OECD Tour de Table Includes Information on U.S. Developments on the Safety of Manufactured Nanomaterials

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 23rd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2023. The Tour de Table lists U.S. developments on the human health and environmental safety of nanomaterials. Risk assessment decisions, including the type of nanomaterials assessed, testing recommended, and outcomes of the assessment include:

  • The U.S. Environmental Protection Agency (EPA) completed review of four low volume exemptions (LVE) that included a graphene material, a titanium dioxide material, and two graphene oxide materials, one of which was a modification to an existing exemption. EPA denied two of the LVEs and granted two under conditions that limited human and environmental exposures to prevent unreasonable risks.
  • According to the Tour de Table, EPA has under review 17 premanufacture notices (PMN), 16 of which are for multi-walled carbon nanotube chemical substances and one of which is for a graphene material. The Tour de Table states that EPA is still reviewing these 17 chemical substances for potential risks to human health and the environment. EPA completed its review of one significant new use notice (SNUN) for a single-walled carbon nanotube, regulating it with a consent order due to limited available data on nanomaterials. The consent order limits uses and human and environmental exposures to prevent unreasonable risks.

The Tour de Table includes the following information regarding risk management approaches in the United States:

  • Between June 2022 and June 2023, EPA received notification of two nanoscale substances based on metal oxides that met reporting criteria pursuant to its authority under the Toxic Substances Control Act (TSCA) Section 8(a), bringing the total number of notifications to 87. Reporting criteria exempted nanoscale chemical substances already reported as new chemicals under TSCA and those nanoscale chemical substances that did not have unique or novel properties. According to the Tour de Table, most reporting was for metals or metal oxides.
  • Since January 2005, EPA has received and reviewed more than 275 new chemical notices for nanoscale materials under TSCA, including fullerenes and carbon nano-onions, quantum dots, semiconducting nanoparticles, and carbon nanotubes. EPA has issued consent orders and significant new use rules (SNUR) permitting manufacture under limited conditions. A manufacturer or processor wishing to engage in a designated significant new use identified in a SNUR must submit a SNUN to EPA at least 90 days before engaging in the new use. The Tour de Table notes that because of confidential business information (CBI) claims by submitters, EPA may not be allowed to reveal to the public the chemical substance as a nanoscale material in every new chemical SNUR it issues for nanoscale materials. EPA will continue to issue SNURs and consent orders for new chemical nanoscale materials in the coming year.
  • Because of limited data to assess nanomaterials, the consent orders and SNURS contain requirements to limit exposure to workers through the use of personal protective equipment (PPE), limit environmental exposure by not allowing releases to surface waters or direct releases to air, and limit the specific applications/uses to those described in the new chemical notification.

Regarding updates, including proposals, or modifications to previous regulatory decisions, the Tour de Table states that “[t]he approaches used, given the level of available information, are consistent with previous regulatory decisions. EPA’s assessments now assume that the environmental hazard of a nanomaterial is unknown unless acceptable hazard data is submitted with nanomaterial submission.”

The Tour de Table lists the following new regulatory challenge(s) with respect to any action for nanomaterials:

  • Standards/methods for differentiating between different forms of the same chemical substance that is a nanomaterial;
  • Standardized testing for the physical properties that could be used to characterize/identify nanomaterials; and
  • Differentiation between genuinely new nanoscale materials introduced in commerce and existing products that have been in commerce for decades or centuries.

Oil Pollution Act: Tips for Spill Response, Compliance, and Enforcement

Oil spills commonly occur when least expected and, even in smaller quantities can significantly disrupt business operations and create risks for enforcement and/or litigation. It’s important that companies are prepared and know the environmental requirements for when the least expected happens, including understanding what actually is “oil” (hint: it’s broader than you might think!), who to notify, legal authorities at play, and best practices to ensure compliance and minimize exposure to regulators and/or private parties.

What is “Oil” Anyway?

Section 311 of the Clean Water Act (CWA) and the Oil Pollution Act (OPA) make up the federal statutory framework for oil spills. However, many companies may not realize that both petroleum-based and non-petroleum-based substances are regulated as “oil” under the CWA and OPA. As a result, many companies may not realize that they are subject to these laws and, therefore, fail to adequately prepare for compliance and/or response both pre- and post-spill.

Specifically, Section 311(a)(1) of the CWA defines oil as “oil of any kind or in any form, including, but not limited to, petroleum, fuel oil, sludge, oil refuse, and oil mixed with wastes other than dredged spoil.” 40 CFR § 112.2 further defines oil as “oil of any kind or in any form, including, but not limited to: fats, oils, or greases of animal, fish, or marine mammal origin; vegetable oils, including oils from seeds, nuts, fruits, or kernels; and, other oils and greases, including petroleum, fuel oil, sludge, synthetic oils, mineral oils, oil refuse, or oil mixed with wastes other than dredged spoil.” This definition is notably broader than what many may consider “oil” (i.e., crude oil and refined petroleum products) and encompasses animal fats, vegetable oils, and non-petroleum oils.

When to Notify?

The CWA and OPA require companies to notify the National Response Center (NRC) of oil spills as soon as they are discovered (i.e., within 15 minutes). This applies to all discharges that reach navigable waters of the U.S. (WOTUS) or adjoining shorelines and (1) cause a sheen; (2) violate applicable water quality standards; or (3) cause a sludge or emulsion beneath the surface of the water or upon adjoining shorelines. In practice, this typically results from a sheen, which 40 C.F.R. § 110.1 defines as an “iridescent appearance on the surface of water.” The Oil Pollution Prevention regulations (discussed further below) also identify discharges from regulated facilities that require reporting, though there are exceptions—for example, when the discharge is in compliance with a permit under Section 402 of the CWA.

Under state and local laws, notification may be much more stringent. For example, California requires immediate reporting of “any significant release or threatened release” of a hazardous material, which includes oil. This can be subjective and requires a fact- and legal-specific evaluation of whether the release qualifies as “threatened” and/or “significant.” In Georgia, immediate notification is required either when the oil creates a “significant sheen on top of state waters” or when the amount discharged is unknown—further creating different criteria for when reporting is required. Regardless of what triggers notification, it is important that companies understand that different agencies—federal, state, and local—may each have different reporting requirements, and accurate and timely reporting is absolutely crucial. Often, failure to timely report is the first violation sought by agencies and can result in increased penalties and additional scrutiny.

What Authorities Are at Play?

At the federal level, two agencies primarily exercise authority over oil spills—the U.S. Environmental Protection Agency (EPA) and U.S. Coast Guard (CG). Depending on the location of the spill, the EPA or CG may lead federal oversight with the EPA overseeing inland spills and CG overseeing offshore spills. The Pipeline and Hazardous Materials Safety Administration and Federal Railroad Administration may also exercise authority for pipeline or railroad releases, respectively.

As mentioned above, Section 311 of the CWA and OPA—enacted in 1990 in response to the Exxon Valdez oil spill—make up the federal statutory framework for oil spills. In practice, these authorities are best categorized into two areas: (1) oil spill response; and (2) oil spill prevention and preparedness. It is important for companies to understand the expectations for both (discussed in more detail below), and the National Oil and Hazardous Substances Pollution Contingency Plan (often referred to as the National Contingency Plan or NCP), which outlines the federal government’s cleanup strategy for responding to oil spills, including other cleanups under CERCLA. The goal of the NCP is to ensure that resources are available and responses are consistent. Thus, when the federal government oversees a cleanup, the federal On-Scene Coordinator will expect that all response efforts, including those conducted by the responsible party, are consistent with the NCP.

At the state level, most utilize their respective water laws to address oil spills, though some states, like Louisiana, have laws comparable to OPA. At the local level, municipalities have notification and emergency response authorities that will be applicable. In the end, it’s very important that companies understand that several layers of government may have some form of oversight depending on the size, impact, and location of an oil spill.

OPA v. CWA

While the CWA and OPA are complimentary, including OPA amending the CWA, companies should understand the goals and implications of both. Generally, the CWA focuses on oil spill enforcement for cleanups and penalties, and the OPA broadens national and regional capability for preventing, responding to, and paying for oil spills.

For the CWA, Section 311(b)(3) expressly prohibits the discharge of oil (or hazardous substances) into or upon WOTUS and adjoining shorelines in quantities that may be harmful.1 For oil, this generally means discharges to WOTUS that cause sheening or violate applicable water quality standards. Sections 311(c) and (e) of the CWA provide extensive authority to the federal government to respond to these discharges, including threatened discharges, by issuing orders—either unilaterally or by consent—to owners, operators, or persons in charge of the facility from which the discharge occurs.

