EPA Sued Over Delayed Risk Evaluations

/in , , ,

Environmental groups have filed a lawsuit against EPA for failing to complete risk evaluations for 22 substances that may cause harm to humans and the environment.

Under section 6 of the Toxic Substances Control Act, EPA is required to conduct risk evaluations on “high priority” existing substances to determine whether they pose an unreasonable risk to human health or the environment.  Section 6(b)(4)(G) requires EPA to complete risk evaluations “as soon as practicable, but not later than 3 years after” they are initiated, with a one-time six-month extension possible.

According to the complaint, EPA missed this statutory 3.5-year deadline for 22 ongoing risk evaluations which were initiated in 2019 and early 2020.  Plaintiffs allege that this delay harms their members, staff, and children by prolonging their exposure to substances with serious health risks and by depriving them of information about their exposures.

The complaint seeks declaratory and injunctive relief, requesting that the U.S. District Court for the District of Columbia set deadlines for EPA to complete the risk evaluations.

The case is Community In-Power and Development Association v. EPA, No. 1:23‑cv‑02715-DLF.

Environmental Group Petitions for Review of EPA’s New Confidential Business Information Rule

/in , ,

On June 29, 2023, the Environmental Defense Fund (EDF), a non-profit organization, filed a petition in the US Court of Appeals for the District of Columbia requesting a review of EPA’s recently finalized rule Confidential Business Information Claims Under the Toxic Substances Control Act (TSCA) (88 FR 37155).  As described in a previous Verdant Law blog post, the final rule implements new requirements for the assertion and treatment of TSCA confidential business information (CBI) claims in light of the Lautenberg Amendments to TSCA.

In a non-binding statement of issues filed August 21, EDF listed the following as preliminary issues to be raised in the petition: whether the final rule is arbitrary, capricious, an abuse of discretion, or otherwise contrary to law because…

  1. It would allow submitters to assert CBI claims to shield the information from the public that TSCA makes categorically ineligible for CBI protection;
  2. It would not require substantiation or EPA review of a CBI claim that was asserted before a chemical’s commercialization for specific chemical identity once the chemical is commercialized;
  3. It unlawfully adopts a regulatory definition of “health and safety study” that is narrower than the TSCA definition, denying TSCA-mandated public access to important information on chemicals;
  4. The Agency purports to give itself unlawfully broad discretion through its regulations where TSCA imposes a duty upon the Agency; or because
  5. It reduces the transparency previously required under EPA’s CBI review procedures without adequate justification.

Briefs have not yet been filed, and EDF did not file a memorandum detailing its positions, so no additional information on EDF’s positions is currently available.

EPA Launches New Interface for the Chemicals and Products Database

/in ,

EPA has released a beta version of ChemExpo, a free, publicly available web application that allows users to explore and visualize data on how chemicals are used in commerce.

ChemExpo will serve as a user-friendly interface for EPA’s Chemicals and Products Database (CPDat).  According to EPA, CPDat maps “more than 49,000 chemicals to a set of terms categorizing their usage or function in 16,000 consumer product types (e.g., shampoo, soap) based on what chemicals they contain.”  EPA characterizes this data, which is curated from public documents, as addressing important gaps in the exposure information needed to evaluate chemicals’ safety under the Toxic Substances Control Act.

The ChemExpo team welcomes comments and feedback on the beta, particularly regarding functionality and usability.

Better Business Bureau Challenge Results in Clarifying Disclosure in Antimicrobial Toilet Seat Advertising

/in , ,

Business Bureau (BBB) National Programs develops self-regulatory industry programs and resolves disputes on issues including advertising and privacy.  According to BBB National Programs, National Advertising Division (NAD) case decisions “represent the single largest body of advertising law in the country.”

A recent NAD case concerned antimicrobial claims made by Ginsey Industries, Inc. (“Ginsey”) on its Clorox-branded toilet seats.  Bemis Manufacturing Company challenged elements of these claims (though not the product’s antimicrobial efficacy).  During the challenge, Ginsey voluntarily committed to add a disclosure acknowledging that the product does not protect uses against bacteria and remove an “antimicrobial checkmark image inside the Clorox chevron logo.”

