1999 Prop 65 Regulatory Update

July 26, 1999

Cal/OSHA and Fed OSHA Negotiations Continue; Rulemaking Commenced

A series of letters between Federal OSHA and Cal/OSHA over the implementation of Prop 65 into the California State Plan continue.  On December 4, 1988, John Howard, Chief of Cal/OSHA wrote to Fed OSHA noting the status of various matters.  Howard noted the decision in ITA v. Henry had found preemption of Prop 65 for out-of-state manufacturers, and Judge Pollak's decision in AYS v. Shell had held that private enforcement could not be applied to MSDS and label requirements for downstream employers and employees.  Howard noted the difficulty an employer may face in complying with Prop 65 if the manufacturer does not provide a Prop 65 warning on its labels and MSDSs, and believed it was necessary to "examine potential amendments or changes to the structure by which Proposition 65 has been incorporated into the California Hazard Communication Standard."  Howard also noted that, even though a regulation had not been adopted regarding monitoring of private enforcement, the Attorney General's office had taken active steps to ensure that private enforcement had been undertaken consistent with the terms of approval of the state plan.

On February 26, 1999, Paula White of Fed OSHA wrote to Howard, noting that the court decisions clarifying the duties of employers, and noting that "revision of the standard may be an effective means of clarifying the intent of the standard and avoiding unnecessary litigation."  She remained concerned over the lack of progress  on the proposed rulemaking, commenting that "Failure to promulgate such a regulation has lef the regulated public without guidance and has resulted in the filing of supplemental enforcement actions which do not meet the conditions of Federal plan change approval." 

On March 19, 1999, Howard wrote to White, noting that Cal/OSHA was intending to issue a notice of proposed rulemaking on a monitoring regulation by June, with the ultimate adoption on or before October 31.

On April 23, 1999, White again wrote to Howard, expressing concern over the time it had taken to promulgate the monitoring regulation and to implement an interagency agreement with the Attorney General's office.  She also stated that settlements entered prior to the 1997 approval may contain conditions contrary to the conditions of approval, but that it was the responsibility of the parties to such agreements to bring them to the courts' attention.

Cal/OSHA has since issued a notice of proposed rulemaking for the adoption of 8 CCR §338, "Special Procedures for Supplementary Enforcement of State Plan Requirements Concerning Proposition 65."  The proposed regulation sets forth specific requirements for 60-day notices, and requires service of the complaint, significant court rulings, and settlements on the Attorney General's office.  The regulation would apply to any private enforcer and all public prosecutors other than the Attorney General.

A public meeting will be held on, and all written comments must be submitted by, August 30, 1999.

OEHHA Says Kitty Litter is "Safe"

OEHHA has issued a safe use determination, holding that exposure to crystalline silica in pet litter does not pose a significant risk of cancer.   The determination was eagerly awaited by many, because only one other safe use determination had ever been sought, and because no NSRL has been approved by OEHHA for crystalline silica.

Although OEHHA did not identify a particular exposure level, it noted that "Estimates derived from epidemiological studies were considered to be most appropriate for this screening evaluation of carcinogenic risk."  Based on the epidemiologic studies:

The highest exposure noted in the pet litter analyses was 0.06 m g/m³, approximately nine times less than the "worst case" concentration relied upon by OEHHA.

To List, or Not to List

OEHHA continued with its run of determinations about listing chemicals under the authoritative bodies provision.  On May 14, 1999, OEHHA issued a notice of intent to list thiabendazole:

Chemical	CAS No.	Toxicological Endpoint	Referencea
Thiabendazole	148-79-9	developmental toxicity	U.S. EPA (1994a,b)

Another notice of intent to list was issued for diuron on May 21, 1999.

Chemical	CAS No.	Toxicological Endpoint	Referencea
Diuron	330-54-1	developmental toxicity	US EPA (1994a,b)

On June 25, 1999, OEHHA issued a notice of intent to list N-methylpyrrolidone

Chemical	CAS No.	Toxicological Endpoint	Referencea
N-Methylpyrrolidone	872-50-4	developmental toxicity male reproductive toxicity female reproductive toxicity	US EPA (1994a,b)

Summaries are available of the bases for listing thiabendazole [text/pdf] diuron [text/pdf] and N-methylpyrrolidone [text/pdf].

