EPA Releases White Paper on Modernizing the Process and Bringing Innovative Science to Evaluating New Chemicals Under TSCA

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EPA recently released a white paper, The New Chemicals Collaborative Research Program: Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA. The document was produced as a summary report to the Board of Scientific Counselors as an integrative research plan under the 2023-2026 Chemical Safety for Sustainability (CSS) Strategic Research Action Plan. This plan seeks to address concerns by both industry and environmental organizations, including the significant lag in EPA’s review of new chemicals, lack of transparency in the process, and insufficient consideration of potential hazards. In addition, the plan would allow EPA’s staff to use new scientific methods to analyze chemical impacts on humans and the environment.

Under TSCA, chemical manufacturers have not been required to provide chemical hazard data in their PMN applications. Under the proposed new processes, data on toxicity, exposure, chemical use, and other databases, in conjunction with computer-based analysis methods, would make chemical reviews easier for the Agency. The plan will focus on five key research areas:

(1) Updates and refinements to chemical analog and category approach.

(2) Development and expansion of databases containing TSCA chemical information.

(3) Development and refinement of predictive models for physiochemical properties, environmental fate/transport, hazard, exposure, and toxicokinetics.

(4) Integration and application of in vitro New Approach Methodologies (NAMs).

(5) Development of a TSCA new chemicals decision support tool that utilizes curated data.

Using these NAMs, the Agency hopes to fill information gaps and address the challenges of its current framework.

Earthjustice Files Petition Requesting EPA Revoke LVE and LoREX Exemptions for 600 PFAS

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On October 13, 2022, Earthjustice, on behalf of numerous environmental organizations and community advocates throughout the country, filed a petition with EPA requesting that the Agency revoke the approval of approximately 600 PFAS Low Volume Exemptions (LVEs) and Low-Exposure Exemptions (LoREXs) to the TSCA Premanufacture Notice (PMN) requirement. The petition argues that EPA has a regulatory and statutory duty under 40 C.F.R. § 723.50(h)(2)(i)(A) to review previously granted LVEs and LoREXs to ensure they meet legal standards for exemption under TSCA section 5 (h)(4). (Earthjustice states that 40 C.F.R. § 723.50(h)(2)(i)(A) implicitly requires EPA to notify a manufacturer “at any time after the [initial] review period,” if it determines that a previously granted exemption no longer meets the legal standard, is that EPA must continue to evaluate chemicals’ eligibility for PMN exemptions in light of new information.)

PMN exemptions require that a substance “will not present an unreasonable risk.” The petition argues that this conclusion cannot be scientifically supported for the exposure levels allowed under the LVEs and LoREXes that have been granted.  The petition notes that EPA has the authority to revoke a previously granted exception at any time if it no longer meets TSCA’s legal standards.  When it issued the LVE rule in 1985, the Agency detailed its revocation authority, explaining that the authority “ensure[s] that eligibility for the exemption will be determined on the basis of the best available information [i.e., scientific evidence], regardless of when the information becomes available.” EPA made a similar statement regarding LoREXes in 1995.  The petition noted that this obligation is further stressed in case law that holds that EPA and other federal agencies have a general duty to consider new scientific information that may bear on whether the Agency’s past decisions or standards are health-protective, and to modify past decisions to ensure legal requirements are met.

The petition further argues that EPA’s prior initiatives to address PFAS LVEs do not adequately address health risks.  Earthjustice highlights numerous studies related to PFAS and human, animal, and environmental health, as well as EPA’s own statements indicating that it expects that chemicals entering commerce through both LVE and LoREX will result in levels of contaminations that far exceed what are now thought to be safe levels for PFAS.

This petition builds on Earthjustice’s 2021 petition that asked the Agency to amend the regulations that create exemptions from the PMN process—the LVE, the LoREX, the Byproducts Exemption, and the Polymer Exemption—to prohibit their use for PFAS.  The Agency has not yet responded to that request. TSCA section 21 permits any person to petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule or order under TSCA section 4 (rules or order requiring chemical testing), section 5(d) or (f) (orders affecting new chemical substances) section 6 (rules imposing regulatory controls on chemicals), and section 8 (rules requiring information).

