Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
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By Lynn L. Bergeson and Carla N. Hutton

Maine enacted “An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution” in July 2021. Under the bill, manufacturers of products with intentionally added per- and polyfluoroalkyl substances (PFAS) must report the presence of the intentionally added PFAS in those products to the Maine Department of Environmental Protection (MDEP) beginning January 1, 2023. The law also prohibits the sale of carpets or rugs, as well as the sale of fabric treatments, that contain intentionally added PFAS beginning on January 1, 2023. Beginning January 1, 2030, any product containing intentionally added PFAS may not be sold in Maine unless the use of PFAS in the product is specifically designated as a currently unavoidable use by MDEP.

According to the MDEP website, MDEP is in the process of developing a rule to clarify the January 1, 2023, reporting requirements. MDEP states that during the rule development process, there will be an opportunity for stakeholder input on the implementation of the program. Stakeholders can subscribe to receive notification of MDEP rulemaking and opportunity to comment notices on its website.

Pending clarification of the reporting requirements, reporting entities may need to request an extension of time to notify MDEP of any products for sale in the state of Maine that contain intentionally added PFAS. At this time, terms in the statutory language are not defined to allow companies to report information with sufficient clarity to comply confidently with the law. Manufacturers will need to obtain information from many industry sectors and upstream suppliers to determine if PFAS was intentionally added to the product or is a component of the product. Suppliers in many industry sectors are numerous, and because of current and ongoing supply chain issues, manufacturers are challenged now more than ever. The frequently asked questions (FAQ) on MDEP’s website list information that will be required, “at a minimum,” but the website states that “[t]hese requirements will be further clarified as part of the rulemaking.”

Tags: Maine, MDEP, PFAS

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on October 13, 2022, on its web-based Interspecies Correlation Estimation (Web-ICE) tool. According to EPA, protecting the diversity of species from the adverse effects of chemicals is a significant environmental challenge. EPA acknowledges that information on the effects of chemicals on species is either very limited or lacking entirely, making management and mitigation of environmental contaminants difficult. EPA developed the Web-ICE tool to allow toxicity extrapolation from standard test organisms to diverse taxa, including endangered species. The publicly-accessible application allows risk assessors and environmental managers from all sectors to estimate chemical toxicity to a diversity of fresh and saltwater invertebrates and fish, birds and mammals, and aquatic plants (algae) that may have limited toxicity data. The training webinar will provide an overview of Web-ICE, including a brief overview of ICE models, demonstration of its application with example case studies, and a tutorial on using the Internet application. Registration is open.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our July 18, 2022, blog item, the U.S. Environmental Protection Agency (EPA) received a petition on June 16, 2022, under Section 21 of the Toxic Substances Control Act (TSCA) from Daniel M. Galpern on behalf of Donn J. Viviani, John Birks, Richard Heede, Lise Van Susteren, James E. Hansen, Climate Science, Awareness and Solutions, and Climate Protection and Restoration Initiative. The petition requests EPA “to phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas (GHG) emissions, fossil fuels, and fossil fuel emissions.” In a September 14, 2022, letter, EPA denied the petition. According to the letter, of the various actions described in the petition, EPA determined that only the request to initiate a proceeding for the issuance of a rule under TSCA Section 6(a) is within the ambit of a TSCA Section 21 petition. EPA states that based on its review, and after careful consideration of the specific requests, it is denying the request to initiate a proceeding for the issuance of a rule under TSCA Section 6(a) because, “although EPA shares the petitioners’ concerns regarding the threat posed by climate change, the Agency found that the petition was insufficiently specific and failed to establish that it is necessary to issue a rule under TSCA section 6, in light of ongoing and expected federal government actions, the relative efficiency of TSCA rulemaking, and lack of TSCA section 6(a) authority to regulate historical GHG emissions.” EPA will publish in a forthcoming Federal Register notice its reasons for denying this portion of the petition, as well as its reasons for declining to address under TSCA Section 21 the other petitioned actions. EPA has posted a prepublication copy of the Federal Register notice.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Department of State (State Department) will hold a joint meeting from 2:00 p.m. to 3:30 p.m. (EDT) on September 22, 2022, to discuss United Nations Environment Assembly (UNEA) Resolution 5/8 and the related upcoming first session of the ad hoc open-ended working group (OEWG) on a science-policy panel (SPP) to contribute further to the sound management of chemicals and waste. In Resolution 5/8, UNEA states that an SPP should be established to contribute further to the sound management of chemicals and waste and to prevent pollution. UNEA further decided to convene, subject to the availability of resources, an OEWG to prepare proposals for the SPP, to begin work in 2022 with the ambition of completing it by the end of 2024. According to the resolution, the principal functions of the SPP should include:

  • Undertaking “horizon scanning” to identify issues of relevance to policymakers and, where possible, proposing evidence-based options to address them;
  • Conducting assessments of current issues and identifying potential evidence-based options to address, where possible, those issues, in particular those relevant to developing countries;
  • Providing up-to-date and relevant information, identifying key gaps in scientific research, encouraging and supporting communication between scientists and policymakers, explaining and disseminating findings for different audiences, and raising public awareness; and
  • Facilitating information sharing with countries, in particular developing countries seeking relevant scientific information.

