Tag: EPA

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 products, Section 4.7.2 Inorganic- and mineral-based products, Section 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.

©2023 Bergeson & Campbell, P.C.
For more news on EPA’s Safer Choice Standard, visit the NLR Environmental, Energy & Resources section.

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.

© Polsinelli PC, Polsinelli LLP in California
For more news on EPA PFAS Rules, visit the NLR Environmental, Energy & Resources section.

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.

©2023 Bergeson & Campbell, P.C.

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.

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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.”

Article By Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.

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©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.

Article By David P. Ruetz of von Briesen & Roper, s.c.

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©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.”

Article By Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.

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©2023 Bergeson & Campbell, P.C.

Canadian PFAS Drinking Water Standards Proposed

We have documented for several years now the U.S. EPA’s efforts to propose enforceable drinking water standards with respect to PFAS, and in September 2022, the World Health Organization (WHO) issues its own draft “PFOS and PFOS In Drinking-Water” Background Document.  Now, on the heels of these developments, Canadian PFAS drinking water standards were introduced, which add another regulatory layer to the globally evolving PFAS regulatory scheme. Notably, Canada takes a different approach than both the United States and the WHO in addressing PFAS drinking water issues, but the proposal will nonetheless have impacts on U.S. PFAS litigation if passed.

Canadian PFAS Drinking Water Standards

Canada’s draft proposal sets a limit of 30 ppt for any detected PFAS combined in a given drinking water source. This is in contrast to the WHO, which only addressed PFOA and PFOS in its draft recommendations for drinking water standards, and the EPA, which by all indications will only propose enforceable drinking water standards for a small subset of the over 12,000 PFAS that exist. The Canadian standards, though, do propose requiring that EPA Testing Methods 533 or 537.1 be used for detection, which only tests for 29 PFAS types. Nevertheless, the large group approach to PFAS drinking water standards is unique for the moment to Canada, although the WHO did include in its proposal a similar limited subset of PFAS for countries to consider when setting or proposing drinking water standards.

Comments to the Canadian draft document are being accepted through April 12, 2023.

EPA’s Drinking Water Actions

We previously detailed how, on June 15, 2022, the EPA issued Health Advisories (HAs) for five specific PFAS, PFOA (interim), PFOS (interim), PFBS (final) and GenX (final). While not enforceable levels for PFAS in drinking water, the EPA’s PFAS Health Advisories are nevertheless incredibly significant for a variety of reasons, including influence on future federal and state drinking water limits, as well as potential impacts on future PFAS litigation.

The levels set by the EPA’s PFAS Health Advisories were as follows:

PFOA .004 ppt
PFOS .02 ppt
GenX 10 ppt
PFBS 2,000 ppt

Since the HAs were published, the EPA has faced several lawsuits challenging the HAs. The lawsuits generally allege that the HAs should be struck down and are not valid, as they were created “arbitrarily and capriciously.”  In support, the moving parties say that the HAs were created in an improper manner because (1) they incorporated toxicity assumptions that deviate from the EPA’s own standard methods; and (2) EPA incorporated grossly incorrect and overstated exposure assumptions―in essence, EPA used the wrong chemical when making its exposure assumptions, thereby resulting in a significantly less tolerant health advisory for [PFAS] than is warranted by the data. In addition, the parties argue that the EPA failed to go through the necessary public comment period before issuing its final GenX HA, and that in creating the GenX HA, the EPA exceeded its authority under the Safe Drinking Water Act.

Canadian PFAS Impacts On EPA Efforts and Litigation

When the WHO PFAS report was released, we wrote that the report will have an impact on existing and future litigation that challenges EPA regulatory actions focused on PFAS. Our reasoning for the prediction was that the standards proposed by the WHO were significantly higher than the EPA’s Health Advisories (which may foreshadow where the EPA’s enforceable drinking water limits will be set) even though the WHO had available to it much of the same scientific literature as the EPA. The Canadian PFAS drinking water proposal of 30 ppt is also higher than the EPA’s Health Advisories and what many predict will be the EPA’s proposed enforceable drinking water limit.  Future legal arguments challenging the EPA will likely say that the EPA is acting by ignoring the science and putting politics over the merits of scientific endeavor.

