U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Plant & Dairy Foods & Beverages
September 20, 2002

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FDA Draft Action Plan for Acrylamide in Food

Summary

FDA has developed a draft action plan for acrylamide in food. The draft action plan outlines FDA's goals and planned actions on the issue of acrylamide in food and includes a timeline of planned meetings. It also discusses FDA's intentions to work with other federal agencies and to participate in international efforts. This action plan will guide FDA's activities on the issue of acrylamide over the next several years. FDA will make the plan available on the CFSAN website. FDA will also present the plan for public and scientific comment at a public meeting on September 30, 2002, with follow-up discussion at a Food Advisory Committee subcommittee meeting in December 2002, and a full Food Advisory Committee meeting in February or March 2003. The draft action plan is a working document, and FDA will revise the plan, as needed, based on public comment from these meetings and on knowledge gained from research developments.

Background

On April 24, 2002, researchers at the Swedish National Food Administration and Stockholm University reported finding the chemical acrylamide in a variety of fried and oven-baked foods. The initial Swedish research indicates that acrylamide formation is particularly associated with traditional high temperature cooking processes for certain carbohydrate-rich foods. Since the Swedish report, similar findings have been reported by Norway, the United Kingdom, and Switzerland. Preliminary analysis by the FDA suggests that U.S. results will be in basic agreement with these findings. The discovery of acrylamide in foods is a concern because acrylamide is a potential human carcinogen and genotoxicant.

Mechanism

Acrylamide appears to form as a byproduct of high-temperature cooking processes (greater than 120C or 248F). It does not appear to be present in food before cooking. Research to date suggests that acrylamide formation is particularly likely in carbohydrate-rich foods. However, tests on carbohydrate-rich foods cooked at lower temperatures (e.g., by boiling) have shown much lower acrylamide levels. At this time, not enough is known about acrylamide formation to identify safe modifications to food processing techniques that will clearly prevent or reduce formation. Identifying mechanisms of formation will ultimately be an important step in identifying ways to reduce or prevent acrylamide formation during cooking.

Toxicology

There are uncertainties about the impact of acrylamide on public health. People have been eating some of the foods now reported to contain acrylamide for many years. To better assess the risk of acrylamide, more information is needed regarding which foods acrylamide is formed in, levels of acrylamide in foods, dietary exposure to acrylamide, the bioavailability of acrylamide in food, the potential of acrylamide to cause cancer when consumed in food, acrylamide's potential to cause germ cell mutations, and biomarkers of acrylamide exposure.

Acrylamide causes cancer in laboratory animals. As a result, acrylamide is considered a potential human carcinogen. However, it is not clear whether acrylamide causes cancer in humans. Scientists have conducted epidemiological studies of people exposed to acrylamide in the workplace. The studies did not show increased cancer risk with acrylamide exposure. However, these studies do not rule out the possibility that acrylamide in food can cause cancer, both because of the limited number of people in the studies and because the route of exposure for the workers was not through food.

WHO/FAO Recommendations

In June 2002, the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) convened an expert consultation on acrylamide. The consultation, which was attended by three FDA experts, concluded that the presence of acrylamide in food is a major concern, and recommended more research on mechanisms of formation and toxicity. Both the WHO/FAO consultation and the FDA have recommended that people continue to eat a balanced diet rich in fruits and vegetables. The WHO/FAO consultation advised that food should not be cooked excessively, i.e., for too long or at too high a temperature, but also advised that it is important to cook all food thoroughly--particularly meat and meat products--to destroy foodborne pathogens (bacteria, viruses, etc.) that might be present.

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

Addressing the issue of acrylamide in foods will require research and activity on multiple fronts. Planned and current actions by the FDA include assessing the dietary exposure of U.S. consumers to acrylamide, gathering new information about the toxicology of acrylamide, and participating in the development of techniques for reducing acrylamide formation. As more data become available on acrylamide, FDA will continue to develop public health messages and regulatory options.

  1. Major goals

  2. Actions

    Development of draft action plan

    FDA has developed this draft action plan to outline its actions and goals on the acrylamide issue. FDA is presenting this draft action plan for input and comments from the public, academia, industry, and scientific experts.

    Testing foods

    FDA is currently testing a limited number of locally collected foods in its laboratories at the Center for Food Safety and Applied Nutrition (CFSAN). In FY03, FDA also plans to test a larger number of samples collected nationwide by FDA's Office of Regulatory Affairs for analysis by CFSAN and possibly other government and non-government laboratories. The local and national samples will be used to estimate variation within and across key food types as part of processing evaluations and to determine the incidence of formation across the food supply. For FY03, FDA also plans to collect and analyze Total Diet Study (TDS) market basket samples to identify exposures from specific U.S. foods. Further testing may occur in FY03 based on the findings of the initial survey and formation research.

  3. Toxicology

    Development of new data on toxicology will provide more information about acrylamide and facilitate risk management choices. FDA is initiating and participating in research on a variety of toxicology related issues.

  4. Research and outreach on formation

  5. Methodologies

  6. Meetings and collaborative projects

    FDA is planning to convene or participate in multiple meetings with the goals of (a) gathering public and expert input on acrylamide in food and (b) fostering coordination of research efforts on acrylamide.

  7. Consumer messages

  8. Regulatory options

The following table highlights the timeline of activities on acrylamide.


Dates* Activities

September 24, 2002 CFSAN-led interagency roundtable of federal public health agencies on acrylamide research.
September 30, 2002 "Assessing Acrylamide in the U.S. Food Supply": A public meeting on acrylamide in food.
October 28-30, 2002 JIFSAN/NCFST Workshop, "Acrylamide in Food: What do we need to know? What are the responses?"
Early December 2002 Meeting of the Subcommittee on Contaminants and Natural Toxicants of the FDA Food Advisory Committee.
February or March 2003 Meeting of the full FDA Food Advisory Committee.
March 17-21, 2003 Codex Committee on Food Additives and Contaminants meeting.
Winter-Spring 2004 WHO/FAO JECFA acrylamide assessment (tentative).
Ongoing or planned National food survey of acrylamide levels in food (including Total Diet Study samples)

Toxicology studies

Methodology studies

*Where applicable. Some dates are tentative.

 


Remarks by Deputy Commissioner at FDA Public Meeting on Acrylamide in the U.S. Food Supply September 30, 2002

Public Meeting: Assessing Acrylamide in the U.S. Food Supply, September 30, 2002 - Agenda September 20, 2002

Detection and Quantitation of Acrylamide in Foods (Draft) July 23, 2002


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Hypertext updated by dav/dms/cjm 2002-OCT-01