Subcommittee's Food Safety Bill Would Increase Penalties, Revise Detention Procedures, Etc.

Full Committee Mark Up Planned for June 17, 2009

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

The following are details of certain penalty, improper import entry filing and administrative detention requirements of the Subcommittee version of H.R. 2749 or (referred to hereafter as H.R. 2749).

Submission of Inaccurate, Incomplete Information, Etc. Would be Prohibited Act

H.R. 2749 would amend the list of prohibited acts in 21 USC 331 to include:

submission of information relating to food that is required by or under Section 801 (Imports and Exports), that is inaccurate or incomplete,

the failure to submit information relating to food that is required by or under Section 801.

(H.R. 2749 would subject customs brokers to new requirements under Section 801, making them subject to the above provision.

Note that the draft version of H.R. 2749 had included as "prohibited acts" the submission of inaccurate or incomplete information required by Section 802 (Export of Certain Unapproved Products or Section 804 (Importation of Prescription Drugs) or the failure to submit information required by those Sections. This newer version does not.)

HHS Could Issue Regulations on Submitting Information for Imported Food

H.R. 2749 would also add a new provision that would allow the Health and Human Services (HHS) Secretary to require by regulation or guidance the submission of documentation or other information for articles of food that are imported or offered for import into the U.S. Such regulation or guidance may specify the format for submission of the documentation or other information.

(Unlike the draft version, this new version of H.R. 2749 does not include drugs, devices, or cosmetics in the above submission of documentation provision.)

Civil Penalties Would Increase for Prohibited Acts, Including Failure to Register

H.R. 2749 would amend Section 303(f) of the Food, Drug, and Cosmetic (FD&C) Act (21 USC 333 - Penalties) so that any person who commits a prohibited act (FD&C Act Section 301-Prohibited Acts) relating to food would be subject to a civil penalty for each such violation of not more than (i) $100,000 (from $50,000) in the case of an individual; and (ii) $500,000 (from $250,000) in the case of any other person. Each violation and each day during which the violation continues would be considered a separate offense.

As H.R. 2749 would make failure of customs brokers to register, etc. a prohibited act, customs brokers would be subject to the above penalty proposal for such a failure.

New Criminal Penalties for Adulterated, Misbranded Foods

H.R. 2749 would add a new paragraph to the criminal penalties provisions in 21 USC 333 which would make any person who knowingly commits the following prohibited acts (Section 301 (a), (b), (c), (k), and (v)) with respect to any food that is misbranded or adulterated subject to imprisonment for not more than 10 years or fined in accordance with 18 USC, or both:

introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded;

adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce;

receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise;

alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded;

introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under FD&C section 413.

(Unlike the draft bill, H.R. 2749 would not revise the U.S. Sentencing Guidelines to reflect the seriousness of violations of the FD&C Act.)

Administrative Detention

Like the draft version, H.R. 2749 would revise the administrative detention provisions in 21USC 334(h) by:

expanding the standard for administrative detention to a "reason to believe that an article is adulterated, misbranded, or otherwise in violation of the FD&C Act" (from the current standard of "credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals").

extending the maximum administrative detention period¹ to 60 days (from 30 days)

extending the period for the FDA to terminate of confirm a detention order after an appeal has been filed.

Seizure Procedures

H.R. 2749 would revise the procedures for seizure in 21 USC 334(b) to state (new text is denoted by ):

The article, equipment, or other thing proceeded against shall be liable to seizure by process pursuant to the libel, and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty; except that on demand of either party any issue of fact joined in any such case shall be tried by jury and except that, with respect to proceedings relating to food, Rule G of the Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture Actions shall not apply in any such case, exigent circumstances shall be deemed to exist for all seizures brought under this section, and the summons and arrest warrant shall be issued by the clerk of the court without court review in any such case.

(Note that the wording of the additional text makes non-substantive changes from the draft bill.)

Quarantine Authority for Foods

H.R. 2749 would amend 21 USC 331 by adding the violation of a quarantine as a prohibited act and would amend 21 USC 334by adding the following new provisions:

Geographic quarantine. If the HHS Secretary determines that there is credible evidence or information that an article of food presents a threat of serious adverse health consequences or death to humans or animals, the Secretary may quarantine any geographic area within the U.S. where the Secretary reasonably believes such food is located or from which such food originated. The authority to quarantine includes prohibiting or restricting the movement of food or of any vehicle being used or that has been used to transport or hold such food within the geographic area.

Quarantine notice. Before any quarantine action is taken in any State under this subsection, the HHS Secretary would be required to notify an appropriate official of the State affected and shall issue a public announcement of (i) the Secretary's findings that support the quarantine action; (ii) the area affected by the intended quarantine action; (iii) the reasons for the intended quarantine action; and (iv) where practicable, an estimate of the anticipated duration of the quarantine. The Secretary would not be required to make such announcement by publication in the Federal Register, but may use a newspaper, radio or television, the Internet, or any reasonable means to make such announcement.

¹if necessary, to enable the HHS Secretary to institute an action under 21 USC 334(a) or Section 302.

(See ITT's Online Archives or 06/12/09, 06/15/09, and 06/16/09 news, 09061205, 09061530 and 09061620, for BP summaries of other aspects of H.R 2749, including importer and broker/filer registration and fees, certification requirements for high risk food imports, facility requirements, etc. See future issues for further BP summaries.

See ITT's Online Archives or 06/11/09 news, 09061105, for BP summary of the House Energy and Commerce Committee's Health Subcommittee's approval of this 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.)

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