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) announced on March 23, 2021, that it is now accepting nominations for the 2021 Safer Choice Partner of the Year Awards.  According to a Federal Register notice scheduled for publication on March 24, 2021, the awards will recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction.  EPA “especially encourages” award applications that show how the applicant’s work in the design, manufacture, selection, and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality.  All Safer Choice stakeholders and program participants in good standing are eligible for recognition.  Interested parties should submit to EPA information about their accomplishments and contributions during 2020.  Submissions are due May 31, 2021.  EPA will recognize award winners at a ceremony in fall 2021.
 
Safer Choice is an EPA Pollution Prevention (P2) program, which includes practices that reduce, eliminate, or prevent pollution at its source, such as using safer ingredients in products.  The Safer Choice program certifies products containing ingredients that have met its “specific and rigorous” human health and environmental toxicological criteria.  EPA notes that the Safer Choice program allows companies to use its label “on certified products that contain safer ingredients and perform, as determined by expert evaluation.”  EPA states that the Safer Choice program certification “represents a high level of achievement in formulating products that are safer for people and the environment.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 23, 2021, the European Agency for Safety and Health at Work (EU-OSHA) announced that in association with other relevant Directorates-General (DG) of the European Commission (EC), DG Environment has opened a call for applications to select members for an expert group, the High-Level Roundtable on Implementation of the Chemicals Strategy for Sustainability.  According to EU-OSHA, the expert group’s mission “is to set the Chemicals Strategy for Sustainability objectives and monitor its implementation in dialogue with the stakeholders concerned.”  Specific tasks include contributing to identifying and addressing social, economic, and cultural barriers to the transition toward safe and sustainable chemicals.  The expert group will act as a core group of ambassadors to facilitate discussions and promote this transition in the economy and society, developing a regular exchange of views, experiences, and good practices between the EC and stakeholders on the main objectives of the Strategy, namely:

  • Innovating for safe and sustainable chemicals, including for materials and products;
  • Addressing pressing environmental and health concerns;
  • Simplifying and consolidating the legal framework;
  • Providing a comprehensive knowledge base on chemicals; and
  • Setting the example for global sound management of chemicals.

The expert group will consist of up to 32 members, with a maximum of:

  • The Member State holding the Presidency of the Council of the European Union;
  • Ten third-sector organizations in the following areas:  health protection, environmental protection, human rights, animal protection, consumer rights, and workers’ rights;
  • Eight scientific organizations, academia, and research institutes providing a suitable balance between expertise in fundamental research, applied research, and training/education;
  • Ten industries, including small- and medium-sized enterprises (SME) or associations of enterprises, including an adequate representation of frontrunners in the production and use of safe and sustainable chemicals.  Those should include chemical industries, downstream users (from different sectors), and retailers; and
  • Three international organizations -- the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO), and the United Nations Environment Program (UNEP).

Interested organizations are invited to submit their applications before March 18, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 17, 2020, that it is accepting nominations for the 2021 Green Chemistry Challenge Awards.  EPA intends these awards to recognize innovation by American businesses and researchers that redesign chemical products and processes to reduce or eliminate the use and manufacture of hazardous substances.  The 2021 Green Chemistry Challenge Awards nomination package is now available, and nominations are due December 4, 2020.  EPA states that it anticipates giving awards to “outstanding green chemistry technologies” in five categories in June 2021.  EPA will host a webinar on September 23, 2020, for those interested in applying.  During the webinar, EPA will provide an overview of the requirements, criteria, and tips for submitting a nomination package.
 
According to EPA, since the inception of the program, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,600 nominations and presented awards to more than 120 technologies.  EPA notes that “by leveraging these technologies, the use or generation of hundreds of millions of pounds of hazardous chemicals have been avoided, and billions of gallons of water and trillions of BTUs in energy have been saved annually.”  An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2021 submissions and make recommendations to EPA for the winners.