Sections 311(b)(6) and (7) of the CWA further empower the federal government to pursue significant penalties—both administrative and civil—for spills that reach WOTUS and/or when responsible parties fail to comply with an order. If gross negligence or willful misconduct is involved, you can expect even greater penalties—commonly more than three-fold—not to mention possible criminal liability. Internally, the EPA utilizes the Civil Penalty Policy for Sections 311(b)(3) and (j) of the CWA and factors outlined in Section 311(b)(8) of the CWA, including the seriousness of the violation, economic benefit to the responsible party, history of prior violations, and efforts to minimize or mitigate the discharge, to evaluate enforcement and penalty calculations.

Akin to the CWA, Section 2702(a) of OPA also makes responsible parties liable for removal costs and natural resource damages resulting from any discharge of oil, including a substantial threat of discharge, to WOTUS and adjoining shorelines. Notably, this includes not only costs incurred by the federal government, but also costs or damages to private parties, including damages for the loss of personal property, loss of revenues/profits due to injury, and cost of additional services during or after a spill. OPA further aims to strengthen national and regional response strategies, amend the National Oil and Hazardous Substances Pollution Contingency Plan, require facilities to develop prevention and response plans, and establish a fund for damages and cleanup costs—each discussed below.

While it is typically always the priority of the federal government to have responsible parties pay for and conduct their own spill cleanups, when a responsible party is unknown, unable, or refuses to pay, funds from the Oil Spill Liability Trust Fund (OSLTF) can be utilized to pay for the response. The OSLTF is managed by the CG’s National Pollution Funds Center (NPFC) and the NPFC thereby manages any oversight or cleanup costs incurred by the federal government. Thus, if an oil spill occurs at your facility and the federal government incurs costs responding or overseeing, the NPFC will be the entity that seeks recovery of those costs—even if the EPA later pursues penalties for the same discharge pursuant to Sections 311(b)(6) and (7) of the CWA. In addition, when a non-liable party performs a cleanup or incurs damages as a result of an oil spill, that party may file a claim for reimbursement directly against the responsible party and/or seek reimbursement from the NPFC.

Lastly, regarding liability, both the CWA and OPA are strict liability and provide limited liability defenses for acts of God, acts of war, or acts/omissions of third parties—comparable to CERCLA. Even so, it’s important to note that Section 309(g)(6) of the CWA states that the federal government may not seek enforcement, including penalties, if the state “has commenced and is diligently prosecuting an action” under a comparable state law. This includes issuing a final order or directing a responsible party to pay a penalty. As mentioned above, states typically pursue oil spill violations via their respective water laws, which may be considered comparable. State penalties may often be substantially less than those sought by the federal government—thus, early engagement with the state can be advantageous depending on the circumstances.

Oil Pollution Prevention Regulations

Section 311(j) of the CWA and OPA, as outlined in 40 C.F.R. Part 112, require facilities that store oil in significant quantities to prepare Spill Prevention, Control, and Countermeasure (SPCC) Plans to prevent accidental releases from reaching WOTUS or adjoining shorelines. Facilities with a greater risk of release and impact to WOTUS may also be required to develop a Facility Response Plan (FRP) to prepare for “worst-case spills.” At the outset, companies should confirm whether these regulations are applicable to their operations and facilities.

SPCC plans are required for facilities that are: (1) non-transportation-related (i.e., they store, process, or consume oil rather than simply move it from one facility to another); and (2) collectively store more than 1,320 gallons of oil above ground or 42,000 gallons below ground that could reasonably be expected to discharge oil to a WOTUS or adjoining shorelines. This can include oil drilling and production facilities, oil refineries, industrial, commercial, and agricultural facilities storing/using oil, facilities that transfer oil via pipelines or tank trucks (including airports), and facilities that sell or distribute oil, like marinas. Practically, these regulations require facilities to have a written plan certified by a professional engineer (apart from qualified facilities), maintain adequate secondary containment for oil storage, maintain updated lists of the federal, state, and local agencies that must be contacted in case of a spill, and follow regular inspection requirements, among other requirements.

In addition to SPCC, FRP plans are required for facilities that could reasonably expect to cause “substantial harm” to the environment by discharging oil into or upon WOTUS. They either have: (1) total oil storage capacity greater than or equal to 42,000 gallons and transfer oil over water to/from vessels; or (2) total oil storage capacity greater than or equal to 1 million gallons and either do not have sufficient secondary containment, are located at a distance such that a discharge could cause “injury” to habitat or shut down a drinking water intake, or within the past five years, have had a reportable discharge greater than or equal to 10,000 gallons. If so, given that FRP is self-identifiable, the facility must prepare and submit its FRP plan to its applicable EPA regional office. Among other things, these plans include evaluating , medium, and worst-case discharge scenarios, descriptions and records of self-inspections, drills, and response training, and diagrams of the facility site plan, drainage, and evacuation plan.

EPA commonly conducts inspections at subject facilities to ensure that SPCC and FRP plans are effectively implemented. Should your facility have an oil spill, plan on an inspection very soon to evaluate compliance and mitigation efforts with your respective requirements.

Suggested Actions

Beyond being aware of the above implications and requirements, below are several actions to consider to ensure compliance and minimize possible enforcement and/or litigation when the least expected occurs.

  • Act Fast: Should an oil spill occur, regardless of size, act fast to respond, mitigate, and determine if notification is required. This includes immediate internal coordination with those responsible for responding, as well as outreach to your environment counsel and/or consultant. If the determination for reporting is close, it is recommended that you report (with a qualified caveat) rather than withhold.
  • Education and Training: Ensure your staff is trained to effectively respond to, report, and prevent oil spills. Oil spills happen despite best attempts otherwise. When the inevitable happens, make sure facility staff are prepared to respond and mitigate the potential impacts of the spill, including having spill reporting hotlines and other contact numbers easily accessible and staff trained on where all information is located. Also, learn from past spills and/or near spills by conducting evaluations and identifying lessons learned to be utilized to prevent future spills.
  • Prepare for Outside Communication: If the spill is significant or causes public impacts, be prepared for outreach by the public, including local news and community groups. Notifications to the NRC are available online and impacts to public or private property often lead to alerts to local news and organizations. Ensure your public affairs contact(s) are aware and develop necessary communication, including desk statements, should the spill create public attention.
  • Review Compliance: Evaluate your current compliance with federal, state, or local requirements, including the development, assessment, and update (if needed) of SPCC and/or FRP response plans. This includes determining if either or both are required at your facility. Should a spill occur, it is important to make sure your response plans are up-to-date and ready for implementation.
  • Regular Audits and Updates: Periodically audit your spill response and prevention measures (SPCC and FRP plans), including any changes to facility operations, secondary containment features, or volumes of oil stored, to identify and correct inaccuracies and ensure that your plans are up-to-date. For FRP, this includes submitting updates to the appropriate EPA regional office within 60 days of each change that may materially affect the response to a worst-case discharge.
  • Insurance: Though not always necessary, consider appropriate insurance coverage to mitigate potential financial liabilities.
  • Consultation: If you have any doubts about your obligations during an oil spill or need assistance with compliance, please do not hesitate to contact your environment counsel or consultants for guidance and support.

1 While this discussion focuses on the impacts of oil spills, it’s important to remember that Section 311 of the CWA (though not OPA) also applies to hazardous substances—discharges to a WOTUS that exceed a reportable quantity pursuant to 40 C.F.R. § 117.3—though the federal government may typically utilize the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund), or combination thereof, to pursue such releases.

Multistate Coalition Supports EPA’s Proposed Revisions to the Safer Choice Standard

As reported in our December 5, 2023, memorandum, the U.S. Environmental Protection Agency (EPA) proposed updates to the Safer Choice Standard on November 14, 2023, that include a name change to the Safer Choice and Design for the Environment (DfE) Standard (Standard), an update to the packaging criteria, the addition of a Safer Choice certification for cleaning service providers, a provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several product and functional use class requirements. 88 Fed. Reg. 78017. On January 16, 2024, California Attorney General Rob Bonta announced that, alongside a coalition of 12 attorneys general, he submitted a comment letter that:

  • Supports EPA’s proposed revisions to its Safer Choice Standard;
  • Recommends that EPA not allow products with plastic primary packaging to use the Safer Choice label or DfE logo;
  • Recommends that if EPA does allow products with plastic primary packaging to use the label and logo, EPA should prohibit the use of chemical recycling in meeting the proposed standard’s plastic packaging recycled content requirements; and
  • Calls on EPA to exclude any products or packaging that contain any per- and polyfluoroalkyl substances (PFAS), “whether intentionally introduced or not.”

