January 20, 2023

Environmental, Natural Resources, & Energy Law Blog

EPA’s Designation of PFOA and PFOS as Hazardous Substances: Far Reaching Implications but not Enough to Combat “Forever Chemicals.” - Ryan Lewis

EPA’s Designation of PFOA and PFOS as Hazardous Substances: Far Reaching Implications but not Enough to Combat “Forever Chemicals.”

Ryan Lewis

 

TABLE OF CONTENTS

 

 

 

 

INTRODUCTION ………………………………………………………………………………1

 

 

BRIEF HISTORY OF PFAS……………………………………………………………………2

 

 

THE PROPOSED RULE………………………………………………………………………4

 

 

THE POSITIVE IMPACT OF HAZARDOUS

SUBSTANCE DESIGNATION…………………………………………………………………6

 

 

WHY THE RULE IS INSUFFICIENT TO COMBAT

THESE FOREVER CHEMICALS…………………………………………………….………7

 

 

 

CONCLUSION………………………………………………………………………………….10

 

 

 

 

EPA’s Designation of PFOA and PFOS as Hazardous Substances: Far Reaching Implications but not Enough to Combat “Forever Chemicals.”

 

Ryan E. Lewis

 

 

             I.          INTRODUCTION:

 

The Environmental Protection Agency’s (EPA) proposed regulation (Rule)[1] classifying perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) as hazardous chemicals is a step in the right direction and will have significant implications for a wide range of industries. However, theseforever chemicalsare now found in people, wildlife, rain and even the arctic air and snow.[2] EPA waited too long to regulate Perfluoroalkyl and polyfluoroalkyl substances (PFAS) and the Rule cannot combat the environmental impact of these chemicals. The Rule is also too narrow in scope. In order to reduce human and environmental exposure to PFAS, EPA should regulate not just PFOS and PFOA but treat and regulate all PFAS as a single  class[JW1] [RL2] .

 

          II.          BRIEF HISTORY OF PFAS:

 

PFAS are a group of over 9,000 synthetic chemicals.[3] They were invented in the 1930s and processed commercially in the 1940s.[4] These chemicals have multiple uses which have contributed to their popularity over the years. PFAS have been used to make nonstick cookware, water-repellent clothing and gear, stain resistant fabrics and carpets, food packaging, microwave-popcorn bags, stain-resistant carpets, pipes and wires that resist corrosion, some cosmetics, some firefighting foams, and generally, products that resist grease, water, and oil.[5]

 

PFAS are often called “forever chemicals” because they are extremely persistent.[6] PFAS contain carbon-fluorine bonds which are some of the strongest chemical bonds in organic chemistry.[7] The strong carbon-fluorine bond means PFAS resist degradation in the human body and the environment.[8] PFAS build up in our bodies and do not break down in the environment resulting in long-term PFAS exposure to humans and the environment.[9] Nearly all Americans, including newborn babies, have PFAS in their blood.[10]

 

The most studied PFAS, and the specific chemicals EPA intends to regulate as hazardous chemicals, are perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). Most uses of PFOA and PFOS were phased out in the United States in the mid-2000s.[11] However, some are still produced domestically for certain purposes and these chemicals remain in the environment due to their long-term resistance to degradation.[12] Also problematic is the fact that some newer PFAS break down into PFOA and PFOS.[13] Thus, even though these chemicals are not widely manufactured, they are still produced in the environment when newer, replacement PFAS degrade into PFOA and PFOS.

 

Peer-reviewed scientific studies have shown that exposure to PFAS may cause cancer, reproductive and immune system harm, and other diseases. Specifically, EPA has found compelling evidence that PFOA and PFOS exposure can cause an increased risk of cancer, decreased fertility, developmental delays in children, and risk of obesity, as well as other affects from exposure.[14]

 

        III.          THE PROPOSED RULE:

 

In October 2021, EPA announced a “Strategic Roadmap to confront PFAS contamination nationwide.”[15] The Roadmap provided for: increasing investments in research; restricting PFAS chemicals from being released into the environment; and accelerating the cleanup of PFAS contamination.[16] On September 6, 2022, EPA published its Rule to designate PFOA and PFOS, including their salts and structural isomers,[17] as hazardous substances under CERCLA in the Federal Register.[18]The comment period closed on November 7, 2022.[19]

