In this issue:

Assessing Acrylamide in the U.S. Food Supply
David R. Lineback, Director
Joint Institute for Food Safety and Applied Nutrition (JIFSAN)

Job Announcements
Food Safety Risk Analysis Clearinghouse Director

Selected Upcoming Events

Recent Additions to the Clearinghouse

New Software Announcements

Editor Notes

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Assessing Acrylamide in the U.S. Food Supply

U.S. Food and Drug Administration, Public Meeting [Docket No. 02N-0393]
Harvey W. Wiley Building, FDA, CFSAN College Park, MD September 30, 2002

As Director of the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) at the University of Maryland, College Park and chair of the Scientific Advisory Panel, American Association of Cereal Chemists (AACC), I have had the opportunity to not only stay informed but also participate in many of the national and international scientific discussions that are ongoing with respect to the occurrence of acrylamide in foods.

The FDA draft action plan indicates JIFSAN will serve as the clearinghouse for continued international coordination and data sharing. We have been asked by the FAO/WHO to manage the international Acrylamide in Food Network that is being established as a result of one of the recommendations from the FAO/WHO Expert Consultation in June. The web-based network will invite all interested parties to share relevant data as well as ongoing investigations. We are actively engaged in this effort and strongly endorse the need for ongoing coordination and information exchange nationally and internationally. I think it is important to keep in mind that this is clearly a topic that has and will continue to be an international issue with efforts underway from governments, academia, and industry.

FDA is to be complimented for developing a thoughtful and very appropriate action plan for addressing the occurrence of acrylamide in food. I believe the Agency has identified a course of action that takes into account what is known, or more precisely what is not known, about acrylamide in foods and is consistent with the activities and directions being taken by national and international scientific bodies and government organizations.

Given that the issue of acrylamide in food only surfaced in late April of this year with the press announcement from Sweden, the progress and level of activity achieved by scientists and government organizations in the United States and other countries is truly outstanding. With the excellent analytical work of the Swedish scientists and the recognition of the potential serious implications, the decision was made to release the findings via a press conference only a short time after the paper describing the investigation had been accepted for publication. This attitude of sharing is now characterizing the approach being used by scientists in many nations. For example, the Central Science Laboratory, who did the analyses in the UK and with whom JIFSAN has a cooperative relationship, shared details of the analytical methodology and some samples with us. This was then shared with FDA and other analytical groups within the U.S. Preliminary data are released and shared before the months required for publication in a scientific journals. This is moving the scientific investigations forward rapidly and emphasizing collaboration in approaching this complex issue.

With the rapidity with which this new and important information is being acquired and shared, I believe that care must be taken not to reach scientific, policy, and regulatory conclusions based on the most recent press statement, media release, or shared information. Plans for rapid, systematic approaches to obtaining essential information, such as FDA has developed, are being prepared in other countries and there is clear evidence that needed work is being initiated as quickly as possible. Decisions about what, if anything, must be done relative to acrylamide in foods should be made as quickly, but also responsibly, as can be done using sound, valid scientific information.

I want to share several observations, particularly with regard to what is occurring internationally. At the outset, I think it is the consensus among scientists, governments, and industry that the new and unexpected information provided in the announced finding of acrylamide in foods from Sweden and subsequently in other countries calls for the concerted effort that is underway to gather additional and new information needed to characterize the potential risks posed by acrylamide in food and determine what are appropriate and effective responses.

These informational needs can be grouped into four major areas:

• Determination of the amount and extent of acrylamide in foods
• Determination of the mechanism(s) involved in its formation
in foods
• Exposure and biomarkers
• Toxicology and metabolic consequences

This approach is being reflected in the meetings, discussions, and initiation of research internationally.

Data on Acrylamide in Foods

Data collected in Sweden and subsequently in a number of other countries, including the United States, UK, Norway, and Switzerland confirm the presence of acrylamide in selected types of food. This general finding has been sufficient to establish acrylamide in foods as a concern and to galvanize action at the international and national level. However, the limited data available on acrylamide in foods has also demonstrated that much more information is needed as a fundamental first step. National and international bodies recognize that the full range of affected food types has not been determined. The extent to which acrylamide is found in home-prepared foods, in particular, remains a significant unknown. Similarly, within specific food types considerable variation has been found in the levels of acrylamide.

I am aware of no country or international body that has used the limited information available on levels of acrylamide in specific food types to take targeted regulatory action and, to my knowledge only one has issue a consumer advisory on specific product types. Norway’s National Food Authority recommended, “that people who eat a lot of potato chips in particular should consider to cut back for additional safety.”

