The most sweeping food safety legislation in the U.S. since the 1930’s, the Food Safety Modernization Act, or FSMA, aims to make the FDA more “preventive, not reactive,” said Former U.S. Food and Drug Administration (FDA) Associate Commissioner of Foods Dr. David Acheson during a meeting with Neogen officials.
FSMA was signed into law by President Obama on Jan. 4, 2011, with the goal of modernizing food safety regulations to reflect the increasingly global nature of the U.S. food supply. The law also gives the FDA power to stop unsafe and possibly contaminated food from entering the food supply, instead of its traditional role of reacting to outbreaks.
“The notion of global – that’s where we’re headed,” Dr. Acheson said. “There’s no doubt about that.”
It’s not just the FDA driving FSMA. Consumers have a “zero tolerance” for unsafe food, and it was pressure from them that drove much of the legislation, Dr. Acheson said.
Consumers’ desires are reflected in the legislation, especially in the areas dealing with allergens and reducing risks stemming from imported products. The legislation also has shifted the focus of testing for harmful substances from finished food products to food processing environments.
For the first time, FSMA has identified unlabeled food allergens as an adulterant with bacterial pathogens and other substances known to cause human illness.
Neogen is a global leader in providing rapid food allergen test kits.
“Having a robust program to determine if you have an allergen risk is becoming more important,” Dr. Acheson said.
On the environmental side, Dr. Acheson said the FDA is gaining access to food suppliers’ operations by requiring those who want to distribute products in the U.S. to register with the FDA. According to FDA figures, there are about 254,000 foreign food manufacturers, processors and distributors doing business in the U.S. Domestically, he said there are about 167,000 similar facilities that must register with the FDA. To obtain a registration with the FDA all companies, foreign and domestic, must be audited to ensure the safety of their operations, and to verify their preventive programs work.
The new law also extends the FDA’s reach beyond the U.S. borders to food suppliers seeking to export products into the U.S. This component of the law, Dr. Acheson said, was in part a reaction to several Chinese companies implicated in a scandal involving milk and infant formula adulteratedwith melamine, a chemical compound used in the manufacture of certain plastics. The unscrupulous use of melamine led to hundreds of thousands of people becoming ill, and several deaths.
“Traditionally, the FDA controlled imports at the border, and about 1% of all imports were inspected,” Dr. Acheson said. “So, importers into the U.S. had about a 1 in 100 shot that the FDA would stop their product and inspect it. FSMA allows the FDA to get inside the growers and manufacturers of foods for the U.S. food supply, wherever they are. We are shifting from just taking a snapshot of what is happening at the border to taking a video of the full stream of food processing.”
Currently, FDA proposed rules for produce safety, foreign supplier verification, hazard analysis and preventive controls, and animal food regulations are pending review from the Office of Management and Budget, or OMB.
Although officials hope the rules will clear the OMB soon, it’s difficult to say when they actually will be implemented, Dr. Acheson said.
Earlier this week, the OMB officially extended the review period for the rules on produce safety, foreign supplier verification, hazard analysis, and animal food.
FSMA also provides the FDA with enforcement capabilities that previously did not exist, including mandatory food recalls, expanded administrative detention, suspension of registration, and user fees. The threshold for administrative action by the FDA also has been lowered, Dr. Acheson said.
“Traditionally the FDA had high bar for taking action — credible evidence that possible contamination will lead to illness. That can be hard to prove,” he said. “Now, all that is required is a reasonable probability of misbranded or adulterated product. That’s a much lower bar.”
The combination of new enforcement capabilities and a lower threshold for action has already led to enforcement actions not seen by the FDA in previous years, he said.
About Dr. Acheson
Dr. Acheson is a now a partner at Leavitt Partners, a Salt Lake City-based health care consulting firm, and oversees the company’s food and import safety practice. Dr. Acheson spent seven years at the FDA, serving as chief medical officer at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), director of CFSAN’s Office of Food Defense Communications and Emergency Response, assistant commissioner for food protection, and associate commissioner of foods. Dr. Acheson graduated from the University of London Medical School in 1980 and practiced internal medicine and infectious diseases in the United Kingdom, then shifted to research at Tufts University and the University of Maryland Medical School in Baltimore. Dr. Acheson has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases.
To read more from Dr. Acheson, check out Leavitt Partners’ blog.