Petition to Remove Polyvinyl from EPA’s Safer Choice and Safer Chemical Ingredients List

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On November 15, 2022, BlueLand and Plastic Pollution Coalition filed a petition with EPA on behalf of itself and numerous non-profit organizations fighting plastic pollution and climate change, requesting that EPA require health and environmental testing and regulation of polyvinyl alcohol under TSCA, and that the substance be removed from EPA’s Safer Choice and Safer Chemical Ingredients lists. TSCA section 21 permits any person to petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule or order under TSCA section 4 (rules or order requiring chemical testing), section 5(d) or (f) (orders affecting new chemical substances) section 6 (rules imposing regulatory controls on chemicals), and section 8 (rules requiring information).

Polyvinyl alcohol, also referred to as PVA or PVOH, is commonly used in consumer-packaged goods, including laundry and dishwasher detergent pods and sheets. PVA is a petroleum-based polymer that serves as the thin layer of plastic film on these pods. The film dissolves in the water during a washing machine or dishwasher cycle. However, the PVA itself does not; tiny pieces of plastic debris called microplastics are contained in the wastewater.

Microplastics are suspected of contributing to plastic pollution in oceans and waterways. A recent study detailed in Degradation of Polyvinyl Alcohol in US Wastewater Treatment Plants and Subsequent Nationwide Emission Estimate stated that approximately 75 % of PVA from these pods persists through conventional wastewater treatment, ultimately ending up in waterways and ecosystems. Additionally, microplastics have been found in human food and water sources, the human bloodstream, and human breast milk.

The petition argues that under TSCA (15 U.S.C 2603), EPA has the authority to and should require extensive health and environmental safety testing of PVA once it is released into ecosystems and waterways. The petition also requests that PVA be removed from EPA’s Safer Chemicals Ingredient List developed by EPA’s Safer Choice Program; the list arranges chemicals by functional-use class to help manufacturers find safer chemical alternatives than traditional chemicals that meet the criteria of the Safer Choice Program. The petition argues that based on PVA’s bioaccumulative and persistence qualities, when applied to the Safer Choice Program’s guidance on polymers, PVA does not meet the requirements to be listed.

EPA Releases Supplemental Proposed Rulemaking to Modify TSCA Fees Rule

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On November 16, 2022, EPA published a supplemental notice of proposed rulemaking (SNPRM) (87 FR 68647) addressing fees for the administration of TSCA. The SNPRM modifies and supplements the Agency’s proposed TSCA fees rule issued on January 11, 2021. The 2021 proposed rule was released pursuant to TSCA section 26(b)(4)(F), which requires EPA to review and, if necessary, adjust fees every three years. EPA determined this SNPRM was necessary based on comments on the proposed rule, adjustments to EPA’s cost estimates, and additional experience in implementing the 2018 Fee Rule. Modifications include:

  • Increasing fee amounts and the estimates of EPA’s costs for TSCA administration.
  • Expansion of the fee requirements to companies required to submit information for test orders.
  • Narrowing the proposed exemptions for the test rule fee activities to only: (1) importers of articles containing a chemical substance; (2) producers of a chemical substance as a byproduct; (3) manufacturers (including importers) of a chemical substance as an impurity; (4) producers of a chemical as a non-isolated intermediate; (5) manufacturers (including importers) of small quantities of a chemical substance solely for research and development and; (6) manufacturers (including importers) of chemical substances with production volume less than 1,100 lbs of a chemical subject to a TSCA section 4 test rule.
  • Adjustments to the self-identification and reporting requirements of EPA-initiated risk evaluation and test rule fees to reduce the burden of calculating and reporting production volumes to comply with the 2021 proposed recordkeeping requirements. EPA is considering using ranking methodologies and reporting production volume ranges instead of averages.
  • The proposal of a partial refund of fees for PMNs withdrawn any time after the first 10 business days during the assessment period for the chemical.
  • Adjustment of the fee payment obligations to require payment by processors subject to test orders and enforceable consent agreements.
  • Extending the time frame for test orders and test rule payments.

