Regulatory Developments

U.S. Senators Vote Against Deputy Secretary Of Energy Nominee and other Biobased Developments

August 6, 2020 PRINT

Federal

U.S. Senators Vote Against Deputy Secretary Of Energy Nominee

On August 4, 2020, U.S. Senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) voted against Mark Menezes, who is nominated to become Deputy Secretary of Energy. In a statement, both Senators said that “[g]iven the uncertainty with the ‘gap year’ small refinery waivers, the wasted time and resources to score the waivers again, the lack of transparency in the entire process, and most importantly, the toll this has taken on Iowa’s farmers and biofuel producers, we could not in good faith support Mr. Menezes at this time.” The two Senators are pushing the U.S. Department of Energy (DOE) for increased transparency and certainty for Iowa’s farmers and producers, asking for information on DOE’s scoring of small refinery waiver petitions. They are also requesting information on when the score recommendation was transmitted back to the U.S. Environmental Protection Agency (EPA). According to the statement, concerns continue to arise as DOE reviews petitions that have already been reviewed, wasting valuable time and resources to score the petitions again. A letter by the two formerly mentioned Senators has been submitted to Mr. Menezes further expressing their constituents’ concerns. The full text of the letter can be accessed here.

U.S. Senate Passes The Sustainable Chemistry Research And Development Act

On July 23, 2020, the National Defense Authorization Act (NDAA) was passed by the U.S. Senate; it includes the bipartisan Sustainable Chemistry Research and Development Act of 2019, led by U.S. Senators Chris Coons (D-DE) and co-sponsored by Senators Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV). Introduced to the Senate in December 2019, the Sustainable Chemistry Research and Development Act of 2019 establishes an interagency working group (IWG) led by the Office of Science and Technology Policy to coordinate federal programs and activities in support of sustainable chemistry. The IWG will develop a roadmap for sustainable chemistry with a framework of attributes characterizing sustainable chemistry, assess the state of sustainable chemistry in the United States, and identify methods by which federal agencies can incentivize sustainable chemistry activities, challenges to sustainable chemistry progress, and opportunities for expanding federal sustainable chemistry efforts. Senator Coons celebrated the victory by stating that this “is an exciting opportunity to maintain our scientific leadership and ensure the sustainability of our chemical enterprise for years to come.”

DOE Announces $64 Million In Funding For H2@Scale Projects

On July 20, 2020, DOE announced that approximately $64 Million in funding for 18 projects to advance the H2@Scale vision. H2@Scale is a concept that explores the potential for wide-scale hydrogen production and utilization in the United States to enable resiliency of the power generation and transmission sectors while aligning diverse domestic industries, competitiveness, and job creation. Funded through DOE’s Office of Energy Efficiency and Renewable Energy (EERE) Hydrogen and Fuel Cell Technologies Office (HFTO), the 18 selected projects will advance hydrogen storage and infrastructure technologies.

FDA DHHS Announces 2021 Biosimilar User Fee Rates

On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through September 30, 2021.

DOE Announces Funding For Bioenergy R&D

On July 31, 2020, DOE announced more than $97 million in funding for 33 projects to support research and development (R&D) of high-impact technology to accelerate the U.S. bioeconomy. The aim is for the selected projects to improve the performance and lower the cost and risk of technologies that can be used to produce biopower, biofuels, and bioproducts from biomass and waste resources. Selected projects will address the following R&D areas:

  • Scale-up of bench applications to reduce scale-up risks for biofuel and bioproduct processes;
  • Waste-to-energy strategies, including strategies for municipal solid waste; wet wastes, like food and manures; and municipal wastewater treatment;
  • Cost reduction of algal biofuels by improving carbon efficiency and by employing direct air capture technologies;
  • Quantification of the economic and environmental benefits associated with growing energy crops, focusing on restoring water quality and soil health;
  • Development and testing of low-emission, high-efficiency residential wood heaters;
  • Innovative technologies to manage major forms of urban and suburban waste, with a focus on using plastic waste to make recycled products and using wastes to produce low-cost biopower; and
  • Scalable carbon dioxide electrocatalysis technologies.

USDA Requests Comments On Update To Bioengineered Foods List

On July 24, 2020, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced its solicitation for comments and feedback on recommendations to update the List of Bioengineered Foods as it pertains to the National Bioengineered Food Disclosure Standard. Comments are due by August 24, 2020.

