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U.S. Department of Health and Human Services

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FDA Action Plan for Acrylamide in Food

March 2004

Summary

FDA has developed an action plan for acrylamide in food. The action plan outlines FDA's goals and planned activities on the issue of acrylamide in food and includes a timeline of major activities on acrylamide. It also discusses FDA's intention to work with other federal agencies and to participate in international efforts. The action plan will guide FDA's activities on the issue of acrylamide over the next several years. FDA made a draft version of the action plan available on the CFSAN website. FDA also presented the draft action plan for public and scientific comment at a public meeting on September 30, 2002, and at a meeting of the Subcommittee on Contaminants and Natural Toxicants of the Food Advisory Committee (FAC) on December 4-5, 2002. A revised version of the draft action plan was presented to the full FAC on February 24-25, 2003, in order to receive input to assist FDA in finalizing the plan. FDA is now releasing the final scheduled revision of the plan. FDA will report to the FAC Subcommittee when significant new developments have occurred that warrant the Subcommittee's attention, and will develop future revisions of the plan, as needed, based on Subcommittee and public comment 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 indicated 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 researchers in numerous other countries, including Norway, the United Kingdom, Germany, Canada, Japan, Korea, and Switzerland. Analysis by the FDA revealed that U.S. results were also in basic agreement with these findings. The discovery of acrylamide in food is a concern because acrylamide is a potential human carcinogen and genotoxicant, based on high-dose animal studies, and a known human neurotoxicant.

Mechanism

Acrylamide appears to form as a byproduct of high-temperature cooking processes (greater than 120°C or 248°F). It does not appear to be present in uncooked food and is present in low or undetectable levels in foods cooked at lower temperatures, such as by boiling. Research to date suggests that acrylamide formation is particularly likely in carbohydrate-rich foods such as potatoes and cereals. Scientists have identified one mechanism responsible for the formation of acrylamide in carbohydrate-rich foods cooked at high temperatures: a chemical reaction between the amino acid asparagine and certain sugars, both of which are found naturally in foods. The discovery of the asparagine-acrylamide connection may ultimately lead to methods for decreasing acrylamide levels in certain foods. However, at this time, not enough is known about acrylamide formation to identify safe, effective, and practical modifications to food processing techniques that will clearly prevent or reduce formation. Identifying all mechanisms of formation is an important step in identifying ways to reduce or prevent acrylamide formation during cooking.

Exposure and Toxicology

There are significant 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 food, dietary exposure to acrylamide, the bioavailability of acrylamide in food, the potential of acrylamide to cause cancer when consumed in food, biomarkers of acrylamide exposure, and acrylamide's potential to cause germ cell mutations and neurotoxic or neurodevelopmental effects.

Acrylamide causes cancer in laboratory animals in high doses. As a result, acrylamide is considered a potential human carcinogen. However, it is not clear whether acrylamide causes cancer in humans at the much lower levels found in food. Scientists have conducted epidemiological studies of people exposed to acrylamide in the workplace and through the diet. 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 because they have limited power to detect this effect. Also, we do not have enough information to rule out the possibility that subtle effects can occur on the developing nervous system at acrylamide doses lower than those that have been studied so far in animals and humans.

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, in which three FDA experts participated, 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 a time 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 Food

Purpose of the Action Plan

FDA has developed an action plan for acrylamide in food. The action plan outlines FDA's goals and planned actions on the issue of acrylamide in food and will guide FDA's activities on the issue of acrylamide over the next several years.

The actions outlined in the plan include developing methods for acrylamide analysis, researching mechanisms of acrylamide formation and means to reduce formation, assessing the dietary exposure of U.S. consumers to acrylamide, gathering new information about the toxicology of acrylamide, assessing the potential risk of acrylamide exposure, and evaluating options for reducing potential risk. Based on information gathered from this work, and especially from information on the risk to human health, FDA will identify appropriate risk management and communication steps.

In carrying out this action plan, FDA will continue to collaborate extensively through public/private partnerships with international organizations, academia, industry, and other stakeholders to gather the most expert knowledge available on the topic. Some of the work described in this plan will be carried out by other agencies or organizations. FDA will provide leadership for these activities by organizational and collaborative efforts, but it does not control other agencies' work or funding. FDA is committed to a continuing exchange of information with the public as the action plan is undertaken and to the rapid dissemination of any new findings as soon as they are known.

