“Carcinogen-Free” Label Program Proposed in House Bill

December 12, 2012

By Etan Yeshua

Manufacturers of foods, drugs and cosmetics might possibly be able to label their products as “Carcinogen-Free” with federal approval.  In November, Rep. Theodore Deutch (D-FL) and Rep. Sue Myrick (R-NC) introduced the "Carcinogen-Free Label Act of 2012" (H.R. 6601), which would require FDA, the Department of Agriculture (“USDA”), the Environmental Protection Agency (“EPA”), and the Consumer Product Safety Commission (“CPSC”) to develop a “Carcinogen-Free” label that manufacturers may affix to products that do not contain any known or probable carcinogens.  Any product that is regulated by FDA, USDA, EPA, or CPSC (and that is intended for individual or residential use) would be eligible to bear the label upon approval of an application submitted by the manufacturer for the specific product, and each agency or department would be required to post on its website the names of all products for which the label has been approved.  Rep. Deutch described the program as “100 percent voluntary” and maintained that the bill’s confidentiality provisions “would protect manufacturers’ hard-earned intellectual property.” 

Under the program outlined in the bill, a manufacturer wishing to affix the label to a product would submit an application (including a sample of the product and a list of all substances “contained within” it) to one of the four participating regulatory bodies.  Approval of an application would require that the product not contain any carcinogens and that the applicant demonstrate a plan to comply with manufacturing, storage, and transportation guidance which the regulatory bodies would be required to publish as part of the program.  The application would include a fee, calculated by each regulatory body, such that the estimated revenue for all “Carcinogen-Free” label application fees would be equal to the estimated cost of running the program.  The bill also calls for random testing of products for which applications have been submitted and random audits of the facilities in which they are manufactured.  The maximum penalty for unauthorized use of the label would be $100,000.

All information submitted with the application would “be treated as trade secrets or confidential information.”  The agency or department would be prohibited from making the information public without the applicant’s consent and from using the information for any purpose other than review of the application.

The bill defines “carcinogen” by adopting two lists of substances compiled by other Federal programs, but broadens the scope of the definition beyond simply the substances contained within the product.  An approvable product must not contain any substance listed in the National Toxicology Program Report on Carcinogens (“NTP Report”) as known, or reasonably anticipated, to be a human carcinogen, or in EPA’s Integrated Risk Information System (“IRIS”) as carcinogenic or likely to be carcinogenic to humans.  In addition, the product may not contain a non-carcinogenic substance that “displays carcinogenicity” when it interacts with other substances in the product or with substance exposed to the product by its intended use.  Thus, for example, hair straighteners (see our previous post here) that do not contain formaldehyde but that do contain methylene glycol would likely be ineligible for the label: although methylene glycol is not listed as a human carcinogen, when heated to straighten hair the chemical releases formaldehyde, which is listed in the NTP Report.

The bill does not address state-mandated carcinogen labeling, such as California’s Proposition 65, thus raising the possibility of putting both manufacturers and consumers in an unfortunate position.  Proposition 65 requires manufacturers to include a warning on products sold in California that contain any chemical that is considered by the State to be toxic.  Therefore, if a product sold in California contains a substance that is included in California’s list but not in the NTP or EPA lists, consumers may soon be faced with a label that reads “Carcinogen-Free: This product does not contain known or likely carcinogens that increase your risk of cancer,” as well as “WARNING: This product contains chemicals known to the State of California to cause cancer….”

H.R. 6601 has been referred to the House Agriculture Subcommittee on Nutrition and Horticulture.  With only days remaining in the 112th Congress, however, it seems unlikely that the bill will gain any traction.