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...
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....
August 26, 2016
EPA Establishes Science Advisory Committee on Chemicals, and Requests Comments and Nominations
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: In its...
August 12, 2016
EPA’s August 9 and August 10 Public Meetings on Proposed Rules Concerning Chemical Risk Evaluation and Prioritization
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...
July 25, 2016
EPA to Host Public Meetings to Obtain Input on Amended TSCA Prioritization and Risk Evaluation Processes
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: The public meetings are scheduled for 9:30 a.m. to 4:30 p.m., and will be held at...
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...
July 22, 2016
BNA’s Daily Environmental Report Cites Experts Regarding EPA’s Detailed New Chemical Notices
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...
July 21, 2016
EPA to Host Workshop on New TSCA Implementation and Industry Meeting for Fees Consultation
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....
July 18, 2016
Environmental Law Institute Hosts TSCA Lawmakers and Supporters for “The Story of TSCA Reform”
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/....
July 15, 2016
Bloomberg BNA Daily Environment Report Quotes Lynn L. Bergeson On New TSCA Chemical Provisions
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...
July 15, 2016
Lynn L. Bergeson Quoted In Bloomberg BNA Daily Environment Report Article On The Need To Submit Thoughtful PMNs to EPA
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...
On July 14, 2016, Bloomberg BNA Daily Environment Report included quotes from the B&C® and Chemical Watch webinar “The New TSCA Series Webinar 2: Impacts on New Chemical Programs.” Chemical manufacturers and processors will need to give exposure and toxicity data to the EPA for it to evaluate the risks of new and existing chemicals as required by the recently amended Toxic Substances Control Act, said Charles Auer, who directed the EPA Office of Pollution...
An Environmental Law Institute Seminar and Webinar, Complimentary for members, $50 for non-members. On June 22, 2016 President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending the Toxic Substances Control Act for the first time since its passage in 1976. While environmental organizations, public health advocates, the regulated community, and EPA have all supported updating the law since at least 2009, political challenges seemed destined to prevent...
Lynn L. Bergeson Comments On TSCA Implementation Featured In Bloomberg BNA Daily Environment Report Article “More Than 300 New Chemicals Snagged as EPA Implements Law” On July 12, 2016, Lynn L. Bergeson, Managing Partner of Bergeson & Campbell (B&C®), was quoted in the Bloomberg BNA Daily Environment Report article “More Than 300 New Chemicals Snagged as EPA Implements Law.” Lynn Bergeson, managing partner of Bergeson & Campbell PC,...
July 1, 2016
EPA Launches Q&A Webpage Regarding Frank R. Lautenberg Chemical Safety for the 21st Century Act
On June 22, 2016, the U.S. Environmental Protection Agency (EPA) rolled out its new Frank R. Lautenberg Chemical Safety for the 21st Century Act Frequent Questions webpage. This webpage will be a resource for Toxic Substances Control Act (TSCA) reform-related updates and implementation plans. EPA has also posted a summary of key provisions, its six essential principles for reform of chemicals management legislation, the presentation from its informational webinar on June 30,...
On June 30, 2016, from 2:00 p.m. to 3:00 p.m. (EDT), the U.S. Environmental Protection Agency (EPA) hosted an informational webinar on the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law No. 114-182. A link to the presentation is available online. The topics from the webinar included: More information concerning EPA’s implementation of the Act is available on EPA’s website....
If you are having trouble understanding basic process flows under the new Toxic Substances Control Act (TSCA), please reference Dr. Richard A. Denison’s flow charts that depict the basic processes applicable to existing chemicals already in commerce, and applicable to new chemicals prior to market entry. Comparisons are shown between the processes under the old and new TSCA. Dr. Denison is a Lead Senior Scientist at the Environmental Defense Fund (EDF). There are three...
On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA’s plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182. EPA notes that the new law imposes new responsibilities on EPA,...
On July 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register soliciting a second round of comments on the burdens and value of information it periodically collects addressing significant new use rules (SNUR) for existing chemicals. Specifically, EPA submitted a request to renew the approval of an existing information collection request (ICR), Toxic Substances Control Act (TSCA) Section 5(a)(2) SNURs for Existing Chemicals, to...
For a deeper dive into how and when Toxic Substances Control Act (TSCA) programs will change and adapt to “New TSCA,” Chemical Watch and Bergeson & Campbell, P.C. (B&C®) are offering a series of complimentary webinars on “‘The New TSCA’ — What You Need to Know,” featuring an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. Federal and State regulatory authorities. The second one in the series, Impacts...
In a June 22, 2016, blog post on The Hill‘s Congress Blog, Lynn L. Bergeson laid out four reasons why the American public has reason to celebrate the signing into law of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, “a comprehensive and vastly improved domestic chemical management law”: Read the full blog post at The Hill: TSCA reform: renewing public confidence in chemical control....
An in-depth memorandum of the reformed Toxic Substances Control Act (TSCA), TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, includes an initial overview, a summary of information on the timing of various activities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) as related to enactment and other important milestones, and a more detailed discussion of the changes in Lautenberg relative to TSCA as they relate...
On May 25, 2018, the U.S. Environmental Protection Agency (EPA) announced it would host a half-day preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five Persistent, Bioaccumulative, and Toxic (PBT) chemicals. Section 6(h) of the Toxic Substances Control Act (TSCA) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances that were identified...
In-House Counsel Beware: TSCA Reform Impacts Everyone, an article by Lynn L. Bergeson, on Law360, outlines the extensive revisions to the Toxic Substances Control Act (TSCA) that will impact legal practices and business operations, due to the new TSCA law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The content includes:...
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 24, 2020, announcing the availability of the final Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride. 85 Fed. Reg. 37942. This is the first risk evaluation that EPA has completed under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA. After evaluating 53 conditions of use of methylene chloride, EPA determined that six...
Lynn L. Bergeson, Managing Partner at Bergeson & Campbell, P.C. (B&C®), presented at Chemical Watch Enforcement Summit Europe in Brussels on November 4, 2016. Topics covered by Ms. Bergeson included “A New [Toxic Substances Control Act (TSCA)] and Expanded Enforcement and Product Liability Opportunities,” “Next Generation Compliance and Implications for Businesses,” and “eDisclosure — The New Normal?” Ms. Bergeson informed attendees of the significant...
April 6, 0200
EPA Extends Comment Period on Supplement to Proposed Rule on Strengthening Transparency in Regulatory Science
On March 3, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.” The SNPRM: EPA published the SNPRM in the Federal Register on March 18, 2020. 85 Fed....