The Food Safety and Modernization Act that has enjoyed strong bipartisan support passed the U.S. Senate on Nov. 30, raising prospects for tougher and more extensive federal inspections and other safeguards. It grants the U.S. Food and Drug Administration (FDA) a number of new powers, including mandatory recall authority, which the agency has sought for many years. In addition, the FDA will have the power to suspend the registration, and thereby suspend the operations, of any food facility if the FDA determines that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
The Food Safety and Modernization Act is divided into four titles: prevention of food safety hazards, detection of and response to food safety problems, improving the safety of imported foods, and miscellaneous provisions. Here are some key provisions of the new law:
- Food facilities are required to register with FDA biennially. Food from an unregistered facility may not be imported into the United States or introduced into interstate or intrastate commerce.
- Registered food facilities are required to conduct hazard analyses and to develop and implement written preventive controls plans.
- Registered food facilities must maintain additional records, including copies of their hazard analyses and preventive controls plans, related records, and additional records to assist the FDA in tracking and tracing high-risk foods.
- Food importers are required to implement foreign supplier verification programs and to take steps to verify that the food they import is safe.
- Food facilities and food importers are subject to new fees, including a fee to be paid by each domestic food facility or importer that undergoes a re-inspection because of a material non-compliance identified during an initial inspection.
- Laboratory tests to be used for regulatory purposes must be performed by either a Federal laboratory or an accredited non-Federal laboratory, and lab test results must be sent directly to the FDA.
- Food facilities will be inspected with greater frequency and not less often than once every 5 years.
Despite the Senate’s passage of the act, it has come to light that the legislators included revenue raisers in this version of the bill, which violates the Constitutional requirement that all revenue related measures originate in the House. According to Roll Call, by pre-empting the House’s tax-writing authority, Senate Democrats appear to have touched off a power struggle with members of their own party in the House. The Senate passed the bill Nov. 30, sending it to the House, but House Democrats are expected to use a procedure known as “blue slipping” to block the bill, according to House and Senate GOP aides.
Section 107 of the bill includes a set of fees that are classified as revenue raisers, which are technically taxes under the Constitution. According to a House GOP leadership aide, that section has ruffled the feathers of Ways and Means Committee Democrats, who are expected to use the blue slip process to block completion of the bill.
The blue slip could lead to one of two likely outcomes. Senate Majority Leader Harry Reid (D-Nev.) could simply drop the issue and let the next session of Congress start from scratch, a strategy that would allow him time in the lame-duck session to tackle other last-minute priorities. Or he could try to force the issue in the Senate after the House passes a new version of the bill. But in order to do that and still tackle the other issues, he would need a unanimous consent agreement to limit debate. According to Senate GOP aides, a unanimous consent agreement is all but certain to be a nonstarter because the bill’s chief opponent, Sen. Tom Coburn (R-Okla.), will not agree to such a deal.
Roll Call article