 

By Lynn L. Bergeson and Carla N. Hutton
 

On June 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the winners of the 2020 Green Chemistry Challenge Awards.  EPA states that this year’s winners “have developed new and innovative green chemistry technologies that turn potential environmental challenges into business opportunities, spurring innovation and economic development.”  The 2020 winners and their innovative technologies are:

  • Genomatica, San Diego, California, for creating Brontide™, a new brand of 1,3-butylene glycol, commonly used in cosmetics for moisture retention and as a carrier for plant extracts.  Butylene glycol is traditionally produced from fossil fuels.  Brontide™ is produced by fermenting E. coli using renewable sugars in a one-step production process, however.  This method reduces greenhouse gas emissions and avoids the use of hazardous chemicals in the production process.
     
  • Merck, Rahway, New Jersey, for improving the process used to produce certain antiviral drugs used for the treatment of diseases including hepatitis C and HIV.  According to EPA, the new process improved manufacturing efficiency and sustainability of one important antiviral by more than 85 percent.  This method reduces waste and hazards associated with the existing process and results in substantial cost savings.
  • Johns Manville, Littleton, Colorado, for developing a biobased, formaldehyde-free thermoset binder for fiberglass reinforcement applications.  Thermoset binders are used to bind glass fibers of fiberglass mats used in carpet tile backing.  EPA states that this technology eliminates the use of hazardous chemicals, reduces water and energy use, and produces a product with a longer shelf life.
     
  • Professor Steven Skerlos, University of Michigan and Fusion Coolant Systems, for creating Pure-Cut™, an alternative to traditional metalworking fluids that uses high-pressure carbon dioxide instead of oil-based lubricants.  According to EPA, Pure-Cut™ can improve performance and machining tool life span compared to traditional metalworking fluids, while greatly reducing hazards to the environment and worker health.
     
  • Vestaron, Kalamazoo, Michigan, for producing a new biopesticide called Spear®.  This pesticide is based on a naturally occurring component inspired by spider venom that can effectively control target pests while showing no adverse effects on people, the environment, and non-target wildlife, such as fish and bees.  EPA notes that Spear® should provide growers with a new pest management tool that also lessens environmental impacts.

EPA plans to recognize the winners at a ceremony in Washington, D.C., later this year.  EPA and the American Chemical Society co-sponsor the awards.  An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute formally judged the 2020 submissions and made recommendations to EPA for the 2020 winners.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) will hold a webinar on the Green Chemistry Challenge Awards Program.  Participants will learn more about applying for the 2020 Green Chemistry Challenge Awards.  The webinar presentation will cover award eligibility, the application process, and evaluation criteria.  There will also be time for questions from the webinar participants.
 
As reported in our September 20, 2019, blog item, EPA is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment.  EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s health.  Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019.  EPA anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 18, 2019, that it is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment.  EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s health.  Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019.  EPA states that it anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020.  According to EPA, since the inception of the awards more than two decades ago, it has received more than 1,600 nominations and presented awards to 118 technologies that reduced the use or generation of hundreds of millions of pounds of hazardous chemicals and saved billions of gallons of water and trillions of BTUs in energy.  An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2020 nominations and make recommendations to EPA for the 2020 winners.


 

By Lynn L. Bergeson

On June 11-13, 2019, the American Chemical Society (ACS) Green Chemistry Institute® will host the 23rd Annual Green Chemistry and Engineering Conference and the 9th International Conference on Green and Sustainable Chemistry.  The Conference will be held right outside of Washington D.C. in Reston, Virginia, and will focus on the theme of “Closing the Loop” in the chemical life cycle.  With over three days of programming, the Conference offers more than 40 technical sessions in seven concurrent tracks and multiple opportunities to network with hundreds of attendees from around the world.  This year’s featured keynote speakers are:

  • Udit Batra, Ph.D., Chief Executive Officer, MilliporeSigma;
  • Lee Cronin, Ph.D., Regis Professor of Chemistry, University of Glasgow; and
  • Dana Kralisch, Ph.D., Professor of Pharmaceutical Technology and Biopharmacy, Institute of Pharmacy, Faculty of Biological Sciences, Friedrich Schiller University of Jena, and Chief Technical Officer, JeNACell GmbH.

Richard E. Engler, Ph.D., Director of Chemistry for Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), will be presenting Regulatory Barriers to a Circular Economy on June 13, 2019, and Ligia Duarte Botelho, M.A., a Regulatory Associate with B&C and Acta and Manager with B&C® Consortia Management, L.L.C. (BCCM), will be presenting Role of Regulations in Circular Economy: Challenge of New Chemical Bias on June 13, 2019.

