Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

On November 13, 2019, Bergeson & Campbell, P.C. (B&C®), presented “Value Chain Communications Required under TSCA Consent Orders and SNURs:  How to Formulate Them and Optimize Their Value,” a complimentary webinar for our clients and friends.  Richard E. Engler, Ph.D., Director of Chemistry, B&C, outlined the categories of legally required risk communications to value chain participants required under TSCA Consent Orders and significant new use rules (SNUR).  Lynn L. Bergeson, Managing Partner, B&C, discussed the considerable value of formulating these communications with a view toward developing a consistent and positive product narrative that resonates far beyond Toxic Substances Control Act (TSCA) compliance.  A recording of this webinar is available now.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On April 30, 2019, the U.S. Environmental Protection Agency (EPA) announced it would be hosting two webinars for companies, organizations, and individuals required to report under the Mercury Inventory Reporting Rule of the Toxic Substances Control Act (TSCA).  The final rule applies to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to TSCA, such as for the manufacture of pharmaceuticals and pesticides).

The first webinar, Mercury Inventory Reporting Rule, will provide background on reporting requirements under the final rule.  It will take place on May 21, 2019, at 2:00 p.m. (EDT).  The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is coming up on July 1, 2019.  Reporters are required to submit their information to EPA using the Mercury Electronic Reporting (MER) application for the first time on July 1, 2019, and then every three years thereafter.  Based on the information collected, EPA will identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use.  Following EPA’s presentation, webinar participants will have an opportunity to ask questions on reporting requirements under the final rule.  Registration is available online.

The second webinar, Mercury Electronic Reporting (MER) Application, will demonstrate how to use the online MER application through EPA’s Central Data Exchange (CDX), which is organized as a fill-in-the-blanks form with drop-down menus and lists of check-box options.  It will take place on May 23, 2019, at 2:00 p.m. (EDT).  Registration is available online.

More information on the Mercury Inventory Reporting Rule is available in our June 25, 2018, memorandum “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” and in our March 19, 2019, memorandum “EPA Releases New Tools to Help Companies Meet July 1 Mercury Reporting Requirements.”


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On April 11, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was partnering with the Physicians Committee for Responsible Medicine (PCRM) and the People for the Ethical Treatment of Animals (PETA) International Science Consortium to host a public webinar related to meeting the goal of reducing, refining, or replacing vertebrate animal testing as stipulated in the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA), specifically New Approaches for Respiratory Sensitization, set for April 24, 2019, at 10:00 a.m. (EDT)Registration is required.  The speakers are Steve Enoch, Ph.D., Liverpool John Moores University, who will be presenting “Chemistry-based Approaches for Identifying Respiratory Sensitizers”; and Arno Gutleb, Ph.D., Luxembourg Institute of Science and Technology, who will be presenting “In Vitro Models to Identify Respiratory Sensitizers.”

The two other webinars in this Webinar Series on the Use of New Approach Methodologies (NAM) in Risk Assessment already took place; the first one was Skin Sensitization Testing and the second one was MPPD and CFD Modeling to Predict Dosimetry of Inhaled Substances.  EPA states that these webinars on the use of New Approach Methodologies (NAMs) in Risk Assessment are part of EPA meeting commitments identified in EPA’s Strategic Plan to Promote the Development and Implementation of Alternative Test Methods, required by amended TSCA.


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham, M.S.

On February 20, 2019, during a cold, snow-filled winter day, the rugged staff of Bergeson & Campbell, P.C. (B&C®) as well as several hearty senior U.S. Environmental Protection Agency (EPA) officials got together over some steaming cups of coffee and discussed the upcoming fate of the Toxic Substances Control Act (TSCA) during a Bloomberg-hosted, B&C-developed webinar:  Chemical Policy Summit Series Part V: Chemical Regulation After the Mid-Terms: What We Can Expect to See in 2019

In attendance were:  The Honorable Alexandra Dapolito Dunn, the newly appointed Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP); Jeffery T. Morris, Ph.D., Director, Office of Pollution Prevention and Toxics (OPPT); Rick P. Keigwin, Jr., Director of the Office of Pesticide Programs (OPP); Beau Greenwood, Executive Vice President, Government Affairs, CropLife America; Lynn L. Bergeson, Managing Partner of B&C; and James V. Aidala, Senior Government Affairs Consultant, B&C.  Ms. Dunn, Dr. Morris, and Mr. Keigwin described their priorities in the webinar.  Ms. Dunn stated 2019 “is going to be one of those buckle-your-seat-belt kind of years” in relation to getting everything done as required under TSCA.  Some of the takeaways from that webinar are listed below. 

