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 The 2019 reconsideration rule rescinded third-party compliance audit requirements, but EPA seeks to reinstate these requirements stating it found there “are likely no legitimate reliance interests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.
Petition to Remove Polyvinyl from EPA’s Safer Choice and Safer Chemical Ingredients List
/in Safer Choice, TSCAOn 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
/in TSCA, TSCA ReformOn 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:
The proposed fee increases are as follows:
*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
/in FIFRA, PesticidesOn 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.
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
/in FIFRA, TSCA, UncategorizedVerdant 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
/in California, DTSC, TransparencyThe 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…
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
/in UncategorizedOn 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:
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
/in EPAOn 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
/in EPA, IRISEPA 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.
Verdant Law Gives Presentation on the PFAS Regulatory Landscape at Annual Product Stewardship Conference
/in PFASVerdant Law is pleased to announce that Irene Hantman gave a presentation on the PFAS Regulatory Landscape at the annual Product Stewardship Conference. Hantman presented brief case studies on how different states are regulating PFAS in their communities, including but not limited to:
Additionally, Hantman discussed PFAS regulations on the federal level. She highlighted EPA’s proposed PFAS reporting rule under TSCA (87 FR 33926), which would require all manufacturers and importers of PFAS listed on the active TSCA Inventory to report uses, volumes manufactured, environmental and health effects, worker exposure, and disposal. Hantman further detailed the reporting the comprehensive reporting standard and industry commentary on the proposed rule.
Also discussed was the National PFAS Testing Strategy released in October 2021, permitting EPA to issue test orders to manufacturers of PFAS substances and the first set of test orders EPA just recently issued. EPA’s ending of LVE exemptions for PFAS, the imposition of SNURs on approximately 150 PFAS, and the new regulation of PFAS under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was also included in Hantman’s presentation. Briefly mentioned were PFAS consumer product litigation including:
If you have questions about the topics of this presentation, please contact Irene Hantman.
Verdant Law Gives Presentation on EPA’s New PMN Review Process at Annual Product Stewardship Conference
/in UncategorizedVerdant Law is pleased to announce that Phil Moffat gave a presentation on EPA’s new PMN review process at this year’s Product Stewardship Conference. Moffat highlighted EPA’s proposed rule (expected to be released in February 2023) updating date procedural regulation to conform with the Lautenberg amendment, which requires EPA to make affirmative determinations on whether new chemical substances present an unreasonable risk to human health or the environment under known, intended or reasonably foreseen conditions of use. The proposed rule, if implemented, would increase the quality of information initially submitted in a PMN and reduce Agency rework in the risk assessment process, and reduce the Agency’s review time for each PMN.
Additionally, in June 2020, EPA launched a series of webinars working towards its goal of increasing transparency and reducing reworks. The webinars highlight common issues that require EPA to reconduct new chemical assessments (reworks), which substantially delay the Agency in completing PMN reviews.
Moffat also discussed EPA’s recently announced effort to implement a streamlined and efficient process for risk evaluations on chemicals used in electric vehicles, semiconductor, and clean energy sectors with the goal of increasing the nation’s energy security. The effort will focus specifically on mixed metal oxides (MMOs), including new and modified cathode active materials (CAMs).
Also detailed was EPA’s recent decision to discontinue the use of exposure modeling thresholds in the new chemical review process. The change would require completing modeling for all potential exposures that may result from air releases and releases to groundwater from landfills, as opposed to only those above an established threshold under the current policy. EPA believes that the adoption of this new policy will allow for a more comprehensive accounting of all potential air and water releases to ensure any needed protections are in place before a new chemical comes to market.
Lastly, Moffat discussed EPA’s efforts to bring innovative science to the chemical review process detailed in an Agency document TSCA New Chemicals Collaborative Research Effort. The effort includes a multiyear research plan in collaboration with federal agencies such as NIH’s National Toxicology Program. The focus areas of the research include:
If you have questions about the topics of this presentation, please contact Phil Moffat.