FDA Issues First New Food Safety Rules

Articles
May 10, 2011

FDA Issues First New Food Safety Rules

The first two rules by Food & Drug Administration under the new authorities granted the agency by the FDA Food Safety Modernization Act (FSMA) were published in the May 5th Federal Register and will take effect July 3rd, in fewer than 60 days, reports The Food Institute. Both will be discussed at the initial segment of The Food Institute’s Food Safety Modernization Act Washington Update Webinar Series on May 25. Comments on the interim rules will be accepted until Aug. 3rd however, thus changes may be instituted after they are implemented.

The first two rules by Food & Drug Administration under the new authorities granted the agency by the FDA Food Safety Modernization Act (FSMA) were published in the May 5th Federal Register and will take effect July 3rd, in fewer than 60 days, reports The Food Institute. Both will be discussed at the initial segment of The Food Institute’s Food Safety Modernization Act Washington Update Webinar Series on May 25. Comments on the interim rules will be accepted until Aug. 3rd however, thus changes may be instituted after they are implemented.

The rule covering Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption strengthens FDA's ability to prevent potentially unsafe food from entering commerce. Section 207 of the FSMA relaxes the criteria for administrative detention of food. Previously, FDA could detain an article of food only if it had “credible evidence” the food posed a threat of serious adverse health consequences or death to humans or animals. Under the amended statute and regulations, FDA may detain an article of food if FDA has “reason to believe” the article is adulterated or misbranded.
 
According to FDA, decisions regarding whether it has a reason to believe a food is adulterated or misbranded “would be based on a case-by-case basis because such decisions are fact specific.” FDA notes it has never administratively detained any food. However, FDA states it is more likely to use this authority under the new criteria in situations where use of or exposure to the food may cause temporary or medically reversible health consequences but the probability of serious adverse health consequences is remote.

Beginning July 3rd therefore, FDA will be able to detain food products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace. The products will be kept out of the marketplace while the agency determines whether an enforcement action such as seizure or federal injunction against distribution of the product in commerce is necessary.

Before this new rule, the 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. In keeping with other provisions in the FSMA, FDA stated it will continue to work with state agencies on food safety and build stronger ties with those agencies.

The second rule regarding prior notice of imported foods requires anyone importing food into the U.S. to inform the FDA if any country has refused entry to the same product, including food for animals. This new requirement will provide the agency with more information about foods that are being imported, improving FDA's ability to target foods that may pose a significant risk to public health.
Section 304 of the FSMA requires one item of additional information in the prior notice submitted to FDA for each article of imported food. The prior notice must now include “any country to which the article has been refused entry.” FDA said it believes this information will help the agency make better-informed decisions in managing the potential risks posed by imported foods.

This new reporting requirement will be administered through the FDA's prior notice system for incoming shipments of imported food established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

"The new information on imports can help the FDA make better informed decisions in managing the potential risks of imported food entering the United States," said FDA Deputy Commissioner for Foods Mike Taylor  "These rules will be followed later this year and next year by a series of proposed rules for both domestic and imported food that will help the FDA continue building the new food safety system called for by Congress." 

For more information about The Food Institute webinar series on Implementing the Food Safety Modernization Act, go tohttp://www.foodinstitute.com/FSMAwebinar.cfm.