Sec. 11610. Report on agricultural innovation
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Not later than 180 days after the date of the enactment of this Act, the Secretary of Agriculture, in consultation with the Administrator of the Environmental Protection Agency and the Commissioner of the Food and Drug Administration, shall prepare and submit a report to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate on plans for improving the Federal government’s policies and procedures with respect to gene editing and other precision plant breeding methods. The report under subsection
(a)shall include plans to implement measures designed to ensure that— the United States continues to provide a favorable environment for research and development in precision plant breeding innovation and maintains its leadership with respect to that innovation; for plants for which premarket review is required under the Plant Protection Act ( 7 U.S.C. 7701 et seq.), the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U.S.C. 136 ), or the Federal Food, Drug, and Cosmetic Act, the process for such review is designed— to minimize regulatory burden while assuring protection of public health and welfare; and to ensure that resources of the Department of Agriculture are focused on plants with less familiar characteristics, more complex risk pathways, or both; each agency referred to in subsection
(a)recognizes that certain applications of gene editing in plants do not warrant such a premarket review process; each agency referred to in subsection
(a)clearly communicates the rationale for the regulatory policies and decisions of such agency to the public through broadly available and easily accessible tools; categories of plants that are familiar and have a history of safe use be identified and exempted from such premarket review or be subject to an expedited, independent premarket review process for which data requirements are reduced; regulatory processes of each agency referred to in subsection
(a)are predictable, efficient, not duplicative, and designed to accommodate rapid advances in plant breeding technology; and where Federal law provides for regulatory oversight of plant breeding technology by more than one Federal agency, the relevant Federal agencies enter into appropriate interagency agreements to shift responsibility for particular categories of plant products and regulatory activities for purposes of meeting the goals specified in paragraphs
(1)through (6).
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