EPA Publishes ANPRM Seeking Information to Assist in Consideration of Future CERCLA Regulations Regarding PFAS

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On April 13, 2023, EPA published an advance notice of proposed rulemaking (ANPRM) seeking input and data regarding potential future hazardous substance designation under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of a number of PFAS substances. The ANPRM identifies PFOA, PFOS, seven other PFAS and their salts and structural isomers, precursors to PFOA and PFOS, and several categories of PFAS as candidates for this designation.

EPA is requesting public input to assist in the potential development of future regulations under CERCLA Section 102(a). Section 102(a) authorizes the EPA Administrator to promulgate regulations designating as hazardous substances that, when released into the environment, may present a substantial danger to the public health or welfare or the environment. The seven PFAS for which EPA is requesting input on are:

  • Perfluorobutanesulfonic acid (PFBS), Chemical Abstracts Service Registry Number (“CAS RN”) 375-73-5;
  • Perfluorohexanesulfonic acid (PFHxS), CAS RN 355-46-4;
  • Perfluorononanoic acid (PFNA), CAS RN 375-95-1;
  • Hexafluoropropylene oxide dimer acid (HFPO-DA), CAS RN 13252-13-6 (sometimes called GenX);
  • Perfluorobutanoic acid (PFBA), CAS RN 375-22-4;
  • Perfluorohexanoic acid (PFHxA), CAS RN 307-24-4; and
  • Perfluorodecanoic acid (PFDA), CAS RN 335-76-2.

Regarding these seven PFAS, EPA solicited the following information:

  • Published scientific literature regarding the environmental fate and transport.
  • Information that EPA could consider in preparing an economic analysis of the potential direct and indirect costs and benefits associated with a potential rulemaking designating any of the above-mentioned compounds as hazardous substances.

Regarding information around the PFAS precursors, EPA is requesting the following :

  • Published scientific literature or data regarding the environmental degradation of the precursors to PFOA, PFOS, PFBS, PFHxS, PFNA, HFPO-DA, PFBA, PFHxA, and/or PFDA.
  • Published scientific literature that characterizes the environmental prevalence of these substances.
  • Methods for measuring these substances in environmental samples.

EPA is also requesting information to help inform its decision-making on whether to designate further PFAS groups or categories as hazardous substances under CERCLA. It is requesting information on published scientific literature that can inform whether categories of PFAS could be designated as hazardous substances:

In addition, EPA asked for input on whether there are other PFAS that the Agency could consider designating as hazardous substances in a possible future rulemaking. The ANPRM requests references to published scientific information these on the hazards for substances that commentors identify in response to this request.

Environmental Groups Request EPA Require TRI Reporting for Waste Incinerators

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Public Employees for Environmental Responsibility (“PEER”) and the Energy Justice Network recently filed a petition with EPA requesting that the Agency require companies to disclose the chemicals discharged from waste incinerators and facilities that recycle plastics (“advanced recycling facilities”). Currently, none of the approximately 400 incinerators and advanced recycling facilities throughout the nation are required to report their facility’s toxic chemical emissions under EPA’s Toxics Release Inventory Program (“TRI”). TRI data provides local communities with information about toxic chemical releases and management activities in their area.

Petitioners argue that waste incinerators are among the largest local air polluters and that the public is entitled to information about these emissions; therefore, they should be TRI data. One particular concern expressed in the petition is that ash generated from the incineration of solid and industrial waste can contain toxic chemicals and heavy metals, including lead and mercury. Additionally, according to petitioners, incineration does not destroy per- and poly-fluoroalkyl substances (“PFAS”). Therefore, petitioners assert that when incinerator ash is placed on top of landfills, as it often is, the contaminants can then travel into communities contaminating local air, water, and soil.

Petitioners have also included advanced recycling facilities in their request for required TRI reporting. Advanced recycling facilities, also called chemical recycling facilities, are categorized by EPA as incinerators. These facilities heat waste, generally plastics, to create a fuel product. While EPA has released a proposed rulemaking to approve the products as renewable fuels, the Agency is also facing litigation for approving a renewable fuel associated with a high cancer risk. Petitioners have the same concerns about emissions from the advanced recycling facilities reaching local communities.

