What constitutes “critical habitat” for a species federally listed as threatened or endangered? And what exactly does “healthy” mean when it’s used on food packaging?

Those are two of the more important regulatory issues the ag and food industries will be monitoring in the coming year as the Biden administration both unspools changes made during the Trump administration and continues to work on longstanding priorities.

The Trump administration issued a definition of “habitat” under the Endangered Species Act where one did not previously exist. Instead, the law has long required that FWS and NMFS designate critical habitat for listed species, a task fraught with controversy because private property owners such as farmers and ranchers become concerned when maps appear that include their operations. The prohibition on destruction or adverse modification of critical habitat kicks in when there is a “federal nexus” such as project funding or authorization.

The Biden administration has proposed rescinding both the habitat definition and another proposal that would have allowed for the exclusion from critical habitat of areas when “credible information” of economic impacts is provided.

That standard is “vague and does not accomplish the stated goal of improving transparency about what information will or will not trigger an exclusion analysis, potentially resulting in inefficiencies and wasting the service's limited resources,” FWS said in its Oct. 27 proposal.

Livestock groups are closely watching the process. The Public Lands Council, National Cattlemen’s Beef Association, American Sheep Industry Association and about 30 other such groups submitted comments.

“It is clear the service must consider economic impacts, among other impacts, during a proposed designation, and the producers we represent are uniquely positioned to provide substantive and compelling information of that nature for the service’s consideration,” the groups said.

In proposing to rescind the Trump-era critical habitat rule, FWS also said it did not agree that areas must be excluded from designation whenever the costs exceed the benefits, so long as it will not result in a species’ extinction. Instead, FWS said it should retain discretion to make those decisions on excluded areas.

FDA, meanwhile, is deciding when manufacturers can label products as "healthy," which is now done for about 5% of all packaged foods.

The proposal, which FDA has been working on since 2016, should be out sometime in 2022. In a summary of its regulatory priorities for fiscal 2022, which ends Sept. 30, the Department of Health and Human Services said FDA’s proposed rule “would update the definition for the implied nutrient content claim ‘healthy’ to be consistent with current nutrition science and federal dietary guidelines. This would ensure that foods labeled ‘healthy’ can help consumers build more healthful diets to help reduce their risk of diet-related chronic disease.”

FDA also began last year to gather information to develop a symbol that can be used by industry to identify healthy products.

Other regulatory developments to watch for in 2022 from the Interior Department and FDA:

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The Bureau of Land Management is working on a broad rewrite of grazing regulations “to update, modernize and streamline the grazing administration regulations and provide additional flexibility for land and resource management,” according to the agency. BLM has “received over 1,500 unique comments and is in the process of identifying issues for analysis and developing alternatives” for a draft environmental impact statement.

FWS and the National Marine Fisheries Service plan to issue a revised policy for determining what constitutes a “significant portion” of a species’ range under the ESA. The interpretation is critical in deciding whether a species should be listed as threatened or endangered. The latest regulatory agenda, issued in December, lists July 2022 as a possible issuance date for the proposed policy, but the timetables in regulatory agendas don’t necessarily correlate to the real world.

FDA has proposed, and will be considering comments on, dropping requirements under the Food Safety Modernization Act that produce growers use microbial testing requirements for water used on their crops. The comment period ends April 5.

FDA plans to issue a proposal establishing “general principles” for modernizing and updating the framework for food standards, including standards of identity, standards of quality, and standards of fill of containers. FDA and USDA’s Food Safety and Inspection Service jointly issued a proposed rule in 2005, but FDA reopened the comment period in 2020 because so much time had elapsed.

FDA has been mulling a revocation of a health claim that consumption of soy protein can help reduce the risk of coronary heart disease. The proposal appeared in late 2017 and received more than 1,000 comments. FDA says in its latest regulatory agenda that a final rule will be forthcoming in September.

“Numerous scientific studies published before and after the soy protein health claim was approved in 1999 show that soy protein lowers LDL-cholesterol and the totality of the evidence supports continued approval of an unqualified health claim,” the American Soybean Association said in comments submitted nearly four years ago.

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