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 The 2019 reconsideration rule rescinded third-party compliance audit requirements, but EPA seeks to reinstate these requirements stating it found there “are likely no legitimate reliance interests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.
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.
EPA Evaluation of PFAS Leaching in Fluorinated Containers
/in EPA, News & Events, PFAS, TSCAOn September 8, 2022, EPA announced findings of the Agency’s evaluation of PFAS leaching in fluorinated containers. Specifically, the evaluation assessed the extent to which PFAS that are present in the packaging leach into the contents of the containers. The study tested the leaching potential of PFAS over a 20-week test period into water, methanol and similar solutions that were packaged in different brands of HDPE fluorinated containers. EPA undertook this evaluation after learning of PFAS contamination in some mosquitocide products, and after conducting a study of other pesticides stored in fluorinated high-density polyethylene containers. In both cases the Agency found varying levels of PFAS in the contents of the containers.
The announcement reported that EPA has determined that any liquid products packaged in HDPE containers that have been treated with fluorination technology could be contaminated with PFAS, including water-based products. The Agency also reported that the amount of PFAS that leach into the products could increase over time. EPA noted that the Agency does not know if all fluorinated containers will leach PFAS because the Agency’s analysis did not test all the different fluorination technologies.
The announcement included a reminder that pesticide registrants must notify the Agency if they discover PFAS in any of their products. Under FIFRA §6(a)(2) and 40 CFR §159.179, “additional factual information on unreasonable adverse effects, including metabolites, degradates and impurities (such as PFAS)” must be reported to EPA within 30 days after the registrant “first possesses or knows of the information.” Note that the Agency considers any level of PFAS to be potentially toxicologically significant and therefore reportable.
The announcement also noted that in many cases, the manufacture of PFAS from the fluorination of polyolefins is subject to the Agency’s significant new use rule for long-chain perfluoroalkyl carboxylates (LCPFACs) under the Toxic Substances Control Act (TSCA). Companies must notify EPA at least 90 days before starting manufacturing or processing of these chemical substances for this significant new use. TSCA requires significant new use notification in these situations to allow EPA review any associated risks and impose any needed protections.
Implementing Statutory Addition of Certain PFAS Substances to the Toxics Release Inventory Reporting
/in EPA, PFAS, TRIIn July 2022, EPA released a final rule adding five PFAS to the list of chemicals required to be reported to the Toxics Release Inventory (TRI) under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). TRI tracks the management of certain toxic chemicals that may pose a threat to human health or the environment and provides this information to the public. Pursuant to the National Defense Authorization Act (NDAA), EPA is required to automatically add PFAS to the TRI whenever it takes one of the following actions:
Under this rule, facilities in specific industry sectors that manufacture, process, distribute, or use any of the five PFAS added to the TRI, must submit a TRI report if they exceed the PFAS reporting threshold of 100 pounds. Four of the substances are added to the list effective January 1, 2022, and the remaining substance is effective January 1, 2021, meaning TRI reporting due in 2023 must account for these substances.
EPA Proposes to Stop Authorized Use of Certain PFAS in Pesticide Products
/in Chemicals of Concern, EPAEPA is proposing to remove 12 PFAS substances from the current list of inert ingredients approved for use in pesticide products. Under EPA’s 2021 PFAS Strategic Roadmap the Agency is reviewing substances approved as inert ingredients in pesticides and potentially taking action to limit their use. Inert ingredients in pesticides serve to increase effectiveness and product performance including improving the ease of pesticide application and extending shelf life.
The 12 chemical substances proposed for removal are no longer in any registered pesticide product, but EPA believes it is important to remove these chemicals. This means that a review of available information for these chemicals would be required for their future use in pesticide products. In discussing the proposal Michal Freedhoff, EPA’s Assistant Administrator for the Office of Chemical Safety and Pollution Prevention stated, “ensuring that these 12 chemicals can no longer be used in pesticides is an important step to protect workers, the public, and our planet from unnecessary PFAS exposure.”
CoverGirl Cosmetics and Coty Inc PFAS Suit
/in Chemicals of Concern, EPA, News & EventsCoverGirl Cosmetics and Coty Inc. are facing a class action lawsuit for marketing their TruBlend Pressed Powder as sustainable and safe while allegedly it contained PFAS. The complaint was filed in the U.S. District Court for the Southern District of California. According to the complaint, independent lab testing found that the product contained increased fluorine levels, an indicator of the presence of PFAS. The complaint also notes that defendants misrepresent the product in their marketing materials which state that they hold themselves to the highest quality standards when it comes to safety and efficacy of their products. Plaintiffs argued that these acts violate the California Unfair Competition Law and the California False Advertising Law, and constitute fraud and negligent misrepresentation.
The plaintiff asserts that the presence of PFAS is a concern because PFAS exposure through inhalation, ingestion, and skin contact can result in PFAS entering the body. The makeup in question is applied directly to the face and is prolonged skin contact. Plaintiff contends that PFAS are present at a greater concentration than recommended by the current EPA health advisory limit for safe consumption.