Guidance, clarity continue to be needed in FSMA roll-out

We caught up with Leah Wilkinson, vice president of public policy and education with the American Feed Industry Association (AFIA) at the International Production and Processing Expo (IPPE) to hear more about the work the association has been doing in terms of industry regulation developments, particularly the ongoing rollout of the Food Safety and Modernization Act (FSMA​​).

The AFIA initially pushed to have compliance staggered​​ for the feed safety regulations connected to the rule, she said.

“We wanted to be able to have time to get used to those [requirements] and doing those on a phase in so that we could learn from the large firms going first,” ​she said.​

Guidance clarity 

Looking forward, the association is continuing to push the US Food and Drug Administration (FDA) to be as clear as possible in its information and in the guidance developed around the regulatory changes, she said.

“We’re trying to get those guidance documents to be as clear as we can,” ​she said. “One of the conundrums is that the regulations aren’t always as straightforward as we’d like, so we’ve asked for them to reopen the rule so that we can get clear direct language in there or roll back those provisions that aren’t applicable to animal feed.”​

In reviewing the rule, AFIA has identified some areas where provisions might be applicable to human food, but are less relevant to animal feed and yet are still applied, said Wilkinson. “We’re continuing to work on that process as well,”​ she added.

“The mantra they’ve had of, ‘Educate before we regulate,’ has been a good one and we’ve seen that from the feedback we’ve gotten from the members,” she said. “They are out there to educate before they regulate and that’s good for everybody, that’s good for the inspectors, that’s good for us.”​

Inspection timing ​

The FDA has finalized guidance for the Current Good Manufacturing Practice (CGMPs). It also released a draft guidance​​ for industry regarding the hazard analysis and risk-based preventive controls process in January.

However, there are more guidance documents to be released at this stage, said Wilkinson. 

In theory, the agency would write its guidance documents and then inspections would start, but that has not been the process with FSMA, she said.  

“They’re going to end up inspecting under that draft guidance, there’s no way they’re going to get it finished in time before inspections start in October,”​ she added.

Hazard identification ​

One area feed manufacturers are unsure about is how to address an identified hazard before it needs a preventive control, she said.

“The other big area of clarity that we continue to seek on the livestock and poultry feed side is getting down to how you can address a hazard before it needs a preventive control,” ​she said. “You’ve identified a hazard, maybe a hazard reasonably likely to occur, but can you address it, mitigate that risk before it becomes a hazard that requires a preventive control.”​

On the livestock feed side, it appears that CGMPs could be used to mitigate those risks before triggering the need to put a preventive controls in place, she said.

“That’s not said anywhere in the regulation, it’s our interpretation, and FDA has said, ‘Yes you can definitely use your current good manufacturing practices,’”​ said Wilkinson. “But, then how do you go about having to write that into your animal feed safety plan? How much documentation do you need?”​

“And that’s where we’re going to have to get into that new guidance that just came out and really dig into it and see what they’re proposing there for that documentation, for that proof that you’re truly mitigating the risk of that hazard,”​ she added.