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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Bergeson & Campbell, P.C. (B&C®) is pleased to offer the recording, slides, and written Question and Answer (Q&A) document from our “PFAS Reporting Rules -- What Every Company Needs to Know” webinar, focusing on the U.S. Environmental Protection Agency’s (EPA) proposed reporting rules for per- and polyfluoroalkyl substances (PFAS), presented by B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D.
 
Do you wonder if the PFAS reporting rules extend to domestically-produced articles? Or if businesses that incorporate PFAS into their products are required to notify the end users? Do you know whether you need to report your Low Volume Exemption (LVE) substance? We encourage you to view the webinar and read the additional materials to learn answers to these and other questions related to EPA’s recent PFAS actions.
 
We also encourage you to consider the following issues discussed in the webinar and to submit comments to EPA regarding how these will affect your operations:

  • Identifying chemicals subject to reporting (i.e., specific PFAS and whether to include imported articles);
  • Considerations for economic analysis;
  • Submission period;
  • Potential duplicative reporting concerns;
  • Scope of “existing environmental and health information” collected;
  • Additional data elements or information collected;
  • EPA’s use and publication of non-confidential business information (CBI);
  • Availability of joint submissions; and
  • Small manufacturer considerations (i.e., regulatory and non-regulatory assistance and outreach).

Comments on EPA’s proposed PFAS rules are due on September 27, 2021.
 
The recording and slides are available online. E-mail .(JavaScript must be enabled to view this email address) to request written answers to selected questions from the Q&A session of the webinar.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on September 24, 2021, for stakeholders to learn how to access and use the pollution prevention (P2) information collected by the Toxics Release Inventory (TRI) Program about projects implemented by companies to eliminate or reduce the creation of chemical waste. According to EPA, community members, local government representatives, facility personnel, and others can access this information through multiple online resources and use it to further the identification and advancement of P2 opportunities. The webinar will include a live demonstration of how to find P2 data for specific facilities, chemicals, and industry sectors, as well as:

  • Details on what data facilities are required to report;
  • Examples of P2 projects implemented at manufacturing facilities; and
  • Resources for and benefits of implementing P2 projects at facilities.

The webinar is also part of a series of webinars to mark the 35th anniversary of the TRI Program. Registration is now open.


 
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This week's All Things Chemical® Podcast will be of interest to readers of the TSCAblog®. A brief description of the episode written by Lynn L. Bergeson is below.
 
This week I sat down with Richard E. Engler, Ph..D., Director of Chemistry with Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), to discuss the U.S. Environmental Protection Agency’s (EPA) continuing struggle to regulate certain persistent, bioaccumulative, and toxic (PBT) chemicals, especially those found in finished products, what EPA refers to as “articles.” The Toxic Substances Control Act (TSCA) has always applied to the products, or articles, that contain chemical substances of interest to EPA under TSCA. While EPA previously used that authority somewhat sparingly, the 2016 Amendments to TSCA have jump-started a new wave of regulations that expressly apply to articles. EPA is required under TSCA to regulate certain PBTs, and EPA issued a final rule earlier this year that inspired chaos in the business community, especially in the electronics sector and its complicated supply chain. Rich and I discuss these PBT rules and help explain what may well be the new normal with regard to the regulation of finished products under TSCA.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On September 17, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 51823. Specifically, EPA is extending the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022. For such articles, EPA states that it is also extending the compliance date for the recordkeeping requirements applicable to manufacturers, processors, and distributors from March 8, 2021, to March 8, 2022. According to EPA, the articles covered by the amendment “include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.” The final rule is effective September 17, 2021. More information on the final PIP (3:1) rule and on EPA’s plan for a new rulemaking on persistent, bioaccumulative, and toxic (PBT) chemicals is available in our September 3, 2021, memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”


 
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By Lynn L. Bergeson and Carla N. Hutton

The New York State Department of Environmental Conservation (NYS DEC) held a virtual public meeting on September 15, 2021, on its forthcoming regulations to implement the Toxic Chemicals in Children’s Products Law. New York’s Environmental Conservation Law (ECL) Article 37 Title 9 establishes an ingredient disclosure program and prohibits certain chemicals in children’s products. ECL Article 37 instructs NYS DEC to promulgate lists of chemicals of concern and high priority chemicals that must be disclosed if present in children's products by March 1, 2022. ECL Article 37 also prohibits the sale of children’s products containing benzene, asbestos, or tris(1,3-dichloro-2-propyl) phosphate effective January 1, 2023. NYS DEC has posted a list of chemicals under consideration and their practical quantification limits. The list includes the evidence that NYS DEC has identified to justify listing the chemicals. Comments may be submitted via e-mail to .(JavaScript must be enabled to view this email address) or via mail to:

Emily Dominiak
NYS DEC -- Division of Materials Management
625 Broadway
Albany, NY 12233-7252
Comments must be submitted by 5:00 p.m. (EDT) on October 15, 2021.