DOE Selects R&D Projects In The Biomanufacturing Sector

On July 10, 2020, DOE EERE announced that it has selected eight projects totaling more than $5 million to conduct R&D needed to accelerate the U.S. biomanufacturing sector. These projects are a part of the Agile BioFoundry (ABF) consortium and will leverage National Laboratory capabilities to address challenges in biomanufacturing. Each of these ABF selected projects has been invited to collaborate with National Laboratory research facilities to conduct their proposed research. The seed awards provide up to $500,000 in DOE funds to the laboratories for up to two years. Full awards, however, will receive up to $2 million for up to three years. The aim is for the projects to develop novel microbial hosts and bioproducts, use artificial intelligence and machine learning in synthetic biology, and address the problem of production heterogeneity in industrial microbiology. Each awardee has committed to a minimum of 20 percent cost-share contribution.

DOE SBIR/STTR Programs Office Announces FOA Topics For FY 2021

On July 13, 2020, DOE’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office (SBIR/STTR Programs Office) issued topics for its FY 2021 SBIR/STTS Phase I Release 1 Funding Opportunity Announcement (FOA). The topics are available online. DOE participating program offices include the Office of Science’s (SC) Office of Advanced Scientific Computing Research (ASCR), Office of Basic Energy Sciences (BES), Office of Biological and Environmental Research (BER), and Office of Nuclear Physics (NP). DOE SBIR/STTR will hold a webinar on August 14, 2020, to discuss the FOA and application process, as well as important changes to the SBIR and STTR programs for 2021. Important upcoming dates include:

  • August 31, 2020 – Letter of Intent (LOI) Due;
  • September 21, 2020 Non-responsive LOI Feedback Provided;
  • October 13, 2020 – Application Due;
  • January 4, 2021 – Award Notification; and
  • February 16, 2021 – Start of Grant Budget Period.

The 2021 important dates are subject to change.

EPA OIG Finds Safer Choice Program Would Benefit From Formal Goals And Additional Oversight

On June 30, 2020, EPA’s Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes. OIG states that EPA’s Safer Choice program does not have formal goals included in the FY 2018-2022 EPA Strategic Plan, and the program has not reported results for FYs 2018-2019. The program does have internal, non-outcome-oriented goals, however, which it is generally achieving. The Safer Choice program’s goal is to add 200 Safer Choice products to the program and 25 chemicals to the Safer Chemical Ingredients List each year. According to OIG, in FY 2019, EPA added 265 products and 24 chemicals. OIG states that by not including formal goals for the Safer Choice program in EPA reports while continuing to receive Congressional funding and support, EPA limits not only accountability to Congress and the public, but also the extent that the program can use performance management information to make policy, budget, and management decisions. OIG notes that the Safer Choice program has general controls in place for the required Safer Choice audit process, and EPA reviews audit summaries and corrective actions provided by third-party profilers (TPP). EPA does not routinely review all supporting documentation, however, relying on TPPs to review and retain these documents. Additionally, the Safer Choice program does not have procedures in place to conduct any formal performance reviews of TPPs or oversight reviews of TPP partner audits. According to OIG, without periodic audit oversight, including full reviews of supporting documents and formal performance reviews of TPPs, EPA risks approving products that do not comply with the Safer Choice Standard. OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop and publish adequate Safer Choice program goals and performance measures, establish and implement procedures for formal audit oversight of TPPs, amend its memorandums of understanding with TPPs to require performance reviews conducted by EPA, and collect and document TPP audit supporting information.

DOE Announces Funding For Small Business R&D

On July 14, 2020, DOE EERE announced that it will fund approximately $53 million to 49 new SBIR and STTR R&D projects. The selected projects will receive Phase II Release 2 grants for principal R&D efforts based on the technical feasibility demonstrated in Phase I projects. Phase II awards range up to $1,500,000 for two years. Further information about the awardees can be found here.

Industry

ACS Opens Call For Nominations For SC&E Lectureship Awards

The American Chemical Society (ACS) has announced its 2021 call for nominations for the ACS Sustainable Chemistry and Engineering (SC&E) Lectureship Awards. The awards will recognize the contributions of early career investigators from around the world who are doing exceptional research impacting sustainability, green chemistry, or green engineering. One award recipient will be chosen from three regions: the Americas, Europe/Middle East/Africa, and Asia/Pacific. Awardees will not only receive an award plaque but also an honorarium of $1,000 and travel and accommodation funding of up to $1,500 to attend and present at the 2021 Green Chemistry and Engineering (GC&E) Conference in Reston, VA, from June 14 through 16, 2021. Eligible nominees include:

  • Faculty members within ten years or less of their initial academic appointment;
  • Industrial and other non-academic scientists within ten years or less from their last professional training (terminal degree or postdoc); and
  • Individuals who have taken formal family leave which affects their eligibility under the ten-year timeline described above.

