TSCAblog®

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing it will be holding a public meeting to receive public input and information on uses and conditions of use for the initial ten chemicals to be evaluated under Section 6(b)(2)(A) of the amended Toxic Substances Control Act (TSCA) on February 14, 2017, from 9:00 a.m. to 3:00 p.m. (EST), at the Ronald Reagan Building and International Trade Center, Polaris Room, 1300...

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of Toxic Substances Control Act (TSCA) Section 14 concerning confidential business information (CBI) claims for information submitted to EPA.  82 Fed. Reg. 6522.  Under the interpretation, EPA expresses its view that new TSCA requires substantiation of all non-exempt CBI claims at the time the information claimed as confidential is submitted to EPA.  In the notice, EPA also states that the...

The U.S. Environmental Protection Agency (EPA) recently published three Toxic Substances Control Act (TSCA) proposed framework rules:  TSCA Inventory Notification (Active-Inactive) Requirements (Jan. 13, 2017); Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (Jan. 17, 2017); and Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (Jan. 19, 2017).  Summaries, insights, and commentary from...

On January 13, 2017, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would establish 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 a potentially exposed or susceptible subpopulation, under the conditions of use.  The process would not consider costs or other nonrisk factors.  Risk evaluation is the second step, after...

On January 11, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be issuing a rule proposing to prohibit the manufacture (including import), processing, and distribution in commerce of trichloroethylene (TCE) for use in vapor degreasing; to prohibit commercial use of TCE in vapor degreasing; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain;...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a proposed rule in the January 17, 2017, Federal Register that would establish a risk-based screening process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time.  The pre-publication version of the proposed rule describes the processes for identifying potential...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a proposed rule on January 13, 2017, that would require a retrospective electronic notification of chemical substances on the Toxic Substances Control Act (TSCA) Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016.  EPA would also accept such notices for chemical substances that were processed.  The recent TSCA amendments require...

The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of 2016...

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and...

On December 21, 2016, the U.S. Environmental Protection Agency (EPA) published a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) in the Federal Register.  Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow.  As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates certain procedural...

On December 15, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act.  81 Fed. Reg. 90843.  The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3...

On December 15, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice requesting public comment on whether a revision of the current size standard definitions for small manufacturers and processors, that are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA), is warranted at this time.  Under amended TSCA Section 8(a)(3)(C), the EPA Administrator, after consultation with the Administrator of the Small Business Administration...

On December 7, 2016, the U.S. Environmental Protection Agency (EPA) announced it would be issuing a rule proposing to prohibit the manufacture, processing, and distribution in commerce of trichloroethylene (TCE) for certain uses under Section 6 of the Toxic Substances Control Act (TSCA), due to its determination that there are significant health risks associated with TCE use in aerosol degreasing and for spot cleaning in dry cleaning facilities.  The proposed action is significant for...

As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act...

On November 29, 2016,  the U.S. Environmental Protection Agency (EPA) announced the initial ten chemical substances on which risk evaluations will be conducted under Toxic Substances Control Act (TSCA) Section 6(b)(2)(A).  The chemicals, all of which were to be drawn from the TSCA Work Plan for Chemical Assessments, are: 1,4-dioxane1-bromopropaneTrichloroethylene (TCE)Carbon tetrachlorideHexabromocyclododecane (HBCD)Methylene chloridePigment violet 29Perchloroethylene...

The U.S. Environmental Protection Agency (EPA) has just announced that its Office of Pollution Prevention and Toxics (OPPT) is holding a meeting on December 14, 2016, from 9:00 a.m. to 12:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  EPA states that it will “describe its review process for new chemicals under the...

On November 10, 2016, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) reportedly received the U.S. Environmental Protection Agency’s (EPA) draft proposed risk evaluation rule under the amended Toxic Substances Control Act (TSCA), Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act.  This is a much anticipated procedural rule that will establish EPA’s process for evaluating the risk of so called...

