FDA Issues First Rules

Two new food-safety regulations give agency more authority

Abbie Westra, Director, Editorial, CSP

Four months after President Obama signed it into law, the Food Safety Modernization Act has received the first of its new rules. The U.S. Food and Drug Administration (FDA) issued two regulations last week; both will take effect July 3.

The first rule allows FDA to administratively detain food the agency believes has been produced under insanitary or unsafe conditions for up to 30 days to ensure it is kept out of the marketplace. While the product is detained, FDA will determine whether an enforcement action such as seizure or federal injunction against distribution of the product in commerce is necessary.

[image-nocss]Previously, FDA's ability to detain food products applied only when it had credible evidence that the item was contaminated or mislabeled in a way that presented a threat or serious adverse health consequences or death. FDA would often work with state agencies to embargo a food product under the state's legal authority until federal enforcement action could be initiated in federal court.

"This authority strengthens significantly the FDA's ability to keep potentially harmful food from reaching U.S. consumers," FDA deputy commissioner for foods Mike Taylor said in a statement released by the agency. "It is a prime example of how the new food-safety law allows FDA to build prevention into our food safety system."

The second rule requires anyone importing food into the United States to inform the FDA if any country has refused entry to the same product. With prior notice, in the event of a credible threat for a specific product or a specific manufacturer or processor, the FDA is able to mobilize and assist in the detention and removal of products that may pose a serious health threat to humans or animals.

Signed into law in January, the Food Safety Modernization Act gives the FDA a more proactive and less reactionary role in ensuring safety and sanitation in food processing plants. It empowers FDA to demand food recalls; requires larger food processors and manufacturers to register with FDA and create detailed food-safety plans; and greatly increases the number of inspections the FDA must conduct of processing plants.

While the act directly affects manufacturers and processors more than retailers, the structure clearly advances the mission of science-based food-safety enforcement. It also heightens the awareness and scrutiny of food safety throughout the food chain. Following are some tips for ensuring food-safety compliance in your operations:

  • Engage and open lines of communication with local, state and federal officials in your jurisdiction. Get face time with state officials to show them your food-safety plan and ask, "Where do you see risk?"
  • If you have a commissary, have a third party audit your foodservice facilities, and invite state inspectors to observe the process.
  • Ask state and local chapters of FDA officials, such as the Association of Food and Drug Officials, to help you understand new regulations.
  • When a violation has occurred, conduct a risk-control plan to determine how the problem can be corrected and how to prevent it from happening again.
Abbie Westra, CSP/Winsight By Abbie Westra, Director, Editorial, CSP
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