The limited data available and the consequent uncertainties about the levels of acrylamide within and across different foods contribute to the position taken in the June FAO/WHO consultation on acrylamide in food and the July opinion of the European Commission Scientific Committee on Food that existing general advice to the public on healthy eating remains valid and appropriate. Individual countries have also taken this approach when considering what, if any, advice is currently appropriate. The language used by the EU Scientific Committee on Food is: “The information available on acrylamide so far reinforces general advice on healthy eating. People should eat a balanced and varied diet, which includes plenty of fruit and vegetables, and should moderate their consumption of fried and fatty foods.” I am not aware of any country, other than the two examples cited, or international body that believes enough information is available to give advice to consumers on individual products or categories of products.

Mechanisms of Acrylamide Formation

A great deal of attention is being given nationally and internationally to determine the mechanisms for acrylamide formation in foods. Temperature and time are two factors that are consistently identified. Given these important factors, however, various ways of preparing food, with the exception of boiling, have not been eliminated as contributing to acrylamide formation. In fact recent evidence tends to indicate that it is the actual temperature and time, rather than the method, which contributes to acrylamide formation in food. Knowing the mechanisms of acrylamide formation, including possible reactants and precursors, is critical information for identifying possible ways of reducing or minimizing formation. There is recognition that home and commercial food preparation methods need to be considered. For example, during the information seminar held by the German Federal Institute for Health Protection of Consumers and Veterinary Medicine, it was noted, “A special problem is posed by the preparation of deep-fried, baked, and fried foods in the home, mass catering facilities, and restaurants. Experiments show that this critical substance is also formed there.”

Ongoing research dealing with the mechanisms of acrylamide formation reinforces the need for FDA and others engaged in dealing with this issue to stay current with rapidly developing information and not to commit to a course of action that may prove inappropriate. On September 11, Health Canada issued a letter that describes model experiments that found when asparagine (the most predominant free amino acid found in potatoes) is heated with glucose, a “reducing” sugar (also present in potatoes), acrylamide is produced. French fries made from some potatoes had only one-fifth the acrylamide levels of others, because the potatoes were initially lower in asparagine. Last week, at an Association of Analytical Chemists meeting, work done by Procter & Gamble was reported showing that the amino acid, asparagine, coupled with a carbonyl source like glucose (dextrose), is a major precursor of acrylamide in food products. The carbons and nitrogen in acrylamide were found to come from asparagine, with the source of nitrogen in acrylamide being the asparagine amide nitrogen. These studies, yet to be published, may be significant in finding ways to affect acrylamide formation and in identifying what foods may be of interest. However, being able to reduce the amount of acrylamide formed does not indicate what the effect will be on food safety or the nature of the food product. These reports demonstrate that mechanistic research is underway and that new information will likely be surfacing at a rapid pace.

Determining Possible Risk to the Public

While national and international organizations are taking the presence of acrylamide in foods very seriously given what is known about the compound, there remains major scientific uncertainties and the need for research to determine if and what the health risk is from acrylamide in foods. Since acrylamide is apparently formed during food preparation at relatively high temperatures, we must remember that we have most probably been exposed to acrylamide in foods since we started using heating in food preparation. Statements from national and international organizations repeatedly emphasize that there is insufficient information to determine what the risk is. Similarly, there is not agreement on whether or if a quantitative risk determination for acrylamide in food is possible.

For example, the need for research to address the question of whether acrylamide and, specifically acrylamide in food, causes human cancer has been described. The FAO/WHO consultation acknowledged that quantitative human cancer risks using experimental animal carcinogenicity data have been attempted using different models. However, the consultation did not reach consensus on how quantitative risk assessment based on animal data should be used to estimate human cancer risk from acrylamide in food. Clearly, determining and, if possible, quantifying human risk is of interest internationally, but without additional research and resolution of scientific uncertainties, there does not appear to be a consensus on this issue within the scientific community or among government organizations.

Relevance of FDA’s Plan of Action to International Efforts

Acrylamide in foods is definitely an issue receiving national and international attention. In my opinion, FDA has developed an appropriate and aggressive plan of action that is consistent and in keeping with other national and international efforts. The EC Science Committee on Food recommended initiatives for research related to the following:

• The mechanisms of formation of acrylamide in food
• Levels in food and extended dietary exposure assessments, covering also national variations
• Bioavailability of acrylamide in food
• Elucidation of the mode of action as a carcinogen
• Investigation of the relationship between dietary intake of acrylamide and formation of glycidamide-DNA adducts
• Analysis of dietary acrylamide intake, exposure biomarkers, and disease endpoints in existing European and worldwide epidemiological cohorts
• Epidemiological studies on cancer in populations of known high exposure, such as occupationally exposed workers

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POSITION ANNOUNCEMENT

JOINT INSTITUTE FOR FOOD SAFETY AND APPLIED NUTRITION (JIFSAN)

Position: Food Safety Risk Analysis Clearinghouse Director

Type: Faculty Research Assistant/Research Associate

Location: University of Maryland, JIFSAN College Park, MD.