The proposed fee increases are as follows:

Fee Category 2018 Fee Rule Current Fees* 2022 Supplemental Proposed Rule
Test order $9,800 $11,650 $25,000
Test rule $29,500 $35,080 $50,000
Enforceable consent agreement $22,800 $27,110 $50,000
PMN and consolidated PMN, SNUN, MCAN, and consolidated MCAN $16,000 $19,020 $45,000
LoRex, LVE, TME, Tier II exemption, TERA, Film Articles $4,700 $5,590 $13,200
EPA-initiated risk evaluation $1,350,000 Two payments totaling $2,560,000 Two payments totaling $5,081,000
Manufacturer-requested risk evaluation on a chemical included in the TSCA Work Plan Initial payment of $1.25M with final invoice to recover 50% of actual costs Two payments of $945,000, with final invoice to recover 50% of actual costs Two payments of $1,497,000, with final invoice to recover 50% of actual costs
Manufacturer-requested risk evaluation on a chemical not included in the TSCA Work Plan Initial payment of $2.5M, with final invoice to recover 100% of actual costs Two payments of $1.89M, with final invoice to recover 100% of actual costs Two payments of $2,993,000, with final invoice to recover 100% of actual costs

*The current fees reflect an adjustment for inflation required by TSCA and went into effect on January 1, 2022.

EPA states that increased fees will ensure recovery of 25% of implementation costs, consistent with the direction of the Fiscal Year 2022 appropriations bill. The Agency also states that the fee increases will strengthen its ability to successfully implement TSCA in a manner that is both protective and sustainable.  Furthermore, EPA asserts that the fee increases will improve on-time performance and quality significantly.

EPA officials have repeatedly argued that the 2016 Lautenberg Amendments tasked the Agency with many new responsibilities but did not increase the TSCA budget accordingly. According to the Agency, while there was a fee increase in 2018, EPA was only able to collect about half of the 25% target fees since the 2018 rule’s finalization. Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff commented, “[f]or the last six years, we’ve lacked the needed resources to build a sustainable chemical safety program that’s grounded in science, protects communities from dangerous chemicals, and supports innovation; with today’s action, we’re continuing to adjust TSCA fees to account for the full costs of running the program the way that Congress intended.”

EPA will hold a webinar on December 6, 2022, from 1:00 PM to 2:30 PM to provide stakeholders with an overview of the SNPRM and accept public comments. Registration closes on December 1, 2022; you can register for the webinar here.

EPA Advances Early Pesticides Protections for Endangered Species

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On November 16, 2022, the Environmental Protection Agency (EPA) released an update to its Endangered Species Act (ESA) Workplan that outlines steps to increase protections for wildlife while also providing regulatory certainty for pesticide users. The update, which follows the EPA’s April 2022 ESA Workplan, aims to address the complexity of meeting the Agency’s obligations under the ESA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). When registering or reevaluating a pesticide, EPA has an obligation under FIFRA to determine whether the pesticide presents unreasonable adverse effects on human health or the environment.   EPA is also obligated under the ESA to ensure pesticide registrations do not imperil the continued existence of ESA-listed species or adversely impact their respective critical habitats.

To better fulfill the Agency’s obligations under the ESA, the Workplan update stresses the need for pesticide registration review and other FIFRA actions to provide protections for nontarget species, including endangered and threatened species, earlier in the review process. As well as resulting in better ESA compliance, these changes could provide farmers with more predictable access to pesticides.

  1. Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.
  2. Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for future conventional and biological pesticide registration and registration review actions to protect non-target species
  3. Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture..
  4. Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.

The FIFRA Interim Ecological Mitigation measures will focus on reducing pesticide spray drift and runoff. and will be applied on a case-by-case basis, depending on the level of risk that a particular pesticide presents to species and the exposure route. This approach is intended to more efficiently protect nontarget species, including listed species, and to standardize protections across similar pesticides, rather than addressing risks on a pesticide or species-specific basis as the EPA has done in the past.

