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 June 15, 2021, the winners of the 2021 Green Chemistry Challenge Awards. EPA states that “[g]reen chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the 2021 winners “developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges, and spur innovation and economic development.” The 2021 winners are:

  • Professor Srikanth Pilla of Clemson University, South Carolina, for creating the first nonisocyanate polyurethane foam. Traditional polyurethane foams are widely used in the plastics industry and are typically manufactured from diisocyanates, a potential human carcinogen. This new foam is made using lignin, a natural polymer from pulp and paper waste that is derived from vegetable oils and uses no isocyanates. According to EPA, the lignin-based foams have the same mechanical properties as traditional polyurethane foams and were specifically designed for chemical recycling at the end of their life, making the foam a more environmentally friendly option.
     
  • XploSafe, Oklahoma, for creating PhosRox, a novel sorbent used to make fertilizer. The product simultaneously removes ammonia, phosphate, and nitrate from contaminated waters. The resulting material is a granulated time-release fertilizer that can help lower dependence on manufactured fertilizers by recycling nutrients. According to EPA, this product will also help wastewater treatment operators maintain compliance with regulations and potentially generate revenue from the sale of the resulting fertilizer. EPA states that when this is added to agricultural soils, it will not only release plant nutrients slowly but, in future years, could enhance the nutrient-holding capacity of the soil, preventing fertilizer runoff and protecting the watershed.
     
  • Colonial Chemical, Tennessee, for developing environmentally friendly, high performing Suga®Boost surfactants. While many surfactants used in traditional cleaners are made from petroleum-based materials and can be highly toxic, EPA states that SugaBoost surfactants are plant-based, biodegradable, generate no air emissions or wastewater discharges, and do not contain known carcinogens or endocrine disruptors. According to EPA, they perform as well as or better than “toxic, energy-intensive petroleum-based surfactants, creating the potential to yield huge environmental improvements in the cleaning industry.”
     
  • Bristol Myers Squibb, New York, for a new class of sustainable reagents -- substances used to cause a chemical reaction. The new reagents use less solvent and are derived from limonene, a waste product from discarded citrus peels, which increases sustainability and decreases environmental impact. They also can tolerate air and moisture better than traditional reagents, eliminating the need for expensive technology and specialized shipping and storage.
     
  • Merck, New Jersey, for developing a green and sustainable manufacturing process for a drug used to treat chronic coughs. According to EPA, by incorporating green chemistry techniques into the manufacturing process, the team not only replaced two highly toxic and hazardous chemicals, it also reduced carbon monoxide and carbon dioxide emissions. According to EPA, life-cycle assessment data show that these changes are expected to decrease the carbon footprint of manufacturing this drug by more than 80 percent.

EPA recognized the winners during the virtual American Chemical Society Green Chemistry & Engineering Conference. EPA states that the 2021 awards have special meaning because it is also the 25th anniversary of the Green Chemistry Challenge Awards. During the quarter century of the Green Chemistry program, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,800 nominations and presented awards to 128 technologies that decrease hazardous chemicals and resources, reduce costs, protect public health, and spur economic growth. According to EPA, winning technologies are responsible for annually reducing the use or generation of hundreds of millions of pounds of hazardous chemicals and saving 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 formally judged the 2021 submissions and made recommendations to EPA for the 2021 winners.


 

By Sheryl L. Dolan and Kathleen M. Roberts

On September 13, 2016, the U.S. Environmental Protection Agency (EPA) convened its second industry stakeholder meeting to discuss the development of a fees rule under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182, “new TSCA”); a copy of the presentation is available here.  Under new Toxic Substances Control Act (TSCA) Section 26(b)(4)(E), EPA is required to solicit input in support of fees rulemaking.  EPA convened its first stakeholder meeting on August 11, 2016.  Comments submitted by the August 24, 2016, deadline are available in the docket.  During its second meeting, EPA stated it would continue to consider input received by Friday, September 23, 2016; any additional comments should be sent to .(JavaScript must be enabled to view this email address).  EPA states it intends to send its proposal to the Office of Management and Budget (OMB) by mid-October 2016, and expects a proposed rule will be published by the second half of December 2016.

In anticipation of the second meeting, EPA shared its general observations as to a way forward for fee assessment under TSCA Sections 4, 5, 6, and 14 and some of EPA’s key take aways from the comments submitted to the docket.  In its meeting presentation, EPA outlined its estimated annual costs by 2019 (i.e., once the Section 6 risk evaluation schedule is ramped up).  While no specific fee proposals emerged from the meeting discussions, the following information was discussed, which provides some insight into EPA’s ongoing process:

  • EPA’s projected annual cost for implementing TSCA Sections 4, 5, 6 and 14 includes both direct and indirect/overhead costs, with a 22.75 percent adjustment to cover overhead, consistent with EPA’s overall budget practice.
  • In estimating the anticipated number of Section 5 submissions, EPA stated that based on industry comments regarding the effect of fees, it assumed a 30 percent reduction from recent years.  EPA essentially stated that 30 percent is an educated guess, noting that Notices of Commencement (NOC) are only filed on approximately 50 percent of premanufacture notices (PMN).
  • EPA stated that, consistent with industry’s comments, it most likely will not propose to charge separately for individual confidential business information (CBI) claims, but instead will incorporate that into overhead costs.
  • EPA stated that it is implementing a time accounting system, which may support future refinements of its cost estimates; EPA is required to review its fee program every three years under TSCA Section 26(b)(4)(F).
  • EPA stated that it is pursuing consultation with the Small Business Administration regarding revisiting the applicable definition of a small business concern.  While clarifying that this is not a proposal, EPA noted that if the producer price index is applied to the small business concern definition in 40 C.F.R. § 700.43, the $40 million revenue cap in the definition would increase to $91 million.  As reflected in the circulated spreadsheet, EPA plans to propose reduced fees for small businesses as required by TSCA Section 26(b)(4)(A).  EPA also stated that approximately 14 percent of TSCA submissions are made by small businesses.
  • Section 6 risk evaluation fees remain one of the greater uncertainties.  During the September 13, 2016, meeting, suggestions were made that these fees should be assessed incrementally, perhaps tied to milestones, with a schedule that perhaps could allow tying the fees to actual costs.  In response, EPA noted that OMB requirements preclude federal agencies from seeking fees in reimbursement for completed activities.

Based on its projected costs, EPA will seek to raise the $25 million annual maximum allowed by new TSCA.  Regardless of how these costs are distributed among Sections 4, 5, and 6 (assuming EPA’s proposal does not separately charge for Section 14 activities), it is clear that the proposed rule will be a significant change from the $2,500 PMN fee in place since the 1980’s.


 

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 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 more strategic, thoughtful and detailed.”

Both the old and newly amended TSCA state the EPA's “authority over chemical substances and mixtures should be exercised in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation,” Bergeson stated, referring to Section 2601(b)(3).  The new law makes “very consequential changes” to the new chemicals provisions of TSCA as EPA will have to balance carefully the requirements imposed by different sections of the law.

Richard A. Denison, Ph.D., Senior Scientist with the Environmental Defense Fund, stated that the changes the amended law makes to EPA's new chemicals program “are not trivial.”  Further, the changes will make it easier for the public to understand why EPA concludes that new chemicals may or may not enter commerce, what restrictions it may impose on the uses of those chemicals, and why.

BNA’s article, “Detailed New Chemical Applications Needed to Boost Market Chances: Attorneys,” is available online, through paid subscription.