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Acrylamide and Proposition 65
Questions and Answers
Office of Environmental Health Hazard Assessment
May 2005
1. What is acrylamide?
A. Acrylamide is a chemical that has been used in grouts and cements, pulp and paper production, ore processing, permanent-press fabrics, and dye manufacture. It is also used to produce polyacrylamide, which is used in water and wastewater treatment, soil conditioning and oil drilling. Acrylamide is present in tobacco smoke. In 2002, Swedish researchers discovered that acrylamide forms during the baking, frying or roasting of certain kinds of foods, particularly starchy foods. Subsequent research has confirmed that acrylamide is present in many kinds of cooked and heat processed foods, including French fries, potato chips, other fried and baked snack foods, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, coffee, roasted grain-based coffee substitutes, prune juice, breakfast cereals, crackers, cookies, breads, and toast.
2. Is acrylamide toxic?
A. A number of scientific studies indicate that acrylamide can cause cancer in laboratory animals, and available information suggests that acrylamide is likely to cause cancer in humans. Acrylamide was added to California 's Proposition 65 list of carcinogens in 1990. Acrylamide has also been shown to harm the human nervous system, as well as the male reproductive system in laboratory animals. Until the discovery of acrylamide in food, concern about the chemical's potential health effects centered on workers who handle the chemical. It now appears that virtually everyone is regularly exposed to acrylamide through the food they eat. Acrylamide has probably been present in cooked foods for thousands of years and is not the result of modern-day environmental contamination.
3. Should I stop eating certain kinds of food?
A. The U.S. Food and Drug Administration (FDA) recommends that the public 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 and other health and scientific organizations are continuing to study the prevalence of acrylamide in food, how it is formed during cooking, its effect on health, and how its formation during cooking can be reduced. This research may form the basis for more specific dietary advice and/or federal regulation of specific food products in the future.
Using information on food consumption by the U.S. population and acrylamide levels measured in foods by the FDA , the Office of Environmental Health Hazard Assessment (OEHHA) has developed estimates of the daily intake of acrylamide resulting from consumption of specific foods , and estimates of the frequency of consumption of a particular acrylamide-containing food that would be expected to result in not more than one additional cancer case (beyond what would otherwise occur) in a population of 100,000 people consuming the food over a lifetime. Interested individuals may find this and other information available on OEHHA's acrylamide web page useful when making individual food choices.
4. What is Proposition 65?
A. Proposition 65, known officially as the Safe Drinking Water and Toxic Enforcement Act of 1986, was a ballot initiative that was approved by California voters in 1986. OEHHA is the lead agency for the implementation of Proposition 65, which requires the state to maintain a list of substances that are known to cause cancer, birth defects or other reproductive harm. Currently, there are more than 750 substances on this list, including acrylamide. Many of these listed substances are additives or ingredients in pesticides, common household products, foods, drugs, dyes, or solvents.
A business that knowingly exposes individuals to a significant amount of a listed substance is generally responsible for providing a clear and reasonable warning to those individuals. In many cases, the warning appears on a product's label, but warnings can be placed on signs in retail outlets or be provided through any other form of communication that conveys the warning in a clear and reasonable manner. Proposition 65 warnings are common throughout California .
The California Attorney General, county district attorneys and certain city attorneys can file civil suits against businesses that they believe are in violation of Proposition 65. Also, there are provisions in Proposition 65 that enable any member of the public to file civil suits in the public interest to enforce the statute.
Proposition 65 does not ban or directly regulate chemicals, nor is it intended to shield the public from exposure to all hazardous substances. Proposition 65 is a “right-to-know” law that helps Californians make informed choices about the products they purchase and activities that may bring them into contact with substances that cause cancer, birth defects or other reproductive harm.
5. Does Proposition 65 apply to acrylamide in food products?
A. Yes. Under Proposition 65, food businesses – including manufacturers, retailers and restaurants – are responsible for providing warnings when they knowingly sell food products that cause exposures to acrylamide.
6. How can widespread warnings concerning acrylamide in food truly serve the public interest? Will these warnings create public alarm? Or will the warnings be so ubiquitous that they will lose their meaning?
A. These are key questions that OEHHA has considered very carefully. OEHHA has reached the following conclusions regarding Proposition 65 warnings for acrylamide in food:
• Warnings should be conveyed in a manner that does not cause public alarm, and that avoids discouraging the public from eating healthy foods, including the high-fiber grains that are part of the balanced diet recommended by the FDA.
• Proposition 65 warnings should educate consumers about the overall prevalence of acrylamide in different foods so that interested individuals can make their own choices about the foods they eat. The traditional Proposition 65 warnings on individual products are not the best way to accomplish this.
7. How can OEHHA achieve these goals for orderly, informative Proposition 65 warnings for acrylamide in food?
A. OEHHA has released three proposed regulatory packages that would provide guidance for businesses in providing Proposition 65 warnings related to acrylamide in food. These regulatory packages cover three elements:
• Businesses could meet the Proposition 65 warning requirement for acrylamide in food with display signs posted at checkout counters in supermarkets and other retail outlets containing prescribed wording that generally describes the kinds of foods that contain acrylamide, cites the FDA advice for consumers to eat a balanced diet, and provides other information about acrylamide in foods. These display signs would be an acceptable substitute for the traditional Proposition 65 warnings on individual product labels. OEHHA believes display signs with the prescribed wording would be more informative, provide better guidance to consumers, and would be less likely to cause unnecessary alarm than the traditional product-label warnings.
