On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan. OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.” Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA)...
June 8, 2018
New York Launches Disclosure Program Intended to Protect Consumers from Chemicals in Household Cleaning Products
On June 6, 2018, the New York State Department of Environmental Conservation (NYSDEC) released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program. The Disclosure Program is similar to the recently enacted California Cleaning Product Right to Know Act of 2017 which requires the disclosure of cleaning product ingredients by way of website or product label. The Household Cleansing Product Information...
The U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) on June 6, 2018, announced two public meetings related to the harmonization of transportation and hazard communication standards with international standards. 83 Fed. Reg. 26338. The first meeting — led by PHMSA — will solicit public input on current proposals and items for inclusion in the agenda of the 53rd session of the United Nations Sub-Committee of Experts...
On June 1, 2018, the U.S. Environmental Protection Agency (EPA) released the much anticipated first ten problem formulation documents; its systematic review approach document; and a significant new use rule (SNUR) proposal enabling it to prevent new uses of asbestos for public comment. Links and short summaries are provided below. EPA states that the problem formulation documents refine the conditions of use, exposures, and hazards presented in the scope of the risk evaluations for the...
On May 24, 2018, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a public meeting on June 28, 2018, from 1:00 p.m. to 4:00 p.m. (EDT) in Washington, D.C. regarding technical issues in the Formaldehyde Emission Standards for Composite Wood Products Final Rule published on December 12, 2016. 83 Fed. Reg. 24104. The Federal Register notice states that the meeting will “inform EPA’s potential development of a...
May 25, 2018
EPA Extends Comment Period On Proposal To Strengthen Transparency In Regulatory Science
On May 25, 2018, the U.S. Environmental Protection Agency (EPA) extended until August 16, 2018, the comment period on its proposed rule titled “Strengthening Transparency in Regulatory Science.” 83 Fed. Reg. 24255. EPA also announced that it will hold a public hearing on the controversial proposed rule on July 17, 2018. The April 30, 2018, proposal (83 Fed. Reg. 18768) is intended to strengthen the transparency of EPA regulatory science. The proposed...
On May 22-23, 2018, the U.S. Environmental Protection Agency (EPA) hosted a Polyfluoroalkyl Substances (PFAS) National Leadership Summit (Summit) in Washington, D.C. The Summit convened federal and state regulators, including representatives from EPA’s Office of Water (OW), EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), the U.S. Food and Drug Administration (FDA), the U.S. Department of Defense (DOD), a small group of invited industry participants, and...
May 17, 2018
EPA Issues Statements of Findings: Five New Chemical Substances Not Likely to Present an Unreasonable Risk
On May 17, 2018, the U.S. Environmental Protection Agency (EPA) issued a notice releasing statements of findings on new chemical substances made on Toxic Substances Control Act (TSCA) Section 5(a) notices during the period from February 1, 2018, to March 31, 2018. 83 Fed. Reg. 22978. EPA is required to do so per TSCA Section 5(g) after its review of TSCA Section 5(a) notices when it makes a finding that a new chemical substance or significant new...
On May 7, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) final rule entitled Mercury; Reporting Requirements for the TSCA Mercury Inventory. The OIRA 2018 Spring Regulatory Agenda for this rulemaking, item RIN 2070-AK22, states that EPA’s rulemaking to implement new Toxic Substances Control Act (TSCA) Section 8(b)(10)(D) will promulgate reporting requirements...
On May 1, 2018, the Hawaii Senate and House of Representatives passed a bill that will ban the sale, offer of sale, or distribution in Hawaii of any sunscreen that contains oxybenzone or octinoxate, or both, without a prescription issued by a licensed healthcare provider to preserve marine ecosystems, beginning January 1, 2021: S.B. No. 2571, Environment; Water Pollution; Sunscreen; Oxybenzone; Octinoxate; Sale; Distribution; Prohibition. The bill received unanimous...
The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization. The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions. OPPT’s other functions are proposed to be...
April 26, 2018
Administrator Pruitt’s Testimony at Budget Hearing Addresses Science Rule and Ethics Issues
On April 26, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt was grilled by Members of the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Environment at a hearing titled The Fiscal Year 2019 U.S. Environmental Protection Agency Budget. The budget was plainly not the primary topic as the House Committee Members covered a lot of ground. Pruitt fielded many questions and comments from House Democrats on his alleged...