According to NYS DEC’s website, NYS DEC has made a recording of the September 15, 2021, meeting available for review. The website notes that NYS DEC “will hold a formal public comment period on the proposed rule at a later date, which will be published in the Environmental Notice Bulletin.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2021, the availability of the draft scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4). 86 Fed. Reg. 50347. As reported in our October 7, 2020, blog item, through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to Section 6 of the Toxic Substances Control Act (TSCA). The draft scope document includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this chemical substance. EPA is also opening a 45-calendar day comment period on the draft scope to allow for the public to provide additional data or information that could be useful in preparing the final scope document. Comments are due October 25, 2021.
 
EPA plans to evaluate manufacturing (including importing); processing; distribution in commerce; industrial, commercial, and consumer uses; and disposal of D4 in the risk evaluation. According to the draft scope document, D4 is manufactured (including imported) in the United States. The chemical is processed as a reactant; incorporated into a formulation, mixture, or reaction product; and incorporated into articles. The draft scope document states that the identified processing activities also include the repackaging and recycling of D4. D4 is primarily used to make other silicone chemicals and as an ingredient in consumer products regulated by the Federal Food, Drug, and Cosmetic Act (FFDCA). Commercial uses include adhesives and sealants, automotive care products, paints and coatings, and other plastic and rubber products. Additional consumer uses include adhesives and sealants, automotive care products, laundry and dishwashing products, paints and coatings, and other plastic and rubber products.
 
EPA notes that some of these conditions of use were identified in the manufacturer request as circumstances on which EPA was requested to conduct a risk evaluation. EPA identified other conditions of use from information reported to EPA through Chemical Data Reporting (CDR), published literature, and consultation with stakeholders for both uses currently in production and uses whose production may have ceased. EPA presented the proposed additions of these EPA-identified conditions of use and the basis for these proposed additions, along with the manufacturer request, for a 45-day comment period in June 2020.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On August 31, 2021, the U.S. Environmental Protection Agency (EPA) released the final scope documents for the Toxic Substances Control Act (TSCA) risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. In its August 31, 2021, press release, EPA notes that both DIDP and DINP “belong to a family of chemicals called phthalates and are commonly used as plasticizers in the production of plastic and plastic coating to increase flexibility.”
 
According to EPA, the final scope documents reflect the policy changes on risk evaluations announced in June 2021. This includes plans to consider exposure pathways that may be regulated outside of TSCA, like air and water, and potential for exposures to fenceline communities (i.e., communities near industrial facilities). EPA states that “[a]ssumptions that personal protective equipment (PPE) in occupational settings will always be properly utilized will not be used as the basis for the risk determination. Use of PPE, and other ways industry protects its workers, will be assessed during the risk evaluation and considered as potential ways to address unreasonable risks during the risk management process.” More information on the policy changes is available in our July 1, 2021, memorandum.
 
The final scope documents explain EPA’s plan for the risk evaluations, including the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA will consider. The documents also include a description of the reasonably available information and the best available science approaches that EPA will use; a conceptual model that outlines the potential hazards and exposures throughout the life cycle of the chemical; an analysis plan to identify the approaches and methods EPA will use to assess health and environmental risks; and a plan for peer review. More information will be available in a forthcoming memorandum that will be posted on our website.


 
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WEBINAR
Thursday, September 9, 2021
11:00 a.m. – 12:00 p.m. (EDT)
Register Now

Bergeson & Campbell, P.C. (B&C®) is pleased to present a complimentary webinar focused on the U.S. Environmental Protection Agency’s (EPA) proposed per- and polyfluoroalkyl substances (PFAS) regulations on September 9, 2021, 11:00 a.m. – 12:00 p.m. (EDT). B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D., will discuss three actions recently taken by EPA:

  • Proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States;
  • Withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS; and
  • Publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory (TRI) maintained under the Emergency Planning and Community Right-to-Know Act (EPCRA).

The proposed rule intended to obtain comprehensive data on PFAS would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal.
 