NAD additionally recommended that Ginsey modify its website to display the disclosure statement more conspicuously and work with retailers to do the same with their websites.  In response, the company stated that while it disagrees that “further modifications to its online product listings are necessary to protect consumers,” it would comply with NAD’s decision.

EPA Faces Lawsuit for Classifying Water Filtration System as a Pesticide Product

/in , ,

The U.S. District Court for the Northern District of Texas will be tasked with determining whether EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) enforcement actions against Berkey, a water filters brand, were arbitrary and capricious in the case Shepherd v. Regan.  The case concerns seven Stop Sale, Use and Removal Orders (SSUROs) issued by EPA against third-party distributors and manufacturers of Berkey water filtration products due to their alleged use of silver as an unregistered antimicrobial pesticide.

The complaint does not deny the presence of silver in Berkey products.  However, the plaintiffs say that they are unaware of any instances where a Berkey-authorized entity claimed that the silver in their products was “used for any purpose other than to protect the filter itself.”  This is significant because articles treated with a FIFRA-registered pesticide for the purpose of protecting the article are exempt from FIFRA under the treated articles exemption at 40 CFR 152.25.

The plaintiffs argue that the orders were the result of an unlawful reinterpretation of a 2007 notice, which clarified EPA’s position that equipment that uses electrodes to emit ions for pesticidal purposes is a “pesticide,” rather than a “device,” under FIFRA.  The complaint alleges that EPA reinterpreted this notice without opportunity for public comment to “now apply to the presence of inert silver in water filters.”

In its response, EPA argues that the plaintiffs—which do not represent Berkey itself—lack standing.  The Agency also characterizes the 2007 notice referenced in the complaint as a “straw man” with no bearing on the case.  EPA does not believe there is any ambiguity regarding the distinction between “pesticides” and “devices,” arguing that EPA has excluded water filters containing pesticidal substances from its interpretation of “devices” since 1975.

EPA focuses on claims made by the SSURO recipients, which allegedly advertised that Berkey filters removed viruses and pathogenic bacteria.  The Agency has long held that such public health claims make a product ineligible for the treated article exemption, EPA says.  Combined with knowledge of the presence of silver in the products, and no pesticide registration, EPA argues that it had “reason to believe” (the requirement for issuance of an SSURO) that the substances were sold in violation of FIFRA.

Canada Bans Many Single-Use Plastics

/in ,

Canada has enacted the Single-use Plastics Prohibition Regulations, SOR/2022-138, prohibiting the manufacture, import, export, and sale of many single-use plastics (SUPs).  The ban will cover the following six types of SUPs by the end of 2025:

  • Checkout bags;
  • Cutlery;
  • Foodservice ware containing expanded polystyrene foam, extruded polystyrene foam (commonly known by the trademark Styrofoam), polyvinyl chloride (PVC), carbon black, or an oxo-degradable plastic;
  • Ring carriers (defined as plastic items “formed in the shape of a series of deformable rings or bands that are designed to surround beverage containers in order to carry them together”);
  • Stir sticks; and
  • Straws.

For ring carriers, the prohibition on manufacture and import takes effect on June 20, 2023, and sale will be prohibited on June 20, 2024.  Manufacture and import of the other five types of SUPs will be prohibited on December 20, 2023, and sale of these items will be prohibited on December 20, 2023.

All six types of SUPs are subject to a temporary exemption for manufacture, import, and sale for the purpose of export; this exemption will be repealed on December 20, 2025.  In the meantime, the regulations institute recordkeeping requirements for persons who manufacture or import SUPs for the purpose of export.

Flexible SUP straws are not subject to the manufacture and import prohibitions for SUP straws, but alternative provisions apply.  For example, retail stores will only be allowed to sell flexible SUP straws if a customer requests straws and the straws are “not displayed in a manner that permits the customer to view the package without the help of a store employee.”

The regulations are the latest in a series of steps taken by Canada to move away from the use of SUPs.  In 2020, Environment and Climate Change Canada (ECCC) released a report on the sources, environmental fate, occurrence, and health effects of plastic pollution, which concluded by stating that “action is needed to reduce macroplastics and microplastics that end up in the environment” in accordance with the precautionary principle.  In 2021, manufactured plastic items were added to the List of Toxic Substances in Schedule 1 to the Canadian Environmental Protection Act.

