Date: Aug 01, 2005
The food industry seems to be the target for label warnings under California's Proposition 65 (officially known as The Safe Drinking Water and Toxic Enforcement Act). In our June issue, we reported that some people want to require wholesale Prop 65 labeling on almost all meat and poultry products.
Now, several Prop 65 bounty hunters have set their sights on an equally large segment of the food industry-manufacturers of snack foods and baked goods-alleging exposure to acrylamide.
Acrylamide is a carcinogen that has been listed under Prop 65 since Jan. 1, 1990 with a "No Significant Risk Level" (NSRL) of 0.2 µg/day. About three years ago, researchers discovered the presence of acrylamide in starchy foods derived from plants (such as potatoes) that are fried or baked at high temperatures. The level of acrylamide found in many of these foodstuffs is considerably greater than the NSRL.
Some quick-food restaurants have already been sued for alleged violations of the warning requirements involving french fries. Now the bounty hunters are going after other products, with the first being potato chips.
Realizing that potential exposure to acrylamide that naturally arises from cooking food is more complicated than it might appear to some, the California Office of Environmental Health Hazard Assessment (OEHHA) has proposed three regulatory actions to deal with the situation.
OEHHA has first proposed to revise the NSRL to 1 µg/day, which is calculated to result in no more than one excess case of cancer in an exposed population of 100,000, assuming exposure over a 70-year lifetime. This is based on a different risk assessment methodology than was originally used, and which OEHHA believes to be more appropriate.
OEHHA's second proposal would establish an alternative risk level for acrylamide in breads and cereals. The proposed alternative risk level is calculated to result in one excess case of cancer in an exposed population of 10,000, assuming lifetime exposure at the level in question, which is equivalent to a concentration of acrylamide in breads and cereals that is less than 200 parts per billion. Heeding advice from FDA, OEHHA thought that a little looser safety standard for breads and cereals was in order given the importance of dietary fiber to a balanced diet.
The third proposal would specify a "safe harbor" warning that can be used when one is required. The proposed regulation allows for a warning to be provided at the point of sale and need not be included on package labels for each individual product. The warning would specify cooking methods that are known and not known to cause acrylamide to form in foods, current advice available from the Food and Drug Administration (FDA) concerning the importance of a balanced diet and references to state and federal web sites. OEHHA believes that the proposed warning language will provide the necessary clear and reasonable warning required by Proposition 65, while not unduly alarming or confusing consumers.
The real answer to the problem may actually be to exempt Prop 65 substances that naturally occur in foods as a result of cooking. OEHHA held a workshop earlier this year to discuss the notion. However, given the comments of some participants, it will likely take much time and effort for this idea to gain traction.
Prop 65 requires manufacturers of products that result in exposure to certain chemicals listed by the State of California as carcinogens or reproductive toxins to provide "clear and reasonable" warnings to those who may be exposed. An exemption from the warning is available when companies can demonstrate that an exposure poses no significant risk. Prop 65 is enforced by private "bounty hunters," who share in any penalties assessed for a violation.
Used with permission. Copyright FOOD & DRUG PACKAGING, August, 2005.
For further information about this article, please contact George G. Misko at 202-434-4170 or by email at firstname.lastname@example.org.