Notice of Intent to Change the Basis for Listing as Known to the State of California To Cause Reproductive Toxicity: 1,2-Dibromo-3-Chloropropane, Ethylene Oxide and Lead

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to change the basis for the listing of 1,2-dibromo-3-chloropropane (DBCP), ethylene oxide and lead as known to the state to cause reproductive toxicity under the Safe Drinking Water and Toxic Enforcement Act of 19861.  DBCP, ethylene oxide2 and lead were originally added February 27, 1987 to the Proposition 65 list as causing reproductive toxicity pursuant to Labor Code Section 6382(d) which is incorporated by reference in Health and Safety Code Section 25249.8(a).  Male and female reproductive toxicity and developmental toxicity are the general endpoints noted for lead and ethylene oxide, and male reproductive toxicity is noted for DBCP.  OEHHA intends to change the basis of these listings to the “formally required to be labeled or identified” listing mechanism3

Chemical

CAS No.

Reproductive Toxicity Endpoints

Reference*

1,2-Dibromo-3-chloropropane
(DBCP)

96-12-8

Male reproductive toxicity

Title 29, CFR, Section 1910.1044

Ethylene oxide

75-21-8

Male reproductive toxicity
Female reproductive toxicity
Developmental toxicity

Title 29, CFR, Section 1910.1047; US EPA (2013)4

Lead

--

Male reproductive toxicity
Female reproductive toxicity
Developmental toxicity

Title 29, CFR, Section 1910.1025

*CFR is the Code of Federal Regulations; US EPA is the US Environmental Protection Agency
OEHHA is initiating this action based on changes to the federal regulations that affect the basis for the original listings.  Specifically, in March 2012, the federal Occupational Safety and Health Administration (OSHA) amended the regulations contained in CFR5 Title 29, section 1910.1200.  These changes have affected the use of this section as a definitive source for identifying chemicals that are known to cause reproductive toxicity. 

Background on listing via the formally required to be labeled or identified mechanism:  A chemical must be listed under Proposition 656 and its implementing regulations (Section 25902) when a state or federal agency has formally required it to be labeled or identified as causing cancer or reproductive toxicity. 
According to Section 25902(b):

  • “‘[F]ormally required’ means that a mandatory instruction, order, condition, or similar command, has been issued in accordance with established policies and procedures of an agency of the state or federal government to a person or legal entity outside of the agency.  The action of such agency may be directed at one or more persons or legal entities and may include formal requirements of general application;”
  • “‘[L]abeled’ means that a warning message about the carcinogenicity or reproductive toxicity of a chemical is printed, stamped, written, or in any other manner placed upon the container in which the chemical is present or its outer or inner packaging including any material inserted with, attached to, or otherwise accompanying such a chemical;”
  • “‘[I]dentified’ means that a required message about the carcinogenicity or reproductive toxicity of the chemical is to be disclosed in any manner to a person or legal entity other than the person or legal entity who is required to make such disclosure”; and
  • As causing reproductive toxicity means:  “…the required label or identification uses any words or phrases intended to communicate a risk of reproductive harm to men or women or both, or a risk of birth defects or other developmental harm.”

OEHHA is the lead agency for Proposition 65 implementation.  After a state or federal agency has required that a chemical be labeled or identified as causing cancer or reproductive toxicity, OEHHA evaluates whether listing under Proposition 65 is required pursuant to the definitions set out in Section 25902.

OEHHA’s determination:  DBCP, ethylene oxide and lead are required to be identified or labeled to communicate a risk of reproductive toxicity by OSHA regulations .  In addition, the US Environmental Protection Agency (US EPA) also requires labels to communicate a risk of reproductive toxicity for ethylene oxide.

Language from the OSHA regulations and US EPA warning requirements which meets the requirements of Section 25902 is quoted below for each of these three chemicals.

1,2-Dibromo-3-chloropropane (DBCP)

“1910.1044(n)(1)(ii)
The employer shall assure that each employee is informed of the following:
“1910.1044(n)(1)(ii)(a)
The information contained in Appendix A…”

Appendix A, under “II. Health Hazard Data”, states:
"…2. Chronic exposure. Prolonged or repeated exposure to DBCP has been shown to cause sterility in humans. It also has been shown to produce cancer and sterility in laboratory animals and has been determined to constitute an increased risk of cancer in man."7

Ethylene oxide

“1910.1047(j)(2)(i)(A)
The employer shall post and maintain legible signs demarcating regulated areas and entrances or access ways to regulated areas that bear the following legend:

“DANGER ETHYLENE OXIDE MAY CAUSE CANCER MAY DAMAGE FERTILITY OR THE UNBORN CHILD RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING MAY BE REQUIRED IN THIS AREA AUTHORIZED PERSONNEL ONLY”

“1910.1047(j)(2)(i)(B)
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.”

“1910.1047(j)(2)(ii)(B)
Prior to June 1, 2015, employers may include the following information on containers of EtO in lieu of the labeling requirements in paragraph (j)(1)(i) of this section:

“1910.1047(j)(2)(ii)(B)(1)
DANGER CONTAINS ETHYLENE OXIDE CANCER HAZARD AND REPRODUCTIVE HAZARD;

“1910.1047(j)(2)(ii)(B)(2)
A warning statement against breathing airborne concentrations of EtO.”

