On September 1, 2017, the Environmental Defense Fund (EDF) filed a petition for review in the U.S Court of Appeals for the D.C. Circuit (No. 17-1201) of the U.S. Environmental Protection Agency’s (EPA) final Toxic Substances Control Act (TSCA) framework rule TSCA Inventory Notification (Active-Inactive) Requirements, published on August 11, 2017 (82 Fed. Reg. 37520). This is the third and final challenge by EDF to the framework rules implementing amended TSCA (there are only three...
September 1, 2017
OMB Reviewing Proposed Rule Regarding Reporting Requirements for a Mercury Inventory
On August 17, 2017, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule regarding reporting requirements for a mercury inventory to the Office of Management and Budget (OMB). The proposed rule would establish reporting deadline(s) and information requirements for the purpose of assisting EPA’s periodic update and publication of the inventory of mercury supply, use, and trade in the U.S. As required under the Frank R. Lautenberg Chemical Safety for the...
On September 6, 2017, at 10:00 a.m. (EDT), the House Science, Space, and Technology Subcommittees on Environment and on Oversight will hold a joint hearing on “Examining the Scientific and Operational Integrity of EPA’s IRIS Program.” The following witnesses are scheduled to testify: Dr. Kenneth Mundt, Principal, Ramboll Environ; Dr. James Bus, Senior Managing Scientist, Exponent; and Dr. Thomas Burke, former Deputy Assistant Administrator of the U.S. Environmental Protection...
As reported in our August 25, 2017, blog item, the U.S. Environmental Protection Agency (EPA) will hold a webinar on September 7, 2017, on its process for gathering use and exposure information on five persistent, bioaccumulative, and toxic (PBT) chemicals under the amended Toxic Substances Control Act (TSCA). EPA will provide background on new requirements for regulating certain PBT chemicals and explain how interested parties can provide use information to EPA on...
The U.S. Environmental Protection Agency (EPA) will hold a September 7, 2017, webinar to explain its process for gathering use and exposure information on five persistent, bioaccumulative, and toxic (PBT) chemicals under the amended Toxic Substances Control Act (TSCA). EPA states that the webinar will provide background on new requirements for regulating certain PBT chemicals and explain how interested parties can provide use information to EPA on these five chemicals:...
On August 22, 2017, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin preliminary research to assess Chemical Data Reporting (CDR) under the Toxic Substances Control Act (TSCA). According to OIG’s Project Notification, the specific objectives for this evaluation are to determine: (1) how EPA is ensuring that companies are compliant with CDR requirements under TSCA; and (2) whether EPA is using CDR data to...
On August 10, 2017, and on August 11, 2017, petitions for review of two of the U.S. Environmental Protection Agency’s (EPA) final “framework rules” issued under the amended Toxic Substances Control Act (TSCA) were filed in federal court. These six lawsuits seek review of the final rule Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation under TSCA. The petitions were filed by Safer Chemicals,...
On August 14, 2017, as the final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule on nanomaterials took effect, the U.S. Environmental Protection Agency (EPA) published “working guidance” intended to assist stakeholders in complying with the rule. The working guidance notes that it “will not provide answers to all of the potential questions that will arise as manufacturers and processors seek to comply with the rule. Commenters to the draft guidance...
August 11, 2017
EPA Publishes TSCA Framework Final Rule on TSCA Inventory Notification (Active-Inactive) Requirements; Sets Dates for Retrospective Reporting
On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. This final rule is effective as of August 11, 2017 (the date of publication). As further detailed in the final rulemaking, chemical manufacturers and importers are required to submit notifications for chemicals that were manufactured or imported over...
August 10, 2017
THE WAIT IS OVER: TSCA Framework Final Rule on TSCA Inventory Notification (Active-Inactive) Requirements Scheduled For Publication
On August 11, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. This final rule is scheduled to become effective on August 11, 2017 (the date of publication). This rule, signed by EPA on June 22, 2017, establishes, among other requirements: A retrospective electronic notification of...
August 8, 2017
EPA Eliminates New Chemical Backlog; Commits to Improvements to New Chemical Safety Reviews
On August 7, 2017, the U.S. Environmental Protection Agency (EPA) issued a press release stating that it has eliminated the new chemical backlog of over 600 chemicals: “[t]he current caseload is back at the baseline and now in line with the typical active workload.” The press release also announces improvements to new chemical safety reviews, which include operating principles, improvement of EPA’s Toxic Substances Control Act (TSCA) new chemicals program, and further...