The November 14, 2016, BNA Daily Environment Report featured comments from James V. Aidala, Senior Government Affairs Consultant for Bergeson & Campbell, P.C. (B&C®), in the story “Trump Transition Team Expected Soon at EPA To Begin Review of Agency Actions, Priorities” (paid subscription): Trump’s EPA transition team will likely receive "massive briefing books" on each of the agency’s programs, including air pollution, water, waste and pesticides, according to Jim Aidala,...

On November 7, 2016, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received a pre-publication proposed rule on Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) from the U.S. Environmental Protection Agency.  Also referred to as the “Prioritization Process Rule,” this procedural rule will stablish EPA's process and criteria for identifying high priority chemicals for...

On October 21, 2016, the U.S. Environmental Protection Agency (EPA) reopened the comment period on a proposed rule revising regulations governing significant new uses (SNU) of chemical substances under the Toxic Substances Control Act (TSCA), per a request from a commenter.  EPA states in its Federal Register notice that this request was “reasonable and is therefore reopening the comment period … [for] all interested persons.”  The proposed rule would amend the TSCA SNU...

Bergeson & Campbell, P.C. (B&C®) Managing Partner Lynn L. Bergeson and Senior Policy and Regulatory Advisor Charles M. Auer have recently published two articles on important issues as related to the amended Toxic Substances Control Act (TSCA):  “Role of ‘Conditions of Use’ Under Sections 5 and 6 of Amended Toxics Law,” BNA Daily Environment Report, October 14, 2016; and “Is The Section 5 Review Period Fixed Or Flexible In New TSCA?,” ABA Section of...

On October 11, 2016, the U.S. Environmental Protection Agency (EPA) announced that it would be taking expedited action on reducing exposures to the following persistent, bioaccumulative, and toxic chemicals (PBT).  As stated in our blog item Deadline for Requesting Risk Evaluation for PBT Chemicals Fast Approaching, Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, outlines a procedure requiring...

On October 4, 2016, Bergeson & Campbell, P.C. (B&C®) hosted its fourth and final webinar in its series of webinars on the new Toxic Substances Control Act (TSCA) in collaboration with Chemical Watch.  The webinar addressed numerous important issues for a wide array of stakeholders.  The webinar was moderated by Lynn L. Bergeson, Managing Partner at B&C, and the expert panel included Charles M. Auer, Richard E. Engler, Ph.D., Lisa R....

On September 21, 2016, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced its regulatory determinations for a batch of Microbial Commercial Activity Notices (MCAN) and premanufacture notices (PMN). The announcement by EPA consisted of ten new microorganisms submitted as MCANs and seven new chemicals submitted as PMNs.  All microorganisms and chemical substances were determined “not likely to present an unreasonable risk” (per...

The September 2016 issue of the Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter is now available.  This newsletter is prepared by the American Bar Association’s (ABA) Section of Environment, Energy, and Resources, and edited by Lynn L. Bergeson.  Several professionals from Bergeson & Campbell, P.C. (B&C®) contributed articles to this issue of the newsletter.  Articles in this special edition of the September 2016 issue are exclusively focused on...

On September 19, 2016, the U.S. Environmental Protection Agency (EPA) posted a notice on the Chemical Data Reporting website that it has amended the CDR regulations to extend the 2016 submission deadline from September 30, 2016, to October 31, 2016.  According to the pre-publication version of the Federal Register notice for the final rulemaking, EPA received a request for an extension, citing problems with certain aspects of the electronic reporting system...

On September 13, 2016, the U.S. Environmental Protection Agency (EPA) convened its second industry stakeholder meeting to discuss the development of a fees rule under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182, “new TSCA”); a copy of the presentation is available here.  Under new Toxic Substances Control Act (TSCA) Section 26(b)(4)(E), EPA is required to solicit input in support of fees rulemaking.  EPA convened its first...

ChemCon The Americas is a global chemical control conference offering authoritative speakers, in-depth sessions, and a global perspective on existing and emerging chemical regulatory schemes.  ChemCon The Americas 2016 will be held October 17 - 21, 2016, in Toronto, Canada.  Highlights from the diverse and substantive program planned for Toronto include: Workshop on the modernized Toxic Substances Control Act, with speakers including Jeff Morris, Deputy Director, U.S....