The Prop 65 list was updated on June 18, 1999.  View the current list [text/pdf]

Meanwhile, OEHHA determined that a number of chemicals did not meet the authoritative bodies provision, and would be referred to the Developmental and Reproductive Toxicity Identification Committee.  On May 21, 1999, OEHHA issued a notice indicating that the following chemicals would not be listed:

Chemical	CAS No.
Anilazine	101-05-3
Naled	300-76-5
Quizalofop ethyl	76578-14-8
Sodium nitrite	7632-00-0
Triphenyltin hydroxide	76-87-9

The justification document is available [text/pdf]

On June 18, OEHHA issued a notice identifying more chemicals which did not meet the authoritative bodies provision:

Prop 65 List Updated March 1, 1999

View the updated list [text/pdf]. The chemicals were the subject of the January 29, 1999, notice of intent to list.

OEHHA Rejects DEHP Petition

On March 5, 1999, OEHHA issued a letter to attorneys representing Baxter Healthcare Corporation, rejecting Baxter's petition regarding the listing of DEHP. Baxter had requested that OEHHA:

OEHHA denied the first four requests, holding that there was scientific evidence sufficient to support the concept of DEHP's carcinogenicity by non-oral routes of exposure.

OEHHA rejected the request to limit the warning duty for prescription medical devices to the "informed consent" doctrine (as is the case for prescription drugs), stating that it "previously considered and rejected the action sought at the time it promulgated the pertinent regulation. OEHHA is not aware of any changed circumstance since the time of the rulemaking (1989). OEHHA may at some point in the future revisit this issue as part of a more general review of the regulations implementing Proposition 65, but it has no present intention to propose any amendments to Section 12601(b)(2)." OEHHA stated that, although it "is the lead agency for implementation of Proposition 65, it does not have the authority to list, modify listings, or remove chemicals from the Proposition 65 list of its own volition. (OEHHA does have authority to place chemicals on the list via the administrative listing mechanisms.) Rather, the State's qualified experts, the SAB composed of the CIC and the Developmental and Reproductive Toxicant Identification Committee, have the authority to decide to list, modify listings, or delist chemicals under Proposition 65. (Health and Safety Code ß25249.8(b))."

Additionally, OEHHA claimed that it lacked the "authority to declare Proposition 65 to be in conflict with other laws, to refuse to enforce Proposition 65 as drafted based on the contention that it is in conflict with other laws, or otherwise refuse to enforce Proposition 65 unless and until "an appellate court has made a determination that such statute is unconstitutional." (Cal. Const. Art. III, Sec. 3.5)"

As to the final request, "OEHHA finds the request to be far too broad to be the exercise of good policy, good science, or otherwise lawful to grant the relief sought. A regulation of the type requested is not supported by the weight of the scientific evidence regarding DEHP, the administration of treatment via intravenous and dialysis therapy prescription medical devices, or otherwise."

OEHHA Intends to List 10 Additional Pesticides and Rejects 9 Others Listed on the TRI

In an April 16 notice, 5 more chemicals listed on the EPA's Toxic Release Inventory as reproductive toxins are proposed for Prop 65 listing under the authoritative bodies procedures. The chemicals are:

Chemical	CAS No.	Toxicological Endpoint	Referencea
Avermectin B1	71751-41-2 65195-55-3 65195-56-3	developmental toxicity	US EPA (1994a,b, 1996)
Delta-8,9-isomer of Avermectin B1	---	developmental toxicity	US EPA (1996)
N-Methylpyrrolidone	872-50-4	developmental toxicity	US EPA (1994a,b)
Imazalil	35554-44-0	developmental toxicity	US EPA (1994a,b)

Summaries of the basis for consideration are available online [text/pdf].