Additionally, the Agency plans to work with registrants of pesticides to add language to pesticide labels that direct users to reference Bulletins Live! Two, a website containing endangered species protection bulletins. These bulletins contain use limitations to protect threatened and endangered species and their designated critical habitat in specific geographic areas. The EPA expects that adding the reference to Bulletins Live! Two, to pesticide labels in advance of consultation with the US Fish and Wildlife Service and the National Marine Fisheries Service, will save time and resources by reducing the number of amendments to labels. It further plans to add language on pesticide incident reporting and advisory language to protect insect pollinators to protect listed and other non-target species better.

Verdant Law’s Irene Hantman Gives Presentation to Chemical Society of Washington on Chemical Commercialization

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Verdant Law is pleased to announce that Irene Hantman gave a presentation, Chemical Commercialization: What to Know about EPA Regulations, before the Chemical Society of Washington. The presentation provided a comprehensive overview of chemical commercialization under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The overview of TSCA detailed the definitions of chemical substances and substances in commerce, background on the TSCA Inventory and the premanufacture notification (PMN) process, and the EPA platforms for reporting and submitting data related to PMNs and active Inventory substances. The overview of FIFRA outlined the definition of pesticides under the law, the pesticide registration process, data requirements, review timelines and fees, and potential tolerance limitations EPA may set on chemicals with food uses. For questions about this presentation, contact Irene Hantman.

California Department of Toxic Substances Hosted Engagement Sessions on Sustainable Chemistry Definition

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The California Department of Toxic Substances Control (CDTSC) hosted two engagement sessions encouraging stakeholders to share their perspectives on an actionable definition of sustainable chemistry that was provided by the Expert Committee on Sustainable Chemistry (ECOSChem). ECOSChem is a 20-person group including representatives from academia, government, industry, and non-governmental organizations.  The group has been tasked with establishing “an ambitious, actionable definition and criteria for sustainable chemistry that can enable effective government policy, inform business and investor decision making, enhance chemistry education, and spur the adoption across all supply chains of chemicals that are safer and more sustainable.”

In its draft, ECOSChem defined sustainable chemistry as “the practice and application of chemistry that eliminates negative impacts to humans and ecosystems, as well as benefits current and future generations.” The definition was drafted with five criteria in mind (1) health and safety through hazard elimination, (2) climate and ecosystem impacts, (3) circularity, (4) equity and justice, and (5) transparency. In addition to the definition, , ECOSChem provided the following indicators of what sustainable chemistry will look like:

A sustainable chemical, material, process, or product will…

  • Eliminate all associated hazards and hazardous emissions to all people and ecosystems across its existence.
  • Not result in releases, including releases of byproducts or breakdown products, that negatively persist or bioaccumulate.
  • Eliminate impacts on climate and biodiversity by utilizing earth-abundant, non-toxic chemical building blocks that minimize habitat and resource degradation, greenhouse gas emissions, carbon footprints, and energy consumption, including for transportation and distribution.
  • Be designed to have [a] lifetime appropriate for its use and enable safe reuse and non-toxic recycling.
  • Prioritize resource and energy conservation and reclamation, reduce consumption of finite resources, and waste prevention, minimization, and elimination.
  • Be designed such that all associated negative social impacts are eliminated.
  • Be made or implemented to prioritize the remediation of harms for communities and societies that have been disproportionately impacted by traditional chemistries, chemicals, and chemical processes, and/or support the needs of workers, marginalized groups (e.g., immigrant communities, and communities of color), and vulnerable groups (e.g., pregnant women and children).
  • Be made or implemented in a way that does not create new problems or shift harm to other communities or societies.
  • Have had its health, safety, and environmental data disclosed in an accessible format to individuals, workers, communities, policymakers, and the public.
  • Use independent, third-party systems to verify sustainability, health, safety, and other claims. The sources for verification should be openly accessible.

ECOSChem members will use the feedback received at the meeting to revise the definition to ensure that the language is clear and actionable.

