1996

Note to Reader: This page is maintained for historical purposes. Since OEHHA reorganized their web site, many of the links below do notwork anymore, but we're not going to go back and try to find these links (you're on your own).

DART Committee Votes on Listed Chemicals

The Developmental and Reproductive Toxin (DART) Identification Committee of OEHHA voted at its December 4, 1996, meeting to add inorganic arsenic (developmental) and cadmium (developmental/male reproductive) to the Prop 65 list of reproductive toxins. The motion to list cadmium as a female reproductive toxin was defeated.

OSHA requests comments on Prop 65 implementation in state plan

The US Occupational Safety and Health Administration announced in the Federal Register on September 13, 1996, that it was seeking comments on whether California's implementation of Prop 65 in the state hazard communication standard should be approved. This action was in response to a petition filed by The Coalition for the Responsible Administration of Prop 65. OSHA seeks comments [closed 11/12] on the following issues:

Is the California standard at least as effective as the federal standard? Because the incorporation of Proposition 65 imposes requirements that go beyond those in the federal standard, it might be viewed as more effective than the federal standard. However, some persons say that the different warnings required by Proposition 65 for exposures not otherwise covered by the hazard communication standard make the standard less effective by engendering confusion. Questions have also been raised about whether occupational safety and health standards can be as effectively enforced by local attorneys and private parties in addition to the state occupational safety and health officials.

OSHA is also seeking comment on whether the California standard:

1. is applicable to products that are distributed or used in interstate commerce;

2. if so, whether it is required by compelling local conditions; and

3. unduly burdens interstate commerce.

Individual employers and employer groups have said that manufacturers may need to have products labeled as carcinogens or reproductive toxins in California but not in other states, and must include specific language not required for products destined for other states, thus creating a burden on interstate commerce.

They also have said that private parties may create a burden on interstate commerce by subjecting out-of-state employers and suppliers to inconsistent requirements depending upon the circumstances of individual lawsuits and the settlement of those cases.

[Excerpted from OSHA Press Release USDL: 96-381, September 13, 1996.]

Web-available comments on the OSHA proceeding. Currently available is a comment from the Synthetic Organic Chemical Manufacturer's Association (SOCMA).

New Listed Chemicals (9/96)

Effective September 1, 1996, three carcinogens (chlorotrianisene, clofibrate, and tamoxifen) and seven reproductive toxins (azathioprine, cladribine, epichlorohydrin, halothane, nickel carbonyl, pentostatin, and teniposide) were added to the Prop 65 list by OEHHA.

Official Listing Notification.

All Prop 65 Listed Chemicals (9/96)

Proposed Regulations

60-day Notice Regulation

OEHHA has issueda 15-day availability notice for last-minute changes to its proposed 60-day notice regulation. This second notice period was required by the California Office of Administrative Law, after OEHHA made minor changes to the proposed regulation after the public comment period closed.

OEHHA's notice of proposed rulemaking on a regulation covering the minimum content of a 60-day notice sufficient to allow a private party to commence an enforcement action is still available on the web. For further information, contact OEHHA directly.

The Act provides that private parties may seek to enforce Prop 65 against an alleged violator if no public prosecutor has commenced and is diligently prosecuting an action within 60 days after receiving notice of the violation. Although this provisions mirrors similar provisions in federal statutes, unlike the federal laws, no regulations currently define the minimum notice required to commence a private action. Private parties have often given minimal notices, using the litigation process to "discover" the true extent of the defendant's claimed violations, and set settlement figures.

Businesses subject to the Act have objected to this lack of procedure, in that it neither furthers either early settlement, nor allows the defendant to attempt to come into compliance upon discovery of deficiencies in its warning program. Public enforcers have also objected to minimal notices, because they deprive the state of the ability to make an intelligent decision about the magnitude of the alleged violations, and whether to take the case.

Notice of Intent to List

On February 7, 1997, OEHHA filed a notice that it intended to list the following chemicals as carcinogens under the authoritative bodies mechanism:

• Nitromethane 75-52-5 NTP (1995a; 1995c)
• Tetrafluoroethylene 116-14-3 NTP (1995b; 1995c)
• Vinyl Fluoride 75-02-5 IARC (1995)

The following chemicals are to be listed under the formally required to be labeled mechanism:

• Spironolactone 52-01-7 FDA, 1990
• Stanozolol 10418-03-8 FDA, 1992

The following reproductive toxins are also to be listed under the formally required to be labeled mechanism:

• Clarithromycin 81103-11-9 FDA, 1995a developmental
• Dihydroergotamine mesylate 6190-39-2 FDA, 1994 developmental
• Hydroxyurea 127-07-1 FDA, 1971 developmental
• Oxymetholone 434-07-1 FDA, 1993 developmental

OEHHA stated that it "is seeking clarifying information from the FDA on simvastatin before deciding whether or not to proceed with an intent to list."

OEHHA sends a number of notices in September/October 1996

Notice to Interested Parties (10/4/96) advises of the availability of the draft procedure for prioritizing chemicals under consideration for listing, the 11/15/96 public workshop on the prioritization procedure, the 11/15/96 forum to receive comments on draft prioritized chemicals, request for information on chemicals to be considered by the Carcinogen Identification Committee, and the 12/4/96 meeting of the Developmental and Reproductive Toxicant Identification Committee.

November 15, 1996 workshop on refinement of prioritization procedure.

OEHHA will present its revised draft procedure at this public workshop. On the notice is a preliminary list of prioritized carcinogens and reproductive toxins. OEHHA later issued a notice postponing prioritization of carbemazepine and progesterone.

Request for information on chemicals to be considered by the Carcinogen Identification Committee. This involves only three chemicals:

• 5-chloro-ortho-toluidine and its hydrochloride
• 2,4,5-trimethylaniline and its hydrochloride
• quinoline

December 4 meeting of the Science and Advisory Board's Developmental and Reproductive Toxicant Identification (DART) Committee. On the agenda are inorganic arsenic and cadmium. The committee will also discuss its proposed mechanism for removing chemicals from the Prop 65 list and prioritization of candidate chemicals.

Request for relevant information on other chemicals being considered for listing. Includes

A. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as carcinogens via the "authoritative bodies" mechanism:

• Nitromethane
• Tetrafluoroethylene
• Vinyl fluoride

B. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as carcinogens via the "formally required to be labeled or identified" mechanism:

• Spironolactone
• Stanozolol

C. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as developmental toxicants via the "formally required to be labeled or identified" mechanism:

• Clarithromycin
• Dihydroergotamine mesylate
• Hydroxyurea
• Oxymetholone
• Simvastatin

• nitromethane
• tetrafluoroethylene
• vinyl flouride

Chemicals under consideration for possible listing via the Formally Required to be Labeled or Identified Mechanism.

A. Carcinogens

• spironolactone
• stanozolol

B. Developmental and Reproductive Toxins

• clarithromycin
• dihydroergotamine mesylate
• hydroxyurea
• oxymetholone
• simvastatin