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"Diaminotoluene (mixed)" and Nitrapyrin are Under Review for Possible Delisting

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 19861 (Proposition 65). The Carcinogen Identification Committee (CIC) advises and assists OEHHA in compiling the list of chemicals known to the state to cause cancer as required by Health and Safety Code section 25249.8. The Committee serves as the state’s qualified experts for determining whether a chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.

CIC MEETING

As announced previously, OEHHA is referring nitrapyrin and diaminotoluene (mixed) to the Carcinogen Identification Committee (CIC)2, the state’s qualified experts for carcinogenicity determinations under Proposition 653, for review for possible delisting at a public meeting scheduled for Wednesday, November 4, 2015. The meeting will be held in the Coastal Hearing Room of the California Environmental Protection Agency headquarters building located at 1001 I Street, Sacramento beginning at 10:00 am and continuing until all business is conducted or 5:00 pm

CONSIDERATION OF NITRAPYRIN

Nitrapyrin (CAS No. 1929-82-4) was listed “as causing cancer” under Proposition 65 on October 5, 2005, based upon its classification by the US Environmental Protection Agency (US EPA, 2000)4 as “likely to be carcinogenic in humans.” In 2012, US EPA revised the classification of nitrapyrin to “Suggestive Evidence of Carcinogenic Potential” (US EPA, 2012a)5. When a chemical is no longer identified by the authoritative body as causing cancer and no other administrative basis for listing applies, the chemical is referred to the CIC6. The CIC then determines whether the chemical has been “clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.” If the CIC makes such a determination, the chemical remains on the Proposition 65 list. Otherwise, the chemical is removed from the list.

CONSIDERATION OF DIAMINOTOLULENE (MIXED) AND RELATED ISOMERS

Diaminotoluene (mixed) was listed “as causing cancer” under Proposition 65 on January 1, 1990, based upon its classification by the US Environmental Protection Agency (US EPA, 1988)7 as a Group B2 carcinogen (probable human carcinogen). OEHHA received a petition from Big Lots Stores, Inc. for reconsideration of listing for diaminotoluene (mixed) on October 21, 2014. While the US EPA (1988) basis document indicates that the hazard ranking of diaminotoluene (mixed) “is applicable to all isomers of diaminotoluene”, and that the “evidence on potential carcinogenicity from animal studies is “sufficient”, the US EPA document also indicates that “this evidence is based on the carcinogenic properties of the isomer 2,4-diaminotoluene”. No other information on the mixture or individual isomers is included in the US EPA document.

OEHHA is referring diaminotoluene (mixed) to the CIC for a determination as to whether the chemical should continue to be included on the list of chemicals known to the state to cause cancer pursuant to Title 27, Cal. Code of Regs., section 25306 (j).

The CIC will determine whether or not diaminotoluene (mixed) has been “clearly shown through scientifically valid testing according to generally accepted principles to cause cancer” and should remain on the Proposition 65 list. The CIC will also determine whether or not diaminotoluenes as a group, or any of the five individual diaminotoluene isomers not currently listed as causing cancer, should be added to the list8.

HAZARD IDENTIFICATION MATERIALS

OEHHA announces the availability for public review of the hazard identification materials on 1) nitrapyrin, including the document entitled: “Nitrapyrin. A Chemical Listed “As Causing Cancer” by the Authoritative Bodies Mechanism and under Review by the Carcinogen Identification Committee”, and US EPA review documents on nitrapyrin, and 2) Diaminotoluenes, including the document entitled: “Diaminotoluenes (DATs). “Diaminotoluene (mixed)” Is Listed “As Causing Cancer” by the Authoritative Bodies Mechanism and These Chemicals are under Review by the Carcinogen Identification Committee”.

Copies of the documents are available below. The documents may also be requested from OEHHA’s Proposition 65 Implementation Office by calling (916) 445-6900.

PUBLIC COMMENT PERIOD

This notice marks the beginning of a 45-day public comment period on these materials. OEHHA must receive comments and any supporting documentation by 5:00 p.m. on Monday, October 12, 2015. Public comments at the meeting will be limited to 5 minutes per commenter, except for those commenters who make requests by October 12, 2015, and receive approval from the Chair for longer comments. If you would like to make public comments to the Committee exceeding 5 minutes, please provide an estimate of the time you will need and the reason you are requesting additional time, to the Proposition 65 mailbox P65Public.Comments@oehha.ca.gov or (916) 445‑6900 by 5:00 p.m. on October 12, 2015.

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 “HIM – Nitrapyrin” or “HIM – Diaminotoluenes” in the subject line. Alternatively, comments may be submitted in paper form and mailed, faxed, or delivered in person to the addresses below:

Mailing Address: Michelle Robinson
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-12B
Sacramento, California 95812-4010
Fax: (916) 323-2265
Street Address: 1001 I Street
Sacramento, California 95814

OEHHA will organize and index the comments received and forward the information to the CIC members prior to the meeting at which the chemicals will be considered. Comments received during the public comment period will be posted on the OEHHA web site after the close of the comment period. Electronic files submitted should not have any form of encryption.

If you have any questions, please contact Michelle Robinson at Michelle.Robinson@OEHHA.ca.gov or (916) 445-6900.

Link to Public Comments

The comment period closed on October 12, 2015. The following comments were received.

Downloads

Footnotes and References

1 Health and Safety Code section 25249.5 et seq.

2 Title 27, Cal. Code of Regs., section 25306(j)

3 Title 27, Cal. Code of Regs., section 25305(a)(1)

4 US Environmental Protection Agency (US EPA, 2000). Cancer Assessment Document. Evaluation of the Carcinogenic Potential of Nitrapyrin (Second Review). Cancer Assessment Review Committee. Health Effects Division. Office of Pesticide Programs. May 5, 2000.

5 US Environmental Protection Agency (US EPA, 2012). Cancer Assessment Document. Evaluation of the Carcinogenic Potential/Mode of Action for Mouse Liver Tumors. Nitrapyrin. PC Code 06923. Cancer Assessment Review Committee. Health Effects Division. Office of Pesticide Programs. March 1, 2012.

6 Title 27, Cal. Code of Regs., section 25306(j)

7 US Environmental Protection Agency (US EPA,1988). Methodology for Evaluating Potential Carcinogenicity in Support of Reportable Quantity Adjustments Pursuant to CERCLA Section 102. Office of Health and Environmental Assessment, Washington DC 20460, EPA/600/8-89/053, June 1988, including Appendix: Hazard Ranking of Potential Carcinogens, and Appendix: Evaluation of the Potential Carcinogenicity of Diaminotoluene (Mixed) (95-80-7). In Support of Reportable Quantity Adjustments Pursuant to CERCLA Section 102, Carcinogen Assessment Group, Office of Health and Environmental Assessment Washington, DC, 20460 EPA/600/8-91/103 June 1988.

8 Note: The listing of 2,4-diaminotoluene will not be re‑considered, as it was individually added to the list by the Science Advisory Panel (the predecessor entity to the CIC) on January 1, 1988.