Nevertheless, whether the arguments challenging the EPA are found to be meritorious in litigation or not, the Canadian report will certainly provide ammunition to parties looking to challenge EPA action.

Conclusion

Now more than ever, the EPA is clearly on a path to regulate PFAS contamination in the country’s water, land and air. The EPA has also for the first time publicly stated when they expect such regulations to be enacted. These regulations will require states to act, as well (and some states may still enact stronger regulations than the EPA). Both the federal and the state level regulations will impact businesses and industries of many kinds, even if their contribution to drinking water contamination issues may seem on the surface to be de minimus. In states that already have PFAS drinking water standards enacted, businesses and property owners have already seen local environmental agencies scrutinize possible sources of PFAS pollution much more closely than ever before, which has resulted in unexpected costs. Beyond drinking water, though, the EPA PFAS Roadmap shows the EPA’s desire to take regulatory action well beyond just drinking water, and companies absolutely must begin preparing now for regulatory actions that will have significant financial impacts down the road.

©2023 CMBG3 Law, LLC. All rights reserved.
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EPA and Army Corps Issue New “WOTUS” Rule While Supreme Court Considers Jurisdiction Over Adjacent Wetlands

Yesterday, the US Environmental Protection Agency (EPA) and the US Army Corps of Engineers (Corps) (together, the Agencies) published a final rule revising the definition of “waters of the United States” (WOTUS) subject to federal regulation and permitting requirements under the Clean Water Act (CWA).  This rule is the latest attempt by the Agencies to craft a durable rule defining WOTUS.  The new rule, which largely mirrors the 2021 proposal, asserts a broader geographic scope of federal jurisdiction than the 2020 Navigable Waters Protection Rule (NWPR).  In particular, the Agencies adopt the broadest possible interpretation of the Supreme Court’s decision in Rapanos (through incorporation of both the plurality’s “relatively permanent” test and Justice Kennedy’s “significant nexus” test).  The final rule would, for the first time, codify aspects of the Agencies’ 2008 Rapanos Guidance and would rely on the significant nexus test’s case-by-case approach for evaluating jurisdiction for tributaries, wetlands, and other waters.  The Agencies released the final rule while the Supreme Court considers the scope of CWA authority over a major category of WOTUS, “adjacent wetlands,” in Sackett v. EPA, and the Supreme Court could hand down a decision in the coming months that could require changes to the rule.

For project proponents, the new rule would likely mean more features would be subject to regulation under the CWA, and projects that might have previously qualified for nationwide permits may no longer meet the acreage limits and would instead require an individual permit.  Also, case-by-case significant nexus determinations could result in lengthy reviews with uncertain and inconsistent results.

The final rule will go into effect on March 20.  While the Agencies previously characterized this rule as Phase 1 of a two-step process to enact a new WOTUS definition, EPA recently indicated that it is not currently planning a major second phase.

Summary of Final Rule

The rule defines WOTUS to include:

