The most sweeping changes in Food and Drug Administration (FDA) oversight of American food safety in more than 70 years were enacted by Congress during the final days of 2010.
The Food Safety Modernization Act of 2010 was passed by Congress and sent to President Barack Obama, who signed it after returning from his holiday vacation at the beginning of the year. This bill is important to the feed and pet food industries, and an industry coalition was able to get several “firewalls” included to ensure human food regulations are not inappropriately applied to animal feed and pet foods.
Under new broad authority granted in the Performance Standards section, the Secretary of Health and Human Services and the FDA commissioner, when writing rules to implement new authority, “shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans.”
The new law carries several additional requirements for FDA to recognize sourcing and production practices unique to the feed industry, including the need to buy ingredients from elevators and others who commingle grains and oilseeds from several farms, and to ensure FDA can exempt the feed and pet food industries from certain regulations when appropriate.
Also in the law is new FDA authority to recognize and officially approve the use of third-party compliance, inspection, and testing organizations as part of compliance regimens. The National Renderers Association (NRA) is confident that the Rendering Code of Practice will be recognized as such a regimen.
The new law does not impose registration fees on companies as the House-passed bill authorized, another major victory for the agriculture/food industry coalition in which NRA participated. The law does authorize user fees to pay the government’s cost of a mandatory recall, facility re-inspections, export certification, and the voluntary importer inspection program.
The new law gives FDA first-time mandatory recall authority, but with administrative protections for regulated industry. The new law requires all companies currently registered under the Bioterrorism Act to re-register every other year with the agency and to develop written, risk-based food hazard control plans.
The feed industry coalition worked successfully to ensure current good manufacturing practices such as those in the Rendering Code of Practice recognized by FDA’s Center for Veterinary Medicine qualify as risk-based controls. The agency will have greater access to registered company records, the ability to trace back contaminations, a voluntary expedited import control program, and penalties are increased.
There is much more work ahead as many of the sections of the new law require rulemaking and compliance guide development by FDA.
The bill is expected to cost about $1.4 billion over the next five years, and includes funding for 2,000 new FDA inspectors. FDA regulates 80 percent of the nation’s food.
February 2011 RENDER | back