FDA Action Plan for Furan in Food

Summary

FDA has developed an Action Plan for Furan in Food. The action plan outlines FDA's accomplishments, goals, and planned activities on the finding of furan in food, and it will guide FDA's activities on the issue of furan over the next several years.

Background

In spring 2004, FDA scientists announced the discovery of the substance furan in an unexpected number of foods. Furan forms as a result of traditional heat treatment techniques, such as retorting foods in cans and jars. These techniques have long been essential methods of food preparation and preservation. Furan has been found in such foods as soups, sauces, beans, pasta meals, and baby foods. The presence of furan is a potential concern because, based on animal tests, furan is listed in the Department of Health and Human Services Report on Carcinogens and is considered possibly carcinogenic to humans by the International Agency for Research on Cancer (IARC).

FDA has developed a gas chromatography/mass spectrometry (GC/MS) method that is capable of detecting and quantifying very low levels of furan in food. Although furan had previously been reported in foods, FDA has applied its highly sensitive method to a wider variety of food samples than previously reported in the literature. FDA has analyzed approximately 300 food samples for furan (including replicates of the same brand/product) and found furan levels ranging from nondetectable (below the limits of detection of the method) to approximately 100 parts per billion (ppb). Jarred baby foods and canned infant formulas are among the foods in which FDA has found measurable furan. FDA has posted these furan data on the agency's Web site at http://www.cfsan.fda.gov/~lrd/pestadd.html#furan, along with a description of its GC/MS method to provide other researchers the opportunity to review and use the method.

FDA held a Food Advisory Committee (FAC) meeting in June 2004 to seek advice about what data are needed to assess fully the risk to consumers, if any, posed by furan. FDA also published a Federal Register Notice in May 2004 requesting data on the occurrence of furan in food, on sources of exposure to furan other than food, on mechanisms of formation of furan in food, and on the toxicology of furan, including mechanisms of toxicity. Both the Federal Register notice and the FAC meeting materials can be found at http://www.cfsan.fda.gov/~lrd/pestadd.html#furan. FDA received limited responses to this request (see http://www.fda.gov/ohrms/dockets/default.htm, enter "2004N-0205").

FDA's Goals and Actions on the Issue of Furan in Foods

Purpose of the Action Plan

This action plan outlines FDA's accomplishments, goals, and planned actions on the issue of furan in food and will guide FDA's activities on the issue of furan over the next several years.

Major goals

• Develop an analytical method for furan and provide improvements to the method as needed.
• Assess the dietary exposure of U.S. consumers to furan by measuring furan levels in various foods and estimating dietary exposure.
• Characterize the potential risks and uncertainties associated with exposure to furan in foods by assessing the available information, by carrying out new toxicology research to reduce uncertainty, and by performing a quantitative risk assessment.
• Work with colleagues and develop and foster public/private partnerships to gather scientific and technological information and data for:
  • Assessing the human risk from furan
  • Identifying mechanisms responsible for the formation of furan in food and identifying means to reduce furan exposure
• Update consumers and food processors about furan as knowledge is gained.
• Provide all the essential elements for risk analysis, i.e., risk assessment, risk communication, and risk management.

Actions

Methodologies

• The FDA/Center for Food Safety and Applied Nutrition (CFSAN) developed gas chromatography/mass spectrometry (GC/MS) methodology for furan analysis in foods and posted this methodology on the CFSAN website on May 7, 2004. The methodology was updated on June 2, 2005. FDA/CFSAN will continue to update and validate its methodology for furan analysis as needed.
• FDA will develop expertise in furan analysis at an FDA/Office of Regulatory Affairs (ORA) field laboratory in Atlanta, Ga., for expanded testing of furan levels in food.

Measuring exposure

• Testing foods
  • FDA/CFSAN has been testing locally collected foods for furan in the CFSAN laboratory. Data on more than 300 samples were posted on the website as of June 15, 2005.
  • FDA will collect approximately 250 samples nationwide in FY05 for analysis by an ORA field laboratory. (Analysis will begin in FY 2005 and may extend into FY 2006.)
  • FDA is planning collection and analysis of 100 additional samples by ORA in FY 2006.
  • FDA is planning analysis of selected Total Diet Study (TDS) samples for furan in FY06.
  • FDA/CFSAN will conduct research on the effects of food preparation at home on furan levels in purchased foods (e.g., analyzing furan levels in canned soup directly from the can and after heating).
• Exposure assessment
  • FDA/CFSAN released a preliminary exposure assessment for furan in 2004 (available at http://www.fda.gov/ohrms/dockets/ac/04/slides/2004-4045s2.htm). Updated assessments will be released periodically as new data on furan levels in food are available.

Toxicology, Risk Assessment, and Risk Management

• FDA will evaluate available toxicology data on furan, including data from an unpublished (as of July 2005) chronic toxicology study of furan in mice.
• FDA's National Center for Toxicological Research will conduct research on furan toxicology, such as a study of the utility of biomarkers for furan genotoxicity and mutagenicity.
• After completion of additional toxicology research, FDA will perform a risk assessment to characterize the potential risk that the presence of furan in food poses to the U.S. population. This information will be used to inform risk managers, to evaluate potential risk reduction options, and to identify any further research needs.

Meetings and Education

• FDA held a public meeting of the Food Advisory Committee in June 2004 to seek input on data needed to evaluate the risk of furan. FDA may hold additional meetings in the future to provide information to the public, to gather information, or to obtain expert scientific advice.
• FDA has posted Questions and Answers on furan on its website and will update the Questions and Answers as important new information becomes available.
• Regarding the question of whether consumers should alter their eating habits based on the current information, FDA has issued a dietary message advising consumers to continue to eat a balanced diet, choosing a variety of foods that are low in trans fat and saturated fat, and rich in high-fiber grains, fruits and vegetables. FDA also stated that FDA's preliminary estimate of consumer exposure is well below what FDA expects would cause harmful effects. FDA will continue to evaluate these preliminary data and conduct additional studies to better determine the potential risk to human health, as program priorities dictate.