The Food Safety Modernization Act (FSMA) is a hot topic in the petfood industry these days. The US Food and Drug Administration is calling for a new, prevention-oriented food safety system, and several of the rules found in the Act are of particular interest and concern to petfood manufacturers.
At Petfood Forum 2014 on April 1, Jason Vickers, head of product safety and regulatory affairs for Proctor & Gamble Pet Care and co-chair of Pet Food Institute (PFI)'s FSMA response team, gave a talk entitled, "FSMA preventive control rule for feed: The petfood industry's response." During the discussion, he updated attendees on the status of the rule (the comment period closed on March 31), what the FDA is aiming to accomplish, and how the impending regulatory changes will affect the industry.
Since 2011, the FDA has had several powers already aimed at food safety: Mandatory recall authority, suspension of registration, administrative detention authority, frequent inspection and records access are all connected to the government agency. Pending petfood industry requirements related to the lengthening stretch of these powers include written food safety plans, a written recall plan, hazard analysis and preventive controls, and supply chain management. And all of this ties into the upcoming rules that the petfood industry has taken a significant interest in: Preventive controls for human food, a foreign supplier verification program, the accreditation of third-party auditors and (arguably most in the spotlight) preventive controls for animal food.
Vickers outlined several concerns the petfood industry has regarding these issues, and in the PFI's comments to the FDA during the open comment period, they highlighted some of those concerns and their ideal solutions:
- The proposed regulation should reflect the Congressional intent specified in the statute requiring that the rules be based on science and risk analysis;
- There should be one animal food regulation applicable to all animal food categories;
- The rule should apply to all petfood and animal feed companies, and there should be no exemptions based on the number of employees or the volume of sales;
- FDA should develop and implement training for animal food producers and FDA officials to ensure smooth implementation of the rule when finalized.
Audits are one topic Vickers provided a little more insight on during his presentation. "We want to make sure the auditors have specific knowledge of, at minimum, the feed industry, but ideally the petfood industry," he said. As for consultative audits, which are informal audits meant to point out areas for improvement prior to an official audit, the petfood industry should be able to focus on achieving top results, rather than who is going to see the preliminaries. "You want to be able to gain knowledge without worrying that it will go directly to the FDA," said Vickers.
Costs to the industry as a result of the rule implementation are another concern Vickers addressed. FDA estimates and independent industry survey results don't quite match up, with the surveying revealing even higher potential costs than initially projected. When it comes to environmental monitoring, "based on survey data from PFI, [companies are] looking at up to $800,000 per facility," said Vickers. In addition, costs for the record-keeping that will be required under the new rules are expected to be significant.
The role of testing under the expanded rules definitely brought up concerns for PFI, and for the industry, said Vickers. "[A company's testing program] should be risk-based off the science that you have," he said. Further, testing programs should be individualized. "I support that each manufacturer should have the right controls in place that they feel are the best way to ensure the safety of their product," said Vickers.
As the FDA begins to go through the comments submitted by every area of the agriculture and food/feed industries, these issues will continue to be discussed and refined, according to Vickers. The process of implementation is not yet complete, and there's still a lot of work to do on both sides of the fence.