Major goals

  • Develop rapid or inexpensive screening methods and validate confirmatory methods of analysis.
  • Identify mechanisms responsible for the formation of acrylamide in food and identify means to reduce acrylamide exposure.
  • Assess the dietary exposure of U.S. consumers to acrylamide by measuring acrylamide levels in various foods and estimating dietary exposure.
  • Characterize the potential risks and uncertainties associated with exposure to acrylamide in food by assessing the available information, by expanding research into acrylamide toxicology to reduce uncertainty, and by performing a quantitative risk assessment with the new information.
  • Develop and foster public/private partnerships to gather scientific and technological information and data for assessing the human risk.
  • Inform and educate consumers and processors about the potential risks associated with acrylamide throughout the assessment process and as knowledge is gained.
  • Provide all the essential elements for risk analysis, i.e., risk assessment, risk communication, and risk management.

Actions

Methodologies

  • FDA will continue to update and validate its current liquid chromatography/tandem mass spectrometry (LC/MS/MS) methodology as needed. FDA developed its own LC/MS/MS methodology for testing for acrylamide in foods and posted this methodology on the CFSAN website on June 20, 2002. The methodology was updated on the website on July 23, 2002, and February 24, 2003, and published on December 17, 2003 in the Journal of Agricultural and Food Chemistry (Roach JAG, et al., 2003). A paper describing the application of the method to the analysis of acrylamide in coffee, a challenging food matrix, is also in press (Andrzejewski D, et al., 2004).
  • FDA will undertake a peer validation of the method and will submit the results to the AOAC International for publication.
  • Researchers at CFSAN will evaluate screening methodologies for more rapid or less expensive detection of acrylamide in the food supply. CFSAN is currently evaluating the feasibility of LC with ultraviolet (UV) detection as a screening method. CFSAN may also consider the feasibility of other screening methods.

Research on formation

  • The National Center for Food Safety and Technology (NCFST) in Illinois, a consortium between FDA, the Illinois Institute of Technology, and food-related industries, will investigate mechanisms of acrylamide formation and processes for reducing formation of acrylamide.
  • FDA will continue to interact with academia and industry to encourage research on mechanisms of acrylamide formation and effects of process changes on acrylamide levels. FDA is fostering such interactions through NCFST and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a consortium between FDA and the University of Maryland. FDA will also explore ways that other government agencies, such as the United States Department of Agriculture-Agricultural Research Service (USDA-ARS), can help with formation studies.
  • NCFST is planning to research the formation of acrylamide during home cooking of toast, French fries, and other foods.

Measuring exposure

Characterizing the public's exposure to acrylamide involves two components: testing acrylamide levels in food and using data on acrylamide levels to perform an exposure assessment. An initial exposure assessment may highlight areas where more sampling is needed, leading to more testing and an update of the exposure assessment.

  • Testing foods

    • FDA has been testing locally collected foods in its laboratories at the Center for Food Safety and Applied Nutrition (CFSAN).
    • FDA will test samples collected nationwide by FDA's Office of Regulatory Affairs for analysis by government or non-government laboratories. Approximately 400 samples will be collected for analysis at an FDA laboratory in Fiscal Year (FY) 04. JIFSAN will administer a contract for FDA for testing approximately 400-500 samples at a private laboratory in FY04.
    • FDA collected and analyzed approximately 700 market basket samples from the FDA Total Diet Study (TDS) for FY03. In several subsequent years, a smaller subset of samples will be collected and analyzed.
    • Further testing may occur in FY04 and beyond based on the findings of the initial survey and formation research. As part of this work, FDA will explore ways to look at variability between lots of food and repeat samples. FDA will also consult with statisticians on sampling needs.
    • FDA releases brand name data on results of its own testing in accordance with the requirements of the Freedom of Information Act. FDA encourages industry to submit data on their own products to FDA or to JIFSAN to expand the pool of available data. Recognizing that companies may be reluctant to submit data with brand name information, FDA or JIFSAN will also welcome industry data submitted in a blinded fashion, such as through a third party.
  • Exposure assessment