Applications: will be accepted until position is filled. for full consideration applications must be received by January 10, 2003

Salary: Commensurate with experience

Additional Salary Information: Contingent II, Faculty position with 22 days annual leave, 3 days personal leave, 15 days sick leave each year, and 14 holidays, with health insurance and retirement subsidies. Payment will not be made for unused annual and holiday leave at the end of your appointment.

Responsibilities:

The successful candidate will serve as the Director of the Food Safety Risk Analysis Clearinghouse. The aim of the Clearinghouse is to assist those professionals involved with any of the many aspects of risk analysis as it pertains to the safety of our food. The Clearinghouse provides data, tutorials, tools and links to numerous sources of information. In addition to providing resources for the food safety risk analysis professional, the clearinghouse provides consumer-oriented links. The successful candidate will have opportunities to work with a broad range of disciplines and the opportunity to contribute to a better understanding of food safety issues from multiple perspectives.

Qualifications:

Applicants must have a M.S. or Ph.D. degree, with a professional background in science, economics or other discipline relevant to food safety risk analysis. Strong leadership skills are required. Familiarity with the language and concepts of risk analysis is critical. A strong background in information structure management is preferred. Academic training or practical experience demonstrating an ability to analyze the relevance and quality of food safety risk analysis information is desired. Academic training or practical experience in evaluating and analyzing risk analysis needs as they pertain to governmental regulatory and/or information policy (e.g., collection and use of information, survey design) is desired.

In addition to a strong background in risk analysis, the successful applicant must have strong interpersonal and communication skills. Demonstrated ability to present ideas, reports, recommendations, clearly both orally and in writing is required. The successful applicant must have the ability to work independently and to organize work - sometimes in a high-pressure environment - so that diverse and conflicting work demands are met.

To apply: Applicants should submit a letter of application, current resume, and the names, addresses and contact information of three references to:

Search Committee: Clearinghouse Director
c/o Ms. Mary Grimley
Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
0220 Symons Hall
University of Maryland
College Park, MD 20742

Materials may also be submitted by email in MSWord or PDF format to: mg49@umail.umd.edu

THE UNIVERSITY OF MARYLAND IS AN EQUAL OPPORTUNITY AFFIRMATIVE ACTION EMPLOYER. WOMEN AND MINORITIES ARE ESPECIALLY ENCOURAGED TO APPLY

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Selected Upcoming Events

Society for Risk Analysis annual meeting
New Orleans, December 8 –11
Early registration deadline is November 1st, 2001

The Food Water Safety Risk Specialty Group (FWSRSG) of SRA is co-sponsoring two full day workshops:

SRA workshop number 5: “Mechanistic Dose Response Modeling for Microbial Risk Assessment “ co-sponsored with the Dose Response Specialty Group. The objective of the workshop is to discuss ways to improve microbial dose-response modeling and to generate a list of the key issues to be addressed when developing mechanistic models for microbial risk assessment. Mechanistic dose-response models allow consideration of the factors that affect the likelihood that an ingested organism will cause disease, and help predict the severity of the outcome. Development of mechanistic models requires an understanding of the virulence capacity of the pathogen, including genetic/ gene expression factors, the mode of action of the pathogen, including human physiological and immune responses, and food matrix factors that may modulate the pathogen’s ability to cause infection. Speakers will discuss their research in this area, and will address the gastrointestinal infectious disease process, gastric survival of microorganisms, the role of the immune system, and the use of animal models and tissue culture data in the context of developing mechanistic dose-response models for microbial risk assessment.

SRA workshop Number 6 “ From Quantitative Risk Assessment to Cost Benefit Analysis: Tools, Methods and Techniques”, co-sponsored with the newly formed Risk and Benefit Analysis Specialty Group. Designed for both Economists and Risk Assessors, this workshop will use one or more case studies, which will illustrate the advantages of integrating risk assessment and cost benefit analysis. In the afternoon, the workshop participants will breakout into small groups in which they will have the opportunity, in the context of the case study-- acrylamide in food—to formulate their own recommendations for integrating risk assessment and cost benefit analysis. The goal of the workshop will be to encourage participants to produce a new kind of “risk analysis” that will help generate new and better answers to risk policy questions.

Both workshops will feature world leading researchers and modelers including: Arie Havelaar (RIVM, The Netherlands), Bob Buchanan & Darcy Hanes (FDA CFSAN), Mark Sobsey, (Univ of North Carolina at Chapel Hill), H. Kirk Ziegler, (Emory Univ School of Medicine) and Phil Tarr, (U WA School of Medicine) for Workshop # 5 and for Workshop # 6: Randall Lutter (AEI- Brookings), Richard Williams, Richard Canady and Clark Nardinelli (FDA-CFSAN), Dom Mancini (OMB), Charles Griffith (EPA), Sue Ferenc (SAF-Risk), and Scott Farrow (GAO).