As a result of these EPA regulatory actions, companies that never expected to need to know the Toxic Substances Control Act (TSCA) are now finding themselves in EPA’s crosshairs. This webinar will explore the full scope of these potential rules, how entities can determine if they will be subject to reporting, and the specific recordkeeping requirements that have been proposed.

Register for the webinar now
 


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The New York State Department of Environmental Conservation (NYSDEC) will hold a virtual public meeting on September 15, 2021, on the toxic chemicals in children’s products law. NYSDEC will present the chemicals under consideration for listing as Chemicals of Concern and High Priority Chemicals and their practical quantification limits. NYSDEC will also re-present select topics from the May 26, 2021, public meeting, as some details have changed in response to feedback received. NYSDEC states that there will be time for stakeholders to discuss the information presented. Those who wish to attend the virtual public meeting must register. NYSDEC will record the meeting and post the recording afterward.
 
New York’s Environmental Conservation Law (ECL) Article 37 Title 9 establishes an ingredient disclosure program and prohibits certain chemicals in children’s products. ECL Article 37 instructs NYSDEC to promulgate lists of chemicals of concern and high priority chemicals that must be disclosed if present in children's products by March 1, 2022. ECL Article 37 also prohibits the sale of children’s products containing benzene, asbestos, or tris(1,3-dichloro-2-propyl) phosphate effective January 1, 2023.
 
NYSDEC is in the process of developing a rule to implement portions of the law. According to NYSDEC, the rule is expected to address the specific product categories that are covered, what chemicals and supporting information must be disclosed, details on how to obtain a waiver from reporting or the sales prohibition, and the fees associated with reporting and applying for a waiver.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 31, 2021, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for winter 2022. According to EPA, the Inventory contains 86,607 chemicals of which 41,953 are active in U.S commerce. Other updates to the TSCA Inventory include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 significant new use rules (SNUR). In April 2021, EPA released a list of 390 chemicals expected to lose their confidential status and move to the public portion of the Inventory. EPA states that it continues to work on final declassifications for these chemicals and plans to include them in the next public posting of the TSCA Inventory.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) is now accepting nominations for the 2022 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. EPA states that in support of the Biden-Harris Administration’s commitment to tackle the climate crisis, it is adding a new award category to recognize technology that reduces or eliminates greenhouse gas emissions. EPA will hold a webinar during Pollution Prevention (P2) Week, on Wednesday, September 22, 2021, from 2:00 p.m. - 3:30 p.m. (EDT), to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. Nominations are due to EPA by December 10, 2021. According to EPA, an independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2022 nominations and make recommendations to EPA for the 2022 winners. EPA anticipates giving awards to outstanding green chemistry technologies in six categories in June 2022.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On August 23, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on guidance on two petition processes applicable to the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations. 86 Fed. Reg. 47102. The guidance covers petitions for full exemption of byproduct substances that are recycled or otherwise used within site-limited, physically enclosed systems and petitions for partial exemption of chemicals for which the CDR processing and use information has been determined to be of “low current interest” by EPA. EPA states that the guidance “is designed to elucidate the process and requirements of CDR-specific petitions and is consistent with both existing regulations and guidance.” The CDR regulations require manufacturers (including importers) of certain chemical substances included on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on the manufacturing, processing, and use of the chemical substances. According to EPA, the guidance identifies and clarifies examples of the types of information submitters can provide to EPA in support of petitions for full or partial exemption from CDR rule requirements. EPA expects the guidance to make the requirements and process of submitting a CDR-specific petition “more comprehensible,” enabling petitioners to determine if a petition is appropriate and to provide better a petition containing the information needed for EPA to reach a determination. Comments on the guidance are due December 21, 2021.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration aims to establish a framework for the Next Generation of Risk Assessments based on NAMs. The collaboration will bring together more than $2 million in both monetary and in-kind contributions, including scientific expertise and equipment, to develop a comprehensive NAMs dataset for a minimum of 40 chemicals. According to EPA, the chemicals will be selected and grouped such that half will be benign and the other half will have known adverse implications for human health. These chemicals will be tested using a wide variety of NAMs, and the results will be compared between the two groups to determine how well particular NAMs can infer differences in risk. EPA states that these data will be used in case studies to evaluate the potential to use NAMs in regulatory decisions. All data generated through the collaboration will be in the public domain, allowing academic, corporate, government, and nonprofit scientists to use the project results in their own research.
 
