With the date for compliance to FSMA’s Preventive Controls rules just around the corner (September 2016 for many facilities), food safety professionals are hopefully putting the finishing touches on their food safety plans. Although the key elements of the rules have been known since the initial proposal a few years ago, FDA has not yet issued guidance to industry that provides “how-to” recommendations for some of the more challenging aspects of the rules.
Trade associations are helping to fill some of the gaps by providing practical, industry-specific guidance. For example, three guidance documents have been developed recently for environmental controls for dairies, safe processing of nuts, and Salmonella control for dry pasta. The three documents can serve as useful references in the development of food safety plans.
- Control of Listeria monocytogenes: Guidance for the U.S. Dairy Industry (http://bit.ly/1SyrdpQ) was released by the Innovation Center for U.S. Dairy in the fall of 2015. Authored by several notable dairy-industry and sanitary-design experts, the approximately 40-page guide highlights key facts about Listeria, guidance on the separation of raw and ready-to-eat products, Good Manufacturing Practices, sanitary facility and equipment design, principles of cleaning and sanitation, and environmental monitoring programs. The guide includes easy-to-use checklists and is written in a way that is understandable to facilities of all sizes. While the guide uses dairy-specific examples, the fundamental principles are based on sound science and are applicable to the breadth of industries looking to address L. monocytogenes in their facilities
- GMA published a document on the Control of Salmonella in Low-Moisture Foods (http://bit.ly/26Aq5rC) in 2009 that continues to be referenced and built upon. The first derivative was a 2010 handbook for the safe processing of nuts. Recently, members of GMA and the Peanut and Tree Nut Processors Association collaborated to update the document, to align it with FSMA requirements. The revision, of more than 150 pages, includes:
- o A new chapter on supply-chain programs, given the requirements in the Preventive Controls rules for such a program when a facility relies on a supplier to control a hazard (such as a candy manufacturer who relies on a supplier to roast nuts to kill Salmonella).
- A chapter dedicated to allergens, given FDA’s emphasis on this, replacing its inclusion as part of prerequisite programs.
- Similarly, in response to continued concerns with post-process contamination of nuts and nut products, the issue of environmental monitoring is addressed in greater detail in a separate chapter.
- The document will continue to be updated with a chapter on food defense to provide recommendations associated with that final rule.
- The National Pasta Association also has leveraged the GMA low-moisture document to tailor it to the dry pasta industry with Mitigation and Control of Salmonella in Dry Pasta Facilities (http://bit.ly/1TAf3LW), which was published in March 2016. Although dry pasta is generally considered to be a not-ready-to-eat product because consumer cooking achieves adequate lethality to control Salmonella, the industry recognized its role in addressing this pathogen. The 27-page guide is formatted with easy-to-read bullets, illustrations, and checklists. The flow of the document mimics the GMA document, and covers topics such as controlling ingress of Salmonella, identifying and managing the Primary Salmonella Control Area, hygienic design of buildings and equipment, pathogen control within the facility, raw material control, validation, verification and corrective actions, and training. Like the dairy guidance, this document, while focused on the dry pasta industry, contains information relevant to any manufacturer concerned about Salmonella control.
By maintaining open lines of communication with our science colleagues in other associations, we’ve become aware that several other guidance documents are in the works. For example, the National Fisheries Institute and Seafood Products Association are collaborating on the updating of a 2002 document on controlling Listeria monocytogenes in seafood products. Such industry guidance documents do not replace those of regulatory agencies, but they do provide an opportunity to build on regulatory guidance and relate the concepts and recommendations to a specific industry or product type. FDA has been finalizing several rules, and we are optimistic that the agency will release guidance in the near term.
In the interim, industry members can look to their trade associations for technical information and support in implementing effective food safety programs.
The author is vice president, science operations, GMA.
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