EPA Proposes Updates Intended to Strengthen the Safer Choice Standard

The U.S. Environmental Protection Agency (EPA) announced proposed updates to the Safer Choice Standard on November 13, 2023. According to the November 14, 2023, notice, the proposed changes include a name change to the Safer Choice and Design for the Environment (DfE) Standard (Standard), an update to the packaging criteria, the addition of a Safer Choice certification for cleaning service providers, a provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several product and functional use class requirements. 88 Fed. Reg. 78017. EPA notes that Safer Choice helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment and states that DfE is a similar program currently used by EPA to help consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the typical pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as other EPA DfE criteria. EPA will hold a webinar on December 19, 2023, on its proposed plans for updating the Standard. After EPA’s presentation, there will be time for a question and answer period. EPA asks that comments be submitted in writing after the webinar. Comments on the proposed changes are due January 16, 2024. EPA has posted on its website the proposed changes to the Standard, as well as a “preamble” explaining the proposed changes.

According to the preamble, when EPA adopts the revisions, it expects to make them effective “upon the finalization and public notification.” EPA states that candidate partners would need to comply with the updated Standard prior to becoming program partners and that existing program partners would be expected to comply with the revisions within the year following their next partnership renewal.

EPA notes that many of its proposed revisions are in the nature of technical amendments. EPA states that in some instances, it also deleted text from the Standard to avoid redundancy with program criteria expressed elsewhere. EPA proposes to introduce the following topics to highlight their importance and specifically requests comments on them:

Entering or Exiting a Product Class (Section 3.4)

EPA has added detail to the Standard on its process for entering and exiting product classes (i.e., a category of products that have similar functions). EPA states that it may solicit public input before entering or exiting a product class. According to EPA, for entering a new product class, it will consider various factors (e.g., product type, functionalities, and improvements to health and the environment) and determine whether entering the new product class will advance the goals of the Safer Choice and DfE programs.

EPA notes that on “rare occasions,” newly available information may indicate that a class of products poses unanticipated serious adverse health or environmental effects. In such circumstances, EPA may find it necessary to end any partnerships and discontinue certification of products in the class, at least until EPA can understand the cause of the adverse effects and, if possible, develop criteria to address them. EPA proposes to add provisions to address these situations in Section 3.4.2.1 Exceptional circumstances affecting health or the environment. The preamble states that “[i]n general, if EPA decides to exit a product class, EPA will allow a period of time for partners to cease use of the product label or logo.”

On-Site Audit (Section 3.6.2)

EPA currently requires audits on a yearly basis throughout the partnership, including one on-site audit in the first or second year of the partnership cycle. To ensure that partners are formulating certified products in compliance with Safer Choice criteria, EPA proposes, in Section 3.6.2 On-site audit, that the first audit for a new partner must be an on-site audit.

Information to Help Reduce Carbon-Based Energy Consumption (Section 4.2.3.1)

EPA proposes to update the Standard to encourage and recognize product manufacturers’ efforts to incorporate energy-saving technologies and approaches. This optional provision in Section 4.2.3.1 Information to help reduce carbon-based energy consumption lists actions manufacturers may implement. Partners may be recognized for demonstrating outstanding leadership and innovation in sustainable energy use.

Primary Packaging (Section 4.2.5)

To respond to increased demand for more sustainable practices, EPA proposes to update its packaging criteria to ensure that certified products also use safer, more sustainable packaging. According to the preamble, the revised requirements are informed by common themes across existing third-party packaging sustainability schemes. EPA notes that the proposed specific recycled content levels “do not necessarily come from existing schemes but, based on research, are understood to be leadership but achievable levels.”

EPA proposes to add requirements to Section 4.2.5 Primary packaging on recyclability and recycled content, label compatibility, and primary packaging ingredients. Specifically, EPA proposes to require that primary packaging either be recyclable and contain a minimum level of post-consumer recycled content or be designed to be reused. Additionally, EPA proposes to require that product labels associated with primary packaging not affect recyclability and that proper recycling method(s) be clearly indicated on the packaging.

EPA also proposes to add per- and polyfluoroalkyl substances (PFAS) and all bisphenol-based chemicals to its list of ingredients that may not be intentionally introduced into primary packaging material. EPA states that it will explicitly list the four heavy metals (cadmium, lead, mercury, and hexavalent chromium) currently covered by the Standard as ingredients that may not be intentionally introduced into primary packaging material.

EPA seeks stakeholder comment on all aspects of the primary packaging requirements, including, but not limited to:

  • Are the proposed minimum post-consumer recycled content levels feasible for primary packaging made of plastic, glass, metal, fiber (e.g., paper or cardboard), or other sustainable materials? If not, what levels would be feasible? How should EPA consider multi-material packaging?
  • Is it reasonable for EPA to require that the entire product primary packaging be recyclable? If not, what is an appropriate minimum percent of recyclable material?
  • Is it reasonable for EPA to require both a minimum recycled content and package recyclability? What are the challenges to achieving both simultaneously?
  • In developing its final criteria, should EPA consider concerns for contaminants that may be intentionally added and/or unintentionally introduced into recycled materials? At what point should testing occur?

Yellow Triangle Content Limit (Section 4.2.8)

To enhance transparency, EPA is updating the Standard to reflect the ongoing practice of allowing the use of yellow-triangle designated chemicals from the Safer Chemical Ingredients List (SCIL) when they do not cumulatively exceed ten percent in the product as sold.

Ingredient Combinations Causing Adverse Effects (Section 4.5)

According to EPA, certain ingredients, while independently meeting Safer Choice ingredient criteria, may cause adverse effects when combined. EPA states that it does not allow ingredient combinations known to cause negative synergistic effects and is updating the Standard to reflect this ongoing practice in Section 4.5 Ingredient Combinations Causing Adverse Effects.

Products in Solid or Particulate-Generating Form (Section 4.6)

EPA proposes to add Section 4.6 Products in Solid or Particulate-Generating Form to require certain information from manufacturers. EPA proposes to require that, upon request, manufacturers of products in particulate-generating or solid form provide information to determine that the product does not contain or generate a substantial portion of particles that are respirable (ten microns or less).

Special Product Classes (Section 4.7)

EPA states that over the years, to extend the reach of the program into product categories where manufacturers sought to lead the market with safer ingredients, it has developed policy criteria and guidance as a supplement to the broader Standard. According to EPA, these policies have been distributed widely and posted on the Safer Choice website. EPA now proposes to add links to the Safer Choice website, where criteria can be found for the following product classes: Section 4.7.1 Ice-melt productsSection 4.7.2 Inorganic- and mineral-based productsSection 4.7.3 Microorganism-based products, and Section 4.7.6 Marine lubricants. EPA proposes to provide a brief description of each product class in the Standard and to refer readers to the Safer Choice website for the full criteria.

Products Intended for Use on Pets (Section 4.7.5)

EPA is adding a product class for non-pesticidal and non-drug pet care products in Section 4.7.5 Products intended for use on pets. EPA states that it will evaluate chemicals used in products intended for use on pets for human and pet health, in addition to environmental toxicity and fate. EPA will not allow ingredients in pet care products that are severely irritating or corrosive to skin or eyes unless whole product testing demonstrates low concern for irritation. EPA will also not allow Globally Harmonized System of Classification and Labeling of Chemicals (GHS) listed sensitizers in certified pet care products (unless the manufacturer provides whole product testing demonstrating low concern for sensitization or a rationale based on functional necessity that also addresses sensitization) and will require that ingredients meet direct release criteria, with the exception of fragrance materials.

EPA requests comment on the feasibility of the requirements for direct release, irritation, and sensitization for pet care products.

Direct Release Products (Section 4.8.1)

According to EPA, a number of stakeholders have approached Safer Choice to request the addition of a label that would distinguish products that meet Safer Choice direct release criteria. The preamble includes the following questions for comment:

  • Would it be helpful to have a version of the Safer Choice label with text that distinguishes products that meet direct release criteria (similar to the Fragrance-Free Safer Choice label)?
  • Would text such as “approved for outdoor use” better communicate the meaning of direct release to consumers and purchasers?
  • Are there alternative phrases to “approved for outdoor use” that EPA should consider?

General Requirements (Section 5.2): Use of New Approach Methodologies (NAM)

EPA states that it continues to advance the use of NAMs to replace laboratory animal studies, and the program will continue to adopt NAMs as they are developed. The proposed revisions to the Standard include changes in the following sections to formalize the ongoing Safer Choice use of NAMs: Section 5.2 General Requirements and Section 4.2.2 pH.

Component-Specific Requirements (Sections 5.3, 5.11, and 5.17)

EPA states that it proposes several revisions and additions to Section 5 Component-Specific Requirements.

Surfactants (Section 5.3)

Under Section 5.3 Surfactants, EPA is proposing to require aquatic toxicity data for at least one trophic level for surfactants (or a close analog). EPA notes its ongoing practice that where data for human health are available, EPA will evaluate chemicals based on the thresholds in the Master Criteria.

