We spoke to Leah Wilkinson, VP of public policy and education, American Feed Industry Association (AFIA), at the IPPE in Atlanta to hear more about the regulatory areas the trade group is tracking.
The ongoing rollout of the FSMA brought about requirements for all feed production facilities for the first time last year, said Wilkinson.
“2018 was a big year,” she said. “That’s the first year that all size facilities needed to be in compliance with at least one portion of the regulation.”
Feed ingredient approvals and claims are some of the priorities for 2019, she said.
“We’ve done the easy ingredients – I think what you’ll see coming out of AAFCO, and part of what is taking longer to review, are the more complex ingredients going through the process.
“Our companies have novel ideas on how to improve our animal’s nutrition or well being, so one of the things that we’re going to start working on is what claims we can make and how we can get the FDA to start thinking a little outside the box [in this regards].”
FSMA progress
Aspects of the FSMA regulation were phased in at different times for facilities of varying sizes, said Wilkinson.
Starting in September 2018, facilities of all sizes – large, small and very small – needed to be compliant with the use of current good manufacturing practices (CGMPs), she said.
“We’re really going to learn a lot this year on how FDA is conducting inspections for hazard analysis and preventive controls,” she said. “We know that there were about seven inspections that happened last year on hazard analysis preventive controls, so this year is really going to be telling to see where are they going, what they are observing, how they are conducting the inspections [and] how long they are taking.”
Impact of shutdown
The FDA has to also release more FSMA guidance documents, she said.
“Unfortunately, the shutdown is delaying its work,” Wilkinson said. “They’ve told us for every week that they were out during the 35-day shutdown it’s going to delay them a month – we’re talking anything from ingredient approvals, to getting things published in the federal register, new guidance documents – it is just going to take a lot longer for things to come out this year.”
“We’ve had companies that are close, or thought they were, to getting a final statement out from FDA on ingredient approval or ingredient review and that’s delayed – because of the shutdown,” she said.
AFIA undertook a study with the Institute for Feed Education and Research (IFEEDER) in 2016 that found “it’s $1.75m of lost revenue for every year of delay for those ingredient companies, so we’re talking significant money.”
“A lot of these are small companies trying to make a go at it, so we’re going to focus a lot this year on ingredient approvals and how we can speed that process up,” she added.
One issue that the FDA has faced is that it has not had the ability to hire much new staff, she said. It has been funded through continuing resolutions for several years and has not received money to hire new employees or replace people that have retired.
“We’re working and focusing our attention on Capitol Hill to try to get them some more money,” Wilkinson said. “It would be targeted at ingredient approvals so staff that could come in because they’ve got stacks of ingredients that are sitting on the handful of people’s desks – they’ve got to prioritize their work and we get that, but [we want to see] what we can do to help bring those stacks down.”
International convergence
The AFIA has also been working with the International Feed Industry Federation (IFIF) along with feed associations and governmental agencies in Canada and the EU to address the ingredient submission and review process through the International Cooperation for Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF), she said.
The project’s goal is to document what is needed to address specific elements within an ingredient approval application for all three regulatory systems, she said. “A company working on a submission can look and see the what the baseline is for all three [regions], [allowing it to] do one study versus three."
Currently, the project members are in the process of writing documentation to address stability and toxicity. However, there is a list of additional topics that need to be assessed in the future, she said.
