Section 27000 - Chemicals Required by State or Federal Law to Have Been Tested for Potential to Cause Cancer or Reproductive Toxicity, but Which Have Not Been Adequately Tested as Required (California Code of Regulations)

§ 27000. Chemicals Required by State or Federal Law to Have Been Tested for Potential to Cause Cancer or Reproductive Toxicity, but Which Have Not Been Adequately Tested as Required

(a) The Safe Drinking Water and Toxic Enforcement Act of 1986 requires the Governor to publish a list of chemicals formally required by state or federal agencies to have testing for carcinogenicity or reproductive toxicity, but that the state's qualified experts have not found to have been adequately tested as required [Health and Safety Code Section 25249.8(c)].

(b) Chemicals required to be tested by the California Department of Pesticide Regulation.

(1) The Birth Defect Prevention Act of 1984 (SB 950) mandates that the California Department of Pesticide Regulation (CDPR) review chronic toxicology studies supporting the registration of pesticidal active ingredients. Missing or unacceptable studies are identified as data gaps.

(2) The studies are conducted to fulfill generic data requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which is administered by the United States Environmental Protection Agency (U.S. EPA).

(3) The studies are reviewed by CDPR according to guidelines and standards promulgated under FIFRA. Older studies may not meet current guidelines.

(4) The existence of a data gap for a compound does not indicate a total lack of information on the carcinogenicity or reproductive toxicity of the compound. In some cases, information exists in the open scientific literature, but SB 950 requires specific additional information.

(5) A data gap does not necessarily indicate that an oncogenic or reproductive hazard exists. For the purposes of this list, a data gap is still considered to be present until the study is reviewed and found to be acceptable.

(6) Following is a listing of SB 950 data gaps for oncogenicity, reproduction, and teratology studies for pesticidal active ingredients. This list changes as data gaps are filled by additional data or replacement studies.

(7) For purposes of this section, "onc mouse" means oncogenicity in mice, "onc rat" means oncogenicity in rats, "repro" means reproduction, "tera rat" means teratogenicity in rats, "tera rabbit" means teratogenicity in rabbits.

Chemical Testing Needed
Acid Blue 9* onc rat, onc mouse, repro, tera
   rat, tera rabbit
Acid Yellow 23* onc rat, onc mouse, repro,
   tera rat, tera rabbit
Bromadiolone* onc rat, onc mouse, repro, tera
   rat, tera rabbit
Butoxy polypropylene glycol* onc rat, onc mouse, repro, tera
   rat, tera rabbit
Butoxy polypropoxy polyethoxy onc rat, onc mouse, repro, tera rat,
ethanol - iodine complex* tera rabbit
Castor oil* onc rat, onc mouse, repro, tera
   rat, tera rabbit
Chlorophacinone* onc rat, onc mouse, repro
Chromic acid* onc rat, onc mouse, repro, tera rabbit
Menthol* onc rat, onc mouse, repro, tera
   rat, tera rabbit
Meta-cresol* tera rat, onc rat, onc mouse,
   repro, tera rabbit
Sodium chlorate* onc rat, onc mouse, repro,
   tera rat, tera rabbit
Sodium fluoride** tera rat, tera rabbit, repro
Sodium phenate* onc rat, onc mouse, repro,
   tera rat, tera rabbit
Tetraglycine hydroperiodide* onc rat, onc mouse, repro,
   tera rat, tera rabbit
Triethylene glycol* onc rat, onc mouse, tera
   rat, tera rabbit
2,4-Xylenol* onc rat, onc mouse, repro, tera
   rat, tera rabbit

* Claims are pending review that data should not be required.

** No product containing this active ingredient is registered with CDPR.

(c) Chemicals required to be tested by the U.S. EPA, Office of Pollution Prevention and Toxics.

(1) Under 15 U.S.C.A. § 2603(a) of the Toxic Substances Control Act, testing of a chemical is required when that chemical may present an unreasonable risk, or is produced in substantial quantities and enters the environment in substantial quantities, or may have significant or substantial human exposure.

(2) For purposes of this section, "tera" means teratogenicity, "rtox" means reproductive toxicity, "onc" means oncogenicity.

Chemical Testing Needed
Hydrocarbons, C>4 rtox

(d) Chemicals required to be tested by the U.S. EPA, Office of Pesticide Programs.

