Prop. 65 Short Form Warning Change

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In January 2021, OEHHA announced a proposal to make changes to use the of the short-form Proposition 65 warnings.  These changes restrict when a manufacturer would be allowed to use the short-form.  Previous use of the short-form warning label had “no limitation on using the short-form warning on larger products”.  The only requirement was that the entire warning text be at least the same size as the largest text for the rest of the consumer information on the product, or at least 6-point in size if the rest of the consumer information text was smaller.

Under the proposal, short-form warnings would only be allowed under the following conditions:

  • The total surface area of the product label available for consumer information is 5 square inches or less, and;
  • The package shape or size cannot accommodate the full-length warning described in section 25603(a).

The shape and size limitation described in section 25603(a) govern the ability to fit the text of the warning on the product and not dimensions of the shape or size of the warning.

OEHHA stated the purpose of the change is to correct widespread overuse use of the short form warning and to provide additional guidance for its use.  The comment period for this proposal is open until March 29, 2021.

BPA and Proposition 65

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On October 19, 2020, a California appeals court ruled in favor of the Office of Environmental Health Hazard Assessment (OEHHA) listing bisphenol A (BPA) as a chemical known to cause cancer or reproductive harm under Proposition 65.  The American Chemistry Council (ACC) had attempted to prevent BPA from being added to the Proposition 65 list. ACC alleged OEHHA abused its discretion by refusing to consider the 2009 determination of a committee working for OEHHA, the Developmental and Reproductive Toxicant Identification Committee (DRTIC).  DRTIC’s 2009 panel voted unanimously that BPA should not be added to the Prop 65 list because it “did not meet the criteria for listing pursuant to the state’s qualified experts listing mechanism.”  The criteria for a chemical being listed under Proposition 65 for developmental or reproductive effects include sufficient evidence in humans, limited evidence in humans supported by sufficient animal data, sufficient evidence in animals that would extrapolate to humans, and statistical considerations with biological plausibility.  However, DRTIC’s 2015 panel, comprised of different members, reversed that recommendation.

Key points from the suit are below.

  • The court rejected the need for clear evidence of a chemical causing cancer or reproductive harm being a requirement.
  • The court made some notable statements:
    • Proposition 65 is not limited to chemicals known to cause cancer in humans.
    • OEHHA need not consider DRTIC’s recommendations.

The ruling raises alarms for many manufacturers.  BPA is found in many different products, such as polycarbonate plastic found in bottles, tableware, and food containers.  According to the California Attorney General, 80 private enforcement actions were commenced in 2020 alleging violations of Proposition 65 for products containing BPA.  For example, Five Below Inc. and 1616 Holdings Inc. received notices of violation in relation to their cell phone cases and Air Pod cases.  The notice of violation claims the cases can cause female reproductive toxicity due to BPA dermal exposure from handling the cases and the possibility of ingesting BPA if placed in contact with the user’s mouth.  The notice also states that plaintiffs “seek[] constructive resolution of this matter without engaging in costly and protracted litigation.”

OEHHA Amends Proposition 65 Clear and Reasonable Warning Regulations

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The Office of Environmental Health Hazard Assessment (OEHHA) received numerous inquiries related to the interpretation and application of several provisions of the August 2016 amendments to the Article 6 Clear and Reasonable Warnings regulations. OEHHA determined that clarification of certain provisions of the new regulations “would be beneficial to the regulated community.” As such, on December 6, 2017, OEHHA issued a notice alerting stakeholders that amendments were approved. The proposed amendments are intended to further clarify the guidance OEHHA provides to businesses to better understand how to comply with the warning requirements.

There are some changes worth mentioning. First, OEHHA eliminated the term “on-product” warning and replaced the term as “short form” warning. It must be noted that there are no substantive changes to the content of the short form warning. Second, OEHHA revised the definition of “label” to indicate that a label can be “printed on or” affixed to a product or its immediate container or wrapper. This change is intended to clarify that there is no requirement to place a separate label with the warning on the product if the warning is printed on the product or the immediate container or wrapper. Third, OEHHA also has revised the definition of “labeling” to delete the reference to “tags at the point of sale or display of a product” because tags are a form of signage, not labeling.

For more information, visit OEHHA’s website here.

