The Food and Drug Administration (FDA) yesterday denied the American Feed Industry Association (AFIA) extra time to comment on the animal feed rules under the Food Safety Modernization Act (FSMA).
The trade group said it was disappointed with the decision given that the FDA itself was granted an extension for final rule publication by the courts.
“The FDA had more than two years to write the animal food rule while allotting the animal feed industry only five short months to review and submit comments on the rule ... in comparison to the human food rule, which had an 11-plus month comment period timeline,” said Richard Sellers, senior VP of legislative and regulatory affairs, AFIA.
He said the trade group will be submitting comments by the 31 March deadline on the proposed ‘Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals’ rule.
But, said Sellers, the AFIA has also informed the FDA that it will continue to filter feedback and comments after that date due to the “enormity of the rule”.
Letter from the FDA
The FDA said it denied the AFIA the extra time based on that fact that it is under a court decree to publish the final rule for preventive controls for food for animals by 30 August 2015.
In a letter to Sellers, the agency said it “needs sufficient time to review, analyze and respond to the comments received, draft the final rule and move the rule forward through clearance to publish by the court ordered deadline.”
Good manufacturing practice rule phase-in sought
“We’ve not seen an impact of this magnitude since FDA was created in 1938,” said Sellers on the potential impact of the regulation on the feed sector.
He told FeedNavigator.com that while Current Good Manufacturing Practice (cGMP) rules for medicated feed have been on the books since 1976, feed ingredient companies and smaller operations are not familiar with them.
Sellers said the AFIA wants the FDA to consider a gradual introduction approach when addressing GMPs and has asked the agency to then look at adding the preventive control rules on a two to four year phase-in basis to allow for greater compliance.
“We believe this would allow firms unfamiliar with GMPs to become acclimatized before fully implementing preventive control programs. Based on our expected economic analysis and later review of our industry’s practices, we may request more compliance time after the rule has been finalized for 18 months,” said the regulatory affairs specialist.
In terms of risk based preventive controls, Sellers said: “Our safe feed/safe food certification program takes this approach, but only several hundred facilities have been certified. So these are very new concepts to the majority of the facilities. However, the large firms making the majority of the tonnage understand them.”
Industry costs underestimated
He added that AFIA members claim the FDA has grossly underestimated the costs of the new rules for the industry and that the trade group may “do a study later this year to justify extending the compliance period.”
Sellers said that he expects the FDA will issue more proposed rules on supplier verification, environmental testing and product testing later. These were removed by the US Office of Management and Budget from this set of rules for being too costly.