House Fails to Pass Food Safety Bill by 2/3 Vote, to Try Again on July 30 (Corrected Version)

On July 29, 2009, the House of Representatives failed to pass as an amendment in the nature of a substitute¹ the Food Safety Enhancement Act of 2009 (H.R. 2749) under a suspension of the rules, which requires a two-thirds majority vote for passage.

1. yea votes were needed to pass the measure, but only 280 yea votes were cast.

The House is scheduled to again take up this amendment in the nature of a substitute on July 30, 2009. No amendments will be allowed and only a simple majority vote is required for passage.

The following are excerpts taken from the bill (as of July 29, 2009) and a House Committee on Energy and Commerce summary:

Brokers Would Not be Subject to Civil Penalties for Certain Violations Relating to Food

H.R. 2749 has a new paragraph stating that a customs broker would not be subject to civil penalties under section 303 (penalties) of the Food, Drug, and Cosmetic Act (FD&C Act) for violations of the following prohibited acts of section 301 of the FD&C Act:

Failure to submit information - the failure to submit information relating to food required by section 801 of the FD&C Act (including failure to submit registration information or unique facility identifiers with the Health and Human Services (HHS) Secretary);

Incomplete/inaccurate information - incomplete or inaccurate submission of information relating to food that is required by section 801 of the FD&C Act (including inaccurate or incomplete registration information or unique facility identifier information);

Failure to register - the failure of a customs broker to register in accordance with section 801(t) of the FD&C Act.

(Section 301 currently lists approximately 50 prohibited acts. The above three would be newly added prohibited acts.)

Misbranding due to failure of broker to register. In addition, a customs broker who violates section 301 because of misbranding that results from his failure to register, would not be subject to civil penalties.

New and Increased Civil Penalties for Violations Relating to Food

Except as noted above, H.R. 2749 would amend section 303 of the Act to require that any person who violates a provision of section 301 relating to food would be subject to a civil penalty for each such violation of not more than $20,000 in the case of an individual, not to exceed $50,000 in a single proceeding; and $250,000 in the case of any other person, not to exceed $1,000,000 in a single proceeding.

"Knowing" violations. In addition,any person who knowingly violates a provision of section 301 relating to food would be subject to a civil penalty for each such violation of not more than $50,000 in the case of an individual, not to exceed $100,000 in a single proceeding; and $500,000 in the case of any other person, not to exceed $7,500,000 in a single proceeding.

Separate offense. Each violation and each day during which the violation continues would be considered a separate offense.

New Criminal Penalties for Violations Relating to Food

H.R. 2749 would amend section 303 to require, among other things, that any person who knowingly violates paragraph (a), (b), (c), (k) or (v) of section 301 with respect to any food that is misbranded or adulterated would be imprisoned for not more than 10 years or fined in accordance with 18 USC, or both.

(Paragraphs (a), (b), (c) and (k) have to do with adulterated or misbranded food in interstate commerce. Paragraph (v) has to do with unsafe dietary supplements in interstate commerce.)

Importer, Broker, Facility Registration Would be Required

H.R. 2749 would require the registration of all importers and customs brokers of food as well as food facilities with HHS two years after enactment, though customs brokers would not be required to pay the registration fee.

Importer registration. H.R. 2749 would require all importers of foods to register with HHS annually and to pay a registration fee in the amount of $500. An importer that is also a registered facility (see below) would only be subject to one fee. Each registered importer would be required to comply with good importer practices, which would be developed by regulation by the HHS Secretary, in consultation with U.S. Customs and Border Protection (CBP).

An importer's registration could be suspended, if the importer is found in violation of the FD&C Act or found to have knowingly or repeatedly made inaccurate or incomplete statements or submissions of information related to the importation of food. An importer's registration could also be canceled if the registration was not updated correctly or contains false, incomplete, or inaccurate information.

Customs broker registration - no fee. Customs brokers, with respect to the importation of food, would be required to register with HHS in a form and manner specified by the HHS Secretary and submit appropriate, unique facility identifiers as a condition of registration, but would not be required to pay a registration fee.

CORRECTION IS UNDERLINED BELOW:

The HHS Secretary would be able to cancel a customs broker's registration, after notice to the customs broker and CBP, if the customs broker's registration is not updated or otherwise contains false, incomplete, or inaccurate information.

(Note that H.R. 2749 no longer has a provision allowing for suspension of customs broker registrations for knowing or repeatedly making of inaccurate or incomplete statements or submissions of information related to the importation of food.)

Facility registration. H.R. 2749 would also require annual registration for food facilities and payment of annual fee of $500 for each facility (not to exceed $175,000 for an individual company). For foreign facilities, the U.S. agent for the facility would have to be provided. H.R. 2749 would also extend the food facility registration requirement to exports. Facility is defined to include any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. (Farms, restaurants, etc. are not considered facilities.)

The HHS Secretary would be authorized to suspend the registration of a facility for a violation of the FD&C Act that could result in serious adverse health consequences or death. The HHS Secretary would also be able to cancel a registration that was not updated or otherwise contains false, incomplete, or inaccurate information, or if the required registration fee has not been paid within 30 days after the due date.

HHS Could Create a Program for "Safe" Food Importers

H.R. 2749 would permit the HHS Secretary to establish by regulation or guidance, in coordination with CBP, a program to facilitate the movement of food through the importation process if the importer of such food verifies that each facility involved in the production, manufacture, processing, packaging, and holding of the food has been determined to be in compliance with food safety and security guidelines developed by the HHS Secretary, in consultation with CBP.

The HHS Secretary would also be required to take into account other relevant federal programs in developing such guidelines.

Brokers, Filers, Etc. Would Notify HHS of Serious Food Threats

H.R. 2749 would require food facilities, importers, customs brokers, and filers that have reason to believe that an article of food is adulterated or misbranded in a manner that presents a reasonable probability that the use or consumption of, or exposure to, the article will cause a threat of serious adverse health consequences or death to humans or animals to notify the HHS Secretary of the identity and location of the article as soon as practicable.

USDA-Regulated Meat, Poultry, Eggs Would be Exempt from H.R. 2749

A food (and its corresponding facility) would be exempt from the requirements of H.R. 2749 to the extent such food is regulated by the Secretary of Agriculture under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.

¹An amendment in the nature of a substitute is an amendment that strikes out the entire text of a bill and inserts a different full text. An amendment in the nature of a substitute can be similar to the bill it replaces, or quite different.

(See ITT's Online Archives or 07/08/09, 07/02/09, 06/30/09, 06/26/09, and 06/25/09 news, 09070820, 09070210, 09063015, 09062625 and 09062515, for BP summaries of various aspects of the House Energy and Commerce Committee version of H.R. 2749.)

House Committee on Energy and Commerce short bill summary (dated July 2009) available at http://energycommerce.house.gov/Press_111/20090729/hr2749_floorsummary.pdf

House Committee on Energy and Commerce section-by-section bill summary (dated July 2009) available at

http://energycommerce.house.gov/Press_111/20090729/hr2749_sectionsummary.pdf

H.R. 2749 amendment in the nature of a substitute available at http://www.rules.house.gov/111/SpecialRules/hr2749/111_substitute_hr2749.pdf