KANSAS CITY, MISSOURI, U.S. — Legal experts recommend food companies prepare early for the new regulations that have been proposed under the U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act.
The FDA’s proposed rule on “Current good manufacturing practice and hazard analysis and risk-based preventative controls for human food,” issued Jan. 4, would require food processors to develop a written food safety plan, including a hazard analysis, preventative controls, monitoring procedures, corrective action procedures, verification procedures and a recall plan.
“FDA has set a high bar with this proposed rule,” said Joe Levitt, a partner with Hogan Lovells and former director of the FDA’s Center for Food Safety and Applied Nutrition. “Although food companies will be allowed to determine their own food safety steps needed in their own circumstances, the FDA has included expectations of rigor and oversight at each step of the process. Food companies will need to be fully prepared.”
The proposal is open for public comment in the Federal Register until May 16, but Levitt said food manufacturers should now begin reviewing food safety plans, environmental testing programs and oversight of suppliers, as well as upgrade recordkeeping practices.
“It would be a mistake to wait until the last minute,” he said.
David Acheson, a partner in the law firm Leavitt Partners and former FDA associate commissioner for foods, said he doesn’t anticipate fundamental changes to the proposed regulations, only clarifications around criteria such as environmental testing programs and supply chain controls.
“I don’t think a lot of substance to this will change,” Acheson said. “I recommend that companies start right now. For some, it’s going to be a heavy lift. As soon as they get their head around the rules and understand where they might have gaps, they are just going to be in a better place.”
Under the proposed rule, all records related to the manufacturing process, including hazard analyses, food safety plans, monitoring records, corrective actions and verification steps, will be subject to FDA inspection, posing a potential challenge for some companies, Levitt noted.
“In the past, FDA inspections were focused on what the company was doing that day – what the FDA inspector was actually able to observe,” he said. “Under the new rules, FDA inspectors will be able to scrutinize not just what the company is doing that day, but what was also done the previous week, the previous month and even the previous year.”
Costs associated with compliance may present another hurdle, particularly for small processors, Acheson said.
“I think it will have an economic impact on businesses,” Acheson said. “It may drive consolidation to some extent.”
For these reasons, some businesses may resist implementing the new standards.
“I hear a recurring theme of, ‘Everyone knows the FDA has limited resources and a limited capacity to enforce this,’ and some in the industry think, ‘Why should I bother? They won’t show up,’” Acheson said. “My view is that much of this rule is based on good practices — not just to be compliant with the law, but to put your business in a good place so you avoid making people sick and thus damaging the brand.”
The proposed rule includes a staggered compliance date based on company size. Large companies would need to comply within a year from publication of the final regulation. Small companies of 500 employees or fewer would have two years to comply, and very small companies would have three years.
“FDA provides this time because the agency knows this will be real work for companies to come into compliance,” Levitt said. “That is why it is not too early to start preparing now.”
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