Federal Focus, Inc.
11 Dupont Circle, N.W., Suite 700
Washington, D.C. 20036

THE FDA BIOTECH HEARINGS:
AN ANALYSIS AND PRESCRIPTION

By Federal Focus, Inc.
May, 2000

TABLE OF CONTENTS

EXECUTIVE SUMMARY E-1 

I. Introduction 1

About Federal Focus and Its Agri-Biotech Symposium 1

Purpose of the Paper 2 

II. Current Regulatory Structure 3

Agricultural Biotechnology Generally 3

A. United States Department of Agriculture (USDA) 4

B. Food and Drug Administration (FDA) 5

C. Environmental Protection Agency (EPA) 8 

and Regulation 12

A. Introduction 13

B. Transparency of the Regulatory Process 14

C. Food Safety and Human Health Concerns 18

D. Environmental Safety Concerns 20

E. Other Concerns 21

Agri-Biotechnology Regulatory Structure 21

1. Executive Order Establishing Federal

Interagency Committee on Biotechnology 22

2. Development of a Unified Regulatory Agenda

Listing for Biotechnology Regulation 23

3. Establishment of a Coordinated Federal

Biotechnology Website 24

4. Expansion of OMB Circular A-130

to Address Data Quality 25

5. Interagency FACA Committee for Biotechnology 26

6. Outreach Programs 27

• 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 students.

– Coordination of the U.S. exhibit on environmentally-friendly technologies as part of the Rio Environmental Summit in 1992.

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• 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 Biotechnology

• 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 and regulation.

-- 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 the conference.

• 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.

• The White Paper includes specific measures for increasing the transparency of the process.

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• The paper consists of three sections:

(1) An overview of the existing regulatory framework, focusing on the roles of FDA, USDA, and EPA.

(2) Key concerns over agri-biotech products that were raised at FDA public meetings in late 1999. These primarily involve:

(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

(c) Environmental safety.

(3) Recommendations on how the agencies can increase transparency in their decision making to address the concerns raised by the interested public. 

• 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: 

-- Federal Focus recommends that the Administration issue an Executive Order to codify the existing regulatory review process for biotechnology.

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-- 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.

(2) 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

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• Notices of advisory committee meetings

• Notices of public hearing

• Paperwork Reduction Act clearances of forms related to biotechnology

• Industry guidance under development 

(3) 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 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.

-- 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 be included.

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-- 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.

(5) Interagency FACA 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 the agencies.

-- 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 agricultural biotechnology.

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(6) Outreach Programs

-- The federal government should, therefore, 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 the public.

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By Federal Focus, Inc.
May, 2000

I. INTRODUCTION 

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 were received.

• 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 included:

– "...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 mainstream media.

• Most recently, the White House issued a press release on May 3^rd 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. 

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 regulation.

II. CURRENT REGULATORY STRUCTURE 

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. 

Overview

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 plants.

Field Testing

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 Agricultural Biotechnology

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). 

Overview

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 pre-market approval.

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 evaluations of:

• 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). 

Labeling

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). 

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

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.

FIFRA

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 Act

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 Policy

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 issues. 

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 appropriate.

• 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 product.

– 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 biotechnology.

• 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 research." 

Enhance Information for Consumers and Farmers

• 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.

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 main categories:

(1) Transparency in the regulatory process and outcome, including product labeling and other right-to-know issues;

(2) Food safety and human health; and

(3) Environmental safety

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 European counterparts.

– There have also been charges of conflict of interest, due to the "revolving door" of employment between government regulators and industry personnel.

– 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.

• 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 law.

– 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 protection.

– 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 informed choices.

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 be purchasing.

– 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. 

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 food).

– 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 unknown.

– 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 been introduced.

• There have also been concerns that genetic modification in foods could somehow alter products’ nutritional content.

• There is concern that recombinant DNA techniques could produce unexpected toxins or carcinogens to a different degree or in an unexpected manner from conventional hybridization.

• 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 manifest.

• 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 genetically-modified products.

• 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 herbicides. 

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. 

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 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.

Federal Focus believes that the following points must be addressed in drafting the Executive Order on a Interagency Biotechnology Committee:

• Membership

– 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

• Leadership of the committee

– Designation of lead agency to chair the committee

• Administration of the committee

– Determination of responsibility for administration and staffing of committee operations

• Charter 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 the committee

– Schedule of meetings for the committee (i.e., fixed, as-needed, or combination thereof) 

(2) 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 concerns.

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 of "sunshine."

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 under consideration

• Notices of advisory committee meetings

• Notices of public hearing

• Paperwork Reduction Act clearances of forms related to biotechnology

• Industry guidance under development 

(3) 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 discussed above.

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. 

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 1^st 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. 

(5) Interagency FACA Committee for Biotechnology

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. 

(6) Outreach Programs

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 the public.