New Prop 65 Regulations Become Operative on August 30, 2018

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New consumer warnings will be required under California’s Prop 65 on August 30, 2018.  On September 2, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a final rule amending Article 6 of the regulations implementing Proposition 65 (Prop 65) that requires enhanced warning messages. Prop 65 requires a “clear and reasonable” warning on products that expose California consumers to chemicals of concern (“Prop 65-listed chemicals”).  The new regulation has changed what constitutes a “clear and reasonable” warning.  As the final rule becomes effective on August 30, 2018, businesses should begin to assess their products, consider the clear and reasonable warning requirements, and prepare for the deadline to minimize the risk of enforcement litigation.

The final rule imposes requirements on content and methods of transmission, which includes disclosure of one or more Prop 65-listed chemicals that resulted in the warning and an accompanying symbol.  An abbreviated warning, however, will be permitted when a company provides an “on-product” warning.  If an “on-product” warning is used, the business need not disclose the specific Prop 65 chemical(s).

Until the August 30, 2018 effective date, companies selling into California can use either the old or the new regulatory warnings. Indeed, businesses are not required to re-label products that are already in the stream of commerce.  OEHHA has ensured that “the regulations allow the old safe harbor warnings to remain and be considered compliant if the product was manufactured prior to the effective date of the new regulations.”  As such, if a business is selling into California, compliance with the new regulatory warnings must be in effect on all manufactured products on August 30, 2018.

It is prudent for businesses to begin the compliance process shortly because it will take time to assess which products are sold into California, to design new product labels and/or compliant materials, to approve such materials, and to implement the necessary changes.

Court to Allow California to List Glyphosate as Possible Cancer Threat under Prop. 65

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In September 2015 the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) announced plans to list the pesticide glyphosate as a possible cancer threat under Proposition 65. OEHHA made the decision to list glyphosate following the International Agency for Research on Cancer March 2015 finding that glyphosate is “probably carcinogenic to humans.” Monsanto sued OEHAA in January 2016, in an effort to block the listing. Global sales of glyphosate were about $7.8 billion in 2014, as a carcinogen under Proposition 65. It is the main ingredient in Monsanto’s Roundup.

A tentative ruling by California Superior Court Judge Kristi Culver Kapetan states that the court intends to dismiss Monsanto’s lawsuit. In the lawsuit, Monsanto claimed that the listing was unconstitutional because OEHHA delegated law-making authority “to an unelected and non-transparent foreign body that is not under the oversight or control of any federal or state government entity,” and because the labor code process violated the due process clauses of the California and U.S. constitutions. In its motion to dismiss the lawsuit, California argued that IARC’s scientific determinations are “the gold standard in carcinogen identification.” The court found that Monsanto’s petition failed to state facts sufficient to constitute a cause of action.

Judge Kapetan will be issuing a formal decision soon.

Final Rule Issued by California on Proposition 65 Article 6: Clear and Reasonable Warnings

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On September 2, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a final rule amending Article 6 (California Health & Safety Code §§25600-25607.9) of the regulations implementing Proposition 65 (Prop 65). The final rule imposes requirements on content and methods of transmission, which includes, in some instances, disclosure of one or more Prop 65-listed chemicals that resulted in the warning. An abbreviated warning, however, will be permitted when a company provides an “on product” warning for consumer products.

The new requirements become effective on August 30, 2018, however, companies can use either the old or the new regulatory warnings during the two-year transition period.

The new clear and reasonable warning requirement for consumer products, other than food or alcoholic beverages, requires the warning language to be preceded by a warning label – a bold, black outlined, yellow equilateral triangle, with an exclamation point in the center.

prop-65

The warning symbol should be followed by one of the following warnings:

When the product can cause exposure to a carcinogen:

WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known in the State of California to cause cancer. For more information, go to  www.P65Warnings.ca.gov.

When the product can cause exposure to a reproductive toxicant:

WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known in the State of California to cause birth defects or other reproductive harm. For more information, go to  www.P65Warnings.ca.gov.

When a product can cause exposure to both a carcinogen and a reproductive toxicant:

WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known in the State of California to cause cancer, and [name of one or more chemicals], which is [are] known in the State or California to cause birth defects or other reproductive harm. For more information, go to  www.P65Warnings.ca.gov.

When a product can cause exposure to a substance listed as both a carcinogen and a reproductive toxicant (e.g. lead):

WARNING: This product can exposure you to chemicals including [name of one or more chemicals], which is [are] known in the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to  www.P65Warnings.ca.gov.

Most importantly, there is now an abbreviated “on-product” warning that is permitted that would not require disclosure of one or more listed chemicals in the product. OEHHA clarified that on-product referred to the product itself, as well as the immediate container, box, or wrapper of the product. On-product warnings must appear in a type size no smaller than the largest type size used for consumer information on the product, and must be no smaller than 6-point font. Consumer information is defined to include warnings, directions for use, and ingredient lists.

