In a statement submitted to FDA, the NGFA strongly urged the agency to adhere closely to the non-prescriptive, flexible and risk-based language used in the Food Safety Modernization Act (FSMA) when developing proposed regulations later this year to implement the law’s requirements that facilities identify, evaluate and develop a written analysis of “known or reasonably foreseeable hazards…associated with the facility,” as well as implement controls to “significantly minimize or prevent” the occurrence of such hazards. Such flexibility should allow for industry sectors to utilize existing practices, quality assurance plans (such as the NGFA’s Model Feed Quality Assurance Program) and other tools compatible and consistent with the requirements and objectives of the law, the NGFA’s statement said.
“Any regulations need to be science- and risk-based, non-prescriptive and provide sufficient flexibility to allow facilities to adopt practices that are practical, effective and cost-effective for their specific, individual operations,” the NGFA said.
But while urging FDA to propose regulations providing a non-prescriptive, outcome-oriented framework, the NGFA encouraged the agency to issue guidance to provide a frame of reference concerning the type(s) of hazards that various industry sectors should consider addressing. Such guidance also should include illustrative examples of effective preventive controls and appropriate points in the supply chain – which often likely will be at the ingredient-supplier stage – where such controls may have the greatest positive impact on significantly minimizing or preventing targeted hazards. However, the NGFA stressed that such guidance not be used inappropriately by FDA inspectors for enforcement purposes, as guidance by law is not legally binding upon either FDA or the regulated industry.
The NGFA’s statement to FDA also addressed the following issues:
• Differentiating Between Human Food and Animal Feed, Including Pet Food: The NGFA cited language it helped draft that was included in the law that authorizes FDA to exempt or modify requirements for hazard analysis, preventive controls and written food/feed safety plans for facilities “solely engaged” in producing animal feed, including pet food, as well as the storage of raw agricultural commodities (such as grains and oilseeds) intended for further processing or distribution. This language “provides additional flexibility for FDA to tailor its hazard analysis and preventive control regulations so they are appropriate for low-risk raw agricultural commodities, such as grains and oilseeds, as well as animal feed and animal food,” the NGFA’s statement said. “Doing so makes sense on both scientific and risk-based grounds.” The NGFA cited as a sound approach FDA’s recent issuance of draft guidance for Salmonella, which identified eight specific Salmonella serotypes it believes merit regulatory concern if present in feed intended for use in specific species, rather than considering all Salmonella to be adulterants in feed.
• Developing Separate, Distinct Approach for Addressing Intentionally Introduced Hazards (Food/Feed Defense): The NGFA strongly recommended that FDA develop a separate, distinct approach to implement the law’s requirement that facilities identify and control hazards that may be introduced intentionally, including by acts of terrorism. “The methods used by the industry to identify, assess and control risks as part of food and feed defense plans is separate – and fundamentally different and distinct – from the type of process used to analyze and address other kinds of naturally occurring or unintentionally introduced hazards as part of a food/feed safety plan,” the NGFA said. “Further, we recommend FDA consider and recognize the existence of food/feed facility risk-assessment and security plans already developed by the industry,” such as the one developed by the NGFA’s Agroterrorism/Facility Security Committee.
• Maintaining Confidentiality of company Records, Food/Feed Safety Plans: The NGFA reiterated its concern that FDA develop specific procedures to protect the confidentiality of facility records and written food/feed safety and defense plans to which agency inspectors now will have access under the new law.
• Implementing Regulations for Sanitary Food Transportation: The NGFA encouraged FDA to develop proposed and final regulations on the sanitary transportation of food and feed in tandem with regulations for facilities on hazard analysis and preventive controls, as mandated by Congress. Doing so is important to make sure both regulations are compatible with one another, the NGFA said. Further, certain facilities may identify transport conveyances in which commodities and ingredients come into direct contact as a potential hazard that needs to be addressed as part of their preventive controls, the association noted. “But in the absence of compatible FDA regulations that apply directly to transporters, those facilities will face the conundrum of potentially attempting to ‘enforce’ cleanliness-related requirements on transporters unilaterally through contract terms” that may not be accepted by transporters who perceive themselves to be outside FDA’s regulatory reach.