(1) The U.S. EPA is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FIFRA requires U.S. EPA to register pesticides based on data adequate to demonstrate that they will not result in unreasonable adverse effects to people or the environment when used in accordance with their U.S. EPA-approved labels.

(2) The chemicals listed below are those for which data are unavailable or inadequate to characterize oncogenicity, teratogenicity, or reproductive effects potential. For purposes of this section, "onc" means oncogenicity, "tera" means teratogenicity, and "repro" means reproductive toxicity.

Revised: July 31, 2020

(1. New section submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 89, No. 17). 2. Amendment submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 90, No. 2). 3. Amendment submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 91, No. 17). 4. Editorial correction of subsection (d) (Register 91, No. 31). 5. Editorial correction of printing error (Register 91, No. 43). 6. Editorial correction instituting inadvertently omitted amendment. Submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 93, No. 20). 7. Editorial correction of printing errors (Register 93, No. 45). 8. Amendment of subsection (d) filed 8-1-94. Submitted to OAL for printing only (Register 94, No. 31). 9. Amendment of subsections (b), (c), and (d) filed 12-23-94. Submitted to OAL for printing only (Register 95, No. 1). 10. Amendment submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 95, No. 52). 11. Amendment filed 1-30-97; operative 1-30-97. Submitted to OAL for printing only pursuant to Health and Safety Code section 25249.8 (Register 97, No. 5). 12. Amendment of subsections (b), (c) and (d) filed 2-13-98; operative 2-13-98. Submitted to OAL for printing only pursuant to Health and Safety Code section 25249.8 (Register 98, No. 7). 13. Amendment of subsections (b), (c) and (d) filed 3-1-2002; operative 3-1-2002. Submitted to OAL for printing only pursuant to Health and Safety Code section 25249.8 (Register 2002, No. 9). 14. Amendment filed 1-7-2003; operative 2-6-2003 (Register 2003, No. 2). 15. Editorial correction implementing inadvertently omitted 1-7-2003 amendments and adding History 14 (Register 2006, No. 3). 16. Amendment of subsections (b)-(d) filed 1-17-2006. Submitted to OAL for printing only pursuant to Health and Safety Code section 25249.8 (Register 2006, No. 3). 17. Change without regulatory effect renumbering title 22, section 14000 to title 27, section 27000 filed 6-18-2008 pursuant to section 100, title 1, California Code of Regulations (Register 2008, No. 25). 18. Amendment of subsections (b) and (d) filed 1-5-2009; operative 1-1-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 25249.8 (Register 2009, No. 2). 19. Amendment of subsection (d) filed 9-8-2011; operative 8-1-2011. Submitted to OAL for printing only pursuant to Health and Safety Code section 25249.8 (Register 2011, No. 36). 20. Amendment of subsections (b) and (d) filed 3-4-2013; operative 3-1-2013. Submitted to OAL for printing only pursuant to Health and Safety Code section 25249.8 (Register 2013, No. 10). 21. Amendment filed 5-13-2014; operative 5-13-2014 pursuant to Government Code section 11343.4(b)(3) (Register 2014, No. 20). 22. Amendment of subsections (b) and (c) filed 3-21-2017; operative 3-21-2017. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 25249.8 (Register 2017, No. 12). 23. Amendment of section and new Note filed 10-30-2017; operative 1-1-2018 (Register 2017, No. 44). 24. Amendment of subsections (b)(7), (c), (c)(2) and (d)(2) filed 2-1-2018; operative 2-1-2018. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 25249.8 (Register 2018, No. 5). 25. Amendment of subsections (b)(7), (c)(2) and (d)(2) filed 7-8-2019; operative 7-8-2019. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 25249.8 (Register 2019, No. 28). 26. Amendment of subsections (b)(7) and (d)(2) filed 9-8-2020; operative 9-8-2020. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 25249.8 (Register 2020, No. 37).)

Note: Authority cited: Section 25249.12, Health and Safety Code. Reference: Sections 25249.5, 25249.6, 25249.7, 25249.8(c), 25249.9, 25249.10 and 25249.11, Health and Safety Code.

Disclaimer: Lawrina makes great effort to keep legal information accurate and updated. However, we cannot guarantee that Section 27000 Chemicals Required by State or Federal Law to Have Been Tested for Potential to Cause Cancer or Reproductive Toxicity, but Which Have Not Been Adequately Tested as Required is an exact copy of the official text as updates may have been made. Please check the accuracy of the information provided against the official resources.

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