Subcommittee Food Safety Bill Would Require Certification for High Risk Food Imports, Allow Program for "Safe Importers," Etc.

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 details of the certification requirement for risky imports, information on a possible program for "safe importers," and other aspects of the Subcommittee version of H.R. 2749 (referred to hereafter as H.R. 2749). (See ITT's Online Archives or 06/12/09 news, 09061205, for BP summary of other aspects of H.R 2749, including importer and broker/filer registration and fees. See future issues for further BP summaries.)

Certification Would be Required for High Risk Foods, Countries, Etc.

H.R. 2749 would require, as an additional entry condition for imports of food articles, that a qualified certifying entity provide a certification that the article complies with specified requirements of the Food, Drug, and Cosmetic Act (FD&C Act) if:

high risk countries/regions - such certification would assist the Secretary of Health and Human Services (HHS) in determining, for food imported from a particular country or region and based on the adequacy of government controls in such country or region or other information relevant to such food, whether to refuse to admit such article.

high risk foods - such certification would assist the HHS Secretary in determining, for types of food which could pose a significant risk to health, whether that food poses such risk; or

agreement requires it - there is an agreement between the HHS Secretary and the government of a particular country providing for such certification.

(A qualifying certifying entity would be defined as: (i) an agency or a representative of the government of the country from which the article originated, as designated by such government or the HHS Secretary; or (ii) an individual or entity determined by the HHS Secretary or an accredited body recognized by the Secretary to be qualified to provide the certification.)

Uncertified subject imports would be refused entry. If a food article requiring such certification were to be imported or offered for import into the U.S. without meeting the certification requirement, it would be refused entry.

In future, uncertified subject imports would be deemed misbranded. In addition, three years after H.R. 2749's enactment, food articles subject to the certification requirement without the certification, would be deemed misbranded which is considered a "prohibited act" under 21 USC 331.

Required information and form. Certification, if required, would need to include such information as the Secretary may specify, and may be provided in the form of shipment-specific certificates, a listing of certified facilities or other entities, or in such other form as the Secretary may specify. The HHS Secretary would be required to provide for electronic submission of the certifications.

Food w/out Certain Country of Origin Labeling Would be Considered Misbranded

Under H.R. 2749, HHS would be required to promulgate final regulations providing that two years after enactment, food would be considered misbranded (which would be a "prohibited act") in the following instances:

for processed food, if the labeling of the food fails to identify the country in which the final processing of the food occurs; and

for non-processed food, if the labeling of the food fails to identify the country of origin.

Knowingly Holding, Distributing Adulterated/Misbranded Food Intended for Import Would be Prohibited Act

H.R. 2749 would make the production, manufacture, processing, preparation, packing, holding, or distribution of an adulterated or misbranded food with the knowledge or intent that such article will be imported into the U.S. a prohibited act.

HHS Could Create a Program for "Safe" Food Importers

Under H.R. 2749, the HHS Secretary could establish by regulation or guidance a program that facilitates the movement of food through the importation process required under H.R. 2749 if the importer of such food:

verifies each facility is in compliance - verifies that each facility involved in the production, manufacture, processing, packaging, and holding of the food is in compliance with the food safety and security guidelines developed as required by H.R. 2749 with respect to such food (see below);

ensures supply chain safety and security controls - ensures that appropriate safety and security controls are in place throughout the supply chain for such food; and

provides supporting info - provides supporting information to the HHS Secretary.

Guidelines for program. For purposes of this program, the Secretary would develop food safety and security guidelines which would take into account: (i) the personnel of the person importing the food; (ii) the physical and procedural safety and security of such person's food supply chain; (iii) the sufficiency of preventive controls for food and ingredients purchased by such person; (iv) vendor and supplier information; (v) other programs for certification or verification by a qualified certifying entity used by the importer; (vi) etc.

(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.