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Prop 65 Regulatory Update-1997
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).
OEHHA Lists Benzene as Reproductive Toxin
On 12/26/97, OEHHA listed benzene under Prop 65 as a reproductive toxicant . See notice of listing.
Update Prop 65 List Available
On 12/26/97, OEHHA issued the most recent list of Prop 65 chemicals, to include the new benzene listing.
OEHHA to Convene Workshop on "Authoritative Bodies" Listing
On 1/23/98, in response to controversy over the listing of chemicals under the "authoritative bodies" provision of Prop 65, and a request from the Developmental and Reproductive Toxicant (DART) Identification Committee, OEHHA called for input on an agenda for an authoritative bodies workshop. Part of the controversy has stemmed from correspondence from USEPA, which has indicated that inclusion of a chemical on the Toxic Release Inventory is not a "formal identification" by EPA that a chemical is a reproductive toxin.
OEHHA Requests Information on Potential Chemicals for Listing
On December 26, 1997, OEHHA isued a Notice to Interested Parties requesting information on Carbamazepine and Progesterone, which are up for consideration by the DART Identification Committee.
Prioritization Process for Consideration of Some Chemicals Completed
OEHHA assigns priorities for consideration for 8 chemicals, and 11 remain in draft. Notice to Interested Parties, December 26, 1997, Availability of Final Data Summaries and Priorities for Chemicals with&127; Respect to Their Potential to Cause Birth Defects or Other Reproductive Harm.
MTBE Considered for Listing
OEHHA is now assessing whether methyl tertiary-butyl ether (MTBE) should be listed under Prop 65. Unlike most other chemicals considered for inclusion on the list, OEHHA's consideration of MTBE is a direct result of The Local Drinking Water Protection Act of 1997 [Assembly Bill 592 (Kuehl) and Senate Bill 1189 (Hayden)], which requires the Carcinogen Identification Committee and DART Identification Committee to make findings on or before January 1, 1999 as to whether has been clearly shown through&127; scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity. On December 5, OEHHA issued a Notice to Interested Parties, requesting information on MTBE.
OEHHA Intends to List 31 New Chemicals
On December 5, 1997, OEEHA issued a Notice of Intent to List 31 of 47 chemicals subject to previous consideration under the Authoritative Bodies Mechanism. The comment period expired January 16, 1998.
The following chemicals were determined by OEHHA to meet the criteria for listing as causing cancer under the authoritative bodies mechanism:
- Aniline hydrochloride
- C.I. Solvent Yellow 14
- p-Chloroaniline hydrochloride
- p-Chloro-o-toluidine and its strong acid&127; salts&127;
- Cytembena
- 3,3' -Dichlorobenzidine dihydrochloride&127;
- Metham sodium&127;
- Methyl carbamate
- Nalidixic acid
- o-Nitrotoluene
- o-Phenylenediamine and its salts
- Salicylazosulfapyridine
- Phenolphthalein
The following chemicals were determined by OEHHA to meet the criteria for listing as causing reproductive toxicity under the authoritative bodies mechanism:
- Benzo[a]pyrene
- o,p' -DDT
- p,p' -DDT
- DDT, technical grade
- Reference
- Endrin
- Ethylene dibromide
- Metham Sodium
- Oxadiazon
- Vinclozolin
- Zearalenone
- Amoxapine
- Beclomethasone dipropionate
- Clobetasol propionate
- Codeine phosphate
- Flunisolide
- Fluticasone propionate
- Histrelin acetate
- Levonorgestrel implants
December 1, 1997
New Prop 65 List Available
The Prop 65 list was augmented by the October 1997 addition of 5-Chloro-o-toluidine and its strong salts, quinoline and its strong acid salts, and 2,4,5-Trimethylaniline and its strong salts. See the notice regarding the listing of these chemicals, and the October 1997 list of Prop 65 chemicals.
New Documents Available from OEHHA
- Notice to Interested Parties, October 31, 1997 Amended Agenda for the Meeting of the Science Advisory Board's Developmental and Reproductive Toxicant (DART) Identification Committee [10/31/97]
- Notice to Interested Parties, October 31, 1997 Extension of Public Comment Period for Chemicals Under Consideration for Possible Listing via Administrative Mechanisms: Request for Relevant Information [10/28/97]
- Notice to Interested Parties, October 10, 1997, Announcement of December 9, 1997 Meeting of the Science Advisory Board's Developmental and Reproductive Toxicant (DART) Identification Committee[10/10/97]
- Notice to Interested Parties, October 3, 1997 Availability of Draft Data Summaries and Draft Priorities for Chemicals with Respect to Their Potential to Cause Cancer[9/25/97]
October 4, 1997
OEHHA Lists 18 Chemicals
On August 15, 1997, OEHHA issued a notice that it was listing, effective August 26, 1997, 18 additional chemicals to the Prop 65 list. The chemicals listed include all on the March 28, 1997, notice, except for premarin. The June 27, 1997, notice of intent to list contains background information upon which the agency is relying.
