FDA Seeks Trade Advice to Implement 2013 Supplier Verification System for Food Imports, Etc.

FDA added that as some of the major importer rulemakings are due soon, such as the one on the verification activities importers will have to conduct of their foreign suppliers, it needs early input from the trade to ensure it gets on the right track from the beginning.

Meeting Covered Major FSMA Issues Affecting Importers but Mostly Sought Input

During the meeting, FDA officials briefed the trade on the major FSMA issues affecting importers, including: the foreign supplier verification program (FSVP), the voluntary qualified importer program (VQIP), importer certifications, and third-party auditing. However, most of the meeting was spent seeking suggestions from importers and others on FDA’s implementation of the FSMA measures affecting imports.

Can Submit Comments on Importer Issues Until April 29

FDA stated several times that the agency is interested in public input on issues affecting imports early on in its implementation process. Therefore, the notice announcing the March 29 meeting opened a docket in order to receive comments and suggestions on the FSMA importer issues raised in the notice and during the public meeting. Comments may be submitted until April 29, 2011. (See ITT’s Online Archives or 03/11/11 news, 11031123, for BP summary of the meeting announcement.)

Prevention & Private Sector Responsibility Are Key Principles of New Law

According to FDA, prevention of food safety problems is the core principle of the FSMA and will be the fundamental goal of FDA’s implementation of it. That’s why the law embraces preventive controls as the foundation for the new food safety system.

The second major principal is the recognition that the food industry (producers, growers, importers, transporters, etc.) has primary responsibility for making food safe. That’s why in the context of imports, the law creates such things as the foreign supply verification program, to make importers more accountable for the food they import.

FDA’s Role Is to Lay out Adequate Approaches, Increase Enforcement

FDA’s role is to set the standard for prevention -- to lay out what is considered an adequate approach to keeping food safe. The FSMA also gave it enhanced enforcement powers to make sure the private sector’s approaches are sufficient through increased inspections, mandatory recalls, a lower threshold for administrative detention, etc.

Trade Wants Foreign Supplier Verification to be like Seafood HACCP, Etc.

FDA explains that the new food safety law requires importers to conduct risk-based foreign supplier verification activities to ensure that imported food is not adulterated or misbranded and is produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable. Facilities in compliance with FDA's Hazard Analysis Critical Control Point (HACCP) programs for seafood and juice or its rules for low-acid canned food are exempt in whole or in part from the FSVP requirements.¹ The statute directs FDA to issue implementing regulations and guidance on the FSVP one year after enactment, or by approximately January 4, 2012, and for importers to start conducting the supplier verification activities by approximately January 4, 2013.

The trade suggested the following regarding the FSVP:

Model FSVP after seafood HACCP. Many participants encouraged FDA to model the foreign supplier verification program after the verification activities that importers must take to ensure the safety of imported seafood under the FDA’s HACCP program. In general terms, the HACCP requires importers and their foreign suppliers to have HACCP plans and for importers to take affirmative steps to ensure their suppliers meet the HACCP requirements (including certain inspection of processor facilities, maintaining copies of processors' HACCP plans, periodically testing the products, etc.). Several members of the trade stated that this type of a approach, in which options from a menu of steps are required, is preferable to one that specifies the exact steps that must be taken.

An FDA official stated in March 2011 that the FSVP program would likely be modeled after the seafood HACCP, but officials at this event stated that the agency will be considering both what has and what hasn’t worked in the seafood HACCP as it implements the FSVP.

Guidance needed soon. The trade stressed that they need guidance as soon as possible on the foreign supplier verification program, as this is one of the first parts of the FSMA that takes effect for importers.

Set up FDA-business group. To most successfully implement the FSVP, several participants suggested establishing an FDA-private sector working group to iron out issues as they are being developed. Another suggested keeping the program as simple as possible and making sure there is significant input from U.S. Customs and Border Protection (CBP).

Voluntary Qualified Importer Program Must Offer Real Benefits

The FSMA requires FDA to establish a voluntary, user-fee funded program to expedite entry into the U.S. of imported food from eligible, qualified importers. To be eligible to participate in the VQIP, an importer must offer food for importation from a facility that has a certification by an accredited third party. FDA will qualify eligible importers to participate in VQIP based on risk considerations. The statute directs FDA to issue guidance on participation in and compliance with VQIP, no later than 18 months after enactment or approximately June 4, 2012.

