Draft Food Safety Bill Would Assign Customs Brokers Registration, Fee, Other Liabilities

A hearing on the draft was held on June 3, 2009. A mark-up of the measure by the Committee (where additional versions of the measure and amendments may be considered) has not yet been scheduled.

(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.)

Draft Would Require Importers, Customs Brokers or Filers to Register, Pay Fee

The draft would require commercial importers of drugs, devices, and food to register with the Food and Drug Administration annually, maintain good importer practices (including the verification of good manufacturing practices and preventative controls of their foreign suppliers) and to pay an annual registration fee.

The draft would also impose a registration and annual fee requirement on Customs brokers or filers.

Registration could be suspended, after notice and an opportunity for an informal hearing, if the Act is violated or for making an inaccurate or incomplete statement or submission of information relating to the importation of the food, drugs, or devices.

In addition, registration could be canceled (after 10 days of notice) if it is not updated or otherwise contains false, incomplete, or inaccurate information. Such updates or corrections would be required to be made within 7 days of notice.

(Certain electronic registration of foreign facilities would also be required.)

Imported Food, Drugs, Devices Could be Penalized if Failure to Register

The failure to register as required would result in the imported products being declared "prohibited" merchandise and "misbranded."

Registration Would Also Include a Unique Facility Identifier

As a condition of registration, the submission of a unique facility identifier would be required for the principal place of business. (The type of identifier required could be specified by the government, in the absence of this, a Dunn and Bradstreet Universal Numbering System (DUNS) number.)

Imported Food, Drugs, Devices Could be Refused Admission if No Identifier

According to the draft, an article of food, a drug, or a device imported or offered for import would be refused admission unless the appropriate unique facility identifiers are provided for such article.

(See ITT's Online Archives or 03/23/09 news, 09032310, for BP summary on the Committee's plans to move strong food safety legislation. See ITT's Online Archives or 03/09/09 news, 09030915, for BP summary on bipartisan Senate food safety bill. See ITT's Online Archives or 03/03/09 news, 09030310, for BP summary on a House food safety bill, H.R. 999.)

Committee press release available at http://energycommerce.house.gov/index.php?option=com_content&view=article&id=1631:waxman-dingell-and-pallone-release-food-safety-enhancement-act-of-2009-draft&catid=122:media-advisories&Itemid=55 .

Committee summary of discussion draft available at http://energycommerce.house.gov/Press_111/20090526/fsea_summary.pdf

Text of discussion draft available at http://energycommerce.house.gov/Press_111/20090526/fsea_draft.pdf .

BP Note

On June 4, 2009, the National Customs Brokers and Forwarders Association of America, Inc. sent a letter to House Energy and Commerce Committee Chairman Waxman expressing concern about the provisions in the Committee's Food Safety Enhancement Act of 2009 "discussion draft" relating to customs broker registration, payment of an annual fee, and greatly expanded penalty provisions.

According to the press release, the discussion draft would subject customs brokers to fees and a mandatory registration that the Secretary of Health and Human Services could suspend or cancel for certain inaccurate or incomplete statements or submissions of information related to the importation of food, drugs, or devices. In addition, the measure would subject the broker to civil penalties of up to $500,000.

(NCBFAA press release, dated 06/04/09, available at http://www.ncbfaa.org/News/PRdetail.cfm?ItemNumber=9015&navItemNumber=491.)