California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (“Proposition 65”) requires the Office of Environmental Health Hazard Assessment (OEHHA) to publish and update a list of chemicals known to the state to cause cancer or reproductive toxicity. Currently, over 750 chemicals are listed.
Companies “doing business” in California must provide a clear and reasonable warning before knowingly and intentionally exposing any individual to a listed chemical. No warning is necessary for exposures below the “no significant risk level” (NSRL) for carcinogens, or 1/1000 of the “no observable effect level” (NOEL) for reproductive toxicants.
OEHHA has established approximately 250 “safe harbor” levels for listed chemicals, which are often orders of magnitude below federal regulatory levels. Acrylamide was listed under Proposition 65 in 1990, as a carcinogen, based on industrial uses of the synthetic chemical, and OEHHA established an NSRL of 0.2 µg/day.Discovery of Acrylamide in Food
In 2002, Swedish researchers discovered that acrylamide is formed in food from natural constituents, usually as a result of cooking carbohydrate-rich food at high temperatures (greater than 120º C). Acrylamide levels in some foods far exceed the NSRL.
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The Food and Drug Administration (FDA) has been studying acrylamide since that year, in collaboration with other agencies and institutions worldwide. Investigations include how it is formed in food, how the levels can be reduced and whether there are health risks. From the research to date, the FDA stated that although acrylamide can cause cancer in laboratory animals at high doses, "it is not clear whether acrylamide causes cancer in humans at the much lower levels found in food."
Results from FDA’s carcinogenicity and neurotoxicity studies on acrylamide in food are expected by 2007. Scientists agree that acrylamide has probably been present in cooked foods for thousands of years, and is not the result of environmental contamination. For now, the FDA’s advice is for 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.
The FDA plans to develop, pursuant to its acrylamide action plan, new consumer messages about dietary choices and cooking methods as additional knowledge is gained about acrylamide in food, considering “the totality of the science.”OEHHA Considers Regulatory Options
In light of the Proposition 65 implications of acrylamide formation in many common foods, OEHHA developed an acrylamide work plan. A workshop was held on May 9 to discuss potential regulatory action regarding a limited exemption for exposure to listed chemicals that are formed solely from constituents naturally present in food, as a result of the food being cooked or heat processed, if the concentration of the chemical has been reduced to the lowest level currently feasible using good cooking and manufacturing processes.
Proposition 65 exempts exposures to listed chemicals that are “naturally occurring” in food. However, the naturally occurring exemption is not applicable to exposures resulting from any known human activity, and OEHHA has taken the position that the exemption could not be expanded to cover the formation of acrylamide in food because cooking is a known human activity.
OEHHA also proposed three regulatory options, which were discussed at a public hearing on May 24, with final regulations anticipated by early 2006:
- Updating the dose response assessment for acrylamide, and revising the NSRL to 1 µg/day.
- Establishing an alternative risk level, 10 times higher than the level of risk generally used under Proposition 65, for acrylamide in most breads and cereals (a concentration of 200 ppb or less).
- Specifying wording for signage to be displayed at the point of sale, rather than on package labels, that a) generally describes the kinds of foods that contain acrylamide, b) cites the FDA’s advice regarding the importance of a balanced diet and c) provides other information about acrylamide in foods (instead of the standard Proposition 65 warning).
The FDA submitted written comments to OEHHA for the hearing, stating, “FDA believes that warning language for acrylamide in foods could confuse consumers by creating unnecessary public alarm about the safety of the food supply and by diluting overall messages about healthy eating. We have separately recommended that California resolve the issue of a potential exemption for chemicals that form from natural constituents in food before the warning language proposals are finalized.”
Attorney General Sues
On August 26, California Attorney General Bill Lockyer sued nine makers of french fries and potato chips — McDonald's, Burger King, KFC, Wendy's, Cape Cod Potato Chips Inc./Lance Inc., Frito-Lay Inc./ PepsiCo Inc., H.J. Heinz Inc., Kettle Foods Inc. and Procter & Gamble Distributing Co. — in Los Angeles County Superior Court. Attorney General Lockyer is seeking Proposition 65 warnings that the products “contain acrylamide, a carcinogen.”
In an op-ed piece in the October 17 issue of the San Francisco Chronicle
, Attorney General Lockyer explained the reason he filed suit prior to OEHHA issuing final regulations and further proposals addressing acrylamide in food: “Since the discovery [of acrylamide in food], some food manufacturers started exploring better cooking methods, but some manufacturers instead have launched a major disinformation campaign about California law. They are even twisting the FDA's glacial pace on addressing this health crisis into an endorsement for the status quo. They're doing what they always do when called upon to stop concealing facts: The junk-food industry is peddling junk science. People have the right to make their own choices, for themselves and their families, based on truthful information. Few manufacturers voluntarily alert the public to the cancer-causing chemicals in their products. That is why right-to-know laws like Prop. 65 are critical.”Possible Federal Preemption
Attorney General Lockyer had filed a lawsuit in San Francisco Superior Court in June 2004 seeking Proposition 65 warnings on canned and packaged tuna products containing mercury and mercury compounds, which are listed as carcinogens and reproductive toxins. On August 12, two weeks before the acrylamide lawsuit was filed, then-FDA Commissioner Lester Crawford sent a letter to Attorney General Lockyer concerning the FDA’s position on Proposition 65 mercury warnings.
Commissioner Crawford stated, “FDA believes that such warnings are preempted under federal law… The [Federal Food, Drug, and Cosmetic] Act provides broad authority to the FDA to regulate the labels of food products. However, rather than requiring warnings for every single ingredient or product with possible deleterious effects, FDA has deliberately implemented a more nuanced approach… taking action in instances of adulterated and misbranded foods and, only under exceptional circumstances, requiring manufacturers to provide warnings on their labels. As part of this deliberate regulatory approach, FDA has required warnings only in those instances where there is clear evidence of a hazard, in order to avoid overexposing consumers to warnings, which could result in them ignoring all such statements, and hence creating a far greater public health problem… The Proposition 65 warnings purport to convey factual information, namely that methylmercury is known to cause cancer and reproductive harm. However, it is done without any scientific basis as to the possible harm caused by the particular foods in question, or as to the amounts of such foods that would be required to cause this harm."
Although the mercury and acrylamide cases differ in some respects, there are multiple similar issues. Given the FDA’s conclusion that federal law preempts Proposition 65 warnings for mercury in tuna, and its serious concerns as expressed to OEHHA in May regarding the possibility of Proposition 65 warnings for acrylamide in food, an FDA preemption challenge to the acrylamide lawsuit may be imminent.
Leslie T. Krasny is a partner at the law firm of Keller and Heckman LLP, San Francisco office. She specializes in food and drug law, with emphasis on food safety, food labeling, ingredient evaluation, organics, biotechnology and advertising. She is a member of the California Bar and holds a master’s degree in cell and molecular biology.