D R A F T

The White House

Executive Order 131XX

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INTERAGENCY COORDINATION OF
AGRICULTURAL BIOTECHNOLOGY REGULATION

By the authority vested in me as President by the Constitution and the laws of the United States of America, including the Federal Advisory Committee Act, as amended (5 U.S.C. App.), and in order to further protect the environment, to ensure the continued safety, abundance, and affordability of the food supply, to increase public knowledge of and confidence in agricultural biotechnology products, and to enhance openness in the regulation of agricultural biotechnology, it is hereby ordered as follows:

Section 101. Policy.

(a) All Federal agencies share a common objective of serving the American public. Although each agency has a defined set of responsibilities, it is only when they work in harmony that the government is most efficient. While agency regulation of agricultural biotechnology products to date has been sufficient to protect the environment and the safety of the public, the regulatory process can and should be improved to ensure these safeguards remain effective and to promote more openness in government decisions affecting these products.

(b) Agricultural biotechnology holds enormous promise for improving the quality of life in the United States and around the world. While the agricultural biotechnology industry is still in a relatively early stage of development, as the industry continues to grow each year it is anticipated there will be growth in experimentation, ultimately resulting in an increase in agricultural production and a broadening of international trade. Agricultural biotechnology provides farmers with additional product options, including the opportunity for reduced inputs and higher yields. The potential benefits are also likely to be significant in terms of improved food quality, including enhanced nutrient content, product variety, and greater shelf-life.

(c) Innovations in agricultural biotechnology should be fostered as expeditiously and as prudently as possible. Intellectual partnerships among researchers, government and industry should be promoted. In addition, the public’s knowledge of, and confidence in, agricultural biotechnology product development and regulatory processes should be supported and expanded.

(d) It is therefore the policy of this Administration to coordinate, harmonize, and make accessible to the public wherever possible the activities of Federal agencies responsible for the regulation of agricultural biotechnology products. Laws and regulations pertaining to agricultural biotechnology should be implemented to advance sustainable development, pollution prevention, environmental justice, ecosystem protection, and biodiversity preservation and in a manner that promotes transparency and public participation.

Sec. 201. Definitions.

For purposes of this order:

(a) "Agency" or "Executive agency" means, unless otherwise indicated, an executive agency as defined in 44 U.S.C. § 3502(1). The term also includes government-owned and contractor operated facilities excluded under 44 U.S.C. § 3502(1)(D).

(b) "Agricultural biotechnology" means any activity intended to affect production of human or animal food that involves the introduction into the environment of organisms having deliberately modified hereditary traits. In addition, agricultural biotechnology includes the use of enhanced crop plants to provide fiber, or special materials. For the purposes used here, livestock improvements and aquiculture are not included within this definition.

(c) "Deliberately modified hereditary traits" refers to changes to genetic traits of an organism by any method.

(d) "Organism" means any biological entity, cellular or noncellular, with the capacity for self-perpetuation and response to evolutionary forces; examples include plants, animals, fungi, prokaryotes, viruses, and viroids. (To avoid repetition in the use of "organisms and its products," the term "organism" includes not only the living organism but any substance (including, for instance, enzymes or proteins)produced by the organism.)

Sec. 301. Establishment of Interagency Agricultural Biotechnology Coordinating Committee and Coordinating Committee Support Office.

(a) There is hereby established an Interagency Agricultural Biotechnology Coordinating Committee ("Coordinating Committee") to provide leadership and oversight for the development and implementation of a coordinated policy for the regulation of agricultural biotechnology products. The Coordinating Committee membership shall consist of one representative from each of the following agencies:

(1) Department of Agriculture
(2) Environmental Protection Agency
(3) Food and Drug Administration;
(4) Department of State;
(5) Department of Commerce;
(6) Office of the United States Trade Representative;
(7) Office of Science and Technology Policy;
(8) Council on Environmental Quality; and
(9) Office of Management and Budget

(b) The representatives from the Department of Agriculture ("USDA"), the Environmental Protection Agency ("EPA"), and Food and Drug Administration ("FDA"), shall serve as Co-chairpersons of the Coordinating Committee. At the discretion of the Co-chairpersons of the Coordinating Committee, other agencies may be added to the Coordinating Committee membership. The Coordinating Committee shall include an Executive Secretary to effect coordination between the Co-chairpersons of the Coordinating Committee and the Coordinating Committee Support Office.