• A regulatory action that would remove the Proposition 65 warning requirement for some foods causing only low exposures to acrylamide. A warning is not required when exposure to a listed substance is so low that it poses no significant health risk. OEHHA establishes regulatory “safe harbor numbers” that indicate when an exposure to a listed substance is sufficiently low that a warning is not required. OEHHA is proposing to replace the acrylamide safe harbor number established in 1990 (0.2 micrograms per day) with an updated number (1.0 microgram per day) that reflects data from more recent studies of acrylamide. The higher number would mean that some foods that contribute relatively low amounts of acrylamide in the average individual's diet, like doughnuts, breaded chicken, canned black olives, roasted almonds and sunflower seeds, would not require warnings. OEHHA believes this will better enable interested consumers to focus their attention on foods with significant acrylamide levels.
• A regulatory action that would remove the Proposition 65 warning requirement for most breads and cereals. As stated in the previous paragraph, a warning is not required when exposure to a listed substance is so low that it poses no significant health risk. The level of cancer risk that is deemed to be not “significant” is normally consistent among different products and listed substances, but OEHHA has the authority to approve a higher level of risk in specific instances when there are sound considerations of public health that support such a decision. OEHHA is proposing to set an alternate level for cancer risk from consumption of acrylamide in breads and cereals, namely a lifetime risk of one excess case of cancer in 10,000 individuals, which is ten times above the level of risk generally used under Proposition 65. This would have the practical effect of removing the warning requirement for most bread and cereal products.
This proposal reflects the fact that sound considerations of public health support encouraging, rather than discouraging, increased consumption of high fiber foods, including breads and cereals. Breads and cereals are grain-based foods that generally have a high-fiber content, and are generally low in trans fat and saturated fat. Whole grain and enriched and fortified breads and cereals are a good source of vitamins and other important nutrients. Moreover, breads and cereals are a significant source of dietary fiber in the U.S. diet, and adequate intake of dietary fiber is widely recognized as an important part of daily nutrition. Increased intake of dietary fiber is associated with decreased risk of stroke and heart attack, decreased blood cholesterol levels, improved control of blood sugar levels in diabetics, and reduced risk of colorectal cancer. OEHHA believes that it is sound public health policy for warnings to reflect a careful balancing of the health risks and benefits of particular foods.
8. Will there be an opportunity for public discussion of these proposals?
A. Yes. OEHHA must comply with legal requirements for the consideration and adoption of regulations by state agencies. OEHHA will provide opportunities for public comment, conduct a public hearing, carefully review all comments, hold additional public comment periods on any significant changes it proposes to these regulatory packages, and provide formal written responses to all relevant comments when it formally adopts any acrylamide regulations. Updated information on the status of the draft regulations is available on OEHHA's Web site at www.oehha.ca.gov .
9. It is understandable that Californians want to be informed when they are exposed to cancer-causing chemicals that have been deliberately added to products. But should Proposition 65 warnings be required for substances, like acrylamide, that are created automatically simply by cooking food?
A. There is no simple answer to this question. Under current regulations, Proposition 65 warnings are not required for chemicals that are naturally occurring in a product under certain circumstances. OEHHA does not believe this exception applies to acrylamide, because cooking is an intentional human activity that results in the formation of acrylamide in food. The acrylamide does not form without human intervention, so it cannot be seen as naturally occurring under the current regulation. However, the acrylamide created by cooking is formed from substances that are naturally present in foods. OEHHA scheduled a workshop on May 9, 2005 to solicit public comment on a possible regulation that, in effect, would eliminate the warning requirement for chemicals in food formed solely from naturally occurring substances as a result of cooking, as long as the concentration of the chemical in the food has been reduced to the lowest feasible level.
OEHHA is not formally proposing such a regulation at this time, and has not concluded that a regulation of this type is in the public interest or is consistent with the intent of Proposition 65. However, in light of the unique and challenging issues associated with Proposition 65 and acrylamide in food, OEHHA believes that a public discussion of the merits and drawbacks of such a regulation should take place. Updated information on the workshop and the regulatory proposal will be available on OEHHA's Web site at www.oehha.ca.gov . The workshop transcript is available by contacting the court reporter, Ms. Phyllis Mank at phylanna@aol.com or (916) 451-2279.
10. Why can't OEHHA postpone action on its acrylamide regulations until the FDA determines what kind of federal regulations, if any, are needed to address acrylamide in food?
A. Acrylamide has been listed under Proposition 65 since 1990, and therefore the warning requirements for acrylamide exposures from food are already in effect. As stated in the response to Question No. 4, any member of the public can initiate legal action to enforce Proposition 65. One lawsuit has been filed over acrylamide in food, and a number of similar lawsuits are pending. If OEHHA does not enact any regulations, legal questions concerning the applicability of Proposition 65 to acrylamide in food will be decided in individual court actions or settlements without public input.
As the lead agency for implementation of Proposition 65, OEHHA believes it should use its scientific expertise to craft regulations that provide needed guidance concerning the applicability of Proposition 65 to acrylamide exposures from food. Regulations developed with public input can minimize the need for litigation and provide for the dissemination of information on acrylamide in food that best serves the public interest.
11. Where can I get more information about acrylamide in foods?
A. Check the special OEHHA acrylamide web page for the most up to date information on OEHHA's regulatory actions and for links to other sources of information. The web page can be found at: http://www.oehha.ca.gov/prop65/acrylamide.html .
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