  1. Traditional navigable waters (TNWs), the territorial seas, and interstate waters.  TNWs include large rivers and lakes and tidally influenced waterbodies used in interstate or foreign commerce.  Interstate waters are rivers, lakes, and other waters that flow across, or form part of, State boundaries.  The TNW definition (i.e., all waters currently used, or were used in the past, or may be susceptible to use in interstate or foreign commerce, including all waters which are subject to the ebb and flow of the tide) is consistent with the text of the 1986 regulations and the NWPR.  However, the preamble indicates that the Agencies plan to include “waters currently being used for … commercial waterborne recreation (for example, boat rentals, guided fishing trips, or water ski tournaments),” which appears to broaden the scope of TNW waters.
  2. Impoundments of WOTUS.  The final rule retains the provision in the 1986 regulations that defines WOTUS to include impoundments of WOTUS.  The preamble defines impoundments as “created by discrete structures (often human-built) like dams or levees that typically have the effect of raising the water surface elevation, creating or expanding the area of open water, or both.”  88 Fed. Reg. at 3,066.
  3. Tributaries.  The final rule extends jurisdiction to tributaries of categories 1 and 2 waters if the tributary meets either the Agencies’ new formulation of the relatively permanent or the significant nexus standards from Rapanos (discussed in more detail below).  Ephemeral streams that meet the significant nexus test would be jurisdictional tributaries.  In this respect, the rule is much broader than the NWPR, which categorically excluded ephemeral tributaries from jurisdiction.
  4. Adjacent wetlands.  The rule retains the definition of “adjacent” from the 1986 regulations meaning “bordering, contiguous, or neighboring” and adds language that adjacent wetlands are considered WOTUSifthey meet the relatively permanent or significant nexus standards.  The NWPR had narrowed the definition of adjacent wetlands to include only those wetlands that abutted or otherwise had a direct surface connection to other jurisdictional waters in a typical year.  The final rule creates a broader category of adjacent wetlands, leading to additional regulatory requirements for activities that cross or impact such features.
  5. Other waters.  The rule asserts jurisdiction over “other waters” under the relatively permanent and significant nexus standards from Rapanos.  Under this provision, which essentially serves as a “catch-all” category, “intrastate lakes and ponds, streams, or wetlands” not identified in categories 1-4 can be assessed for jurisdiction under the relatively permanent standard or significant nexus standard.  This list is intended to be exclusive, 88 Fed. Reg. at 3,100, but broad enough to include a large variety of water types (e.g., prairie potholes, sloughs, playa lakes, etc.).  This category is a clear departure from the 2008 Rapanos Guidance, which did not assert jurisdiction over “other waters” based on the relatively permanent waters or significant nexus standards.

Exclusions.  The final rule provides a list of features that are excluded even where they would otherwise qualify as jurisdictional impoundments, tributaries, adjacent wetlands, or other waters.  Importantly, features that qualify as category 1 waters (TNWs, territorial seas, and interstate waters) cannot be excluded even if they meet the criteria of the exclusions provided.  Key non-jurisdictional waters or exclusions include waste treatment systems, ditches, prior converted cropland, artificially irrigated areas, artificial lakes or ponds, and swales and erosional features.  The list of exclusions is similar to the list provided in the 2015 WOTUS Rule and 2020 NWPR, although it does not provide the clear definitions that were included in the NWPR and in some instances changes the exemption based on preamble interpretations.

Key Definitions. The rule also includes a number of important definitions.

  • The “relatively permanent standard” asserts jurisdiction over relatively permanent, standing or continuously flowing waters connected to category 1 waters, and waters with a continuous surface connection to such relatively permanent waters or to category 1 waters.  88 Fed. Reg. at 3,006.  The final rule does not define or quantify what constitutes “relatively permanent” flow.  The preamble states that the relatively permanent standard encompasses surface waters that have flowing or standing water year-round or continuously during certain times of the year.  88 Fed. Reg. at 3,084.
  • The significant nexus standard asserts jurisdiction over waters that, either alone or in combination with similarly situated waters in the region, significantly affectthe chemical, physical, or biological integrity of category 1 waters.  In a change from the proposal, the final rule defines “significantly affect” to mean “a material influence on the chemical, physical, or biological integrity of [category 1] waters.”  To determine whether waters, either alone or in combination with similarly situated waters in the region, have a material influence on the chemical, physical, or biological integrity of category 1 waters, the Agencies will assess the  list of functions and factors, including, for example contribution of flow, distance from a category 1 water, and hydrologic connections.  The preamble states distance from a category 1 water and hydrology—will generally be given the greatest weight in the assessment.  88 Fed. Reg. at 3,120.  The new significant nexus standard will likely allow for broader assertions of jurisdiction because it allows the Agencies to aggregate all tributaries and adjacent wetlands within a particular geographic area and evaluate whether they have a “material influence” on category 1 waters based on a case-by-case application of the enumerated factors and functions.  This type of case-by-case significant nexus analysis has resulted in lengthy review times as well as unpredictable and inconsistent results.