(c) Coordinating Committee members shall each be appointed by the Secretary, Agency Administrator, Commissioner, or other authorized official of their respective agency on the basis of their scientific or other expertise in agricultural biotechnology and program regulation. Coordinating Committee members may ask appropriate staffs of their respective agencies to attend Coordinating Committee meetings to ensure adequate information sharing.

(d) Each member of the Coordinating Committee shall serve for a period of up to three years, with one-third of the membership terms expiring on a staggered annual basis.

(e) The USDA, EPA and FDA shall provide the funding and administrative support necessary to assist the Coordinating Committee and the Support Office in fulfillment of its duties.

(f) Within 120 days of this order the Secretary of Agriculture, the FDA Commissioner and the EPA Administrator shall establish a Coordinating Committee Support Office ("Support Office") to assist the Coordinating Committee by developing plans and projects that would further the coordination, harmonization, and public openness of regulatory activities affecting agricultural biotechnology products. The Support Office shall ensure effective day-to-day coordination of actions designed to implement plans and guidance provided by the Coordinating Committee and respond to recommendations made by the Coordinating Committee. All agencies represented on the Coordinating Committee or that have capabilities and missions related to the work of the Coordinating Committee shall be invited to participate in the operation of the Support Office. At the request of the Coordinating Committee, and drawing on particular expertise of officials from the agencies represented on the Coordinating Committee, the Support Office may establish and facilitate the work of task forces, ad hoc working groups, or similar temporary bodies to advise and assist the Coordinating Committee on technical issues.

(g) At the end of a five year period, based upon a review of the accomplishments of this Committee as evidenced through the public reports, meeting minutes, and other results and materials, an assessment shall be made of the continued need for this Committee. Recommendations shall be put forward to the President for the continuation of the Committee, reduced annual workload, or the discontinuation of the Committee.

Sec. 302. Purposes and Functions of Coordinating Committee.

The purpose and functions of the Coordinating Committee shall be:

(a) To provide a forum where member agencies share information related to agricultural biotechnology products, including product development, marketing, and production, environmental safety, research, educational initiatives, risk analysis, policies, programs and other activities which may potentially impact public health and/or the environment.

(b) To promote coordination of agency activities relating to (a) above, including policy development, rulemaking, educational initiatives, risk analysis and research;

(c) To promote collaboration whereby agencies, where authorized, might enter into joint activities which would make the most effective use of resources, eliminate regulatory inconsistences among different agencies, and avoid unnecessary duplication of activities relating to agricultural biotechnology regulation;

(d) To promote public education in agricultural biotechnology issues and to facilitate and promote public participation in the development of federal policies, programs and regulations pertaining to agricultural biotechnology.

Sec. 303. Duties of Coordinating Committee and Support Office.

(a) The Coordinating Committee shall adopt a charter stating that the Coordinating Committee is authorized and directed to carry out the following duties:

(1) promote the United States as an example and leader in the development and regulation of agricultural biotechnology products;

(2) serve as the United States Government’s single entity for all matters, both national and international, pertaining to the development and implementation of agricultural biotechnology policies;

(3) provide leadership and coordination among all Federal agencies with respect to regulation of agricultural biotechnology products, including facilitating and coordinating the activities of agencies, where the agencies pursue joint or closely related action, and reviewing all agency regulations affecting agricultural biotechnology;

(4) identify any gaps in agricultural biotechnology product regulation among the federal agencies’ respective jurisdictions;

(5) respond to any such regulatory or jurisdictional gaps by assigning lead authority over given agricultural biotechnology product regulation to individual agencies and by making specific proposals to the President, as necessary;

(6) consult with, and act as final arbiter in disputes among, established committees at Federal agencies charged with developing and/or overseeing policies, programs, research and other activities relating to agricultural biotechnology, as appropriate, including EPA's Biotechnology Science Advisory Committee (BSAC) and USDA's Agricultural Biotechnology Research Advisory Committee (ABRAC);

(7) consult with other interagency committees, councils and similar bodies established under other Executive orders, as appropriate, including, for example, the Interagency Council on Biobased Products and Bioenergy (Executive order 13134), the Steering Committee on Greening the Government through Waste Prevention and Recycling (Executive order 13101), the National Bioethics Advisory Commission (Executive order 12975), the President's Council on Sustainable Development (Executive order 12852), and the National Nutrition Monitoring Advisory Council (Executive order 12747);

(8)exercise supervisory authority over all policy making activities undertaken by the agencies referenced in paragraphs (7) and (9) of this section;

(9) consult with the National Academy of Sciences' Standing Committee on Biotechnology, Food and Fiber Production, and the Environment, as appropriate;

(10) consult with other Federal agencies, State, local, and tribal government agencies, and consumer, producer, scientific, and industry groups, as appropriate;

(11) strive to include all appropriate stakeholders and the public in the development and implementation of agricultural biotechnology policies and regulations.

