Senate Committee Food Safety Bill Would Require New Importer Programs and Fees

Similarities and Differences with House-Passed Food Safety Bill

Like the food safety legislation passed by the House in July 2009 (H.R. 2749), S. 510 would require certification for certain high risk food imports; increase food-related inspections; require food facility hazard analysis and preventive controls; institute a program for "safe" food importers; require certain food tracing and food standards; and give the Food and Drug Administration (FDA) new authority.

Unlike the house bill, S. 510 would not require food importers and brokers to register or pay registration fees; would not increase civil penalties; would not introduce as many prohibited acts and reasons for denied entry; and would limit the food tracing and food standards to produce. However, S. 510 contains certain provisions not found in the house bill such as a foreign supplier verification program for importers, new fees, new FDA programs, etc.

The following are highlights of S. 510's provisions with respect to importers (see future issue for bill's provisions on facilities, produce tracing and standards, new agency authorities, etc.):

Importers Would Establish Foreign Supplier Verification Program

Two years after S. 510's enactment, each importer of food would be required to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or its agent is:

produced in compliance with either: (i) the hazard analysis and preventive controls that S. 510 would require food facilities to implement; or (i) the production and harvesting standards that S. 510 would require for certain produce; and

is not adulterated under section 402 of the Food, Drug, and Cosmetic Act (FD&C Act) (21 USC 342) or misbranded under section 403(w) of the FD&C Act (21 USC 343(w)), which covers major food allergen labeling.

(For purposes of this requirement, importer would mean the U.S. owner or consignee of the article of food at the time of entry of such article into the U.S. or if there were no U.S. owner or consignee, 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.)

Regulations for verification program. Not later than 1 year after S. 510's enactment, the Health and Human Services (HHS) Secretary would be required to promulgate regulations to provide for the content of the foreign supplier verification program. The regulations would include a process for verification by an importer with respect to each foreign supplier from which it obtains food that the imported food is produced in compliance with the requirements outlined above and is not adulterated or misbranded.

The verification activities under a foreign supplier verification program could include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.

Lack of verification program. It would be a prohibited act to import or offer for importation a food if the importer does not have in place a foreign supplier verification program. In addition, any article of food that is in violation of the foreign supplier verification program would be refused entry into the U.S.

Deemed compliance for certain programs. A facility that is required to comply with one of the following FDA standards and regulations would be deemed to be in compliance with the foreign supplier verification requirements: (i) the Seafood Hazard Analysis Critical Control Points Program; (ii) the Juice Hazard Analysis Critical Control Points Program; (iii) the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards (or any successor standards).

"Qualified Importer Program" Would Allow for Expedited Reviews, Etc.

Not later than one year after enactment, the HHS Secretary would be required to establish a program and issue guidance, in consultation with the Secretary of Homeland Security, to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in a "qualified importer program."

(For this program, the term 'importer' would mean the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the U.S.)

Eligibility based on risk. In reviewing the applications and making determinations on requests to participate in the program, the HHS Secretary would consider the risk of the food to be imported based on factors, such as the:

nature of the food to be imported;

compliance history of the foreign supplier;

capability of the regulatory system of the country of export to ensure compliance with U.S. food safety standards.

compliance of the importer with the foreign supplier verification program;

recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer;

potential risk for intentional adulteration of the food; and

any other factor that the HHS Secretary determines appropriate.

Required use of certified facilities. In addition, eligibility would be limited to an importer offering food for importation from a facility that has a certification by an accredited third-party auditor that the facility meets the applicable requirements of the FD&C Act (see future issue for details).

Reevaluation and revocation. Any importer determined to be qualified would be reevaluated at least once every three years, and the HHS Secretary would be required to promptly revoke the qualified importer status of any importer found not to be in compliance with the eligibility criteria.

High-Risk Imports Would Have More Inspections, Better Targeting of Resources

S. 510 would require the Secretary, in consultation with the Secretary of Homeland Security to allocate resources to inspect articles of food imported into the U.S. according to the risk profile of the article of food (e.g., the risk of the food and the country of origin, the importer's compliance history, whether the importer participates in the qualified importer program, etc.).

The HHS Secretary would also be required to improve coordination and cooperation with the Secretary of Agriculture to target food inspection resources.

Prior Notice Submissions Would ID Countries that Refused Entry

In addition, not later than 120 days after S. 510's enactment, the HHS Secretary would be required to issue an interim final rule amending 21 USC 381(m)(1) on "prior notice of imported food shipments" to require prior notification of any country to which an article of food has been refused entry.

Access to Importer's Records if Use/Exposure Concerns

The records inspection requirements of 21 USC 350c would be expanded such that if the HHS Secretary believes there is reasonable probability that the use of or exposure to an article of food will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article would be required, upon request to permit a Secretary-designated official, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article of food.

Would Introduce Importer Reinspection Fee, Qualified Importer Fee, Etc.

For fiscal year 2010 and each subsequent fiscal year, the HHS Secretary would be required to assess and collect fees from:

each importer participating in the voluntary qualified importer program who would be required to pay an annual fee to cover the administrative costs of the program; and

each importer subject to a reinspection² in such fiscal year in order to cover reinspection-related costs for such year.

an importer who does not comply with a recall order in such fiscal year to cover food recall activities associated with such order performed by the Secretary, including technical assistance, follow up effectiveness checks, and public notifications.

The above fees would be based on the HHS Secretary's estimate of 100% of the cost of the related activity.

(Note that there is also a provision in S. 510 which states that nothing in S. 510 (or an amendment made by it) could be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the U.S. is a party.)

¹The bill was approved as an amendment in the nature of a substitute which is an amendment that strikes out the entire text of a bill and inserts a different full text. An amendment in the nature of a substitute can be similar to the bill it replaces, or quite different. In this case, it was similar, and only certain minor amendments were made.

²Reinspection for importers would be considered one or more examinations conducted under 21 USC 381 (Imports and Exports) subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved to the HHS Secretary's satisfaction.

(See ITT's Online Archives or 09/01/09, 08/25/09, 08/12/09, 08/10/09 and 08/04/09 news, 09090120, 09082510, 09081205, 09081015 and 09080415, for BP summaries of House-passed H.R. 2749's provisions on: ceramicware, Bisphenol A & infant formula; facilities and exporting; food tracing; broker registration and new reasons to detain food; and importer registration, certification for high-risk imports, and increased inspections.

See ITT's Online Archives or 03/09/09 news, 09030915, for BP summary of S. 510 as introduced in the Senate in March 2009.)

S. 510 as ordered reported with an amendment in the nature of a substitute available at http://help.senate.gov/Hearings/2009_11_18_E/WHI09A06.pdf