Reduced rates for advanced registration are available until May 31, 2019.  Registration is available online


 

By Lynn L. Bergeson

On June 10, 2019, at 5:00 p.m., the American Chemical Society (ACS) will hold the 2019 Green Chemistry Challenge Awards ceremony in Washington, D.C.  Sponsored by the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP), in partnership with the ACS Green Chemistry Institute® and members of the chemical community, these prestigious annual awards recognize chemical technologies that incorporate the principles of green chemistry into chemical design, manufacture, and use. 

EPA usually presents one Green Chemistry Challenge Award in each award category.  For the 2019 competition, there are five award categories:

  • Focus Area 1:  Greener Synthetic Pathways;
  • Focus Area 2:  Greener Reaction Conditions;
  • Focus Area 3:  The Design of Greener Chemicals;
  • Small Business (for a technology in any of the three focus areas developed by a small business); and
  • Academic (for a technology in any of the three focus areas developed by an academic researcher).

If you are interested in attending this event, please RSVP to .(JavaScript must be enabled to view this email address) for more information.


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton

On July 20, 2018, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit of EPA’s implementation of the OIG recommendations for the Presidential Green Chemistry Challenge Awards (PGCCA) Program.  The PGCCA Program is sponsored by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) to promote the environmental and economic benefits of developing and using green chemistry by recognizing industry innovations.  In 2015, OIG reported that award results submitted to the EPA’s Pollution Prevention (P2) Program from PGCCA recipients were not adequately supported or transparent.  In its audit, OIG found that EPA discontinued the use of unverified PGCCA results in EPA performance metrics, but “a lack of documented controls presents risk that these data may be used in the future.”

Please see the full memorandum for more information including a short history on performance metrics of the Green Chemistry Program.


 

By Zameer Qureshi

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. Burchi, and Sheryl L. Dolan.

Mr. Auer, Senior Regulatory and Policy Advisor at B&C, addressed “Administration of the Act” and described important changes between old and new TSCA.  Mr. Auer’s presentation consisted of three segments:  (1) “Section 26 Science Requirements”; (2) “Section 26 Information and Guidance”; and (3) “Section 26 ‘Savings’ Provision.”  

Mr. Auer addressed the “Scientific Standards” requirements of new TSCA Section 26(h), the “Weight of Scientific Evidence” requirements of Section 26(i), and the Section 26(o) provisions of new TSCA relating to Consultation with the Science Advisory Committee on Chemicals (SACC).  Mr. Auer addressed a number of additional rules and requirements in Section 26, including the U.S. Environmental Protection Agency’s (EPA) obligation to submit a report to Congress and issue an Annual Plan under Sections 26(m)-(n).

Ms. Burchi, Of Counsel at B&C, discussed “Preemption” under Section 18 of new TSCA. Ms. Burchi described preemption as “one of the most debated subjects in [the TSCA reform] debate” and stated that she had heard it referred to as a “linchpin” in terms of reaching agreement on provisions for TSCA reform to occur.  Ms. Burchi stated “Everything in the new Section 18 is new or very significantly changed from what we were used to with regard to preemption … The final provisions are fairly complicated … It will remain to be seen whether states continue to act with regard to chemical substances in the way that they have been.”

Ms. Burchi addressed the three “main” provisions related to preemption under new TSCA Sections 18(a)(1)(A)-(C), and analyzed more specific issues (e.g., pause preemption) and the related exceptions.  Ms. Burchi described the TSCA Section 18(d)-(e) provisions relating to “Exceptions” and “Preservation of Certain Laws.”  Ms. Burchi also addressed new TSCA’s Section 18(f) “Waivers” provisions and concluded her segment of the presentation with the following statement:  “It remains to be seen whether states are going to be jumping in to [take action] when EPA has already identified a chemical for prioritization and review … [There will be some interesting provisions and interplay] to be seen as we move forward under new TSCA.” 