This April’s petition is not the environmental organizations’ first attempt to discuss the matter with EPA; petitioners sent a letter to EPA last October highlighting their health concerns related to incineration.

EPA Receipt of Pesticide Petitions Files for Residues

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Late last year, EPA published receipt of initial pesticide petitions filed regarding residues of pesticide chemicals in or on various commodities by representatives of RRStewart Consulting, LLC, Delta Analytical Corporation on behalf of Borchers Americas, Inc., Crop Enhancement, Columbia River Carbonates, BASF Corporation, American Spice Trade Association, and Interregional Research Project Number 4.  EPA intends to review the data from the petitions filed under the Federal Food, Drug, and Cosmetic Act (FFDCA) to determine whether such actions are warranted.  As specified by FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is required to publish notices regarding petitions received so that the public has an opportunity to comment on requests for the establishment or modification of regulations for residues of pesticides in or on food commodities.  The comment period for these particular petitions has closed.

The petitions include five different requests for tolerance exemptions for various chemicals. All of the exemptions requests were made under 40 CFR §180, which details the requirements for food tolerances and exemptions for pesticide chemicals in food.

RRStewart Consulting, LLC, on behalf of Aicello America Corporation, requested a tolerance exemption for residues of diglycerol.  This request is for use of the chemical as a plasticizer inert ingredient in pesticide formulations used on crops.

Delta Analytical Corporation on behalf of Borchers Americas, Inc., requested that EPA establish an exemption for .alpha.-D-Glucopyranoside, .beta.-D-fructofuranosyl, polymer with 2-methyloxirane and oxirane.  The exemption would be for use of the chemical as a pesticide inert ingredient in various pesticide formulations. The petition also requested that EPA treat the chemical as an inert ingredient in a pesticide chemical formulation for which tolerance requirements are exempted under FFDCA section 408 if the chemical use follows good agricultural or manufacturing practices.

Crop Enhancement requested a tolerance exemption for residues of the insecticide/miticide linseed oil for when use in or on all raw agricultural commodities.

Columbia River Carbonates requested a tolerance exemption for residues of the biochemical active ingredient calcium carbonate for use in or on all agricultural food commodities.

BASF Corporation, Agricultural Products requested a tolerance exemption for residues of the herbicide imazapic for use in or on rice grains at 0.05 parts per million (ppm) and in or on rice bran at 0.2 ppm.  The company also requested a tolerance exemption for the herbicide imazapyr for use in or on rice grains at 0.06 ppm and in or on rice bran at 0.2 ppm.

American Spice Trade Association requested a tolerance exemption for residues of the pesticide cypermethrin in or on raw agricultural spice commodities.  American Spice Trade Association specifically named dozens of different types of spices in its request, including anise pepper, ashwagandha fruit, batavia-cassia fruit, belleric myrobalan, and caper buds.

Interregional Research Project Number 4 requested a tolerance exemption for residues of the fungicide cyprodinil 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine in or on cranberries at 0.4 ppm.

 

Keurig Reaches $10M Settlement in False Advertising “Recyclable” Class Action

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Keurig has reached a $10 million settlement in a class action lawsuit. The case filed in 2018, Smith v. Keurig Green Mountain, Inc., alleged the company falsely advertised its K-Cups as recyclable. The lawsuit claimed violations of the California Consumer Legal Remedies Act, the fraudulent, unlawful, and unfair prongs of the California Unfair Competition Law, breach of express warranty, and unjust enrichment.

The Complaint states that Keurig marketed the K-Cups in an untruthful or deceptive manner, misleading the “reasonable consumer” to believe the product was recyclable. Members of the Class claim that they relied upon Keurig’s false representations and followed Keurig’s recycling instructions, and, had they known the K-Cups were not recyclable, they would not have purchased them or paid the amount they did. Keurig presented the K-Cups as recyclable, yet there were unmentioned caveats that prevented the product from being recycled even when customers placed the products into the recycling stream, including:

  • Many communities do not accept the plastic used in K-Cups (polypropylene), into recycling.
  • Keurig’s instructions prevent recyclability by advising users that they do not need to remove the K-Cup’s paper filter, although not doing so makes the product ineligible for recycling.
  • The K-Cup design hinders recyclability because the foil lids are difficult to remove, but without doing so, the product is ineligible for recycling.