In a February 26 notice, OEHHA identified 5 additional TRI reproductive toxins that it intended to list under the authoritative bodies provision. The chemicals are:

Chemical	CAS No.	Toxicological Endpoint	Referencea
Chlorsulfuron	6490-27-23	developmental toxicity female reproductive toxicity male reproductive toxicity	US EPA (1994a,b)
Ethyl dipropyl-thiocarbamate	759-94-4	developmental toxicity	US EPA (1994a,b)
Quizalofop-ethyl	76578-14-8	male reproductive toxicity	US EPA (1994a,b)
Dichlorophene	97-23-4	developmental toxicity	US EPA (1994a,b)
2,4-DP (dichloroprop)	120-36-5	developmental toxicity	US EPA (1994a,b)

Meanwhile, OEHHA has determined that an additional 9 chemicals on the TRI list do not meet the scientific criteria (22 CCR 12306(g)) for authoritative bodies listing as causing reproductive toxicity under Prop 65. See notice. The chemicals are:

Chemical	CAS No.
Dicamba	001918-00-9
Dimethoate	000060-51-5
Fenoxycarb	072490-01-8
Potassium N-methyldithiocarbamate	137-41-7
Propachlor	001918-16-7
Sodium dicamba	00198-69-0
Simazine	000122-34-9
Tebuthiuron	034014-18-1
Triphenyltin chloride	000076-87-9A

Summaries of the basis for rejection are available online [text/pdf].

New Members Appointed to Science Advisory Board

OEHHA has issued a notice identifying three new members of the Science Advisory Board. They are David A. Eastmond, Ph.D, Hillary Klonoff-Cohen, Ph.D, and Patricia H. Shiono, Ph.D. The appointments were made on January 2, 1999 with Dr. Eastmond's term ending on May 4, 2001 and Dr. Klonoff-Cohen and Dr. Shiono's terms ending on May 4, 2000.

4 Carcinogens and 17 Reproductive Toxins Proposed for Listing

A March 19, 1999, notice from OEHHA identified the agency's intent to list four additional carcinogens and 5 reproductive toxins under the authoritative bodies mechanism, and 12 drugs as reproductive toxins under the formally required to be labeled mechanism (FDA-required labeling).

The four carcinogens are:

Chemical	CAS No.	Reference
Oxythioquinox	2439-01-2	U.S. EPA (1996a)
Primidone	125-33-7	NTP (1996a, 1996b)
Thiodicarb	59669-26-0	U.S. EPA (1996b)
Vinclozolin	50471-44-8	U.S. EPA (1996c)

The five reproductive toxins listed under the authoritative bodies provision are:

Chemical	CAS No.	Toxicological Endpoints	Reference
2,4-Dinitrotoluene	121-14-2	male reproductive toxicity	U.S. EPA (1986a)
2,6-Dinitrotoluene	606-20-2	male reproductive toxicity	NIOSH (1985) U.S. EPA (1986a)
Technical Grade Dinitrotoluene	---	female reproductive toxicity male reproductive toxicity	NIOSH (1985)
Heptachlor	76-44-8	developmental toxicity	U.S. EPA (1980, 1986b)
Methyl chloride	74-87-3	developmental toxicity male reproductive toxicity	NIOSH (1984, 1994)

Summaries of the basis for consideration are available online [text/pdf].

The 12 drugs listed as reproductive toxins on the basis of the FDA labeling requirements are:

Chemical	CAS No.	Toxicological Endpoints	References
Acetazolamide	59-66-5	developmental toxicity	FDA (1990a)
Altretamine	645-05-6	developmental toxicity male reproductive toxicity	FDA (1993a)
Etodolac	41340-25-4	developmental toxicity female reproductive toxicity	FDA (1996)
Flurbiprofen	5104-49-4	developmental toxicity female reproductive toxicity	FDA (1989a)
Gemfibrozil	25812-30-0	male reproductive toxicity female reproductive toxicity	FDA (1995a)
Halobetasol propionate	66852-54-8	developmental toxicity	FDA (1990b)
Idarubicin hydrochloride	---	developmental toxicity male reproductive toxicity	FDA (1995b)
Mebendazole	31431-39-7	developmental toxicity	FDA (1989b)
Pimozide	2062-78-4	developmental toxicity female reproductive toxicity	FDA (1994)
Prednisolone sodium phosphate	125-02-0	developmental toxicity	FDA (1993b)
Sermorelin acetate	---	developmental toxicity	FDA (1991)
Streptozocin	18883-66-4	developmental toxicity male reproductive toxicity female reproductive toxicity	FDA (1986)

February 22, 1999

Prop 65 List Updated January 29, 1999

View the updated list [text/pdf]. The chemicals were the subject of the November 27, 1998, notice of intent to list. See the 12/31/98 Regulatory Update.

