Archive for May, 2022

EPA Seeks Nominations for Technical Experts to Review New Chemicals Collaborative Research Program

Posted on May 31st, 2022 in Uncategorized | No Comments »

I would like to share with you a fabulous opportunity for those of us in the nanotechnology community and chemical industry.

EPA Seeks Nominations for Technical Experts to Review New Chemicals Collaborative Research Program

Authored by
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell
Carla N. Hutton, Regulatory Analyst, Bergeson & Campbell

On May 27, 2022, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as special government employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to EPA’s Office of Research and Development (ORD). 87 Fed. Reg. 32161. BOSC will be evaluating ORD’s draft Strategic Research Action Plans Fiscal Years 2023-2026 in fall 2022. According to EPA, the fall 2022 meeting will provide a more in-depth evaluation of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and associated research plan. EPA states that it will provide an additional draft document that summarizes technical details of the research plan. ORD, in partnership with the Office of Chemical Safety and Pollution Prevention (OCSPP), proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA.

EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity.

EPA invites nominations of individuals to serve as SGEs with expertise or extensive experience in the following scientific disciplines and topic areas as they relate to human health and the environment:

– Using data to develop predictive models and use of predictive models in data-poor environments:

  • Read across and analogue selection;
  • Chemical structures and cheminformatics; and
  • Quantitative structure-activity relationships (QSAR);

– Development, implementation, and validation of new approach methods (NAM). Relevant expertise may include:

  • Veterinary pathology or comparative physiology for perspective on relevance of laboratory animals for predicting human outcomes; and
  • Reference data curation to support validation;

– Computational modeling, bioinformatics, and/or statistics;

– Toxicokinetics, physiologically based pharmacokinetic models (PBPK), and in vitro to in vivo extrapolation (IVIVE);

– Systems biology;

– Human health and ecological risk assessment;

– Exposure modeling and/or assessment, including near-field and far-field sources;

– Knowledge of TSCA; and

– Environmental fate of chemicals.

Nominations are due June 30, 2022. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in our March 14, 2022, memorandum.

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On Wednesday, April 20, 2022 I had the opportunity to testify on behalf of the NanoBCA at the EPA’s TSCA New Chemicals Collaborative Research Program Meeting. I would like to share my testimony with our nanotechnology community.

CLICK HERE TO VIEW MY TESTIMONY

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In addition to recommending events that are relevant to our nanotechnology community, NanoBCA offers our members the opportunity to participate in our monthly webinars. Our monthly webinars address topics involving the relationship between the science of nanotechnology and Environmental, Health & Safety (EHS), US Legislation, Covid-19, Education, Finance, Manufacturing and Foreign Policy.

Our next NanoBCA webinar is scheduled for Wednesday, June 22nd at 2PM ET.

INDIVIDUAL MEMBERSHIP $250

ACADEMIC/YOUNG PROFESSIONAL MEMBERSHIP $100

START-UP CORPORATION MEMBERSHIP $1,000

CORPORATION MEMBERSHIP $2,500

One of the benefits of NanoBCA membership is access to our previous webinars with America’s leading scientists and engineers.

We look forward to continuing our legacy relationships and welcoming a new generation of NanoBCA members.

——————————————–
I highly recommend that you take the time to consider this unique opportunity.

NanoBCA Webinar – Weds 5/25 2PM ET

Posted on May 25th, 2022 in Uncategorized | No Comments »

AGENDA

2:00-2:05  Opening Remarks

Vincent Caprio
Executive Director, NanoBusiness Commercialization Association (NanoBCA)
vincentcaprio@nynanobusiness.org

Domestic Chemical Regulation and Achieving Circularity Webinar
Wednesday, May 18, 2022
Presented by Bergeson & Campbell, P.C. (B&C®)

Lynn L. Bergeson, Managing Partner, B&C

Richard E. Engler, Ph.D., Director of Chemistry, B&C

Kate Sellers, Technical Fellow at ERM

Mathy Stanislaus, Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory

2:05-2:15  EHS Update
Carla N. Hutton
Regulatory Analyst, Bergeson & Campbell, P.C.
chutton@lawbc.com