On September 12, 2016, Chemical Watch and Bergeson & Campbell, P.C. (B&C®) presented the third webinar in “The New TSCA:  What You Need To Know” webinar series:  “Webinar 3:  Inventory, CDR, and CBI (Sections 8 & 14).”  This webinar provided insight and information regarding Toxic Substances Control Act (TSCA) reform as it is being enacted and implemented, specifically related to Sections 8 and 14 of the reformed TSCA, which included the TSCA...

The American Chemical Society (ACS), together with the Johns Hopkins Bloomberg School of Public Health (JHSPH) and Honorary Co-Hosts Representatives Ken Calvert (R-CA) and Earl Blumenauer (D-OR), through ACS’ Science & the Congress Project have announced that they will be hosting a panel on “Alternatives to Animal Testing:  Emerging Uses and Policy Implications” on Tuesday, September 13, 2016, from Noon - 1:30 p.m. on Capitol Hill at the Cannon House Office...

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) released additional guidance on its implementation of the new Toxic Substances Control Act (TSCA) in the form of additional questions and answers (Q&A).  EPA added a series of Q&As of particular relevance given the fast-approaching TSCA Section 6(h) deadline of September 19, 2016, for industry to request a risk evaluation for persistent, bioaccumulative, and toxic (PBT) chemicals listed in the 2014 TSCA...

The U.S. Environmental Protection Agency (EPA) posted guidance regarding changes to the requirements for making confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The “key changes” that EPA notes are: New Certification Requirement.  Pursuant to TSCA § 14(c), a submitter of information claimed as CBI must now certify agreement with several...

Monday, September 12, 20168:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time Register Today With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016. All chemical stakeholders doing...

On August 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice of the establishment of a Science Advisory Committee on Chemicals (SACC) under Section 9(a) of the Federal Advisory Committee Act and pursuant to Section 26(o) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The notice also solicits comments and requests nominations for new members of the SACC.  The SACC expects to...

Section 6(h) of new TSCA addresses persistent, bioaccumulative, and toxic (PBT) chemical substances listed in the 2014 TSCA Work Plan.  For such chemicals, Section 6(h) outlines a procedure requiring “expedited” regulatory action that is intended to reduce exposures to these chemicals to the “extent practicable.”  As written, chemicals subject to Section 6(h) will not undergo a risk evaluation as will other high-priority chemicals.  Instead, EPA will proceed immediately to...

On August 11, 2016, the U.S. Environmental Protection Agency (EPA) convened a public meeting to solicit comments prior to development of a proposed rule to implement the revised Section 26 fees provision under the new Toxic Substances Control Act (TSCA).  Public comments may be submitted through regulations.gov in docket EPA-HQ-OPPT-2016-0401 until August 24, 2016. During the meeting, EPA solicited public comment in particular on the following five issues: To be able to...

On August 9 and August 10, the U.S. Environmental Protection Agency (EPA) held two public meetings to obtain input prior to development of a proposed rule for chemical risk evaluation (August 9) and a proposed procedural rule regarding prioritization of chemicals for further risk evaluation (August 10) under the new Toxic Substances Control Act (TSCA).  Bergeson & Campbell, P.C.’s (B&C®) Oscar Hernandez, Ph.D. and Richard E. Engler, Ph.D. were in attendance,...

On August 11, 2016, the Bloomberg BNA Daily Environment Report quoted Kathleen M. Roberts, Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®), on the implication of additional fees created by Toxic Substance Control Act (TSCA) reform. Companies that pay the costs of generating toxicity, exposure and other data should not be “double billed” through additional fees to review the resulting...

On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed to update the Toxic Substances Control Act (TSCA) Significant New Use Rule (SNUR) procedures. 81 Fed. Reg. 49598. As discussed in our previous memorandum on this proposed rule, Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards, while some of the proposed changes are not consequential, other changes, such as those related to workplace protections, are more clearly...

