AFIA, NGFA applaud FDA’s slowdown of regulatory inspections for FSMA preventive controls

By Aerin Einstein-Curtis contact

- Last updated on GMT

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The slowdown in regulatory review gives more time for the US Food and Drug Administration (FDA) to offer guidance to members, said the feed organizations.

The temporary pause on the start of certain regulatory inspections for large animal food producing facilities was announced Thursday, August 10 during a meeting of the Association of American Feed Control Officials, additional information also was shared​. The slowdown pertains to an upcoming regulatory step for the Food Safety and Modernization Act (FSMA), as it applies to hazard analysis and risk-based prevention inspections of large animal food facilities.

In September, small and large feed producing facilities will have to start meeting routine inspections to assess their use of current good manufacturing practice (cGMPs) in accordance with FSMA, said Jenny Murphy, consumer safety officer at FDA’s Center for Veterinary Medicine.

At that point, large production facilities, or those with more than 500 full-time employees, also have to meet requirements for preventive controls, she said. However, the FDA will not be starting routine compliance inspections until the fall of 2018.  

“There will still be cGMP inspections, but not those looking at preventive controls for now,”​ she said.

Delay details

The FDA decided not to postpone the compliance date because preventive controls have a role to play in public health, said Murphy.

“The responsibility is on the firm to make sure it is addressing animal food safety,” ​she said. “By keeping the compliance dates but not beginning routine regulatory inspections, we’re protecting food safety while giving facilities additional time to make sure the system is working correctly and to make adjustments if needed.”

If a problem is found in a facility that should have preventive controls in place, they will be able to work with the FDA to develop that next layer of protection, she said.

However, the change does not mean that companies would not be held accountable, she said. “Whether it’s a potential or actual food safety hazard, we will use the tools available to us to keep that food out of the marketplace,” ​she added.

“FSMA strengthened our authorities to include mandatory recalls and suspension of registration to block a facility’s ability to distribute food,”​ said Murphy. “This is an important message to get across. We don’t want people to think that by not beginning preventive controls inspections we’ll be letting our guard down when it comes to keeping consumers, both human and animal, safe.”

Additionally, the delay means that foreign firms that have to comply with the Foreign Supply Verification (FSVP) will have a pause before they see some inspections start, she said. “This way the start of the FSVP inspections for these importers will be aligned with the start of preventive controls inspections for animal food,”​ she added.

Industry response

The delay is “prudent and appropriate,”​ said David Fairfield, senior vice president for feed services with the National Grain and Feed Association (NGFA) in a release.

It also offers companies more time to focus on implementing portions of the feed safety rule that apply to cGMPS, he said.

“The NGFA continues to receive questions from member companies about certain aspects of the hazard analysis and preventive controls requirements that need to be addressed by FDA through guidance,”​ he said. “This extension of the inspection date will be useful in improving the prospect for successful education, training and inspection efforts to bring about compliance.”

The change is one that the American Feed Industry Association (AFIA) has been requesting, said Richard Sellers, senior vice president for public policy and education for AFIA.

“Given FSMA's far-reaching and expensive regulatory impact that extends into all areas of our members' business operations, we have been asking the administration and Congress to provide a reasonable time frame so that our members can conduct the necessary actions they need and dedicate new resources to come into full compliance with the law,” ​he said. “We feel that by providing a more reasonable deadline, FDA and its field staff will be able issue guidance documents that fully address our members’ questions so that, no matter the size of the facility, the industry will understand their responsibilities in preparing for compliance.”

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