Under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), the state is required to maintain a list of chemical substances known to the state to cause cancer, birth defects, or other reproductive harm. The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has recently proposed that acrylamide, a Proposition 65 listed chemical carcinogen produced during the cooking of certain foods, should also be listed as a reproductive toxicant.
Since its discovery by the Swedes in 2002, acrylamide is known to form naturally in many starchy foods when they are fried, roasted, or toasted at high temperatures in the Maillard Browning Reaction, in which glucose and fructose react mainly with the amino acid asparagine. For acrylamide as a carcinogen, a No Significant Risk Level (NSRL) of 0.2 micrograms per day had previously been established by the state of California as the average daily intake a consumer could be exposed to under Proposition 65 without giving a cancer warning on the product label. The February 26, 2010 OEHHA document further proposes a “Maximum Allowable Dose Level” (MADL) for acrylamide of 140 micrograms a day, and OEHHA is seeking public comments on the proposed listing and MADL by April 27, 2010.
OEHHA has concluded that based on a number of animal studies, “the evidence is sufficient for listing acrylamide as known to cause reproductive toxicity by the authoritative bodies mechanism.” The U.S. National Institute for Occupational Safety and Health (NIOSH) and the U.S. National Toxicology Program (NTP) are the two designated authoritative bodies that OEHHA is using as the formal basis for the proposed listing. In addition, OEHHA believes that the evidence for acrylamide considered by these two bodies meets the “sufficient evidence” criterion.
What might be the regulatory and labelling impact to food companies and consumers if acrylamide is eventually added to the list of reproductive toxicants? Even the highest consumers of acrylamide in the U.S. FDA’s exposure assessment (0.4 micrograms per kilogram body weight per day, or about 30 micrograms per day in the entire diet) would take in levels that are more than four times below the proposed MADL (140 micrograms per day). Consequently, the daily consumption of no one food or beverage containing acrylamide could ever exceed the proposed MADL or require a reproductive toxicity warning label. In addition, there are no adverse reproductive toxicity effects from acrylamide exposure that have ever been demonstrated to occur in humans. Such effects have only been shown in very high-dose animal experiments. Therefore, the acrylamide intakes to which consumers are exposed in their daily diets are thousands of times lower than the high doses producing adverse effects in animals, so there is a very wide safety margin for reproductive toxicity from acrylamide intake in the human diet. Therefore, there appears to be no California product labeling requirement and no regulatory impact for companies from the addition of acrylamide as a reproductive toxicant.
Quick Q&A on Acrylamide:
Q. If acrylamide becomes listed as a reproductive toxicant, does this change how it is handled as a listed carcinogen in foods?
A. No, the carcinogen and reproductive toxicant requirements under Proposition 65 are independent. Listing as a reproductive toxicant will not alter the acrylamide cancer warnings currently being given for French fries in California.
Q. Should consumers avoid foods containing trace levels of acrylamide because of possible reproductive harm?
A. No, the reproductive effects are only seen in high-dose animal testing and will not occur in humans because consumers are exposed to acrylamide intakes so much lower than the test animals.
Q. Just to be safe, shouldn’t I simply avoid acrylamide-containing foods?
A. No, acrylamide is found at trace levels in foods making up about 40% of a person’s daily calorie intake, and all of these foods are part of a regular healthy diet. The FDA and other public health advisory bodies around the world urge consumers to eat a balanced diet as part of a healthy eating plan.