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| Title: 06/15/2011 - Requirement to name hazardous ingredients on MSDSs. | |
| Record Type: Interpretation | Standard Number: 1910.1200 |
| OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov. |
ILPI Notes: This interpretation is based on and references the HCS 1994 which is now obsolete. While some parts have been deleted or changed, the conclusions of this interpretation appear consistent with the current regulation. Specifically, the reportable concentration cutoffs did not change between editions and we are unaware of any new carcinogenicity findings. However, be aware that the 2012 update changed the way that hazard determinations/classifications are made, and, more importantly, established significantly expanded guidelines for carcinogenicity determination.
June 15, 2011
[Withheld]
One Constitution Plaza, 7th Floor
Hartford, CT 06103
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 [in 2011 context: HCS 1994 | current regulation: HCS 2012] 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. [in 2011 context: HCS 1994 | current regulation: HCS 2012] 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 [this list is now retired; see the following for current guidance:]EPA’s Registered Antimicrobial Products Effective Against Bloodborne Pathogens: Human immunodeficiency virus (HIV), Hepatitis B and Hepatitis C [List S]. 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
The original official public domain version of this document is available from OSHA at https://www.osha.gov/laws-regs/standardinterpretations/2011-06-15.