NGFA Submits Statements to FDA on Proposed Rules Implementing Foreign Supplier and Third-Party Certification Provisions of FSMA
Date Posted: February 5, 2014
Washington—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
In its statement on FDA's proposal to establish a program for accrediting third-party auditors, the NGFA stressed that FSMA expressly authorized such programs for only two specific purposes - certification of FDA-designated imported foods determined based upon risk, and foods subject to a voluntary qualified importer program created under the statute.
The NGFA emphasized that Congress was "silent within FSMA on the use or recognition of third-party inspection...for domestic facilities."
As such, the NGFA said it believed that FDA "needs to weigh the absence of express statutory language carefully when considering whether, and to what extent, to rely on third-party certification as a means to verify that food and feed from U.S. facilities also meet applicable safety standards."
The NGFA added that it was incumbent upon FDA to engage in additional public rulemaking to seek comment from stakeholders before proceeding in such a manner, particularly given the lack of express statutory language.
Pertaining to any potential future recognition by FDA of accredited third-party certification of domestic facilities, the NGFA conveyed its strong belief that the decision of whether to voluntarily utilize third-party certification should remain within individual companies based upon their assessment of the costs-versus-benefits of doing so.
The NGFA stated that FDA-regulated establishments may well make a prudent business decision that third-party certification programs provide little value, based upon their assessment of the risk of products they are manufacturing and distributing, the adequacy of their internal product-safety and quality-control programs, their compliance histories and other factors.
Among other issues addressed within NGFA's statement on FDA's proposed regulation for third-party auditors were the following:
• Reporting of Audit Results to FDA: The NGFA strongly opposed FDA's proposed requirement that reports emanating from audits by accredited third-party auditors conducted for foreign supplier verification programs (FSVP) purposes be sent to the agency. The NGFA said such reporting exceeds the authority provided by FSMA, would not advance food and feed safety, and would have a chilling effect on the use of third-party audits for such purposes.
• Audit Criteria: The NGFA conveyed its strong belief that FDA needs to establish meaningful and appropriate audit criteria by which to evaluate the regulatory compliance status of an audited facility. In addition, the NGFA emphasized that both auditors and facilities need an accurate and comprehensive understanding of the criteria to ensure that audit results appropriately reflect the regulatory status of the facility.
• Third-Party Reporting of Deficiencies: The NGFA urged FDA to limit the reporting of audits by accredited third parties to those infractions that are serious and pose a danger to human or animal health - equivalent to what FDA now categorizes as a Class I recall that is subject to reporting under the agency's Reportable Food Registry. Doing otherwise does not conform to FSMA and "would result in the unintended and counterproductive consequence of incentivizing food and feed companies to use unaccredited auditors to avoid expanded and unnecessary reporting...to FDA," the NGFA said.
• Ensuring that Third-Party Auditors are Independent and Free from Conflicts of Interest: NGFA strongly supported the provisions proposed by FDA to ensure that third-party accreditation bodies and third-party auditors are independent and free from conflicts of interest. The NGFA stated that having rigorous safeguards to prevent conflicts of interest would help offer the transparency and credibility necessary to establish confidence in accredited third-party audits and certification programs.
The FDA is under a court-mandated deadline to issue its final regulations for foreign supplier verification and third-party auditors by June 30, 2015.
The FDA proposals were mandated by FSMA, which was enacted in 2011, and these two sets of proposed rules are significant and directly will affect companies involved in importing foreign foods and feeds.
FDA's proposed regulation to establish FSVP would require all importers of foreign foods and feeds to conduct certain activities to verify that the foreign product was produced under conditions that provide the same level of public health protection as that required of domestic food/feed producers.
Among the required verification activities proposed by FDA are:
1. a review of the regulatory compliance status of the food/feed and its foreign supplier;
2. an analysis of the hazards associated with the food/feed, and the severity of illness or injury posed by such hazards;
3. onsite auditing of foreign suppliers;
4. periodic or lot-by-lot sampling and testing of food/feed;
5. review of foreign supplier food safety records; and
6. review of any complaints received about the imported product.
Meanwhile, FDA's proposed rule for third-party auditors would establish a program for accreditation by the agency of third-party auditors to conduct food/feed safety audits and issue certifications of foreign facilities and the foods and feeds they produce.
FSMA requires such certifications of foreign facilities and their products if FDA has made a risk-based determination that such a certification is necessary to provide assurance that the product meets U.S. safety requirements.
In addition, FSMA requires certification of foreign foods and feeds that will be imported for use in the United States under FDA's yet-to-be established voluntary qualified importer program, which will provide expedited entry of such products.
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