New warning requirements proposed for California's Prop. 65.

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This week, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced its proposal to amend Proposition 65 warnings. OEHHA’s proposal is aimed at improving the quality of Prop. 65 warnings, and is part of the suite of Prop. 65 reforms advocated by Governor Jerry Brown.

A pre-regulatory public workshop on the same topic was held in July; the new proposal provides more detail and incorporates changes and feedback from comments received in response to the agency’s initial pre-regulatory proposal. OEHHA has prepared a Draft Pre-Regulatory Initial Statement of Reasons for the Warning Regulation [PDF] and Draft Pre-regulatory Warning Regulation [PDF], as well as a side-by-side comparison [PDF] between the draft regulatory language and current regulations.

Generally, the proposal establishes certain standards for what warning language counts as “clear and reasonable.” The draft regulations would require the word “WARNING” to appear in all capital letters and bold print, and specifies use of the word “expose” in the following warning language. Notably, the new proposal requires the use of a standard pictogram for toxic hazards from the Globally Harmonized System (GHS), except for on food products, drugs, and medical devices. A new OEHHA website would provide the public with more detailed information on warnings, including exposure pathways and methods of reducing exposure. The proposal also specifies the following twelve common substances (already listed under Prop. 65) that must be identified by name in the warning:

  • Acrylamide
  • Arsenic
  • Benzene
  • Cadmium
  • Chlorinated Tris
  • 1,4-Dioxane
  • Formaldehyde
  • Lead
  • Mercury
  • Phthalates
  • Tobacco smoke
  • Toluene

In addition, the proposal recognizes court-approved warning language and provides for “tailored” warning language for certain scenarios, such as dental care, apartment buildings and hotels, parking facilities, and amusement parks. OEHHA also proposes a new “Opportunity to Cure” provision for small retailers to fix certain minor violations within 14 days and avoid private enforcement actions, with the goal of avoiding frivolous litigation.

OEHHA will hold a public workshop to discuss the proposal on April 14 and will accept comments through May 14, 2014. After the workshop and comment period, OEHHA plans to propose the formal regulation in early summer 2014, with the expectation that final regulations could be adopted in the summer of 2015.

California Prop. 65: TCE added as reproductive toxicant, new additions proposed.

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California’s Office of Environmental Health Hazard Assessment (OEHHA) has finalized the addition of trichloroethylene (TCE) to its Proposition 65 list of reproductive toxicants. OEHHA proposed the listing in November 2013, based on data and conclusions from U.S. EPA’s IRIS Assessment and report finding that TCE causes male reproductive and developmental toxicity in laboratory animals. TCE, which is used as an industrial solvent, was already listed under Prop. 65 as a carcinogen.

On February 7, OEHHA filed several Notices of Intent to List various substances as cancer-causing under Prop. 65. OEHHA proposed listing beta-myrcene and “nitrite in combination with amines or amides” as carcinogenic under the “authoritative bodies listing mechanism.” Beta-myrcene is a plant derivative used as a flavoring agent or fragrance in various consumer products, and is also synthesized as a high-production chemical for the manufacture of alcohols, polymers and other chemicals. The National Toxicology Program concluded in 2010 that beta-myrcene causes kidney and liver cancers in laboratory animals. Nitrites in combination with amines or amides are commonly found in food, and its proposed listing is based on a 2010 report from the International Agency for Research on Cancer (IARC), which found “sufficient evidence” of the substance’s carcinogenicity. OEHHA also proposed listing pulegone, a plant-derived compound, as carcinogenic under the Labor Code mechanism, which is based on the Federal Hazard Communication Standard and IARC’s identification of a substance as a human or animal carcinogen. Megestrol acetate was also proposed for listing as a carcinogen in accordance with requirements by the federal Food and Drug Administration.

In addition, OEHHA announced its intent to list the triazine-class herbicides atrazine, propazine, simazine and their chlorometabolites DACT, DEA and DIA as reproductive toxicants. The listing is proposed under the “authoritative bodies” mechanism, based on various EPA studies finding that the substances “cause developmental and reproductive effects through a common mechanism of toxic action.”

OEHHA is accepting public comments on all of the above proposed listings through March 10, 2014.

DTSC spring quarterly meeting will address Safer Consumer Products.

