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House-Passed Food Safety Bill Would Require Establishment of Food Tracing System

On July 30, 2009, the House of Representatives passed the Food Safety Enhancement Act of 2009 (H.R. 2749), a bill to require registration of importers and brokers; generate resources to support FDA oversight of food safety; increase inspections; and require food imports to demonstrate safety; among other things.

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(Although the House has passed H.R. 2749, it is not yet in effect. Generally, in order for a bill to be implemented, identical versions of that bill must be passed by both the House and Senate, and then the bill must be approved (enacted) by the President.)

The following is a summary of the food tracing system provisions of House-passed H.R. 2749. (See ITT's Online Archives or 08/10/09 and 08/04/09 news, 09081015 and 09080415, for BP summaries of the broker and importer-specific requirements of the bill. See future issues of ITT for BP summaries of other aspects of the bill.)

Tracing System Would be Required for Domestic and Imported Food

H.R. 2749 would add a new paragraph to Section 414 of the Food, Drug & Cosmetic Act (FD&C Act) (21 USC 350c) that, in general, would require the Health and Human Services (HHS) Secretary to establish by regulation a tracing system for food that is located in the U.S. or is for import into the U.S.

Violation of a Food Tracing System Requirement Would be Prohibited Act

H.R. 2749 would make the violation of any requirement of the food tracing system a prohibited act under Section 301 of the FD&C Act (21 USC 331).

Food Could be Refused Admission for Certain Recordkeeping Violations, Including for Food Tracing

H.R. 2749 would also require that imported food be refused admission if the requirements of Section 414 of the FD&C Act (Maintenance and Inspection of Records), which would include the food tracing system requirements, were not complied with.

Tracing System Would Identify Each Person Who Grows, Packs, Holds Food, Etc.

The food tracing system established by the HHS Secretary would enable the Secretary to identify each person who grows, produces, manufactures, processes, packs, transports, holds, or sells such food in as short a timeframe as practicable but no longer than 2 business days.

Tracing System Could Require Lot Numbers, Standard Pedigree Format, Etc.

The HHS Secretary could include in the regulations establishing the food tracing system: (i) the establishment and maintenance of lot numbers; (ii) a standardized format for pedigree information; and (iii) the use of a common nomenclature for food.

Only Limited Compliance Needed for Certain Grains, Fish, Etc.

H.R. 2749 would limit the compliance of certain foods with the food tracing system requirements as follows:

Grains or similarly handled commodities. With regard to any "grain or similarly handled commodity"1 the food tracing system would be limited to enabling the HHS Secretary to identify persons who received, processed, packed, transported, distributed, held, or sold the grain or similarly handled commodity from the initial warehouse operator that held the grain or similarly handled commodity for any period of time to the ultimate consumer.

Fish. Food that is produced through the use of a fishing vessel would be exempt from the food tracing system requirements until such time as the food is sold by the owner, operator, or agent in charge of such fishing vessel.

Other. The HHS Secretary could also exempt a food or a type of facility, farm, or restaurant from, or modify the requirements with respect to, the requirements of the food tracing system if the Secretary determines it is not necessary to protect public health.

(For a food or person covered by one of the above three limitations, the HHS Secretary would require each person who produces, receives, manufactures, processes, packs, transports, distributes, or holds such food to maintain records to identify the immediate previous sources of such food and its ingredients and the immediate subsequent recipients of such food.

Note that food that is produced on a farm and sold by the owner, operator, or agent in charge of such farm directly to a consumer or to a restaurant or grocery store would be exempt from H.R. 2749's food tracing requirements.)

Prior to Establishment, Tracing Technologies/Methodologies Would be Assessed

Before issuing a proposed regulation to establish such a food tracing system, the HHS Secretary would be required to identify technologies and methodologies that are, or may be, used by members of different sectors of the food industry for tracing the distribution history of a food.

These would include technologies and methodologies to enable each person who produces, manufactures, processes, packs, transports, or holds a food to:

maintain the full pedigree of the origin and previous distribution history of the food;

link that history with the subsequent distribution of the food;

establish and maintain a system for tracing the food that is interoperable with the systems established and maintained by other such persons; and

use a unique identifier for each facility owned or operated by such person for such purpose.

The HHS Secretary would be also be required to assess, to the extent practicable, the costs and benefits associated with the adoption and use of such technologies; the feasibility of such technologies for different sectors of the food industry; and whether such technologies are compatible with the requirements of H.R. 2749's food tracing system provisions.

Prior to Establishment, HHS Would Conduct One or More Pilot Projects

In addition, before issuing a proposed regulation to create a food tracing system, the HHS Secretary would be required to conduct one or more pilot projects in coordination with one or more sectors of the food industry to explore and evaluate tracing systems for food.

1The term "grain or similarly handled commodity" means wheat, corn, grain sorghum, barley, oats, rice, wild rice, rye, soybeans, legumes, sugar cane, sugar beets, sunflower seed, rapeseed, canola, safflower, flaxseed, mustard seed, crambe, sesame seed, camelina, cottonseed, cocoa beans, grass hay, and honey. In addition, the term may include any other commodity as determined by the HHS Secretary in coordination with the Secretary of Agriculture.

(See ITT's Online Archives or 07/31/09 and 07/30/09 news, 09073110 and 09073005, for BP summaries of the House passing H.R. 2749 and the House failing to pass H.R. 2749 under expedited procedures, respectively.

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.)

H.R. 2749 as passed by the House available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h2749rfs.txt.pdf

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