Lynn L. Bergeson And Christopher R. Blunck, "Expert Focus: What Are the Implications of the US EPA’s Expected Final Rule on Persistent, Bioaccumulative and Toxic Chemicals?," Chemical Watch, March 26, 2020: Persistent, bioaccumulative, and toxic (PBT) chemicals have long been recognized to behave differently in the environment and in biological systems from non-PBT substances. The U.S. Congress acknowledged this when amending TSCA in 2016 by crafting special provisions under Section 6(h) that were uniquely applicable to PBTs. Last July, EPA proposed a rule that would implement the Section, but this caused much controversy and led to comments from, among others, the retail, coatings, and aerospace sectors and non-governmental organizations (NGO). It also raised several novel legal issues relating to TSCA’s interpretation. The full article is available to download.

Materials Available From ChemCon TSCA Seminar: Materials are now available from the last conference held before the novel coronavirus put face-to-face meetings on hold. B&C was pleased to sponsor ChemCon The Americas, held March 2-6 in Philadelphia, PA, which featured valuable updates from EPA representatives and others regarding the latest TSCA developments.

Resources available now include:

• Interview with Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP), and Lynn L. Bergeson, Managing Partner, B&C, in which they discuss the implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and what can be expected through 2020. The interview can be seen here.

• Complimentary materials from the “Workshop on TSCA CDR-rule (Chemical Data ReportingCDR) ,”presented by Susan Sharkey, Chemical Control Division, OPPT, EPA; Mark Herwig, Senior Director, Global Chemicals Compliance and Risk Management, United Technologies Corporation; and Kathleen M. Roberts, Senior Regulatory Consultant, B&C. Download the materials here.

•  Materials for purchase (€75) from “The amended TSCA and its 2020 priorities, implementation and direction for new and existing chemicals” seminar, presented by Alexandra Dapolito Dunn, Assistant Administrator, EPA; Mark Hartman, Deputy Director for Management, OPPT, OCSPP; Tala Henry, Deputy Director for Programs, OPPT, OCSPP; Richard E. Engler, Ph.D., Director of Chemistry, B&C; Lynn L. Bergeson, Managing Partner, B&C; and others. Order the materials using the order form available on the ChemCon website.

NGOs File Suit Against EPA For Failing To Disclose Information About New Chemical Substances: On March 18, 2020, a coalition of NGOs filed suit in the U.S. District Court for the District of Columbia against EPA, claiming that EPA fails to disclose information about new chemical substances under TSCA. According to the plaintiffs’ complaint, EPA fails to publish full and complete notices of its receipt of new chemical applications in a timely fashion and does not disclose all non-confidential information, including health and safety studies, supporting such applications. The plaintiffs state that action by the court is needed to ensure that the NGOs and their members “have timely access to information and are able to provide input on the potential risks of new chemicals and the need for protections from those risks prior to completion of EPA’s reviews.” The coalition includes the Environmental Defense Fund (EDF), Center for Environmental Health, Environmental Health Strategy Center, Natural Resources Defense Council (NRDC), and Sierra Club. More information is available in our March 23, 2020, memorandum.

EPA Seeks Nominations For TSCA SACC: EPA published a Federal Register notice on March 20, 2020, inviting the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the TSCA Science Advisory Committee on Chemicals (SACC). 85 Fed. Reg. 16094. EPA is seeking nominations of individuals who have demonstrated high levels of expertise in scientific and/or technical fields relevant to chemical safety and risk assessment, including, but not limited to: human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics, toxicology and pathology, and the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations. Any interested person or organization may nominate qualified persons to be considered for appointment to SACC. Individuals also may self-nominate. The preferred method for submitting nominations is via e-mail to Steven Knott, the SACC’s Designated Federal Officer (knott.steven@epa.gov). Nominations are due no later than April 20, 2020.

