Group wants implementation to take risk-based approach
The National Grain and Feed Association (NGFA) on March 26 submitted comments to the Food and Drug Administration (FDA) regarding Food Safety Modernization Act (FSMA) implementation.
According to the comments, NGFA’s membership “recognizes the paradigm shift FSMA represents in terms of placing the principal focus on prevention of hazards that can pose a risk to human or animal health. The law also codifies a fundamental principle that the grain, feed and grain processing industry has long held — that the industry bears the principal responsibility for producing and distributing safe products.
“That is a responsibility our industry embraces and takes very seriously,” said NGFA.
As such, the association seeks to ensure FSMA implementation takes a risk-based approach with a clear understanding — from regulators and industry — about what is involved under new FSMA-related rules. In its comments, the association focused on:
A common understanding of responsibilities and obligations must be developed: For regulatory officials and industry to have a clear and common understanding of responsibilities and obligations under the new FSMA-related rules, FDA will need to issue multiple guidance documents for various industry sectors in a timely manner after final rules are issued.
According to its statement, NGFA urges “FDA to work closely with the regulated industry while developing such documents so that content reflects the realities of industry practices, aligns with regulatory requirements and serves to further enhance the safety of human food, animal feed and pet food.”
Investigators must undergo comprehensive training: While FDA has signaled that it intends to develop metrics to measure the industry’s compliance with FSMA requirements, the NGFA also believes that the agency must establish clear metrics to accurately measure its investigators’ understanding and application of the regulations.
“Consistent and reasonable inspectional activities will play an essential role in establishing the constructive relationship between regulators and industry that is necessary to advance food and feed safety,” according to NGFA’s statement.
FDA should use an “educate before regulate” approach: NGFA strongly supports FDA’s stated FSMA-compliance philosophy of “educate before it regulates.” However, NGFA urges FDA to provide adequate time for industry to fully understand and comply with the new and far-reaching FSMA requirements.
FDA should use a risk-based approach when setting inspection priorities: NGFA believes that FDA should rely upon currently collected and publicly available information and data when determining whether a facility or its products should be subject to more frequent inspections as mandated under FSMA.
According to its comments, NGFA strongly believes that “FDA’s inspectional resources should be focused on facilities that have a higher risk of affecting human and animal health.”
FDA should continue to use state regulatory officials for inspections: The NGFA strongly supports FDA’s continued use of state feed regulatory officials to conduct FDA-credentialed inspections of animal feed and pet food facilities.
NGFA said, state regulatory officials who are familiar with and knowledgeable about animal feed and pet food facilities and the types of products manufactured and distributed can conduct inspections that are more meaningful. In contrast, inspections conducted by investigators who are not familiar with animal feed and pet food facilities can result in negative outcomes for both industry and FDA. This is not a theoretical concern, the NGFA noted, as such negative outcomes have occurred in the past.
In addition, NGFA’s statement provides recommendations on FDA’s proposed use of a “two-tiered” inspection program for companies with corporate-wide programs and its interest in evaluating food safety culture during the inspection process.