EPA states that in addition to the data generated through the collaboration, EPA and Unilever will use chemical data from EPA’s high-throughput screening efforts and the federal government’s Tox21 consortium, which is a collaboration among EPA, the National Institutes of Health (NIH), and the U.S. Food and Drug Administration (FDA). According to EPA, “[t]hese automated chemical screening technologies rapidly test thousands of chemicals for their effects on human cells or cellular components that are critical to normal function.” EPA notes that data from these technologies are then incorporated into computational models to predict potential adverse health effects and estimate the amount of chemical that may cause these effects.


 
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By Lynn L. Bergeson and Carla N. Hutton

On August 17, 2021, Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Energy and Commerce Committee, Diana DeGette (D-CO), Chair of the Subcommittee on Oversight and Investigations, and Paul Tonko (D-NY), Chair of the Subcommittee on Environment and Climate Change, sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Michael Regan to request information regarding “concerning reported irregularities” in EPA’s chemical review program. The Committee’s August 17, 2021, press release states that “[a]ccording to recent allegations made by four whistleblowers -- each a current or former staffer in EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) -- the OCSPP has for many years downplayed the dangers of new chemicals and inappropriately interfered with risk assessments conducted pursuant to the Toxic Substances Control Act (TSCA).” The press release states that additional reports “have described the interference alleging that OCSPP manipulated the review of dozens of chemicals” to make the chemicals appear safer. EPA employees “were reportedly pressured to downplay evidence of chemicals’ potential adverse effects such as cancer, birth defects, and neurological effects,” and “EPA’s scientific staff were subject to retaliation.”

The August 17, 2021, letter requests a briefing from EPA, as well as written responses to the following issues:

  • Describe EPA’s understanding as to the veracity of the complaints raised by whistleblowers regarding interference in the chemical program. Explain what actions, if any, EPA has taken to look into these allegations.
  • Is EPA considering reevaluating any chemicals in light of concerns that their review process may have been subject to interference or that they may include precursors to per- and polyfluoroalkyl substances (PFAS)? If so, describe the process and timeline for any reevaluation.
  • Does EPA have any ongoing or planned efforts to review and strengthen whistleblower protections? If so, describe these efforts, including the EPA office responsible for these improvements and any associated timelines.

 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) met with the Environmental Defense Fund (EDF) on August 5, 2021, to clarify concepts from the July 27, 2021, tiered data reporting (TDR) webinar. EPA’s meeting summary states that EDF representatives requested clarification on the following issues discussed during the webinar:

  • Whether EPA intends to scale back the Chemical Data Reporting (CDR) requirements with respect to the amount of information collected per chemical or to the number of chemicals reported.
    • EPA responded that the changes to CDR discussed in the webinar presentation would reduce the data collected per chemical and would not impact which chemicals were required to be reported under CDR.
  • Whether the data expected to be used to inform the identification of potential candidate chemicals for prioritization was limited to CDR.
    • EPA responded that the webinar presentation was not intended to identify all sources of information that would be used for the various steps of the overall existing chemicals process, including informing the identification of the pool of potential candidate chemicals for the prioritization process. Rather, the intent was to identify the data that would be available from either CDR or TDR for use for each step in the process.
  • Reasoning behind EPA’s decisions regarding timing of the collection tiers and selected data elements.
    • EPA responded that the specifics of what data elements would be included in which collection tiers was under development and that the Agency is interested in comments from EDF or other stakeholders to help inform the TDR proposal.
  • Whether EPA had any more details about the post-risk management stage, which was included in the webinar presentation as “TBD.”
    • EPA responded that there were no additional details at this time.

According to the meeting summary, EDF provided additional comments during the meeting, including concern about scaling back CDR; belief that data should be collected earlier in the existing chemicals process to be more useful and enable EPA to make better use of TSCA Section 4; and a request to make the reported data publicly available in a timely manner to inform public comment. EDF “also reiterated their concern with the length of the comment period following the webinar.” The meeting summary states that EPA will accept supplemental comments after August 16, 2021, that are e-mailed to Susan Sharkey (.(JavaScript must be enabled to view this email address)), but that such comments should be provided as soon as possible. EPA noted that interested parties could comment during interagency review and following the publication of the proposal.

More information on EPA’s July 27, 2021, webinar is available in our July 29, 2021, memorandum. As reported in our August 6, 2021, blog item, EPA posted a memorandum in Docket ID EPA-HQ-OPPT-2021-0436 stating that it will not extend the August 16, 2021, comment period stemming from the July 27, 2021, public webinar.


 
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