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.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has named Dr. Lynn Dekleva as Associate Deputy Assistant Administrator for New Chemicals.  Dr. Dekleva joined EPA in October 2018 as a Science Advisor, working to streamline and improve EPA’s processes and timeliness concerning the review of new chemicals under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  Dr. Dekleva is an environmental engineer with degrees in environmental microbiology, medical technology, and biology.  Her contributions are expected to help EPA meet the ambitious mandates of the amended Toxic Substances Control Act (TSCA).


 

By Lynn L. Bergeson and Carla N. Hutton
 
Section 5(g) of the Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to publish a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.  On August 12, 2019, EPA published a statement of its findings for June 2019.  84 Fed. Reg. 39828.  EPA notes that such statements apply to premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN) submitted to EPA under TSCA Section 5.  In the Federal Register notice, EPA provides the following information (to the extent that such information is not claimed as confidential business information (CBI)) on the PMNs, MCANs, and SNUNs for which, during this period, EPA has made findings under TSCA Section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:  EPA case number assigned to the TSCA Section 5(a) notice; chemical identity (generic name, if the specific name is claimed as CBI); and website link to EPA’s decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA Section 5(a)(3)(C). 


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a spreadsheet with a list of all active cases and each case’s status.  More information and commentary is available in our August 5, 2019, memorandum, "EPA Improves Transparency for New Chemicals Review Program under TSCA."


 

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 Carla N. Hutton
 
The House Science, Space, and Technology Subcommittee on Research and Technology will hold a hearing on “Benign by Design:  Innovations in Sustainable Chemistry” on July 25, 2019.  Witnesses will include:

  • Dr. Tim Persons, Chief Scientist and Managing Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO);
     
  • Dr. John Warner, President and Chief Technology Officer, Warner Babcock Institute for Green Chemistry;
     
  • Dr. Julie Zimmerman, Professor and Senior Associate Dean, School of Forestry and Environmental Studiesa and Deputy Director, Center for Green Chemistry and Green Engineering, Yale University;
     
  • Ms. Anne Kolton, Executive Vice President, Communications, Sustainability, and Market Outreach, American Chemistry Council; and
     
  • Mr. Mitchell Toomey, Director of Sustainability, BASF in North America.

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 28, 2019, announcing that the EPA Safer Choice Program is accepting submissions for its 2019 Safer Choice Partner of the Year Awards.  84 Fed. Reg. 31066.  The Safer Choice Program partners with businesses and others to help consumers and commercial buyers identify products with safer chemical ingredients, “without sacrificing quality or performance.”  Toward this end, according to EPA, the Safer Choice Program certifies products containing ingredients that have met the Program's “specific and rigorous human health and environmental toxicological criteria.”  The Safer Choice Program allows the use of its label on products that perform and contain safer ingredients, as determined by expert evaluation.  According to EPA, recognition by the Safer Choice Program represents a high level of achievement in formulating products that are safer for people and the environment.  EPA states that the purpose of the Partner of the Year Awards “is to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown outstanding achievement in the design, manufacture, selection, and use of products with safer chemicals.”  All Safer Choice stakeholders and Program participants in good standing are eligible for recognition.  According to the notice, interested parties must inform the Program that they would like to be considered for an award and submit supporting information.  Submissions are due July 31, 2019.  EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony in fall 2019.

Tags: Safer Choice,

 

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

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has updated its Statistics for the New Chemicals Review Program under TSCA web page, which is under EPA’s Reviewing New Chemicals under the Toxic Substances Control Act (TSCA) section, to make it easier to find and understand how many chemicals are in each stage of the new chemicals review process.  The revised web page now includes a flow chart showing the number of new chemicals cases (premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN)) at each stage of review and detailed descriptions of each step in the process.

EPA states that these changes “are the first step in a larger effort to increase the transparency of the new chemicals program and ensure stakeholders and the public can quickly and easily view EPA’s progress in reviewing new chemicals submissions as the Agency receives them.”  EPA Assistant Administrator Alexandra Dunn has repeatedly expressed her and EPA’s commitment to enhance the transparency of EPA’s operations, and this latest development reflects that commitment.


 

By Lynn L. Bergeson, Charles M. Auer, Oscar Hernandez, Ph.D., Richard E. Engler, Ph.D., and Carla N. Hutton

On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act.  The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA).  GAO reviewed documents from the National Academy of Sciences (NAS) and EPA and interviewed EPA officials and representatives from two environmental and two industry stakeholder organizations.  GAO found that while EPA made improvements in the IRIS Program, between June and December 2018, EPA leadership directed the Program to stop the assessment process during discussions about program priorities.  GAO states that while EPA has responded to initial statutory deadlines in TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), challenges remain.  Read the full memorandum for more information on the report including why GAO did the study, GAO’s findings, and an insightful commentary.


 

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, Richard E. Engler, Ph.D., and Margaret R. Graham

On February 1, 2019, Lynn Vendinello, Acting Director, Chemical Control Division, of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) signed the pre-publication version of a notice announcing that, due to the recent lapse of appropriations and the Agency shutdown, EPA is extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018.  

Due to a lack of authorized funding, from December 29, 2018, until EPA operations for the TSCA New Chemicals operations fully resumed on January 31, 2019, certain EPA functions were suspended including the processing of submissions made through the Central Data Exchange (CDX), e-PMN, or other methods.  Further, no review work was performed on the TSCA section 5 notifications received by EPA on or before December 29, 2018, and for which the review period had not yet expired as of December 29, 2018.  Consequently, the review period for any TSCA Section 5 notice submitted during the shutdown did not begin until TSCA New Chemical operations fully resumed on January 31, 2019.

EPA states that the duration of the extension period will be a total of 33 days, which is equivalent to the duration of the time period from December 29, 2018 (the date on which certain EPA operations shutdown) and the date on which EPA operations for the TSCA New Chemicals Program fully resumed (January 31, 2019).  The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3).  


 
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