Consumers who purchased Keurig’s K-Cups between June 8, 2016, and August 8, 2022, are eligible for an award of up to $36. If any money remains in the settlement fund after these payments, 75 percent of the remaining funds will be given to Ocean Conservancy, an environmental non-profit organization that formulates ocean policy and the national and state levels; the remaining 25 percent will go to Consumer Reports, a non-profit organization that conducts independent product testing and consumer advocacy.

EPA Takes Action Against Denka for Air Pollution

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On March 20, 2023, the Department of Justice (“DOJ”), on behalf of EPA, filed a motion for a preliminary injunction under the Clean Air Act (“CAA”), asking the federal district court for the eastern district of Louisiana to order Denka Performance Elastomer LLC (“Denka”) to immediately reduce chloroprene emissions from its neoprene manufacturing facility in LaPlace, Louisiana. The motion follows DOJ’s February complaint arguing that plant operations present an imminent and substantial endangerment to public health and welfare due to cancer risks posed by Denka’s chloroprene emissions.

The Denka facility is currently the only facility in the country producing neoprene, a flexible, synthetic rubber used to manufacture a variety of products, including wetsuits, automotive belts and hoses, and orthopedic braces. Chloroprene is a liquid raw material used to produce neoprene.  It is emitted into the air from various production processes at the facility.

In 2010, EPA Integrated Risk Information System (IRIS) found that chloroprene is “likely to be carcinogenic to humans.” In a separate civil proceeding, Denka has challenged the process by which the Environmental Protection Agency considered the scientific information supporting its understanding of the human health risks posed by chloroprene.

According to the complaint, air monitoring conducted by both the EPA and Denka over the past several years consistently shows chloroprene concentrations in the air near Denka’s LaPlace facility that are as high as 14 times the recommended levels.  In the complaint, DOJ expressed particular concern for students attending the 5th Ward Elementary School, located approximately 450 feet from Denka’s facility.

Associate Attorney General Vanita Gupta commented on the complaint stating, “We allege that Denka’s emissions have led to unsafe concentrations of carcinogenic chloroprene near homes and schools in St. John the Baptist Parish, Louisiana. The Justice Department’s environmental justice efforts require ensuring that every community, no matter its demographics, can breathe clean air and drink clean water. Our suit aims to stop Denka’s dangerous pollution.”

Biden Administration Announces Goals to Advance Biotechnology and Biomanufacturing

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Last month, the Biden Administration announced “new bold goals and priorities” to promote American biotechnology and biomanufacturing.  The announcement comes after a September 2022 executive order intended to bolster biotechnological innovation.

“Biomanufacturing – or the use of biological systems to produce goods and services at commercial scale – has the potential to drive new sustainable alternatives across industries, including plastics, fuels, and medicines,” the Administration stated.  “These innovations can unlock new solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”

The announcement included the release of several documents related to biotechnology and biomanufacturing, including a report jointly authored by multiple agencies that outlines ten goals and associated R&D needs for biotechnological innovation.  The goals fall under four themes: development of more carbon-neutral transportation and stationary fuels, reduction of greenhouse gas emissions in chemicals and materials production, development of climate-focused agricultural systems and plants, and carbon dioxide removal.  The White House Office of Science and Technology is in the process of developing an implementation plan to address the R&D needs identified by the report.

The announcement also released a Department of Defense (DOD) memorandum establishing the Department’s biomanufacturing strategy, which will guide nearly $1.5 billion in DOD biomanufacturing-related investments. The strategy focuses on three key priorities: establishing the customers within the DOD that stand to benefit from early-stage innovations, advancing biomanufacturing capabilities through innovation, and mapping the biomanufacturing ecosystem and tracking metrics that support future efforts.  The Department is also issuing a formal request for information on biomanufactured products and process capabilities that could address defense needs.

