Committee Food Safety Bill Would Restructure/Add Penalties Revise Detention Procedures, Etc.

New Version Would Restructure/Add New Civil Penalty, Etc.

The new version of H.R. 2749 (referred to hereafter only as H.R. 2749) would retain most of the requirements of the Health Subcommittee's version with respect to penalties, improper import entry filing and administrative detention, but it would restructure the civil penalties related to food and add a new civil penalty for "knowing" violations related to food.

The following summary of H.R. 2749 parallels BP's summary of the Subcommittee version. (Note that the changes from the Subcommittee version are underlined.)

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 (e.g. registration), making them subject to the above provision.)

Documents or Other Info on Imported Food Could be Required

H.R. 2749 would 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.

Civil Penalty Structure Would be Revised

H.R. 2749 would amend 21 USC 333 (Penalties) so that any person who violates a provision of Food, Drug, and Cosmetic (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) $20,000in the case of an individual, not to exceed $50,000 in a single proceeding; and (ii)$250,000 in the case of any other person, not to exceed $1,000,000 in a single proceeding. 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.

(Note that the current civil penalty is not more than $50,000 in the case of an individual and $250,000 in the case of any other person, not to exceed $500,000 for all such violations adjudicated in a single proceeding. The Subcommittee version called for civil penalties of $100,000 for individuals and $500,000 for other persons.)

New Civil Penalty Would be Created for "Knowing" Violations

H.R. 2749 would also add a new civil penalty for any person who knowinglyviolates a provision of FD&C Act Section 301 (Prohibited Acts) relating to food. The penalty for each such violation would be not more than $50,000 in the case of an individual, not to exceed $100,000 for each such violation in a single proceeding; and $500,000 in the case of any other person, not to exceed $7,500,000 in a single proceeding. Each violation and each day during which the violation continues would be considered a separate offense.

New Criminal Penalties for "Knowingly" Adulterating, Misbranding Foods, Etc.

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, etc., 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.

Administrative Detention

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.

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 an imminent 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. Any quarantine under this paragraph shall be no greater than is appropriate, as determined by the Secretary, to protect the public health.

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.

(See ITT's Online Archives or 06/17/09 news, 09061725, for BP summary of these provisions as laid out in the Subcommittee version of H.R. 2749.)

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 06/26/09 and 06/25/09 news, 09062625 and 09062515, for BP summaries of other aspects of the Committee version of H.R. 2749.

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.