By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on August 6, 2021, that it will provide $9,272,545 in funding to seven institutions for research to estimate better children’s chemical exposures from soil and dust ingestion. According to EPA, the research will focus on improving estimates of children’s ingestion rates of chemicals such as lead, mercury, polychlorinated biphenyls (PCBs), and asbestos. EPA states that “[a]ccurate, comprehensive measurements of soil and dust ingestion rates are critical for effective risk assessment, reduction, mitigation, and prevention measures.” The following researchers are receiving funding through EPA’s Science to Achieve Results (STAR) program to help improve children’s health:
- Emory University, Atlanta, Georgia, will conduct a community-based research study to understand and mitigate chemical contaminant exposure among children in neighborhoods with high lead and heavy metal contamination in soils around West Atlanta;
- Florida International University, Miami, Florida, will estimate soil and dust ingestion rates in children by identifying specific tracers of dust and soil exposure combined with relevant environmental information;
- Johns Hopkins University, Baltimore, Maryland, will create an integrated and innovative portfolio of tools and approaches to assess dust and soil exposures for children ages six months to six years via activity pattern and tracer studies;
- New York University, New York, New York, will evaluate specific home environment factors and practices that lead to elevated levels of individual toxic substances ingestible by infants. According to EPA, the researchers hope to evaluate mitigation strategies to reduce infants’ exposure to harmful chemicals in household dust;
- North Carolina Agricultural and Technical State University, Greensboro, North Carolina, will obtain data on dust loading on various objects and surfaces in children’s homes, foods, and children’s hands. The researchers will also conduct computer-aided investigations about children’s hand contacts and mouthing patterns;
- University of California Davis, Davis, California, will develop an innovative method for determining children’s dust ingestion rates using unique tracer compounds identified in household dusts; and
- University of Nevada-Reno, Reno, Nevada, will develop a behavior-driven dust and soil ingestion model to predict the dust and soil ingestion rate from children’s microenvironmental features and behavioral factors.
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 Christopher R. Bryant and Lynn L. Bergeson
On December 27, 2017, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) ordered the U.S. Environmental Protection Agency (EPA) to revise its nearly 17-year-old standard for levels of lead in paint and dust within one year. A Cmty. Voice v. EPA, No. 16-72816. The Ninth Circuit held that “EPA was under a duty stemming from the Toxic Substances Control Act and the Residential Lead-Based Paint Hazard Reduction Act of 1992 to update lead-based paint and dust-lead hazard standards in light of the obvious need, and a duty under the Administrative Procedure Act to fully respond to petitioners’ rulemaking petition.” The decision stems from a petition filed in June 2016 by environmental and health groups seeking this action. The order came in the form of a writ of mandamus, an unusual court order and extraordinary judicial remedy that requires an official or agency to perform a certain duty, in this case for EPA to issue a proposed rule within 90 days of this decision and to promulgate the final rule within a year of when the proposed rule is issued. The court stated that in doing so, it was mindful of the Agency’s arguments that officials needed more time to deliberate a complex new standard.
While not entirely surprising given the Circuit, the decision relies on a seldom used remedy that rarely succeeds in judicial settings. It reflects the court’s sharp rebuff of the Administration’s apparent decision to delay action on the lead standard. Given the many challenges EPA’s Office of Pollution Prevention and Toxics will face in the New Year, complying with the court’s order will not be easy.
By Sheryl L. Dolan and Kathleen M. Roberts
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.