Notice of Intent to List: TRIM® VX

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list TRIM^® VX as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986^[1].  This action is being proposed under the authoritative bodies listing mechanism^[2].

Background on listing via the authoritative bodies mechanism:  A chemical must be listed under the Proposition 65 regulations when two conditions are met:

1. An authoritative body formally identifies the chemical as causing cancer (Section 25306(d)^[3]).
2. The evidence considered by the authoritative body meets the sufficiency criteria contained in the regulations (Section 25306(e)).

However, the chemical is not listed if scientifically valid data which were not considered by the authoritative body clearly establish that the sufficiency of evidence criteria were not met (Section 25306(f)).

The National Toxicology Program (NTP) is one of several institutions designated as authoritative for the identification of chemicals as causing cancer (Section 25306(m)). 

OEHHA is the lead agency for Proposition 65 implementation.  After an authoritative body has made a determination about a chemical, OEHHA evaluates whether listing under Proposition 65 is required using the criteria contained in the regulations.

OEHHA’s determination: TRIM^® VX meets the criteria for listing as known to the state to cause cancer under Proposition 65, based on findings of the NTP (2016).

Formal identification and sufficiency of evidence for TRIM^® VX:  In 2016, NTP published a report on TRIM^® VX, entitled Toxicology and Carcinogenesis Studies of TRIM^® VX in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies), that concludes that the chemical causes cancer (NTP, 2016).  This report satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations.

OEHHA is relying on the NTP’s discussion of data and conclusions in the report that TRIM^® VX causes cancer.  NTP (2016) states in the Conclusion section of the report’s Summary (page 6):

“We conclude that exposure to aerosols of TRIM VX caused tumors of the lung in male and female mice…”

The NTP (2016) report states in the Conclusion section of the report’s Abstract and main body of the report (pages 9 and 71, respectively):

“Under the conditions of these 2-year inhalation studies… There was clear evidence of carcinogenic activity of TRIM VX in male B6C3F1/N mice based on the increased combined incidences of alveolar/bronchiolar adenoma or carcinoma of the lung.”
“There was clear evidence of carcinogenic activity of TRIM VX in female B6C3F1/N mice based on the increased combined incidences of alveolar/bronchiolar adenoma or carcinoma (primarily carcinoma) of the lung.” (Emphasis in original)

Thus, NTP (2016) found that TRIM^® VX causes increased incidences of malignant and benign alveolar/bronchiolar tumors in male and female mice. 

Request for comments:  OEHHA is requesting comments as to whether TRIM^® VX meets the criteria set forth in the Proposition 65 regulations for authoritative bodies listings.  In order to be considered, OEHHA must receive comments by 5:00 p.m. on February 26, 2018.  Comments may be submitted electronically through our website at https://oehha.ca.gov/comments.  Comments submitted in paper form can be mailed, faxed, or delivered in person to the address below.

Mailing Address:      Michelle Ramirez
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

Comments received during the public comment period will be posted on the OEHHA website after the close of the comment period.  By sending us your comments you are waiving any right to privacy you may have in the information you provide.  Individual commenters should advise OEHHA when submitting documents to request redaction of home address or personal telephone numbers.  Electronic files submitted should not have any form of encryption.

If you have any questions, please contact Ms. Ramirez at Michelle.Ramirez@oehha.ca.gov or at (916) 445‑6900.

Link to Public Comments

• Comment Submissions - Notice of Intent to List: Trim® VX

Chemical Reference

• TRIM VX

Footnotes and References

National Toxicology Program (NTP, 2016).  NTP Technical Report on the Toxicology and Carcinogenesis Studies of TRIM^® VX in Wistar Han [Crl:WI (Han)] Rats and B6C3F1/N Mice (Inhalation Studies). Technical Report Series No. 591. US Department of Health and Human Services, NTP, Research Triangle Park, NC.  Available at https://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr591_508.pdf