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3 July 2009
Congress Moving Quickly to Overhaul Imported Food Safety System

After enacting a sweeping overhaul of U.S. consumer product safety laws in 2008, the U.S. Congress has turned its attention this year to updating the statutory framework for food safety. Incidents involving food and food ingredient products from China were among the major drivers of this effort, and the food safety legislation now moving through Congress will likely have a major impact on producers, manufacturers and exporters in the mainland.

On 17 June, the House Energy and Commerce Committee approved the Food Safety Enhancement Act of 2009, which has undergone a number of revisions in the few short weeks since it was introduced by Committee Chairman Henry Waxman (Democrat-California). This bill requires all food facilities operating within the U.S. and all importers of foods, drugs and medical devices to register annually with the Food and Drug Administration and pay a registration fee. The bill had initially proposed a fee of US$1,000, but after charges that this amount would impose a hardship on small and medium-sized businesses, legislators lowered the fee to US$500 per company. Registered food facilities must also pay for any FDA costs associated with re-inspections and food recalls. Customs brokers handling food imports must register with the FDA as well, but they are not required to pay the registration fee and will not be subject to any good importer practices.

Another key aspect of the bill is a schedule of inspections of food facilities, both foreign and domestic. High-risk facilities must be inspected at least once every six to 12 months, while low-risk facilities are only required to be inspected every 18 months to three years. Warehouses that store food are to be inspected at least once every three to five years. The committee inserted a provision allowing the FDA to modify the inspection schedule for certain producers in order to limit any negative impact. The FDA can prohibit the entry of food products produced, manufactured, processed, packed or held in any farm factory, warehouse or establishment in a foreign country where the owner, operator or agent, or any agent of the governmental authority of that country, delays or limits inspection or refuses to permit entry.

With regard to origin labelling, all processed foods must be labelled to indicate the country in which final processing occurred, while all non-processed foods must be labelled with their country of origin. The bill had initially required food manufacturers to also identify the country of origin of all their ingredients on their Web sites, but that was struck down early in the legislative process.

While many of the bill's provisions are generally aimed at preventing food safety problems, there are also a number of enforcement measures to address incidents that do occur. For example, criminal penalties are raised to a maximum of US$100,000 for individuals and US$500,000 for organisations. The bill newly establishes civil monetary penalties that may be imposed on food facilities that fail to comply with safety requirements, knowingly or otherwise, and allows the maximum penalty to be assessed for each day the violation continues. The FDA itself is granted a host of new or strengthened authorities, including issuing mandatory recalls of tainted foods, detaining unsafe food products; restricting or prohibiting the movement of unsafe food products from particular geographic areas, and obtaining records related to possible violations. The FDA could also 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.

The food safety bill approved by the committee includes a number of other provisions as well, including the implementation of safety plans that identify and protect against food hazards, an expedited entry programme for importers meeting voluntary security guidelines developed by FDA, traceability requirements for food producers, manufacturers, processors, transporters or holders, a requirement for FDA to accept test results only from duly accredited laboratories, and enhanced measures to assure the safety of new infant formulas before they go on the market.