The first session of the OEWG will be held in two parts, with the first part taking place on October 6, 2022, in a hybrid format, while the second part will be held in person in Bangkok early in the first quarter of 2023.
 
Industry and environmental non-governmental organization (NGO) stakeholders who would like to participate in the joint meeting on September 22, 2022, should .(JavaScript must be enabled to view this email address) by 10:00 a.m. (EDT) on September 22, 2022. This meeting is for U.S. stakeholders only and is not open to non-U.S. organizations, companies, or individuals.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2022, that it selected 39 recipients that will receive nearly $12 million in pollution prevention (P2) grants made possible by President Joseph Biden’s Bipartisan Infrastructure Law’s $100 million program investment. According to EPA, the grants will allow states and Tribes to provide businesses with technical assistance to help them develop and adopt P2 practices to prevent or reduce pollution before it is even created, while also reducing business and liability costs. Proposed projects include reducing per- and polyfluoroalkyl substances (PFAS) contamination in food packaging and food waste recycling streams, increasing awareness of green cleaning chemicals in businesses and schools, and helping underserved communities implement P2 best practices to reduce waste and emissions from industrial plants.
 
EPA notes that the P2 program advances President Biden’s Justice40 Initiative, which aims to deliver at least 40 percent of the benefits of certain government programs to underserved communities. State and Tribal programs awarded grants will not be required to provide matching funds, as is required by traditional P2 grants.
 
According to EPA, selected and awarded grantees will document and share P2 best practices they identify and develop through these grants so that others can replicate the practices and outcomes. Each selected grantee will address at least one of the National Emphasis Areas (NEA) established to focus resources to achieve measurable results and to create opportunities to share information among P2 grantees and businesses affiliated with similar NEAs. Each selected grantee will also develop at least one case study during the grant period on P2 practices that are new or not widely known or adopted, or where detailed information on P2 practices could benefit other businesses or P2 technical assistance providers. The NEAs include food and beverage manufacturing and processing; chemical manufacturing, processing, and formulation; automotive manufacturing and maintenance; aerospace product and parts manufacturing and maintenance; metal manufacturing and fabrication; and supporting P2 in Indian country and for Alaska Native Villages.

Tags: P2, PFAS, pollution

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On September 6, 2022, the U.S. Environmental Protection Agency proposed to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 87 Fed. Reg. 54415. According to EPA, “[s]uch a designation would ultimately facilitate cleanup of contaminated sites and reduce human exposure to these ‘forever’ chemicals.” Comments are due November 7, 2022. EPA states that under the Paperwork Reduction Act, “comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before October 6, 2022.”
 
Upon designation, any person in charge of a vessel or an offshore or onshore facility, as soon as they have knowledge of any release of such substances at or above the reportable quantity (RQ) must immediately report such releases to the federal, state, tribal, and local authorities. The RQ for these designations is one pound or more in a 24-hour period. EPA states that once it has collected more data on the size of releases and the resulting risks to human health and the environment, it may consider issuing a regulation adjusting the RQs for these substances.
 
The five broad categories of entities potentially affected by this action include:

  • PFOA and/or PFOS manufacturers (including importers and importers of articles);
  • PFOA and/or PFOS processors;
  • Manufacturers of products containing PFOA and/or PFOS;
  • Downstream product manufacturers and users of PFOA and/or PFOS products; and
  • Waste management and wastewater treatment facilities.

More information is available in our August 29, 2022, memorandum.

Tags: PFAS, PFOA, PFOS, CERCLA

 
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By Lynn L. Bergeson and Carla N. Hutton
 
ASTM has announced that a new subcommittee will develop standards on per- and polyfluoroalkyl substances (PFAS) that are present in consumer products. ASTM describes PFAS as “a group of chemicals that are used to make fluoropolymer coatings and products that resist heat, oil, stains, grease and water.” The new subcommittee (F15.81) will operate under the jurisdiction of ASTM’s consumer products committee (F15). According to ASTM, the new subcommittee “will develop standards that provide guidance on how to prepare and analyze a wide variety of consumer product samples for PFAS.” ASTM “welcomes participation in the development of its standards. Chemical engineers, analytical chemists, and advocacy group technical personnel are particularly encouraged to join the subcommittee.” More information is available online regarding ASTM membership.