“1910.1047(j)(2)(ii)(C)
The labeling requirements under this section do not apply where EtO is used as a pesticide, as such term is defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), when it is labeled pursuant to that Act and regulations issued under that Act by the Environmental Protection Agency.”8
The US EPA 2013 required precautionary statements on the conditional registration and use label for ethylene oxide (registration number 89514-1) reads:

DANGER! CANCER HAZARD AND REPRODUCTIVE HAZARD

“OTHER POSSIBLE DELAYED HEALTH EFFECTS:
“May cause nervous system injury, cataracts, adverse reproductive effects, chromosomal and mutagenic changes, and cancer.

“  DO NOT REMOVE THIS LABEL.  ”

Lead
“1910.1025(g)(2)(vii)(A)
The employer shall ensure that labels of bags or containers of contaminated protective clothing and equipment include the following information:

“DANGER: CLOTHING AND EQUIPMENT CONTAMINATED WITH LEAD. MAY DAMAGE FERTILITY OR THE UNBORN CHILD. CAUSES DAMAGE TO THE CENTRAL NERVOUS SYSTEM. DO NOT EAT, DRINK OR SMOKE WHEN HANDLING. DO NOT REMOVE DUST BY BLOWING OR SHAKING. DISPOSE OF LEAD CONTAMINATED WASH WATER IN ACCORDANCE WITH APPLICABLE LOCAL, STATE, OR FEDERAL REGULATIONS.”
1910.1025(l)(1)(i)

Each employer who has a workplace in which there is a potential exposure to airborne lead at any level shall inform employees of the content of Appendices A and B of this regulation.”
Appendix A under “II. Health Hazard Data” states:

“(2) Long-term (chronic) overexposure. Chronic overexposure to lead may result in severe damage to your blood-forming, nervous, urinary and reproductive systems…
“Chronic overexposure to lead impairs the reproductive systems of both men and women. Overexposure to lead may result in decreased sex drive, impotence and sterility in men. Lead can alter the structure of sperm cells raising the risk of birth defects. There is evidence of miscarriage and stillbirth in women whose husbands were exposed to lead or who were exposed to lead themselves. Lead exposure also may result in decreased fertility, and abnormal menstrual cycles in women. The course of pregnancy may be adversely affected by exposure to lead since lead crosses the placental barrier and poses risks to developing fetuses. Children born of parents either one of whom were exposed to excess lead levels are more likely to have birth defects, mental retardation, behavioral disorders or die during the first year of childhood.”
Appendix B in “XI. SIGNS - PARAGRAPH (M)” states:

“The standard requires that the following warning sign be posted in the work areas when the exposure to lead exceeds the PEL [Permissible Exposure Limit]:

“DANGER LEAD MAY DAMAGE FERTILITY OR THE UNBORN CHILD CAUSES DAMAGE TO THE CENTRAL NERVOUS SYSTEM DO NOT EAT, DRINK OR SMOKE IN THIS AREA

“However, prior to June 1, 2016, employers may use the following legend in lieu of that specified above:

“WARNING LEAD WORK AREA POISON NO SMOKING OR EATING”9

Request for comments:  OEHHA is requesting comments as to whether these chemicals meet the criteria set forth in the Proposition 65 regulations for listings via the formally required to be labeled or identified mechanism (Section 25902).  Because these are ministerial listings, comments should be limited to whether OSHA requires that DBCP, ethylene oxide or lead be labeled to communicate a risk of reproductive harm. OEHHA cannot consider scientific arguments concerning the weight or quality of the evidence considered by OSHA when it established the labeling requirement and will not respond to such comments if they are submitted. 

In order to be considered, OEHHA must receive comments by 5:00 p.m. on MONDAY, October 21, 2013.  We encourage you to submit comments in electronic form, rather than in paper form.  Comments transmitted by e-mail should be addressed to P65Public.comments@oehha.ca.gov.  Please include “Formally Required - DBCP” or “Formally Required – ETHYLENE OXIDE” or “Formally Required - LEAD” in the subject line.  Comments submitted in paper form may be mailed, faxed, or delivered in person to the address below.

Mailing Address: Sam Delson
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010
Fax: (916) 323-2265      
Street Address: 1001 I Street, Sacramento, California 95814

Any public comments received will be posted after the close of the comment period.  If you have any questions, please contact Sam Delson at sam.delson@oehha.ca.gov or at (916) 445-6900.

Link to Public Comments

Footnotes and References

1 Commonly known as Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986 is codified in Health and Safety Code section 25249.5 et seq.

2 Ethylene oxide was listed February 27, 1987 as causing reproductive toxicity (female reproductive endpoint); two additional reproductive toxicity endpoints (developmental and male reproductive toxicity) were added August 7, 2009.

3 See Health and Safety Code section 25249.8(b) and Title 27, Cal. Code of Regs., section 25902.  All further references are to sections of Title 27 of the California Code of Regulations, unless indicated otherwise.

4 US EPA Office of Pesticide Programs, Notice of Pesticide Registration, Name of Pesticide Product: Ethylene Oxide, EPA registration number
89514-1, May 20, 2013

5 CFR refers to the Code of Federal Regulations throughout this document

6 See Health and Safety Code section 25249.8(b).

7 The OSHA regulation for DBCP quoted above can be accessed online at: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10061

8 The OSHA regulation for ethylene oxide quoted above can be accessed online at:
https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10070.

9 The OSHA regulation on lead quoted above can be accessed online at: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10030.