Subcommitee Food Safety Bill Would Extend Facility Registration to Exports, Require Facility Food Safety Plans, 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. 2749 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 certain facility requirements, including extended registration and food safety plan requirements, of the Subcommittee version of H.R. 2749 (referred to hereafter as H.R. 2749). (See ITT's Online Archives or 06/12/09 and 06/15/09 news, 09061205 and 09061530, for BP summaries of other aspects of H.R 2749, including importer and broker/filer registration and fees, certification requirements for high risk food imports, etc. See future issues for further BP summaries.)

Facility Registration Would Also Apply to Exports, Become Annual, Etc.

H.R. 2749 would amend the registration requirements of 21 USC 350(d)(a) that state that any facility (i.e., any factory, warehouse, or establishment, including those of importers) that engaged in manufacturing, processing, packing, or holding food for consumption in the U.S. must be registered with the Health and Human Services (HHS) Secretary by: (partial list):

Expanding requirement to exports. H.R. 2749 would require that any facility engaged in manufacturing, processing, packing, or holding food for consumption for export from the U.S. also be registered with the HHS Secretary.

Making registration annual, charging fee. Any food facility (whether for imports or exports) that is required to register would be required to do so on or before December 31st of each year. H.R. 2749 would also require an annual registration fee for these facilities of $500 for fiscal year 2010, and adjusted annually thereafter for inflation.

Requiring more info. The facility would also need to include more information than is currently required in the registration process including: the primary purpose and business activity of the facility, the general food category of each food manufactured, processed, packed or held at the facility, 24-hour emergency contact information, a unique facility identifier, etc.

Registration could be suspended. H.R. 2749 would allow for suspension of facility registration for violations of the Food, Drug, and Cosmetic Act (FD&C Act) that could result in serious adverse health consequences or death to humans or animals.

Unregistered food would be deemed misbranded. Under H.R. 2749, food that was manufactured, processed, packed, or held in a facility that is not duly registered, including a facility whose registration is canceled or suspended, would be considered misbranded (which is a "prohibited act" under 21 USC 331).

(See ITT's Online Archives or 06/12/09 news, 09061205, for BP summary of other H.R. 2749 registration requirements specific to importers, customs brokers or filers of imported food.)

Hazard Analysis Would be Required for Any Registered Facility

H.R. 2749 would add new hazard analysis and preventive risk-based controls requirements for owners, operators, or agents of facilities (any domestic or foreign facility¹ required to meet the above registration requirements) including: conducting a hazard analysis, identifying and implementing effective preventive controls; monitoring the controls; instituting corrective action when necessary; conducting verification activities; recordkeeping; and reanalyzing hazards every two years or less.

Food not meeting hazard requirements. Food that was manufactured, processed, packed, transported, or held under conditions not meeting these hazard requirements would be considered adulterated, which is a "prohibited act" under 21 USC 331.

Regulations or guidance. The HHS Secretary would be required to issue regulations or guidance to establish science-based for conducting a hazard analysis, documenting hazards, implementing preventive controls, etc.

Food Safety Plan Would be Required for Registered Facilities Before Food Introduced in Interstate Commerce

In addition, before a registered facility could introduce or deliver for introduction into interstate commerce any shipment of food, H.R. 2749 would require it to develop and implement a written food safety plan that includes the hazard analysis described above along with a description of the procedures and controls in place regarding that analysis.

In addition, the food safety plan would require descriptions of the facility's procedures for (partial list): (i) the recall of articles of food; (ii) tracing the distribution history of articles of food, (iii) ensuring a safe and secure supply chain for the ingredients or components used in making the food manufactured, processed, packed, transported, or held by such facility; and (iv) other information.

Possible exceptions. The Secretary could, by regulation, exempt or modify the requirements for compliance with the food safety plan with respect to facilities that are solely engaged in: (i) the production of food for animals other than man or the storage of packaged foods that are not exposed to the environment; or (ii) the storage of raw agricultural commodities for further processing.

HHS Would Have to be Notified of Identity, Location of Adulterated or Misbranded Food

H.R. 2749 would require responsible parties or registered facilities to notify HHS as soon as practicable of the identity and location of an article of food if the party/facility has reason to believe that the article of food, when introduced into or while in interstate commerce or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that presents a reasonable probability that the use or consumption of, or exposure to, the article (or an ingredient or component used in any such article) will cause a threat of serious adverse health consequences or death to humans or animals.

HHS Could Request Voluntary Recalls, Could Issue Cease Distribution Orders

Under H.R. 2749, the HHS Secretary, in addition to being able to request voluntary recalls for articles of food that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of the FD&C Act, would also be able to issue an immediate cease distribution order if the Secretary has reason to believe that the use or consumption of, or exposure to, an article of food may cause adverse health consequences or death to humans or animals.

Exporters of Food/Feed Could Request Certification of Compliance from HHS

H.R. 2749 would also allow any person who exports food (including animal feed) from the U.S. to request the HHS Secretary to certify that the food meets the applicable requirements of the FD&C Act, based on whatever criteria the HHS Secretary determines appropriate. (The FD&C Act already allows for such certification for exported drugs, animal drugs, or devices.)

(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.