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Officials from California’s Department of Toxic Substances Control (DTSC) will discuss the Safer Consumer Products program and Priority Products at the agency’s upcoming Quarterly Public Meeting. DTSC recently posted the agenda [PDF] online, but more detailed presentation and supporting materials are not yet available. At the agency’s last quarterly public meeting [PDF], held in December, officials estimated that draft Priority Products would be identified before April 2014 and draft Alternatives Analysis guidance would be released in spring 2014.

In addition to Safer Consumer Products, other topics to be addressed at the meeting include DTSC’s proposed budget for 2014-15; an update on the ongoing permit program review; and an update on the agency’s work on cost recovery. The meeting will be held on March 17, 2014, at 9 a.m. in the Sierra Room of the Cal/EPA Building in Sacramento.

Members of California’s second Green Ribbon Science Panel announced.

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Yesterday, California’s Department of Toxic Substances Control (DTSC) announced the appointment of 15 members to the newly reconstituted Green Ribbon Science Panel. The appointments include reappointed members from the first panel as well as new members. Panel members include experts on public and environmental health as well as chemicals policy, law, and engineering, and are drawn from academia, NGOs, industry, and government. As we previously discussed, the Panel advises DTSC on green chemistry and chemicals policy issues, including implementation of the Safer Consumer Products regulations.

A Green Ribbon Science Panel Webinar Meeting will be held January 29, 2014. More information from DTSC will be posted online in the near future.

DTSC releases strategic plan.

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California’s Department of Toxic Substances Control (DTSC) plans to focus on improving departmental operations while addressing health and safety issues through a variety of new and continuing initiatives to reduce hazardous waste and toxic substances. In late December, DTSC released its Strategic Plan for 2014-2018: Fixing the Foundation – Building a Path Forward, [PDF] which lays out approaches and specific objectives for five broad goals: Cleanup, Hazardous Waste Management, Safer Consumer Products, Support Services, and Public Engagement.

DTSC’s approach to achieving its Hazardous Waste Management objectives includes holding businesses accountable for costs associated with regulation and cleanup, maximizing enforcement reach, and improving data quality and transparency. Notably, the plan calls for reforming the agency’s hazardous waste fee system by making fees “fairer” and in line with the goals of source reduction, recycling, polluter-pays principle, and in-state management. Following an external review of the agency’s permit program, DTSC plans to work on ensuring that permits are protective, timely, and enforceable, and also that enforcement is effective, efficient, and consistent. The agency hopes to improve public confidence in this area through a range of different efforts, including making the “enforcement program’s information and processes more accessible to the public” and launching an IT system that “improves the availability and accuracy of hazardous waste tracking data” for both the agency and the public. Other Hazardous Waste Management objectives include: working with Cal/EPA to train and evaluate local authorities responsible for enforcing hazardous waste laws at the local level; expanding DTSC’s capacity to respond to natural disasters and chemical emergencies; and assessing the classification of metal shredder waste.

The agency’s approach to its newly-launched Safer Consumer Products (SCP) program includes: changing how products are designed and manufactured; avoiding product redesigns that result in “regrettable substitutes”; holding manufacturers responsible for the life cycle impacts of their products; and increasing public access to data on chemicals in consumer products while protecting trade secret information. First among its objectives for the SCP program is the adoption of the initial list of Priority Products and development of guidance documents for Alternatives Analysis. DTSC also plans to develop a data system to support implementation of the SCP regulations and provide information tools for manufacturers and consumers on chemical hazard traits and exposures.

More information on DTSC’s “Fixing the Foundation” initiative is available in Director Debbie Raphael’s online message.

California accepting applications for second Green Ribbon Science Panel.

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California’s Department of Toxic Substances Control (DTSC) is currently accepting applications to serve on the Green Ribbon Science Panel. Members of the Panel come from both the private and public sectors and are experts in a variety of fields, including chemistry, public health, risk analysis, and materials science. The Panel draws on its scientific and technical expertise in advising the DTSC as well as the California Environmental Policy Council on various green chemistry and chemicals policy issues. The first Panel was assembled in 2009 and advised DTSC on developing the Safer Consumer Products regulations which just went into effect last month. Moving forward, the new Green Ribbon Science Panel will address implementation of the Safer Consumer Products program.

