All ethoxylated materials are said to contain trace amounts of EO and 1, 4 Dioxane. If my product contains well bellow .1% of ethylene oxide, does this need to be mentioned in the SDS in order to be compliant with California Prop 65?
According to The Office of Environmental Health Hazard Assessment (http://oehha.ca.gov/prop65/crnr_notices/admin_listing/requests_info/092013ChangeBasis.html) regarding Prop 65 and ethylene oxide.
Prior to June 1, 2016, employers may use the following legend in lieu of that specified in paragraph (j)(2)(i)(A) of this section:
“DANGER ETHYLENE OXIDE CANCER HAZARD AND REPRODUCTIVE HAZARD AUTHORIZED PERSONNEL ONLY ”
“1910.1047(j)(2)(ii)(A)
The employer shall ensure that labels are affixed to all containers of EtO [ethylene oxide] whose contents are capable of causing employee exposure at or above the action level or whose contents may reasonably be foreseen to cause employee exposure above the excursion limit, and that the labels remain affixed when the containers of EtO leave the workplace. For the purposes of this paragraph (j)(2)(ii), reaction vessels, storage tanks, and pipes or piping systems are not considered to be containers.”
"Action level" means a concentration of airborne EtO of 0.5 ppm calculated as an eight (8)-hour time-weighted average (https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10070).
So here's my math:
.5/1,000,000= 0.0000005
0.0000005 x 100=0.00005%
I can't find a clear answer, or if there's a new regulation concerning EO. Many of our products would only contain trace amounts, if any at all since EO is extremely volatile and they were not required to be reported before, but the UN's Global Harmonizing System or California may have changed the rules.
Hello,
Proposition 65 is specific to California. This is sometimes considered a "right to know" regulation and is separate from OSHA or other occupational regulations, and is independent from the federal government.
Proposition 65 requires that a clear and reasonable warning be provided on a product that contains a chemical known to the State of California to cause cancer or birth defects (ethylene oxide is listed as both) IF the exposure from using the product would be above what is called a "Safe Harbor Level (SHL)." It is complicated because the SHL is in units of micrograms/day instead of as a concentration. For ethylene oxide there is a cancer endpoint SHL of 2 microgram/day and a developmental toxicity endpoint SHL of 20 microgram/day. http://oehha.ca.gov/prop65/pdf/safeharbor081513.pdf
For a volatile substance, you could calculate workplace exposure by determining how much might be released into the breathing space of the worker (convert to a unit of microgram/cubic meter and then multiply that by the amount of air that someone would breath in during an 8 hour work day (m3/hr x 8 hr/day) using the product. If the result you get (microgram/day) using reasonable conservative assumptions (e.g., high activity job) is greater than the SHL then a prop 65 warning would be required. If there is potential for skin contact and hand to mouth indirect ingestion that would also need to added to the exposure amount. Often you can find proposition 65 warnings on section 15 (other regulatory information) of an MSDS. However, note that OEHHA which is responsible for Proposition 65 is currently working on updating the requirements for what constitutes a "clear and reasonable warning". Any changes should be posted to their website
Best Regards
Lois Haighton
I think you may be confusing requirements for federal rules with Prop 65 and the state's Hazard Communication Standard. California's HCS is different than the federal one. Consult section 5194 (dir.ca.gov/title8/5194.html). There are lists that must be used for classification, aside from the general approach of Appendix A. See (d)(3). Prop 65 requirements can be met by using data sheets. Always good to check with Cal/OSHA about data sheet rules as the GHS requirements are integrated into the current law.
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