The U.S. Food and Drug Administration (FDA) has opened its new Reportable Food Registry (RFR), an electronic portal that food and feed industry officials must use to alert the FDA quickly when they find their products might sicken or kill people or animals. The requirement, a result of food safety legislation passed in 2007 in part because of the melamine in pet food incident and other food recall situations, took effect with the launch of the portal on September 8, 2009.
Facilities that manufacture, process, or hold food or feed for consumption in the United States must now tell the FDA within 24 hours if they find a reasonable probability that an article of food or feed will cause severe health problems or death to a person or an animal. A “reportable food” is defined by FDA as one having the reasonable probability that the use of or exposure to would cause serious adverse health consequences or death in humans or animals. This includes any food, feed, ingredient, or pet food product. There are some exemptions described in a question and answer guide issued by FDA, available at www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
The guide should be read carefully and evaluated to determine the need to file a reportable food.
The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of reasons a food or feed may be reportable include bacterial contamination, allergen mislabeling, or elevated levels of certain chemical components.
As the National Renderers Association understands it, FDA will treat routine animal feed ingredients the same as it has except for animal feed that may go into a human household, primarily pet food. A positive Salmonella test in food or feed that will be in a household is probably reportable. In normal commerce of feed ingredients, a company can reason that a feed ingredient batch testing positive (and in many cases the load is already long gone before the test results are determined) is not a significant risk because there is another kill step such as pelleting or extruding feed before the product is finished.
The reporting requirements apply to any company that must submit registration information to the FDA for a food or feed facility that manufactures, processes, packs, or holds food or feed for human or animal consumption in the United States. The individual at the facility responsible for registration is termed a responsible party, who:
• must investigate the cause of the adulteration if the adulteration of food or feed may have originated with the responsible party;
• must submit initial information, followed by supplemental reports; and
• must work with FDA authorities to follow up as needed.
A responsible party is not required to report if it found the problem before the food or feed was shipped, and corrected the problem or destroyed the product. Facilities need only report incidences of contamination that rise to a “class 1 recall” level, which the company will determine.
While the question and answer guide left it unclear, industry representatives believe a responsible party’s obligations extend only to a particular article of food or feed that it manufactures, processes, packs, or holds, and that the product is reportable only where the responsible party has determined there is a reasonable probability that this particular article of food or feed will cause serious adverse health consequences or death to humans or animals.
FDA is required to contact the facility making the report and gather additional information to determine if the report is, in fact, about a reportable food or feed. If the FDA determines the product is a reportable food or feed, the agency will enter the product into the RFR, contact the facility for other information, set deadlines for the facility, and may issue public notices about the reportable food or feed to alert the public and protect the public health. Local, state, and other federal health officials may also report reportable foods or feeds to the electronic portal.
FDA issued draft guidance on the RFR in June 2009 and sought comment. The agency also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work. A Federal Register notice was issued September 8, 2009, announcing the opening of the RFR electronic portal and the availability of final guidance to assist the food and feed industries in complying with the RFR requirements.
Failure to report a reportable food or feed is a prohibited act under the RFR and federal Food, Drug, and Cosmetic Act, and each firm must make the decision as to whether the food or feed is reportable. FDA intends to consider exercising enforcement discretion for a period of 90 days, until December 8, 2009, in circumstances where FDA determines that a responsible party has made a reasonable effort to comply with the requirements of the RFR and act, and has otherwise acted to protect public health.
For more information, log on to www.fda.gov/reportablefoodregistry.
Newsline – October 2009 RENDER | back