EPA Proposes Methylene Chloride Ban

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On April 20, 2023, EPA released a proposed rule under Section 6(a) of the Toxic Substances Control Act (“TSCA”) that would drastically limit the use of methylene chloride. Section 6(a) of the statute provides EPA authority to ban or restrict the manufacture, processing, distribution, and use of chemical substances that pose an unreasonable risk of injury to human health or the environment. EPA explains that its decision is driven by concerns about the risks posed to workers, occupational non-users, consumers, and individuals in close proximity to consumer usage. The Agency stated that it is particularly concerned about adverse health effects such as neurotoxicity, liver damage, and cancer resulting from inhalation and dermal exposure to methylene chloride.

EPA’s proposed rule seeks to “rapidly phase down” the manufacturing, processing, and distribution of methylene chloride for consumer use, as well as most industrial and commercial uses. The phase down is expected to be completed within 15 months of the effective date of the final rule. EPA’s analysis indicates that alternative products with similar cost and effectiveness to methylene chloride are generally available for most of the that the Agency intends to prohibit.

According to EPA, methylene chloride poses an unreasonable health risk, without considering costs or other non-risk factors, including an unreasonable risk to potentially exposed or vulnerable subpopulations identified as relevant in the 2020 methylene chloride risk evaluation, under specific conditions of use (“COU”). (EPA defines COU as the circumstances in which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.) To address the unreasonable risk, EPA proposes the following restrictions:

  • Prohibit the manufacture, processing, and distribution of methylene chloride for all consumer use.
  • Prohibit most industrial and commercial uses of methylene chloride.
  • Enforce a workplace chemical protection program (“WCPP”) that includes inhalation exposure concentration limits, workplace exposure monitoring, and exposure controls for ten specific conditions of use of methylene chloride.
  • Require recordkeeping and downstream notification requirements for the manufacturing, processing, and distribution of methylene chloride in commerce.

The rule does provide an exemption to the prohibition on industrial uses for ten years for civilian aviation uses to prevent significant disruptions to critical infrastructure. This exemption will be subject to conditions such as compliance with the WCPP.  An exemption is also provided for emergency use of methylene chloride in support of the National Aeronautics and Space Administration’s mission. The exemption is limited to specific critical or essential conditions when no technically and economically feasible safer alternatives are available. This exemption will also require compliance with the WCPP. It too is time-limited to ten years.

EPA clarified that all COUs of methylene chloride under TSCA (except its use in consumer paint and coating removers, which was previously addressed under TSCA Section 6) will be covered by this proposal.

Regarding the WCPP for methylene chloride, EPA’s press release states that the agency collaborated with the Occupational Safety and Health Administration (OSHA) during the development of the proposed rule, taking into account existing OSHA requirements to ensure comprehensive worker protections. The Agency asserts that the proposed risk-based limits are based on up-to-date data and fulfill the TSCA mandate to eliminate unreasonable risks. If the rule is finalized, employers would have one year to comply with the WCPP and would be obligated to periodically monitor the workplace to ensure that workers are not exposed to methylene chloride at levels that pose an unreasonable risk.

In the Federal Register notice, EPA particularly requested comments on the feasibility and effectiveness of the proposed worker protection requirements from parties that would be responsible for implementing the program. (The comment period closed on July 3.) Additionally, EPA hosted a public webinar on June 7 to present overview of the proposed regulatory action and provide an opportunity for participation in discussion on the proposed WCCP. Materials from the webinar are available on EPA’s website.

New Tech Being Developed to Remove PFAS from Drinking Water

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Canadian researchers have developed a potentially revolutionary method of filtering and eliminating poly-fluoroalkyl and perfluoroalkyl substances (PFAS) from water. Limiting and removing PFAS has been a national focus and is particularly important because the substances are highly durable. They persist in the environment and the body for years and have been linked to infertility, thyroid problems, and several types of cancer.

Existing methods of removing PFAS from water have limitations, with activated carbon, for example, filtering long-chain PFAS but not effectively trapping the shorter-chain variants of the chemicals. Existing methods also typically create waste products that contain high concentrations of PFAS, which often end up in landfills or are incinerated, potentially causing further harm to the environment.

The new technology developed by the University of British Columbia involves tiny, porous plastic beads that can remove long- and short-chain chemicals at rates that match or exceed industry standards. These PFAS could be stripped away, making the beads potentially reusable or recyclable. The team has also engineered techniques to break the leftover PFAS down into harmless compounds. While the technology is promising, it has yet to be proven in real-world settings at scale, and the team is currently conducting pilot trials in British Columbia.

Experts agree that removing PFAS from water and breaking them down is only part of the solution to the PFAS problem. National and state regulations on PFAS are also necessary to reduce PFAS’s impact. However, the potential impact of this new technology is significant, and it could be part of a collective toolbox for addressing PFAS contamination of our water supplies.

European Commission Sets Implementation Dates for New Hazard Classes

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The European Commission has released implementation dates for new hazard classes introduced by an amendment to the Classification, Labelling, and Packaging of Substances and Mixtures Regulation.  The new hazard classes are as follows:

  • Endocrine disruption for human health (ED HH) in category 1 and category 2
  • Endocrine disruption for the environment (ED ENV) in category 1 and category 2
  • Persistent, bioaccumulative, toxic (PBT) / very persistent, very bioaccumulative (vPvB)
  • Persistent, mobile, toxic (PMT) / very persistent, very mobile (vPvM)

The delegated regulation is in force as of April 20, 2023.  New substances must come into compliance by May 1, 2025, while existing substances will have until November 1, 2026, to comply.  There is a separate transition timeline for mixtures: new mixtures must be compliant on May 1, 2026, and existing mixtures have until May 1, 2028, to update classifications and labeling.

The regulation covers all chemicals substances and mixtures in the EU market under REACH, as well as active substances in biocidal products and plant protection products.  The regulation applies to manufacturers, importers, downstream users, and distributors in the EU market.

EPA Hosts CERCLA PFAS Enforcement Listening Sessions

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In March, EPA hosted two public listening sessions requesting individual feedback regarding concerns about PFAS liability under CERCLA. The listening sessions follow the Agency’s August 2022 proposed rule, which would designate two of the most widely used PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”). EPA  has stated that the information gathered during these sessions and any written comments submitted on the topic will be reviewed and considered in drafting its enforcement and discretion policy.

The webinars each began with presentations summarizing CERCLA, detailing the potential harms of PFAS substances, and describing EPA’s plan to issue an enforcement discretion and settlement policy. In addition to comments voiced during the webinars, EPA is reviewing written comments received on the proposed rule. The Agency stated it intends to focus enforcement efforts on manufacturers, federal facilities, and other industrial parties whose actions result in the release of significant amounts of PFAS. EPA clarified that parties that resolve their liability with EPA through settlement would not be liable for third-party claims. Therefore, settlements may provide CERCLA contribution protection to some parties. The Agency’s enforcement discretion policy will be contingent on a party’s cooperation, and it retains the ability to address any situations which present imminent and substantial endangerment.

The Agency also commented on parties against which it does not intend to pursue CERCLA enforcement for PFAS contamination, including:

  • Water utilities and publicly owned treatment works;
  • Publicly owned and/or operated municipal solid waste landfills;
  • Farms that apply biosolids; and
  • Certain airports and fire departments.

EPA further commented that enforcement discretion under this policy would be limited to CERCLA and not impact EPA enforcement actions under any other applicable statute.

EPA has posted the recordings of the sessions, which can be viewed here.

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.