EPA Releasing Additional Data on the Ongoing Uses of Chrysotile Asbestos

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On March 17, 2023, EPA released additional data for public comment related to the proposed risk management rule for chrysotile asbestos. The proposed rule, introduced in April 2022, aims to prohibit the ongoing use of the only known form of asbestos currently imported into the United States, chrysotile asbestos. The Agency claims that if implemented, the rule will protect people from the unreasonable risk to human health presented by chrysotile asbestos. EPA evaluated human health risks for chrysotile asbestos in Part 1 of the Risk Evaluation for Asbestos; and is currently working on Part 2 of the Risk Evaluation for Asbestos. That document will evaluate legacy uses and associated disposals, including other types of asbestos fibers in addition to chrysotile.

EPA originally proposed that the prohibition on the commercial use of chrysotile asbestos would occur two years after the effective date of the final rule to give facilities time to transition away from asbestos technology. However, after the comment period, EPA received comments and met with stakeholders, including affected industry and other interested groups, about the use of chrysotile asbestos diaphragms in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. Raw chrysotile asbestos currently imported into the U.S. is used exclusively by the chlor-alkali industry. It is a main component of systems used for the disinfection of drinking water, but most chlor-alkali plants no longer use asbestos diaphragms, and alternatives are available.

Many commenters argued that the two-year timeline would not provide the chlor-alkali industry with a reasonable transition period and requested additional time to allow the industry to transition away from asbestos-containing diaphragms.  According to EPA, a letter from the Asbestos Disease Awareness Organization (ADAO) provides contrasting information that shows that the chlor-alkali industry has shut down a substantial portion of its asbestos diaphragm production capacity in the last three years and is in the process of transitioning to non-asbestos membrane technology.

EPA is seeking comments on how to consider the additional information received regarding maintaining the prohibition compliance dates, staggering the prohibition compliance dates, or establishing longer deadlines for the prohibition on processing, distribution in commerce, and commercial use of chrysotile asbestos. EPA also seeks comments on the new information provided regarding the practicability of measuring 0.005 fibers per cubic centimeter (f/cc) and 0.0025 f/cc for an eight-hour work shift by existing sampling and analytical protocols. Further, the Agency requests suggestions as to how EPA could effectively implement interim exposure reduction requirements in a way that they are compatible with Occupational Safety and Health Administration (OSHA) requirements and industrial hygiene practices.

EPA states that the Agency plans to use the data it collects during this comment period in the development of the final rule, including the proposed chrysotile asbestos prohibition compliance dates for these uses.

EPA Proposes PFAS Drinking Water Standard

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On March 14, EPA released a proposed rule establishing national drinking water standards for PFAS. The proposed rule is part of the Agency’s PFAS Strategic Roadmap. It seeks to regulate PFOA and PFOS as individual contaminants and four additional PFAS (PFNA, PFHxS, PFBS, and GenX chemicals) as mixtures. EPA intends to regulate PFOA and PFOS at the lowest level of which they can be reliably measured, which the Agency has determined to be 4 parts per trillion.

For the additional four PFAS, EPA proposed maximum concentration limits (MCLs) for any mixture containing one or more of these substances. This would require water systems to use an approach called Hazard Index Calculation to determine if the combined levels of these PFAS pose a potential risk. Hazard Indexing is a tool used to evaluate the health risks of simultaneous exposure to mixtures of related chemicals. To determine the Hazard Index for these four PFAS, water systems would  be required to monitor drinking water and compare the amount of each PFAS in the water to its associated Health-Based Water Concentration (HBWC). HBWCs are the levels at which no health effects are expected.

In remarks accompanying the Agency’s press release on the proposed rule, Administrator Michael S. Regan commented, “EPA’s proposal to establish a national standard for PFAS in drinking water is informed by the best available science and would help provide states with the guidance they need to make decisions that best protect their communities. This action has the potential to prevent tens of thousands of PFAS-related illnesses and marks a major step toward safeguarding all our communities from these dangerous contaminants.”

The proposed rule is causing great concern in the wastewater utility and chemicals industries.  They are apprehensive about the logistical and financial hurdles that  implementing the rule would entail. Both the American Chemistry Council and the National Association of Water Companies, a trade group representing investor-owned utilities, have voiced concerns, claiming that compliance with the rule will cost billions of dollars. The Agency is actively working with financial institutions to help utilities in vulnerable communities with limited resources comply with the rule and claims $9 billion is already earmarked for this purpose from bills approved by Congress since 2021.