Existing Jurisdictional Determinations

Landowners may obtain a jurisdictional determination in the form of either: (1) an approved jurisdictional determination (AJD), which is a Corps document identifying the limits of WOTUS on a parcel; or (2) a preliminary jurisdictional determination (PJD), which is a non-binding document in which an applicant can assume all waters will be treated as jurisdictional without making a formal determination.

The Agencies take the position that AJDs issued pursuant to the NWPR may not be relied upon in making new permit decisions.  According to the preamble, because the NWPR was vacated by two district courts, NWPR AJDs “may not reliably state the presence, absence, or limits of [WOTUS] on a parcel and will not be relied upon by the Corps in making new permit decisions.”  88 Fed. Reg. at 3,136.  The Agencies take the position that AJDs issued under earlier WOTUS definitions—except those AJDs issued under the NWPR—remain valid until the AJD’s expiration date.  Also, the new rule will govern any pending requests for AJDs, if the AJD is issued on or after the effective date of the rule (March 20, 2023).

In contrast to AJDs, PJDs are advisory in nature and have no expiration date.  The preamble clarifies that the new WOTUS rule has no impact on existing PJDs.

Potential Litigation and the Sackett Case

Multiple challenges to the new rule are likely to be filed in district courts across the country.  The state of Texas and an industry coalition immediately filed suits in the U.S. District Court for the Southern District of Texas, and other suits are likely.  At the same time, the Supreme Court’s pending decision in Sackett may have implications for the durability of provisions of the rule.

Many commenters recommended that the Agencies defer issuing a final rule until the Supreme Court issues a decision in Sackett—a case in which the issue before the Court is “the proper test for determining whether wetlands are [WOTUS] under the [CWA].”  A decision in the Sackett case is expected in the next few months.  Perhaps trying to insulate the rule from a potentially unfavorable Supreme Court decision, the Agencies assert in the preamble the severability of the individual provisions of the rule.  The preamble states, “if a court were to determine that a wetland cannot be treated as adjacent if it is separated from a jurisdictional water by road or other barrier, the agencies intend that other categories of wetlands within the rule’s definition of ‘adjacent’ would remain subject to jurisdiction.”  88 Fed. Reg. at 3,135.  Although it is not clear how the Supreme Court will rule in Sackett, it is possible that the decision could require the Agencies to make changes to the new WOTUS definition or face legal challenges.

Article By Kerry L. McGrath, Brian R. Levey, Andrew J. Turner, Karma B. Brown, Deidre G. Duncan, and Matthew Z. Leopold of Hunton Andrews Kurth

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Copyright © 2023, Hunton Andrews Kurth LLP. All Rights Reserved.

Environmental Justice Update: EPA Announces $100 Million in EJ Grants to Local Groups and Issues Guidance Outlining Potential Federal ‘Cumulative Impact’ Claims

“Environmental justice” (EJ) continues as the primary leitmotif of Biden Administration environmental policy in the first weeks of 2023.

Below, we unpack two recently announced EJ efforts: a grant program for groups in environmentally overburdened communities and guidance on legal resources to address “cumulative impacts” issued by the US Environmental Protection Agency’s (EPA) Office of Legal Counsel and outline what these mean for the regulated community taken together in the context of other recent EJ developments.

EPA Announces $100 Million in Grants to Community Groups

This week, EPA announced the availability of approximately $100 million in grants for projects that “advance EJ in underserved and overburdened communities.” The grant programs are part of funding allocated by the Inflation Reduction Act programs discussed here.

