Biobased Products News and Policy Report – Update from Bergeson & Campbell, P.C.


EPA OIG To Begin Fieldwork On Audit Of EPA’s Process For Conducting New Chemical Reviews

According to an October 26, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin fieldwork on an audit of EPA’s process for conducting reviews of new chemicals under the Toxic Substances Control Act (TSCA). The memorandum states that the audit “is self-initiated based on OIG’s oversight plan for fiscal year [(FY)] 2022 and to address complaints submitted to the OIG Hotline.” The audit also addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.

OIG states that its objective is to determine the extent to which EPA uses and complies with applicable records management requirements, quality assurance requirements, and employee performance standards to review and approve new chemicals under TSCA to manage human health and environmental risks. OIG plans to conduct work with the Office of Chemical Safety and Pollution Prevention (OCSPP) in EPA headquarters. According to OIG, the anticipated benefits of the audit are “improved operational efficiency and greater human health and environmental protections.”

To expedite the audit, OIG asks that OSCPP provide the following information:

  • Any training materials, handbooks, or other materials related to the review of new chemicals;
  • Resource allocations for the New Chemicals Review Program for FYs 2018 through 2021;
  • Scopes of work for any contracts related to the new chemicals review process;
  • Any OCSPP guidance under which products developed during the review of new chemicals would constitute records and how the records should be managed; and
  • New Chemicals Review Program organization charts before and after the October 2020 reorganization.

As reported in Bergeson & Campbell, P.C.’s (B&C®) October 28, 2021, memorandum, “House Committee Holds Hearing on ‘TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act,’” Dr. Michal Ilana Freedhoff, OCSPP Assistant Administrator, has let OIG know that OCSPP will cooperate fully with its investigation.

EPA Announces Legally Mandated Changes To TSCA Fees

EPA announced on November 23, 2021, legally mandated changes to the fee requirements under TSCA. This is not the fee adjustment we have been awaiting. It is a routine increase that TSCA directs EPA every three years to adjust the fees. The adjustment will go into effect on January 1, 2022, and will apply to all TSCA fees. The fee adjustment will not be retroactive and will not impact previous fee invoicing. According to EPA, separate from this action, EPA plans to propose additional revisions in 2022 to the 2018 TSCA fees rule to supplement its January 2021 proposal to ensure that TSCA fee amounts capture up to 25 percent of the actual costs of TSCA activities, fees are distributed equitably, and fee payers are identified through a transparent process.

In its announcement, EPA states that the TSCA program “has been and remains seriously underfunded.” The 2016 amendments to TSCA provided EPA with expanded authority to collect fees from chemical manufacturers and processors to help defray up to 25 percent of the costs associated with eight categories of TSCA implementation activities, including risk evaluations, new chemical notices, test rules, consent agreements, and test orders, as well as the cost of reviewing and managing confidential business information (CBI). EPA published a final TSCA fees rule in October 2018, meaning that EPA did not collect any fees under the rule until fiscal year 2019, and excluded 100 percent of the costs of the first ten risk evaluations. According to EPA, as a result of this and other factors, TSCA fees collected since the 2016 amendments have covered only half of the 25 percent target. EPA states that it “estimates it has less than half of the resources needed to review and approve new chemicals in the manner Congress intended and observes that the statutory deadlines for completing nine of the first 10 risk evaluations were missed.”

According to EPA’s TSCA Fees Table, consistent with the formula in the 2018 final rule, EPA will increase fees by the inflation rate, calculated to be 18.9 percent. EPA calculated the inflation rate by dividing the Producer Price Index (PPI) for September 2021 (348.8) by the PPI for January 2019 (293.4).

EPA states that consistent with the formula in the proposed rule, in any scenario where there is not a single consortium composed of all manufacturers subject to a single fee, it will take the following steps to allocate fees:

  • Count the total number of manufacturers, including the number of manufacturers within any consortia;
  • Divide the total fee amount by the total number of manufacturers and allocate equally on a per capita basis to generate a base fee;
  • Provide all small businesses that are either (a) not associated with a consortium, or (b) associated with an all-small business consortium with an 80 percent discount from the base fee referenced previously;
  • Calculate the total remaining fee and total number of remaining manufacturers by subtracting out the discounted fees and the number of small businesses identified; and
  • Reallocate the remaining fee across those remaining individuals and groups in equal amounts, counting each manufacturer in a consortium as one person.