 

 

 

 

Biden-Harris Administration Expands Cybersecurity Partnership in Chemical Sector

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On October 26, 2022, the Biden-Harris Administration announced it is expanding its Industrial Control Systems (ICS) Cybersecurity Initiative to the chemical sector. The ISC Cyber Security Initiative was launched in April 2021 to strengthen the cybersecurity of critical infrastructure across the country through private sector and government collaborations. The focus of the collaboration is to facilitate the deployment of technologies and systems that provide threat visibility, indications, detections and warnings, and facilitate responses. The Initiative is currently underway in other industrial sectors including water and wastewater, and energy.

The U.S. Cybersecurity and Infrastructure Agency (CISA) and the nation’s leading chemical companies are jointly developing the Chemical Action Plan over the next 100 days. The Plan will detail the chemical industry self-assessment of current cybersecurity practices, lessons learned and best practices. The plan will include the following:

  • Focus on high-risk chemical facilities that present significant chemical release hazards, with the ultimate goal of supporting enhanced ICS cybersecurity across the entire chemical sector.
  • Drive information sharing and analytical coordination between the Federal Government and the chemical sector.
  • Foster collaboration with sector owners and operators to facilitate and encourage the deployment of appropriate technologies, based on each chemical facility’s own risk assessment and cybersecurity posture (the Federal Government will not select, endorse, or recommend any specific technology or provider).
  • Support the continuity of chemical production critical to the national and economic security of the country.

For more information on CISA’s role in securing critical infrastructure and the Securing Industrial Control Systems initiative, visit the Agency’s website.

EPA Proposed Rule Making Changes to Clean Air Act Risk Management Program

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On August 31, 2022, EPA published a proposed rule, Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air Act; Safer Communities by Chemical Accident Prevention. The proposed rule aims to address several changes and amplifications to the accident prevention program requirements, enhancements to the emergency preparedness requirements, increase the public availability of chemical hazard information, and provide changes and clarity to definitions currently lacking. The proposed rule applies to a variety of industries, including but not limited to chemical manufacturing.

 

Below is a summary of the key changes and additions within the proposed rule. A table that identifies the full scope of proposed changes and additions can be found here.

 

Subpart C – Program 2 Prevention Program

40 CFR § 68.58 Compliance audits.

The proposed rule revises paragraph (a), advising that a third-party audit may be required under added paragraph (f) of this section. Additionally, the proposed rule adds paragraphs (f), (g), and (h) to this section. Paragraph (f) states that a third-party audit is required when one or more of the following apply: (1) two accidental releases have occurred within five years, meeting the criteria in § 68.42(a) from a covered process at a stationary source; (2) one accidental release as occurred within five years meeting the criteria in § 68.42(a) from a covered process at a stationary source in NAICS code 324 or 325, located within one mile of another stationary source in NIACS code 324 or 325; or (3) an implementing agency requires a third-party audit due to conditions at the stationary source that could lead to an accidental release of a regulated substance or when a previous third-party audit failed to meet the competency or independence requirements of § 68.59(c).

 

40 CFR § 68.59 Third-party audits.

Section 68.59 is added in its entirety. The 2019 reconsideration rule rescinded third-party compliance audit requirements, but EPA seeks to reinstate these requirements stating it found there “are likely no legitimate reliance interests associated with the 2019 reconsideration rule’s elimination of these requirements.” EPA has ensured that the proposed section is consistent with existing OSHA PSM requirements.

 

40 CFR § 68.62 Employee participation.

The proposed rule adds § 68.62 in its entirety and addresses employee participation in Program 2 prevention programs. Paragraph (a) of this section requires the owner or operators to “develop a written plan of action regarding the implementation of the employee participation required [by paragraphs (b) and (c) of this section].” Paragraph (b) requires the owner or operators “to develop and implement a process to allow employees and their representatives to anonymously report unaddressed hazards that could lead to a catastrophic release, unreported RMP-reportable accidents, or any other non-compliance with 40 CFR part 68.” Paragraph (c) states that the owner or operator must “provide to employees and their representative’s access to the hazard reviews and to all other information required to be developed under this rule.”

 

Subpart D – Program 3 Prevention Program

40 CFR § 68.79 Compliance audits.

The modifications to this section mirror those in 40 CFR § 68.58 detailed above.