August 3, 2017
EPA Nominates Additional Candidates for Science Advisory Committee on Chemicals; Requests Public Comments
On August 3, 2017, the U.S. Environmental Protection Agency (EPA) published a notice on further nominations to the Science Advisory Committee on Chemicals (SACC). EPA’s notice provides the names and affiliations of 64 additional candidates currently under consideration for appointment to SACC. Biographical sketches for these candidates will be are posted on EPA’s website. EPA will also be considering the 29 candidates for membership previously identified in...
On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda. The U.S. Environmental Protection Agency’s (EPA) Agency Rule List included many items under the Toxic Substances Control Act (TSCA), including six in the final rule stage, ten in the proposed rule stage, and one in the prerule stage. The six items in the final rule stage are: RIN 2070-AK20: Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control...
On July 20, 2017, the U.S. Environmental Protection Agency (EPA) published two of the three Toxic Substances Control Act (TSCA) framework final rules in the Federal Register: Procedures for Chemical Risk Evaluation; and Procedures for Prioritization of Chemicals for Risk Evaluation. These rules will become effective on September 18, 2017. The TSCA Inventory Notification (Active-Inactive) Reporting Requirements final rule has not yet been published. EPA also published...
On July 10, 2017, the U.S. Environmental Protection Agency (EPA) issued a prepublication version of a direct final rule, Significant New Use Rule on Certain Chemical Substances, noting the issuance of significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 29 chemical substances that were the subject of premanufacture notices (PMN) and subject to consent orders under TSCA Section 5(e). These are the first rules with consent orders negotiated...
On July 7, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of the scope documents for the risk evaluations of the first ten chemicals that it will be conducting under the amended Toxic Substances Control Act (TSCA). 82 Fed. Reg. 31592. The notice states that each scope document includes “the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the EPA expects to...
On June 26, 2017, Bergeson & Campbell, P.C. (B&C®) issued a summary and analysis of the three final Toxic Substances Control Act (TSCA) framework rules released by the U.S. Environmental Protection Agency (EPA) on June 22, 2017, EPA Issues Final TSCA Framework Rules. The final rules include the prioritization process rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals for which risk...
As required by the amended Toxic Substances Control Act (TSCA), on June 22, 2017, one year after passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the U.S. Environmental Protection Agency (EPA) has issued the three framework rules in final. EPA also released draft guidance to assist in developing and submitting draft risk evaluations. The final rules are: Procedures for Chemical Risk Evaluation; Procedures for Prioritization of Chemicals for Risk...
June 21, 2017
EPA Opens Comment Period on Risk Evaluations for First Ten Chemicals under Revised TSCA
On June 19, 2017, the U.S. Environmental Protection Agency posted a memo authorizing the opening of comment periods for the public to comment on the risk evaluation process for the first ten chemicals it is evaluating under the revised Toxic Substances Control Act (TSCA) to determine whether they “present an unreasonable risk of injury to health or the environment.” Specifically, EPA states it is interested in “information from the public that could be useful to the...
On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval. Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested...
The U.S. Environmental Protection Agency (EPA) has released a pre-publication version of its direct final rule signed on April 5, 2017, which states that EPA will be promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 37 chemical substances which were the subject of premanufacture notices (PMN). This action will require persons who intend to manufacture or process any of these 37 chemical substances for an activity that is designated as a...
On June 1, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Evaluating Existing Chemical Risks under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval. EPA’s proposed rule describes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to...
June 1, 2017
EPA Issues Notice on the Establishment of the Negotiated Rulemaking Committee and Sets Public Meeting Dates
On June 5, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice of public meetings and a notice regarding the establishment of the Negotiated Rulemaking Committee (NRC). The NRC’s objective is to “negotiate a proposed rule that would limit chemical data reporting requirements under Section 8(a) of the Toxic Substances Control Act (TSCA), [as amended], for manufacturers of any inorganic byproduct chemical substances...
On May 23, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval. In the proposed rule, EPA describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the...
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, released today by the American Bar Association (ABA). This new book is a comprehensive guide to the substantial revisions to the Toxic Substances Control Act (TSCA) occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, to produce “new TSCA,” amending and replacing “old...
The U.S. Small Business Administration’s (SBA) Office of Advocacy (Advocacy) has announced that it will be hosting regional small business roundtables “to hear firsthand from small businesses facing regulatory burdens [on] … which federal agency regulations should be considered for reform or elimination,” and “which regulations are problematic for your business,” as a result of the recent Executive Orders 13771 and 13777 on regulatory reform. The first two roundtables in this series...
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” 82 Fed. Reg. 22452. The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are...