Disposable Wipes (Section 5.11)

EPA notes that the Standard currently limits the composition of wipe materials to those that are readily compostable and cites cotton and bamboo as examples. To reinforce current industry practice, EPA proposes to require that all wipe-based products indicate they are not flushable to carry the Safer Choice label or DfE logo. EPA proposes to modify Section 5.11 Disposable Wipes to indicate that wipes made from both natural fibers and synthetic fibers from renewable sources are acceptable, provided they have similar biodegradability profiles (as demonstrated by one of the following or similar methods: EN13432, ASTM 6400, ASTM 5338, or ISO 14855). Wipes-based products must also include a “do not flush” logo and language on product labels to qualify for certification. Since fibers are often treated with processing chemicals to create the nonwoven substrates, EPA states that it is also adding clarifying language on additive components (such as binders or coatings) in nonwoven substrates and how they must also meet program criteria.

EPA requests comment on the functionality and consumer acceptance of wipes that are composed of natural fibers and synthetic fibers from renewable sources, and the preamble includes the following question:

  • Should EPA only allow natural fibers in disposable wipes or also allow compostable synthetic fibers from renewable sources?

Odor Elimination Chemicals (Section 5.17)

EPA proposes to add Section 5.17 Odor Elimination Chemicals to formalize the evaluation criteria already used for odor elimination chemicals, which function to reduce or eliminate odorous chemicals. According to EPA, it would continue to evaluate odor elimination chemicals based on general requirements in Section 5.2 and based on requirements provided on the Safer Choice website.

SCIL (Section 5.18)

EPA states that it believes that additional language further describing the relationship between the SCIL, the Standard, and Safer Choice- and DfE-certified products would provide additional transparency. Specifically, EPA proposes to describe the evaluation process for single Chemical Abstracts Service Registry Numbers® (CAS RN®) that cover broad ranges of chemical structures.

Use of the Safer Choice Label by Raw Material Suppliers (Section 6.3)

EPA states that it is aware that raw material suppliers may wish to communicate that they supply ingredients that meet Safer Choice criteria and proposes to add language to the Standard that explains how the Safer Choice label should be used by material suppliers. EPA proposes to add Section 6.3 Use of the Safer Choice Label by Raw Material Suppliers to document the ongoing practice under which raw material suppliers may use the Safer Choice label to indicate that certain raw materials meet Safer Choice criteria or that a specific supplier can formulate to meet Safer Choice criteria. EPA notes that it currently allows this practice for raw material suppliers with chemical ingredients listed on CleanGredients (https://cleangredients.org/). EPA proposes to continue to work with interested raw material suppliers on a case-by-case basis.

Safer Choice Cleaning Service Certification (Section 7)

EPA requests comment on whether it should establish a Safer Choice Cleaning Service Certification for cleaning service providers that use Safer Choice-certified products for cleaning and DfE-certified products for disinfecting. EPA states that residential and commercial cleaning service providers, as well as facility owners, managers, and government entities that provide in-house cleaning would be eligible for this certification. Entities that could be certified must be organizations and businesses that use cleaners, detergents, disinfectants, and related products as part of their primary operations. According to EPA, program certification would require organizations and businesses to use exclusively Safer Choice-certified products for cleaning and DfE-certified products for disinfecting, in product categories with Safer Choice- and DfE-certified products, to the maximum extent practicable. EPA may grant exceptions at its discretion on a case-by-case basis. Certified cleaning service providers would be permitted to display the Safer Choice Service Certification logo (outlined in Section 7.6), and their name and contact information would be listed on the Safer Choice website.

EPA states that candidates for Safer Choice Cleaning Service Certification must use a Safer Choice-qualified third-party profiler to prepare and submit applications, document exceptions, and conduct annual virtual audits. There is a cost associated with obtaining these services. The proposal for the Safer Choice Cleaning Service Certification is in Section 7 of the Standard, with a template partnership agreement in Annex D. EPA requests comment on the following questions:

  • Other than the exceptions outlined in Section 7.3.1.1, should other exceptions be included? Are these exceptions overly broad? Is granting the exceptions under this certification appropriate?
  • Do you have a preference between the Safer Choice Service Certification logos in Section 7.6? Comments on the logo elements (e.g., tagline, color, and shape) would be especially valuable. Which do you think would best communicate the meaning of the certification?
  • Should any of the locations for use of the Safer Choice Service Certification logo listed in Section 7.6.2 be removed or should additional locations be added?

Private Label, Licensee, and Toll Manufacture Products (Sections A.13 and B.13): Private Label Company Dilution

To document the ongoing practice under which EPA explicitly allows for dilution of a concentrated form of a product by a private label company at its facility, EPA proposes to add language to the Safer Choice Partnership Agreement template in Section A.13 Private Label, Licensee, and Toll Manufacture Products and in the equivalent section (B.13) in the DfE Partnership Agreement template to allow dilution of a certified concentrate conducted by a private label company. EPA states that it allows such “Ready To Use” private label products to be certified on a case-by-case basis. The partner must communicate that the concentrate is being diluted and the corresponding dilution rates to EPA.

Commentary

We commend EPA for seeking to expand the utility of its Safer Choice/DfE recognition. Such recognition provides consumers and end users a robust system from which to select “greener” products. Many have argued that the Safer Choice/DfE program should be managed by a non-governmental organization (like other green standards), but our view is that Safer Choice provides benefits to the marketplace because it carries EPA’s imprimatur and it provides EPA greater visibility in an area EPA is committed to promote.

The packaging criteria are important but present many challenges to Safer Choice partners. Most packaging is considered an article under TSCA, and there is limited supply chain visibility into the content of packaging. Participants in Safer Choice and their suppliers need to provide EPA with a practicable standard. Supply chain agreements can provide insight into what is intentionally added and may include limits on impurities, but will have to avoid “free of” standards because suppliers may be reluctant to provide certification that any particular contaminant is not present at all at any level. The spate of PFAS consumer product litigation has made that reality abundantly clear. This is especially true for recycled content, such as recycled plastic. If the Safer Choice standard is such that it can only be met by virgin plastic resin, the standard that is meant to drive circularity will instead effectively force products out of Safer Choice when participants cannot meet an impossibly difficult packaging standard.

EPA’s proposed consideration of synergistic effects could benefit from clarity on how EPA will consider and evaluate synergistic effects. Will EPA require testing for synergistic effects, or will EPA consider such effects only in cases in which EPA has had some indication of synergistic effects? In those cases, will the standard prohibit one or both of the ingredients, or only prohibit the combination?

EPA’s proposed category for non-pesticidal and non-drug pet care products is a sensible expansion for Safer Choice. It may be surprising to readers that while a shampoo intended for humans is regulated as a cosmetic in the United States by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA), an identical formulation for a shampoo intended for pets is regulated by EPA under TSCA. EPA’s criteria for household care products should provide a foundation upon which EPA can develop criteria for pet care.

A key expansion that EPA proposes is recognition for service providers. The idea is that a cleaning service provider that uses Safer Choice/DfE products to the extent practicable can receive recognition and advertise that recognition to potential customers. This expansion of Safer Choice has the potential to increase substantially the quantity of Safer Choice-recognized products by encouraging service providers to maximize their use of such products.

There are great opportunities for the expansion of Safer Choice. It is important for suppliers and formulators to engage with EPA to ensure that the criteria are robust and practicable.

October PFAS Regulatory Update

In October 2023, the United States Environmental Protection Agency (EPA) finalized two separate but analogous rulemakings – one under the Toxic Substances Control Act (TSCA), and one under the Emergency Planning and Community Right to Know Act (EPCRA). Both rulemakings pertain to per- and polyfluoroalkyl substances (“PFAS”), commonly referred to as ​“forever chemicals.” PFAS are manmade chemicals ​that have been widely used in industry and consumer products since their inception in the late 1930s. PFAS are most known for their resistance to tricky substances such as grease, water, and oil and have been commonly used in a variety of products like cleaning products, water and stain resistant fabrics, nonstick cookware, medical devices, firefighting foam, beauty products, and even things like microwave popcorn bags and pizza boxes.

These rulemakings are significant because they place broad recordkeeping and reporting requirements on facilities that may not have previous experience with either environmental statute. Under the new TSCA rule, any entity that manufactures or has manufactured (including import or previously ​imported) PFAS or PFAS-containing articles in any year since January 1, 2011, must now report certain information to EPA. Additionally, under the new EPCRA rule, facilities that use more than 100 pounds of PFAS annually must comply with Toxics Release Inventory (“TRI”) reporting obligations and provide downstream businesses with notifications that products may contain PFAS.