More information on the regulations can be found in an ECCC guidance document.

Canada Overhauls Assessment of Toxic Substances in CEPA Update

/in ,

On June 13, 2023, the Strengthening Environmental Protection for a Healthier Canada Act received royal assent.  The act, which revises Canada’s toxic substances law and enshrines a right to a healthy environment, is the first significant revision to the Canadian Environmental Protection Act (CEPA) since its passage in 1999.

The act implements some, but not all, of the 87 recommendations made by the House of Commons Committee on Environmental and Sustainable Development in 2017.  Key provisions of the act, including a new chemical management plan and implementation of the right to a healthy environment, are unspecified and will be determined by future regulations.

Revisions to Toxic Substances Law

One of the most important changes in the act is the requirement that the government develop a new chemical management plan within the next two years.  The plan must identify substances that should be prioritized for assessment, specify initiatives that should be prioritized by Parliament to control risks posed by substances, promote alternatives to vertebrate testing, and be reviewed at least once every eight years.  To avoid harmful substitutions—when a problem chemical is replaced by a chemical that itself becomes a problem—the ministers are instructed to consider whether it would be more advantageous to assess substances by class than individually.

In 1999, CEPA required the prioritization of substances in commerce for assessment.  According to a backgrounder by Environment and Climate Change Canada, the “resulting process to assess these substances has largely been completed.”  However, a new plan will address “new chemicals being developed, new uses for existing chemicals, increasingly complex supply chains, and emerging science about risks.”

The act also institutes a new classification system for assessed chemicals.  CEPA originally contained two lists of hazardous chemicals: a List of Toxic Substances in Schedule 1 and a Virtual Elimination List.  The act scraps the Virtual Elimination List, which was almost never used, and divides Schedule 1 into Parts 1 and 2.  Part 1 contains 19 chemicals prioritized for total, partial, or conditional prohibition, including PFOS and DDT.  Part 2 contains all other substances deemed toxic, which will be prioritized for pollution prevention.  The 132 substances initially placed in Part 2 include asbestos and manufactured plastic items.

As an alternative to Parts 1 and 2 in Schedule 1, the act creates a watch list for “substances that the ministers have reason to suspect are capable of becoming toxic or that have been determined to be capable of becoming toxic.”  The backgrounder states that the list “will help importers, manufacturers, and Canadian consumers to select safer alternatives and avoid [harmful] substitutions.”  Any person can file a request that the ministers assess a substance’s toxicity or capability to become toxic.

Other changes introduced in the act include requiring the ministers to consider “whether exposure to the substance in combination with exposure to other substances has the potential to cause cumulative effects” and “whether there is a vulnerable population or environment in relation to the substance” when interpreting the results of an assessment; requiring a rationale to support requests for the confidential treatment of business information; and requiring that an explanation be provided if an assessment has not been completed after two years.

Right to a Healthy Environment

Also included in the act, for the first time in Canadian legislative history, is a “right to a healthy environment.”  The government has two years to “develop an implementation framework to set out how the right to a healthy environment will be considered in the administration of this Act.”  The framework must “elaborate on” the act’s principles, such as environmental justice, non-regression, and intergenerational equity.  However, the right is not absolute.  The implementation framework must “determine[e] the reasonable limits to which it is subject.”

Canadian representatives have questioned whether the right to a healthy environment will be enforceable.  The act does not amend section 22 of CEPA, which allows individuals to bring an “environmental protection action” in limited circumstances against persons who commit an offence under CEPA.  The Senate Committee on Energy, the Environment, and Natural Resources stated that “the right to a healthy environment cannot be protected unless it is made truly enforceable,” noting concern that Section 22 “contains too many procedural barriers and technical requirements that must be met to be of practical use” when it comes to enforcement.

TSCA Enforcement Action Taken Over Failure to Comply with PFAS SNUR

/in , , ,

In December 2022, two separate lawsuits were filed against Inhance Technologies USA regarding its alleged production of certain PFAS substances in violation of the Toxic Substances Control Act (“TSCA”). These lawsuits are important as they raise novel questions of TSCA interpretation and enforcement.