On May 9, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a notice stating that it was reopening the comment period regarding whether revision to the current size standards for small manufacturers and processors, which are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA) Section 8(a), is warranted. 82 Fed. Reg. 21542. EPA is opening the comment period for another 15 days, until May 24,...
The amended Toxic Substances Control Act (TSCA) has ushered in new developments in testing strategies. In March 2017, Andre E. Nel, Ph.D. (Division of NanoMedicine, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California (UCLA); California NanoSystems Institute, UCLA (CNSI)) and Timothy F. Malloy (CNSI; UCLA School of Law; UCLA Center on Environmental and Occupational Health) published Policy reforms to update chemical safety...
Facing a government shutdown, late on April 30, 2017, lawmakers reached agreement on a spending bill that funds the federal government through September 2017, which is the end of Fiscal Year (FY) 2017. President Trump’s budget blueprint sought to slash EPA’s coffers by some 31 percent (and more if certain programs were eliminated from the base). The deal reached by lawmakers, however, would essentially fund EPA at its current levels and retain current staff...
On May 2, 2017, the U.S. Environmental Protection Agency (EPA) announced it would convene a public meeting to clarify and discuss the process of negotiated rulemaking on changes to Chemical Data Reporting (CDR) requirements for inorganic byproducts. The meeting will be held on May 9, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) and on May 10, 2017, from 9:00 a.m. to 3:00 p.m. (EDT), in Washington, D.C. at the Capital Hilton, 1001 16th Street, N.W, in the General Session Room (South...
May 1, 2017
EPA Extends Comment Date for Proposed Rules Banning Certain Uses of TCE, NMP, and Methylene Chloride
On May 1, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating it was reopening and extending the comment period for two proposed rules: (1) to prohibit the use of trichloroethylene (TCE) in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers, of TCE for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited...
April 27, 2017
“TSCA Reform: Key Provisions and Implications” Published In Environmental Quality Management Journal
On April 14, 2017, Lynn L. Bergeson’s article “TSCA Reform: Key Provisions and Implications,” was published in Volume 26, Issue 2, of Environmental Quality Management. On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which substantially amended the Toxic Substances Control Act (TSCA), and, in so doing, fundamentally altered the domestic management of industrial chemicals -- the lifeblood of many manufacturing...
On April 25, 2017, the U.S. Environmental Protection Agency (EPA) issued two notices in the Federal Register expressing its determination that 28 new chemical notifications are “not likely to present an unreasonable risk of injury to health or the environment.” 82 Fed Reg. 19044 (Statement of Findings for December 2016); 82 Fed. Reg. 19046 (Statements of Findings for February 2017). The statements of findings list premanufacture notices (PMN) and microbial commercial...
According to press reports, Nancy Beck, Ph.D., DABT has been hired as the Principal Deputy Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). Dr. Beck holds a doctorate in environmental health from the University of Washington. For the past five years she served as the Senior Director for Regulatory Science Policy at the American Chemistry Council (ACC). For a decade prior to ACC, she was an analyst...
On August 18, 2017, the U.S. Environmental Protection Agency (EPA) announced that it would be holding a public workshop on the use of the paint remover methylene chloride in furniture refinishing on September 12, 2017, from 9:00 a.m. to 4:00 p.m. (EDT) at its Region 1 Headquarters in Boston, Massachusetts. It is holding the workshop in collaboration with the Small Business Administration (SBA) Office of Advocacy. The meeting aims to “facilitate an exchange of information...
On August 18, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register stating that it will be holding the third and fourth committee meetings of the Negotiated Rulemaking Committee (NRC) on September 13, 2017, from 9:00 a.m to 5:00 p.m. (EDT) to September 14, 2017, from 9:00 a.m to 3:00 p.m. (EDT); and on October 25, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) to October 26, 2017, from 9:00 a.m. to 3:00 p.m. (EDT). The...
On August 14, 2017, Bergeson & Campbell, P.C. (B&C®) announced it would be forming a Toxic Substances Control Act (TSCA) New Chemicals Coalition. That the U.S. Environmental Protection Agency (EPA) is now required to make a determination on all new chemicals (or significant new uses of existing chemicals) is at the heart of the changes in EPA’s review of new chemicals, and the new policies and practices that have emerged since June of 2016. What is less clear is how EPA is...
A trio of recent internal U.S. Environmental Protection Agency (EPA) memoranda are providing insight into how EPA intends to implement President Trump’s review and potential pogrom of EPA regulations. Virtually no program or regulation appears to be secure from the chopping block. Many stakeholders in industry and other sectors may be alarmed to see programs that are of benefit to them assigned a slot in the guillotine. Supporters of these programs, thus, would be wise to...