    • CFSAN researchers are deriving exposure estimates of the U.S. population to acrylamide in food. The estimates are derived by combining distributions of acrylamide levels in foods with appropriate food intake distributions using Monte Carlo methodology to provide a distribution of estimated exposures to acrylamide. FDA researchers can predict exposures of the average consumer and high percentile consumer to acrylamide, identify different exposures for different age groups with different diets, and identify which foods contribute most significantly to overall acrylamide exposure. In the future, researchers will also look at consumption patterns of different ethnic and geographic groups within the U.S.
    • The data being used in the exposure assessments are acrylamide levels from samples analyzed at FDA and food consumption data from USDA's 1994-1996, 1998 2-day and 1989-92 3-day CSFII databases on food consumption. Older food consumption data from a Market Research Corporation of America 14-day food frequency survey conducted from 1982-87 are being used to more accurately account for foods eaten less frequently. Additionally, a model of "usual food consumption" is being developed to better reflect lifetime consumption of foods containing acrylamide.
    • Exposure estimates will be updated periodically as new data are acquired on acrylamide levels in food. The estimates will incorporate quality data from other sources, e.g., data on foods consumed in the U.S. submitted to JIFSAN for the WHO/FAO Acrylamide Infonet.

Toxicology and Health Effects

Development of new data on toxicology will provide more information about acrylamide and facilitate informed risk management choices. Research in this area includes both general and animal toxicology, and study of human health effects.

  • General and Animal Toxicology

    FDA's National Center for Toxicological Research (NCTR) will conduct studies on acrylamide and its reactive metabolite glycidamide under the National Toxicology Program as FDA's high priority chemical selections for FY03. The National Institute of Environmental Health Sciences (NIEHS) will also conduct acrylamide studies under the National Toxicology Program. The range of studies to be performed includes long-term carcinogenicity assays and shorter-term studies that will provide mechanistic, toxicokinetic, and biomarker data to extend the carcinogenicity assays' usefulness and low-dose predictive power.

    • Adducts: NCTR is conducting studies of acrylamide adducts on hemoglobin and DNA. The adducts are reaction products between acrylamide (and/or its metabolite glycidamide) and both DNA and proteins. Studies on characterizing adducts and developing a method to quantitate adducts have already been completed (Gamboa da Costa, G., et al., 2003). Ongoing adduct studies include measuring adduct accumulation and repair in rodents and studying the dose-response relationship between acrylamide exposure and formation of DNA adducts in rodent liver and leukocytes. Studies on hemoglobin adducts will include developing a method for measuring hemoglobin adducts of acrylamide and glycidamide, measuring accumulation and elimination of adducts resulting from short-term exposure in rodents, and correlating glycidamide-DNA adducts and hemoglobin adduct formation. NCTR adduct studies began in FY03 and are expected to end by December 2004. NIEHS, in collaboration with NCTR, will also study acrylamide metabolism and adduct formation, focusing on the difference between mice that are wild-type and null for CYP2E1, the enzyme believed to be responsible for metabolism of acrylamide to glycidamide. These studies are expected to be completed in January-March 2004.
    • Toxicokinetics: NCTR is conducting a range of toxicokinetic studies. A study on development of a method for measuring acrylamide and glycidamide in serum has already been completed (Twaddle, N.C., et al., in press). Ongoing work includes bioavailability studies of acrylamide and metabolism to glycidamide in mice and rats exposed to acrylamide in diet, by gavage, and by intravenous exposure, and physiologically based pharmacokinetic (PBPK) modeling of toxicokinetic data. The bioavailability studies should clarify the effect that consumption in a food matrix has on acrylamide absorption and should shed light on possible differences with previous toxicology assays in which rats were administered acrylamide in drinking water. The PBPK modeling will facilitate extrapolation of data derived from animal studies to human exposures and will incorporate any available high-quality human data. (1) Work on toxicokinetic studies began in FY03 and is expected to end in FY05.
    • In vivo mutagenicity: NCTR studies will involve the use of transgenic mice to identify point mutations (Big Blue mouse) and large deletion mutations (Tk ± mouse) caused by acrylamide and glycidamide in order to identify mechanisms and tissues that are targets for acrylamide carcinogenicity. Exposure to acrylamide will be for one month through drinking water. Changes in mutation frequency will be correlated with glycidamide-DNA adducts. Work on in vivo mutagenicity at NCTR will begin in FY03 and end by September 2004. Also, NIEHS is planning to compare induction of micronuclei and dominant lethal mutations in CYPE21 null and wild-type mice. These studies are expected to be completed by June 2004.
    • Carcinogenicity bioassays: NCTR will conduct three types of carcinogenicity bioassays for acrylamide and glycidamide. First, a shorter-term assay (less than one year) will be conducted in a neonatal mouse model that is a sensitive indicator of direct-acting genotoxic carcinogens. This assay is scheduled to start in FY03 and to be completed in FY06. Second, NCTR will also conduct a two-year chronic rodent carcinogenicity bioassay in rats and mice under the auspices of the National Toxicology Program. This assay will include study of dose-response relationships, histopathology, and correlation of adduct levels in target tissues with tumor incidence. The dose range-finding and subchronic studies, which are necessary preludes for and integral components of the chronic study, will begin February-March 2004 in preparation for the beginning of the chronic exposures in June-October 2004. The chronic carcinogenicity bioassay is expected to be completed in FY08. Third, NCTR will conduct a neonatal mouse carcinogenicity study, in which pregnant mice are exposed perinatally to acrylamide in drinking water. The neonatal and transplacental carcinogenicity studies will start after the adult exposure studies are initiated, June to September 2004.
    • Neurotoxicity: NCTR is planning to study the potential for developmental neurotoxicity with acrylamide exposure in rats. The planned studies will include dose range-finding studies to identify doses that do not cause frank toxicity in mothers or pups, toxicokinetic analysis of acrylamide and glycidamide levels in brain and blood, and behavioral assessment in pups. Work is expected to start in January 2004 and to be completed in 2006.
  • Human Toxicology and Health Effects