The deadline for applications is this Friday, November 15, 2013.

California's Proposition 65 reformed to end "frivolous" lawsuits.

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On October 5, 2013, California Governor Jerry Brown signed into law A.B. 227, amending Proposition 65. The bill aims to end “frivolous shakedown” lawsuits against businesses based on California’s Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Prop. 65, a voter-initiative-based law which requires businesses to post warnings about chemicals known to the state as causing cancer or reproductive harm. We previously discussed this legislation and Gov. Brown’s Prop. 65 reform package in June.

A.B. 227 amends the law so business owners faced with a private enforcement action may take corrective action, pay a $500 fine and provide notice of the fix – a solution that the bill’s sponsor, Assemblyman Mike Gatto (D-Los Angeles), compared to motorist “fix-it” tickets. The changes went into effect immediately, on October 5.

Under Prop. 65, private citizen enforcers must send a “60-day notice” of the violation to the alleged violator, along with the California’s Office of the Attorney General, before filing suit. Businesses sued for failing to post proper Prop. 65 warnings face steep penalties of $2,500 a day, plus the private enforcer’s attorneys’ fees and costs. Some of these private enforcement actions have led to the development of what some critics, including Gov. Brown, call a “cottage industry” based on “nuisance” suits and shakedowns.

Under A.B. 227, businesses that receive a 60-day notice of violation could avoid costly litigation or settlements by correcting the violation within 14 days. The alleged violator would send to the private enforcer the $500 penalty and a completed proof of compliance form describing the corrective action taken and attaching a copy of the new warning along with a photograph of the warning’s placement on the premises. Of the $500 penalty, 75 percent will be paid to the state’s Safe Drinking Water and Toxic Enforcement Fund and the remaining 25 percent will be paid to the private enforcer. An alleged violator could use this “fix-it ticket” option only once, and the amendments do not prevent the Attorney General or other public prosecutor from taking enforcement action.

The new amendments only apply to certain Prop. 65 actions involving exposure to (1) vehicle exhaust at parking garages; (2) alcohol; (3) second-hand smoke; and (4) certain chemicals in food or beverages that are not intentionally added and occur naturally in preparation processes like grilling or frying, such as a acrylamide or benzene.

Gov. Brown’s broader array of proposed reforms – including capping attorneys’ fees and limiting settlement payments – were not adopted in legislation this year.

California's new SCP law may threaten trade secrets.

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Under California’s Department of Toxic Substances Control (DTSC) Safer Consumer Products (SCP) program, discussed last week, manufacturers may be required to publicly disclose the ingredients of those products that contain one or more chemicals deemed hazardous by the DTSC.

The regulations require DTSC to evaluate a list of Candidate Chemicals for development of an initial “Priority Products” list. (See overview [PDF]). If manufacturers of products on the Priority Products list choose not to remove the relevant chemicals, they will be required to disclose all product ingredients in an Alternatives Analysis (AA) report. The AA reports will include:

  • the quantities of chemicals of concern used;
  • the function of these chemicals and rationale behind their use;
  • the brand and product names under which a product containing a chemical is sold or used;
  • the identities of both the manufacturer and importer; potential adverse impacts associated with the product;
  • disposal and handling requirements; and
  • possible alternative chemicals the company has considered using.

DTSC will post these reports online and email them to interested parties for public review and comment. The state will also publicly announce notices of ongoing review, compliance, deficiency and disapproval.

The disclosure requirements may present potential hurdles to companies seeking to comply with the SCP regulations. First, companies that may not know the complete chemical make-up of their product ingredients will have to research their suppliers to gather more detailed information on their supply chains. Given the size of California’s economy, its product regulations could greatly affect global supply chains beyond state borders; if companies marketing products in California choose to reformulate their products in response to the SCP program, the impact will likely be felt throughout the country. Second, protecting confidential business information (CBI) might also complicate disclosure because, although some ingredients may be redacted if they are considered trade secrets, DTSC is entitled to deny such claims under certain circumstances.

Companies seeking to comply with the new rules may benefit from reviewing and documenting their strategies to protect trade secrets. Certain documentation is required by DTSC to substantiate trade secret claims. Companies may want to consider seeking patent protection for new products, new formulations of existing products, or new manufacturing methods. There may also be additional limited opportunities to obtain patents for existing products under the Leahy-Smith America Invents Act.

