FDA Q&A on FSMA Food Certifications, Importer and 3rd Party Fees

(The FSMA became law on January 4, 2011. See ITT’s Online Archives or 01/04/11 news, 11010426, for a comprehensive BP summary. This Q&A, which was last updated on April 20, 2011, is also comprehensive and brings out some additional points on fees, certifications, registration, preventive controls, recordkeeping, auditing, etc.)

Foreign Supplier Verification Program

Importers Will Need Program to Verify Suppliers Have FSMA-Equivalent Controls

Under a new Foreign Supplier Verification Program (FSVP), importers will be specifically required to have a program and to conduct risk-based foreign supplier verification activities to verify that imported food is not, among other things, adulterated and that it was produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable.

Will Apply to All Importers and All Food, Unless Exempt

When the FSVP requirements take effect, they will apply to all importers, unless there’s an exemption, and to all food imported by the importer or agent of the importer, unless there’s an exemption.

(For the FSVP program, the FSMA defines “importer” as: (A) the U.S. owner or consignee of the article of food at the time of entry of such article into the U.S.; or (B) in the case when there is no U.S. owner or consignee as described in (A), the U.S. agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the U.S.)

Exemptions for Certain HACCP Compliance, Items in Small Quantities

The FSVP requirements do not apply to a facility if the owner, operator, or agent in charge is subject to, and in compliance with FDA’s seafood, juice, or low-acid canned food products requirements (i.e, the Hazard Analysis Critical Control Point (HACCP) programs). However, the exemption relating to low-acid canned food applies only with respect to microbiological hazards. The statute also directs FDA to exempt, by notice in the Federal Register, food imported into the U.S. in small quantities for research and evaluation purposes or for personal consumption.

Certification and Auditing

Certification Only Needed in Certain Situations

“Certification” differs from the “foreign supplier verification program.” Foreign supplier verification is a general requirement applicable to all food importers, unless there’s an exemption. In contrast, certification is only required in those situations where FDA requires certification. FDA must base its decision to require certification on the risk of the food, including taking into account certain factors specified in the law.

Working on Defining High-Risk Food Needing Certification

FDA is now working on determining how to define and identify high-risk food imports (for certification purposes).

FDA to Establish System for Accrediting Auditors to Issue Certifications

The FSMA directs FDA to establish a system for the recognition of accreditation bodies that accredit third-party auditors to, among other things, issue certifications for purposes of the import certification for food. The statute directs FDA to issue implementing regulations, including provisions on conflicts of interest, financial ties, and unannounced audits, as well as model accreditation standards, including requirements for regulatory audit reports.

Auditors Must Notify FDA of Conditions that Could Pose Serious Risk

The FSMA requires that during an audit, an accredited third-party auditor or audit agent of such auditors must immediately notify FDA if they discover a condition that could cause or contribute to a serious risk to the public health.

Auditors Must Submit Regulatory Audits to FDA

An accredited third-party auditor or audit agent of such auditor will need to prepare an audit report for each audit conducted. In the case of a regulatory audit, which the law distinguishes from consultative audits, it must submit the report to FDA. The law also has a provision whereby FDA may require the submission of certain reports from a regulatory audit and can access the results of a consultative audit in accordance with its records access authority under another provision of the Federal Food, Drug, and Cosmetic Act.

Foreign Governments Can Serve as Third-Party Auditors

Foreign cooperatives and governments agencies are eligible for accreditation as third-party auditors.

FDA Will Consider Int’l Standards When Developing Model Standards

In developing the model standards under the third party auditory accreditation program, there is explicit language in the law that FDA must look to standards in place on the date of the enactment of this section for guidance, to avoid unnecessary duplication of efforts and costs. FDA will continue to consider international standards and leverage with accreditation bodies in developing these standards.

Voluntary Qualified Importer Program

Participants Would Import Food from Certified Facilities for Expedited Entry

Section 302 of the statute requires FDA to establish a user-fee funded voluntary qualified importer program (VQIP) to expedite entry into the U.S. of imported food from eligible, qualified importers. To be eligible to participate in 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 new law directs FDA to issue guidance on participation in and compliance with VQIP.

Registration and Fees

All Facilities Required to Register Must Submit Biennial Renewal from Oct-Dec

Under FSMA, all food facilities that are required to register will need to submit a biennial renewal registration. However, an abbreviated registration process will be available for firms that are already registered, if their registration information has not changed.

The FSMA also amended existing statute to provide that facilities required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

No Fee for Facilities to Register/Renew with FDA

FSMA does not require a registration fee (or registration renewal fee) to be paid by registered facilities.

FDA Will Charge Fee for Reinspection, but not for Initial Inspection

FSMA authorizes FDA to assess and collect fees related to certain domestic food facility, foreign food facility, and importer reinspections. There is no fee for an initial FDA inspection. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems.

Can Collect Fees to Cover Recalls if Importer Doesn’t Comply

FDA has authority to assess and collect fees for food recall activities associated with a recall order when a domestic food facility or importer does not comply with such order.

Can Charge Fee for VQIP, Export Certifications, 3rd Party Accreditation

There are also fees that can be collected for administrative costs of the voluntary qualified importer program, for costs associated with issuing food export certifications and for costs to establish and administer the third-party accreditation program.