Safer Choice Program Accepting Submissions For 2020 Safer Choice Partner Of The Year Awards: EPA published a Federal Register notice on March 23, 2020, announcing that the EPA Safer Choice program is accepting submissions for its 2020 Safer Choice Partner of the Year Awards. 85 Fed. Reg. 16334. EPA states that it developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals, furthering outstanding or innovative source reduction. Interested parties who would like to be considered for this award should submit to EPA information about their accomplishments and contributions during 2019. EPA notes that there is no form associated with this year’s application. EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony that is being planned for fall 2020. Submissions are due May 31, 2020.

EPA Will Consider Exemptions To TSCA Fees Rule For EPA-Initiated Risk Evaluations: EPA announced on March 25, 2020, that it will consider a proposed rule that would look at potential exemptions to the TSCA fees rule in response to stakeholder concerns about implementation challenges. According to EPA, it plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:

• Import the chemical substance in an article;

• Produce the chemical substance as a byproduct; or

• Produce or import the chemical substance as an impurity.

EPA intends to issue proposed amendments to the current fees rule later in 2020, with the goal of promulgating the amendments in 2021. EPA published a Federal Register notice on April 10, 2020, announcing the availability of a memorandum signed by the Assistant Administrator of the Office of Enforcement and Compliance Assurance (OECA) providing a “no action assurance” to these categories of manufacturers. 85 Fed. Reg. 20275. The memorandum is in effect from March 24, 2020, until either: (1) 11:59 p.m. (ET) September 30, 2021; or (2) the effective date of a final rule addressing the proposed exemptions to manufacture definition of the TSCA fees rule, whichever occurs earlier.

EPA Announces Temporary Enforcement Discretion Policy: EPA announced on March 26, 2020, a temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic. EPA states that its temporary enforcement discretion policy applies to civil violations during the COVID-19 outbreak. The policy addresses different categories of noncompliance differently. For example, according to EPA, it “does not expect to seek penalties for noncompliance with routine monitoring and reporting obligations that are the result of the COVID-19 pandemic but does expect operators of public water systems to continue to ensure the safety of our drinking water supplies.” The policy describes the steps that regulated facilities should take to qualify for enforcement discretion. To be eligible for enforcement discretion, the policy requires facilities to document decisions made to prevent or mitigate noncompliance and demonstrate how the noncompliance was caused by the COVID-19 pandemic. The policy applies retroactively beginning on March 13, 2020. EPA will assess the continued need for and scope of this temporary policy on a regular basis and will update it if EPA determines modifications are necessary. To provide fair and sufficient notice to the public, EPA states that it will post a notification on its website at least seven days prior to terminating the temporary policy. EPA announced on April 2, 2020, that it sent a letter to all members of Congress to correct the record on its temporary policy. According to EPA, it expects regulated entities to comply with all obligations, and if they do not, EPA emphasizes that the policy states EPA will consider the pandemic, on a case-by-case basis, when determining an appropriate response. Furthermore, in cases that may involve acute risks, or imminent threats, or failure of pollution control or other equipment that may result in exceedances, “EPA’s willingness to provide even that consideration is conditioned on the facility contacting the appropriate EPA region, or authorized state or tribe, to allow regulators to work with that facility to mitigate or eliminate such risks or threats.” More information is also available in our March 27, 2020, and April 1, 2020, pesticide blogs.

Yvette T. Collazo Will Be New Director Of OPPT: Effective March 29, 2020, Yvette T. Collazo is the new Director of EPA’s OPPT. Ms. Collazo previously worked for the U.S. Department of Energy (DOE), where she led activities related to federal contracts and agreements of more than $250 million for the cleanup of radiological, industrial, and groundwater hazards resulting from decades of nuclear material production at DOE’s Savannah River facility. Ms. Collazo also served as Senior Advisor and Director for the Office of Technology Innovation and Development at DOE’s Office of Environmental Management. In this capacity, she led the identification and advancement of technologies, processes, and technical practices that improved the performance of waste processing, groundwater and soil, facility decontamination and decommissioning, and nuclear materials projects over their life cycles, from planning to disposal. Starting in 2013, Ms. Collazo served as District Director of the U.S. Small Business Administration (SBA) Puerto Rico and Virgin Islands District Office. As District Director, she was responsible for the delivery of the SBA’s financial assistance, business counseling, entrepreneurial training, and federal contracting programs throughout the District. Ms. Collazo has a Master of Science in Environmental Management from the Illinois Institute of Technology and a Bachelor of Science in Mechanical Engineering from the University of Puerto Rico, Mayagüez Campus.

