House members circulate modified food safety bill
June 1, 2009
World Trade\Interactive
Members of the House Energy and Commerce Committee released last week a discussion draft of the Food Safety Enhancement Act of 2009, which is largely based on the food provisions of the Food and Drug Administration Globalization Act of 2009 (H.R. 759) introduced in January. The committee has scheduled a hearing on the measure for June 3.
A committee summary of the discussion draft indicates that it includes the following provisions.
Facility Registration - requires all food facilities operating within the U.S. as well as all importers of foods, drugs and medical devices to register annually with the Food and Drug Administration
Fees - requires registered facilities to pay an annual registration fee of $1,000 (which press reports state is substantially lower than originally proposed), requires registered food facilities to pay for FDA costs associated with reinspections and food recalls, and allows FDA to charge a fee to domestic firms requesting export certificates for exported food
ID Number - creates unique identification numbers for all food, drug and medical device facilities and importers
Increased Inspections - requires high-risk facilities to be inspected at least once every six to 18 months, low-risk facilities to be inspected at least once every 18 months to three years, and warehouses that store food to be inspected at least once every three to four years
Stronger Enforcement - provides FDA with new authority to issue mandatory recalls of tainted foods, strengthens criminal penalties, establishes civil monetary penalties that may be imposed on food facilities that fail to comply with safety requirements, strengthens FDA’s authority to administratively detain unsafe food products, grants FDA quarantine authority under which it may restrict or prohibit the movement of unsafe food products from a particular geographic area, and grants FDA new authority to subpoena records related to possible violations
Expedited Imports - importers meeting voluntary security guidelines developed by FDA for imported foods would receive expedited processing
Country of Origin Labeling - requires all processed food labels to indicate the country in which final processing occurred, requires food manufacturers to identify the country of origin for all ingredients on their Web sites, and requires country-of-origin labeling for all produce
Foreign Government Certification - FDA would be able to require food to be certified as meeting all U.S. food safety requirements by the government of the country from which the article originated or by certain qualified third parties
Safety Plans - requires all food facilities operating within the U.S. or importing food to the U.S. to implement safety plans that identify and protect against food hazards and gives FDA the authority to specify minimum food safety plan requirements and audit food safety plans
Hazard Mitigation Efforts - directs FDA to identify industry and regulatory approaches to minimize hazards in the food supply
Traceability - FDA would have to issue regulations that require food producers, manufacturers, processors, transporters or holders to (a) maintain the full pedigree of the origin and previous distribution history of the food and link that history with the subsequent distribution history of the food and (b) establish an interoperable record to ensure fast and efficient traceback
Expanded Lab Capacity - requires FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories; also gives FDA the ability to require laboratories to send test results to FDA
Foreign Inspectorate - requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, medical devices and cosmetics for U.S. consumers
Infant Formula - enhances FDA’s ability to assure the safety of new infant formulas before they go on the market
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