Draft Food Safety Bill Would Increase Penalties, Revise Detention Procedures, Etc.

Subcommittee Markup Scheduled for June 10

A mark-up of the measure by the Health Subcommittee (where additional versions of the measure and amendments may be considered) has been scheduled for June 10, 2009. A hearing on the draft was held on June 3, 2009.

The following are highlights of the discussion draft provisions on penalties, improper import entry filings, administrative detention, etc. (See future issues for additional details.)

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

The draft bill would amend the list of prohibited acts in 21 USC 331 to include:

submission of information required by or under section 801 (Imports and Exports), 802 (Export of Certain Unapproved Products), or 804 (Importation of Prescription Drugs) that is inaccurate or incomplete,

the failure to submit information required by or under section 801, 802, or 804

(The draft bill would subject customs brokers to new requirements under Section 801, thereby making them subject to the above provision.)

HHS Could Issue Regulations on Submitting Information for Imported Food

The draft bill would also add a new provision on submission of documentation which would allow the Secretary to require by regulation or guidance the submission of documentation or other information for articles of food, drugs, devices, or cosmetics 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 Penalties Would Increase for Prohibited Acts, Including Failure to Register

The draft bill 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 the draft will 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

The draft bill 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.

Sentencing guidelines would be revised. The draft bill would also revise the U.S. Sentencing Guidelines to reflect the seriousness of violations of the FD&C Act, including the criminal penalties for the violations of the FD&C Act contained in the draft bill.

Administrative Detention

The draft bill 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

The draft bill 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 , 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

The draft bill would amend 21 USC 331 by adding the violation of a quarantine (see below) as a prohibited act.

The draft bill would also amend 21 USC 334 by adding the following new provisions:

Geographic quarantine. If the 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 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 Secretary to institute an action under 21 USC 334(a) or Section 302.

(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.)

Food Safety Enhancement Act of 2009 discussion draft available at http://energycommerce.house.gov/Press_111/20090526/fsea_draft.pdf.