EPA Publishes 2020 Mercury Inventory Report: On April 2, 2020, EPA published a Federal Register notice announcing the availability of the 2020 Mercury Inventory Report on the supply, use, and trade of mercury in the United States. 85 Fed. Reg 18574. The report presents aggregated data submitted on imported mercury, mercury manufactured in the United States, imported mercury-added products, mercury-added products made in the United States, and mercury used in manufacturing processes. The inventory report also provides a broad view of U.S. mercury stored, sold, and exported, as well as industry sectors and countries involved in the supply, use, and trade of mercury. More information is available in our March 31, 2020, memorandum, “EPA Publishes 2020 Mercury Inventory Report, Enhancing Transparency of Data.”

EPA Publishes Draft Risk Evaluation Of Asbestos: On April 3, 2020, EPA published a Federal Register notice announcing the availability of the draft risk evaluation of asbestos. 85 Fed. Reg. 18954. EPA reviewed a suite of potential asbestos exposures and made the following initial determinations on risk:

• EPA did not find risk to the environment; and

• EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, and bystanders.

EPA will hold a virtual peer review meeting of the SACC on the draft risk evaluation April 27-30, 2020. The virtual peer review meeting is open to the public to attend and provide comments. EPA asks that comments on the draft risk evaluation be submitted by April 22, 2020, to allow SACC time to review and consider them before the peer review meeting. Comments received after April 22, 2020, and prior to the end of the oral public comment period during the meeting will still be provided to SACC for their consideration. Comments on the draft risk evaluation are due June 2, 2020. More information is available in our April 1, 2020, memorandum, “EPA Publishes Draft Risk Evaluation of Asbestos, Will Hold Virtual Peer Review Meeting.”

EPA Seeks Public Comment On First Batch Of Draft Scope Documents: On April 9, 2020, EPA published a Federal Register notice announcing that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under TSCA is available for comment. 85 Fed. Reg. 19941. EPA released draft scope documents for 13 of the next 20 chemicals undergoing risk evaluation, and stated that it will soon release and accept public comments on the seven remaining draft scope documents. As is the case on all TSCA Section 6 actions taken by EPA, the scoping documents are substantial documents that will require thorough review by stakeholders. This is especially true if any of the 13 substances is in a company’s supply chain. Comments are due May 26, 2020. More information on the first batch of draft scope documents is available in our April 7, 2020, memorandum, “EPA Seeks Public Comment on First Batch of Draft Scope Documents.”

EPA Receives Manufacturer Request For Risk Evaluation Of D4: On April 8, 2020, EPA announced that it received a complete manufacturer request for EPA to conduct a risk evaluation of octamethylcyclotetrasiloxane (D4) from Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center. EPA states that D4 is used to make other silicone chemicals and as an ingredient in some personal care products. D4 was identified in the 2014 Update to the TSCA Work Plan. Within 60 business days of receipt of a facially complete request, EPA will submit for publication the receipt of the request in the Federal Register, open a public docket for the request, and provide no less than 45 calendar days for public comment.

EPA Amends CDR Rule And Extends 2020 Submission Period: On April 9, 2020, EPA promulgated a final rule amending the CDR rule. 85 Fed. Reg. 20122. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Lautenberg Act’s amendments to TSCA. EPA states that some of the key revisions include:

• Simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD);

• Updating requirements for making confidentiality claims to align with the requirements in amended TSCA; and

• Adding reporting exemptions for specific types of byproducts manufactured in certain equipment.