(12) provide staffing and material support for agricultural biotechnology development activities;

(13) oversee administration of the Federal Agricultural Biotechnology Internet Website;

(14) 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").

(15) prepare an annual public report to the President, through the Co-chairpersons of the Coordinating Committee, on the activities of the Coordinating Committee and on other developments in agricultural biotechnology during the preceding 12 months, in both the private sector and with respect to government programs and regulations, and discussing projected developments and regulatory activities in agricultural biotechnology for the next two years; and

(16) oversee implementation of the other directives contained in this order.

(c) The Coordinating Committee shall coordinate its activities with actions called for in all relevant Executive orders and shall not be in conflict with proposals advocated by other Executive orders.

(d) The Support Office shall:

(1) serve as an executive secretariat and support the work of the Coordinating Committee as determined by the Coordinating Committee, including the coordination of multi-agency, integrated research, development, and demonstration ("RD&D") activities;

(2) facilitate use of new information technologies for rapid dissemination of information on agricultural biotechnology products to and among farm operators; agribusiness, chemical, crop production, and other business sectors; the university community; and public interest groups that could benefit from timely and reliable information;

(3) monitor the activities of all Federal and State agencies significantly affecting research, development, production, or marketing of agricultural biotechnology products;

(4) consult with agencies, States, and international counterparts in developing agricultural biotechnology policies and implementation strategies;

(5) develop and make recommendations concerning agricultural biotechnology activities to the agencies, as approved by the Coordinating Committee;

(6) participate in projects that promote the goals and objectives of the Coordinating Committee;

(7) provide day-to-day staff and technical support to the Coordinating Committee for purposes of maintaining the Federal Agricultural Biotechnology Internet Website.

(a) The Coordinating Committee shall meet at the headquarters of USDA, EPA or FDA, or at a suitable alternative site in the Washington, D.C. area. Such meetings shall be held at least semi-annually but may be held more frequently as determined by the Co-Chairpersons of the Coordinating Committee.

(b) An appropriate period for public comment shall be provided at all meetings of the Coordinating Committee.

(c) The Executive Secretary of the Coordinating Committee, shall keep minutes of the meetings of the Coordinating Committee, and these minutes shall be timely posted on the Agricultural Biotechnology Internet Website and made available at the headquarters of USDA, EPA and FDA.

Sec. 401. Transparency: Establishment of Federal Agricultural Biotechnology Internet Website.

(a) The Coordinating Committee is directed to establish a Federal Agricultural Biotechnology Internet Website ("Website"). The Website shall provide a clear discussion of the federal regulatory regime for agricultural biotechnology and the division of responsibilities among all relevant federal agencies, consistent with the provisions of section 801 of this order,

Sec. 402. Purposes and Content of the Agricultural Biotechnology Internet Website.

(a) The primary purposes of the Federal Agricultural Biotechnology Internet Website shall be to increase transparency in Federal regulation of agricultural biotechnology. The Website shall serve as an interactive point of reference for government agencies, consumers, industry, environmental organizations, researchers, and the public.

(b) The Website is intended to convey to the public and interested parties, in plain terms, the internal workings of the Coordinating Committee. The agencies represented on the Coordinating Committee shall, as appropriate, post information on new initiatives and procedures under consideration or being developed. Availability of reports, announcements of meetings, and similar information shall be posted on the Website. Links to the Website shall be placed on the individual websites maintained by all the agencies represented on the Coordinating Committee.

(c) The Website is also intended to serve as an educational tool for the public and shall provide information on basic scientific principles and developing issues in agricultural biotechnology. The Website shall provide tutorials in layman’s terms on key terminology and processes, and shall include updated bibliographic information to facilitate additional inquiry on subject matters.

(d) The Website shall closely follow and report on Federal review of new and developing agricultural biotechnology products and processes. Clear explanations of the review processes shall be provided, including step-by-step descriptions and timing of multi-agency or multi-level reviews. Each product or process under review shall be tracked separately, the particular issues pertaining to each product or process at each review stage shall be clearly explained, and the lead agency in charge of deciding each issue with respect to that product or process shall be identified. The Website shall provide the names and telephone numbers of the lead agency officials participating in each review stage. All postings relating to such review processes shall be updated promptly following action at any review stage. Minutes or transcripts of review meetings and copies of related reports and decisional papers shall be posted. All laws pertaining to disclosure of trade secrets and confidential business information shall be observed in connection with posting of information pertaining to specific products or processes.

