Committee Food Safety Bill Would Still Extend Facility Registration to Exports, Require Facility Food Safety Plans, Etc.
At a June 17, 2009 mark up of the Food Safety Enhancement Act of 2009 (H.R. 2749), the House Energy and Commerce Committee adopted a new version of the measure as an amendment in the nature of a substitute.1
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H.R. 2749 Would Require Facility Registration for Exports, Safety Plans, Etc.
The new version of H.R. 2749 (referred to hereafter only as H.R. 2749) would retain all of the following requirements of the Health Subcommittee's version with respect to facilities:
Facility registration would apply to exports, etc. H.R. 2749 would expand the food facility registration requirement to exports, make food facility registration annual, charge a registration fee, deem food from an unregistered facility misbranded, and allow registration to be suspended 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.
Facility hazard analysis. H.R. 2749 would add new hazard analysis and preventive risk-based controls requirements for all registered food facilities and consider food that was manufactured, processed, held, etc. under conditions not meeting these hazard requirements to be adulterated (which is a "prohibited act" under 21 USC 331).
Facility food safety plans. With certain exceptions, 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 preventive controls in place regarding that analysis.
Notifying HHS of adulterated, misbranded food. Registered facilities would be required to notify the Health and Human Services (HHS) Secretary of the identity and location of an article of food if the responsible party/facility has reason to believe that the article of food is adulterated or misbranded in a manner that has reasonable probability to cause a threat of serious adverse health consequences or death to humans or other animals.
H.R. 2749 Would Add Recall Authority, Allow Certification for Exports
H.R. 2749 would also retain the following requirements of the Health Subcommittee's version with respect to recalls and certification of food exports:
Recalls, etc. Under H.R. 2749, the HHS Secretary, in addition to being able to request voluntary recalls for articles of food that are believed to be 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 other animals.
Certification for food exports. 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 06/16/09 news, 09061620, for detailed BP summary of these provisions as they have not changed in substance from the Subcommittee version of H.R. 2749.)
1An amendment in the nature of a substitute is an amendment that strikes out the entire text of a bill or other measure and inserts a different full text.
(See ITT's Online Archives or 06/30/09, 06/26/09 and 06/25/09 news, 09063015, 09062625 and 09062515, for BP summaries of other aspects of the Committee version of H.R. 2749.
See ITT's Online Archives or 06/18/09 news, 09061805, for BP summary of the House Energy and Commerce Committee approving this version of the food safety bill.)
See ITT's Online Archives or 06/11/09, 06/12/09, 06/15/09, 06/16/09, and 06/17/09 news, 09061105, 09061205, 09061530, 09061620, and 09061725, for BP summaries of the Subcommittee version of H.R 2749.
See ITT's Online Archives or 05/28/09, 06/05/09 and 06/09/09 news, 09052815, 09060505 and 09060915, for BP summaries of the "discussion draft" version of H.R. 2749.)
Committee amendment in the nature of a substitute to H.R. 2749 available at http://energycommerce.house.gov/Press_111/20090617/hr2749_ans.pdf.