Subcommittee Food Safety Bill Contains Importer, Broker/Filer Registration, Fee Provisions

During the markup of H.R. 2749, the Health Subcommittee adopted an amended version of H.R. 2749 (an amendment in the nature of a substitute).

Full Committee Mark Up Planned for June 17, 2009

The House Energy and Commerce Committee Chairman has stated that he plans to hold a full Committee mark up of H.R. 2479 on June 17, 2009. Additional amendments or another version of H.R. 2749 could be adopted at that mark up.

The following are highlights of certain importer, customs broker, filer registration and fee requirements from the Subcommittee version of H.R. 2749 (referred to hereafter as H.R. 2749). See future issues for summaries on additional aspects of H.R. 2749.

New Registration and Fee Requirements for Importers, Customs Brokers, Filers

H.R. 2749 would impose registration and fee requirements as follows:

Food importers. H.R. 2749 would require importers of food to (i) register with the Secretary of Health and Human Services (HHS); (ii) pay an annual registration fee; and (iii) comply with good importer practices (including the verification of good manufacturing practices and preventative controls of their foreign suppliers).

(Note that the draft version of the bill would have applied the registration and fee requirements to importers of food, drugs, or devices. The Subcommittee's version limits the provision to food.)

Customs brokers or filers for imported food. H.R. 2749 would also require customs brokers or filers, with respect to the importation of food to (i) register with HHS Secretary; and (ii) pay an annual registration fee.

(Note that the Subcommittee's version would limit the registration requirement to the importation of food. The draft version did not make such a distinction.)

Personal use and other exemptions. The Secretary, by Federal Register notice, would be required to establish an exemption from the importer, customs broker, and filer registration requirements in H.R. 2749's Section 205(a) for importations for personal use. The HHS Secretary would also be able to establish other exemptions.

Fee. According to H.R. 2749, for FY 2010 the fee would be set by the HHS Secretary and would be adjusted in subsequent years based on a formula specified in the legislation. (See bill text for details on the fee's collection, etc.)

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 783 for the registration of one or more facilities under FD&C Act Section 415 and an importer registration fee, to waive the lesser of the two fees.

Failure to register would be a prohibited act, food declared misbranded. The failure to register as required would be considered a "prohibited act" under Federal Food, Drug and Cosmetic (FD&C) Act 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 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:

Person 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.

(Note that the Subcommittee's version does not contain the reference to registration of a facility pursuant to FD&C Act Section 510 contained in the draft bill.)

According to H.R. 2749, the HHS Secretary may, 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.

(Note that in the draft version, the identifier would have been a Dunn and Bradstreet Universal Numbering System (DUNS) number), in the absence of a HHS Secretary-specified type of identifier.)

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.

(Note that in the draft version, this provision would have refused admission to food, drugs, or devices offered for import without the appropriate identifier, but the Subcommittee version applies it only to food.)

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 making of an inaccurate or incomplete statement or submission of information relating to the importation of food.

(Note that the draft version of this provision contained references to devices and drugs (in addition to food) which were subsequently removed.)

An importer, customs broker, or filer would be able to request that a suspension be vacated after corrective action has been taken. The HHS Secretary would be able to vacate a suspension if it determines 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 a new provision 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.

(See ITT's Online Archives or 06/11/09 news, 09061105, for BP summary of the Energy and Commerce Committee Health Subcommittee's approval of an amended version of H.R. 2749.

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See ITT's Online Archives or 06/09/09 news, 09060915, for BP summary of the penalty, detention, etc. provisions in the "discussion draft."

See ITT's Online Archives or 06/05/09 news, 09060505, for BP summary of certain of the discussion draft's provisions affecting customs brokers.

See ITT's Online Archives or 05/28/09 news, 09052815, for initial BP summary of the discussion draft based in the Committee's summary. See future issue for detailed summary of these provisions and other trade-related aspects of discussion draft.)

Health Subcommittee's version of H.R. 2479 available at http://energycommerce.house.gov/Press_111/20090610/hr2749_ans.pdf.