Broad PFAS Reporting under TSCA

Considered one of the most significant rulemakings of the year, on October 11, 2023, EPA finalized a rule under TSCA Section 8(a)(7) requiring any person that manufactures (including import) or has manufactured (including imported) PFAS or PFAS-containing articles in any year since January 1, 2011, to electronically report information regarding “PFAS uses, production volumes, byproducts, disposal, exposures, and existing information on environmental or health effects” through EPA’s agency-wide Chemical Data Exchange (“CDX”) portal. The new rule, effective November 13, 2023, triggers specific reporting dates and deadlines depending on the entity’s size and previous and/or current usage of PFAS.

The first of the reporting dates under the new rule applies to any entity, including small entities, that have manufactured and/or currently manufacture (including imported or currently import) PFAS in any year since January 1, 2011. These entities will have 18 months from the effective date of the rule to report PFAS data to the EPA. The second reporting date applies to “small manufacturers” as defined under 40 CFR 704.3 whose reporting obligations are exclusively from article imports. Entities meeting this definition will have 24 months from the effective date of the rule to report PFAS data to EPA. These dates are estimated to fall in May 2025 and November 2025, respectively.

This rule is likely most applicable to those in the electronics, food packaging, and automotive industries, but will also likely ripple to many other types of industries, including those that manufacture and/or import items such as textiles, circuit boards, wires, cables, and pharmaceuticals.

If you believe you may be impacted ​by this new rule, we recommend developing a strategy immediately to determine whether your company has manufactured or imported PFAS since January 1, 2011. Additionally, if your company has acquired another company since January 1, 2011, we also recommend ​reviewing that company’s documentation to determine whether there may be any additional reporting requirements triggered.

PFAS Reporting to the Toxics Release Inventory under EPCRA

On October 20, 2023, just a week after the TSCA PFAS rulemaking was finalized, EPA finalized a second PFAS rulemaking under EPCRA. This rule revised the TRI program to impose two new sets of reporting obligations related to 189 specified PFAS. Scheduled to go into effect on November 30, 2023 (and for annual reporting purposes ​beginning January 1, 2024), the new rule now requires:

  1. An annual reporting obligation to EPA for facilities that use more than 100 pounds of PFAS annually, and
  2. A requirement for business-to-business downstream notifications of the presence of PFAS in certain products

These new requirements are significant because the previously applicable de minimis exception that exempted products containing less than 1% of PFAS (or 0.1% for PFAS qualifying as carcinogens, such as PFOA) from ​being considered for either reporting or notification purposes, is now removed. Now, under this new rule, any quantity of the 189 specified PFAS counts towards the 100-pound threshold and triggers the downstream notification obligation. While the new rule only applies to 189 specified PFAS, EPA retains the authority to add additional PFAS in the future.

This rule is ​significant as it could result in ​numerous products being newly identified as containing PFAS throughout the supply chain. Companies that manufacture, process, or otherwise use PFAS in their operations should immediately develop a strategy to better understand this new rulemaking and determine whether the TRI reporting requirements may be triggered. Additionally, companies that supply PFAS-containing products to downstream business purchasers should evaluate whether additional notifications of the presence of PFAS in the products they supply may be required.

Conclusion

These rulemakings are complex and will have significant impacts on those in the industrial and manufacturing industries. These rules are also likely just the beginning of the PFAS regulatory iceberg.

EPA Issues SNPRM Modifying and Supplementing 2021 Proposed TSCA Fees Rule

On November 16, 2022, the U.S. Environmental Protection Agency (EPA) published a much-anticipated supplemental notice of proposed rulemaking (SNPRM) to modify and supplement its 2021 proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 87 Fed. Reg. 68647. EPA states that “[w]ith over five years of experience administering the TSCA amendments of 2016, EPA is publishing this document to ensure that the fees charged accurately reflect the level of effort and resources needed to implement TSCA in the manner envisioned by Congress when it reformed the law.”

What Action Is EPA Taking?

After establishing fees under TSCA Section 26(b), TSCA requires EPA to review and, if necessary, adjust the fees every three years, after consultation with parties potentially subject to fees. The SNPRM describes proposed changes to 40 C.F.R. Part 700, Subpart C as promulgated in the 2018 Fee Rule (83 Fed. Reg. 52694) and explains the methodology by which EPA determined the proposed changes to TSCA fees. The SNPRM adds to and modifies the proposed rulemaking issued on January 11, 2021 (2021 Proposal) (86 Fed. Reg. 1890). EPA proposes to narrow certain proposed exemptions for entities subject to the EPA-initiated risk evaluation fees and proposes exemptions for test rule fee activities; to modify the self-identification and reporting requirements for EPA-initiated risk evaluation and test rule fees; to institute a partial refund of fees for premanufacture notices (PMN) withdrawn at any time after the first ten business days during the assessment period of the chemical; to modify EPA’s proposed methodology for the production volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed; to expand the fee requirements to companies required to submit information for test orders; to modify the fee payment obligations to require payment by processors subject to test orders and enforceable consent agreements (ECA); to extend the timeframe for test order and test rule payments; and to change the fee amounts and the estimate of EPA’s total costs for administering TSCA Sections 4, 5, 6, and 14. More information on the 2018 Fee Rule is available in our September 28, 2018, memorandum, and more information on the 2021 Proposal is available in our December 30, 2020, memorandum.

The SNPRM includes the following summary of proposed changes to TSCA fee amounts:

Fee Category 2018 Fee Rule Current Fees1 2022 SNPRM
Test order $9,8002 $11,650 $25,000
Test rule $29,500 $35,080 $50,000
ECA $22,800 $27,110 $50,000
PMN and consolidated PMN, significant new use notice (SNUN), microbial commercial activity notice (MCAN) and consolidated MCAN $16,000 $19,020 $45,000
Low exposure/low release exemption (LoREX), low volume exemption (LVE), test-marketing exemption (TME), Tier II exemption, TSCA experimental release application (TERA), film article $4,700 $5,590 $13,200
EPA-initiated risk evaluation $1,350,000 Two payments resulting in $2,560,000 Two payments resulting in $5,081,000
Manufacturer-requested risk evaluation on a chemical included in the 2014 TSCA Work Plan Initial payment of $1.25M, with final invoice to recover 50 percent of actual costs Two payments of $945,000, with final invoice to recover 50 percent of actual costs Two payments of $1,497,000, with final invoice to recover 50 percent of actual costs
Manufacturer-requested risk evaluation on a chemical not included in the 2014 TSCA Work Plan Initial payment of $2.5M, with final invoice to recover 100 percent of actual costs Two payments of $1.89M, with final invoice to recover 100 percent of actual costs Two payments of $2,993,000, with final invoice to recover 100 percent of actual costs
1 The current fees reflect an adjustment for inflation required by TSCA. The adjustment went into effect on January 1, 2022.
2 In the 2018 final rule, the fees for TSCA Section 4 test orders and test rules were incorrectly listed as $29,500 for test orders and $9,800 for test rules. The 2021 Proposal proposes to correct this error by changing the fees for TSCA Section 4 test orders to $9,800 and TSCA Section 4 test rules to $29,500.

Why EPA Is Taking the Action

EPA states that the fees collected under TSCA are intended to achieve the goals articulated by Congress by providing a sustainable source of funds for EPA to fulfill its legal obligations under TSCA Sections 4, 5, and 6 and with respect to information management under TSCA Section 14. According to EPA, information management includes collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under Section 14 information on chemical substances under TSCA. In 2021, EPA proposed changes to the TSCA fee requirements established in the 2018 Fee Rule based upon TSCA fee implementation experience and proposed to adjust the fee amounts based on changes to program costs and inflation and to address certain issues related to implementation of the fee requirements. According to the SNPRM, EPA consulted and met with stakeholders that were potentially subject to fees, including several meetings with individual stakeholders and a public webinar in February 2021. EPA is hosting a December 6, 2022, webinar to hear from stakeholders on the proposed TSCA fees. This engagement and the previous stakeholder outreach will inform EPA’s final rule.

According to EPA, based on comments received in response to the 2021 Proposal, adjustments to EPA’s cost estimates, and experience implementing the 2018 Fee Rule, EPA is issuing this SNPRM and is requesting comments on the proposed provisions and primary alternative provisions described that would add to or modify the 2021 Proposal. EPA notes that TSCA allows it to collect approximately but not more than 25 percent of its costs for eligible TSCA activities via fees. EPA states that fee revenue has been roughly half of the estimated costs for eligible activities than EPA estimated in the 2018 Fee Rule, however. According to EPA, the shortfall was, in part, due to EPA’s use of cost estimates based on what it had historically spent on implementing TSCA prior to the 2016 amendments, not what it would cost to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). In the first four years following the 2016 Lautenberg Act’s enactment, EPA also did not conduct a comprehensive budget analysis designed to estimate the actual costs of implementing the amended law until spring 2021. In the SNPRM, EPA proposes to revise its cost estimate to account adequately for the anticipated costs of meeting its statutory mandates, which are based on the comprehensive analysis conducted in 2021. EPA states that these proposed revisions are designed to ensure fee amounts capture approximately but not more than 25 percent of the costs of administering certain TSCA activities, fees are distributed equitably among fee payers when multiple fee payers are identified by revising the fee allocation methodology for EPA-initiated risk evaluations, and fee payers are identified via a transparent process.

