government should consider the following specific recommendations to increase
the transparency of the regulatory process for agricultural biotechnology.
Order Establishing Federal Interagency Committee on Biotechnology
While the three-agency process for the
regulation of agricultural biotechnology has functioned effectively to date, to
some extent, the public’s perception of the process has been that it is ad
hoc and disorganized, largely due to the division of responsibilities among
the agencies based upon existing statutes. Federal Focus, therefore, recommends
that the Administration issue an Executive Order to codify the existing
regulatory review process for biotechnology.
A key element of the Executive Order
would be the establishment of a federal interagency committee on biotechnology.
The core of the committee would be drawn from officials at FDA, USDA, and EPA,
although additional representation would come from various other federal
departments including the Department of State and the Office of the U.S. Trade
The Executive Order and the interagency
committee would provide a structural unity to the regulatory process for
biotechnology. It would make the process more transparent to the public and
demonstrate a greater sense of permanence to the process. At the same time, the
process would maintain its flexibility and focus on safety of the products under
Federal Focus believes that the
following points must be addressed in drafting the Executive Order on a
Interagency Biotechnology Committee:
– Designation of federal
Departments and agencies to serve on the committee
– Selection of officials
to serve on the committee and principles for delegation of
responsibilities related to the committee
of the committee
– Designation of lead
agency to chair the committee
of the committee
– Determination of
responsibility for administration and staffing of committee
for the committee
– Outline of functions and
duties of the committee
– Outline of procedures
for the committee, including opportunities for public involvement
– Establishment of the
term of the committee and provisions for renewal
– Workproduct/output of
– Schedule of meetings for
the committee (i.e., fixed, as-needed, or combination thereof)
Development of a Unified
Regulatory Agenda Listing for Biotechnology Regulation
As part of its duties, the above
interagency committee on biotechnology should prepare a joint statement of
planned regulatory actions in the field of agricultural biotechnology as part of
the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified
Agenda). Such listing would increase transparency in the government’s
processes by demonstrating coordination of agency activities related to
agricultural biotechnology. It would also demonstrate government acknowledgment
of public concerns related to this issue and efforts underway to meet those
A core part of this Unified Agenda
listing should include a separate Regulatory Calendar for Biotechnology. This
measure would serve a variety of purposes. First, it would give interested
parties a clear understanding of the regulatory events taking place at each of
the three key agencies. The federal government should commit to holding periodic
public meetings to air biotechnology issues as part of this Regulatory Calendar.
Even a tentative schedule of regulatory
activities would presumably increase participation levels and improve the
quality of debate through better preparation. It would also foster greater trust
in the regulatory process, since all activities will receive an additional dose
The Unified Agenda listing and the
Regulatory Calendar for Biotechnology would contain a schedule of all regulatory
actions related to agricultural biotechnology, including:
• Proposed and final rules
• Notices of advisory
• Notices of public hearing
• Paperwork Reduction Act
clearances of forms related to biotechnology
• Industry guidance under
Establishment of a
Coordinated Federal Biotechnology Website
Although the current division of
responsibilities for regulation of agricultural biotechnology is reasonable and
workable in practice, presentation of information by three agencies can be
cumbersome and confusing to consumers. Comprehensive and easily accessible
information would counter misinformation, allay many public fears, and generally
raise the quality of the debate surrounding the biotechnology issue.
In order to promote transparency in the
existing regulatory process and to increase public understanding, Federal Focus
recommends the creation of a single comprehensive federal Internet site for
agricultural biotechnology. Such a website could be maintained by the
interagency committee for biotechnology established under the Executive Order
In clear and understandable terms, the
website would discuss the current federal regulatory regime for agricultural
biotechnology and the division of responsibilities among agencies. The website
would also contain the biotechnology listing in the Unified Agenda, as discussed
above. Links to this comprehensive biotech website would also be placed on the
individual agency website.
Coverage under the website would be
broad. For example, the biotech website would also serve as an interactive point
of reference for consumers. The government could post information on new
initiatives and procedures, and the public could voice its concerns, including
views on the adequacy of new government measures in this field. Availability of
reports and meeting announcements could also be covered on the site.
of OMB Circular A-130 to Address Data Quality
Especially in an area of heightened
public concern such as biotechnology, it is imperative that government
information presented to the public is accurate and reliable. Thus, particularly
as regards federal website listings with information on biotechnology, there
should be a mechanism to ensure data quality and to allow for the correction of
information lacking in quality, objectivity, utility, or integrity.