TSCA Milestones:  2019 and Beyond

 

 

 

 

 

 

 

 

 

Risk Evaluations:

  • EPA must complete the first ten risk evaluations by December 2019, with a possible extension up to June 2020; EPA may need to take advantage of the extension;
  • By April 2019, EPA will need to release the “20 high- and 20 low-” priority candidate chemicals;
  • EPA released its first draft chemical risk evaluation -- Colour Index (C.I.) Pigment Violet 29 -- on which many comments were submitted.  EPA realized that this selection was challenging given certain data ownership issues and restrictions on those data occasioned by European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation issues; therefore, this initial evaluation was not the best representation of how the other evaluations will be conducted (more information on the risk evaluation is available in our memo EPA Publishes First Draft TSCA Chemical Risk Evaluation);
  • EPA is using a new risk assessment program process called “Systematic Review” that has been used in non-risk assessment fields; EPA is the first agency to use this process.  EPA welcomes input on the process and stated that the National Academy of Sciences (NAS) will be reviewing this process as well;
  • In March 2019, EPA will release a proposed rule outlining how it will review and substantiate all Confidential Business Information (CBI) claims seeking to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory; and
  • EPA will be proposing its rule to regulate five persistent, bioaccumulative, and toxic chemicals by June 2019; EPA will be using a different approach than what is typically used for risk assessments.

Approving New Chemicals:

  • EPA intends to explore its process for new chemical review to be more predictable and to make reviews final within 90 days;
  • EPA will post “frequently asked questions” documents to help chemical manufacturers submit clearer applications online;
  • EPA is urging pre-submission meetings between premanufacture notice (PMN) submitters and EPA staff prior to submitting a PMN for a new product to reduce agency time spent clarifying omissions; and
  • EPA has pledged to make all PMNs, all health and safety studies, attachments, amendments and other associated information available in public dockets.

B&C’s other upcoming seminars and webinars are available here.  Some other resources of interest are B&C’s newly minted TSCA Tutor™ Modular Training Program which provides live in-person training at a company’s site, live online training, and pre-recorded webinar training modules -- all designed to offer expert, efficient, and essential TSCA training; as well as B&C’s All Things Chemical™ Podcasts, which provide intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals.


 

By Lynn L. Bergeson and Margaret R. Graham

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 reporting application (Central Data Exchange, or CDX), and will provide time for questions and answers.”  Registration for the webinar is not required.  The webinar will be available through the following link on May 23: http://epawebconferencing.acms.com/tsca_inventory/.  A link to access the TSCA Inventory is available here.  The upcoming deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.

More information on TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and in our memorandum “EPA Issues Final TSCA Framework Rules.”


 

By Lynn L. Bergeson and Margaret R. Graham

On September 20, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating that it is extending the compliance date by which submitters of Toxic Substances Control Act (TSCA) submissions containing information claimed as Confidential Business Information (CBI) and filed between June 22, 2016, and March 21, 2017, had to submit to EPA the substantiation required by TSCA Section 14(c)(3) for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA Section 14(c)(2).  82 Fed. Reg. 43964.  The new deadline for substantiation of these claims is October 19, 2017.  EPA states that this extension is in response to “concerns raised by industry stakeholders regarding the ability for companies to meet the previous September 19, 2017, deadline due to recent severe weather events,” and that it is “providing this additional flexibility for stakeholders because of the impacts of hurricanes Harvey and Irma.”  Further, “because EPA published its interpretation that TSCA section 14(c)(3) requires up front substantiation after some companies had already asserted confidentiality claims subject to TSCA section 14(c)(3), the Agency set a future deadline for submission of substantiations pertaining to those submissions.” 