Regarding the VQIP, the trade suggests the following:

Deliver on promises of speed. FDA has to ensure that there are enough resources are at borders so as to actually speed entry for qualified importers as the program promises. They state that speeding up the process, especially for those with perishable food products, would be the most effective incentive to join the program.

Should be available for all countries. One participant stated that an importing company with a strong food safety program should be able to use the qualified importer program no matter what country they are importing from. This statement was likely in response to the fact that FDA will be able to qualify eligible importers to participate in VQIP based on risk considerations.

Accreditation of Auditors and Third-Party Testing System

FSMA directs FDA to establish a system for the recognition of accreditation bodies that accredit third-party auditors to issue certifications for purposes of the import certification for food (which FDA can require for foods/countries it determines are high risk) and VQIP program. Foreign governments, foreign cooperatives, and any other third parties (including private entities) are eligible to be considered for accreditation as third-party auditors. The statute further provides that if FDA has not, within a specified timeframe, identified and recognized an accreditation body to meet the requirements of this provision, FDA may directly accredit third party auditors. The statute directs FDA to issue implementing regulations, no later than two years after enactment or by approximately January 4, 2013.

Regarding the accreditation system that FDA must establish, the trade made the following comments and suggestions:

• Need oversight of auditors. The trade warned that there has to be somebody auditing the auditors, as there is a big difference between auditing systems that have oversight and those that don’t. Several suggested that third-party auditors also need to have some sort of standardized training, evaluation, and continuing education as the system is only as strong as the quality of the auditors.

• Follow CPSC, EPA models. One presenter suggested following the third-party accreditation systems established by the Consumer Product Safety Commission and the Environmental Protection Agency. For example, CPSC accredits third party labs that are accredited by an International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement (ILAC--MRA) signatory accrediting body and whose scope of accreditation explicitly includes testing in compliance with certain CPSC regulations.

• Accommodation for SMEs. Some suggested that there should be some sort of accommodation for small and medium sized enterprises (SMEs) as they may have difficulty affording certification by a third-party auditor.

• Role of foreign governments. A few members of the trade stated that foreign governments should not be allowed to accredit third-party auditors as they may have conflicts of interest. However others said that foreign departments of agriculture with clear divides between their public safety mission and their export promotion mission could provide unbiased accreditation of third-party auditors.

• Not a substitute for inspection. One consumer group warned that third-party auditing and certification should not be a substitute for government inspection. Private, third-party auditors are not accountable to the U.S. public, but the FDA is.

FDA Also Urged to Standardize Operations Across Ports, Increase Its Efficiency

Several participants suggested that FDA take the opportunity presented by the FSMA to rethink and address other FDA problems such as:

Lack of standardization. One participant stated that as part of its reworking of the food safety system, FDA needs to have standardization across ports of entry as there is at least a perception that things are enforced differently at different ports of entry.

Inefficiencies. Another participant stated that FDA should make various changes to improve its efficiency such as implementing a centralized compliance team, updating its databases more quickly, implementing a centralized on-screen review team by mode of transport; and redeploying FDA resources to some of the slower ports.

(Note that the break-out sessions on the VQIP program and certification were not viewable on the webcast, so this summary includes less information on these topics.)

¹FDA must also exempt, by notice in the Federal Register, importers of food imported into the U.S. in small quantities for research uses or for personal consumption.

(See ITT’s Online Archives or 03/11/11 news, 11031125, for BP summary of a related FDA public hearing on March 30- 31, 2011 to provide stakeholders the opportunity to discuss FDA’s use of international comparability assessments to enhance the safety of imported foods and animal, as well as FDA’s efforts to gather information from regulators in other countries.

See ITT’s Online Archives or 03/07/11 news, 11030720, for BP summary of an FDA summary of the FSMA, including the above importer provisions.

See ITT’s Online Archives or 01/04/11 news, 11010426, for a comprehensive BP summary of the FSMA, including the above importer provisions as well as other provisions which will affect imports.

See ITT’s Online Archives or 03/04/11 news, 11030435, for BP summary of an FDA official describing the importer verification activities as similar to those now required for seafood as they will require importers to establish “standards and proof” of compliance.)