On April 24, 2018, the U.S. Environmental Protection Agency (EPA) announced that it would be presenting a webinar to assist processors with reporting under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule, published in the Federal Register on August 11, 2017. This webinar, scheduled for May 23, 2018, from 1:00 p.m. to 4:00 p.m. (EDT) will “include an overview of reporting requirements for processors, a demonstration of the electronic...
On April 24, 2018, the U.S. – Canada Regulatory Cooperation Council (RCC) Stakeholder Group announced that a 2018 RCC Stakeholder Event will be held on; June 4-5, 2018, in Washington, D.C. to “bring together senior regulatory officials, industry, and other members of the public on both sides of the border to provide progress reports on existing RCC work plans and to discuss new opportunities for regulatory cooperation.” The announcement states that details regarding the 2018...
On April 19, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) proposed rule entitled “Strengthening Transparency and Validity in Regulatory Science.” This new proposed rule, item 2080-AA14, has not been published in the regulatory agenda; the only information available concerning the content of this rule is its title. On April 11, 2018, OIRA received an advanced...
On April 24, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register that it will be adding a supplemental analysis, “Supplemental Analysis of Alternative Small Business Size Standard Definitions and their Effect on TSCA User Fee Collection,” to the rulemaking docket for the User Fees for the Administration of the Toxic Substances Control Act (TSCA) proposed rule published on February 26, 2018. EPA will also...
The U.S. Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) have released an educational primer on U.S. and Canadian regulations regarding chemical substances. EPA states that the purpose of the primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations — Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada. EPA,...
The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available. For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following: EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices...
The National Academies of Sciences, Engineering, and Medicine released a new report on April 11, 2018, that finds that the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has made “substantial progress” in implementing recommendations outlined by the National Academies in previous reports. According to the April 11, 2018, press release, the transformation of IRIS began several years ago, after the release of a 2011 National...
April 10, 2018
EPA Appoints Additional Members to Science Advisory Committee on Chemicals; NGO Scientists Decline Appointment
On March 22, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt appointed 11 additional members to the Science Advisory Committee on Chemicals. Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the purpose of the Committee is to provide independent advice and expert consultation, at the request of the EPA Administrator, with respect to the scientific and technical aspects of risk assessments, methodologies, and pollution prevention...
On April 4, 2018, the U.S. Environmental Protection Agency (EPA) announced the following management changes in its Office of Pollution Prevention and Toxics (OPPT): These are significant leadership changes and are likely intended to maximize OPPT efficiency. We applaud OPPT’s continuing efforts to implement TSCA and the changes occasioned by the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act almost two years ago....
On March 28, 2018, the Superior Court of California, Los Angeles County, issued its Statement of Decision (Phase II) (Defendants’ Alternative Significant Risk Level (ASRL) Affirmative Defense) that found that the defendants failed to meet their burden of proof on their ASRL affirmative defense. Council for Education and Research on Toxics (CERT) v. Starbucks Corporation (Starbucks), No. BC435759 (L.A. Super. Ct., filed April 13, 2010). CERT’s (plaintiff)...
March 23, 2018
EPA, OSHA, DHS Agree to Create New Protocols Requiring Notification And Coordination With First Responders
U.S. Senate Minority Leader Charles E. Schumer (D-NY) on March 20, 2018, announced that, after his intervention, representatives from the U.S. Occupational Safety and Health Administration (OSHA), the U.S. Environmental Protection Agency (EPA), and the Department of Homeland Security (DHS) are working to create new protocols for communicating and training with local governments and first responders. OSHA, EPA and DHS will convene the Chemical Facility Security and Safety Working...
March 16, 2018
GAO Issues Technology Assessment on How to Make Processes and Products More Sustainable
On February 8, 2018, the U.S. Government Accountability Office (GAO) issued a technology assessment report to congressional requestors entitled Chemical Innovation: Technologies to Make Processes and Products More Sustainable. GAO states it conducted this technology assessment “to explore, among other things, the opportunities, challenges, and federal roles in sustainable chemistry.” This report discusses (1) how stakeholders define and assess sustainable chemistry;...
On March 13, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people. Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental,...
