Feb. 16, 2016

Lutter: Herding Genetically Engineered Animals to Market

The US Food and Drug Administration’s (FDA’s) recent decision to approve a genetically engineered salmon for human consumption bodes well for people interested in cheaper fish that are rich in omega three fatty acids. The salmon, produced by AquaBounty, is designed to reduce the time and therefore the cost for fish to reach market size. Other genetically engineered (GE) animals could also save resources and help producers, consumers or the environment.  New enviro-pigs have excrement low in phosphorous, which pollutes waterways. GE sows produce more milk, so piglets grow faster. GE cows resist mad cow disease and mastitis, a costly disease requiring treatment with antibiotics. GE chickens developed in the United Kingdom do not transmit bird flu; their use could save millions of infected birds from being culled and reduce the risk of bird flu epidemics leading to new flu epidemics in people. 

These products are not hypothetical—their developers have all publicly reported their existence. Whether or when these or similar products might become available to farmers remains unclear, however. FDA’s salmon decision could signal either a new era of innovative animal biotechnology or continuing stagnation.

The lack of clarity is largely FDA’s doing. It has publicly reported nothing about the number of GE animal products that it has under review and is providing no information about how quickly or slowly it is working to approve or reject those products. In the case of AquaBounty’s newly approved AquaAdvantage salmon, the only GE animal approved for human consumption, FDA took more than 15 years to approve the product. FDA staff reported to an FDA advisory committee five years ago that eating the fish was “as safe as” conventional salmon. FDA needs to manage its program so as to make such delays extremely rare because slow and unpredictable reviews deter investment by eliminating the expectation of timely financial returns.

Slow and unpredictable reviews also conflict with policy goals of the Obama administration. Various executive orders and directives of the White House Office of Management and Budget proclaim that federal regulatory programs should be efficient, as well as transparent. A July 2015 memo from the heads of four White House agencies to FDA and other agencies emphasized “improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products.”

FDA has recently asserted, in response to a request for information under the Freedom of Information Act, that it cannot report the total number of investigational new animal drug (INAD) files using genetic engineering each year, explaining that its regulations prevent it from revealing the existence of “an” INAD. Its position reflects a strained interpretation of the meaning of the word “an.” It is contrary to President Obama’s 2009 directive that agencies adopt a “presumption” of disclosure.

FDA should commit publicly to making the review and approval of GE animal products as quick as other animal drug applications. It should now report the number of new GE animal products that have been submitted to it for review since before FDA’s 2009 decision to regulate GE animals using its animal drug authorities. Specifically, it should report both the number of INAD files for GE animals intended for food use, and notices of claimed investigational exemptions for new animal drugs. As long as FDA reports only sums that exceed some modest minimum, it is difficult to see how such reporting would cause harm to the competitive positions of the developers of those GE animal products. Indeed, FDA routinely provides the number of INADs and new animal drug applications for its entire program, reporting to Congress that its workload included, for example, 247 INADs in 2009, and 198 in 2013. FDA should break down these and similar figures into products related to ag biotech and all other products to give Congress and the public information adequate to judge the performance of its regulatory program for GE animals.

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Professor of Public Policy
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Garrett L052