 

In its Rule[JW3] , EPA maintains the “adverse human health effects, mobility, persistence, prevalence and other factors related to PFAS” support EPA’s finding that PFOA and PFOS “when released into the environment may present substantial danger to the public health or welfare” such that it warrants a “designation as a CERCLA hazardous substance.”[20] The Rule has three provisions to regulate PFOA and PFOS.[21] First, the Rule will trigger a reporting obligation. Under CERCLA Section 102(b), the reportable quantity for any hazardous substance is one pound.[22] The Rule does not include a reportable quantity (RQ) adjustment for PFOA and PFOS and EPA is using the statutory default of one pound.[23] Under the reporting obligation, any person in charge of a vessel or facility must immediately notify the National Response Center if there is a release of one pound of PFOA or PFOS within a 24-hour period.[24] There are also additional reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA). Property owners ofPFOA or PFOS Superfund sites will be required to clean up those sites.[25] The second prong of the Rule requires that upon any transfer or sale of property by a Federal agency, the agency must provide notice of hazardous substances, including PFOA and PFOS, that were stored on the property, information regarding any releases of the hazardous substances and provide covenants of remediation.[26] The final requirement of the Rule requires that PFOA and PFOS must be listed and regulated as hazardous materials by the Department of Transportation (DOT) under the Hazardous Materials Transportation Act (HMTA).[27]

 

There are numerous entities which may be affected by this Rule. The Rule highlights five broad categories of industries that may be affected and a list of North American Industrial Classification System (NAICS) codes.[28] The categories listed include: PFOA and/or POAS manufacturers; PFOA and/or PFOS processors; manufacturers of products containing PFOA and/or PFOS; downstream product manufacturers and users of PFOA and/or PFOS products; and waste management and wastewater treatment facilities.[29] The type and number of industries affected by the Rule are wide-ranging and significant.

 

        IV.          THE POSITIVE IMPACT OF HAZARDOUS SUBSTANCE DESIGNATION:

 

The Rule will have immediate positive impacts. Designating PFOA and PFOS as hazardous substances under CERCLA gives EPA authority to order the cleanup of contaminated sites, many of which are in under-served areas already burdened with pollution. If the government initiates the clean-up of PFOA and PFOS, it may recover costs. Moreover, designating PFOA and PFOS as hazardous substances under CERCLA will improve transparency and accountability.[30] The reporting requirement of the Rule will also provide EPA with data that could trigger cleanups and protect public health.[31] The ability to recover cleanup costs will likely encourage better waste management and will require that costs be covered by the responsible party rather than the community.[32]

 

Another positive outcome of the Rule is that all states will now have PFOA and PFOS regulation. Currently, some states have enacted phase-outs of PFAS in food packaging, and restrictions on PFAS in carpeting, children’s toys, cosmetics, and fire-fighting foam.[33] However, other states have not enacted any protections against PFAS.[34] The new Rule will reduce exposure to PFAS for all citizens and address contamination sites in all states.

 

           V.          WHY THE RULE IS INSUFFICIENT TO COMBAT THESE FOREVER CHEMICALS:

 

The implications of EPA’s designation of PFOS and PFOA as Hazardous Substances will be far reaching. H, however the Rule’s ability to combat the environmental impact of these types of forever chemicals” is not commensuratewith their severity because the Rule is limited to PFOS and PFOA. For example, although the reporting requirement is important, it is limited to the release of one pound of PFOA or PFOS within a 24-hour period. Since many companies have stopped manufacturing PFOA or PFOS, this Rule is not enough. A reporting requirement for the accidental release of one pound of all PFAS is necessary.

 

Similarly, cleanup of contamination on a site-specific basis for PFOA and PFOS is an improvement, but it will not assist in reducing the exposure that stems from the ground contaminants of other PFAS chemicals. The Rule will not remedy the human and environmental exposure to PFAS unless EPA extends the Rule to cover all PFAS. In the Rule, EPA hints that it will likely expand the Regulation and designate other PFAS as hazardous chemicals.[35] EPA should go a step farther and declare the entire class of PFAS as hazardous substances.

