WASHINGTON, D.C., U.S. — The National Grain and Feed Association (NGFA) said on Feb. 5 that it wants raw agricultural commodities, other than fruits and vegetables, to be exempted from foreign supplier verification programs.
NGFA made the comments in its statement on the U.S. Food and Drug Administration’s (FDA) proposed regulations. NGFA asked for the exemption 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.
• 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 U.S. to another country or imported for future export so long as the product is neither consumed nor distributed in the U.S.
• 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.
• 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 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.
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.
• 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.
• 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.
• 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 FDA is under a court-mandated deadline to issue its final regulations for foreign supplier verification and third-party auditors by June 30, 2015.
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