In addition to sponsoring the workshops, the FWSRSG worked with the Conference Program Committee to ensure that Food Water related symposia and presentations have as little scheduling and subject matter conflict as possible.

The FWSRSG is also co-hosting a mixer with the Dose Response Specialty Group on Tuesday December 10 from 5:30 PM to 6:30 PM. Dr. Arie Havelaar will address both groups with a presentation of common interest.

For more information about the FWSRSG sponsored events visit the FWSRSG web site at http://members.tripod.com/Cristina704/Foodrisk/ or go to http://www.sra.org/ and follow the links. You can also contact Cristina McLaughlin at 301 436 1978 or e-mail Cristina.Mclaughlin@cfsan.fda.gov or Don Schaffner at (732) 932-9611 x 214 or Schaffner@aesop.rutgers.edu.

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Recent Additions to the Clearinghouse

• Cost of Restrictions on Gulf Oyster Harvesting for Control of Vibrio vulnificus-Caused Disease
  Report of a study conducted by the Research Triangle Institute (RTI) for the Food and Drug Administration (FDA) on the costs of various control plans for Vibrio vulnificus in Gulf of Mexico oysters. It includes an estimate of the compliance costs of the Interstate Shellfish Sanitation Conference (ISSC) interim control plan for Vibrio vulnificus in oysters. Data is provided in tables and charts on oyster harvests, oysters bound for raw consumption, number of harvesters, processing plants, and shippers, baseline prices, and more



• Dietary Supplement Sales Database (DSPD)
  A survey conducted by Research Triangle Institute (RTI) under contract with FDA. The access database contains labeling and catalogue information of approximately 3,000 dietary supplement products sold in the United States. The database includes information such as the product's name, the name and address of the manufacturer or distributor, the product's ingredients, and claims about the product. Claims may be about the health benefits or nutrient content of the product or may be nutritional support statements. Thus, the database provides information on the range of products available for sale in the United States, where these products are sold, what they contain, and what claims are being made about these products. Also available are the final report of the project, which includes information on the procedures used and a description of the database, and a supplement to the final report, which includes detailed records from the data collection process.
  


• Food Testing Laboratory Database (FTLD)
  A survey conducted by Research Triangle Institute (RTI) under contract with FDA. The access database contains 546 records of private laboratories that test food. It includes the variables needed to support the kinds of analyses FDA expects to undertake-such as location and contact information, economic variables, test capabilities, and Quality Assurance Programs. The FTLD allows users to sort laboratories by location such as state or country, query laboratories owned by one parent company, sort laboratories by capabilities, and sort laboratories that use quality assurance guidelines such as International Organization for Standardization (ISO) standards, and determine laboratories associated with a certain geographic area or FDA district. This page also contains the final report of the project, which describes the selection process used to distinguish food laboratories from other laboratories, the structure of the FTLD, including the variables, tables, and forms that make up the database. It also describes testing capabilities and summarizes a preliminary analysis of the QAP status of private food testing laboratories and presents recommendations for further research.

New Software Announcements

FARE^TM- Food Analysis and Residue Evaluation ProgramTM

FARE^TM is modular software for performing probabilistic microbial risk assessment. It was developed by Exponent (formerly Novigen Sciences, Inc.) at the request of, and in conjunction with the US Food and Drug Administration (FDA). Although it uses algorithms developed by FDA for the L. monocytogenes risk assessment, FARE^TM- Microbial is capable of performing risk assessments for a wide variety of food borne pathogens. This program and instructions manual are available to download free of charge from “Tools” section of the Clearinghouse.

LifeLine™ Version 2.0

Software for Characterizing Aggregate and Cumulative Exposures to Pesticides and Dietary Exposure to Contaminants in Food and Tapwater

LifeLine Version 2.0 was developed by The LifeLine Group is a non-profit 501(c)(3) corporation that develops and distributes without charge software for performing aggregate and cumulative assessments of pesticide exposure and risk. LifeLine™ Version 2.0 was developed with funding from EPA, USDA, industry, and private sources. Licensed copies of LifeLine Version 2.0 are available without charge (a voluntary fee of $75 dollars is requested to cover shipping and handling expenses). To obtain a licensed copy of LifeLine contact: Dr. Christine Chaisson, Director The LifeLine Group, 4610 Quarter Charge Drive, Annandale, VA 22003 USA.

chaissoninc@erols.com

1 703 978 6962 Fax
1 703 978 6496 Phone

The use of product or company names is for informational purposes only and should not be construed as a JIFSAN Food Safety Risk Analysis Clearinghouse endorsement or preference for certain products or firms over others that are not mentioned.

Editor Notes

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