California Glyphosate Warning Requirement Ruled Unconstitutional Compelled Speech

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California’s requirement that glyphosate-containing products display a carcinogen warning violates the First Amendment, a Ninth Circuit Court of Appeals panel ruled in a 2-1 decision on November 7, 2023. The decision in the case Nat’l Assoc. of Wheat Growers v. Bonta affirmed a district court’s summary judgment and injunction against the requirement.

Proposition 65 (known as “Prop 65”) requires that any product intentionally containing a chemical on California’s list of known carcinogens warn customers of the product’s carcinogenicity. Glyphosate, one of the most widely used herbicides and the active ingredient in the weed killer Roundup, was automatically added to the list of Prop 65 carcinogens following a 2015 determination by the International Agency for Research on Cancer that glyphosate is “probably carcinogenic to humans.” Other organizations, such as EPA, have not found that glyphosate poses a risk to humans, however.

According to the court, compelled commercial speech must pass intermediate scrutiny unless it is “purely factual and uncontroversial information,” in which case a lesser level of scrutiny applies. The panel found that this exemption was not applicable because whether glyphosate is carcinogenic is subject to scientific debate. The panel then determined that the labeling requirement did not survive intermediate scrutiny because “warn[ing] consumers of a potential ‘risk’ never confirmed by any regulatory body” does not directly advance California’s interest in preserving public health.

The warning was previously struck down by a California district court on the grounds that its phrasing would be misleading to customers, it was not purely factual and uncontroversial, and a more equivocal warning would likely not comply with Prop 65. In this case, the panel analyzed three new proposed warning messages from California’s Attorney General and another from California’s Office of Environmental Health Hazard Assessment (OEHHA) but concluded that these warnings were also not purely factual and uncontroversial.

Judge Consuelo M. Callahan wrote for the panel and was joined by Judge Patrick J. Bumatay. Writing in the dissent, Judge Mary M. Schroeder argued that, at minimum, the new OEHHA warning should be remanded to the district court. Schroeder argued that the majority applied inappropriate precedent in determining what makes a statement uncontroversial, failed to examine the actual content of the warning, and ignored the fact that EPA’s most recent determination that glyphosate is unlikely to cause cancer was vacated by the Ninth Circuit in Nat. Res. Def. Council v. U.S. Env’t Prot. Agency (2022) because it was not supported by substantial evidence.

OEHHA Proposes Amendments to Prop 65 Warning Requirements

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This October, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to the “safe harbor” warning requirements under Proposition 65, the California Law that requires businesses with at least ten employees to provide a “clear and reasonable” warning to customers about exposures to chemicals known to the state of California to cause cancer or reproductive toxicity (officially called the Safe Drinking Water and Toxic Enforcement Act of 1986). The proposed amendments to the safe harbor warning requirements for Proposition 65 (known as “Prop 65”) focus on short-form warnings, provisions for internet and catalog purchases, and warnings for motor vehicles and recreational marine vessel parts.

Requirement of chemical identification in short-form warnings

Under regulations adopted in 2016, safe harbor warnings generally require the name of at least one chemical for each health effect covered by the label. However, because small products may not have space for a full-length warning, OEHHA included an optional short-form label that does not require businesses to identify the chemical(s) prompting the warning. However, since the adoption of the regulations, OEHHA has found that many businesses have chosen to use the short-form label regardless of product size. OEHHA also found that some businesses use short-form labels in situations where there is no risk of exposure to a Prop 65 chemical as a litigation avoidance strategy, diluting the impact of legitimate warnings. As a result, OEHHA proposes that short-form labels identify a chemical for each health effect covered by the label beginning two years after the rule’s effective date.

Provisions for internet and catalog purchases

OEHHA is aware of confusion among businesses about how to provide warnings for products purchased online. For example, some businesses have expressed confusion as to whether an online warning is necessary if the product has a warning on its label and vice versa. To clarify, OEHHA proposes that warnings be required both online and on the product label, or in the case of a catalog, both in the catalog and on the product. OEHHA additionally clarifies the requirements for online warnings; a business must include either a warning on the product display page, a hyperlink on the product display page using the word “WARNING” that links to the warning, or an otherwise prominently displayed warning made to the purchaser prior to completing the purchase.

Warnings for motor vehicles and recreational marine vessel parts

OEHHA states that passenger and off-highway motor vehicles and recreational marine vessel parts present a unique challenge because parts are often too small to comfortably fit full-length warnings and because consumer exposure varies substantially from person to person. To address these concerns, OEHHA proposes that businesses selling these parts can choose to provide a general exposure warning (either at each retail point of sale or point of display) in lieu of a warning on the product label.

Other proposed revisions include explicitly allowing the use of short-form warnings on food products, allowing warnings to begin with “CA” or “CALIFORNIA WARNING” instead of just “WARNING,” allowing more flexibility for warning font sizes and adding additional language to clarify that warnings be placed conspicuously.

The proposed amendments are similar to amendments proposed by OEHHA in January 2021. OEHHA was unable to complete that rulemaking within the regulatory time limit. The current proposal is the first on safe harbor warning requirements since that time.

Comments on the proposed amendments are due December 20, 2023. In addition, OEHHA will hold a hybrid public hearing on the proposed amendments on December 13, 2023, at 10:00 AM PST.

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.