This is the Final Statement of Reasons for specific regulatory levels posing no significant risk for eight chemicals listed as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (hereinafter “the Act” or Proposition 65; Health and Safety Code 25249.5 et seq.). On June 13, 2003, the Office of Environmental Health Hazard Assessment (OEHHA) issued a Notice of Proposed Rulemaking to adopt regulatory levels for ten chemicals listed pursuant to the Act as known to the State to cause cancer (Title 22 Cal. Code of Regs. §12000) (benz[a]anthracene, benzene, benzo[b]fluoranthene, benzo[j]fluoranthene, bromoform, chrysene, 7H-dibenzo[c,g]carbazole, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene, and 5-methylchrysene). The Notice also announced a proposed regulatory level for adoption in Title 22 Cal. Code of Regs. §12805 for one chemical listed as known to cause reproductive toxicity (Title 22 Cal. Code of Regs. §12000) (arsenic [inorganic oxides]). The Initial Statement of Reasons set forth the grounds for the proposed regulations.
Pursuant to the Notice of Proposed Rulemaking, a public comment period was held between June 13 and July 31, 2003, and a public hearing was held on July 31, 2003.
Final regulations for two chemicals included in the original Notice of Proposed Rulemaking, benzene and bromoform, were adopted on May 12, 2004. A regulation for arsenic (inorganic oxides) will be proposed at a later time. This regulation hereby adopts regulatory levels for eight chemicals, all in the class of chemicals termed polycyclic aromatic hydrocarbons, included in the original Notice of Proposed Rulemaking: benz[a]anthracene, benzo[b]fluoranthene, benzo[j]fluoranthene, chrysene, 7H-dibenzo[c,g]carbazole, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene, and 5-methylchrysene.
UPDATE OF INITIAL STATEMENT OF REASONS
UPDATE OF TECHNICAL INFORMATION IN THE INITIAL STATEMENT OF REASONS
All data, studies, reports, or other documents relied on for this regulation were identified in the Initial Statement of Reasons of June 13, 2003, except as noted immediately below.
The technical support document “No Significant Risk Levels (NSRLs) for the Proposition 65 Carcinogens Benzo[b]fluoranthene, Benzo[j]fluoranthene, Chrysene, Dibenzo[a,h]pyrene, Dibenzo[a,i]pyrene, and 5-Methylchyrsene by the Oral Route” included with this notice has been modified, based upon comments received, to delete a brief discussion comparing cancer potencies generated from intraperitoneal and oral route carcinogenicity studies of a related class of compounds called nitro-arenes. These changes do not alter the NSRL values proposed for the six polycyclic aromatic hydrocarbons (PAHs) noted above that are the subject of the document.
In addition, language has been added to make clear that the methodology used in the above named document is equivalent to a potency equivalency factor approach. That is, the cancer potencies are scaled to that of a chemical with an adopted cancer potency, in this case, benzo[a]pyrene. A few editorial changes have also been made to the summary on the first two pages of the document. All changes are noted in underline/strikeout in Attachment 1.
The technical support document “No Significant Risk Levels (NSRLs) for the Proposition 65 Carcinogens Benz[a]anthracene (Oral) and 7H-Dibenzo[c,g]carbazole (Oral)” (Attachment 2) has been corrected on the eighth line of the paragraph on page 7 to read “upper confidence limits on q1” instead of “upper confidence limits on q1*.” This change does not alter the NSRL values proposed in the document.
UPDATED INFORMATIVE DIGEST
22 CALIFORNIA CODE OF REGULATIONS
The Office of Environmental Health Hazard Assessment (OEHHA) adopts the regulatory levels for the eight chemicals, benz[a]anthracene, benzo[b]fluoranthene, benzo[j]fluoranthene, chrysene, 7H-dibenzo[c,g]carbazole, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene and 5-methylchrysene, which were included in the Notice of Proposed Rulemaking published in the California Regulatory Notice Register on June 13, 2003. OEHHA decided not to proceed with the regulatory adoption of the Maximum Allowable Dose Level (MADL) for the chemical arsenic at this time. The regulation for arsenic will be proposed at a later date. There have been no other changes in the laws related to the proposed regulations or to the effect of the proposed regulations from the laws and effects described in the Notice of Proposed Rulemaking.