When providing an on-product warning, the same warning symbol is required, as above, followed by one of the following warnings:

When the product can cause exposure to a carcinogen:

WARNING: Cancer – www.P65Warnings.ca.gov

When the product can cause exposure to a reproductive toxicant:

WARNING: Reproductive Harm – www.P65Warnings.ca.gov

When a product can cause exposure to both a carcinogen and a reproductive toxicant:

WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov

The regulations now permit a manufacturer, producer, packager, importer, supplier, or distributor to comply with Article 6 by either affixing a label to the product with an appropriate warning (as described above) or by sending the authorized agent for a retail seller in California a written notice that: (1) states the product at issue may result in an exposure to one or more listed chemicals, (2) identifies the product with specificity (e.g., by Universal Product Code), and (3) includes all necessary warning materials (or warning language, with respect to internet sales). The manufacturer, producer, packager, importer, supplier, or distributor must obtain confirmation of receipt by the retailer electronically or in writing. The notice must be renewed within six months during the first year after August 30, 2018, and then annually thereafter. If a retailer fails to post a warning when the manufacturer, producer, packager, importer, supplier, or distributor has provided the appropriate written notice, liability falls on the retailer for failure to warn.

California refers five chemicals to Prop. 65 Carcinogen Identification Committee.

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This week, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that five chemicals, including methyl chloride and vinyl acetate will be considered by the Proposition 65 Carcinogen Identification Committee (CIC) at its November 15, 2016 meeting. The chemicals or chemical groups are:

  • Aspartame
  • Asphalt and Asphalt Emissions Associated with Road Paving and Asphalt and Asphalt Emissions Associated with Roofing
  • Methyl Chloride
  • Type I Pyrethroids
  • Vinyl Acetate

Methyl chloride and vinyl acetate are both common intermediates in polymer production, while the latter is a High Production Volume chemical. Type I Pyrethroids are a group of synthetic insecticides also found in home and garden pest control products. Aspartame is a widely used artificial sweetener.

The CIC will advise OEHHA on prioritizing the chemicals for possible preparation of hazard identification materials, an intermediate step toward listing a chemical as carcinogenic under Prop. 65. No listing decisions will be made for these chemicals at the November meeting. However, the CIC will consider listing “nitrite in combination with amines or amides” at this meeting.

The five chemicals were chosen based on epidemiologic and animal data screens, followed by a preliminary toxicological evaluation. OEHHA prepared and has made available summaries of the relevant studies identified during the preliminary toxicological evaluation for each of the five chemicals.

The announcement marks the beginning of a public comment period which runs to October 24, 2016.

California may add BPA to Prop. 65 list.

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On Friday, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that bisphenol A (BPA), a chemical found in common consumer products like food packaging and paper receipts, will be considered for possible listing under the state’s Proposition 65 program, which requires businesses to provide warnings for exposures to listed chemicals. The Developmental and Reproductive Toxicant Identification Committee (DARTIC), an advisory panel that helps OEHHA compile the list of chemicals known to cause reproductive toxicity, will meet on May 7, 2015 to “consider whether BPA has been clearly shown by scientifically valid testing according to generally accepted principles to cause female reproductive toxicity.”

In April 2013, BPA was added to the Prop. 65 list as a reproductive toxicant for development endpoints via the Prop. 65 “authoritative bodies” mechanism, based on the National Toxicology Project’s findings that BPA caused reproductive toxicity at high doses. However, California delisted BPA the next week, in response to a lawsuit brought by the American Chemistry Council, and simultaneously withdrew that attempt to list the chemical.

DARTIC will now be revisiting BPA per a 2009 request from the committee to reconsider the chemical “if additional epidemiological or other specific types of data on reproductive and developmental toxicity became available.” Substantial relevant data has become available since 2009, including a significant 2014 review of studies published from 2007-2013 concluding that BPA is a reproductive toxicant.

OEHHA has compiled hazard identification materials on BPA and female reproductive toxicity for the consideration of both DARTIC and the public. The agency is accepting comments on the hazard identification materials through April 6, 2015. These comments will be forwarded to DARTIC members before the May 7 meeting, and also posted online. Instructions for submitting comments are in the meeting notice.

The May 7 meeting will begin at 10:00am in the Coastal Hearing Room of the Cal/EPA Headquarters building, 1001 I Street, Sacramento, and will also be webcast. If DARTIC require more time for deliberations, the meeting will be continued on May 21 at the same location.

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.