In line with OMB’s recommendation, OMB
Circular A-130 (Management of Federal Information Resources) could serve such a
data quality function. Circular A-130 provides uniform information resources
management policies across the government as required by the Paperwork Reduction
Act of 1980 (PRA), as amended by the Paperwork Reduction Act of 1995 (44 U.S.C.
Chapter 35). To understand the information requirements imposed by the PRA, the
following description found in the Background section of the Circular is useful:
The Paperwork Reduction Act
establishes a broad mandate for agencies to perform their information
resources management activities in an efficient, effective, and economical
manner. To assist agencies in an integrated approach to information resources
management, the Act requires that the Director of OMB develop and implement
uniform and consistent information resources management policies; oversee the
development and promote the use of information management principles,
standards, and guidelines; evaluate agency information resources management
practices in order to determine their adequacy and efficiency; and determine
compliance of such practices with the policies, principles, standards, and
guidelines promulgated by the Director.
Section 9(a)(10) of Circular A-130
allows interested parties to petition the agencies for correction of
information. In discussing the responsibilities of agency heads, that section
states that each agency shall:
Direct the senior official appointed
pursuant to 44 U.S.C. 3506(a) to monitor agency compliance with the policies,
procedures, and guidance in this Circular. Acting as an ombudsman, the senior
official shall consider alleged instances of agency failure to comply with
this Circular and recommend or take corrective action as appropriate. The
senior official shall report annually, not later than February 1st
of each year, to the Director those instances of alleged failure to comply
with this Circular and their resolution.
Federal Focus believes that through the
interagency committee on biotechnology, the relevant agencies should formulate
and adopt clear procedures based upon OMB Circular A-130 to allow for the public
to seek correction of information related to biotechnology either on website or
disseminated via other means. Such a mechanism would help ensure the ongoing
quality of information related to biotechnology and increase public
participation and confidence in the regulatory process.
Interagency FACA Committee
The agencies currently route
biotechnology questions through their existing science FACA committees. Such
committees already have an extremely heavy workload in a variety of fields.
Others have argued that these committees do not have sufficient expertise in
biotechnology to advise the agencies properly.
Therefore, the federal government should
consider the establishment of a single FACA committee for agricultural
biotechnology. This would be a standing committee devoted to these issues,
perhaps run out of the White House’s Office of Science and Technology Policy.
The committee could meet at set intervals to discuss issues brought to it by
FDA, USDA, or EPA. Special meetings could also be held as needed.
As an alternative to this unitary FACA
approach, Federal Focus would support FDA’s idea of broadening its existing
FACA membership to include scientists with specific expertise in agricultural
biotechnology. EPA and USDA should similarly broaden the membership of their
scientific FACA committees if a unitary FACA committee approach is not adopted.
Under either approach, the agencies
should develop specific procedures for public notice and comment on the
biotechnology issues under consideration. Public comments should be sought on
charges given to such panels to sharpen the questions and the debate. Such steps
would enhance both transparency and opportunities for public participation.
This FACA Committee would have
jurisdiction over the entirety of the three-agency regulatory process for
biotechnology. Federal Focus recommends that the FACA Committee be permitted to
consider and offer advice on biotechnology issues which the committee deems
important, in addition to reacting to specific questions and charges brought
forward by the agencies. An area where a FACA Committee for Biotechnology may be
useful is in structuring the federal government’s public outreach efforts.
While the three key agencies do conduct
outreach efforts related to biotechnology, such as through the formation of FACA
committees, maintenance of website, and publication of guidance, the level of
concern demonstrated at the FDA public hearings suggests that agency outreach
efforts could be improved. Federal government efforts to communicate to the
public about agricultural biotechnology have been largely passive. Such
deficiencies in current outreach efforts may have contributed to public
misunderstanding and the increasing level of concern.
The federal government should consider
adoption of a comprehensive public education plan related to agricultural
biotechnology. Such efforts might include:
• Agency presentations to a
variety of consumers groups.
• Workshops on biotechnology
for scientists, public interest representatives, and professionals from
the public health community.
• Publication of a periodic
biotechnology newsletter for interested parties.
• Scheduled "town meetings"
on biotechnology to allow regulators direct interface with concerned members of