Estimated Incremental Impacts of the SNPRM

EPA evaluated the potential incremental economic impacts of the 2021 Proposal, as modified by this SNPRM for fiscal year (FY) 2023 through FY 2025. The SNPRM briefly summarizes EPA’s “Economic Analysis of the Supplemental Notice of Proposed Rule for Fees for the Administration of the Toxic Substances Control Act,” which will be available in the docket:

  • Benefits. The principal benefit of the 2021 Proposal, as modified by this SNPRM, is to provide EPA a sustainable source of funding necessary to administer certain provisions of TSCA.
  • Cost. The annualized fees collected from industry under the proposed cost estimate described in the SNPRM are approximately $45.47 million (at both three percent and seven percent discount rates (EPA notes that the annualized fee collection is independent of the discount rate)), excluding fees collected for manufacturer-requested risk evaluations. EPA calculated total annualized fee collection by multiplying the estimated number of fee-triggering events anticipated each year by the corresponding fees. EPA estimates that total annual fee collection for manufacturer-requested risk evaluations is $3.01 million for chemicals included in the 2014 TSCA Work Plan (based on the assumed potential for two requests over the three-year period) and approximately $2.99 million for chemicals not included in the 2014 TSCA Work Plan (based on the assumed potential for one request over the three-year period). EPA analyzed a three-year period because the statute requires EPA to reevaluate and adjust, as necessary, the fees every three years.
  • Small entity impact. EPA estimates that 29 percent of Section 5 submissions will be from small businesses that are eligible to pay the Section 5 small business fee because they meet the definition of “small business concern.” EPA estimates that the total annualized fee collection from small businesses submitting notices under Section 5 is $666,810. For Sections 4 and 6, reduced fees paid by eligible small businesses and fees paid by non-small businesses may differ because the fee paid by each entity would be dependent on the number of entities identified per fee-triggering event and production volume of that chemical substance. EPA estimates that average annual fee collection from small businesses for fee-triggering events under Section 4 and Section 6 would be approximately $103,574 and $2,896,351, respectively. For each of the three years covered by the SNPRM, EPA estimates that total fee revenue collected from small businesses will account for about six percent of the approximately $52 million total fee collection, for an annual average total of approximately $3 million.
  • Environmental justice. Although not directly impacting environmental justice-related concerns, EPA states that the fees will enable it to protect better human health and the environment, including in helping minority, low-income, Tribal, or indigenous populations in the United States that potentially experience disproportionate environmental harms and risks, and supporting the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation and enforcement of environmental laws, regulations, and policies involving TSCA. EPA notes that it “identifies and addresses environmental justice concerns by providing for fair treatment and meaningful involvement in the implementation of the TSCA program and addressing unreasonable risks from chemical substances.”
  • Effects on state, local, and Tribal governments. The SNPRM would not have any significant or unique effects on small governments, or federalism or Tribal implications.

Commentary

Bergeson & Campbell, P.C. (B&C®) has anticipated the public release of the SNPRM for some time and is not surprised by the proposed increases in fees. We recognize, however, that many readers may review these proposed fees and truly feel a sense of “sticker shock,” as Dr. Michal Freedhoff, the current Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), cautioned regulated entities earlier this year. B&C has not evaluated the underlying budgetary analysis, so assumes that EPA’s estimate of its costs is accurate. Given that assumption and EPA’s authority to recover 25 percent of those costs, B&C focuses on other aspects of the proposal.

Taking an optimistic view, the increase may benefit regulated entities. EPA states in the SNPRM that “Collecting additional resources through TSCA fees will enable EPA to significantly improve on-time performance and quality.” The absence of these two metrics, as well as others, has mired EPA’s activities under TSCA Sections 4, 5, and 6 for years. The influx of funding, along with proper leadership, training, and management, will aid EPA with meeting its statutory deadlines under TSCA, and the transparency elements of its Scientific Integrity Policy and the scientific standards under TSCA Section 26. Below, we provide representative examples of how the fees increase will aid EPA with avoiding the repetitious shortcomings that have permeated its decision making under TSCA Sections 4, 5, and 6.

TSCA Section 4

B&C notes that EPA states the following about its intended use of its order authority under TSCA Section 4: “The Agency believes it is reasonable to assume that approximately 75 test orders per year will be initiated between FY 2023 and FY 2025. Approximately 45 of these test orders are expected to be associated with the Agency’s actions on PFAS.” In comparison, EPA has issued 20 TSCA Section 4 test orders on 11 existing chemical substances since March 2020. The issued test orders have, however, suffered from significant lapses in transparency. as well as outcomes that conflict with the scientific standards under TSCA Section 26 and the obligations under Section 4.

These concerns with transparency and EPA’s failure to meet the scientific standards under TSCA Section 26 are likely due in part to EPA’s resource and staffing limitations. Therefore, the increased cost of test orders from $11,650 to $25,000 will enable EPA to develop test orders that are focused on data needs, rather than data gaps, during its prioritization and risk evaluation activities. It will also provide EPA with the requisite funding to ensure that it responds timely to technical inquiries from test order recipients, rather than months and in some cases more than a year later.

TSCA Section 5

B&C has decades of experience reviewing EPA’s assessments on new chemical substances under TSCA Section 5. Of relevance here are our observations since TSCA was amended in 2016. Since this time, we have observed a decrease in transparency in EPA’s risk assessments on new chemical substances. For example, EPA routinely identifies analogs from which it reads across potential hazards for new chemical substances. It is not uncommon, however, for EPA to identify multiple analogs for doing so. What is common is that EPA selects an analog amongst many and does not state the scientific basis for the selected analog. This also applies to analogs identified by submitters that are often dismissed by EPA without a scientific basis for doing so. Furthermore, EPA routinely claims those analogs as confidential business information (CBI) without reviewing whether they are actually still confidential. It is important for EPA to protect legitimate CBI, but the statute also requires disclosure of information that is not actually CBI. Additional resources will allow EPA to update its databases to reflect the current state of CBI claims and to better evaluate whether old CBI claims are still justified.

We also hope that additional resources will enable EPA to rely on fewer “worst-case” shortcuts in its evaluations of PMNs. For example, EPA routinely uses the acute potential dose rate (PDR) as the exposure metric for assessing potential unreasonable risks, even when the hazard is a chronic effect. Evaluating against a PDR is a reasonable first pass calculation — if EPA does not identify risk using a PDR, no further evaluation is necessary. We do not, however, agree with EPA making unreasonable risk determinations on the screening-level assessments without further refinements — it is simply not justifiable scientifically to predict chronic risk using a PDR (as reflected in EPA’s assessments under Section 6). Performing the refined calculation requires additional effort, which the fee rule would help support.

We expect EPA will resolve the above issues with the increased funding that it intends on receiving for new chemical substance notifications (e.g., from $19,020 to $45,000 on PMNs). EPA states that the “Additional funding collected through TSCA section 5 fees will help EPA reduce the backlog of delayed reviews and support additional work for new cases.” These monies will also provide EPA the necessary budget to better justify the selection of analogs. Collectively, we hope these improvements will allow EPA’s risk assessors to exercise their inherently government function of evaluating and approving and/or modifying the contractor-generated work products as EPA-approved work products. This will provide more transparent and timely evaluations on novel chemistries notified to the Agency. This level of transparency will also ensure that EPA is satisfying its requirements under EPA’s Scientific Integrity Policy, which states “At the EPA, promoting a culture of scientific integrity is closely linked to transparency. The Agency remains committed to transparency in its interactions with all members of the public.” In doing so, EPA will additionally be providing risk assessments that clearly document its decision making and how those decisions satisfy the scientific standards under TSCA Section 26. These considerations are critical for submitters, not in the sense that they must agree with EPA’s determinations, but rather that they understand the bases for those determinations.

Unanswered questions about when the increased fees will improve the throughput of new chemicals reviews remain. Hiring and training staff takes time; EPA is currently working to fill open positions and train new staff. Submitters paying substantially higher fees would reasonably expect that EPA improve its performance or, if EPA cannot complete timely its reviews (absent suspensions by the submitter), expect that EPA would refund the submission fee.