The newly-listed carcinogens are
- 1-Amino-2,4-dibromoanthraquinone 81-49-2 NTP (1994a; 1994c)
- C.I. Direct Blue 15 2429-74-5 IARC (1993)
- C.I. Direct Blue 218 28407-37-6 NTP (1994b)
- 3,7-Dinitrofluoranthene 105735-71-5 IARC (1996a)
- 3,9-Dinitrofluoranthene 22506-53-2 IARC (1996a)
- Nitrobenzene 98-95-3 IARC (1996b)
- Estropipate 7280-37-7 FDA (1994)
- Ganciclovir sodium 82410-32-0 FDA (1995a)
OEHHA noted that CI Direct Blue 15 and 218 were previously listed as "benzidine-based dyes," but their listing "is to provide specificity to the existing categorical listing of benzidine-based dyes."
Newly-listed reproductive toxins are
- Amiodarone hydrochloride 19774-82-4 FDA (1995c)
- Atenolol 29122-68-7 FDA (1996a)
- Estropipate 7280-37-7 FDA (1994)
- Ethionamide 536-33-4 FDA (1969)
- Ganciclovir sodium 82410-32-0 FDA (1995a)
- Goserelin acetate 65807-02-5 FDA (1995d)
- Leuprolide acetate 74381-53-6 FDA (1996b)
- Paclitaxel 33069-62-4 FDA (1996c)
- Quazepam 36735-22-5 FDA (1991)
- Trimetrexate glucuronate 82952-64-5 FDA (1993)
View the August 1997 Prop 65 List.
OEHHA Sets its Sights on Additional Chemicals For Listing
"Authoritative Bodies" Listing
An August 22, 1997, OEHHA issued a notice of Chemicals Under Consideration for Possible Listing Via Administrative Mechanisms: Request for Relevant Information. The following 36 chemicals are under consideration, with written comments due no later than October 21, 1997:
A. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as carcinogens via the "authoritative bodies" mechanism:
- Aniline hydrochloride
- C.I. Solvent Yellow 14
- Carbon black (by inhalation)
- p-Chloroaniline hydrochloride
- p-Chloro-o-toluidine and its strong acid salts
- Cytembena
- Metham sodium
- Methyl carbamate
- Nalidixic acid
- o-Nitrotoluene
- o-Phenylenediamine and its salts
- Salicylazosulfapyridine
B. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as reproductive toxicants via the "authoritative bodies" mechanism:
- Acrylamide
- Benzo[a]pyrene
- Boric Acid
- 1,3-Butadiene
- Carbon dioxide (by inhalation)1
- o,p¢ -DDT
- p,p¢ -DDT
- DDT, technical grade
- (2,4-dichlorphenoxy) acetic acid
- 2,4-D n-butyl ester
- 2,4-D isopropyl ester
- 2,4-D isooctyl ester
- Propylene gylcol butyl ether ester (of 2,4-D)
- 2,4-D butoxyethanol ester
- 2,4-D dimethylamine salt
- 2,4-D butyric acid
- Endrin
- Ethylene dibromide
- Linuron
- Metham Sodium
- Oxadiazon
- Tetraborate and its salts (including Sodium Borate)
- Vinclozolin
- Zearalenone
C. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as reproductive toxicants via the "formally required to be labeled or identified" mechanism:
- Amoxapine
- Beclomethasone dipropionate
- Clobetasol propionate
- Codeine phosphate
- Flunisolide
- Fluticasone propionate
- Histrelin acetate
- Levonorgestrel implants
- Pravastatin sodium
The list was expanded on September 12, 1997, to include phenolphthalein.
