AFIA Reiterates FSMA Costs Trump Benefits
"We recognize the inclusion of many of the industry's suggested changes by FDA to the proposed rules as they continue to reduce the cost of the implementation of the final rule. However, it is not enough," said Richard Sellers, AFIA senior vice president of legislative and regulatory affairs. "Our comments urge the agency to take additional steps to lower the rule's cost while strengthening any overall benefits to the animal food industry."
Other comments submitted by AFIA revolved around the language of the rule. The organization believes there is still language within the rule that could be confusing to industry despite its thorough attempt in its March comments to offer alternative wording and definitions. AFIA urged FDA to more closely align with the agency's medicated feed CGMPs that have been in place for more than 40 years, as there is already an understanding and excellent compliance, according to FDA's own data.
"Compliance with the rules and the implementation period is still a large and looming issue with AFIA," stated the comments. "We urge the agency to closely examine our request for changing FDA's one, two and three year implementation period for regular, small and very small businesses, respectively, and consider the two, three and four year approach AFIA has advocated in previous comments."
The Foreign Supplier Verification Programs was re-proposed with the animal food rules Sept. 29, with a 75-day comment period for both sets of rules. AFIA stated the importance of FSVP aligning with the proposed domestic risk-based supplier program under the preventive controls supplemental rule and also addressed the ongoing language issues of the FSMA rules.
"We urge FDA to recognize that one regulatory solution may not be appropriate for both human food and animal feed. FDA has separated the human and animal food preventive controls rules. Although there will be a single Foreign Supplier Verification Program rule for food for humans and animals, FDA should consider different approaches for animal feed where appropriate," stated AFIA in the comments on FSVP.
Of particular concern is that the domestic supplier verification rules agree with the foreign supplier rules, as the U.S. treaty obligations and the World Trade Organization require treating domestic firms similarly to foreign firms with respect to regulatory control.
AFIA will continue to work with its membership and the industry as FDA moves forward in the comment review process. The final animal food rule is mandated by a court order to be published by Aug. 30, 2015. The "Foreign Supplier Verification Programs for Importers of Food for Humans and Animals" is expected to be finalized by Oct. 31, 2015.