FDA Revises Proposal on Foreign Supplier Verification Requirements for Importers, Other FSMA Rules

September 19, 2014 by Tim Warren|Top News

The Food and Drug Administration is proposing to revise its previous proposed rules for several Food Safety Modernization Act regulations. The revised proposed rules involve the foreign supplier verification programs (FSVP), manufacturing practices for human and animal foods and produce safety. Comments on the proposed revisions are due within 75 days of publication in the Federal Register, scheduled for Sept. 29. "FDA is proposing new ways to make the original proposals more flexible, practical and targeted," it said.

The new proposal would eliminate two requirements for importers to review the risks associated with foods and foreign suppliers, said the notice (here). "We are issuing these revisions in response to extensive public input we have received regarding these provisions and in alignment with" with other changes to FSMA rule proposals, the agency said. After considering a number of concerns submitted in the public comments, " we tentatively conclude that it is appropriate to more clearly specify that importers must consider certain information relevant to the risks associated with a food and the foreign supplier," said the notice. The agency is instead "incorporating these compliance concerns into the proposed risk evaluation requirements." The agency previously made a proposal on FSVP in July of 2013 (see 13072628).

Revised Compliance Considerations for FSVP

The revised regulatory text for FSVP would require importers to consider:

The entity that will be applying controls for the identified hazards, such as the foreign supplier or the foreign supplier’s raw material or ingredient supplier. FDA believes that the person who will be controlling a hazard in a food is an important, though not necessarily the only, factor in determining an appropriate supplier verification activity for the food.

The foreign supplier’s procedures, processes, and practices related to the safety of the food. Many comments stated that various aspects associated with the manner in which a foreign supplier produces a food can affect the risk associated with the supplier.

Applicable FDA food safety regulations and information regarding the foreign supplier’s compliance with those regulations, including whether the supplier is the subject of an FDA warning letter or import alert. Documents such as warning letters and import alerts are available on FDA’s website. The agency proposal would not require importers to consider non-public information regarding compliance with FDA regulations unless such information was available to the importer (e.g., provided to the importer by the foreign supplier).

The foreign supplier’s food safety performance history, including results from testing foods for hazards, audit results relating to the safety of the food, and the supplier’s record of correcting problems.

Any other factors as appropriate and necessary, such as storage and transportation practices. There might be factors not previously specified that in certain circumstances an importer should consider in evaluating food and supplier risks, such as storage and transportation practices or recent changes to the management of a foreign supplier.

The FDA intends "to issue guidance on the specific information that we believe should be considered under each of these factors and how these factors might be weighed in evaluating overall risk," it said.

Hazard Analysis

The revised FSVP proposal would also change the requirement to analyze hazards that are reasonably likely to occur to a requirement to analyze known or reasonably foreseeable hazards to determine if they are significant, it said. "Under the revised proposal, a significant hazard would be defined as a known or reasonably foreseeable hazard in a food for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis, establish controls to significantly minimize or prevent and components to manage those controls (such as monitoring, corrections and corrective actions, verification, and records), as appropriate to the food, the facility, and the control."

Changes to Supplier Verification Measures

Rather than requiring importers to maintain a list of their foreign suppliers, "importers would be required to establish and follow procedures to ensure that they import foods only from foreign suppliers that they have approved (except, when necessary and appropriate, from unapproved suppliers on a temporary basis)." it said. "Consistent with the revised proposal’s focus on a broader evaluation of risks, we are proposing that, rather than being designed to ensure that identified hazards are adequately controlled, the purpose of importers’ supplier verification activities should be to provide adequate assurances that the foreign supplier produces the food in a manner consistent with FDA’s regulations on preventive controls or produce safety, if either is applicable to the foreign supplier, and to assure that the food is not adulterated and not misbranded regarding allergen labeling."

The importer would also be required to determine and document what and how frequent supplier verification activities are appropriate for a food and foreign supplier, based on the risk evaluation the importer conducts. Appropriate activities could include "onsite auditing of the foreign supplier, sampling and testing of food, review of the supplier’s food safety records, or some other procedure determined to be appropriate based on the identified risks." If there is a hazard could result in serious adverse health consequences or death to humans or animals, "an importer would need to conduct or obtain documentation of an onsite audit of the foreign supplier before initially importing the food and at least annually thereafter, unless the importer specifically determined that some other supplier verification activity and/or less frequent auditing would adequately address the identified risks," the agency said. This would "establish a clear verification standard for these most serious food hazard," it said.

The new proposal also says that if a foreign supplier is a farm that is not subject to the produce safety regulations, the importer of food from the supplier would not be subject to the “standard” verification requirements previously noted but would instead be required to obtain written assurance of compliance biennially, it said. Additionally, the revised rule would also say that "when importers or their customers are in compliance with the requirements on supplier programs in the proposed preventive controls regulations, the importers would be deemed in compliance with most of the FSVP requirements."

Other Changes

According to a fact sheet on the FSVP changes (here), to make the proposed rule consistent with the revisions to the proposed rules on preventive controls for human food and preventive controls for animal Food, FDA revisions include:

changing the definitions of “very small importer” and “very small foreign supplier” to having no more than $1 million in annual food sales rather than the previously proposed limit of $500,000 in annual food sales, and
deeming that importers that operate food facilities in compliance with any potential supplier verification provisions that may be included in the preventive controls rules are in compliance with any parallel FSVP requirements to avoid duplicative regulations.

See future issues of ITT for detailed summary of the other proposed rules.

(Federal Register 09/29/14)