 

The Regulation acknowledges that recent human epidemiological studies indicate that negative health effects occur at much lower exposure levels than previously understood.[36] Waiting for studies to confirm what has been suspected for decades will only perpetuate the effects of these chemicals on humans and the environment. In order to combat theseforever chemicals,EPA must lead by reducing the initial exposure to all PFAS, not attempt to solve the problem after significant exposure. To properly combat PFAS, EPA must take a proactive, rather than reactive, approach in its Rule.

 

To understand why PFAS must be regulated as a class, it is important to understand the underlying chemistry of PFAS. In 2006, EPA launched a program called the “2010/2015 Stewardship Program” and eight major chemical companies agreed to phase out PFOA and PFOS.[37] This program worked to reduce the “long chain” chemicals. PFOA and PFOS are known as “long chain chemicals” because they contain eight carbon atoms.[38] Since these chemicals have been phased out, scores of “short chain” replacements, PFAS with six carbon atoms, have replaced PFOA and PFOS.[39] The short chain replacements are not part of the phase-out program. Chemical companies claim this structure makes them safer but there is evidence that these “short chain” PFAS cause cancerous tumors in lab animals.[40] One study found that short-chain PFAS may pose an even greater risk to humans and the environment than long-chains.[41] These studies suggest that the entire class of PFAS are hazardous and should all be regulated as hazardous substances.

 

PFOA and PFOS have been produced and released into the environment since the 1940s. These chemicals do not degrade, so it will be difficult, if not impossible, to reduce exposure toforever chemicalsif the Rule does not include the “replacement” PFAS. While the Rule will remove one source of exposure, it ignores thousands of other PFAS that scientists believe have the same, if not greater, impact on humans and the environment. “When chemicals have similar molecular structures, environmental properties, and/or biological hazards, managing them as a class can be an effective means of reducing adverse effects on human and ecological health.”[42] Since it is not possible to thoroughly assess every single PFAS, EPA must regulate these chemicals as a class so that they do not continue to accumulate and cause harm.[43]

 

The language of the Rule itself supports a finding that PFAS should be regulated as a class. The Rule maintains that the “adverse human health effects, mobility, persistence, prevalence and other factors related to PFAS” supports EPA’s finding that PFOA and PFOS “when released into the environment may present substantial danger to the public health or welfare” such that it warrants a “designation as a CERCLA hazardous substance.”[44] Moreover, regulating the chemicals as a class will provide more certainty and direction for relevant industries. Otherwise, these industries are likely to face expanding regulations in the future.

 

        VI.          CONCLUSION:

 

EPA’s proposed Regulation to classify PFOA and PFOS as hazardous chemicals is the most significant and far-reaching aspect of the EPA’s attempt to address PFAS contamination. However, the biological accumulation and environmental persistence of PFAS along with new evidence that these chemicals are more harmful than originally believed, warrant an unprecedented response. EPA should regulate all PFAS as a single class.[45] While rRegulating PFAS as an entire class may be inconvenient and expensive, it is the only way to ensure a reduction in PFAS exposure[JW4] .

 

 



[1]The author anticipates the proposed regulation will face significant litigation regarding its legality. Due to substantial costs involved in complying with the regulation and questions regarding whether the EPA has “clear congressional authorization” to regulate PFOA and PFOS in this manner, it is possible that this regulation will invoke the “Major Questions Doctrine” recently set forth in West Virginia v. EPA. 597 U.S. ___ (2022). Since this paper addresses the effectiveness of the regulation, not its legality, the author does not discuss the Major Questions Doctrine due to the narrow and limited scope of this paper; See generally, Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54415, 5417 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302).

[2]Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54415, 5417 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302).

[3] Annie Sneed, “Forever Chemicals Are Widespread in U.S. Drinking Water,” Scientific American, January 22, 2021, available at https://www.scientificamerican.com/article/forever-chemicals-are-widespread-in-u-s-drinking-water/

[4]What Are PFAS?Rachel Ross published April 30, 2019, available at https://www.livescience.com/65364-pfas.html (PFAS were invented in the 1930s); See also, Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54418 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302) (“PFAS have been used in industry and consumer products since the 1940s”).

[5]Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54415, 54442 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302) (discussing multiple manufactured goods that use PFAS).

