FDA, USDA Establish Memorandum of
Understanding to Clarify Roles and Responsibilities for Regulation
of Intentional Genomic Alterations in Animals
SILVER
SPRING, Md., May 1, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration took
important steps to advance the FDA's regulatory process for
intentional genomic alterations (IGAs) in animals. The updated
guidance documents underscore the agency's commitment to further
modernize its approach to evaluating and supporting the development
of innovative animal and veterinary products to increase regulatory
flexibility, predictability and efficiency. In addition, the
agency established a memorandum of understanding (MOU)
with the U.S. Department of Agriculture (USDA) to clarify roles and
responsibilities for regulation of IGAs in animals.
"We recognize that innovations in animal
biotechnology offer tremendous opportunities for advancing human
and animal health, and that we as an agency need to keep our
regulatory approach current with the evolution of the science,"
said Tracey Forfa, director of
the FDA's Center for Veterinary Medicine. "These updated
guidance documents demonstrate our commitment to
facilitating innovation while ensuring product safety. These
technologies hold great promise for many uses and public and animal
health benefits, such as animal disease resistance, control of
zoonotic disease transmission, improved animal husbandry, and
increased food production and quality."
IGAs in animals can be made using modern molecular
technologies, which may include random or targeted DNA sequence
changes, including nucleotide insertions, substitutions, or
deletions, or other technologies that introduce specific changes to
the genome of the animal. IGAs in animals have many different
intended uses, including applications in human health (e.g.,
reduced allergenicity; "biopharm" animals that produce substances,
generally in their milk or eggs, for use in the production of human
therapeutics; animals used to model human disease), in improved
animal health, well-being, and husbandry practices (e.g., disease
resistance, heat tolerance), and in enhanced production and food
quality (e.g., faster growth, feed efficiency, nutritional
benefits).
The two documents released today, final Guidance for Industry
(GFI) #187A, "Heritable Intentional Genomic Alterations in Animals:
Risk-Based Approach," and draft revised GFI #187B, "Heritable
Intentional Genomic Alterations in Animals: The Approval Process,"
are intended to help industry understand the existing statutory and
regulatory requirements as they apply to IGAs in animals and to
inform the public about the FDA's process for regulating
them.
The guidance documents align with the goals of the FDA's Animal
and Veterinary Innovation Agenda (AVIA), which aims to foster
development of safe, innovative products and implement smart,
risk-based approaches to regulating modern animal and veterinary
products, while protecting human, animal and environmental
health.
The FDA first issued final guidance on the regulation of certain
IGAs in animals in 2009. In January
2017, due in part to evolution in the science of IGA
technologies, the agency clarified the scope of its guidance
to include animals with intentionally altered genomic DNA developed
through use of genome editing technologies, in updated draft
GFI #187, "Regulation of Intentionally Altered Genomic DNA in
Animals."
Final GFI #187A outlines the FDA's overarching policy for
regulating all IGAs in animals and describes the agency's
risk-based regulatory approach to the oversight of heritable IGAs.
This final GFI also describes how the FDA determines when it is
appropriate to exercise enforcement discretion over certain
products. The types of products that may be appropriate for
enforcement discretion have expanded since the 2017 draft to
include IGAs in food-producing animals, such as SLICK cattle, in
circumstances including where they have been altered to be
equivalent to animals of the same species that already exist and
have a history of safe use. In a complementary document, Draft GFI
#187B, we describe how the FDA approval process applies to
heritable IGAs in animals.
The FDA is committed to collaborating with its regulatory
partners across the federal government to ensure that approved IGAs
are safe for the animal, safe for people, and that the product does
what it claims to do. On April 18,
2024, the FDA and USDA signed an MOU that
applies to the FDA's activities involving IGAs in animals that are
also subject to certain USDA authorities. The MOU establishes
policies and procedures to enhance the exchange of information
between the agencies, describes the regulatory roles of the
agencies, and promotes coordination of regulatory responsibilities
in a manner that will enable an efficient, seamless regulatory
process. It does not change or add regulatory requirements for
developers. Additional details can be found here.
The FDA encourages developers of IGAs in animals to approach the
agency early in their research and development phase to
discuss the specific risk profile of the proposed product and the
appropriate pathway for commercialization. For products that
qualify, the agency recommends participation in the Veterinary
Innovation Program (VIP), which is intended to assist
developers of innovative veterinary products, including certain
IGAs in animals, by providing intensive technical and programmatic
assistance throughout the approval process in order to make it as
efficient as possible.
The FDA will continue to work with its domestic and global
partners as the agency implements an appropriate, risk-based
regulatory approach based on sound science that facilitates the
development of safe innovative products and ensures consumer
confidence. This action also aligns with the goals of Executive
Order 14081, Advancing Biotechnology and Biomanufacturing
Innovation for a Sustainable, Safe, and Secure American
Bioeconomy.
The agency is requesting public comment on GFI #187B
for 90 days starting on May 2, 2024.
To ensure the FDA considers comments before it begins work on the
final version of GFI #187B, members of the public should submit
comments by July 31,
2024.
Additional Information:
- Intentional Genomic Alterations (IGAs) in Animals
- Q&A for Consumers on Intentional Genomic Alterations in
Animals
- GFI 187A - Heritable Intentional Genomic Alterations in
Animals: Risk-Based Approach
- GFI 187B - Heritable Intentional
Genomic Alterations in Animals: The Approval Process
- MOU between FDA and USDA
- FDA Supports Innovation in Animal Biotechnology, Veterinary
Products, Food for Animals Through New Comprehensive
Agenda
Media Contact: Veronika
Pfaeffle, 310-301-2576
Veterinary and Consumer Inquiries: AskCVM@fda.hhs.gov,
800-835-4709
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration