Implementation and enforcement of the Current Good Manufacturing Practices and Hazard Analysis and Preventive Controls for Food for Animals, the Food Safety Modernization Act (FSMA) regulation most relevant to pet food safety, was a key focus of the 2015 Feed and Pet Food Joint Conference held September 29-October 1 in Columbus, Ohio, USA. The two organizations hosting the conference, the National Grain & Feed Association (NGFA) and Pet Food Institute (PFI), have played a leadership role in providing industry response to the Food and Drug Administration (FDA) on the rule.
The conference’s opening sessions were presented by two FDA representatives: Daniel McChesney, PhD, director of the agency’s Center for Veterinary Medicine Office of Surveillance and Compliance, who provided an overview of how the rule will be implemented; and Scott MacIntire, director of FDA’s Division of Enforcement/Office of Enforcement and Import Operations within the Office of Regulatory Affairs, who spoke about enforcement of the rule. A workshop on the second day of the conference helped attendees understand the rule’s requirements and how to demonstrate compliance.
McChesney reiterated that the regulation, commonly referred to as the animal feed preventive controls rule, establishes current good manufacturing practices (cGMPs) for animal feed and pet food for the first time and requires all registered manufacturing facilities within those industries to have written preventive controls plans. After several hundred comments from industry members, FDA also looked at existing industry standards and revised the requirements for cGMPs in the final rule, making them more flexible and less prescriptive because of the wide range in types of facilities, products being made and species of animals the products are manufactured for.
The cGMPs in the rule cover personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, holding and distribution, and holding and distribution of human food by-products for use as animal food, McChesney said. He added that it is up to each company/facility to determine which of these might have hazards that need control.
He also discussed the food safety plan, which must include hazard analysis, preventive controls (including process, sanitation, supply chain controls, plus a recall plan), monitoring of hazards/controls, corrective actions and controls, verification, validation, verification of implementation/effectiveness and re-analysis of plan itself. “This rule is heavy on documentation; everything must be documented,” McChesney said.
The rule also includes a supply-chain program, which involves supplier verification activities (such as on-site audits), sampling and testing, and review of relevant safety records, among other elements. The activity and frequency should be based on the nature of the hazard, where it is controlled and the supplier performance.
To help pet food and feed manufacturers comply with the rule, FDA is issuing guidance documents. One on cGMPs is finished, McChesney said, and in the process of being cleared through the federal government’s channels; a document on hazard and analysis and preventive controls is under development.
MacIntire discussed the training requirements of FSMA and FDA’s role. The agency has established a Food Safety Preventive Controls Alliance, in conjunction with NGFA and PFI, which is developing and providing training to industry as well as regulators. Food and feed safety staff from FDA will be required to attend this training, and industry members will receive a certificate proving they did the training, which will count under FSMA, MacIntire said. The preventive controls training will take three to four years because of the sheer number of people needing training, he added. In addition, the agency has formed a Food Safety Technical Assistance Network to provide central, consistent sources of outreach and real-time technical assistance to industry and regulators before, during and after inspections. Training for that is also under way.
MacIntire emphasized that the underlying philosophy for his division’s enforcement of FSMA is to try and change the culture in FDA, from one of enforcement only to gaining industry compliance. That includes having an open-door policy to industry at all levels and recognizing companies when they self-identify problems and fix them, coming up with different ways to address things. Because of the flexibility of the animal feed preventive controls rule, FDA will not use a one-size-fits-all approach, MacIntire said. That likely means spend less time in facilities with very good safety records and more time in ones that need more help.
Other speakers at the conference, including Bob Ehart, senior policy and science advisor for the National Association of State Departments of Agriculture, questioned whether FDA would receive full and adequate funding from the US Congress to enforce FSMA regulations.