Newly-available OEHHA Documents Regarding Data Summaries and Priorities
Proposition 65 First Round Pilot Random Selection of Chemicals
DART and Cancer Data Summaries (download from OEHHA as compressed MS-Word documents)
OEHHA Makes Several Hazard Identification Documents Available
Draft Hazard Identification of the Developmental and Reproductive Effects of Benzene
August 4, 1997
OSHA Conditionally Approves State Plan's Incorporation of Prop 65
On June 5, 1997, the Occupational Safety and Health Administration approved the California State Implementation Plan, incorporating Proposition 65, subject to several conditions. In 1991, the California Court of Appeal had ordered Cal/OSHA to implement Prop 65 into the state plan (California Labor Federation, AFL CIO v. California Occupational Safety and Health Standards Board, 221 Cal.App.3d 1547 (1991)). The Board responded by requiring employers to comply with the Hazard Communication Standard (HAZCOM) for exposures to any substance which fell within Prop 65. Cal. Code Regs., Title 8, §5194(b)(6)(B). The revision tothe state plan was submitted to Federal OSHA in 1992, but never received formal approval.
In April 1995, the Coalition for the Responsible Administration of Proposition 65 filed a petition with OSHA requesting that the plan be rejected. The Coalition argued that the state plan violated the "product clause" of the OSH Act, in that various provisions of Prop 65 unduly burdened interstate commerce and were not justified by "compelling local conditions." On September 13, 1996, OSHA requested public comment on the petition and, on June 5, announced approval of the state plan, subject to several conditions, published at 62 Fed. Reg. 31159 (June 6, 1997). See OSHA Press Release.
The conditions OSHA imposed on the approval are applicable to all enforcement actions brought by public officials or private parties over occupational exposures First, employers subject to Prop 65 may comply with its occupational requirements by complying with the OSHA or Cal/OSHA HAZCOM. Second, Cal/OSHA is responsible for ensuring that enforcement of HAZCOM and Prop 65 results in "at least as effective" protection for workers. This condition requires the agency to take "appropriate action to assure that court decisions in supplemental enforcement actions do not result in . . . inconsistencies with the conditions under which the standard is Federally approved." Third, and perhaps most significantly, OSHA specifically disallowed enforcement of Prop 65 through HAZCOM against out-of-state manufacturers
OSHA rejected many of the arguments advanced by the Coalition in its petition. It found that the adoption of Prop 65 into the state plan was based on a "compelling local condition," rejecting the suggestion that in order to establish a compelling condition a state must show a "unique" condition. According to OSHA, "California's interest in protecting the public's `right to know' is particularly compelling here because it is acting not only to protect the general public health and safety, but to protect the rights of individuals to make informed decisions about matters affecting their own health and welfare."
OSHA also was unpersuaded by comments asserting that the private enforcement provisions of Prop 65 violated the OSH Act and constituted an undue burden on interstate commerce. OSHA held that anecdotal evidence of "extortion" through voluntary settlements with private group was insufficient to show any impropriety in the state plan, and noted that most of these claims were not subject to the OSH Act, as they involved out-of-state manufacturers and/or consumer products and environmental exposures. OSHA did, however, require Cal/OSHA to "take appropriate and necessary administrative, legislative or judicial action to correct any deficiencies in their enforcement programs resulting from adverse administrative or judicial determinations." This includes "taking appropriate action when necessary to address adverse court decisions in private party suits."
Reaction was mixed. A press release from the U.S. House of Representatives Committee on Small Business quoted Chairman Jim Talent as saying that "The extortion and intimidation of small business at the hands of these bounty hunters is over." He declared that "it was imperative that Federal OSHA take into consideration the concerns of small businesses nationwide and modify the private right of action provision." On the other hand, the Environmental Defense Fund issued a press release calling the ruling "an important victory for citizen power and the right of states to use stronger health protections than the federal government."
OEHHA's 60 Day Notice Regulation Becomes Effective
On April 22, 1997, a new 60-day notice regulation proposed by the California Environmental Protection Agency Office of Health Hazard Assessment (OEHHA) was approved by the California Office of Administrative Law. The new regulation can be found in California Code of Regulations, Title 22, §12903. View the regulation and the final statement of reasons.
Prop 65 allows for enforcement by various public prosecutors, or any person on behalf of the general public if, 60 days after having been given notice, public prosecutors have not commenced and are not "diligently prosecuting" the alleged violations. The 60-day provision is similar to a number of federal environmental laws but, unlike the federal regimes, there had been until now no regulations addressing the legal sufficiency of notices under Prop 65, and rulings in litigation had been inconsistent.
According to a press release, Dr. Richard Becker, OEHHA director, explained that "it has been clear to OEHHA and many other people for some time that there needed to be clarificatioof the information" that must be included in a 60-day notice. Under the new regulation, the private party giving notice must provide such information as the approximate time period the alleged violation took place, the specific listed chemical(s) involved, how the alleged exposure occurred, and an accurate description of the products or services involved.
