Notice of Addition of Documents and Information to OAL Notice File No. Z-07-0619-02, Amendment to Title 22, Section 12805, MADL for Reproductive Toxicity for Di(n-butyl)phthalate (DBP)
Notice of Addition of Documents and Information to OAL Notice File No. Z-07-0619-02 Amendment to Title 22, California Code of Regulations, Section 12805, Specific Regulatory Levels: Chemicals Causing Reproductive Toxicity
Proposition 65 Maximum Allowable Dose Level (MADL) for Reproductive Toxicity for Di(n-butyl)phthalate (DBP)
Pursuant to the requirements of Government Code sections 11346.8(d), 11346.9(a)(1), and 11347.1, the Office of Environmental Health Hazard Assessment (OEHHA) is providing notice that documents and other information which the agency has relied upon in proposing amendments to Title 22, California Code of Regulations, section 12805*, have been added to the rulemaking file and are available for public inspection and comment.
On June 29, 2007, OEHHA published a Notice of Proposed Rulemaking (California Regulatory Notice Register, 2007, No. 26-Z, pages 1123-1125; Notice File No. Z-07-0619-02) to adopt regulatory levels for DBP pursuant to Title 22, California Code of Regulations, section 12805. The Initial Statement of Reasons set forth the grounds for the proposed regulation. Pursuant to the Notice of Proposed Rulemaking, a public comment period of 45 days was provided from the publication of the Notice until August 13, 2007. A total of three sets of written comments were received. These comments cited a number of publications that had not been previously included in the proposed rulemaking file (OAL Notice File No. Z-07-0619-02). In addition, a number of research or review papers became available to OEHHA after the draft MADL document was completed.
The purpose of this notice is to enter all relevant documents into the proposed rulemaking file (OAL Notice File No. Z-07-0619-02). All of the documents on the list below have been reviewed by OEHHA. None of these documents contributed directly to the development of the MADLs and were thus not cited in the main text of the document supporting the MADL (OEHHA, 2007). However, these papers have been reviewed by OEHHA and are sources of relevant information.
These documents are available for inspection at OEHHA’s Sacramento office located at 1001 “I” Street, 19th Floor, Sacramento, CA from December 7, 2007 through January 7, 2008, between the hours of 8:00 a.m. and 5:00 p.m. OEHHA will accept written comments regarding the documents and other information included in this notice. All written comments must be submitted to OEHHA by e-mail, mail, fax, courier or hand-delivered, no later than 5:00 p.m. on January 7, 2008 and addressed to:
Office of Environmental Health Hazard Assessment
Street Address: 1001 I Street, 19th Floor
Sacramento, CA 95814
Mailing Address: P.O. Box 4010
Sacramento, CA 95812
Fax No.: (916) 323-8803 Telephone: (916) 445-6900
Comments transmitted via email should be addressed to: P65Public.Comments@oehha.ca.gov
It is requested but not required that hard-copy statements or arguments be submitted in triplicate. All written comments received by January 7, 2008, which pertain to the documents listed below will be reviewed and responded to by OEHHA’s staff as part of the compilation of the rulemaking file.
Inquiries concerning the action described in this notice may be directed to Sam Delson in writing at the address given above, or by telephone at (916) 445-6900.
Documents and information added to Notice File No. Z-07-0619-02:
Adibi JJ, Perera FP, Jedrychowski W, Camann DE, Barr D, Jacek R, Whyatt RM (2003). Prenatal exposures to phthalates among women in New York City and Krakow, Poland. Environ Health Perspect 111, 1719-22.
Australian Department of Human Health and Aging (2007). Draft Human Health Hazard Assessment: Dibutyl Phthalate (DBP), (CAS No. 84-74-2) (April 2007). Submitted to OEHHA by the American Chemistry Council. Available at http://www.nicnas.gov.au.
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Clark BJ, Cochrum RK (2007).The steroidogenic acute regulatory protein as a target of endocrine disruption in male reproduction. Drug Metab Rev 39, 353-70.
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Damgaard IN, Jensen TK, Petersen JH, Skakkebaek NE, Toppari J, Main KM (2007). Cryptorchidism and maternal alcohol consumption during pregnancy. Environ Health Perspect 115, 272-7.
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Gwinn MR, Whipkey DL, Tennant LB, Weston A (2007). Gene expression profiling of di-n-butyl phthalate in normal human mammary epithelial cells. J Environ Pathol Toxicol Oncol 26, 51-61.
Hallmark N, Walker M, McKinnell C, Mahood IK, Scott H, Bayne R, Coutts S, Anderson RA, Greig I, Morris K, Sharpe RM (2007). Effects of monobutyl and di(n-butyl) phthalate in vitro on steroidogenesis and Leydig cell aggregation in fetal testis explants from the rat: comparison with effects in vivo in the fetal rat and neonatal marmoset and in vitro in the human. Environ Health Perspect 115, 390-6.
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Hutchison GR, Sharpe RM, Mahood IK, Jobling M, Walker M, McKinnell C, Mason JI, Scott HM (2007). The origins and time of appearance of focal testicular dysgenesis in an animal model of testicular dysgenesis syndrome: evidence for delayed testis development? Int J Androl 30, 1-7.
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Footnotes and References
*All further references are to Title 22 of the California Code of Regulations, unless otherwise noted.