 

40 CFR § 68.80 Third-party audits.

The modifications to this section mirror those in 40 CFR § 68.59 detailed above.

 

40 CFR § 68.83 Employee participation.

The modifications to this section mirror those in 40 CFR § 68.62 detailed above.

 

Subpart E – Emergency Response

40 CFR § 68.90 Applicability.

The proposed rule amends paragraph (b)(1) to extensively detail all components required within the facility’s community response plan, which under the current regulation is only referenced as “the community response plan developed under 42 U.S.C. 11003.” The proposed rule also revises paragraph (b)(3) to include specific relevant information that should be included when notifying emergency responders that there is a need for a response, whereas the current regulation states only that “appropriate mechanisms” to notify must be in place. The proposed rule further adds paragraph (b)(6), requiring that “the owner or operator maintains and implements, as necessary, procedures for informing the public and the appropriate Federal, state, and local emergency response agencies about accidental releases of RMP-regulated substances and ensure that a community notification system is in place to warn the public within the area potentially threatened by the release.”

 

40 CFR § 68.95 Emergency response program.

Paragraph (c) is completely rewritten to address issues with responding facilities notifying the public of releases. The revision requires facilities to provide necessary entities with initial RMP accidental release information during the release of regulated substances to efficiently convey such information to the public and the appropriate federal, state, and local emergency agencies. This information includes the regulated substance released, the estimated time the release began, the estimated quantity of the substance already released, the potential quantity to be released, and the potential consequences of the release on human health and the environment.

 

Subpart G – Risk Management Plan

40 CFR § 68.160 Registration.

The proposed rule adds paragraph (b)(22), which requires adding the method of communication and location of the notification of a chemical hazard to the public residing within six miles of the stationary source to the registration form included in the RMP.

 

Subpart H – Other Requirements

40 CFR § 68.210 Availability of information to the public.

The proposed rule amends § 68.210, adding paragraphs(d), (e), and (f). Paragraph (d) details the chemical hazard information a facility must provide to any requesting member of the public residing within six miles of the stationary source. This information includes (1) regulated substance information, (2) SDS for all regulated substances at the facility, (3) five-year accident history, (4) the emergency response program, (5) a list of the scheduled and required exercises, and (6) LEPC contact information. Paragraph (e) dictates that the company must provide ongoing notification on its website, social media platforms, or through other publicly accessible means. Such notifications should convey that the information in paragraph (d) is available and accessible to community members living within 6 miles of the RMP facility. Paragraph (f) requires that the owner or operator of the facility provide the information outlined in paragraph (d) within 45 days of receiving the request.

EPA Releases Draft Toxicological Review of Hexavalent Chromium

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EPA recently released its draft Integrated Risk Information System (IRIS) toxicological review of hexavalent chromium (also known as chromium-6). Hexavalent chromium is used in pigment manufacturing, metal finishing and chrome plating, stainless steel production, leather tanning, and wood preservatives. It has various other industrial applications as well. The metal is also emitted into the air when fossil fuels are burned.

The metal gained significant attention in 2000 with the release of the movie Erin Brokovich. The film detailed the story of a class action lawsuit by Californians against Pacific Gas & Electric Company for dumping wastewater containing chromium into ponds, subsequently polluting groundwater supplies.

Hexavalent chromium is a known carcinogen in humans when inhaled, including increased lung cancer rates found in workers exposed at higher than normal levels in industries that process or use chromium or chromium compounds. The metal is also known to cause nasal and sinus cancers, kidney and liver damage, nasal and skin irritation, and other adverse health effects.

Less information has been known about the effects of ingesting hexavalent chromium. EPA’s current standard for the metal in drinking water is a maximum contaminant level of 100 parts per billion. The draft IRIS reports that ingestion through drinking water is likely carcinogenic, and once finalized, EPA will use the IRIS review to make assessments of risk related to ingestion exposure.

The draft is currently open for public comment until December 19, 2022. EPA Scientific Advisory Board will hold a hearing to discuss hexavalent chromium following the closing of the comment period.