With New Administration, Where Does FSMA Stand Now?

The Food Safety Modernization Act (FSMA) went mostly into effect last fall. Where do things stand now with a new Administration in the White House?

It’s hard to know for certain, in part because the Food and Drug Administration (FDA) which oversees FSMA, is hanging in limbo without a new Commissioner in place. Plus, with all the other issues and policy differences on the front burner right now, food safety has pretty much been pushed into the deep background of White House priorities. For now, the timetable for rollout and compliance remains in effect (see compliance schedule chart).

Yet careful observers should be able to spot some indicators of what might happen in the months ahead.

For one thing, the newly-approved head of the Department of Health and Human Services, former Georgia Rep. Tom Price, is well-known for his strong views against government regulation. HHS oversees the FDA (a relationship often overlooked), and with the new Republican regime hustling to assemble a new federal budget, it would hardly be surprising if FDA’s already slim budget for FSMA enforcement were cut back some more. Reducing the FDA’s budget for inspectors would create obvious enforcement problems. State governments were allocated federal budget dollars to support local inspectors; these funds also might be reduced or eliminated.

For another, while the major chunks of the sweeping new food safety act have been implemented, compliance with the new regulations was postponed for a year last September, except in cases of gross violations by food manufacturers or transporters. Between now and August, FDA is committed to “educating” the industry on the law’s many and complex requirements. As a result, the new Administration simply might extend the compliance deadline even further into the future; in effect, turning FSMA into a voluntary set of guidelines, not federal law backed by severe fines and even imprisonment for violations.

Finally, compliance on the part of small manufacturers was specifically postponed to give them more time to figure out how to cover the costs of the law’s requirements, such as creating a food safety manager at each plant site. Thus, it would be easy for the Administration to either delay compliance by small companies even farther into the future, or to exempt them from FSMA altogether.

The interesting factor in this is the influence of the major manufacturers towards the new law. The big brands who churn out thousands of manufactured food products every day got on board with FSMA early on, figuring that a position opposing food safety standards was a non-starter, but also because most of the companies felt that food safety was, in fact, a growing concern as the global supply chain grew in size and complexity.

Experience has taught manufacturers (and retailers, which aren’t under FSMA) that food contamination outbreaks and widespread product recalls can have a serious negative impact on sales and brand reputation. FSMA’s entire approach to regulation is aimed at preventing outbreaks by instilling a “safety first” mantra at every link in the food supply channel.

All of these factors point to the conclusion that the Food Safety Modernization Act, like many federal regulations enacted during the previous eight years, could face delays in actual compliance. While that may please those who object to government involvement in business, it may distress others in the food industry who see the need for across-the-board standards that promote a safe food production and transportation environment.

 

 

 

 

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FSMA’s Record-Keeping Challenge

 

Of the many new requirements in the Food Safety Modernization Act, one of the most challenging is maintaining detailed records of compliance with the new law.

It’s a requirement that going to be especially difficult for small food manufacturers, those that typically do not operate with large administrative staffs. Even though small businesses (defined as those with less than 500 FTE employees) have until August 30, 2017 to achieve compliance, they still face a challenge: who are they going to tap to manage the array of records FSMA requires?

In fact, industry experts point out, FSMA requires that companies assign a management-level person to handle the record keeping, as well as an internal auditor to insure that the records are accurate and honest.

This will be no small assignment. FSMA’s record keeping regulations will require constant attention, for one thing, because the law says FDA inspectors can ask to review the records on just 24-hour notice. For another, once the August grace period ends and enforcement begins, operators who don’t meet the record keeping requirements could face costly fines.

The Food and Drug Administration (FDA) justifies the records maintenance requirement as being cost-effective in the long run. “We estimate that processed foods covered by this rulemaking are responsible for approximately 903,000 foodborne illnesses each year, at a total cost to the American public of approximately $2.2 billion,” FDA’s economic analysis of the rule explains.

Another wrinkle in FSMA is that the company’s records must be available whenever the FDA comes calling.  “Currently, the FDA only has broad records access in emergency situations when it uses authority granted by the Bioterrorism Act,” explained Maile Gradison Hermida, an Associate with the global law firm Hogan Lovells, in a 2015 Food Online blog post. “However, FSMA gives the FDA this broad records access every day, for routine inspections and without cause. The FDA will review records to assess whether you have the systems in place to make safe food and whether you are always following these programs.”

Through contractors, the FDA is offering training sessions to help companies understand the breadth of what they’ll need to keep track of: from hazard analyses to safety plans to documentation of suppliers and transporters. Still, there are common sense procedures that small and medium-sized manufacturers can implement early in 2017 (if they haven’t already been put in place):

  • Undertake a company-wide audit of existing record-keeping procedures, including how they are stored, who does the compilation, and what data might be located on cloud-based servers;
  • Assemble a FSMA compliance team that includes representatives of senior management (or ownership), operations, IT, accounting, legal and marketing. Its role would be to oversee all aspects of food safety implementation, including record-keeping and tracking. To assure efficiency, someone with the requisite experience in records handling should be designated as the team leader.
  • Invest in new technologies that will ease the record-keeping burden. Manufacturing software that monitors products throughout the manufacturing process should be a top priority. Cloud-based technology will not only provide a cost-effective way to store digital documents, but also offer an array of predictive analytics that can unearth potential production issues and also preempt alarm and failure events.

The enthusiastic buy-in of senior management to place food safety at the pinnacle of production is essential. In a very real sense, FSMA is a risk management tool intended to help companies in food production to protect their brands while maintaining product quality and safety.

Managing risk, after all, is a fundamental necessity for any business. Now, under FSMA, it can be the spur to efficient, profitable – and safe – performance.

 

 

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