California’s Safer Consumer Products program launches.

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As October begins, California’s long-awaited Safer Consumer Products (SCP) program is finally launching as the first step in carrying out the state’s Green Chemistry Initiative. The regulations implementing the program go into effect today, October 1, 2013. The state’s Department of Toxic Substances Control (DTSC) will administer the SCP program, which identifies potentially harmful products and requires manufacturers to evaluate their safety and, if necessary, reformulate with safer alternatives or otherwise decrease risks. In addition, the SCP website has launched with some new features: an informational list of candidate chemicals and a Toxics Information Clearinghouse.

We have discussed the development of the SCP regulations over the past several months on this blog. Writing in ChemicalWatch, DTSC Director Debbie Raphael describes the regulations as taking a “preventive approach to keeping dangerous chemicals out of everyday products,” to help keep consumers safe, while providing industry with “a more predictable process for ensuring product safety” and offering a “competitive advantage for innovators who see an opportunity in the growing market for toxic-free or toxic-reduced products.” The SCP program contrasts with the piecemeal, chemical-by-chemical approach which state regulators have previously used, as well as the federal Toxic Substances Control Act (TSCA), which generally does not require safety testing for existing chemicals in consumer products.

The DTSC has made available an initial candidate chemicals informational list, which includes 164 substances. The agency describes this list as a “subset” of Candidate Chemicals that meet the two regulatory criteria (based on hazard traits and exposure potential) for developing the initial list of “Priority Products” which will be evaluated for safety. Those seeking revisions to the Candidate Chemicals list may submit a petition to the agency, which will post proposed revisions online for public review and comment before adopting regulations to enact them; however, the SCP regulations do not allow petitions “to remove an entire chemicals list” until October 2016. The DTSC is required to identify the first Priority Products by April 2014.

The Toxics Information Clearinghouse (TIC) is a decentralized, publicly-accessible system for information on certain chemicals. The TIC is initially using an open approach as a web-based portal to both public and private information sources on chemical hazard traits and environmental and toxicological endpoint data. The TIC was authorized separately from the SCP program by legislation passed in 2008, and represents another of the DTSC’s six policy recommendations for implementing the California Green Chemistry Initiative.

CA’s Safer Consumer Products regulations (almost) finalized.

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California’s Safer Consumer Products final regulations were generally approved by the Office of Administrative Law (“OAL”) and filed with the Secretary of State on August 28. As we have previously discussed, the Safer Consumer Products program establishes a statewide system that implements a key element of the California Green Chemistry Initiative: accelerating the use of safer products through a science-based process to evaluate chemicals of concern and identify safer alternatives. To recap, this process consists of four steps:

  1. The regulations establish a starting list of about 1,200 Candidate Chemicals based on the work of other authoritative organizations. DTSC will identify additional Candidate Chemicals.
  2. DTSC will evaluate and prioritize Candidate Chemical/consumer product combinations to develop a list of “Priority Products.”
  3. Manufacturers (or other responsible entities, such as importers or retailers) of Priority Products must notify DTSC when their product is listed as a Priority Product and conduct Alternatives Analyses.
  4. DTSC will identify and implement regulatory responses designed to protect public health and the environment and maximize the use of acceptable and feasible alternatives.

The regulations that will set this process in motion will go into effect starting October 1, 2013.

We discussed the development of these regulations in April and February of this year. DTSC made further revisions based on the April proposal after receiving feedback from the OAL, which are generally minor.

Although most of DTSC’s proposed regulations were approved, the OAL disapproved [PDF] three minor provisions of the regulations for failing to meet standards for clarity. In response, DTSC has proposed revisions which would re-add those provisions with minor drafting changes, and emphasized the necessity for their inclusion in order to maintain flexibility in collecting information and to maximize transparency while protecting validly claimed trade secrets. The first provision specifies that documents submitted to DTSC must be in English and in “an electronic format accessible” to the agency, while the other two provisions specify how DTSC will handle trade secret claims, and how submitting parties can dispute the agency’s trade secrecy determination. DTSC will be accepting comments on these revisions through September 9, 2013; the 15-day notice discussing the revisions is here [PDF] and the revised text is here [PDF].