The rule was published by the US Food and Drug Administration (FDA) last week.
Among the changes from the proposed drafts of the rule was a movement toward a staggered implementation timeline for the new procedures to take effect, said the trade officials.
“We’re grateful that FDA finalized a staggered compliance schedule, as it should provide enough time for industry to understand and fully comply with new and far-reaching FSMA requirements,” said David Fairfield, NGFA’s vice president of feed service.
AFIA representatives said the change was one of the “biggest victories” they could claim.
The new rule has extended the time period for companies to develop any preventative controls needed, said Richard Sellers, AFIA senior vice president of legislative and regulatory affairs
“One of the things we wanted to applaud the agency for was the flexibility with which the final rule was [presented] to the industry, that’s important because the less rigid it is, the less costly it will be,” he said.
A regular size firm will have one year to comply with current good manufacturing practices (CGMPs) and two years to comply with any preventive controls they need to create, said Sellers. “Likewise, any small business would have two years and three respectively, and a very small business would have three years and four years to comply with the preventive controls respectively. Those phase-in dates will lower the cost significantly and allow companies to better adapt to this new provision,” he added.
Cost savings
Other amendments around recordkeeping and personnel could herald in costs savings as well.
Initially, it appeared that many facilities would need a qualified individual for preventive control to check the hazard analysis plans, preventive control, corrective actions and any changes made at a plant, said Sellers. The rule has been amended so that facility employees involved in the manufacturing, processing and packing need to be qualified individuals, however being a qualified individual means being trained and having feed safety and hygiene training, and is not the same as being a preventive control qualified individual.
“The cost is dramatically reduced because the hazard analysis needs to be signed by an expert with training and experience, but it does not have to be this qualified person for preventive controls,” said the regulation expert.
Other amendments in the final rule lessen the amount of paperwork involved for feed establishments and thus also cut down on expenditure.
Both trade groups are continuing to study the new rule. AFIA has already announced several additional training or discussion sessions on the rule throughout the year. The first is set for 7 October.
And, as every facility registered with the FDA has to be in compliance with the rule, the AFIA is working with the University of Minnesota to develop a hazard analysis plan that can be provided to feed facilities, said Sellers.