Time needed to see FSMA rule effects - Hogan Lovells

The US Food and Drug Administration (FDA) issued three final rules under FSMA last month.

They are the Produce Safety rule, the Foreign Supplier Verification Programs (FSVP) rule, and the Accredited Third-Party Certification rule.

The rules were welcomed by the majority​ but not all reacted positively​.

Phased-in schedule​

Joe Levitt, a partner at law firm Hogan Lovells, said compliance dates for the rules have a phased-in schedule, depending on rule complexity and the size of the company affected.

“Most of the rules become effective over a one to three year time period, based on the date of publication. Smaller businesses are given more time to comply than larger ones,” ​he told FoodQualityNews. ​

“Reducing foodborne illness will occur over time, but it is a matter of years, not months. In the short term, recalls may actually increase due to greater vigilance by companies and government regulators. ​

“That is actually a good thing, because a product recall means less people get sick than if the problem went undetected.”​

There are seven final rules under FSMA. 

Two were published in September (Preventive Controls for Human Food and Preventive Controls for Animal Food), three more in November (Foreign Supplier Verification Program, Third Party Accreditation, and Fresh Produce Safety) and the final two are scheduled for spring (Sanitary Transportation of Food in April 2016 and Food Defense in June 2016).

Regulations move the government closer to implementing a law passed by Congress in 2010, which marked the biggest overhaul of federal food-safety oversight in 70 years.

The former director of the FDA’s Center for Food Safety and Applied Nutrition said the new rules on fresh produce will likely have a significant effect, but it will take a number of years to see those effects.

Levitt served as director of FDA's Center for Food Safety and Applied Nutrition (CFSAN) from February 1998 through December 2003.

“This is the first time this segment of the food industry has been subject to mandatory Federal food safety requirements, so it will take time for them to take hold, but it is reasonable to expect significant public health benefits over the long term,” ​he said.

“For the packaged food industry, FSMA codified many leading industry practices based on modern food safety principles, so the effect on this segment will be largely of a fine-tuning nature.​

“​For medium and smaller sized companies that may have to make more significant changes, FDA has given them a longer period in which to comply so as to moderate the financial impact.” ​

Asked about the move from ‘reactive’ to ‘preventative’, Levitt said it is like medicine – it is better to vaccinate a person to prevent them from getting sick, than to treat that person after they get sick. 

“Under FSMA, the emphasis is on instituting proven methods to prevent harmful bacteria from getting into the food during processing, and to kill any bacteria that may originate earlier in the supply chain. This provides a far greater level of assurance that the finished product – that you and I eat – is as safe as possible,” ​he said.

“The key is that the food safety methods must be proven scientifically to work, and then monitored carefully to be sure they continue to work effectively in practice. This way the majority of effort is applied before people get sick, not afterwards.​

Time to see effect​

Levitt said it is natural that new FDA regulations take time for companies to implement and for the agency to enforce. 

“FDA has partnered with academia and industry to establish a training curriculum, which will be key. FDA will also develop additional guidance documents to further educate the food industry on how to comply,” ​he said.  ​

“Finally, FDA has stated repeatedly that is will conduct extensive training of its own inspectors in this new food safety regulatory paradigm. So it will be a learning process all around.” ​

Keller and Heckman said the Foreign Supplier Verification Program (FSVP) final rule is effective January 26, 2016, but companies generally have 18 months to comply, i.e., May 28, 2017.

The final rule on the Third-Party Accreditation Program is effective January 26, 2016, although implementation depends on when FDA finalizes its model accreditation standards.

The Produce Safety Standards rule is effective January 26, 2016, but companies generally have two years to comply, i.e., January 26, 2018.