    • The Center for Disease Control and Prevention's (CDC's) National Center for Environmental Health (NCEH) is planning a study to monitor changes in acrylamide and glycidamide-related hemoglobin adduct concentrations in volunteers with defined changes in specific food sources of acrylamide. FDA and CDC are exploring the potential for FDA collaboration with CDC in this study. CDC NCEH has completed a laboratory method validation pilot study and is currently developing the timeline for the main study.

      • FDA and NCEH are also exploring the possibility of expanding such a study to include the relationship of acrylamide- and glycidamide-hemoglobin adduct levels with levels of glycidamide DNA adducts from leukocytes.
      • As data on levels of acrylamide and glycidamide-related protein and DNA adducts in humans become available in the future, NCTR will explore how to correlate these human data with adduct data from its studies on rats (see above descriptions).
    • FDA will obtain some human toxicology information from other federal agencies and industry sources.

      • CDC NCEH plans to use acrylamide- and glycidamide-related hemoglobin adducts to monitor acrylamide exposures in humans. This effort will include monitoring acrylamide- and glycidamide-hemoglobin adducts in the National Health and Nutrition Examination Survey (NHANES), an ongoing cross-sectional survey that collects biological samples and health data from a nationally representative sample throughout the U.S. This work will begin with blood samples drawn in 2003 and is expected to be completed in 2004.
      • CDC's National Institute for Occupational Safety and Health (NIOSH) has initiated a pilot study on worker exposures to acrylamide, as a precursor to an epidemiological study of occupational exposures to acrylamide that will consider neurotoxicity and reproductive health. The pilot study is expected to begin in early FY04.
      • A major manufacturer of acrylamide is currently studying the toxicokinetics of orally ingested acrylamide in humans. FDA will seek information from these studies and other external studies to complement its knowledge base on acrylamide toxicology.
      • FDA will continue to pursue contacts with the National Institutes of Health about the potential for research or funding interactions related to acrylamide toxicology.

Epidemiology

Epidemiology studies may be useful in elucidating the relationships among acrylamide levels in food from chemical analysis; dietary intake of acrylamide, as measured by interviews and questionnaires; and biomarkers of acrylamide exposure, such as levels of hemoglobin adducts. Epidemiology studies may also be useful in elucidating relationships between acrylamide exposure through food and disease endpoints in populations. FDA is gathering information on current or planned acrylamide research in the epidemiology community and exploring additional studies.