More information on the CBI substantiation process is available in our memorandum The September 19th CBI Substantiation Deadline Fast Approaching.

Also on September 20, 2017, EPA announced it was scheduling three webinars to assist the regulated community with reporting under the TSCA Inventory Notification (Active-Inactive) rule.  The webinars, scheduled for September 27, 2017, October 25, 2017, and November 29, 2017, from 1:00 p.m. - 3:00 p.m. (ET), will be identical and will include an overview of reporting requirements, a demo of the electronic reporting application (Central Data Exchange (CDX)), and will provide time for questions and answers.  Registration for the webinars is not required.  EPA’s TSCA Inventory webpage contains the information on how to access the webinar.

More information on the TSCA Inventory Notification (Active-Inactive) rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 

By Lynn L. Bergeson and Carla N. Hutton

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 these five chemicals:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics, wiring insulation, and building and construction materials;
  • Hexachlorobutadiene (HCBD), used as a solvent in the manufacture of rubber compounds and as hydraulic, heat transfer, or transformer fluid;
  • Pentachlorothiophenol (PCTP), used as a mercaptan (sulfur) cross-linking agent to make rubber more pliable in industrial uses;
  • Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer products and as lubricant, hydraulic fluid, and other industrial uses; and
  • 2,4,6-Tris(tert-butyl) phenol, an antioxidant that can be used as a fuel, oil, gasoline, or lubricant additive.

Due to significant interest in the webinar, EPA is requesting information from participants who would like to offer public input following the EPA presentation, in an effort to accommodate as many commenters as possible.  If you would like to speak following the presentation, please send an e-mail to .(JavaScript must be enabled to view this email address) by Tuesday, September 5, 2017, that includes the following information:

  • Your name;
  • The organization you represent; and
  • The PBT chemical on which you will speak.

EPA has established public dockets for each of the chemicals to facilitate receipt of information on exposure and use that may be useful to EPA’s rulemaking effort.  EPA requests that any information be submitted to the dockets by December 9, 2017, so that the information can inform any regulatory action.


 

By Lynn L. Bergeson and Carla N. Hutton

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:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics, wiring insulation, and building and construction materials;
  • Hexachlorobutadiene (HCBD), used as a solvent in the manufacture of rubber compounds and as hydraulic, heat transfer, or transformer fluid;
  • Pentachlorothiophenol (PCTP), used as a mercaptan (sulfur) cross-linking agent to make rubber more pliable in industrial uses;
  • Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer products and as lubricant, hydraulic fluid, and other industrial uses; and
  • 2,4,6-Tris(tert-butyl) phenol, an antioxidant that can be used as a fuel, oil, gasoline, or lubricant additive.

Under TSCA Section 6(h), EPA is required to take expedited regulatory action to address risks and exposures from certain PBT chemicals.  By June 22, 2019, EPA must propose rules for the above five PBT chemicals that have been identified under TSCA Section 6(h)(1).  EPA is currently identifying where these chemicals are used and how people are exposed to them.  Following EPA’s presentation, participants will have an opportunity to provide their comments on uses of these five chemicals.


 

By Lynn L. Bergeson and Margaret R. Graham

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 preparation for this change, OPPT revised the CDX TSCA reporting applications to allow for upfront substantiation of CBI claims.

OPPT’s first webinar will be March 15, 2017, at 1:00 p.m. (EDT) and the second will be on March 21, 2017, at 1:00 p.m. (EDT).  EPA states that these webinars will cover technical aspects of making upfront substantiations within the CDX reporting applications, and that OPPT would appreciate help in identifying participants that currently use CDX reporting applications or will do so under the new requirements to participate in these events.

Registration is available online.  The webinars will be limited to the first 1,000 registrants and registration will close at 11:00 a.m. (EDT) on the date of each webinar.  After the webinar, OPPT will post the webinar materials on its Confidential Business Information under TSCA webpage.  More information on the statutory requirements for substantiation of CBI claims is available in our blog item EPA Issues Guidance On Substantiation Requirements For CBI Claims Under TSCA.


 
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