Acrylamide

Characteristics

Uses

Environmental Transport

Environmental Deposition

Methods for Monitoring in the Environment

Methods for Monitoring Human Exposure

Safeguards Against Acrylamide Exposure


Harmful Effects

Dose Response

Absorption, Distribution and Metabolism

Primary Sites for Toxicity

Biomarkers

Mechanism of Action

Risk Assessment and Management

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Acrylamide Policy

Introduction to Policy

Decision Makers and Stakeholders

Current Policy

Policy Recommendations


References

POLICY RECOMMENDATIONS

Research Policy

Endorsed Policy Option – Research

Current acrylamide policy focuses primarily on research. We agree that further research is needed before additional policy decisions can be made. Research should be conducted in order to provide decision-makers with the information that will allow them to make future policy decisions. Therefore, we advocate goal-directed research that would allow for further policy development. We specifically advocate research in the following areas:

  • Risk Assessment

The goal of this research is to determine the need for regulatory policy on acrylamide in food (see further discussion in “Risk Assessment Discussion” section).

  • Dose Response
  • Quantification of acrylamide levels in foods
  • Quantification of human acrylamide consumption
  • Concentrations of acrylamide in humans
    The goal of this research is to set an “acceptable limit” or action level for acrylamide in foods. An action level must be set before any further regulatory policies can be considered.
  • Determination of best practices for food production and preparation that reduce acrylamide levels in foods

The goal of this research is to create voluntary “best practice” guidelines to aid the food industry in reducing acrylamide in the foods they produce and prepare.

When endorsing research as a policy option, we must consider who is controlling and funding the research. Currently, the FDA is the primary decision-maker for acrylamide policy but is not involved with controlling or funding acrylamide research. We advocate placing greater control and responsibility for research in the hands of the decision-makers (the FDA). Specifically, the FDA should set objectives and criteria for all acrylamide research that will be considered for policy development. We also advocate for increased allocation of FDA funds to acrylamide research rather than relying on the funding of outside research organizations.

Benefits – Research

We feel that a policy that includes additional research would be beneficial in terms of aiding policy makers with future decisions. A goal-directed approach to research would provide the information needed to set an action level for acrylamide in foods and to create a set of best practice guidelines for the food industry. We believe that further regulatory policy is not possible without first obtaining this information. A focus on research also allows for a better understanding of the problem without inciting public fears or incurring unnecessary risks or costs to the food industry.

Giving the decision-makers greater control over the research that is conducted will ensure that the research is truly helpful in creating future policy. A large body of acrylamide research is currently available, but much of this research is currently not helpful in creating acrylamide policy. Additionally, given the affiliations of some of the research organizations (e.g. the food industry or consumer advocacy groups), the validity of some of the existing research is in question. By granting the FDA greater influence over the process, the risk for bias in the research will be diminished.

Costs – Research

Conducting research can obviously be economically costly. However, we believe that focusing the research on specific goals will reduce the research costs to some extent (currently, the scope of acrylamide research is quite broad). Shifting the allocation of government funds to acrylamide research (rather than the current policy of using funding from outside research organizations) will place a greater burden on already constrained government budgets. However, we believe that allocating funds in this way will push the decision-makers to ask appropriate research questions in a timely manner.

There are potential social costs to a policy that focuses on research. There is concern that decision-makers are taking too long to develop regulatory policies because they continue to push for more research. By delaying the development of restrictions on acrylamide in foods, consumers may be put at unnecessary risk. Consumer advocacy groups (such as CSPI) are pushing for regulatory policy now. They argue that a sufficient body of evidence already exists to create such a policy.

Administrative Feasibility – Research
The current FDA policy for acrylamide in foods focuses primarily on continued research advocating that the FDA set specific research objectives and criteria and allocate funding for this research. This plan would require additional government funds and resources.

Political Considerations – Research
The primary political considerations for research policy include balancing industry and consumer interests and allocation of funding.

As discussed in the stakeholders section, the food industry and consumers (and the groups that advocate for them) are often at odds when it comes to food policy. In the case of research, the food industry is motivated to continue with research in order to avoid or delay the development of regulations. Additionally, the food industry has interest in conducting their own research that will provide results that are in their best interest. Therefore, the results of the research conducted by the food industry have the potential to be biased. Conversely, consumers and consumer advocacy groups often favor development of regulations as soon as possible in order to protect consumers. In some cases strict regulations are appropriate, but without further research, the need for these regulations may not be known. Given the motivation of consumer advocacy groups, research conducted by them also has the potential to be biased. Therefore, we are advocating that the research used for policy decisions not be conducted or funded by these potentially biased groups.

Allocation of research funding is another political consideration that must be addressed. Within a budget constraint, there will always be controversy about how best to allocate these funds.

