Food safety regulation
"The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperature and even what animals can roam which fields and when," Trump said.
WASHINGTON, D.C., U.S. — Forecasting the direction of food safety policy and enforcement may be difficult in the wake of any general election. The incoming administration will select its own team, and this team may bring new visions and perspectives to federal agencies and offices. Priorities may differ from those that informed the previous administration’s focus and approach to regulatory affairs. This certainly may prove to be the case as the nation prepares for possibly wide departures from recent practice when Donald J. Trump is inaugurated as the 45th President of the United States on Jan. 20, 2017.

As of this writing, there are things known and things unknown about the direction of food safety policy and enforcement in 2017.

It is known President-elect Trump has been critical about what he asserted was federal regulatory overreach under the Obama administration, including by the Food and Drug Administration.

In a speech before the Economic Club of New York in September, Trump said, “The FDA food police, which dictates how the federal government expects farmers to produce fruits and vegetables, even dictates the nutritional value of dog food. The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperature and even what animals can roam which fields and when. It also greatly increased inspections of food ‘facilities’ and levies new taxes to pay for this inspection overkill.”

Also known is Trump’s choice to head the U.S. Department of Health and Human Services, to which the FDA reports, Representative Tom Price of Georgia. Price is an orthopedic surgeon and a critic of the Affordable Care Act, or Obamacare. But as of this writing, Trump had yet to announce his choices to head the FDA and the U.S. Department of Agriculture, the lead agencies with responsibility for food safety.

It was unknown how much the skeptical attitude toward “regulatory overreach” of the incoming administration may affect how food safety law as embodied in the FDA Food Safety Modernization Act will be managed and enforced now that the FDA has issued its congressionally mandated final rules and the act is in the process of being implemented. Regardless, food industry sources and analysts said it remained essential for the entire food chain to ensure their operations are in compliance with the FSMA and its implementing rules.

The Grocery Manufacturers Association said, “We have worked collaboratively with FDA throughout the development of these final rules. We are confident that our members have made where necessary the proper adjustments in their manufacturing processes to be compliant with the new regulations. We also look forward to working with the agency in an inclusive and deliberative manner as additional FSMA rules are implemented in 2017.”

David Acheson, president and chief executive officer, The Acheson Group, said he expected the FSMA and its implementing rules to comprise the food safety regulatory framework in the many years ahead.  Acheson pointed to the broad support the act had in Congress, in the food industry and among consumers.

“2017 will be when we begin to see FSMA implementation bite on large businesses,” Acheson said. “I think this will go slowly at first with a focus on specific areas, such as ‘environmental monitoring program’ and ‘supply chain control.’”

At the same time, the Trump administration may view how the FDA should enforce the act and its rules differently from how the Obama administration has or a Clinton administration might have, Acheson said. That will become clear over time.

Under the Obama administration, the U.S. Department of Justice has adopted a robust approach with regard to enforcement of food recall procedure. It was uncertain to what extent this approach may be retained in the coming years.

As to how the industry was adjusting to the current DOJ approach, Acheson said many companies to an extent still seemed to have “their heads in the sand.” Acheson added, “Most don’t understand their extreme vulnerability to DOJ actions and focus if their brand is linked to an outbreak and they have not followed good practices to control risk. Maybe under Trump, this will back off some.”

Asked what other recent trends in FDA’s food safety approach may be extended into 2017, Acheson said he expected the use by the FDA of whole genome sequencing in investigating food safety issues will continue to accelerate.

The use of whole genome sequencing by both the FDA and food companies has vastly improved the detection and identification of foodborne pathogens, their origins and spread, and enabled response to related disease outbreaks to be more prompt, targeted and effective. The technology has been employed in several recent high-profile and complicated food recalls and, indeed, has resulted in a marked increase in overall recalls.

“The key point is, if you make ready-to-eat (food), watch out,” Acheson advised. “FDA, the Centers for Disease Control and Prevention and increasingly the Food Safety and Inspection Service are looking at whole genomic sequencing as a tool to shut down issues before they lead to an outbreak or even a single case of illness.”

A priority for the food industry in 2017 will be to secure the harmonization of compliance dates for implementing the FDA’s Nutrition Facts Panel updates and the USDA’s disclosure standard for bioengineered foods, the GMA said.

Food manufacturers, except for small businesses, must comply with the FDA’s mandatory revisions to the Nutrition Facts Panel by July 26, 2018. Additionally, Congress has mandated the USDA to issue the final disclosure standard for bioengineered food by July 29, 2018.

The food industry associations pointed to the time and cost that would be expended in undertaking not one but two major revisions to product labeling in a short period. Additionally, the associations asserted if there was a single compliance date for both required label changes, “consumers will be introduced to a single label format instead of potentially being exposed over several years to different versions of the same label at the same time.”

Acheson suggested there was some doubt over the future of menu nutrition labeling under the incoming administration. Menu nutrition labeling was required under the Affordable Care Act, which President-elect Trump has vowed to repeal and replace. Menu labeling has been postponed a couple of times, and compliance now is required by May 5.