Additional information can be found in EPA’s Proposal to Limit PFAS in Drinking Water Fact Sheet.

Study Finds Roundup Cancer Risk Isn’t from Active Ingredient Glyphosate

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A newly released study has found that glyphosate, the active ingredient in Roundup, may not be directly responsible for the increased risk of cancer that has been associated with the weedkiller. The study was conducted by a team of federal and private sector researchers who tested glyphosate and herbicide mixtures using glyphosate on human B-lymphoblastoid TK6 cells. The researchers concluded that neither glyphosate nor its metabolite forms damaged DNA, causing cancer. Instead, they found that some other ingredient in weedkillers containing glyphosate may be responsible for the DNA damage attributed to glyphosate. This finding contradicts the 2015 World Health Organization (“WHO”) conclusion that glyphosate was “probably carcinogenic to humans” and genotoxic (meaning it damages DNA). WHO’s conclusion has led to numerous lawsuits against Bayer AG and Monsanto Co., as well as lawsuits against the Environmental Protection Agency for concluding that the herbicide would not cause cancer.

Although the study indicates that DNA damage was caused by other components of the formulations, not glyphosate, it did not rule out the possibility that exposure to glyphosate might cause cancer through other mechanisms, according to the National Toxicology Program. Bayer AG has long maintained that glyphosate does not cause cancer and is not genotoxic, and the company released a statement in response to the study, stating that “the extensive body of research on glyphosate-based herbicides and findings of leading health regulators worldwide support the conclusion that glyphosate does not cause cancer and is not genotoxic.”

Coca-Cola Wins Greenwashing Case

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The DC Superior Court has granted Coca-Cola Company’s motion to dismiss a 2021 lawsuit filed against it for false and deceptive marketing practices. Plaintiffs argued that the company had falsely represented itself as a sustainable and environmentally friendly company. The 2021 Complaint alleged that Coca-Cola’s representations violate the District of Columbia Consumer Protection Procedures Act (“DC CPPA”) because its marketing and advertising “tend to mislead and are deceptive about the true nature and quality of its products and business.”

The Complaint stated that the marketing is false and deceptive because the company “portrays itself as ‘sustainable’ and committed to reducing plastic pollution while polluting more than any other beverage company and actively working to prevent effective recycling measures in the U.S.” The Complaint cites numerous examples, including:

  • A statement on the Coca-Cola website stating, “Our planet matters. We act in ways to create a more sustainable and better shared future. To make a difference in people’s lives, communities and our planet by doing business the right way.”
  • A statement on the company website stating, “Make 100% of our packaging recyclable globally by 2025. [And] [u]se at least 50% recycled material in our packaging by 2030.”
  • A statement on the company’s Twitter account stating, “Scaling sustainability solutions and partnering with others is a focus of ours.” “Make 100% of our packaging recyclable globally by 2025. [And] [u]se at least 50% recycled material in our packaging by 2030.”

Coca-Cola filed a motion to dismiss in response. The DC Superior Court found that Coca-Cola’s statements were aspirational in nature and, therefore, not a violation of the DC CPPA. The Court stated that Earth Island Institute had not alleged that any statement made by Coca-Cola was provably false or plausibly misleading or that the company misled consumers as to its products’ characteristics. The Court acknowledged that Coca-Cola may have failed to meet advertised environmental goals in the past, but that does not impede its ability to set future environmental goals publicly.  In addition, the Court held that Coca-Cola’s statements were not tied to a “product or service” as required by DC CPPA. None of the statements were included on the bottle of any product or in the marketing of any product. Furthermore, the Court determined that Coca-Cola’s statements are not sufficient to create a misleading “general impression” or a “mosaic of representations” to a reasonable DC consumer as a matter of law under the DC CPPA.

The Court further stated that the Complaint could not prevail because it was based on how Coca-Cola has branded itself, and the DC CPPA does not have any controlling authority on how a brand cultivates its image. Coca-Cola made no specific environmental commitments, which further made it difficult for the Court to take any action. The Court stated that in other similar cases, companies made claims such as “100% recycled and recyclable bottles,” which is concrete and indicative of a promise to customers, as opposed to vague aspirational statements from Coca-Cola, such as the recyclable packaging by 2025.