WASHINGTON (Feb. 5) – The National Grain and Feed Association (NGFA) submitted extensive statements recently to the U.S. Food and Drug Administration (FDA) in response to two proposed rules issued to implement provisions of the Food Safety Modernization Act (FSMA).
The first FDA proposal would require importers to verify the safety of foreign foods and feed/feed ingredients imported and intended for use in the United States, while the second would establish criteria under which the agency would recognize and accredit third-party auditors that perform safety audits for such products.
In its statements, the NGFA provided more than 30 pages of suggestions and comments for the FDA to consider; below summarizes NGFA’s submissions.
NGFA Comments on Foreign Supplier Verification Programs
In its statement on the agency’s proposed regulations to require importers to establish foreign supplier verification programs, the NGFA in particular urged FDA to exempt raw agricultural commodities – other than fruits and vegetables – intended for further processing and distribution, noting the complex and commingled nature of commodity systems through which grains, oilseeds and other commodities move through the supply chain. The NGFA also noted such agricultural commodities, other than fruits and vegetables, already have been recognized as a low risk to human and animal health under its proposed preventive control rules for human food and animal feed.
In addition, the NGFA supported FDA’s plan to establish less-demanding foreign supplier verification requirements for importers sourcing products from facilities in countries whose food safety system are deemed by FDA to provide comparable or equivalent protection to public health.
The NGFA also conveyed these other significant comments to FDA on its proposed foreign supplier verification rules:
- Flexibility for Importers: The NGFA strongly urged FDA to provide flexibility for appropriate management oversight of hazards and verification activities that are tailored to each facility’s operation and commensurate with the nature of food/feed safety risk that may be present, rather than to mandate that all foreign suppliers be audited.
- Role of Audits: The NGFA cautioned FDA to not overemphasize the role of audits of foreign facilities when establishing required verification activities. The NGFA statement acknowledged that audits may be an effective verification tool in certain situations, but also stated that such audits only offer a “snapshot” of a supplier’s performance at a given time. As such, the NGFA urged FDA not to mandate the use of audits in a narrow and prescribed manner.
- Exclusion of Food Transshipped for Export: The NGFA supported FDA’s proposal to exempt from foreign supplier verification those food or feed shipments transshipped through the United States to another country or imported for future export so long as the product is neither consumed nor distributed in the United States.
- Limit Investigations of Complaints to Those Related to Safety: The NGFA strongly opposed FDA’s proposal that importers investigate “any” complaint related to an imported product. Instead, the NGFA urged the agency to require importers to review only those complaints related to the safety of food or feed that have a bearing upon the firm’s foreign supplier verification activities.
- Submission of Electronic Records to FDA: The NGFA strongly opposed FDA’s proposed provision that would require importers to send records associated with its verification activities to the agency electronically rather than making the records available for agency review at the importer’s place of business. In doing so, the NGFA stated it is not possible for FDA to make accurate inspectional observations, including those related to records, unless an inspector is at the place of business and able to observe and understand the context of its operations.
NGFA Comments on Third-Party Auditors