OEHHA Issues Notice of Intent to List Additional Chemicals

On January 29, OEHHA issued a notice of intent to list 11 pesticides being considered under the authoritative bodies procedures because of reproductive toxicity listing by EPA under the Toxic Release Inventory The chemicals are:

Chemical	CAS No.	Toxicological Endpoint	Referencea
Amitraz	33089-61-1	developmental toxicity	US EPA (1994a,b)
Disodium cyano-dithiomidocarbo-nate	138-93-2	developmental toxicity	US EPA (1994a,b)
Fenbutatin oxide	13356-08-6	developmental toxicity	US EPA (1994a,b)
Metiram	9006-42-2	developmental toxicity	US EPA (1994a,b)
Metribuzin	21087-64-9	developmental toxicity	US EPA (1994a,b)
Nabam	142-59-6	developmental toxicity	US EPA (1994a,b)
Nitrapyrin	1929-82-4	developmental toxicity	US EPA (1994a,b)
Potassium dimethyl-dithiocarbamate	128-03-0	developmental toxicity	US EPA (1994a,b)
Sodium dimethyl-dithiocarbamate	128-04-1	developmental toxicity	US EPA (1994a,b)
Triadimefon	43121-43-3	developmental toxicity male reproductive toxicity Female reproductive toxicity	US EPA (1994a,b)
Triphenyltin hydroxide	76-87-9	Developmental toxicity	US EPA (1994a,b)

Summaries of the basis for consideration are available online [text/pdf]

OEHHA Considers Three Additional Chemicals

In a February 5, 1999, notice, OEHHA is calling for public comment on three additional chemicals under consideration for listing under the authoritative bodies mechanism. The chemicals are:

Chemical	CAS No.	Reference
Diethanolamine	111-42-2	NTP (1997a) NTP (1997b)
Palygorskite fibers (> 5m m in length)	12174-11-7	IARC (1997)
Pyridine	110-86-1	NTP (1997c) NTP (1997b)

Summaries of the basis for consideration are available online [text/pdf].

A public meeting will be held March 2, 1999, and comments must be filed by April 6.

OEHHA Releases Draft Data Summaries

On February 18, OEHHA released a notice regarding the availability of draft data summaries for numerous chemicals on the prioritization list. The list is too lengthy to reproduce here, but is included in the notice. As described in the notice, there has been some change in how OEHHA is handling the prioritization process:

The procedure used by OEHHA to identify, prioritize and select candidate chemicals for evaluation by the SAB Committees is described in, "Procedure for Prioritizing Candidate Chemicals for Consideration Under Proposition 65 by the State's Qualified Experts," May 1997 and is available on the Internet at http://www.oehha.ca.gov/prop65/prioproc.htm. In accordance with this procedure, prioritized chemicals with a final priority of High Carcinogenicity Concern are assigned to the Candidate List, from which chemicals will be chosen for the preparation of hazard identification documents, and subsequent evaluation by the Carcinogen Identification Committee. All chemicals not assigned a final "high" level of carcinogenicity concern are assigned to Category II. In a slight change from previous releases, where draft priorities of Medium High, Medium, and Low Carcinogenicity Concern were stated explicitly in the data summaries, here draft priorities are identified as either "High" Carcinogenicity Concern, or "Not High" enough to merit placement on the Candidate List. We are implementing this change following the recognition that considerable resources have been expended by both the interested public and the State in the course of providing and responding to comments not pertinent to the placement of chemicals on or off the Candidate List. The main purpose of this phase of the prioritization process is to decide which chemicals should appear on the Candidate List; many of the comments received on previous releases focused on refining the priority of chemicals within Category II. We welcome comments from the public on this change.

The draft data summaries are available only in PDF format.