Additionally, EPA issued a final rule extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool. 85 Fed. Reg. 19890. The reporting period will still begin on June 1, 2020. More information is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

EPA Publishes Updated Data On TSCA CBI Reviews: On April 10, 2020, EPA published the quarterly update of the TSCA confidential business information (CBI) review statistics. The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020. In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available. EPA states that making this information publicly available “continues to demonstrate the agency’s commitment to transparency while fulfilling its responsibilities under the Lautenberg Act amendments to TSCA.” According to EPA, it has established “numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.” The updated statistics show EPA’s progress toward meeting these requirements.

EPA Will Host April 16 Call On TSCA Fees For EPA-Initiated Risk Evaluations: EPA will hold a call on April 16, 2020, from 1:00 p.m. to 2:00 p.m. (EDT) on its recently announced plan to reduce burden for certain stakeholders subject to the TSCA fees rule requirements for EPA-initiated risk evaluations. The call will cover:

• TSCA fees rule requirements and processes associated with EPA-initiated risk evaluations;

• EPA’s March 25, 2020, rulemaking announcement and “No Action Assurance” and the implications for certain manufacturers who: (1) import a high-priority chemical in an article; (2) produce a high-priority chemical as a byproduct; or (3) produce or import a high-priority chemical as an impurity; and

• Reporting obligations during the current comment period for the preliminary lists of fee payers, closing May 27, 2020.

Registration is now open.

EPA Coordinates With Retailers And Third-Party Marketplace Platforms To Discuss Steps To Protect American Consumers From Fraudulent Coronavirus Disinfectant Claims: On April 3, 2020, EPA hosted an interactive telephone call with U.S. retailers and third-party marketplace platforms to discuss imposter disinfectant products and those that falsely claim to be effective against the novel coronavirus, SARS-CoV-2, the cause of COVID-19. EPA hosted the call due to recent complaints on the availability of products with unsubstantiated and potentially dangerous claims of protection against SARS-CoV-2 and has enlisted the help of the retail community to prevent these products from coming to market.

EPA Administrator Andrew Wheeler described the call as “informative and productive,” and stated that “together, we will work diligently to ensure that consumers have access to EPA-approved and verified surface disinfectant products; products that we know to be effective against the novel coronavirus.” Additional information on the recent telephone conference is available here. More information can be found in our blog.

EPA Announces New Surface Disinfectant Products Added To List N In Effort To Combat COVID-19: On April 2, 2020, EPA announced the addition of new surface disinfectants on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N) that may be used to combat SARS-CoV-2, the novel coronavirus that causes COVID-19. List N now contains 357 products. The web page for List N also now has enhanced functionality to allow users to sort these products by surface type and use site. EPA states that it continues to expedite the review process for new disinfectants. Additional information on EPA’s efforts to address the novel coronavirus is available here. More information is also available in our April 3, 2020, Pesticide Law and Policy Blog^®.

EPA Announces Additional Action To Assure Availability Of Disinfectant Products For Use Against The Novel Coronavirus: On March 31, 2020, EPA announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing manufacturers of certain already-registered EPA disinfectant products to obtain certain active ingredients from any source without prior approval from EPA. This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N). EPA announced on March 26, 2020, similar action on certain inert ingredients. Applications must be submitted via the CDX portal. At this time, EPA is not accepting paper applications. Once an application is submitted, EPA requests that an e-mail be sent to disinfectantslist@epa.gov with the CDX tracking number (CDX _ 2020 _ XXXXXXX). A registrant may distribute or sell a product modified according to this temporary amendment to Pesticide Registration (PR) Notice 98-10 once EPA receives the notification. Additional information on submission information for registrants is available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants and in our March 31, 2020, blog and in our March 26, 2020, blog.

EPA To Schedule FIFRA SAP Meeting On New Approaches To Human Health Risk Assessment For Organophosphates: In September 2020, EPA’s Office of Pesticide Programs (OPP) plans to convene a FIFRA Scientific Advisory Panel (SAP) meeting to discuss New Approach Methodologies (NAM) for organophosphate (OP) pesticides. EPA states that these NAMs could reduce reliance on default uncertainty factors for human health risk assessment and also reduce animal testing. Additional details, including dates, times, and agenda, will be forthcoming at www.epa.gov/sap. More information is available in our blog.