March 9, 2018
EPA Seeks Input from Small Entity Representatives on Development of PBT Chemical Regulation
On March 9, 2018, as a first step in developing a proposed rule regulating certain persistent, bioaccumulative, and toxic (PBT) chemicals, the U.S. Environmental Protection Agency (EPA) announced that it is seeking nominations for individuals who represent small businesses, small governments, and small non-for-profit organizations to serve as Small Entity Representatives (SER) to provide input on potential impacts of PBT regulation. EPA states the role of a SER is “to provide advice and...
On March 6, 2018, in the U.S. Court of Appeals for the D.C. Circuit, the Environmental Defense Fund (EDF) filed its Principal Brief in the litigation case that petitions for review the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule (EDF v. EPA, No. 1701 (D.C. Cir.)). EDF’s brief includes, among other required statements, a statement of the issues, a statement of the case, a summary of...
On March 7, 2018, the U.S. Environmental Protection Agency (EPA) released a draft Strategic Plan to Promote the Development and Implementation of Alternative Test Methods to reduce the use of vertebrate animals in chemical testing, fulfilling another milestone under the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA). Under amended TSCA, EPA is required to develop a strategy to promote the development and...
On February 26, 2018, the U.S. Environmental Protection Agency (EPA) published its proposed fees rule entitled User Fees for the Administration of the Toxic Substances Control Act (TSCA), as permissible under TSCA Section 26(b). 83 Fed. Reg. 8212. The rule as proposed will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA...
February 23, 2018
California District Court Vacates EPA Final Rule to Delay Compliance with Formaldehyde Emission Standards
On February 16, 2018, the U.S. District Court for the Northern District of California issued an order granting plaintiffs’, the Sierra Club and A Community Voice-Louisiana, motion for summary judgment. The court determined that the U.S. Environmental Protection Agency’s (EPA) final rule delaying the compliance date for the formaldehyde emission standards for composite wood products (Delay Rule) exceeded EPA’s authority under the Formaldehyde Standards in Composite Wood Products Act...
On February 8, 2018, the U.S. Environmental Protection Agency (EPA) announced it is releasing a third alternative approach for assigning and applying unique identifiers (UID) to reconcile the competing requirements of Toxic Substances Control Act (TSCA) Section 14(g) for comment. 83 Fed. Reg. 5623. EPA’s first and second alternative approaches were released for comment in its notice on May 8, 2017 (82 Fed. Reg. 21386). Under amended TSCA, EPA is required to develop...
February 6, 2018
EPA Issues Final Rule on Formaldehyde Emission Standards for Composite Wood Products under TSCA
On February 7, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to issue in the Federal Register a final rule on Voluntary Consensus Standards Update; Formaldehyde Emission Standards for Composite Wood Products that will revise the formaldehyde standards for composite wood products regulations. The revision updates the incorporation by reference of multiple voluntary consensus standards originally published in the Toxic Substances Control Act...
On January 31, 2018, the U.S. Environmental Protection Agency (EPA) announced the release of its 2018 Annual Report on Risk Evaluations. Pursuant to Section 26(n)(2) of the amended Toxic Substances Control Act (TSCA), EPA is directed to publish an annual plan at the beginning of each calendar year identifying the chemical substances that will undergo risk evaluations during that year. The plan is to include both risk evaluations that will be initiated and that will be...
On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt. In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” Toxic Substances Control Act (TSCA), as being of “significant importance” and a “top...
On February 7, 2018, manufacturers that manufactured (including imported) chemicals for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, will be required to report to the U.S. Environmental Protection Agency (EPA) for the retrospective reporting period that began on August 11, 2017, per the Toxic Substances Control Act (TSCA) Inventory Notification (Active/Inactive) Requirements final rule that established a retrospective electronic notification of...
January 19, 2018
EPA Offers Assistance to Manufacturers Reporting for the TSCA Inventory February 7, 2018, Deadline
On January 18, 2018, the U.S. Environmental Protection Agency (EPA) posted additional documents on its website, specifically materials from two webinars, designed to assist manufacturers reporting for the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule that became effective on August 11, 2017. The rule, which established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured...
The U.S. Environmental Protection Agency (EPA) has updated its eNOA upload template that was initially released in 2017 to assist filers with the Central Data Exchange (CDX) system. The eNOA, or electronic Notice of Activity (NOA) Form, is used for retrospective reporting under the amended Toxic Substances Control Act’s (TSCA) Inventory notification requirements. The eNOA template, available for download from within the eNOA system on CDX, assists users to upload many...