Tags: ASTM, PFAS,

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340:

These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS at .(JavaScript must be enabled to view this email address). For questions regarding confirmation requests, contact APHIS at .(JavaScript must be enabled to view this email address).


 
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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 14, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2022, that it is planning to consolidate several Information Collection Requests (ICR) covering reporting and recordkeeping activities under Section 8 of the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 12954. EPA has since submitted the ICR to the Office of Management and Budget (OMB) for review and approval. EPA published a notice on August 30, 2022, allowing for an additional 30 days for public comment. 87 Fed. Reg. 52967. Comments are due September 29, 2022.
 
The consolidated ICR is entitled “Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA)” and is identified under EPA ICR No. 2703.01 and OMB Control No. 2070-[NEW]. According to EPA, it is consolidating the existing ICRs to streamline the presentation of the paperwork burden estimates, thereby reducing the administrative burden for both the public and EPA and allowing a better assessment of the burden and costs for reporting and recordkeeping activities under TSCA Section 8. EPA’s Supporting Statement summarizes the currently approved ICRs that would be consolidated in the new ICR:

  • TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR): Under TSCA Section 8(a), persons who manufacture or import chemical substances listed at 40 C.F.R. Section 712.30 are subject to the Section 8(a) PAIR requirements. These manufacturers and importers must submit information about production, use, and/or exposure-related data. Certain specific chemical testing and reporting requirements under 40 C.F.R. Part 766 Subpart B that are very similar to the PAIR requirements are also covered within this information collection activity.
     
  • Chemical-Specific Rules, TSCA Section 8(a): Under TSCA Section 8(a), persons who manufacture, import, or process certain chemical substances or mixtures, or propose to manufacture, import, or process certain chemical substances or mixtures, are subject to chemical-specific rules promulgated under TSCA Section 8(a). A chemical-specific Section 8(a) rule requires more detailed and more types of information than is required by a PAIR rule. Any chemical covered by TSCA for which the Office of Pollution Prevention and Toxics (OPPT), other EPA offices, or another federal agency has a reasonable need for information, and that cannot be satisfied via readily available sources or by use of other rulemakings, is a proper potential subject for a chemical-specific TSCA Section 8(a) rulemaking.
     
  • Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment: Under TSCA Section 8(c), persons who manufacture, import, process, or distribute in commerce any chemical substance or mixture must keep records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. TSCA Section 8(c) requires that allegations of adverse reactions to the health of employees be kept for 30 years, and all other allegations be kept for five years. The rule also prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator.
     
  • Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies: Under TSCA Section 8(d), certain persons, who manufacture, import, process, or distribute in commerce (or propose to manufacture, import, process, or distribute in commerce) chemical substances and mixtures, are required to submit to EPA lists and copies of health and safety studies in their possession that relate health and/or environmental effects of the chemical substances and mixtures.

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing. EPA notes that there will be limited availability in person at EPA headquarters in Washington, DC, on October 12-13, 2022, and a virtual option will also be available. Conference topics include:

  • Variability and Relevance of Traditional Toxicity Tests;
  • Evolution of Validation and Scientific Confidence Frameworks to Incorporate 21st Century Science; and
  • Breakout groups discussing Variability of Traditional Toxicity Tests, Relevance of Traditional Toxicity Tests, and Feedback on EPA Scientific Confidence Framework.

EPA asks that attendees register for the NAMs conference before October 7, 2022.
 
On October 18, 2022, EPA will provide training on the Computational Toxicology (CompTox) Chemicals Dashboard, which is part of a suite of databases and web applications developed by EPA to support the development of innovative methods to evaluate chemicals for potential health risks. The computational toxicology tools and data in the Dashboard help prioritize chemicals based on potential health risks. Specifically targeted for decision-makers, the training will provide:

  • An overview of the Dashboard content and function;
  • Application-oriented use-case demonstrations in the areas of general use, hazard/bioactivity, exposure/absorption, distribution, metabolism, and excretion (ADME)-in vitro to in vivo extrapolation (IVIVE), and chemistry; and
  • Opportunities for participatory learning and engagement.

The training will offer information about the latest release of the Dashboard and how it can be used to gather actionable information about chemical properties and risks through case examples, demonstrations, and hands-on exercises. Registration is now open (attendees must register for the training portions individually):


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According to EPA, due in part to the automation of modeling, it has become less burdensome to complete these calculations. Furthermore, according to EPA, removing the thresholds supports President Biden’s Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which calls on federal agencies to advance equity, including by reviewing and revising as needed government policies and programs impacting underserved communities.
 
