Food-safety law expands role of FDA, exempts small producers

Stateline Midwest, Volume 20, No. 1- January 2011

For a few days in December, it looked as though technical issues might stop the Food Safety Modernization Act (S. 510) from making its way through the U.S. Congress.

But in one of their final acts of the year, the House and Senate passed the measure and, in the process, set the stage for a major overhaul of the nation’s food-safety system. The bill is designed to prevent outbreaks of foodborne illnesses and to address some of the problems that came to light as the result of recent tomato, egg and spinach recalls.

Its exact impact on states in the Midwest and their food producers won’t be fully known until U.S. Food and Drug Administration rulemaking is complete — a process that the region’s entire agricultural community will be following closely.

Under the new law, the FDA has been given statutory authority to write regulations governing all aspects of the growing, harvesting and processing of 80 percent of the U.S. food supply. (U.S. Department of Agriculture regulations and inspections of meat, eggs or poultry have not been changed.)

Certain provisions in the Food Safety Modernization Act were fairly non-controversial from the start.

For example, more imported foods will be inspected; the FDA will have the authority to deny entry to foods from foreign facilities that have refused U.S. inspections; and, for the first time, imported foods will be subject to the same standards in place for foods made in the United States. Meanwhile, U.S. processing plants will be inspected more frequently (every five years instead of every 10 years), and those considered “high risk” will be checked every three years.

The FDA will also now be able to mandate recalls of suspect food and to track fruit and vegetable shipments — from the fields to grocery stores and restaurants. In addition, it has the authority to develop produce-safety standards on how to grow and raise crops.

And to improve understanding of foodborne illnesses, the federal government will examine the relationship between these illnesses and how the food was made, processed and delivered. (For example, do certain-sized farms or processing plants tend to be linked or not be linked to disease outbreaks?)

Other provisions in the Food Safety Modernization Act expand on registration requirements first implemented by Congress in the 2002 Bioterrorism Act. That 9-year-old measure required facilities that manufacture, process or pack food to register with the FDA, but it exempted “retail food establishments” and farms.

Registration under the Bioterrorism Act has been a “passive,” one-time event. The new law requires biannual registration as well as the development of a Hazard Analysis & Critical Control Points management system, or HACCP.

The idea behind HACCP is to bring an engineering mind-set to food safety: first determine where hazards could occur in production; put procedures in place at these “critical control points”; and then verify that these procedures worked. The FDA has estimated that it will take a trained team 100 hours to develop a HACCP plan for an individual facility.

Without an exemption for size, tens of thousands of local food businesses and small farms already inspected by state and local health departments would have been required to develop HACCP plans.

Concerns about the burden that a mandated HACCP would place on small-scale food businesses and farms led to inclusion of the Tester amendment. Sen. Jon Tester, a Montana rancher, says the amendment “protects the ability for farmers markets to flourish and provide food for people locally.”

It has two distinct pieces: an exemption for qualifying facilities and an exemption for qualifying farms.

Facilities with annual sales of less than $500,000 and that sell at least half of their products directly to consumers, restaurants or institutional buyers within 275 miles of the facility do not have to develop a HACCP plan.

Similarly, a farm that grosses under $500,000 a year and that sells more than half of its products directly to end users is exempt from the HACCP requirement. These small-scale producers are only required to attach a product label or display a sign with the farm’s name and address.

Some small-scale producers also are exempted from the Bioterrorism Act’s registration requirements as well as any new produce-safety standards issued by the FDA.