On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a Petition for Review in the U.S. Court of Appeals for the Second Circuit (Second Circuit) of what is characterized as a U.S. Environmental Protection Agency (EPA) “final rule” issued November 7, 2017, entitled “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” The Framework Document, as it has come to be called, is the “final rule” at issue...
Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global...
January 3, 2018
EPA to Host Two Webinars on Generating and Entering the Annual Report into CDX for Third-Party Certifiers
On January 3, 2018, the U.S. Environmental Protection Agency announced it would be hosting two webinars to support Third-Party Certifiers (TPC) in generating and entering annual report information into the Central Data Exchange (CDX). Registration is available online through the following links: the webinars will be held on January 9, 2018, from 1:00 p.m. to 3:00 p.m. (EST); and on February 1, 2018, from 9:00 a.m. to 11:00 a.m. (EST). Both webinar presentations will provide...
On December 27, 2017, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) ordered the U.S. Environmental Protection Agency (EPA) to revise its nearly 17-year-old standard for levels of lead in paint and dust within one year. A Cmty. Voice v. EPA, No. 16-72816. The Ninth Circuit held that “EPA was under a duty stemming from the Toxic Substances Control Act and the Residential Lead-Based Paint Hazard Reduction Act...
On December 22, 2017, the U.S. Environmental Protection Agency (EPA) sent to the Office of Management and Budget (OMB) a proposed rule establishing fees on certain submissions under amended Toxic Substances Control Act (TSCA) Sections 4, 5, and 6. EPA has indicated that it expects to propose the rule in the early part of the New Year: EPA’s regulatory agenda lists February 2018 for the proposed rule and September 2018 for the final rule. More...
December 22, 2017
In Case of First Impression, Court Rules EPA Wrongly Dismissed Citizen Group’s TSCA Section 21 Petition
On December 21, 2017, the U.S. District Court for the Northern District of California ruled that the U.S. Environmental Protection Agency (EPA) had wrongly dismissed a Toxic Substances Control Act (TSCA) Section 21 petition submitted by Food & Water Watch, Inc. and other citizens seeking the regulation of fluoridation of drinking water supplies under TSCA Section 6(a) on grounds that the ingestion of fluoride poses an unreasonable risk to humans. Food & Water Watch, Inc. v....
December 18, 2017
EPA Extends Comment Date for Proposed Rule on Reporting Requirements for Mercury Inventory Under New TSCA
On December 19, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice extending the comment period for the proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory for 16 days, from December 26, 2017, to January 11, 2018. The notice states that “EPA received requests to extend the comment period and believes it is appropriate to do so … to give stakeholders...
December 14, 2017
EPA’s Approaches for Prioritization under TSCA Discussed at December 11, 2017, Public Meeting
On December 11, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened its public meeting on possible approaches for identifying potential candidates for prioritization under the amended Toxic Substances Control Act (TSCA). Key presenters were Jeffery Morris, Ph.D., Directory of OPPT, as well as several other OPPT staff, Health Canada (HC) and Environmental and Climate Change Canada (ECCC), and Russell S. Thomas with EPA’s...
On December 11, 2017, in the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the Fourth Circuit granted the petitioners’ motions to transfer to the Ninth Circuit. This was not entirely unexpected, as the U.S. Court...
December 7, 2017
EPA to Withdraw Direct Final Rule to Update Voluntary Consensus Standards for Composite Wood Products
On December 8, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice that it is withdrawing its direct final rule issued on October 25, 2017, to update the voluntary consensus standards that were originally published in the Toxics Substances Control Act (TSCA) Title VI formaldehyde emission standards for composite wood products final rule on December 12, 2016. EPA issued both a direct final rule and a proposed rule...
On December 6, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the public comment period to receive information on the five persistent, bioaccumulative, and toxic (PBT) chemicals that are subject to Section 6(h) of the Toxic Substances Control Act (TSCA) which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals. Comments were initially due on December 9, 2017; they are now due on January 12, 2018. EPA...
December 6, 2017
EPA’s New Chemicals Review Program—Highlights from the December 6, 2017, Public Meeting
On December 6, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened a much anticipated public meeting on implementing changes to the new chemicals review program under the amended Toxic Substances Control Act (TSCA). EPA offered brief prepared remarks and previously solicited questions from stakeholders. Stakeholders expressed their appreciation to EPA for developing the draft Points to Consider and related documents...