TSCA Section 6

B&C views the fee increases for EPA’s administration of TSCA Section 6 as the most controversial, not necessarily because of the intended increased costs, which are substantial (e.g., EPA-initiated risk evaluation from two payments resulting in $2,560,000 to two payments resulting in $5,081,000), but rather because of EPA’s decision making in the risk evaluations and its incorporation of new policy directions into its revised risk determinations. EPA has stated that its revisions to the final risk evaluations on eight of the “first 10” chemical substances and accompanying revised risk determinations are “supported by science and the law.” EPA spent the last year revisiting its risk determinations, with little change other than EPA’s conclusion about the “whole chemical.” EPA has not addressed weakness in the risk evaluations identified by commenters; nor has EPA addressed the weaknesses in EPA’s systematic review process identified by the U.S. National Academies of Science, Engineering, and Medicine’s (NASEM) review of EPA’s “Application of Systematic Review in TSCA Risk Evaluations.” NASEM’s review concluded that “The OPPT approach to systematic review does not adequately meet the state-of-practice [and] OPPT should reevaluate its approach to systematic review methods, addressing the comments and recommendations in this report.” The foregoing issues are troubling and are expected to be contested by regulated entities when EPA proposes its draft risk management rules on the “first 10” chemical substances. EPA did, however, state in the SNPRM that:

Although section 6 cost estimates were informed by risk management and risk evaluation activities for the first 10 chemicals, EPA will not be recovering fees for those chemicals.

Though this may seem like a hollow victory for potentially regulated entities, given EPA’s risk determinations on these substances, the intended fees for the EPA-initiated risk evaluations at least provide a baseline of deferred costs that may be allocated for disputing scientific and legal shortcomings when EPA issues the draft and final risk management rules. Moving forward, we anticipate that EPA will use the intended increased funding from the various risk evaluation costs to ensure that the above issues are addressed in its future risk evaluations on high-priority substances.

Conclusions

B&C recognizes that its position on the proposed fees increase in the SNPRM may not be well received by regulated entities. We note that the increased fees will aid with decreasing uncertainty in EPA’s decision making and its timely completion of evaluations on new and existing chemical substances and improve transparency and documents that meet the scientific standards under TSCA Section 26. There is also no question that EPA has the statutory authority to raise fees to recover 25 percent of its costs. B&C’s view is that commenters should focus on the distribution of the fees among the categories, proposed exemptions, and other aspects of the rule, including when manufacture or import must cease to avoid paying fees, rather than focusing on the magnitude of the fee increase.

We also hope that regulated entities will welcome EPA’s use of the best available science and weight of scientific evidence in its risk evaluations. As we discussed above, these statutory requirements have not been met in the “first 10” risk evaluations. We recognize that the deadlines for risk evaluations are not necessarily the critical issue for regulated entities, rather it is EPA’s unreasonable risk determinations, which are based on risk evaluations that were developed in a manner inconsistent with TSCA Section 6 and the implementing regulations. The increased fees under TSCA Section 6 should aid with addressing these issues.

Finally, B&C is optimistic that the SNPRM will provide EPA with the requisite funding to ensure its successful oversight of activities under TSCA. Despite our optimism, we do recognize that increased funding alone will not improve EPA’s administration of TSCA. To ensure success, EPA’s leadership will have to manage and lead this program properly. These latter components are critical and if the SNPRM is promulgated as, or as close to as proposed, the expectation on this Administration to produce results will be sky high.

Biden Administration Revitalizes and Advances the Federal Government’s Commitment to Environmental Justice

On April 21, 2023, the eve of Earth Day, President Biden continued his Administration’s spotlight on environmental justice issues by signing Executive Order 14096, entitled “Revitalizing Our Nation’s Commitment to Environmental Justice for All.”

This Executive Order prioritizes and expands environmental justice concepts first introduced in President Clinton’s 1994 Executive Order 12898. The 1994 Order directed federal agencies to develop environmental justice strategies to address the disproportionately high and adverse human health or environmental effects of federal programs on minority and low-income populations.

One of President Biden’s early actions [covered here], Executive Order 14008, introduced the whole-of-government approach for all executive branch agencies to address climate change, environmental justice, and civil rights. It created the White House Environmental Justice Interagency Council, comprising of 15 federal agencies, including the United States Environmental Protection Agency (“EPA”) and the Department of Justice. Biden’s new Executive Order expands the whole-of-government approach by: (1) adding more agencies to the Environmental Justice Interagency Council and (2) establishing a new White House Office of Environmental Justice within the White House Council on Environmental Quality (“CEQ”). The new Office of Environmental Justice will be led by a Federal Chief Environmental Justice Officer and will coordinate the implementation of environmental justice policies across the federal government.

This new Executive Order emphasizes action over aspiration by directing federal agencies to “address and prevent disproportionate and adverse environmental health and impacts on communities.” It charges federal agencies with assessing their environmental justice efforts and developing, implementing, and periodically updating an environmental justice strategic plan. These new Environmental Justice Strategic Plans and Assessments are to be submitted to the CEQ and made public regularly, including through an Environmental Justice Scorecard, a new government-wide assessment of each federal agency’s efforts to advance environmental justice.

Specifically, defining “environmental justice” is one strategy to make concrete what federal agency efforts will address. Under the Executive Order, “environmental justice” means “the just treatment and meaningful involvement of all people, regardless of income, race, color, national origin, Tribal affiliation, or disability, in agency decision-making and other Federal activities that affect human health and the environment so that people: (i) are fully protected from disproportionate and adverse human health and environmental effects (including risks) and hazards, including those related to climate change, the cumulative impacts of environmental and other burdens, and the legacy of racism or other structural or systemic barriers; and (ii) have equitable access to a healthy, sustainable, and resilient environment in which to live, play, work, learn, grow, worship, and engage in cultural and subsistence practices.” This definition adds “Tribal affiliation” and “disability” to the protected categories and expands the scope of effects, risks, and hazards to be protected against. The Fact Sheet accompanying the Executive Order explains that the definition’s use of the phrase “disproportionate and adverse” is a simpler, modernized equivalent of the phrase “disproportionately high and adverse” originally used in Executive Order 12898. Whether this change in language from “disproportionately high” to “disproportionate” will affect agency decision-making is something to watch for in the future.

As part of the government-wide mission to achieve environmental justice, the Executive Order explicitly directs each agency to address and prevent the cumulative impacts of pollution and other burdens like climate change, including carrying out environmental reviews under the National Environmental Policy Act (“NEPA”), by:

  • Analyzing direct, indirect, and cumulative effects of federal actions on communities with environmental justice concerns;
  • Considering the best available science and information on any disparate health effects (including risks) arising from exposure to pollution and other environmental hazards, such as information related to the race, national origin, socioeconomic status, age, disability, and sex of the individuals exposed; and,
  • Providing opportunities for early and meaningful involvement in the environmental review process by communities with environmental justice concerns potentially affected by a proposed action, including when establishing or revising agency procedures under NEPA.
    The Executive Order also emphasizes transparency by directing agencies to ensure that the public, including members of communities with environmental justice concerns, has adequate access to information on federal activities. These activities include planning, regulatory actions, implementation, permitting, compliance, and enforcement related to human health or the environment when required under the Freedom of Information Act, the Clean Air Act, the Clean Water Act, the Emergency Planning and Community Right-to-Know Act, and any other environmental statutes with public information provisions.

CEQ is expected to issue interim guidance by the end of the year and more long-term guidance by the end of 2024 as to implementing the Executive Order’s directives. It is too early to know whether any directives will go through rulemaking under the Administrative Procedure Act. But with a presidential election looming and ongoing budget negotiations between the White House and Congress that propose modest cuts to NEPA as part of permitting reform, CEQ’s efforts may be limited to guidance for now.

© 2023 Ward and Smith, P.A.. All Rights Reserved.

For more environmental legal, news, visit the National Law Review here.

President Biden’s FY 2024 Budget Includes Additional Funding for TSCA and Funding to Address PFAS Pollution

On March 9, 2023, President Biden released his fiscal year (FY) 2024 budget. According to the U.S. Environmental Protection Agency’s (EPA) March 9, 2023, press release, the budget requests over $12 billion in discretionary budget authority for EPA in FY 2024, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024 budget include:

  • Ensuring Safety of Chemicals for People and the Environment: The budget provides an investment of $130 million, $49 million more than the 2023 enacted level, to build core capacity to implement the Toxic Substances Control Act (TSCA). Under TSCA, EPA has a responsibility to ensure the safety of chemicals in or entering commerce. According to EPA, in FY 2024, it “will focus on evaluating, assessing, and managing risks from exposure to new and existing industrial chemicals to advance human health protection in our communities.” EPA states that “[a]nother priority is to implement [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] to ensure pesticides pose no unreasonable risks to human health and the environment.”
  • Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: The budget provides approximately $170 million to combat PFAS pollution. This request allows EPA to continue working toward commitments made under EPA’s 2021 PFAS Strategic Roadmap, including: increasing its knowledge of PFAS impacts on human health and ecological effects; restricting use to prevent PFAS from entering the air, land, and water; and remediating PFAS that have been released into the environment.

