Ensuring the safety and quality of pet food in the United States continues to be a challenging and complex endeavor. Despite the highly regulated nature of the industry and pet food manufacturers’ best efforts, there are many challenges, such as the growing complexity of global supply chains, emerging contaminants and evolving regulatory, and customer requirements. With these challenges as a backdrop, several well-known incidents linked to microbiological hazards, natural toxins, and chemical contaminants have occurred in recent years.

In Pet Food in the U.S. (11th Edition), market researcher Packaged Facts projects that U.S. sales of pet food will continue to grow strongly, rising 16% between 2015 – 2018 to reach $33 billion. Much of that growth will be driven by continued shifts towards premium and super premium segments and robust interest in dog treats, including functional offerings intended to ameliorate pet health conditions and promote overall wellness. Numerous reports of illness and an ongoing investigation by FDA has also brought imported jerky treats under the spotlight.

Leading safety and quality issues of interest among pet food manufacturers include process control and validation, ingredients, finished product and environmental testing, and supply chain risk assessment.

FSMA
The above-mentioned topics are central to both Food Safety Modernization Act (FSMA) proposed rules and Global Food Safety Initiative (GFSI) certification standards. Perhaps not surprisingly, there is a very high degree of alignment between the measures included in the FSMA proposed rules and the elements typically found in GFSI certification schemes. Published opinions by industry experts and commentators generally argue that proactive efforts to achieve GFSI certification will put food manufacturers in a strong position with respect to FSMA compliance. This line of reasoning will also apply to pet food manufacturers.

Much has been published elsewhere regarding FSMA and a number of enforcement tools have already been implemented by FDA including mandatory recall authority, expanded administrative detention, suspension of registration, and pilot studies for enhanced product tracing capabilities.

IMPACT
The core regulatory components of FSMA will have an impact on the vast majority of manufacturers and importers of animal food. Regulatory provisions having a direct impact on the pet food and feed industry include:

  • Requirements for hazard analysis and preventive controls

  • Current Good Manufacturing Practices (cGMPs)

  • Regulations related to import safety and supplier verification

  • Requirements for sanitary transportation

TIMING
Proposed rules covering the above regulatory provisions were first released between July 2013 and January 2014 following the publication of earlier proposed rules for produce and preventive controls for human food in January 2013. Extensive discussions on all of the proposed rules have taken place among various stakeholder groups, resulting in FDA receiving more than 25,000 comments by the close of the comment periods. In an unprecedented step on September 29, 2014, FDA published supplemental proposed rules for produce safety, preventive controls for human food, preventive controls for animal food, and foreign supplier verification programs. The supplemental proposed rules describe FDA’s current thinking on specific issues based on stakeholder input and seek feedback on various new provisions during a more limited comment period closing December 15, 2014. It is important to realize that input will only be accepted on the new provisions defined in the supplemental proposed rules. Final rules will be published by August 2015 for preventive controls and October 2015 for foreign supplier verification.

TAKEAWAYS
Broadly speaking, FDA has been responsive to industry concerns and has provided clarification on a number of important definitions and language used in the original proposed rules. In general, the revisions provide more flexibility, are more risk based, and tailored to industry circumstances. FDA has also streamlined the cGMP provisions for animal food to allow flexibility for the wide diversity in types of animal food facilities and proposed rules for product testing, environmental monitoring, and supplier controls. The supplement to the foreign supplier verification program proposed rule includes a new provision that is in effect a hybrid of the two options that were included in the original proposed rule. This is intended to offer more flexibility to determine appropriate verification measures and provide greater consistency with the human or animal preventive control rules as applicable.

Moving forward, the FSMA represents a new paradigm for pet food safety. In contrast to the historical approach of reacting to food safety problems, the act mandates a public heath preventive approach. Proactive preparation is the key to a smooth transition and compliance with the new regulations. Pet food companies with an established food safety management program may find that many of the FSMA requirements will align with their existing systems.

ACTION ITEMS
To meet the evolving regulatory challenges of FSMA, pet food manufacturers should evaluate their current food safety management system and identify any areas not likely to be in compliance. By conducting a hazard analysis and implementing preventive controls now, pet food manufacturers will be ahead of the curve when the final rules are published in 2015. The development of a food safety plan enables facilities to establish sanitation procedures, conduct employee training, implement microbiological environmental monitoring, conduct supplier verification activities, and update record keeping procedures in advance of the final regulations. For importers, supplier verification activities could require onsite auditing of foreign suppliers, sampling and testing of imported food, and review of foreign supplier safety records.

The breadth and depth of FSMA demands industry experience, scientific expertise, and regulatory knowledge. Industry compliance with the emerging regulatory paradigm will require proficiency with a multitude of food safety activities, including risk assessment, analytical testing, auditing, and employee training.

Pet food manufacturers and their suppliers can demonstrate a commitment to safe products by seeking and maintaining certification against a GFSI benchmarked certification scheme such as SQF, BRC, or FSSC 22000. As noted earlier, this step should put manufacturers in a strong position in relation to FSMA compliance. Download our pet food services brochure!

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