Ingredient disclosure on disinfecting wipe safety sheets

June 15, 2011

[Withheld]

[Recipient address omitted]

Dear [Withheld]:

Thank you for your letter requesting information on behalf of your constituent, [withheld], regarding the safety of a commercially available brand of disinfecting towelettes used in many healthcare settings. Your letter was forwarded to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs for a response. [Withheld] raised concerns that the product may be unsafe for consumer use because the hazardous ingredients listed on the manufacturer's material safety data sheet (MSDS) are inconsistent with the active ingredients listed on the product container labeling.

We have reviewed the information and confirmed that the container label lists an additional chemical as an active ingredient that is not listed on the MSDS. According to the MSDS, Isopropanol is the predominant hazardous ingredient, accounting for 14% of the chemical composition of the product. There is no mention on the MSDS of the chemical diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride, which is listed on the product container label as an active ingredient present in the towelettes at 0.23%.

OSHA's Hazard Communication standard requires each chemical manufacturer or importer to include the chemical and common names of all hazardous ingredients which comprise 1% or greater of the composition on the MSDSs of chemicals to which workers may be exposed. The standard makes an exception in the case of chemicals identified as carcinogens. In this case, the name of a carcinogen must be included on the MSDS if the concentration is 0.1% or greater. We are unaware of any evidence that diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride is a carcinogen. Therefore, based on the manufacturer's claim of the amount of this chemical contained in the disinfectant towelettes (0.23%), the Hazard Communication standard does not require it to be listed on the accompanying MSDS.

Please keep in mind that the U.S. Environmental Protection Agency's (EPA) Office of Pesticide Programs has jurisdiction over registration and labeling of this and other microbial disinfectants. Commercial availability of disinfectants is based on evaluation and registration done by the EPA. The product of concern is listed among the EPA's List E registered antimicrobial products effective against mycobacterium tuberculosis, human HIV-1 and hepatitis B virus. Specific questions regarding the nature of the evaluation (i.e., studies reviewed; evidence submitted regarding the harmful properties of each hazardous chemical contained in the product, etc.), labeling requirements and registration process used by the EPA in determining the product's efficacy and appropriateness for commercial use should be directed to the EPA. We have enclosed a copy of the EPA list to further assist your constituent.

I appreciate receiving your letter. If we may be of further assistance, your staff may contact Sharon Block in the Office of Congressional and Intergovernmental Affairs at (202) 693-4600.

Sincerely,

David Michaels, PhD, MPH

Enclosure

cc: Washington, DC Office