The New Chemicals Program will implement this change by making minimal changes to the coding in the New Chemical Review application to remove the thresholds and will update standard operating procedures and training materials for exposure and human health risk assessors. EPA states that it will implement this policy change “as soon as feasible.” According to EPA, despite the resource challenges it is currently facing in the TSCA program, it anticipates that the change “will have minimal impact on the amount of time it takes to complete new chemical reviews and that the benefits gained from a more comprehensive accounting of all potential air and water releases will help ensure any needed protections are in place before a new chemical can come to market.”
 
More information and a detailed commentary that discusses thresholds of toxicological concern (TTC) are available in our August 22, 2022, memorandum.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 18, 2022, that it is accepting nominations for the 2023 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. The awards again include a category to recognize technology that reduces or eliminates greenhouse gas (GHG) emissions. EPA will hold a webinar on September 28, 2022, from 2:00 to 3:30 p.m. (EDT) to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. Registration for the webinar is open. Nominations are due to EPA by December 9, 2022.
 
EPA states that green chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of chemicals that are hazardous to the environment and people’s health. According to EPA, its efforts to “speed the adoption of this revolutionary and diverse discipline” have led to significant environmental benefits, innovation, and a strengthened economy. Green chemistry aims to prevent pollution before it is created, making it the preferred approach for providing solutions to some of the most significant environmental challenges.
 
An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2023 nominations and make recommendations to EPA for the 2023 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in fall 2023.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On August 12, 2022, the Office of Management and Budget (OMB) completed its review of a proposed rule that would designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Such designations would require facilities to report on PFOA and PFOS releases that meet or exceed the reportable quantity. Publication of the proposed rule in the Federal Register will begin a public comment period.
 
As reported in our October 19, 2021, memorandum, as part of a multi-agency effort to address pollution from per- and polyfluoroalkyl substances (PFAS), the U.S. Environmental Protection Agency (EPA) released its PFAS Strategic Roadmap on October 18, 2021. The key actions outlined in the roadmap include proposing to designate PFOA and PFAS as CERCLA hazardous substances.

Tags: PFOA, PFOS

 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”

EPA also changed the status for one chemical on the SCIL and will remove the chemical from the list in one year “because of a growing understanding of the potential health and environmental effects.” According to EPA, the chemical was originally listed on the SCIL based on data from a closely related substance that EPA marked with a grey square earlier this year. EPA’s process for removing a chemical from the SCIL is first to mark the chemical with a grey square on the SCIL web page to provide notice to chemical and product manufacturers that the chemical may no longer be acceptable for use in Safer Choice-certified products. A grey square notation on the SCIL means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list the chemical on the SCIL. EPA states that the data required are determined on a case-by-case basis. In general, data useful for making such a determination provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA then removes the chemical from the SCIL 12 months after the grey square designation.

According to EPA, after this update is made, there will be 1,055 chemicals listed on the SCIL. EPA is committed to updating the SCIL with safer chemicals on a regular basis. EPA states that the SCIL is a resource that can help many different stakeholders:

  • Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
  • Chemical manufacturers use the SCIL to promote the safer chemicals they manufacture;
  • Retailers use the SCIL to help shape their sustainability programs; and
  • Environmental and health advocates use the SCIL to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published a supplemental proposed rule that would add the diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 87 Fed. Reg. 48128. EPA previously issued a proposed rule on September 5, 2000, in response to a petition filed under EPCRA, to add a DINP category to the list of toxic chemicals subject to the reporting requirements under EPCRA and the PPA. EPA proposed to add this chemical category to the EPCRA toxic chemical list based on its preliminary conclusion that this category met the EPCRA toxicity criterion. According to the supplemental proposed rule, EPA has updated its hazard assessment for DINP and is proposing to add DINP as a category defined to include branched alkyl di-esters of 1,2 benzenedicarboxylic acid in which alkyl ester moieties contain a total of nine carbons. EPA states that the updated hazard assessment “demonstrates that the proposed DINP category meets the EPCRA toxicity criterion because the members of the category can reasonably be anticipated to cause cancer and serious or irreversible chronic health effects in humans; specifically, developmental, kidney, and liver toxicity.” EPA is proposing to add the DINP category to the toxic chemical list on this basis and requests comment on the updated DINP hazard assessment and associated updated economic analysis. Comments are due October 7, 2022.

Tags: DINP, EPCRA, PPA

 
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