The first lawsuit was filed by the U.S. Department of Justice, Environment and Natural Resources Division on behalf of the U.S. Environmental Protection Agency (“EPA”).  The second case is a citizen suit filed by the non-profit organizations Center for Environmental Health (“CEH”) and Public Employees for Environmental Responsibility (“PEER”). U.S. v. Inhance Technologies LLC, U.S. Eastern District of Pennsylvania, Case No. 2:22-cv-05055; Center for Environmental Health v. Inhance Technologies USA, U.S. District Court for the District of Columbia, Case No. 1:22-cv-03819. It is rare that EPA pursues TSCA enforcement actions in federal court. Similarly, the citizen suit provision of TSCA is exercised infrequently.

Defendant Inhance Technologies USA (“Inhance”) is a Texas-based corporation that treats plastic containers, including high-density polyethylene (HDPE), using a fluorination process. Inhance is the principal supplier of post-mold fluorination services in the United States.

According to the Complaints, Inhance has been in violation of the Long-Chain Perfluoroalkyl Carboxylate (“LCPFAC”)  Significant New Use Rule (“SNUR”) that requires manufacturers to file a Significant New Use Notice (“SNUN”) for any manufacturing (including importing) or processing of an LCPFAC for which there were no ongoing uses as of January 21, 2015. See 40 CFR 721.10536. This includes substances that are typically exempt byproducts under TSCA and LCPFACs that are imported as part of articles. Inhance allegedly violated two SNUR requirements.  The complaints assert that Inhance failed to submit a SNUN for LCPFAC substances formed during the fluorination of plastic containers at least 90 days prior to the manufacture of these substances. The second violation charged is the company’s manufacture of these substances before completion of the requisite 90-day SNUN review period.

Inhance received warning of its violation of the LCPFAC Rule by the Plaintiffs of each lawsuit months prior to litigation. The lawsuits follow a March 2022 letter EPA sent to the HDPE industry. EPA issued the letter, first “to remind industry of this issue to help prevent unintended PFAS formation and contamination,” and second, to “emphasize the requirement under TSCA as it related to PFAS and fluorinated polyolefins.” In its letter, EPA reminded the industry of the SNUR, highlighting that while LCPFAC chemical substances are byproducts of the fluorination process from the chemical and commercial standpoint, these substances are not eligible for the byproducts exemption in 40 CFR § 721.45(e). The Agency letter further encouraged the industry to pursue alternative fluorination processes which are less likely to foster unintentional PFAS creation. EPA’s lawsuit is its first enforcement matter against the HDPE industry following the Agency’s warnings.

In March 2022, EPA issued a Notice of Violation (NOV), requesting that Inhance provide the Agency with additional information on changes the company may have made to the HDPE fluorination process that would eliminate PFAS production. The NOV stated that if no changes to the manufacturing process had been made, Inhance would need to immediately cease manufacturing PFAS and submit a SNUN to the Agency for review. Agency review of the information submitted by the company confirmed that the company was producing substances that are subject to the LCPFAC Rule.

In September 2022, Inhance notified EPA that it intended to submit a SNUN for its fluorination processes, but that it was unwilling to cease its fluorination processes before or during the EPA SNUN review period. Inhance has consistently maintained that it believes its operations are in full regulatory compliance.

EPA’s lawsuit was filed on December 19, 2022, with the non-profit lawsuit following about a week behind. The Complaints allege a variety of TSCA violations, namely the following:

  • Section 5(a)(1) of TSCA, which states no person may manufacture or process a chemical substance for a significant new use unless (1) that person submits a Significant New Use Notice (“New Use Notice”) to the EPA; (2) the EPA reviews that notice; and (3) the EPA makes a determination on that use under Section 5(a)(3) of TSCA, 15 U.S.C. § 2604(a)(3). 15 U.S.C. § 2604(a)(1).
  • Title 40 C.F.R. § 721.25 prescribes similar requirements for any person seeking to engage in a significant new use of a chemical substance.
  • Section 15 of TSCA, which states that it is a prohibited act to fail or refuse to comply with any requirement of TSCA or any rule promulgated under TSCA. 15 U.S.C. § 2614.
  • Under 40 C.F.R. § 721.35, it is a violation of Section 15 of TSCA to fail to comply with any provision of Title 40, Part 721 of the regulations implementing TSCA.

