BIO Comments on USDA Rulemaking on Animal Biotechnology
February 26, 2021
The Biotechnology Innovation Organization (BIO) submits these comments in response to the U.S. Department of Agriculture’s (USDA’s) advance notice of proposed rulemaking and request for public comment on a proposed framework for oversight of certain animals modified or developed through genetic engineering. In particular, USDA proposes a new regulatory framework for amenable species intended for agricultural use, to be administered jointly by USDA’s Animal and Plant Health Inspection Service (APHIS) and the Food Safety Inspection Service (FSIS).
The use of biotechnology to improve the genetics of animals used in agriculture has the potential to address a broad array of important societal issues—improvements in animal health and welfare; improved human health and nutrition; responding effectively to zoonotic disease; adaptation to climate change; and increasing the sustainability of animal agricultural production. The success of these innovations is critically dependent on regulatory systems that ensure animal health and welfare, food safety, and protection of the environment, but does so in a way that does not disincentivize development and commercialization of innovation. Without an efficient and effective system for oversight of animal biotechnology, the U.S. risks its leadership role in utilizing important, cutting-edge tools to address these critical societal challenges.
The U.S. Food and Drug Administration (FDA) currently regulates the safety of animals containing “intentional genomic alterations” utilizing the new animal drug authority of the Federal Food, Drug, and Cosmetics Act (FFDCA), as described in draft “Guidance for Industry #187” (GFI 187).2 For reasons discussed in more detail below, BIO has long expressed concern over FDA’s approach to oversight of animal biotechnology, the implementation of which is having real and immediate impacts on our members and the U.S.’s ability to remain the leader in animal biotechnology. We appreciate USDA’s leadership in proposing an alternative approach to oversight of biotechnology in animals intended to address some of the concerns expressed by BIO and other animal biotechnology stakeholders. We remain committed to continuing to work collaboratively with USDA, FDA, and other Executive Branch offices on the urgent need to develop a regulatory system for products of animal biotechnology that continues to ensure the safety of the animals, consumers, and the environment while fostering innovation and expedited commercialization of beneficial improvements to agricultural animals.
Our comments are organized into the following sections: 1) outline of general “good governance” principles for effective regulatory oversight, with an outline of BIO’s policy goals for oversight of animal biotechnology; 2) critical review of FDA’s current system of oversight; 3) comments on the regulatory framework proposed by USDA; and 4) issues to consider related to the transition of
oversight from FDA to USDA.
For clarification, our comments herein relating to USDA’s proposal are limited to those specific applications of animal biotechnology intended for agricultural use. Our comments on that proposal should not be interpreted to suggest that USDA adopt oversight of non-agricultural, non-food applications of biotechnology in animals (e.g., ornamental fish, pharmaceutical production, models of
human disease, xenotransplantation) or animal species other than those proposed to be subject to USDA jurisdiction under the proposed framework.
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The Biotechnology Innovation Organization (BIO) submits these comments in response to the U.S. Department of Agriculture’s (USDA’s) advance notice of proposed rulemaking and request for public comment on a proposed framework for oversight of certain animals modified or developed through genetic engineering. In particular, USDA proposes a new regulatory framework for amenable species intended for agricultural use, to be administered jointly by USDA’s Animal and Plant Health Inspection Service (APHIS) and the Food Safety Inspection Service (FSIS).
The use of biotechnology to improve the genetics of animals used in agriculture has the potential to address a broad array of important societal issues—improvements in animal health and welfare; improved human health and nutrition; responding effectively to zoonotic disease; adaptation to climate change; and increasing the sustainability of animal agricultural production. The success of these innovations is critically dependent on regulatory systems that ensure animal health and welfare, food safety, and protection of the environment, but does so in a way that does not disincentivize development and commercialization of innovation. Without an efficient and effective system for oversight of animal biotechnology, the U.S. risks its leadership role in utilizing important, cutting-edge tools to address these critical societal challenges.
The U.S. Food and Drug Administration (FDA) currently regulates the safety of animals containing “intentional genomic alterations” utilizing the new animal drug authority of the Federal Food, Drug, and Cosmetics Act (FFDCA), as described in draft “Guidance for Industry #187” (GFI 187).2 For reasons discussed in more detail below, BIO has long expressed concern over FDA’s approach to oversight of animal biotechnology, the implementation of which is having real and immediate impacts on our members and the U.S.’s ability to remain the leader in animal biotechnology. We appreciate USDA’s leadership in proposing an alternative approach to oversight of biotechnology in animals intended to address some of the concerns expressed by BIO and other animal biotechnology stakeholders. We remain committed to continuing to work collaboratively with USDA, FDA, and other Executive Branch offices on the urgent need to develop a regulatory system for products of animal biotechnology that continues to ensure the safety of the animals, consumers, and the environment while fostering innovation and expedited commercialization of beneficial improvements to agricultural animals.
Our comments are organized into the following sections: 1) outline of general “good governance” principles for effective regulatory oversight, with an outline of BIO’s policy goals for oversight of animal biotechnology; 2) critical review of FDA’s current system of oversight; 3) comments on the regulatory framework proposed by USDA; and 4) issues to consider related to the transition of
oversight from FDA to USDA.
For clarification, our comments herein relating to USDA’s proposal are limited to those specific applications of animal biotechnology intended for agricultural use. Our comments on that proposal should not be interpreted to suggest that USDA adopt oversight of non-agricultural, non-food applications of biotechnology in animals (e.g., ornamental fish, pharmaceutical production, models of
human disease, xenotransplantation) or animal species other than those proposed to be subject to USDA jurisdiction under the proposed framework.