5/12/97
Prop 65 List Updated
On May 1, 1997, the updated Prop 65 list was published, including the chemicals subjec to the February 1997 notice of intent to list. View the May 1, 1997 list [html] [pdf] [Word/Excel]
Chemicals Under Consideration
OEHHA has given notice that premarin has been withdrawn from the list of chemicals currently under consideration. See notice of withdrawal. "OEHHA has determined that no further action towards listing of Premarin is appropriate at this time, since it is already covered by previous listings of conjugated estrogens as carcinogens and reproductive toxicants."
View the current document (4/22) entitled "Chemicals Under Consideration for Possible Listing Via the 'Formally Required to be Labeled or Identified' Mechanism."
Risk Assessment Advisory Committee
OEHHA has given notice of a May 14, 1997, meeting of the Risk Assessment Advisory Core Committee. One of the purposes of the meeting is to discuss Cal/EPA's initial plans to implement the Review of the California Environmental Protection Agency's Risk Assessment Practices, Polices and Guidelines, previously issued by the Committee, and accepted in large part by Governor Wilson.
Prioritization Procedure Finalized
OEHHA has made available the final version of its Procedure for Prioritizing Candidate Chemicals for Consideration for Prop 65 listing. See the notice of availability, download the actual Procedure document (PDF), or the summary of comments received on the draft (PDF).
Advisory Issued on Risk Assessment
OEHHA issues an April 1, 1997 Advisory entitled "Improving the Scientific Basis of Risk Assessment Through Harmonization."
April 14, 1997
OEHHA rejects NRDC petition to list EPCRA chemicals.
On March 31, 1997, OEHHA Chief Counsel William Soo Hoo responded by letter to the request of the Natural Resources Defense Counsel that OEHHA list under Prop 65 a number of chemicals included in the Emergency Planning and Community Right to Know Act (EPCRA) by US EPA.
Soo Hoo rejected NRDC's claim that the inclusion of these claimed reproductive toxins were "automatically" included in the Prop 65 list by virtue of their listing under EPCRA (as an "authoritative body"), stating that OEHHA must evaluate the sufficiency of evidence upon which another regulatory body lists chemicals . Since EPA lists chemicals under EPCRA on the basis that they are either "known to cause, or can reasonably be anticipated to cause in humans" either cancer or reproductive toxicity, an EPCRA listing does not mean that a chemical is "known" to cause cancer or reproductive toxicity" under Prop 65, and is not entitled to automatice listing.
Soo Hoo also rejected NRDC's assertion that the EPCRA listing triggered automatic listing under Prop 65's "formally required to be labeled" provision. Soo Hoo stated that an EPCRA listing "does not include any language intended to communicate a risk of cancer or reproductive harm, and therefore does not qualify as a requirement that the chemical to be labeled or identified as causing reproductive toxicity."
On August 6, 1997, NRDC and others filed suit against OEHHA, seeking the listing of the 66 TRI chemicals omitted from the Prop 65 list. See litigation updates.
OEHHA issues Request for Comment on Draft Records Management Policy
After coming under fire for its record retention policy, OEHHA has sent a Notice to Interested Parties seeking comment on its draft records retention policy. The comment period closed April 7, 1997.
Risk Assessment Advisory Committee Report Available
An expert panel called by state legislation to review the risk assessment practices of OEHHA issued its report on December 3, 1996. The report is entitled A Review of the California Environmental Protection Agency's Risk Assessment Practices, Polices and Guidelines, and is available for download directly from OEHHA as compressed Word 7 and Excel 7 files. The report finds that OEHHA's practices are generally of good quality, but makes some specific recommendations for harmonization between state and federal governments and strengthening the peer review process.
Governor Wilson's Executive Order of December 10, 1996, required Cal/EPA to implement most of the recommendations. Notably absent was any mention of the RAAC's recommendation that the 1000-fold safety factor for reproductive toxins be replaced with a scientific basis. View the Cal/EPA News Release, letter from Governor Wilson to Dr. Seiber, head of the RAAC, and Executive Order W-137-96.
OEHHA rejects listing of chemicals based on post-natal effects
OEHHA counsel announced at a December 4, 1996 DART Committee meeting, that OEHHA will not pursue listing of chemicals under Prop 65 solely on the basis of potential post-natal effects. This potential regulation was first raised by the DART in May 1995, and will still be an area of concern under other substantive laws administered by OEHHA.