EPA Amends Several TSCA Section 4 Test Orders for Chemicals Undergoing Risk Evaluation

Improvements to ECHA’s Chemicals Database Include Nanomaterial Form Characterization Information

EPA Publishes Notice Concerning Court-Ordered Stay of Effectiveness for Pesticide Application Exclusion Zone Provision of the Agricultural Worker Protection Standard

2:15-2:30 Legislative Update
Paul Stimers
Partner, K&L Gates
NanoBCA Policy Advisor
paul.stimers@klgates.com

2:30-2:50 State of the Water Industry 2022
Alan Hinchman
Chief Revenue Officer, GrayMatter Systems
GrayMatter Events & Webinars
ahinchman@graymattersystems.com

2:50-3:00 Q&A

3:00 Conclusion

NanoBCA Recommends: Domestic Chemical Regulation and Achieving Circularity Webinar 5/18

Posted on May 10th, 2022 in Uncategorized | No Comments »

The NanoBusiness Commercialization Association (NanoBCA) would like to recommend the following complimentary Bergeson & Campbell, P.C. (B&C®) webinar:

Domestic Chemical Regulation and Achieving Circularity
Wednesday, May 18, 2022
12:00 p.m. – 1:00 p.m. (EDT)
Register Today

A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable system that fosters innovation to develop a circular economy. Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., Kate Sellers, and Mathy Stanislaus, as Bergeson & Campbell, P.C. (B&C®) presents “Domestic Chemical Regulation and Achieving Circularity.”

Topics Covered:

  • Achieving sustainability and the promise of the circular economy
  • Defining sustainable chemistry under the Sustainable Chemistry Research and Development Act
  • Federal policy and Toxic Substances Control Act (TSCA) regulatory shifts intended to support sustainability and circularity
  • Transitioning chemicals from research and development (R&D) platforms into the market
  • Changes to TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that affect chemical innovation

Speakers Include:

Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. His expansive understanding of the specific challenges and opportunities that TSCA presents for green and sustainable chemistry is a powerful asset for clients as they develop and commercialize novel chemistries.

Kate Sellers, Technical Fellow at ERM, leads a multi-disciplinary team of professionals dedicated to helping companies recognize the business value of product stewardship. Over the past year, Kate has seen an uptick in several product sustainability trends, including implementation of the TSCA life-cycle assessment, circular economy programs, and sustainability initiatives. In addition to her consulting work, Kate teaches “Product Stewardship and Chemical Sustainability” at Harvard University

Mathy Stanislaus, was recently appointed as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, bringing interdisciplinary expertise in environmental sciences, engineering, law, health, business, economics, policy, and humanities to co-design transformative environmental solutions. Stanislaus joined Drexel from the Global Battery Alliance (GBA), a multi-stakeholder initiative established at the World Economic Forum (WEF), where he served as its first interim director and policy director with a focus on establishing a global transparent data authentication system to scale up electric mobility and clean energy. He also led the establishment of the Platform for Accelerating Circular Economy at WEF. Mathy served for eight years as the Senate-confirmed Assistant Administrator for EPA’s Office of Land & Emergency Management for the Obama Administration, leading programs to revitalize communities through the cleanup and redevelopment of contaminated sites, hazardous and solid waste materials management, chemical plant safety, and oil spill prevention and emergency response. During this Administration, he led the establishment of the G7 Alliance for Resource Efficiency that focused on the opportunities in the supply chain to drive circularity and de-carbonization.

Register Now

——————————————–
In addition to recommending events that are relevant to our nanotechnology community, NanoBCA offers our members the opportunity to participate in our monthly webinars. Our monthly webinars address topics involving the relationship between the science of nanotechnology and Environmental, Health & Safety (EHS), US Legislation, Covid-19, Education, Finance, Manufacturing and Foreign Policy.

Our next NanoBCA webinar is scheduled for Wednesday, May 25th at 2PM ET.

INDIVIDUAL MEMBERSHIP $250

ACADEMIC/YOUNG PROFESSIONAL MEMBERSHIP $100

START-UP CORPORATION MEMBERSHIP $1,000

One of the benefits of NanoBCA membership is access to our previous webinars with America’s leading scientists and engineers.