[6]The Clean Water FundPFAS: The Forever Chemicals, available at

https://www.cleanwateraction.org/sites/default/files/MA_FactSheet_PFAS_04.14.20a.pdf

[7]See, Per- and Polyfluoroalkyl Substances Technical and Regulatory Guidance, The Interstate Technology & Regulatory Council PFAS Team June 2022

[8]Id.

[9]Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54417 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302) (stating that PFOA and PFOS are widely detected in surface water samples collected from lakes and rivers, in soil samples, in groundwater including private drinking wells and public drinking water systems, and in wild and domestic animals such as fish, shellfish, alligators, deer, and avian eggs).

[10]The Clean Water Fund “PFAS: The Forever Chemicals,” available at

https://www.cleanwateraction.org/sites/default/files/MA_FactSheet_PFAS_04.14.20a.pdf

[11]U.S. Environmental Protection Agency,Questions and Answers: Drinking Water Health Advisories for PFOA, PFOS, GenX Chemicals and PFBS,Lastupdatedon JULY 18, 2022 available at https://www.epa.gov/sdwa/questions-and-answers-drinking-water-health-advisories-pfoa-pfos-genx-chemicals-and-pfbs; See also, Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54415, 54417 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302).

[12]Id.

[13]U.S. Environmental Protection Agency, “Questions and Answers: Drinking Water Health Advisories for PFOA, PFOS, GenX Chemicals and PFBS,” Last updated on JULY 18, 2022 available at https://www.epa.gov/sdwa/questions-and-answers-drinking-water-health-advisories-pfoa-pfos-genx-chemicals-and-pfb; Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54415, 54417 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302).

[14]U.S. Environmental Protection Agency, “Our Current Understanding of the Human Health and Environmental Risks of PFAS.” Last updated March 2022, available at https://www.epa.gov/pfas/our-current-understanding-human-health-and-environmental-risks-pfas (The EPA has found compelling evidence that PFOA and PFOS exposure can cause: reproductive effects such as decreased fertility or increased high blood pressure in pregnant women; developmental effects or delays in children, including low birth weight, accelerated puberty, bone variations, or behavioral changes; increased risk of some cancers, including prostate, kidney, and testicular cancers; reduced ability of the body’s immune system to fight infections, including reduced vaccine response; interference with the body’s natural hormones; increased cholesterol levels and/or risk of obesity ).

[15]U.S. Environmental Protection Agency, “EPA Administrator Regan Announces Comprehensive National Strategy to Confront PFAS Pollution.” October 18, 2021, available at https://www.epa.gov/newsreleases/epa-administrator-regan-announces-comprehensive-national-strategy-confront-pfas

[16]Id.

[17]Per- and Polyfluoroalkyl Substances Technical and Regulatory Guidance, The Interstate Technology & Regulatory Council PFAS Team June 2022 (explaining that an isomer is a molecule with the same molecular formula as another molecule, but with a different chemical structure).

[18]Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54415, 54429 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302).

[19]Id. at 4415(detailing that the EPA received 62,559 comments on the Rule).

[20]Id. at 54417.

[21]Id. at 54429.

[22]Id.

[23]The Rule indicates that the agency may adjust the RQ in the future. See, Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54415, 54429 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302).

[24]Id. at 54429 (“Section 103 of CERCLA requires any person in charge of a vessel or facility to immediately notify the NRC when there is a release of a hazardous substance, as defined under CERCLA section 101(14), in an amount equal to or greater than the RQ for that substance. The reporting requirements are further codified in 40 CFR 302.6. If this action is finalized, any person in charge of a vessel or facility as soon as he or she has knowledge of a release from such vessel or facility of one pound or more of PFOA or PFOS in a 24-hour period is required to immediately notify the NRC in accordance with 40 CFR part 302. EPA solicits comments on the number of small entities affected by and the estimated cost impacts on small entities from these reporting requirements. In addition to these CERCLA reporting requirements, EPCRA section 304 also requires owners or operators of facilities to immediately notify their SERC (or TERC) and LEPC (or TEPC) when there is a release of a CERCLA hazardous substance in an amount equal to or greater than the RQ for that substance within a 24-hour period. EPCRA section 304 requires these facilities to submit a follow-up written report to the SERC (or TERC) and LEPC (or TEPC) within 30 days of the release.”).

