On March 19, 2021, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (“OEHHA”) announced that it intends to list perfluorooctanoic acid (“PFOA”) as a chemical known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (“Proposition 65”). For several years now PFOA has been included on the Prop. 65 list as a chemical known to cause reproductive toxicity, but this proposed change would list PFOA as a chemical “known to cause cancer.”
The change in language means that any company with more than 10 employees doing business in California must provide a “clear and reasonable” warning label, unless it meets the exemption of having “no significant risk level.” Before now, as a chemical deemed to cause reproductive toxicity by OEHHA, businesses had to prove any PFOA in the product fell within the “Maximum Allowable Dose Level” to avoid adding a warning label. If, however, a warning label is required because the exposure does not qualify for an exemption, the statute provides safe harbor clear and reasonable warnings that satisfy the warning requirement. Note, Prop 65 applies to companies outside of California that manufacture products with PFOA chemicals for sale inside the state of California, too.
It is vital that these businesses remain up to date on all changes made to the Prop. 65 list annually so they can determine if they need to add a warning label or change the language of their current warning labels. This change could become effective as soon as this year, and, if it does, companies have one year to comply.
Adding PFOA to the Prop. 65 List as a Known Carcinogen Under the Authoritative Bodies Mechanism:
California Health and Safety Code § 25249.8(a) requires each year that the Governor of California revise and publish a list of chemicals known to the state to cause cancer or reproductive toxicity. Since 2017, PFOA has been included on the Prop. 65 list as a chemical known to cause reproductive toxicity; however, OEHHA now seeks to also add PFOA to the Prop. 65 list as a known carcinogen under the “Authoritative Bodies” listing mechanism.
The “Authoritative Bodies” listing mechanism is detailed in Title 27, Cal. Code of Regs., § 25306. Pursuant to this code section, OEHHA will list a chemical under the Prop. 65 regulations as one “known to cause cancer” when two conditions are met:
- An authoritative body formally identifies the chemical as causing cancer (§ 25306(d)).
- The evidence considered by the authoritative body meets the sufficiency criteria contained in the regulations (§ 25306(e)).
As to the first condition, OEHHA is relying on the National Toxicology Program (“NTP”) as its authoritative body. NTP has been formally identified and listed as an authoritative body for the identification of chemicals as causing cancer under Title 27, Cal. Code of Regs., § 25306(m).
As to the second condition, OEHHA points to a 2020 report published by NTP, entitled NTP Technical Report on the Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid (CASRN 335-67-1) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley® SD®) Rats, that purportedly concluded that PFOA causes cancer. In its study, NTP found that PFOA causes increased incidences of combined malignant and benign tumors at two sites (liver and pancreas) and increased the incidences of rare malignant tumors (hepatocellular carcinoma and pancreatic acinar cell adenocarcinoma) in male rats.
OEHHA is currently requesting comments as to whether PFOA meets the criteria set forth in the Prop. 65 regulations for authoritative bodies listings. Interested parties have until May 3, 2021, to submit their comment.
Complying with Warning Requirements if PFOA is Listed as a Known Carcinogen:
Pursuant to Health & Saf. Code § 25249.6, no person in the course of doing business may knowingly and intentionally expose an individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. “Person in the course of doing business” is defined as those businesses that employ greater than ten people. Unless otherwise exempt, in order to provide consumers with the clear and reasonable warnings required by this code, a business, at a minimum, should utilize the safe harbor clear and reasonable warnings provided in Title 27, Cal. Code of Regs., § 25601, et seq. For example, under its current Prop. 65 listing, a business with potential PFOA exposures should likely utilize the following language for its warning to consumers:
- A symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline. The symbol shall be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING”.
- The word “WARNING:” in all capital letters and bold print, and
- “This product can expose you to perfluorooctanoic acid (PFOA), which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
However, the language of the warning statement above will change when/if PFOA is also added to the Prop. 65 list as a known carcinogen. Although requirements 1 and 2 will remain the same, a business would then be required to have the following language for its warning statement:
“This product can expose you to perfluorooctanoic acid (PFOA), which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
Lathrop GPM’s experienced attorneys are well versed in a wide range of PFAS and Prop 65 related issues. You can read more about the firm’s PFAS capabilities here or contact a Lathrop GPM attorney for more information.
 Available from URL: https://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr598_508.pdf
 Title 27, Cal. Code of Regs., § 25603(a)(2)(B); § 25603(a)(2)(E).
 Title 27, Cal. Code of Regs., § 25603(a)(2)(D); § 25603(a)(2)(E).
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Lathrop GPM has deep experience developing regulatory strategy and defending litigation in the area of per- and polyfluoroalkyl substances (PFAS), and we have been involved in some of the nation’s most-publicized cases. The PFAS Playbook blog is dedicated to helping readers stay up to date and understand the latest regulatory updates on PFAS.