Self-nominations are allowed. The deadline for nominations is August 31, 2020. Selected winners will be announced in the fall of 2020.

ACS Announces Call For Symposia For Its 25th Annual GC&E

ACS has also recently announced a call for symposia topics for its 25th GC&E conference mentioned in the article above. The theme of the conference is “Sustainable Production to Advance the Circular Economy,” which directly links to the United Nations (U.N.) Sustainable Development Goal 12: Responsible Consumption and Production. The proposal submission deadline is October 9, 2020, and notifications of acceptance will be announced by November 20, 2020.

B&C

B&C To Present At PSX Virtual Conference In September 2020

Bergeson & Campbell, P.C.’s (B&C®) Karin F. Baron, MSPH, and Richard E. Engler, Ph.D., will present “Evaluating New Chemicals and Disconnects in Hazard Communication” during this year’s virtual PSX Conference from September 15 to 17, 2020.  Ms. Baron is a Senior Regulatory Consultant with B&C and has more than 15 years of experience developing, implementing, and managing complex chemical regulatory compliance matters for industrial and specialty chemical companies around the globe.  Dr. Engler is B&C’s Director of Chemistry and a 17-year EPA senior staff veteran.  Conference registration is now open.  Register by August 10, 2020, to get early-bird rates!

Available On-Demand: “TSCA Reform -- Four Years Later” Virtual Seminar

On June 24, 2020, B&C, The Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Four Years Later.” A full recording of the seminar, including a keynote address by Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA, and comments by the Hon. John Shimkus, U.S. Representative, 15th District of Illinois, is available to watch now.

This complimentary all-day virtual seminar marked the fourth Toxic Substances Control Act (TSCA) Annual Conference, with top EPA officials and industry leaders reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Panelists covered “TSCA Implementation: Where Are We Now?” “Science Policy Issues,” and “Regulatory and Policy Issues” while offering unique insights into the decision-making process of EPA.

Building on the timely information shared during this event, B&C’s All Things Chemical ™ podcast has released an exclusive interview with Alexandra Dunn focusing on the current state of TSCA, “TSCA at Four -- A Conversation with Alexandra Dunn, OCSPP AA.” Lynn L. Bergeson and Alexandra Dunn focused their discussion on the implementation of the amendments to TSCA, which Congress enacted in 2016. As pollution prevention is an integral part of EPA’s mission, this episode also focuses on initiatives under way to introduce safer and greener chemicals. Finally, the discussion includes a look ahead to what is on EPA’s agenda for the remainder of the year, which promises to be extraordinarily busy.

CDR Cross-CheckTM

Chemical manufacturers and processors have just under four months to submit Chemical Data Reporting (CDR) data by the November 30, 2020, close of the reporting period. To assist companies in that process, B&C affiliate The Acta Group (Acta®) developed CDR Cross-Check™, an ingenious and cost-efficient tool to identify whether a company’s chemicals are subject to CDR reporting and if so, at what reporting threshold.

CDR Cross-Check will identify:

  • Whether the chemical is listed as active or inactive;
  • Whether the chemical was subject to specific TSCA regulatory actions in 2016;
  • Whether the chemical is exempt; and
  • What the reporting thresholds are based on the updated data released by EPA on May 29, 2020.

Visit the CDR Cross-Check page on the Acta website for a sample report and information on how to use CDR Cross-Check.

A TSCA Retrospective – A Conversation With Congressman John M. Shimkus

The July 23, 2020, All Things Chemical™ Podcast will be of interest to readers. A brief description of the episode written by Lynn L. Bergeson is below.

This week I sat down with Congressman John M. Shimkus, a Member of the United States House of Representatives for the 15th District of Illinois. As listeners of the podcast know well, Congressman Shimkus is a senior Member of the House Energy and Commerce Committee. In this capacity, Congressman Shimkus has become a rock star in the industrial chemical community, given his tireless efforts to modernize TSCA , which of course resulted in passage four years ago of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).

Given Congressman Shimkus’s extensive involvement in and personal commitment to reforming TSCA, our conversation focused on the efforts that have been under way since June 2016 to implement the massive and complicated new law. We address many aspects of Lautenberg’s implementation, not just by EPA, but also efforts under way by other industrial chemical stakeholders, including industry, non-government organizations (NGOs), states, and the courts. We discuss the many, many rulemakings EPA has issued since 2016 and survey the next leg of EPA’s journey to implement the new law over the next 12 to 24 months, which will be extremely busy. Congressman Shimkus is as passionate today as he was four years ago about chemical safety, as you will hear in this recording.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

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