Must Publish New Fees by August of Each Year, Amounts yet to Be Determined

The law requires FDA to publish a notice of any new fees in the Federal Register no later than 60 days before the start of each fiscal year. The amount of any of these fees is still to be determined. FDA will publish the fees each August with the methodology used to arrive at those fees.

Inspections and Compliance

Foreign Facility Inspections Must Increase by 2012 and Annually Thereafter

Within one year of the bill’s signing (by January 4, 2012), FDA is to increase inspections of foreign facilities, and then increase that number every year for five years. (See FAQ for information on the increase in domestic facility inspection.)

Can Suspend Facility Registration Which Would Prevent Imports from Facility

The legislation provides FDA authority to suspend a facility’s registration under certain circumstances, which would prevent that facility from introducing any food into commerce in the U.S., including importing or exporting food into the U.S.

More Flexibility in Using Administrative Detention Authority

It also provides more flexibility for FDA in using its administrative detention authority to keep potentially adulterated or misbranded products from entering the marketplace.

New Certification and Denied Entry Authority, to Need New Info on PN

FDA can also deny entry to an import if a foreign facility refuses an FDA inspection, and it can also require certification for high-risk foods. In addition, prior notice submissions will need to include, as an additional element, any country to which the food has been refused entry.

New Mandatory Recall Authority but Will Use It Rarely

FDA is required to first give a responsible party the opportunity to cease distribution and conduct a voluntary recall of an article of food. If the responsible party refuses to or does not voluntarily cease distribution or recall such food within the time and in the manner prescribed by FDA, FDA may proceed under the new mandatory recall authority set forth by the FSMA.

FDA anticipates that this mandatory recall authority will be used in rare instances. Companies will also be provided with an opportunity for an informal hearing before an order to require recall is made.

Preventive Controls

Once Preventive Controls Are in Place, Facilities Should Monitor Them

Preventive controls are scientifically- and risk based-based practices that facilities use to address hazards that their products might be exposed to. Once preventive controls are in place, facilities should monitor them to make sure they are working as they were designed.

Covered Facilities Would Develop Plan Tailored to Their Facility & Food Risks

FDA’s intention is that all covered facilities would need to develop a plan; identify the hazards, identify and implement preventive controls; and then monitor to make certain that the controls work. However, not every facility will have the same hazards or preventive controls. Each plan should be tailored to fit the facility and the risks associated with the facility's food.

Certain Records Would Have to Be Kept for at Least 2 Years

Certain records under the new hazard analysis and preventive controls provisions would have to be kept for at least two years.

CGMPs Will Form Foundation and Should Be Used Until Final Rule Issued

The requirementfor creating and implementing these plans is not effective now and will not be effective before FDA issues a final rule implementing the requirements. Firms need to continue to comply with Current Good Manufacturing Processes (CGMPs). Further, FDA does not anticipate that the new preventive control requirements will replace CGMPs. Rather, CGMPs will form the foundation for preventive controls.

Facilities that Comply with Certain HACCP Programs & Small Facilities Exempt

FSMA provides for exemptions or modified requirements in certain circumstances, such as when a facility is already required to comply and is in compliance with seafood or juice HACCP, or if a facility is very small. FDA states that there is also an exemption for facilities subject to the low-acid canned foods regulations, but the exemption is limited to microbiological hazards, and the preventive control requirements will apply as to other hazards.

Produce Safety

Produce Regulations Must Provide for Flexibility, Recognize Diversity of Industry

In conducting the produce safety rulemaking that is required by the new law, FDA recognizes the tremendous diversity in this industry, in size of operations, growing practices, growing conditions, and more. FDA states that the regulations must provide for flexibility.

Will Provide Outreach to Help Producers Implement Produce Standards

There will be considerable outreach to help producers implement upcoming produce safety standards. FDA is actively working with USDA’s Agricultural Marketing Service and Cornell University in a cooperative effort called the Produce Safety Alliance. FDA will consider collaboration and input from its stakeholders, including academia, industry, and consumers, as an integral part of the success in putting together a meaningful education campaign in this area and ensuring understanding of and compliance with the regulations that will be issued.

Scope

FSMA Covers Pet Food, but FDA Can Modify/Exempt It from Preventive Controls

FDA states that all sections of the law apply to pet food as well, however, it is expressly authorized to modify the preventive controls requirements for facilities that are solely engaged in the production of animal foods or to exempt those facilities entirely from the preventive controls requirements. FDA would need to promulgate a regulation to accomplish such a modification or exemption.

Restaurants & Food Retailers Exempt from Some Provisions, May Have to Comply with FSVP

Some but not all provisions of the law exclude restaurants and food retailers. For example, restaurants and retail food establishments are not required to register with FDA, so they are not subject to requirements for registered facilities, such as preventive controls. However, other provisions could apply to restaurants and food retailers, such as the foreign supplier verification program, which applies to importers.

(See ITT’s Online Archives 04/08/11 news, 11040822, for BP summary of FDA saying that imports, controls and inspection are among its top FSMA priorities.

See ITT’s Online Archives or 03/07/11 news, 11030720, for BP summary of FDA’s overview of the FSMA.

See ITT’s Online Archives or 03/31/11 news, 11033124, for BP summary of FDA seeking input from importers on major FSMA provisions such as the 2012 Supplier Verification System.

See ITT’s Online Archives or 03/04/11 news, 11030435, for BP summary of FDA saying the new food safety law would require importer “standards and proof.”)