AFIA Stands Ground on FSMA Qualms at FDA Public Meeting
Paul Keppy, AFIA government affairs specialist, admitted the 75-day comment period is not ideal in length; however, AFIA appreciates "the chance to see certain sections for the first time and review others for a second time, such as CGMPs."
AFIA remains concerned with items addressed in its original comments that are not fully addressed in the supplemental, particularly the differentiation between human food and animal food as well as the looming high costs of the rule for its members.
"There are a few proposed CGMP provisions that still appear geared toward human food, not animal food. This is frustrating because the spirit of the law clearly allows for treating animal food and human food regulations differently," stated Keppy in oral comments to the agency. "On the other hand, there are places where animal food is left out of important rules."
In the Foreign Supplier Verification Program rule, FDA allows for an exemption if a firm and its customer implements adequate human food preventive controls, but animal food preventive controls are not mentioned.
Keppy said the additions in the supplemental represent significant cost increases. He stated FDA's own numbers in the original Preliminary Regulatory Impact Analysis (PRIA) concur, showing the cost of the rule to far exceed the benefit.
"Feed is already 70 percent of the cost of raising an animal. AFIA members want to make animal food safer, not more expensive. We continue to believe the costs can be reduced by a less prescriptive set of CGMPs and a strong approach to controlling significant hazards through CGMPs," said Keppy.
AFIA has supported the development and enactment of FSMA, working since 2011 with FDA and industry organizations on the largest set of rules to impact the feed industry since the 1950s. The organization is equally devoted to ensuring understanding within its membership during FSMA's implementation. AFIA has hosted more than five compliance trainings and several dozen presentations on FSMA with additional trainings on the calendar.
AFIA will submit comments on the proposed supplemental rules, which are due by Dec. 15.