House Energy and Commerce Committee's Food Safety Bill Still Requires Importer, Broker/Filer Registration

New Version Would Waive Registration Fee for Brokers/Filers, Etc.

The Committee version of H.R. 2749 (referred to hereafter only as H.R. 2749) retains most of the importer, customs broker and filer registration requirements for food in the Health Subcommittee's previous version, with certain changes:

no registration fee for customs brokers and filers of food;

a set registration fee of $500 for importers of food;

allowing the Secretary of Health and Human Services (HHS) to waive either the registration fee or facility fee for those required to pay both; and

lightening the grounds for suspension of registration by making suspension dependent on "knowing or repeated" inaccurate or incomplete statements or submissions of information relating to imports of food.

Summary of Registration Requirements for Importers, Brokers, Filers

The following is a summary of H.R. 2749's registration requirements for food imports which parallels BP's previous summary of the Subcommittee version. (Note that the changes from the Subcommittee version are underlined.)

Food importers. H.R. 2749 would require importers of food to (i) register with the HHS Secretary; (ii) pay an annual registration fee of $500 in fiscal year 2010 (and adjusted for inflation thereafter); and (iii) comply with good importer practices (including the verification of good manufacturing practices and preventative controls of their foreign suppliers). (Note that the Subcommittee version stated that the HHS Secretary would determine the registration fee amount.)

Customs brokers/filers of imported food. H.R. 2749 would also require customs brokers or filers, with respect to the importation of food, to register with the HHS Secretary. However, the Committee version of H.R. 2749 contains no registration fee for customs brokers and filers of food. (The Subcommittee version would have required a registration fee for customs brokers and filers.)

Personal use and other exemptions. The HHS Secretary, by Federal Register notice, would be required to establish an exemption from the importer, customs broker, and filer registration requirements for importations for personal use. The HHS Secretary would also be able to establish other exemptions.

Fee waiver for importers required to pay facility fee. H.R. 2749 would require the HHS Secretary, in the case of a person who is required to pay both a fee under FD&C Act Section 743 for the registration of one or more facilities under Federal Food, Drug and Cosmetic (FD&C) Act Section 415 and an importer registration fee, to waive one of the fees. (The Subcommittee version would have required the Secretary to waive the lesser of the two fees.)

Failure to register would be prohibited act, food declared misbranded. The failure to register as required (for importers, customs brokers or filers) would be considered a "prohibited act" under FD&C Section 801, and food that is imported or offered for import by an importer or a customs broker or filer not registered as required would be considered "misbranded."

Regulations. The HHS Secretary would be required to promulgate regulations carrying out the importer, customs broker, and filer registration requirement; registration suspension/cancellation; and exemptions provisions discussed above not later than 24 months after the date of the enactment of H.R. 2749.

Effective date. H.R. 2749 states that the importer, customs broker, and filer registration requirements would take effect 24 months after the enactment of H.R. 2749.

Unique facility identifiers. H.R. 2749 would require a unique facility identifier to be submitted at the time of registration for the following:

Persons required to register a facility pursuant to FD&C Act Section 415 -for the facility or establishment.

Food importers, customs brokers, and filers - for the principal place of business.

According to H.R. 2749, the HHS Secretary could, by guidance, specify the unique numerical identifier system to be used to meet the identifier requirements listed above and the form, manner, and timing of a submission.

Refusal of admission for failure to provide identifier. An article of food imported or offered for import would be refused admission unless the appropriate unique facility identifiers are provided for such article.

Suspension of registration. Registration could be suspended, after notice and opportunity for an informal hearing, for a (i) violation of the FD&C Act, or (ii) the knowing or repeated making of an inaccurate or incomplete statement or submission of information relating to the importation of food. (The Subcommittee version of H.R. 2749 did not include the phrase "knowing or repeated.")

An importer, customs broker, or filer would be able to request that a suspension be vacated after corrective action had been taken. The HHS Secretary would be able to vacate a suspension if it is determined that adequate reasons do not exist to continue the suspension.

After required notice, the HHS Secretary would be allowed to cancel a registration that it is not updated or otherwise contains false, incomplete, or inaccurate information. (The registration would not be cancelled if the importer, customs broker or filer updates or corrects its registration within specified time limits.)

Facility, Record Inspections for Food Importers, Customs Brokers, and Filers

H.R. 2749 would amend the factory inspection provision of 21 USC 374 to add new provisions which would require every person engaged in the importing, brokering for import, or filing for import of any food, upon request of an officer or employee designated by the Secretary, to permit such officer or employee at all reasonable times to inspect the facilities of such person and have access to, and to copy and verify, any related records.

¹An amendment in the nature of a substitute is an amendment that strikes out the entire text of a bill or other measure and inserts a different full text.

(See ITT's Online Archives or 06/18/09 news, 09061805, for BP summary of the House Energy and Commerce Committee approving this version of the food safety bill.)

See ITT's Online Archives or 06/11/09, 06/12/09, 06/15/09, 06/16/09, and 06/17/09 news, 09061105, 09061205, 09061530, 09061620, and 09061725, for BP summaries of the Subcommittee version of H.R 2749.

See ITT's Online Archives or 05/28/09, 06/05/09 and 06/09/09 news, 09052815, 09060505 and 09060915, for BP summaries of the "discussion draft" version of H.R. 2749.)

Committee amendment in the nature of a substitute to H.R. 2749 available at http://energycommerce.house.gov/Press_111/20090617/hr2749_ans.pdf.