On March 28, 2017, Senators Chris Coons (D-DE), Shelley Moore Capito (R-WV), Steve Daines (R-MT), and Gary Peters (D-MI) announced that they will serve as co-chairs of the newly formed Senate Chemistry Caucus. Senators John Boozman (R-AR), Joe Donnelly (D-IN), John Neely Kennedy (R-LA) and Joe Manchin (D-WV) have also agreed to join the Caucus. Senator Coons’ press release states that the Senate Chemistry Caucus will provide “a bipartisan forum for Senators to work together on...
On March 29, 2017, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register a notice releasing its initial inventory report of mercury supply, use, and trade in the United States pursuant to Section 8(b)(9)(10) of the amended Toxic Substances Control Act (TSCA). Specifically, the report is a “compilation of readily available, previously published data on the supply, use and trade elementary mercury and mercury compounds,” and its purpose is to “identify...
On March 8, 2017, Senator James Lankford (R-OK) introduced S. 578, the “Better Evaluation of Science and Technology Act” or “BEST Act,” a bill that would amend title 5 of the United States Code, commonly referred to as the Administrative Procedure Act (APA), to “provide requirements for agency decision making based on science.” Although the BEST Act does not refer to the recently amended Toxic Substances Control Act (TSCA), it is apparent that it plans to implement the same...
March 16, 2017
EPA’s Extension of Comment Date for TSCA Inventory Notification Proposed Rule Issued in Error
On March 15, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be extending the comment period on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) proposed rule issued on January 13, 2017. On March 16, 2017, however, EPA rescinded this extension, stating it was issued in error, but did state that it would “make every effort to consider comments received outside of the formal comment period, if provided by March 24, 2017.” EPA is...
On March 10, 2017, the U.S. Environmental Protection Agency (EPA) announced that its Office of Pollution Prevention and Toxics (OPPT) would be hosting two webinars covering the use of the Central Data Exchange (CDX) for upfront confidential business information (CBI) substantiation. Per EPA’s notice on January 19, 2017, the statutory requirements for substantiation of CBI claims will change effective March 21, 2017, for Toxic Substances Control Act (TSCA) submissions. In...
On March 6, 2017, the White House’s Office of Management and Budget (OMB), via the Office of Information and Regulatory Affairs (OIRA), issued Memorandum: Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions, a memorandum for regulatory policy officers at executive departments and agencies and managing and executive directors of certain agencies and commissions, with the subject: Spring 2017 Data Call for the Unified Agenda of Federal...
March 7, 2017
EPA Denies TSCA Section 21 Petition on Fluoride Chemicals in Drinking Water; Provides Response to Petition
On February 27, 2017, the U.S. Environmental Protection Agency (EPA) announced in a Federal Register notice that it was denying a Toxic Substances Control Act (TSCA) Section 21 petition that requested regulatory action under Section 6 to “prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies,” and that it was making available its response to the petition. 82 Fed. Reg. 11878. The petition was received by EPA on November 23, 2016, and EPA had...
On March 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register reopening the comment period on the risk evaluation scoping efforts under the Toxic Substances Control Act (TSCA) for the ten chemical substances that were designated on December 19, 2016: 1, 4 Dioxane; Methylene Chloride; 1-Bromopropane; N-Methylpyrolidone; Asbestos; Pigment Violet 29; Carbon Tetrachloride; Trichloroethylene; Cyclic Aliphatic Bromide Cluster...
On March 1, 2017, President Trump’s Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda, issued on February 24, 2017, was published in the Federal Register. 82 Fed. Reg. 12285. This EO follows closely on the heels of his previous EO concerning government regulations (EO 13771), but is different in that it is intended to further and enforce President Trump’s EO as well as EO’s issued in prior administrations, instead of creating an entirely new set of...
On February 21, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice delaying the effective date from March 20, 2017, to March 21, 2017, of the notice issued on January 19, 2017. 82 Fed. Reg. 11218. The February 21 notice appears to correct a miscalculation of the 60-day freeze period required under the Regulatory Freeze Pending Review memorandum issued on January 20, 2017, to the notice EPA issued on January 19, 2017, titled Statutory Requirements for Substantiation of...
The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on its website on February 9, 2017, that it has established the Science Advisory Committee on Chemicals (SACC). EPA was required to form the SACC within one year after enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The timing is interesting given that the deadline for public comments on the nominees was January 9, 2017, and the EPA...