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.

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.

Chemical Safety Improvement Act May Be Overhauled in Senate Hearing Next Week.

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Since its introduction in late May, the bipartisan Chemical Safety Improvement Act of 2013 (“CSIA,” S. 1009) has already had an eventful history which looks like it will get even more interesting next week when the Senate Environment and Public Works (“EPW”) Committee holds a day-long hearing on reforming federal chemical law. The hearing, scheduled for July 31, will focus on the CSIA but also consider other proposals to reform the 1976 Toxic Substances Control Act (“TSCA”) – the only major environmental statute that hasn’t been updated since its initial passage.

The CSIA, introduced by Senator David Vitter (R-LA) and the late Senator Frank Lautenberg (D-NJ), has already been the subject of two House committee hearings. The bill was introduced just weeks before the death of Sen. Lautenberg, who was known for his dedication to pollution protection and public health, and some have called for its passage as a tribute to his legacy. The CSIA is backed by industry and some environmental groups, but has been criticized by other environmental groups and consumer and health advocates who argue that the bill is critically flawed; for example, if passed, the law might override state consumer safety laws like California’s Proposition 65, which require warnings on products that contain certain chemicals. In California, Attorney General Kamala Harris and the state’s Department of Toxic Substances Control have expressed concern that the bill could not only preempt Prop. 65 but also derail the state’s nascent green chemistry regulations.

Senator Barbara Boxer (D-CA), who chairs the Senate EPW Committee and co-sponsored some of Sen. Lautenberg’s previous TSCA reform proposals, is reportedly planning a major overhaul of the bill “that would amount to starting over.” Sen. Boxer’s goal is to combine parts of the Chemical Safety Improvement Act with parts of the Safe Chemicals Act of 2013 (S. 696). The Safe Chemicals Act was introduced by Sen. Lautenberg in April 2013 without Republican support, and mirrors legislation that passed the Senate EPW committee last year. Details on the hearing, including the witness list, are not yet available.

OEHHA to Hold Public Workshop on Potential Regulation Addressing Proposition 65 Warnings.

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On July 30, 2013, California’s Office of Environmental Health Hazard Assessment (OEHHA) will hold a public pre-regulatory workshop in order to gather input from interested parties on potential rulemaking to modify Proposition 65 warnings. If formally proposed and adopted, the regulation would either supplement or replace existing OEHHA regulations governing Proposition 65 warnings and conform to any statutory changes that may be enacted, such as the legislative reform package currently championed by Governor Brown.

Proposition 65 currently requires businesses to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to listed chemicals that are known to cause cancer, birth defects and other reproductive harm. This warning can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper. However, with more businesses posting blanket warning signs in attempting to comply with Prop. 65, many are concerned that the signs have become meaningless to the public and a source of frivolous litigation. In response to these concerns, Governor Brown announced in May that he was seeking reform of Proposition 65 in order to end frivolous lawsuits and improve warning signs.

According to OEHHA, the potential rulemaking would provide for more informative and meaningful warnings to individuals concerning exposures to carcinogens and reproductive toxicants. The regulation would offer a variety of options for businesses that are required to provide these warnings, and would provide businesses with greater certainty that their warnings comply with Prop. 65.

At this time, OEHHA believes the regulation should include the following:

  • A requirement that a warning inform consumers that they will be exposed to a listed chemical;
  • The minimum information that must be included in all warnings, such as the health effect of exposure, how a person will be exposed, or how to avoid or reduce exposure to a listed chemical
  • Approved warning methods and content regarding exposures to listed chemicals in consumer products and in foods, including those sold at retail establishments and via the Internet;
  • Approved warning methods and content for environmental exposures, including for some common scenarios such as parking lots, hotels, apartments, and other businesses;
  • Requirements and approved methods for providing additional contextual information concerning exposures to listed chemicals. This information would not have to be available to the public before exposure, but must be available on a website or other generally accessible location;
  • Reasonable transition times for businesses to come into compliance with this regulation and recognition of existing warnings that are included in court-approved settlements.

Written comments are due August 30, 2013. The workshop will take place from 10 am to 3:30 pm in the Coastal Hearing Room at the Cal/EPA Headquarters Building, 1001 I Street, Sacramento, CA, and the agenda is now available online [PDF]. The workshop will be webcast at http://calepa.ca.gov/Broadcast. OEHHA notes that if it decides to formally propose a Proposition 65 warning regulation, it will provide additional opportunities for public input.

Prop. 65 Reform on California’s Agenda.

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Last month, California Governor Jerry Brown unveiled his proposed reforms to Proposition 65, the 27-year-old law passed by voter initiative to protect Californians from harmful chemicals. Gov. Brown directed the California Environmental Protection Agency (“Cal/EPA”) to work with the legislature to improve the law and put an end to the proliferation of abusive “shakedown” lawsuits. Prop. 65 is best known for requiring clear warnings about chemicals known to the state to cause cancer or reproductive harm, often seen in retail stores and restaurants and on many consumer products. Like several other landmark environmental laws, Prop. 65 permits private citizens acting in the public interest to enforce the law by suing violators. Under the current law, unscrupulous lawyers are incentivized to bring Prop. 65 lawsuits because they may be able to recover all attorneys’ fees plus damages of up to $2,500 per day, or otherwise extract settlements with little proof of a meritorious claim.

The governor’s reform package includes:

  • capping attorney’s fees;
  • requiring plaintiffs to make a stronger showing of a violation before bringing suit, as well as other disclosures;
  • limiting the amount of money from an enforcement action that can go into settlement funds (as opposed to penalties);
  • authorizing the state to adjust the level at which warnings about reproductive harm are required; and
  • making more useful information available to the public on chemical exposure and protection.

The governor’s announcement adds to growing momentum in the legislature to reform Prop. 65. Assemblyman Mike Gatto introduced legislation this session which would allow business owners to avoid a costly lawsuit or settlement by paying a $500 fine and correcting the violation within 14 days after receiving a notice of violation. The bill, AB 227, has passed the state Assembly and this week was approved by the Senate committee on environmental quality; the Senate judiciary committee will consider it on Tuesday, June 25.