The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA’s March 2012 final rule modifying the HCS to conform to the United Nations’ (U.N.) Globally Harmonized System of Classification and Labelling of...

On July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted on its website the first four Section 5(a)(3) determinations for premanufacture notices (PMN) under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182) (new TSCA). All four of the new chemicals were determined to satisfy the "not likely to present an unreasonable risk" determination at Section 5(a)(3)(C). It is notable that all...

On July 25, 2016, the U.S. Environmental Protection Agency (EPA) announced its intention to hold two public meetings on August 9, and August 10, 2016, to obtain input on the processes that will be used to prioritize and evaluate chemicals under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act: August 9, 2016:  EPA states that this public meeting will inform its proposed rule on conducting risk evaluations to...

On Friday, July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted the first four Toxic Substances Control Act (TSCA) Section 5(a) determinations made following review of pre-manufacture notifications (PMN) according to TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century law, Pub. L. No. 114-182 (Lautenberg).  EPA’s determination on all four chemical substances was “not likely to present and unreasonable risk,” under new TSCA Section...

On July 18, 2016, Bloomberg BNA’s Daily Environmental Report reported on the U.S. Environmental Protection Agency’s (EPA) new chemical notice process, and included insight from industry leaders at Bergeson & Campbell, P.C.’s (B&C®) July 14, 2016, webinar, The New TSCA: Impacts on New and Existing Chemicals Programs.  B&C Managing Partner Lynn L. Bergeson was quoted as saying that premanufacture notifications, or PMNs, that chemical manufacturers must submit before they...

Bergeson & Campbell, P.C. (B&C®) has learned that the U.S. Environmental Protection Agency (EPA) is planning to convene a stakeholder workshop in Washington, D.C. on August 9-10, 2016, for a public dialogue on prioritization and risk evaluation.  We also understand that EPA may host an industry meeting on August 11-12, 2016, to consult on fees.  The dates and topics will be confirmed when EPA makes announcements in the Federal Register.

On July 14, 2016, the Environmental Law Institute (ELI) hosted an event in which the individuals and organizations critical to Toxic Substances Control Act (TSCA) reform, discussed the intricacies and challenges faced in drafting the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), the amended law, and its ultimate enactment.  The panelists included John Pendergrass, VP of Programs & Publications, ELI (moderator), Lynn L. Bergeson, Managing Partner, Bergeson...

The House’s Office of the Law Revision Counsel has posted the U.S. Code version of the Toxic Substances Control Act, as revised by the Frank R. Lautenberg Chemical Safety for the 21st  Century Act, Public Law No. 114-182.  The U.S. Government Publishing Office (GPO) has not yet posted the official version of the public law, but is expected to soon.  The GPO version of the public law will be available at https://www.gpo.gov/fdsys/.

On July 15, 2016, Bloomberg BNA Daily Environment Report quoted Lynn L. Bergeson, Managing Partner of Bergeson & Campbell (B&C®), in the article “Give EPA Detailed New Chemical Notices, Attorneys Advise.” Pre-manufacture notifications, or PMNs, that makers must submit before they can produce or import a new chemical, and significant new use notifications, which companies must submit before they can make or use certain chemicals in new ways, “need to be much...

On July 15, 2016, Bloomberg BNA Daily Environment Report quoted Lynn L. Bergeson, Managing Partner of Bergeson & Campbell P.C. (B&C®), in the article, “Give EPA Detailed New Chemical Notices, Attorneys Advise.” Pre-manufacture notifications, or PMNs, that makers must submit before they can produce or import a new chemical, and significant new use notifications, which companies must submit before they can make or use certain chemicals in new ways, “need to be...

On July 1, 2016, Inside EPA published "Committee Jurisdiction Issues Blocked Green Chemistry From TSCA Reform," an article discussing the passage of the Toxic Substances Control Act (TSCA) law and the lack of language from previous versions boosting federal support of green chemistry. The majority of the bill was reviewed by the House Energy and Commerce Committee, but the green chemistry provision would have needed to be reviewed by the House Science, Space, and Technology Committee,...