The National Grain and Feed Association (NGFA) has submitted extensive recommendations to the Food and Drug Administration (FDA) in response to the agency’s request for comments on how to implement provisions of the new food/feed safety law that require facilities to identify and address hazards that could cause products to be adulterated or misbranded.
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 was involved extensively over the past three years during development and consideration of the legislation by Congress, and provided specific legislative language that was incorporated into the final law to protect the interests of the grain-handling, feed and feed ingredient, and grain processing sectors. The law ostensibly requires FDA to issue final regulations by July 2012 on the law’s hazard analysis and preventive control provisions.
Concerning hazard analysis and preventive controls, the NGFA also urged FDA to recognize that external hazards not associated with a facility rightfully are the responsibility of the supplier of such ingredients or products, and should be addressed as part of a facility’s supplier verification or supply chain management activities, if appropriate, based upon the facility’s own risk-assessment. The NGFA also commented that environmental and product testing, which is referenced in the law, may be appropriate in certain instances as verification steps, but should not be required as a preventive control by the agency. “It is the facility’s responsibility to determine the appropriate scope and extent of testing needed to verify that its preventive controls are effective and functioning properly,” the NGFA said.
In addition, the association urged FDA to provide a lengthy phase-in period for the hazard analysis and preventive control requirements to be implemented before enforcement begins, in part to allow for the education and training of both industry and inspectors. The NGFA noted the immense diversity in the types, sizes and sophistication of domestic and foreign facilities (exporting products to the United States) and range of products covered by the new law, which it said will require a “broad and deep information and education initiative” by FDA, states and industry prior to enforcement.