Risk Assessment / Risk Communication of Acrylamide

The risk communication component of the current FDA proposal on Acrylamide contains ongoing research in the areas of exposure assessment, hazard identification, and potential forms of risk communication. The overall risk assessment scheduled for release will mimic closely the assessment scheduled for release in 2005 by the World Health Organization.

Further breakdown of the FDA’s proposal is to develop a working recommendation that will be subject to modification as more research is conducted and new relevant information is released in toxicology research and epidemiological studies. As such, more emphasis is being developed for the risk communication portion of the assessment which will be integral into the FDA’s educational implementation plan. As will be discussed in the education section, public committee meetings, web sites, public relations statements and labeling campaigns are but a few of the control measures that the FDA is proposing in its Acrylamide Risk communication strategy.

Of the critical components to any risk assessment, Acrylamide is receiving much attention in further defining the exposure assessment portion of the risk assessment document. The Center for Food Safety and Applied Nutrition in conjunction with the FDA is developing Monte Carlo based distributions of Acrylamide levels in foods based on appropriate food intake levels. This estimated distributional range of Acrylamide intake is aimed at identifying foods that show significant contribution to daily diets.

Table 1 show that available data used in Acrylamide exposure modeling ranges from 1982 to the present.

Table1. Past and Present Exposure data used in Acrylamide Monte Carlo Modeling

Study Name
Date Collected
Ideology
Market Research Corporation of America 14 day food study 1982-1987 Contains data on “unusually eaten foods”
Continuing Food Survey Intake Inventory 3-day (CSFII) 1989, 1992
CSFII 2-day 1994, 1996, 1998
FDA Total Diet Study (TDS) 2002, 2003 Market based sample of 700 Acrylamide containing foods
FDA Office of Regulatory Affairs Sample over 900 2004, 2005 Acrylamide containing foods

It should be noted that both studies being directly conducted by the FDA are currently on going and that these data have not yet been introduced into Monte Carlo simulation techniques.

Analysis of the Risk Characterization Process:

With appropriate and accurate data, the overall recommendation statement issued by the FDA and WHO could become a powerful tool in regards to Acrylamide policy decision making. A firm definitive risk statement could entail regulatory control measures if Acrylamide containing foods are considered to be “adulterated” as defined by the FDA, and consequently, have an action limit placed on them as proposed by CSPI. (Insert source #)

While this action limit may not necessary mean mandatory testing of all food products, it may instigate industry compliance to ensure avoiding lengthy and expensive legal litigation. Politically, the only viable solution to Acrylamide would be voluntary corporate compliance based on potential regulatory actions if a company is found to be in violation.

A definitive recommendation stating numerical levels of acrylamide that will clearly depict violations will mark a substantial change in U.S. food safety policy.

Education

The government must always be careful when educating the public. Public trust is hard to gain and very easy to lose. If too little is said about acrylamide, then the government is thought to be hiding something. If too much is said too quickly, then the government is considered overly cautious about the effects. Either approach could cause unnecessary panic or indifference and diminish credibility. Most of the data currently point towards acrylamide being a threat; but, there is a very small chance that the human body has a mechanism to decrease the toxic effects of acrylamide.

The first step would be to encourage food companies to label products that contain acrylamide. Currently there is no inexpensive screening process, and companies may not be able to afford the current method. To make this option more feasible, companies that cannot afford to analytically quantify the amount should just place a warning statement or list it in the ingredients. For example, pastries or taco shells would say: WARNING: HEATING MAY CAUSE ACRYLAMIDE FORMATION or cereal could say: WARNING: PRODUCT CONTAINS TRACE AMOUNT OF ACRYLAMIDE.

Companies may be unwilling to do this and the government unable to spend a large amount on enforcing labeling. Therefore, creating some public outrage may be necessary. The easiest way to do this is to start public education campaigns. Television, radio and internet communication have already began. There is already an acrylamide website that informs the public where to find data and discoveries or research that is currently taking place. The media is also helping by covering the story during talk shows and in news clips. Unfortunately the media is not always reliable and may change the story so private ads may also be necessary. Widespread, multimedia campaigns would reach more people; however, public education meetings in communities may be cheaper than ads. It would also help the government to understand how consumers feel about the risk associated with acrylamide. A public campaign would allow consumers to make educated choices about the food they eat. Consumers would also be able to learn better food preparation methods to reduce acrylamide consumption that could cause health effects

There have also been a number of meetings involving other governments which should continue so that information and ideas are exchanged. The FDA is planning a number of public education campaigns; however, the process is too slow. If they continue in this way, they will be criticized since they have been aware of this for more than two years and made no attempt to make people concern. This would be a huge social cost that could not only hurt the acrylamide issue but many other areas that concern the FDA.