  • As noted in the Toxicology section, FDA is seeking information from the following proposed or planned studies that draw on both toxicology and epidemiology:

    • Monitoring acrylamide- and glycidamide-related hemoglobin adducts by CDC's NCEH in the CDC NHANES survey.
    • A planned study by NCEH, potentially in collaboration with FDA, to monitor changes in hemoglobin adduct concentrations in volunteers with defined changes in specific food sources of acrylamide.

      • Possible expansion of such a study to relate levels of hemoglobin adducts to levels of DNA adducts.
    • Exploration of how to correlate human adduct data with adduct data from NCTR's studies on rats.
  • Ongoing, prospective cohort studies in the U.S. and other countries monitor large groups of individuals (tens of thousands or more) for associations between risk factors and disease endpoints over a period of years. Some studies have stored frozen biological samples, including red blood cells, collected at the beginning of the study. It may be feasible to compare acrylamide hemoglobin adduct concentrations in cancer cases and controls (nested case control design) in prospective studies to assess whether acrylamide exposure is associated with risk of cancer. Other endpoints such as neurologic status might also be studied. FDA is gathering information on current efforts on acrylamide in prospective studies and exploring the feasibility of designing studies of sufficient power to address the human health risk from acrylamide in food.
  • FDA will evaluate all relevant epidemiology studies on acrylamide and integrate relevant information into its risk assessment.
  • FDA will pursue contacts with the National Institutes of Health about the potential for research or funding interactions related to acrylamide epidemiology.

Risk assessment

The risk assessment will characterize the potential risk that the presence of acrylamide 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. The risk assessment will combine data from the exposure assessment and toxicology research.

  • The risk assessment will culminate in a document/report. This assessment will be completed when more data are available on exposure and toxicology. For toxicology, the crucial data needs are in the areas of bioavailability (toxicokinetics), biomarkers, and metabolism.
  • The risk assessment will use appropriate modeling approaches and will include evaluation of uncertainty in the areas of health effects and exposure.
  • As with any risk assessment, it will be revised when there are developments of such significance that would materially change the risk assessment.

Meetings

FDA has been actively participating in and/or convening, as appropriate, meetings with the goals of (a) gathering public and expert input on acrylamide in food and (b) fostering coordination of research efforts on acrylamide. FDA will continue to exert leadership through meetings. Examples of meeting activities include the following:

  • CFSAN conducted an interagency roundtable of federal public health agencies involved in acrylamide research on September 24, 2002. Participants in the roundtable included the Department of Health and Human Services (FDA, NIEHS, NIOSH, and NCEH), USDA (ARS, Food Safety and Inspection Service), and the Environmental Protection Agency (EPA). Topics included the results of the WHO consultation, plans for acrylamide toxicology studies at each agency, EPA's reevaluation of its dose-response evaluation for acrylamide, the potential use of biomarkers to monitor acrylamide exposure, epidemiological studies, occupational exposures, and heritable mutagen assays. As a followup to the September 24 meeting, CDC hosted a meeting on January 27, 2003, that focused on the use and harmonization of methods to measure hemoglobin adducts of acrylamide and glycidamide in humans and animals across laboratories currently considering epidemiological or toxicological research on acrylamide. FDA is planning a second interagency meeting for February 2004 to review ongoing developments relating to acrylamide. FDA hosted a second interagency meeting on February 24-25, 2004, to review ongoing developments relating to acrylamide.
  • FDA convened a Public Meeting, "Assessing Acrylamide in the U.S. Food Supply," on September 30, 2002, to update the public on FDA's activities related to acrylamide in food, to present FDA's draft action plan for acrylamide, and to obtain comments on the plan.
  • FDA participated in the JIFSAN/NCFST Workshop, "Acrylamide in Food: What do we need to know? What are the responses?", held on October 28-30, 2003. JIFSAN will continue to run the WHO/FAO Acrylamide Infonet clearinghouse for continued international coordination and data sharing on acrylamide. JIFSAN is planning to conduct a second international meeting on acrylamide in Chicago in April 2004.
  • FDA held a meeting of the FDA FAC Subcommittee on Contaminants and Natural Toxicants on December 4-5, 2002. At that meeting, FDA presented its draft action plan for acrylamide and preliminary data on acrylamide levels in foods. FDA sought input on the draft action plan, on research and analysis needs, and on exposure and toxicology issues.
  • FDA held a meeting of the full FDA FAC on February 24-25, 2003. FDA presented its revised action plan, updated to reflect input from the Subcommittee, as well as preliminary data on acrylamide levels in foods, an exposure assessment based on the preliminary data, and more specific information on ongoing or planned research. FDA sought input to finalize its action plan on research and analysis needs, and exposure and toxicology issues.
  • The Codex Committee on Food Additives and Contaminants met March 17-21, 2003, and included a WHO/FAO workshop on acrylamide for the delegates, including several presentations by the U.S. A drafting group led by the United States and the United Kingdom was appointed to prepare a discussion paper on acrylamide for the 36th session of CCFAC.
  • FDA and JIFSAN have been participating as collaborators in a large European Union research program (6th Framework) on acrylamide.
  • If invited, FDA scientists will participate in an assessment of acrylamide by the WHO/FAO Joint Expert Committee on Food Additives and Contaminants (JECFA), planned for February 2005.