Ms. Dolan, Senior Regulatory Consultant at B&C, analyzed “Fees” under new TSCA and addressed EPA’s obligations to:  (1) set lower fees for small business concerns; (2) consider balance between manufacturers and processors; and (3) consult with the regulated community.  Ms. Dolan stated “new TSCA directs EPA to review its fee program on a three-year cycle and revise it as needed to raise the target fees … While new TSCA did not set a deadline for developing the fees program, it really didn’t have to -- EPA, of course, has every incentive to knock this rulemaking out quickly.” 

Ms. Dolan indicated that a final rule is expected on fees under new TSCA by June 2017, and provided an overview of comments received on the proposed rule.  Ms. Dolan stated that “overarching themes” in the comments included that:  (1) fees should be tied to the level of required effort; (2) fees should encourage innovation; and (3) fees should not be overly complex or difficult to administer.  In relation to (3), Ms. Dolan quoted a commenter that stated “don’t give us the [Internal Revenue Service (IRS)] Code.” 

Ms. Dolan stated “everyone seems to want to know how much will a [pre-manufacture notice (PMN)] cost in the future … I think the answer to that [will come with a big red bow] in December.  Specifically, EPA states that it will send a proposal to [the Office of Management and Budget (OMB)] in mid-October … EPA may well set a comment period of at least 60 days for this proposed rule.”

Dr. Engler, Senior Chemist at B&C, discussed Sustainable Chemistry (i.e., Green Chemistry) under new TSCA.  Dr. Engler stated “new TSCA is largely silent on sustainability” and indicated that the “primary benefit” to Sustainable Chemistry under new TSCA is the abbreviated review period when EPA determines that a new chemical is “not likely to present” an unreasonable risk (i.e., 90-day period waived and manufacturers can commence manufacturing immediately).  Dr. Engler addressed chemicals that EPA considers to present low hazard for health and ecotoxicity (“low/low” chemicals) and stated that new TSCA could be “more of a driver for Sustainable Chemistry,” if only low/low chemicals escape regulation.

Dr. Engler addressed “Relative Risk under New TSCA” and EPA’s “Safer Choice Program” (SCP).  Dr. Engler discussed the Senate Report on S. 697, which suggested that EPA should consider “private sector voluntary consensus standards as an alternative” to SCP.  Dr. Engler indicated that as the relevant section of the Senate report concerns Section 23, the Sustainable Chemistry Section that was not included in the enacted new TSCA, it is unclear how it applies to new TSCA as enacted.  Dr. Engler stated that EPA is proceeding with SCP and hosting a summit in November on this topic.

The webinar concluded with a Questions and Discussion (Q&D) session, and B&C’s expert panel provided useful answers and analyses in response to attendees’ questions.  Ms. Bergeson moderated the Q&D session, which was organized by topic. 

In the Q&D session, Ms. Bergeson stated and asked Ms. Dolan: “Fees are super important … [small businesses and startups] might have a hard time mustering any type of financial liquidity to get their notifications through the gauntlet of EPA -- so how would you expect EPA to be defining lower fees for purposes of small business provision?”

Ms. Dolan responded by stating “[currently, the ratio is $2,500 and $100 for small businesses.  I would imagine there will be some kind of comparable proportionality and currently there are other submissions (e.g., Low Volume Exemptions) that don’t require any fees.  EPA has got to raise the money somewhere -- the more they put it on something else or the more they try to avoid charging fees for things, the more it’s going to jack up the cost and other things.  I would imagine that they are going to charge something for everything.  Whether they maintain that proportionality of 100:2500 remains to be seen.  Another consideration is what constitutes a small business.  There is a lot of conversation about that and the fact that definition hasn’t been updated in quite a while … This might be something that is the focus of a lot of attention in the proposed rule.]”

Ms. Bergeson drew on Mr. Auer’s extensive experience with EPA on several occasions during the Q&D session, starting questions with “If you were back at EPA,” and Mr. Auer’s responses were comprehensive.   Dr. Engler responded to questions regarding Green Chemistry and discussed Persistent, Bioaccumulative, and Toxic (PBT) substances under new TSCA, and Ms. Burchi answered questions on California’s Safer Consumer Products Regulation (SCPR) and preemption under new TSCA.

More information on TSCA reform and B&C’s “The New TSCA: What You Need to Know” webinar series is available online.


 
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