FDA: New Rules Prevent Foodborne Illnesses From Becoming Outbreaks

The U.S. FDA announced yesterday that it had proposed 2 new food safety rules with regards to foodborne illness prevention and produce safety, under the Congressional mandate of the bipartisan FDA Food Safety Modernization Act (FSMA) passed by Congress in 2010, and signed into law by Pres. Obama in January 2011.

This brings to 5 the number of rules proposed by the FDA since passage of the FSMA in 2010.

Foodborne illness in the United States has become a substantial problem over the last decade.

According to data from the Centers for Disease Control and Prevention (CDC) roughly 48 million people are affected by foodborne illnesses every year, with 128,000 requiring hospitalization, and 3000 reported deaths from foodborne illnesses each year.

The mandate gives the FDA sweeping powers to regulate the domestic and foreign suppliers of produce to the United States, in an effort to promote public health and protect consumers from food borne illnesses.

The FDA Food Safety and Modernization Act gives the FDA the Authority to prevent food borne illnesses, whereas previously the FDA could only respond to reports of outbreaks of illnesses caused by contaminated food.

“Preventing problems before they cause harm is not only common sense, it is the key to food safety in the 21st century,” said Margaret A. Hamburg M.D., Commissioner of the U.S. FDA. “We cannot afford to wait until people become ill to realize there is a problem.”

“The FDA Food Safety Modernization Act is a common sense law that ships the food safety focus from reactive to preventive,” HHS Sec. Kathleen Sebelius said. “With the support of industry, consumer groups, and the bipartisan leadership in Congress, we are establishing a science-based, flexible system to better prevent foodborne illness and protect American families.”

The 1st proposed new regulation requires makers of any food to be sold in the United States, whether imported or produced domestically, to adopt a formal plan for preventing their food products from causing foodborne illnesses, also making accommodations for corrective measures should problems arise with their product.

The FDA seeks public comment on these proposals. For contact information follow this link.

To comment on the proposed new rules, follow this link.

The 2nd proposed new regulation seeks to initiate enforceable safety standards for the production and harvesting of fruits and vegetables, using current science and risk based industry standards.

“The FDA knows that food safety, from farm to fork, requires partnership with industry, consumers, local, state and tribal governments, and our international trading partners,” said FDA Commissioner Margaret A. Hamburg M.D. “our proposed rules reflect the input we have received from the stakeholders and we look forward to working with the public as they review the proposed rules.”

The FDA plans to coordinate the comment periods on the major FSMA proposals as fully as possible to better enable public comment on how the rules can best work together to create an integrated, effective and efficient food safety system.

Implementation of these new rules required the FDA to conduct extensive outreach to the various diverse industries that will be affected by these new rules. The FDA held 5 federal public meetings, as well as local,state, and regional meetings in 14 states, also visiting farms and facilities of various sizes across the country. This outreach provided for flexibility with regards to the parameters of the new regulations.

“We know one-size-fits-all rules won’t work,” said Michael R Taylor, the FDA’s deputy commissioner for food and veterinary medicine. “We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system.”

Previously, the U.S. FDA had announced on May 4, 2011 the 1st new regulations to ensure the safety and security of the food supply in the United States. The goal of these new regulations is to provide oversight of foreign fresh fruit and vegetable providers to the U.S. market.

The 1st new rule allows the FDA to prevent potentially unsafe food from entering the United States. Beginning in July 2011, if the FDA has reason to believe any misbranded or adulterated foods have entered the United States, it can detain these products for up to 30 days, ensuring they are kept out of the U.S. marketplace, while the agency determines if seizure is warranted or if a federal injunction prohibiting distribution of the product is necessary.

It allows the FDA to detain certain foods the agency believes may have been produced in unsanitary or unsafe conditions, and previously the FDA could only detain food products when presented with credible evidence of contamination.

“This authority strengthens significantly the FDA’s ability to keep potentially harmful food from reaching U.S. consumers,” said FDA deputy commissioner Mike Taylor. “It is a prime example of how the new food safety law allows FDA to build prevention into our food safety system.”

The 2nd new rule requires all food importers doing business in the United States to inform the FDA if any other country has refused importation of the same product that is being imported into the U.S. This regulation improves the FDA’s ability to target foods that pose a significant risk to public health, and is part of the FDA’s prior notice system. The prior notice system was established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

The 3rd proposed regulation involves preventive controls for animal food at facilities preparing and processing food for livestock and domestic animals in the United States, similar to those rules regarding human food processing.

“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 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.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also would responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Links\ References

http://www.fda.gov/food/foodsafety/fsma/default.htm

http://www.fda.gov/foodsafety/fsma/ucm334156.htm

http://www.cdc.gov/foodsafety/diseases/

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm253983.htm

http://www.fda.gov/regulatoryinformation/dockets/comments/default.htm

http://www.fda.gov/aboutfda/contactfda/default.htm

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm334156.htm

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm253983.htm

http://www.fda.gov/aboutfda/commissionerspage/default.htm

http://www.fda.gov/aboutfda/centersoffices/officeoffoods/ucm196721.htm

http://www.hhs.gov/secretary/index.html

http://www.fda.gov

http://www.hhs.gov

Article by Jim Donahue