Inform and Educate the Public

FDA is committed to active risk communication with the public on the issue of acrylamide.

  • FDA has held a Public Meeting, a meeting of the Contaminants and Natural Toxicants Subcommittee of the FAC, and a meeting of the full FAC to inform the public about its activities on acrylamide.
  • FDA has posted numerous items about acrylamide on the CFSAN website, including meeting presentations, transcripts, and data on acrylamide levels in food. FDA Consumer magazine published an article on acrylamide for the public in the January/February 2003 issue.
  • FDA will prepare and post a consumer-oriented web article discussing FDA data on acrylamide and summarizing the activities on acrylamide outlined in the Action Plan.
  • FDA has issued a dietary message advising consumers 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.
  • As messages are developed and refined, FDA will recruit the aid of agricultural extension services and home economics, diet, and nutrition organizations, such as the Institute of Food Technologists, American Society for Clinical Nutrition, and the American Society for Nutritional Sciences, in getting its message out to consumers.
  • Acrylamide in food is a complex issue for such reasons as its ubiquity in our food supply, its formation from traditional cooking techniques, and uncertainty about the risks associated with its presence in food. Complex issues present distinct risk communication challenges. FDA will consider whether it would be generally useful to expand research and strategy development in the area of risk communication on complex food issues and consumer acceptance of health messages.

Further actions

  • FDA will develop and revise regulatory options as additional knowledge is gained on acrylamide in food. Many of the items in the action plan are geared toward achieving that end.
  • FDA will encourage industry to adopt feasible, practical, and safe processes that are successful at reducing acrylamide, if needed.
  • FDA will develop and revise consumer messages about dietary choices and cooking methods, as additional knowledge is gained about acrylamide in food. FDA understands the importance of consumer messages that can assist consumers in making informed dietary choices. Any adjustments in consumer messages would consider the totality of the science.


 


 

1One example of human data that may be incorporated in the model is the effect of varying activity of Cyp2E1, a major enzyme that metabolizes acrylamide into glycidamide. ILSI, the International Life Sciences Institute, is also planning on preparing a PBPK model that will incorporate human data. NCTR will participate with the ILSI group by producing experimental data for the model and in model validation.


 



 

The following table highlights the timeline of major activities on acrylamide.
DatesActivities
September 24, 2002CFSAN-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, 2002JIFSAN/NCFST Workshop, "Acrylamide in Food: What do we need to know? What are the responses?"
December 4-5, 2002Meeting of the Subcommittee on Contaminants and Natural Toxicants of the FDA Food Advisory Committee.
February 24-25, 2003Meeting of the full FDA Food Advisory Committee.
March 17-21, 2003Codex Committee on Food Additives and Contaminants meeting.
February 24-25, 2004Second interagency roundtable of federal public health agencies on acrylamide research.
April 13-15, 2004Second JIFSAN workshop on acrylamide.
February 2005WHO/FAO JECFA acrylamide assessment.
Ongoing or PlannedMethodology studies
Formation studies
Exposure assessment studies
Toxicology and epidemiology studies
Education