Food safety debate shifts to the Senate

by Jay Sjerven
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WASHINGTON — As Congress reconvened last week, predictably, health care legislation took center stage. But not far behind was food safety reform, where prospects for consensus seemed much greater than in most other legislative arenas.

Before the August recess, the House of Representatives passed the Food Safety Enhancement Act of 2009, H.R. 2749, by a vote of 283 in favor to 142 opposed. The bill passed with the support of 54 Republicans.

After the recess, the debate shifted to the Senate, where the Committee on Health, Education, Labor and Pensions was expected to consider the Food Safety Modernization Act, S. 510, which was introduced by Senator Dick Durbin of Illinois and cosponsored by five Republicans and five other Democrats.

The House and Senate bills were in general agreement on several key points, including facility registration, the need for each facility to have a food safety plan based on HACCP (hazard analysis and critical control point) principles, increased inspection and access to records, traceability and mandatory recall authority. The bills differed in details regarding how those major goals would be accomplished.

Food facility registration was contained in both bills. The House bill called for registration of all food facilities, including warehouses, and the payment of annual fees amounting to $500 per facility. A person or company operating multiple facilities would not be liable to pay more than $175,000 in aggregate fees during each fiscal year. The Senate bill called for biennial registration of food facilities but required no registration fees.

Each bill would provide the Secretary of Health and Human Services (the cabinet secretary responsible for the F.D.A.) authority to suspend the registration of any facility found to be in violation of provisions of the act and outlined procedures for a facility to appeal or regain its registration and hence approval to resume operation.

Both bills called for increased inspection of food facilities with frequency of inspection dependent on risk of the food processed or manufactured and other important risk factors. The House bill would create three categories of food facilities and assign a frequency of inspection to each. Under the bill, a category one facility is a high-risk facility that manufactures or processes food. Such facilities would be inspected at least every 6 to 12 months. A category two facility is a low-risk facility that manufactures or processes food or a facility that packs or labels food. These facilities would be subject to inspection at least every 18 months to 3 years. A category three facility is one that holds food, and the F.D.A. would inspect each facility at least once every five years.

S.510 would require categorization of food facilities according to risk profiles that would consider among other things the food manufactured, processed or packed at the facility; the facility’s history of food recalls, outbreaks and violations of food safety standards, and the rigor of its food safety control plan. The Senate bill would have the F.D.A. inspect each high-risk facility once a year with "non-high-risk" facilities subject to inspection not less often than once every four years.

Both bills would require the collection of fees from a facility should additional inspections be required or to cover the costs resulting from a food recall.

Each bill would require a food facility to prepare, implement and monitor a written food safety plan based on HACCP. Each facility would be responsible for making adjustments to its plan based on a regular reanalysis of operations, which would take place at least every two years under the House bill, every three years under the Senate bill, or more frequently if required.

Food safety plans would be subject to review by the F.D.A., including by inspectors when they inspect a facility. The Senate bill differed from the House bill in that it would provide the secretary of H.H.S. the authority to exempt or modify compliance with this section of the bill with respect to facilities that are solely engaged in producing food for animals or in the storage of packaged foods that are not exposed to the environment.

The House and the Senate bills both would require food processors provide access to all records relating to a food that was suspected of being adulterated or misbranded as long as the request was within reasonable limits with regard to time and manner. Records must be made available at the time of inspection if the facility is notified a reasonable time before the inspection and told what records must be made available.

The House bill further would require high-risk facilities to submit any finished product test results documenting the presence of contaminants in food in possession or control of the facility that pose a risk of severe adverse health consequences or death. This provision would take effect upon completion of pilot projects and a feasibility study or two years after enactment, whichever comes first.

Both bills would provide the F.D.A. with mandatory food product recall authority to be invoked in the event a food company does not promptly respond to a request it recall the food reasonably thought to be adulterated or misbranded and a risk to health.

The House bill included a section requiring the F.D.A. to establish a tracing system requiring manufacturers and handlers of food to maintain "the full pedigree" of the origin and previous history of the food; link that history with the subsequent distribution of the food; establish and maintain a system for tracing food that is interoperable with the systems established and maintained by other such persons; and use a unique identifier for each facility.

S.510 also addressed traceability but limited its scope to produce. It would require a pilot project in coordination with the produce industry to be launched within nine months of enactment. A report on the project must be submitted to Congress within 18 months of enactment, and a trace-back system for produce implemented not later than 24 months after enactment.

Full downloads of both H.R.2749 and S.510 are available on the Library of Congress web site: http://Thomas.loc.gov.

This article can also be found in the digital edition of Food Business News, September 15, 2009, starting on Page 38.

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