EPA states that it will release the full Congressional Justification and Budget in Brief materials “soon.”

©2023 Bergeson & Campbell, P.C.

The EPA and Army Corps’ “Waters of the U.S.” (WOTUS) Rule to Become Effective on March 20

In January of 2023, the federal Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (USACE) published in the Federal Register (see Federal Register/Vol. 88, No. 11, January 18, 2023) new rules that define which water bodies are classified under the Clean Water Act (CWA) as “waters of the U.S.” (WOTUS). While this may not appear to be significant, the adoption of these rules will have major implications for how federal agencies will identify the types of water bodies that are subject to jurisdiction under the CWA. The January 18th Federal Register publication provides that these new rules will become effective on March 20, 2023.

The CWA is the law that provides federal agencies the authority to prohibit or limit various activities that can impact WOTUS, such as the regulation of industrial and municipal wastewater discharges to navigable waters, the dredging or filling of wetlands, and the requirement to prepare “Stormwater Pollution Prevention Plans” (SWPPP) for industrial facilities. It also is the basis for much State law water regulation.

Applicability of the CWA

To be classified as a WOTUS, a water body must be considered to be “navigable,” but this term is more arcane than it might at first appear. Navigable waters as defined by the CWA includes, “waters of the United States,” and has been further defined by regulation to include those waters that “are subject to the ebb and flow of the tide and/or are presently used, or have been used in the past, or may be susceptible for use to transport interstate or foreign commerce.” This approach to navigability has led some states to adopt a “saw log test” as to whether the body of water could float a saw log for commercial purposes. In other states, such as Wisconsin, the test for navigability is whether the body of water can on a recurring basis – even if intermittent – support navigation by the smallest recreational craft, such as a canoe or kayak. Therefore, navigable waters not only can include larger lakes, rivers and streams, but can also include less obvious smaller water types such as wetlands adjacent to navigable waters, and even in some instances, ditches that hold water. While the CWA provides federal jurisdiction over WOTUS, the CWA does not actually define the term WOTUS; rather, it provides authority for EPA and the USACE to define WOTUS in regulations, which since the 1970s, the agencies at various times have done.

The Rapanos Decision and Competing Rationales

Further, the definition of what constitutes WOTUS has been reviewed in several U.S. Supreme Court cases, but the most significant case on this subject is the 2006 case of Rapanos v. United States, 547 U.S. 715 (2006), in which the Supreme Court interpreted the definition of WOTUS using two separate tests. In a four-justice plurality opinion written by Justice Scalia, WOTUS was defined as “only those relatively permanent, standing or continuously flowing bodies of water forming geographic features that are described in ordinary parlance as streams[,] … oceans, rivers, [and] lakes,” and “wetlands with a continuous surface connection” to a “relatively permanent body of water connected to traditional interstate navigable waters.” However, Justice Kennedy applied a different approach in a concurring opinion and stated that WOTUS must possess a “significant nexus” to waters that are or were navigable in fact or that could reasonably be so made.” He added that adjacent wetlands could possess a significant nexus if the wetlands “either alone or in combination with similarly situated lands in the region, significantly affect the chemical, physical, and biological integrity of other covered waters more readily understood as ‘navigable.'”

Regulatory Attempts to Define WOTUS Following Rapanos

Following Rapanos, the agencies have at various times developed guidance for implementing the WOTUS definition. For example, in 2015, under the Obama administration, the agencies amended their regulations defining WOTUS as part of the “Clean Water Rule, which expanded the definition of which water bodies were defined as WOTUS, and included the use of the “significant nexus” test. Again, in 2020, under the Trump administration, another rule was adopted, known as the “Navigable Waters Protection Rule” (NWPR), which limited the types of water bodies that were considered WOTUS under the previous 2015 Clean Water Rule. However, in 2021, in Pasqua Yaqui Tribe v. EPA, (Case No. 4:20-cv-00266), the U.S. District Court for the District of Arizona vacated implementation of the NWPR nationwide. The new rules published in the January 2023 Federal Register represents the Biden administration’s effort to rewrite the WOTUS rules following the vacation of the NWPR, allowing the agencies the ability to use both Justice Scalia’s “relatively permanent” test or Justice Kennedy’s “significant nexus” test in determining whether they have jurisdiction over water bodies.

WOTUS under the New Rule

Use of the “relatively permanent” test or the “significant nexus” test is apparent in the new rule’s definition of WOTUS. The 2023 rules identify the following waters as WOTUS:

  • Traditional navigable waters, the territorial seas, and interstate waters;
  • Impoundments of waters otherwise identified as WOTUS;
  • Tributaries of navigable waters, territorial seas, interstate waters, or impoundments if the tributaries meet the relatively permanent test or the significant nexus test;
  • “Adjacent wetlands,” which includes wetlands adjacent to navigable waters, wetlands adjacent to and with a continuous surface connection to relatively permanent impoundments, wetlands adjacent to tributaries that are relatively permanent, and wetlands adjacent to impoundments or tributaries which meet the significant nexus test; and
  • Intrastate lakes and ponds, streams, or wetlands not listed above which meet the relatively permanent test or the significant nexus test.

The 2023 rules specifically exclude the following from the WOTUS definition, though some activities may still be subject to Wisconsin rules:

  • Prior converted cropland;
  • Waste treatment systems;
  • Ditches (including roadside ditches) excavated wholly in and draining only dry land, and that do not carry a relatively permanent flow of water;
  • Artificially irrigated areas that would revert to dry land if the irrigation ceased.
  • Artificial lakes or ponds created by excavating or diking dry land, that are used exclusively for stock watering, irrigation, settling basins or rice growing;
  • Artificial reflecting pools or swimming pools, and other small ornamental water bodies created by excavating or diking;
  • Waterfilled depressions in dry land incidental to construction activity and pits excavated in dry land for obtaining fill, sand or gravel unless the construction is abandoned and the water body meets the definition of WOTUS; and
  • Swales and erosional features that are characterized by low volume, infrequent, or short duration flow.

Where is this Going?

While these new WOTUS rules become effective on March 20, 2023, the future of these new rules is in question as the U.S. Supreme Court is reviewing a case (Sackett v. EPA, 142 S. Ct. 896 (2022)) in which the legal sufficiency of the “significant nexus” test, in the context of wetland permitting, is under review. The Court’s opinion is expected to be issued after the 2023 rules becomes effective. Therefore, depending on the Court’s opinion related to the “significant nexus” test, it is possible that the 2023 rules may need to be revised. Further, in early March, a federal Congressional Committee (the House Transportation and Infrastructure Committee) approved a joint resolution to overturn the 2023 rules. In addition, several industry groups have filed suits to overturn the 2023 rules. These definitions have always been politically and scientifically contentious and we expect that to continue.

Due to the potential flux in which this new rule may ultimately be applied and considered, it will be increasingly important for the regulated public to keep abreast of which water bodies are ultimately determined to be classified as WOTUS, either by the agencies through regulation or guidance, by a U.S. Supreme Court decision in Sackett, and/or other legal or Congressional challenges. We will be tracking the implementation of this new rule by the agencies and related caselaw developments and Congressional challenges and will provide timely future Legal Updates. In the meantime, the extent of regulations of WOTUS – particularly wetlands – will continue to be very challenging.

©2023 von Briesen & Roper, s.c

EPA Updates TSCA Inventory, Plans Next Update in Summer 2023

The U.S. Environmental Protection Agency (EPA) announced on February 16, 2023, that the latest Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available on its website. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, this update to the public TSCA Inventory is part of its biannual posting of non-confidential Inventory data. EPA plans the next regular update of the TSCA Inventory for summer 2023.

EPA states that the TSCA Inventory contains 86,685 chemicals, of which 42,170 are active in U.S. commerce. Other updates to the Inventory include new commercial activity data, unique identifier data, and regulatory flags (e.g., significant new use rules and test orders). EPA notes that additionally, several hundred substances are now listed with their specific chemical identities after having been moved from the confidential portion of the Inventory to the public portion as part of EPA’s TSCA confidential business information (CBI) review efforts.

Lastly, EPA reminds TSCA submitters to check regularly for any correspondence relating to their submissions in EPA’s Central Data Exchange (CDX). EPA states that it sends “critical and time-sensitive information regarding confidentiality claims through CDX, and failing to open this correspondence can delay the Agency’s processing of those claims.”

©2023 Bergeson & Campbell, P.C.