Summaries of the two programs:

  • The Environmental Justice Collaborative Problem-Solving Program (EJCPS) Cooperative Agreement Program. The EJCPS program provides $30 million in funding directly to community-based non-profit organizations for projects focused on addressing local environmental or public health issues in their communities. Five million of the funding is reserved for small community-based nonprofit organizations with five or fewer full-time employees. EPA anticipates funding approximately 50 awards of $500,000 and 30 awards of $150,000.

  • Environmental Justice Government-to-Government (EJG2G) Program. EJG2G will provide an estimated $70 million in funding for state, tribal, and local projects completed in conjunction with community-based organizations. In total the agency anticipates funding approximately 70 projects of up to $1 million each for a 3-year project.

Interested applicants must submit proposal packages on or before April 10, 2023, for projects to begin on October 1, 2023.

EPA’s efforts to fund local groups are part of its broader strategic goal of enhancing equitable apportionment of resources and the benefits of environmental policies. EPA’s Equity Action Plan, discussed here, prioritizes building capacity in environmentally underserved communities to lead projects. Projects like these would lead to increased community engagement, which in turn could lead to more equitable outcomes in the environmental space. The strategy of building up local capacity to engage on environmental issues, mirrors private-sector efforts like Bloomberg Philanthropies $85 million “Beyond Petrochemicals” campaign, discussed here.

Federal Cumulative Impact Guidance

EPA’s Office of General Counsel released its Cumulative Impacts Addendum this week. This addendum builds on EPA’s Legal Tools to Advance Environmental Justice, which was released in May 2022. Taken together, these encyclopedia-like documents were created with the purpose of “identifying and making appropriate use of every authority and tool available to EPA under the law to incorporate environmental and climate justice considerations in our work,” in the words of EPA Administrator Michael Regan. The addendum itself indicates that it “is not intended to prescribe when and how [EPA] should undertake specific actions, nor does it provide methodologies for how to conduct a cumulative impacts assessment.” (Note: EPA’s Office of Research and Development has advanced a definition of “cumulative impacts,” summarized here, and is researching methodologies to deploy the concept.)

Structurally, the addendum breaks EPA’s authorities to address cumulative impacts into six subject-matter focused chapters:

  • Clean Air Act Programs

  • Water Programs

  • Waste Management and Emergency Response Programs (i.e. Resource Conservation and Recovery Act; Oil Pollution Act; the Emergency Planning and Community Right-to-Know Act; and the Comprehensive Environmental Response, Compensation, and Liability Act)

  • Pesticides and Toxics Programs (i.e. Federal Insecticide, Fungicide, and Rodenticide Act; the Federal Food, Drug, and Cosmetic Act; and the Toxic Substances Control Act); and

  • Environmental Review Programs (i.e. National Environmental Policy Act and Clean Air Act Section 309 Reviews).

EPA’s intent with the addendum was to outline legal resources for federal, state, and local regulators to consult situationally outlining potential tools that could be used to address cumulative impacts. These legal tools, used in conjunction with EJ-focused screening tools like EJSCREEN (discussed here) and newly developed and (increasingly available) data (see our discussions here and here), are part of EPA’s high prioritization of EJ issues.

Takeaways for the Regulated Community

We offer two takeaways from these developments:

First, EPA’s commitment to a “whole of government” approach to address EJ issues continues unabated. Over time, the Biden Administration has exhibited a willingness to allocate money to address EJ issues; reorient EPA and DOJ to better address them; develop new tools; and indeed, build capacity to engage local communities in an effort to benefit more Americans regardless of their race, language or socioeconomic status.

Second, taken collectively, these efforts will necessitate changes in process for regulated entities because governmental and community engagement in the EJ space is altering the policymaking process at a rapid rate. Relevant here, we expect that a secondary effect of EPA and private parties “building capacity” in local communities will be an increase in community involvement — and potentially opposition — to businesses operating in their communities. These groups are likely to deploy all available resources — including those outlined in the addendum — to address their concerns.

© 2023 ArentFox Schiff LLP
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