EPA notes that it is providing an approximately 80 percent reduction in TSCA administration fees to submitters who qualify as small businesses. EPA states that small business fees are only applicable to qualifying small businesses that are either not associated with a consortium or associated with an all-small business consortium.

This announcement appears to be a routine increase in the TSCA fees based on the regulations in 40 C.F.R. Section 700.45, which requires that every three years fees be adjusted for inflation. This action is independent from the rulemaking that EPA initiated in January 2021.

EPA Extends Compliance Dates Under RFS Program

On November 26, 2021, EPA issued a proposed rule to modify certain compliance dates under the Renewable Fuel Standard (RFS) program. For small refineries only, EPA is proposing to extend the RFS compliance reporting deadline and the associated attest engagement reporting deadline for compliance year 2019. EPA is also proposing to extend the RFS compliance reporting deadline and the associated attest reporting deadline for 2020 and 2021 compliance years for all obligated parties. Lastly, EPA is also proposing to change the way that it determines future RFS compliance and attest engagement reporting deadlines.

Comments on the proposed rule are due on or prior to January 3, 2022.


University Of Iowa Scientists Uncover New Genetic Variation In Yeast That Can Improve Ethanol Production

On November 11, 2021, the University of Iowa announced that its Department of Biology scientists discovered a new type of genetic variation in yeast that can improve the production of ethanol. According to the study conducted by the University’s biologists, yeast strains with certain alleles of gene MED15 are more efficient at fermentation. The study was led by Professor Jan Fassler, who states that these findings may assist scientists in engineering a better yeast strain to produce more efficiently bioethanol for fuel and wine.

ACS GCI Announces Opportunity For Nina McClelland Memorial Award

On November 23, 2021, the American Chemical Society (ACS) Green Chemistry Institute (GCI) announced that it is accepting applications for the Nina McClelland Memorial Award for postdoctoral chemists engaged in green chemistry research. Annually, two awardees will receive a $2,000 sponsorship to participate in and present their research at the annual ACS Green Chemistry & Engineering Conference (GC&E).

The 2022 GC&E will be held in Reston, Virginia, from June 6 to June 8, 2022. Both U.S. and international postdoctoral scholars are eligible to apply for this opportunity. For purposes of this award, ACS GCI characterizes green and sustainable chemistry innovation activities as:

  • Elimination and reduction of toxics and pollution;
  • Holistic systems design;
  • Maximization of resource efficiency; and
  • Utilization of life cycle thinking.

Applications must address at least one of these attributes, and nominees are encouraged to address as many of them as possible. The application deadline is December 31, 2021. Additional information on how to apply is available here.

ACS Announces Fellowship In Green Chemistry Opportunity

On November 23, 2021, ACS announced that it is accepting applications for its Heh-Won Chang, Ph.D. Fellowship in Green Chemistry. This opportunity provides $5,000 in financial support to full-time graduate students conducting research in green chemistry. This one-time payment may be used for any purpose, including conference travel, professional development, and living expenses while the recipient is in graduate school. This opportunity is open to full-time graduate students across the globe who have at least one full year of study remaining in their graduate programs. Recipients must present their research at the annual ACS GC&E, where the award will be presented formally. Applications are due by December 31, 2021. Additional information on application requirements is available here.


B&C Launches FIFRA Tutor™ Online, On-Demand Regulatory Training

B&C is pleased to announce that FIFRA Tutor™ regulatory training courses are now available at Professionals can preview and enroll in on-demand classes to complete at their own pace and timing. FIFRA Tutor joins B&C’s existing TSCA Tutor® training courses in offering efficient and essential training for chemical regulatory professionals, and a third training program, HazCom GHS Tutor, is planned for 2022. These courses are intended to provide on-demand knowledge to assist with the strategic planning that is critical to global product development. More information is available here.

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