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Defining the Food Safety Modernization Act

January 1, 2011
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The FDA Food Safety Modernization Act (S. 510) passed the Senate with several amendments designed to balance coverage fairly among large, small and medium-sized farms/producers/processors. While there has been much argument about what the 241-page document covers, here are a few specifics.

First, the act doesn’t change the powers of the Federal Meat Inspection Act, Poultry Products Inspection Act or Egg Products Inspection Act; however, it makes no reference to USDA/FSIS-monitored products, e.g., beef, poultry and pork. Second, since the act addresses the responsibility of exporting countries to provide safe food to the US, the US must be allowed to have its own inspectors visit foreign sites when necessary. In addition, there are provisions for electronic data sharing, training of foreign governments and producers, multilateral acceptance of lab methods, testing and detection techniques and “recommendations on whether and how to harmonize with requirements under the Codex Alimentarius.” Third, there is supposed to be increased monitoring of processors under FDA jurisdiction, and electronic recordkeeping will almost be an absolute necessity for fast response times to recalls.

According to Jack Payne, CDC Software vice president of enterprise software, S. 510 will expand the powers of FDA to conduct more frequent inspections and set testing requirements of food facilities, standardize mandatory recalls and the closing of facilities, provide access to additional records and more comprehensive data collection, provide assistance to state and local governments in handling food emergencies and establish new regulations, and ensure imported foods meet the same standards.

“The Tester-Hagen amendment is not the only provision in the final bill that would help small businesses and farmers,” says Jaydee Hanson, senior policy analyst at the Center for Food Safety. “There are provisions from Senators Sanders and Stabenow that would help small processors. Altogether, their amendments introduced some 60 places in the bill where it directs the FDA to help small farmers and processors or exclude them from most of the regulations of the bill.”

With the small staff the FDA has had over the last 10 years or more, frequent inspections haven’t been conducted at plants like Peanut Corporation of America. Hanson isn’t convinced the bill  improves the situation. “The bill does not just protect big Agribusiness, but it does give them a laughable inspection schedule. In the first five years, the most hazardous facilities only have to be inspected once, and then every three years after that,” he states

According to Hanson, the same section on getting foreign governments to do a better job makes clear the bill doesn’t apply to dietary supplements and their ingredients regulated by the Dietary Supplement and Education Act of 1994. The problem is, according to Hanson, that this bill maintains the status quo of some 12 agencies monitoring American’s food products. Hanson thinks a Cabinet-level food safety agency is the best long-term solution.

Concerning electronic recordkeeping, biannual registration for regulated entities is required within five years, says Hanson. Results of food safety tests may be sent to FDA electronically.

Processors that have been certified as GFSI-compliant will have a head start with the new bill, says Payne. “These facilities have already been inspected by certified auditors and should pass FDA inspections with flying colors.” However, for those that are not participating in GFSI certification nor required to participate in HACCP, the new regulations and inspections will present new challenges, he adds.

“It will be the many small regional and local food facilities that will be challenged by the recordkeeping and track and trace regulations that will become law,” says Payne.  “Initially, many of these facilities will not have the resources and expertise to develop HACCP-based food safety plans, nor will they have resources for records maintenance.  In order to comply, they will have to increase prices to cover the additional costs of compliance or risk fines for non-compliance.”

Whether small and medium-sized processors must implement track and trace will depend on how FDA interprets the act and its amendments, says Hanson. FDA is specifically charged with examining “the feasibility of such technologies for different sectors of the food industry, including small business,” according to S. 510.

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