It would be a stretch to say that US petfood manufacturers welcomed last week's release, finally, of the proposed feed/petfood preventive control rule under the Food Safety Modernization Act (FSMA). Complying to the new regulations, once the final version is released next year, will require significant investments by some manufacturers. Yet after months -- actually, years -- of waiting to see these specific rules that apply to feed and petfood, at least the industry finally knows exactly what it's facing.
I did find it curious that the US Food and Drug Administration (FDA) released the rule in the same week that it issued an update on the investigation into jerky pet treats from China. Of course, mainstream media immediately conflated the two, as if FDA had released the new regulations in response to the jerky treat situation; I even received calls from reporters with that as their first line of questions.
Obviously, these two things are related in that both fall under the umbrella of petfood safety and regulation. Many elements within FSMA, not only the preventive control rules but also the Foreign Supplier Verification Act, are designed to prevent situations like the jerky treat illnesses. (Though it's important to note that FDA has been tracking and investigating complaints related to these treats for nearly two years, even working with China's Administration of Quality Supervision, Inspection and Quarantine, along with manufacturers and distributors of the treats, and still has not been able to identify potential sources of contamination or causes of the illnesses. So there are questions as to whether this really is a contamination problem that could have been prevented by increased regulations, inspections or controls.)
Perhaps FDA simply completed both items -- the update on the jerky pet treats investigation and the proposed preventive control regulations -- at about the same time and released them as soon as possible. With the preventive control regulations already being so badly delayed, along with other FSMA regulations, that FDA was ordered by a federal court to release them no later than November 30 this year, it was in the agency's best interests to announce them as soon as they were ready. Yet just three days after the jerky treat update? Was FDA counting on the media and the public to immediately connect the two, thus helping make the case for the new regulations?
What's really important, however, is what's in the rule and what that means for petfood manufacturers. For the first time, producers of animal feed and petfood will be required to prove, in writing, that they have risk-based preventive controls in place to prevent contamination of ingredients and products (among other safety standards) and to follow good manufacturing practices (GMPs), with documentation proving they are following GMPs. While many petfood manufacturers, particularly the larger companies, already have preventive control and GMP programs, there is a fair amount of concern throughout the industry, including among members of organizations like the Pet Food Institute (PFI) and American Feed Industry Association (AFIA), that the rules will be too prescriptive and not account for the variation in types of manufacturing and products manufactured in the industry.
Even Dan McChesney, PhD, director of the Office of Surveillance and Compliance for FDA’s Center for Veterinary Medicine, admitted during the 2013 Feed and Pet Food Joint Conference in September that the agency needs industry's input on the proposed GMPs. "We probably made them too stringent and need to back off some; we're looking for feedback from you for justification to back off,” he said, adding that FDA understands there is a wide spectrum of types of manufacturing facilities in the petfood and feed industries and, therefore, hazards and risks can vary greatly.
So, our industry has its marching orders. Groups like PFI and AFIA will definitely be analyzing and commenting on the proposed preventive control rule. You can, too, on the federal register website. As of today, you have exactly 118 days.