[25]Id. at 54429.

[26]Id.

[27]Id.

[28]Id. at 54416-55417 (listing the potentially affected US industries as: aviation operations; carpet manufacturers; car washes; chemical manufacturing; chrome electroplating, anodizing, and etching services; coatings, paints and varnish manufacturers; firefighting foam manufacturers; landfills; medical devices; municipal fire departments and firefighting training centers; including federal agencies that use, trained with, and tested firefighting foams, paper mills, pesticides and insecticides; petroleum and coal product manufacturing, petroleum refineries and terminals, photographic film manufacturers, polish, wax, and cleaning product manufacturers; polymer manufacturers, printing facilities where inks are used in photolithography, textile mills (textiles and upholstery), waste management and remediation services; wastewater treatment plants).

[29]Id. at 554416.

[30]U.S. Environmental Protection Agency, “EPA Proposes Designating Certain PFAS Chemicals as Hazardous Substances Under Superfund to Protect People’s Health,” last updated August 31, 2022, available at https://www.epa.gov/newsreleases/epa-proposes-designating-certain-pfas-chemicals-hazardous-substances-under-superfund

[31]Id.

[32]Id.

[33]Safer States, “PFAS,” last visited December 11, 2022, available at https://www.saferstates.com/toxic-chemicals/pfas/ (stating that Eleven states including CA, CO, CT, HI, ME, MD, MN, NY, RI, VT, and WA have enacted phase-outs of PFAS in food packaging. Five states including CA, CO, MD, ME, and VT have adopted restrictions on PFAS in carpets, rugs, and aftermarket treatments and regulatory action is pending on these products and other home textiles in WA. CO adopted restrictions on indoor and outdoor furniture as well as oil and gas products. CA is phasing out PFAS in children’s products, and VT has banned PFAS in ski wax. Three states including CA, CO, and MD are taking action to eliminate PFAS in cosmetics. Eleven states including CA, CO, CT, HI, IL, ME, MD, NH, NY, VT, and WA have put in place bans on the sale of firefighting foam containing PFAS)

[34]Id.

[35]40 CFR Part 302; September 6. 2022, 87 FR 54415, pages 54415-54442 comment period ended 11/7/2022 at p. 54418 (stating that in addition to this action, in 2022, EPA will be developing an advance notice of proposed rulemaking seeking comments and data to assist in the development of potential future regulations pertaining to other PFAS designation as hazardous substances under CERCLA).

[36]Id. at 54417.

[37]Id. at 54430.

[38]Environ. Working Group, “What Are PFAS Chemicals” last visited December 11, 2022, available at https://www.ewg.org/what-are-pfas-chemicals.

[39]Id.

[40]Environ. Working Group, “What Are PFAS Chemicals” last visited December 11, 2022, available at https://www.ewg.org/what-are-pfas-chemicals.

[41]Id.

[42]Environ. Sci. Technol. Lett. “Scientific Basis for Managing PFAS as a Chemical Class” 2020, 7, 532−543 (providing examples of cases in which substances with common chemical characteristics are currently managed as a class include organophosphate pesticides, organochlorine pesticides, and organohalogen flame retardants).

[43]Id.

[44]Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances, 87 Fed. Reg. 54415, 54417 (proposed Sept. 6, 2022) (to be codified at 40 C.F.R. pt. 302) (emphasis added).

[45]Environ. Sci. Technol. Lett. “Scientific Basis for Managing PFAS as a Chemical Class” 2020, 7, 532−543.


  

 [JW1]Very good intro para and thesis statement.And good sidenote in FN 1, good to just flag that but not go into detail.

  

 [RL2]Thank you for all of your helpful comments.

  

 [JW3]Rule is more appropriate as the “proposal” phase of a regulation. But proposed regulation also fine if you prefer to keep that. Just pick one or the other. I didn’t change them all in case you prefer to stick with the latter.

  

 [JW4]I wonder if you can also assert (short since this is already long) that regulating now, as a class, is also a better way to go for the industries.They don’t love regulation, of course, as a general rule, but they do desire certainty and long view planning.Better all around to do it in one class now, instead of nibbling at the margins slowly. It gives a heads up to the industry sooner.Maybe there is a phase in process.