Ukrainian Law Blog: Storms and stability ahead for food safety efforts in 2017

Food safety in 2017 will be dependent on our “complicated bureaucracies” that exist to get through transitions and times of change. Both USDA’s Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) are sure to be taking many “business as usual” actions in January.

Confucius taught the Ancient Chinese bureaucracies that rituals were important for times when politics and maintaining relationships were important. The lesson has not been lost on the modern era.

USDA’s Food Safety Inspection Service

Just before the New Year, FSIS came out with a new five-year plan, setting “broad goals” for increased inspections, toughen food safety regulations and expanded processes for evaluating imported meat, poultry and egg products.

The $1 billion agency with 10,000 employees — more than 7,500 of them working as inspectors in the nation’s meat, poultry and egg businesses — is betting on action as the best way to meet the new administration in Washington D.C.

Specific to food safety, the FSIS plan promises to expand “the breadth, depth and frequency of its sampling” to “better address gaps in testing for pathogens and chemical residues” in the products it regulates include meat, poultry and eggs.

In “unifying testing,” FSIS plans to collect a single sample from each product with tests for multiple microbiological hazards or chemical residues. The agency plans to use new genetics-based testing technologies, just as FDA has done.

In addition to the stepped up agenda for food safety, especially as it relates to recalls and traceability, FSIS also plans additional emphasis on humane handling. This will include action on how animals are handled, restrained and stunned.

Al Almanza, the career civil servant who has run the agency for the past decade, remains in charge as FSIS administrator. He’s waiting for the Senate to confirm the President-elect’s nominee for his new boss, the Secretary of Agriculture.

Federal law calls for Trump to appoint an Under Secretary for Food Safety, an office that’s been vacant for three years. During the time there’s been no under secretary, Almanza was one of two deputy under secretaries, while he worked as acting FSIS administrator. On Jan. 20, he apparently drops the deputy under secretary and “acting” titles, and again takes up the administrator title he has held on and off since 2007.

Food and Drug Administration

While FSIS will be taking predictable actions under stable leadership, the same cannot really be said for its major food safety partner, the U.S. Food and Drug Administration, which is responsible for watching out for about 80 percent of the food sold in the United States.

Political storm clouds are building up over the agency that regulates products worth more than $1 trillion, or 25 cents out of every dollar spent by consumers on food, drugs, vaccines, medical devices, animal feed and animal drugs.

FDA Commissioner Robert Califf is not likely to see his first anniversary on the job. A top cardiologist, Califf is reportedly willing to serve in the new administration, but it is not likely. FDA’s Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff has only been on the job since June. It remains to be seen if he will survive what could be a housecleaning.

Troubles at FDA are coming from the side of the house involved with drug and medical device approvals. Unlike food and dietary supplements, drugs and medical devices require FDA’s affirmative approval before they can be marketed.

The FDA, say the critics, no longer merely rules on safety, but now considers new drugs based on their effect and even the demand that might exist in the marketplace. That’s brought FDA a mix of criticisms ranging from those who finance drug development to patients and their families waiting for approvals.

Many believe President-elect Trump will name an FDA commissioner who is sympathetic to those concerns.

While the potential shakeup looms, the food side of the FDA house does know what it is supposed to be doing. The agency will be enforcing the Food Safety Modernization Act (FSMA) as more compliance dates are reached under the new rules.

The whole purpose of the FSMA — to prevent foodborne illnesses instead of just responding to outbreaks — will be put to the test for the first time. If Ostroff remains in charge of food safety, he will probably have to deal with some push-back from the industry about FSMA enforcement activities. FDA’s tardy answers to some specific questions, especially about the FSMA produce rule, has already upset growers who by spring will be demanding specific answers to compliance and enforcement questions.

Also for all of FDA, rulemaking will now come under the thumb of Rep. Mike Mulvaney, R-SC, who Trump has named as the new director of the Executive Office of Management and Budget (OMB). The OMB must approve all rules and regulations. Mulvaney, who helped found the House Freedom Caucus, sees regulation mostly as a burden on the economy, which comes at the expense of jobs.

One measure of rules and regulation is the production of pages in the Federal Register, which is required to hold them all. Friday was the last day of the year for the publication, which reported a record-setting 97,110 pages to hold everything produced in 2016.

One of those was the Dec. 27 announcement by FDA to extend to April 26, 2017, the comment period for the use of the word “healthy” in labeling human food products. It originally called for comments this past Sept. 28.

“In the notice, we requested comments on the term ‘healthy,’ generally, and as a nutrient content claim in the context of food labeling, we also requested comments on the specific questions contained int he notice,” the FDA’s Federal Register notice about the comment period said.

FDA is also accepting confidential comments on the issue. The comment period was to have ended on Jan. 26.

Congress
Just as the agencies will continue to do what they do, Congress will begin work on a new farm bill. The leadership of the agricultural committees apparently want to get an early start by getting underway in early 2017.

One might think there is plenty of time as the shelf life for the 2014 farm bill does not end until Sept. 30, 2018. However, the last two farm bills came together late and thus the committees called for an early start.

One debate will be whether nutrition programs like the food stamp program now called SNAP, should even be included in the farm bill. The conservative think tank, the Heritage Foundation, favors pulling nutrition programs from the farm bill, and the House Agriculture Committee is studying the issue.

Next to the farm bill, look for congressional action to limit or overturn changes the exiting Obama administration put forward in the obscure Grain Inspection, Packers and Stockyards Act (GIPSA) rules. The National Pork Producers Council called the last minute action “an apparent attack on rural America for its role in helping elect Donald Trump as President.”

The new rules would give USDA more power to punish companies involved in GIPSA contract disputes and open disputes to more litigation possibilities.

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