FDA, USDA still at odds regarding livestock gene-editing

In public comments earlier this week, the current Food and Drug Administration Commissioner Dr. Stephen Hahn says he would refuse to sign the memorandum of understanding between the FDA and USDA addressing gene-edited livestock shifting oversight to USDA. The statement again reveals the ongoing turf war between the two agencies and likely continued discussion as it moves to President-elect Biden’s administration.

On Monday evening, reports indicated Hahn told Health and Human Services officials that he would refuse to sign a memorandum of understanding transferring regulatory power to USDA citing “concerns about its legality and the potential health repercussions of relaxing oversight of certain genetically altered products,” Politico reports.

In an advanced notice of proposed rulemaking, the Trump administration announced Dec. 21 its intention for USDA to have primary oversight over gene-edited livestock. Gene editing is used to make specific changes within an animal’s own genome. Gene editing will allow the production of animals that are more disease-resistant, require fewer antibiotics and with a smaller environmental footprint. Notwithstanding its significant promise, U.S. agriculture had been in a holding pattern, as USDA and FDA were locked in a regulatory tug of war over authority on gene editing in livestock. FDA has treated genomic modifications as drugs and created significant roadblocks for U.S. companies looking to blaze a path for future disease-resistant and nutritionally enhanced livestock species.

Meanwhile, China, Brazil, Canada and other global competitors moved ahead in the race to pursue this technology.

USDA’s advanced notice of proposed rulemaking will transition portions of FDA’s pre-existing animal biotechnology regulatory oversight to USDA. USDA will consult with FDA to ensure its reviews benefit from FDA’s expertise, while providing developers with a one-stop-shop for their products.

Related: USDA looks to end FDA turf war on gene-editing livestock oversight

“The USDA has put forward an open and transparent process to establish regulatory certainty surrounding a promising technology,” says National Pork Producers Council President Howard “A.V.” Roth, a hog farmer from Wauzeka, Wisc. “We are disappointed that the FDA continues to engage in delay tactics that are holding back U.S. agriculture. U.S. pork producers are dedicated to rigorous, science-based policies to ensure food safety for all consumers.”

The USDA’s Animal and Plant Health Inspection Service already has a review process in place for gene editing in plants, which can serve as a model for livestock, NPPC says.

Whenever new technologies are introduced, consumer acceptance is critical. The U.S. pork industry says it is committed to transparency when using this technology in the future; there are currently no gene-edited pigs entering the food supply. The focus now is on establishing a regulatory framework that will not stifle innovation and drive use of this breakthrough technology overseas.

“FDA regulation will result in an impractical, lengthy and expensive approval process,” adds Roth. “U.S. agriculture can’t continue to be sidelined while our competitors move ahead with this critical technology. USDA needs to be in the driver’s seat on gene-edited livestock, and we look forward to working with the Biden administration on its implementation.”

Karen Batra, managing director of communications at BIO, says USDA’s jurisdiction in gene-editing livestock has been a “priority for the biotechnology industry and should be for the country to drive USDA investment in animal innovation and biotechnology.” She adds that in order to maintain United States’ leadership in animal biotechnology innovation, it needs to be addressed.

She recognizes often these rulemaking efforts take time and over multiple administrations, but appreciated the final push by Secretary of Agriculture Sonny Perdue. Meanwhile, likely incoming Secretary of Agriculture Tom Vilsack hails from an important pork producing state and he’s always been pro-innovation.

Comments on USDA’s proposal

In in comments submitted Wednesday to USDA, NPPC says jurisdiction under USDA will “foster innovation, allow for producer access to this technology, and preserve the preeminence of American agriculture globally,”

“…[M]any of our competitor nations have or are moving towards common sense, risk-based regulatory models that capture all agricultural applications and that offer clear pathways to commercialization….Even the European Union, long viewed as a bastion against agricultural innovation, is having meaningful discussion about accessing the benefits of gene editing. This is already placing U.S. livestock and poultry producers at a disadvantage,” NPPC wrote. “This disadvantage will be more acute if these countries approve the significant gene edits that we know are on the horizon long before the U.S. is able to do so. We simply cannot allow U.S. farmers and ranchers to lack the same animal health and food safety advantages as producers in other countries,” NPPC adds.

Alison Van Eenennaam, extension specialist in animal biotechnology and genomics at the University of California-Davis department of animal science, has seen her research significantly stalled because of FDA’s long-time frame and approach to regulating animal biotechnology.

Van Eenennaam says this is a definite improvement over FDA’s approach. That being so, she also pointed out in her blogs that there are some logical inconsistencies in the proposal as it currently stands.

In contemplating an improved regulatory approach for genetically modified animals, Van Eenennaam suggests it is time to ditch the process-based trigger requiring additional regulatory scrutiny of plants and animals that could have been achieved using conventional breeding, and rather take the advice of the 1996 Coordinated Framework. The framework states that regulatory review should be confined to organisms deliberately formed to contain an intergeneric combination of genetic material from sources in different genera (aka foreign or transgenic DNA that could plausibly produce a toxin or an allergen), and that oversight should be exercised only where the risk posed by the introduction is unreasonable, that is, when the value of the reduction in risk obtained by additional regulatory oversight is greater than the cost thereby imposed.

The bottom line is that as long as animals produced using genetic engineering, even those that could have been produced using conventional breeding, are subjected to unique regulatory scrutiny not required of identical products produced using conventional breeding, research in food animals using genetic engineering for agricultural applications will be cost-prohibitive in the U.S., Van Eenennaam says.

There is a 60 day public comment period that closes Feb. 26. Comments can be posted Federal eRulemaking Portal: Go to www.regulations.gov/​#!docketDetail;​D=​APHIS-2020-0079. Supporting documents and any comments that are received on this Advance Notice of Proposed Rulemaking may be viewed at www.regulations.gov/​#!docketDetail;​D=​APHIS-2020-0079

Source: Jacqui Fatka, Policy Editor Farm Futures