FDA Clarifies Approach to Gene-Editing Alterations in Animals

The following report is a blog post by the Food and Drug Administration (FDA) on May 1st:

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.

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.

said Tracey Forfa, director of the FDA’s Center for Veterinary Medicine.

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 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.  

Read the full report here.

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AUTHOR COMMENTARY

I mention this because, as I have noted across a growing number of reports, a new era of gene-spliced animals and crops are the wave moving forward, which allows these mad scientists to radically change the genetic properties of these animals and foods to do all sorts of things. Unsurprisingly, there is zero evidence and studies that show the effects on the animals and crops, the environment, and the people who consume them. Those belated “studies” will only be allowed to be conducted and discussed until after a raft of people become sick and die. SEE: FDA Releases Guidance On Gene-Edited Crops For Food

The FDA has already approved some gene-edited meat before this latest shift in regulations.

SEE: FDA Approves Gene-Edited CRISPR Pigs Made Into German Sausages, ‘Safe For Human Consumption’

FDA Approves Second Lab-Grown Meat Product, Safe For Human Consumption

Proverbs 24:21 My son, fear thou the LORD and the king: and meddle not with them that are given to change: [22] For their calamity shall rise suddenly; and who knoweth the ruin of them both?

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[7] Who goeth a warfare any time at his own charges? who planteth a vineyard, and eateth not of the fruit thereof? or who feedeth a flock, and eateth not of the milk of the flock? [8] Say I these things as a man? or saith not the law the same also? [9] For it is written in the law of Moses, Thou shalt not muzzle the mouth of the ox that treadeth out the corn. Doth God take care for oxen? [10] Or saith he it altogether for our sakes? For our sakes, no doubt, this is written: that he that ploweth should plow in hope; and that he that thresheth in hope should be partaker of his hope. (1 Corinthians 9:7-10).

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