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Groups comment on pair of FSMA import rules

The comment period expired Jan. 27 on the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, known in short as the foreign supplier verification rule, that is part of the proposed Food Safety Modernization Act (FSMA). The import safety rules also include measures for the accreditation of third-party auditors.

The United Fresh Produce Association and the Produce Marketing Association (PMA) were among the industry organizations submitting comments.

United’s comments reflect review by diverse expert working groups who spent 10 months reviewing the proposed rules. The working groups represent numerous member companies throughout the fresh produce supply chain.

“From the beginning of our work to pass food safety legislation, we’ve advocated for a level playing field for foreign and domestic producers,” said David Gombas, United senior vice president of food safety and technology. “It’s critical that FDA establishes food safety requirements that keep consumers safe and that all suppliers meet, no matter what their geographic location or size.”

United’s comments, summarized below, raise several key issues.

Direct suppliers: The importer’s Foreign Supplier Verification Program (FSVP) should be limited to the direct supplier, not the supplier’s suppliers. We agree that the importer should hold the aggregator accountable for meeting food safety regulatory requirements in its supply chain, but the importer should not be responsible for having specific detailed information about each of the original growers. 

Verify compliance with relevant regulation: FSVP should be limited to verifying compliance with the relevant regulation. We encourage FDA to limit importers’ requirements to verification that direct suppliers are in compliance with the relevant regulation and to not require importers of fresh produce to perform a hazard analysis beyond the scope of the produce safety rule.

Same requirements as domestic suppliers: Foreign suppliers should follow the same requirements as domestic suppliers; therefore, standards for foreign suppliers should be the same as those in the produce safety rule, subject to the revisions we have recommended. In the produce safety rule, FDA proposed to limit the risks covered in the rule to microbiological, not chemical or physical hazards.  However, in the foreign supplier verification rule, FDA proposes to require importers to evaluate potential chemical and physical hazards in fresh produce exported to the United States. This potentially requires foreign fresh produce growers to comply with food safety standards that exceed requirements of domestic operations, inviting a World Trade Organization challenge. 

No exemption for small foreign suppliers: While very small foreign suppliers may have size-appropriate requirements, there should not be any exemptions.  Importers’ requirements should be the same, regardless of the importer’s or foreign supplier’s size.

Flexibility of tools and approach: Importers should be allowed to use whatever tools/approach they deem appropriate for evaluating foreign suppliers’ compliance with the applicable regulation.

To review United’s complete comments on the FSMA rules, visit the United Fresh FSMA website.

Jim Gorny, PMA vice president of food safety and technology, said the organization’s comments call on FDA to harmonize requirements across rules and to be mindful of the global nature of the produce supply chain, which demands that safe practices be harmonized both in the U.S. and around the world.

PMA’s comments covered a number of key issues, according to its executive summary. On the FSVP rule, PMA is concerned about four issues.

Importer verification activities of foreign suppliers (FDA Proposed Option 2): Option 1 of the FDA proposed FSVP requirements for importers requires annual onsite food safety audits of foreign suppliers, while FDA proposed Option 2 provides much greater flexibility by allowing importers to choose from a portfolio of verification activities such as periodic onsite auditing, periodic or lot-by-lot product sampling and testing, periodic review of the foreign supplier’s food safety records and/or other appropriate procedures.

English-only requirements for FSVP recordkeeping: One means of FSVP verification that importers have available is periodic review of operational records to verify that the foods they import are produced in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). These foreign supplier operational records will appropriately be the native language of the country in which the foreign supplier is operating. Copies of foreign supplier operational records, in a foreign language, may be copied and retained by the importer as part of their foreign supplier verification program to document foreign supplier compliance. It is strongly recommended that FDA allow for FSVP recordkeeping in English as well as other languages.

Mandatory importer use certifying bodies (i.e., auditors) accredited by FDA-recognized accreditation bodies for FSVP verification activities: FDA has not established and implemented the processes and procedures necessary to recognize accreditation bodies. Therefore it is unclear if there would be sufficient certification-body audit capacity to accomplish all the audits if required. This issue should be revisited by the agency at a later date when FDA has established and implemented the processes and procedures necessary to recognize accreditation bodies.

Reduced redundancy and harmonization of the FSVP rule with other FSMA rules: PMA supports that importers should be required to conduct foreign supplier verification activities and be subject to the same FSVP requirements, when importing food from entities under the same corporate ownership. Seamless integration and harmonization of the Preventive Controls for Human Foods Supplier Controls (approval and verification program) regulations and FSVP regulations is absolutely needed to reduce costly verification activity redundancy. However, PMA does request the opportunity to comment on any proposed supplier verification and testing provisions in the final preventive controls for human food rule and urges FDA to seek additional comments once the FDA has a detailed proposal for these provision areas.

These are some of the issues were also raised about third-party accreditation of auditors.

How will FDA determine when an accredited third-party audit will be required? The precise circumstances and decision points for how and when FDA will determine that specific products from a foreign country or region will require a third-party audit in order to be imported into the U.S. is important to understand and more clarification is required.

Transparency and balance: We also need to further explore how FDA will balance the need for an open and transparent system for accreditation of third-party auditors/certification bodies with the equally important need to protect the proprietary business information of the eligible entities.

Unannounced audits: The concept of unannounced audits is important for the credibility of the program and FDA has outlined a process that will insure audits are conducted within the framework of normal business hours and that the food safety documentation can be appropriately accessed and evaluated.

Importance of consultative audits: It will be important to ensure that the food safety tool of “consultative” audits is unencumbered by a requirement to report observations directly to FDA.

Ramifications of direct reports to FDA by accreditation and certification bodies: It is understandable that observations of conditions that could seriously affect public health made by third-party auditors would be reported to FDA. However, careful consideration needs to be given to more fully developing and describing the process for how this is to be accomplished, the lines of communication that need to be opened with the audited entity and the recourse options for facilities and operations.

Domestic food safety audits: As this process moves forward, the industry is anxious to engage the agency to determine what impact this system of limited foreign accreditation and certification might have on universal accredited third-party auditing for domestic fruit and vegetable production.

For more comment highlights, view this PMA TV interview with Bob Whitaker, chief science and technology officer, or read the executive summaries of PMA’s comments by visiting PMA’s FSMA Resource Center.

Originally posted Tuesday, Jan. 28, 2014

Tags: fda, food safety, fsma, pma, united fresh

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