(e) The Website shall contain the agricultural biotechnology listing in the Unified Agenda.

(f) The Website shall note and describe in detail Federal participation in any agricultural biotechnology research projects. Descriptions of the research projects shall be drafted and posted in close consultation with universities, private industry, or other government research partners, where applicable, to assure accuracy in the description and to avoid public disclosure of trade secrets, confidential business information or other data that would be exempt from public disclosure under the Freedom of Information Act, 5 U.S.C. § 552.

(g) The Coordinating Committee, through the Website staff, shall provide a mechanism for receipt and publication of public comment on the Website. Comments received on the Website generally shall be made available on the Website for public viewing. The public comment mechanism shall provide for collation and summary of all public comments received before they are reposted on the Website.

Sec. 403. Operation of the Federal Agricultural Biotechnology Internet Website.

(a) The Website shall be maintained jointly by staff from the USDA, FDA and EPA. The USDA, FDA and EPA shall provide the funding and administrative support necessary to maintain the Website and to meet the requirements of this order.

(b) Staff administering the Website may utilize expertise of other agencies, as appropriate, including but not limited to those agencies represented on the Coordinating Committee, to obtain and assure technical quality in the Website’s operations.

(c) The Coordinating Committee, through the Website staff, shall ensure that the information posted on the Website comports with the requirements of this order, including Section 901 of this order relating to data quality. In addition to the formal petition process referenced in Section 901, the Coordinating Committee and Website staff should adopt informal procedures to effect prompt correction of clerical or technical errors in posted data that are brought to the attention of the Coordinating Committee or Website staff.

Sec. 501. Establishment of Unified Regulatory Agenda.

(a) The Coordinating Committee shall 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.

(b) The Unified Agenda listing shall include a separate Regulatory Calendar for Biotechnology. The listing shall be designed to provide interested parties with clear information concerning all regulatory events scheduled at USDA, EPA and FDA. The Unified Agenda listing and the Regulatory Calendar for Biotechnology shall contain a schedule of all regulatory actions related to agricultural biotechnology at USDA, EPA and FDA, including: (i) proposed and final rules under consideration; (ii) notices of advisory committee meetings; (iii) notices of public hearings; (iv) Paperwork Reduction Act clearances of forms related to agricultural biotechnology products, policies, or initiatives; and (v) industry guidance under development.

(c) As part of this Regulatory Calendar, the Coordinating Committee shall commit to holding public meetings to discuss agricultural biotechnology regulatory policy and jurisdictional issues at least twice annually.

Sec. 601. Establishment of Interagency Advisory Committee on Agricultural Biotechnology.

(a) The Secretary of Agriculture, the Commissioner of the Food and Drug Administration and the Administrator of the Environmental Protection Agency shall establish an "Interagency Advisory Committee on Agricultural Biotechnology ("FACA Committee"), under the Federal Advisory Committee Act, as amended (5 U.S.C. App.), to provide information and advice for consideration by the Committee.

(b) The Co-Chairpersons of the Coordinating Committee shall, in consultation with other members of the Coordinating Committee, appoint up to 20 members of the advisory committee representing stakeholders including representatives from the farm, biotechnology, food producing, crop production, chemical manufacturing and other businesses, environmental organizations, conservation organizations, the university research community, and other critical sectors. The Co-Chairpersons of the Coordinating Committee shall designate three Co-Chairpersons from among the members of the FACA Committee.

(c) Among other things, the FACA Committee shall provide the Coordinating Committee with an independent assessment of:

(1) the goals established by the Federal agencies for developing and promoting agricultural biotechnology products;

(2) proposed research and development activities in which the federal government is participating;

(3) the effectiveness of programs designed to encourage adoption and use of agricultural biotechnology products; and

(4) the environmental, health, and economic benefits or consequences of agricultural biotechnology products.

(1) plant or animal genetics;

(2) molecular biology;

(3) public health, including clinical dietetics, public health nutrition, epidemiology, clinical medicine, health education, or nutrition education;

(4) nutrition science;

(5) food production and distribution, including agriculture, biotechnology, food engineering, or economics;

(6) ecology and environmental sciences;

(7) veterinary medicine and animal well-being; and/or

(8) bioethics.