Plaintiffs in both cases are seeking declaratory and injunctive relief under Section 15(a) of TSCA (15 U.S.C. § 2616(a)) and the Declaratory Judgment Act (28 U.S.C. § 2201) for Inhance to cease production of all products using the PFAS forming fluorination process. To resume production, Inhance must demonstrate to EPA that it has altered its production process to eliminate PFAS production.

Case Update

In April 2023, the U.S. District Court of the District of Columbia dismissed the lawsuit brought by CEH and PEER. Shortly after CEH and PEER filed their lawsuit, Inhance filed a motion to dismiss the case arguing that the lawsuit was inappropriate under TSCA’s diligent prosecution bar. DOJ filed an amicus brief supporting Inhance’s motion to dismiss. For the CEH and PEER lawsuit to proceed, the organizations would have needed to demonstrate that DOJ was not diligently prosecuting the case. The court granted Inhance’s motion stating that “[n]othing in the eight days between when DOJ filed its lawsuit and when the Plaintiffs filed theirs suggests that [DOJ] was not diligently prosecuting the case.”

On June 13, the court presiding over the DOJ lawsuit scheduled oral arguments for August 23, 2023.

EPA Report: Pesticide Products Test Negative for PFAS

/in , ,

EPA has released a summary of its findings from a test of 10 pesticide products that reportedly contained PFAS.  While a previous study in the Journal of Hazardous Materials detected PFAS in over half of these pesticide products, EPA’s laboratory concluded that PFAS substances were not present.

EPA’s study employed two different testing methods.  The first method was the same method used in the previous study, and the second was a newly developed testing method specifically designed to detect the presence of PFAS in pesticide products formulated with surfactants.  According to the Agency, one of the most important differences between the testing methods is that the new testing method eliminates interference from oils and surfactants which can sometimes result in false positive detections.

The previous study discovered PFOS in six of the 10 tested pesticides, which are all insecticides commonly used to treat cotton.  Non-targeted techniques suggested that additional PFAS species were present in seven of the 10.  However, despite testing the same samples tested in the previous study, EPA’s study did not find evidence of PFOS or 28 other types of PFAS above the testing instrument’s background levels.

EPA writes that concern over PFAS contamination in pesticides arose in 2020, when the Agency learned of potential contamination in “a small number of mosquitocide products.”  In 2021, EPA preliminarily determined that the PFAS in those products were most likely formed during their containers’ fluorination process.  In 2022, EPA notified the fluorinated container industry of this concern and later released a study evidencing that PFAS can leach into pesticide products through these plastics.  More information on that study can be found in a previous Verdant Law blog post.

EPA’s First PFAS Clean Water Act Enforcement

/in ,

On April 26, 2023, EPA announced that the Agency has taken the first federal Clean Water Act enforcement action for PFAS discharges.  The Agency ordered Chemours Company to follow corrective measures relating to exceedances of the limits set for per and polyfluoroalkyl substances (PFAS) in stormwater and wastewater discharges from the Washington Works facility in Parkersburg, WV.  The PFAS limits were set by in the company’s National Pollution Discharge Elimination System (NPDES) permits.

EPA issued an administrative order on consent (AOC) for the facility for exceeding permit limits on PFOA and HFPO Dimer Acid on more than 20 dates from September 2018 to March 2023.  The exceedances were documented in the discharge monitoring reports submitted by the company to the West Virginia Department of Environmental Protection – a permit requirement.  EPA also stated that Chemours was in violation of requirements for properly operating and maintaining all facilities and systems for permit compliance.  The AOC requires that Chemours take the following actions:

1) Implement a sampling plan to analyze PFAS and conduct analysis on the presence of PFAS in the stormwater and wastewater discharges.  The plan must be submitted to EPA for approval.

2) Submit and implement a PFAS treatment plan or minimizing plan to EPA for compliance with the permit limits.

3) Submit its existing Standard Operating Procedures for their management of wastewater for various systems and their revised Storm Water Pollution Prevention Plan.

In its press release, EPA noted that “Administrator Regan has directed EPA staff to use every enforcement tool at our disposal to compel manufacturers of PFAS to characterize, control, and clean up ongoing and past PFAS contamination,”

The AOC can be accessed here.