We look forward to continuing our legacy relationships and welcoming a new generation of NanoBCA members.

——————————————–
I highly recommend registering for B&C’s Domestic Chemical Regulation and Achieving Circularity webinar.

EPA Posts Presentations from Meeting on New Chemicals Collaborative Research Program

Posted on May 2nd, 2022 in Uncategorized | No Comments »

I would like to share with you a comprehensive review of the EPA’s Virtual Public Meeting on New Chemicals Collaborative Research Program, April 20-21, 2022.

This review was authored by  Lynn L. Bergeson, Managing Partner, Bergeson & Campbell and Carla N. Hutton, Regulatory Analyst, Bergeson & Campbell.

EPA Posts Presentations from Meeting on New Chemicals Collaborative Research Program

The U.S. Environmental Protection Agency (EPA) held a virtual public meeting on April 20-21, 2022, to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As described in EPA’s draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. EPA has posted the following presentations from the April 20-21, 2022, meeting:

More information on the meeting is available in our April 22, 2022, memorandum, and more information on EPA’s draft document is available in our March 14, 2022, memorandum. Written comments on the draft document are due May 10, 2022.

——————————————–
On Wednesday, April 20, 2022 I had the opportunity to testify on behalf of the NanoBCA at the EPA’s TSCA New Chemicals Collaborative Research Program Meeting. I would like to share my testimony with our nanotechnology community.

CLICK HERE TO VIEW MY TESTIMONY

——————————————–
In addition to recommending events that are relevant to our nanotechnology community, NanoBCA offers our members the opportunity to participate in our monthly webinars. Our monthly webinars address topics involving the relationship between the science of nanotechnology and Environmental, Health & Safety (EHS), US Legislation, Covid-19, Education, Finance, Manufacturing and Foreign Policy.

Our next NanoBCA webinar is scheduled for Wednesday, May 25th at 2PM ET.

INDIVIDUAL MEMBERSHIP $250

ACADEMIC/YOUNG PROFESSIONAL MEMBERSHIP $100

START-UP CORPORATION MEMBERSHIP $1,000

One of the benefits of NanoBCA membership is access to our previous webinars with America’s leading scientists and engineers.

We look forward to continuing our legacy relationships and welcoming a new generation of NanoBCA members.

——————————————–
I highly recommend the review of the EPA’s Virtual Public Meeting on New Chemicals Collaborative Research Program.

NanoBCA Webinar April 27 2PM ET

Posted on May 2nd, 2022 in Uncategorized | No Comments »

AGENDA

2:00-2:10  Opening Remarks
Vincent Caprio
Executive Director, NanoBusiness Commercialization Association (NanoBCA)
vincentcaprio@nynanobusiness.org

Review of EPA’s TSCA New Chemicals Collaborative Research Program Meeting – April 20-21, 2022

On Wednesday, April 20, 2022 I had the opportunity to testify on behalf of the NanoBCA at the EPA’s TSCA New Chemicals Collaborative Research Program Meeting. I would like to share my testimony with our nanotechnology community.

CLICK HERE TO VIEW MY TESTIMONY

2:10-2:30  EHS Update 
Lynn L. Bergeson
Managing Director, Bergeson & Campbell, P.C.
NanoBCA EHS Chair
lbergeson@lawbc.com

James V. Aidala
Senior Government Affairs Consultant, Bergeson & Campbell, P.C.
jaidala@lawbc.com

FDA Publishes Final Guidance for Industry on Drug Products, Including Biological Products, that Contain Nanomaterials

Senate Committee Hearing on Proposed FY 2023 EPA Budget Includes Discussion of TSCA and FIFRA Issues

Meeting Recordings and Transcript Available for TSCA SACC Peer Review of Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities

2:30-2:45 Review of EPA’s TSCA New Chemicals Collaborative Research Program Meeting – April 20-21, 2022
2021 NanoBCA Lifetime Achievement Award Recipient
Sam Brauer, PhD
Founder & Principal, Nanotech Plus
sbrauer@nano-biz.com

CLICK HERE TO VIEW SAM BRAUER’S TESTIMONY

2:45-3:00 Q&A

3:00 Conclusion