(1) To the extent permitted by law and subject to the availability of appropriations, the Department of Agriculture shall serve as the secretariat for, and provide the financial and administrative support to, the FACA Committee.

(2) The heads of agencies shall, to the extent permitted by law, provide to the FACA Committee such information as it may reasonably require for the purpose of carrying out its functions.

(3) The FACA Committee Co-Chairpersons may, from time to time, invite experts to submit information to the FACA Committee and may form subcommittees or working groups within the FACA Committee to review specific issues.

(a) The Coordinating Committee shall design and implement a series of public outreach and educational programs intended to promote public understanding and awareness of current issues in agricultural biotechnology. These programs shall present the best available data on current issues of interest in agricultural biotechnology. Such programs may include, for example, agency presentations to consumer groups, workshops for researchers and public health experts on particular issues of concern, publication of targeted newsletters, and live or electronic public "town meetings" with agency officials.

(b) The Coordinating Committee shall include a statement of progress regarding its public outreach and educational initiatives in the annual report to the President referenced in Section 303 of this order.

Sec. 801. Designation of FDA as Lead Agency for Evaluation of Adverse Health Effects from Agricultural Biotechnological Products.

(a) Consistent with applicable statutes and regulations, the Food and Drug Administration shall have lead authority among all federal agencies, including those represented on the Coordinating Committee, for assessing risks to human health alleged to be associated with exposure to agricultural biotechnological products. Such authority shall include, for example, determinations of whether the product in question constitutes a threat to human health resulting from its: (i) immunotoxicity; (ii) neurotoxicity; (iii) allergenicity; (iv) genotoxicity; (vi) carcinogenicity; or (vii) likelihood of causing or increasing the severity of significant involuntary weight loss, growth impairment, muscular or musculoskeletal disorders, ocular or auditory impairment, cardiovascular disorders, digestive disorders, renal disorders, hematologic disorders, respiratory disorders, arthritis, skin disorders, or adverse endocrine effects, neurological disorders, or dietary disruption or adverse dietary consumption patterns.

(b) If, in fulfilling any statutory duty, any agency reaches a determination contrary to any determination made by FDA pursuant to paragraph (a) of this section, that agency shall supply to the Coordinating Committee a statement explaining the scientific basis for its contrary conclusion. Such statement shall also include a description of the agency’s statutory authority to make its own health effects determination on the matter in question. The agency statement shall be posted on the Federal Agricultural Biotechnology Internet Website.

(c) Within one year from the date of this order, FDA shall issue rules requiring prompt reporting to FDA any of adverse health effect allegedly resulting from exposure to any agricultural biotechnology product(s).

(d) Within one year from the date of this order, FDA shall issue rules requiring any manufacturer of a new agricultural biotechnology product to inform FDA, at least 120 days before such product is introduced into the food supply, of the manufacturer’s intention to market the product. The rules shall require that the manufacturer participate in a mandatory consultation process with FDA before the product is marketed. Such rules shall provide for timely transmittal to FDA of all information within the manufacturer’s possession pertaining to the safety of the product. All product information conveyed to FDA shall be posted on the Federal Agricultural Biotechnology Internet Website, subject to all statutory exemptions from disclosure. Upon completion of the mandatory consultation process, FDA shall issue a letter stating its conclusions regarding the safety and regulatory status of the product.

(e) FDA shall consult with the Department of Health and Human Services in exercising its authority under this section.

Sec. 901. Assurance of Data Quality in Agricultural Biotechnology Regulation.

(a) Pursuant to P.L. 104-18, in implementing this order the Coordinating Committee and all agencies represented thereon shall take necessary measures to ensure and maximize the quality, integrity, objectivity and utility of the data disseminated by Federal agencies. The agencies represented on the Coordinating Committee shall develop, within one year from the date of this order, and with public participation, rules consistent with achieving these goals.

(b) The agency rules referenced in paragraph (a) of this section shall contain administrative mechanisms allowing affected persons to petition for correction of information which does not comply with such rules.

Sec. 1001. General Provisions.

(a) This order is intended only to improve the internal management of the executive branch and is not intended to, nor does it, create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its agencies, its officers or any person. Nothing in this order shall affect or alter the statutory responsibilities of any Federal agency charged with environmental protection, food safety, or other responsibilities related to agricultural biotechnology.

(b) Review of Implementation. The President's Council on Integrity and Efficiency shall request that the Inspectors General periodically review agencies' implementation of this order.

THE WHITE HOUSE,

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