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

Federal

EPA Announces Grant Opportunity Supporting Innovative Solutions For Reducing Pollution, Including In The Chemical Manufacturing, Processing, And Formulation Sector

On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking grant applications through the Source Reduction Assistance Grant Program from states, federally recognized tribes, universities, local governments, and other groups to support innovative solutions for source reduction or pollution prevention (P2) through research, education, training, or certain other methods. EPA notes that as it highlights chemical safety during the month of March, “these grants support that goal by providing information, training, and tools to improve public health and the surrounding environment, reduce pollutants, and decrease resource use (e.g., water and energy).” EPA anticipates awarding individual grants in the range of $20,000 – $200,000 for a two-year funding period (or between $10,000 and $100,000 per year), though award amounts may vary based on EPA region. EPA anticipates awarding 20 grants in total. EPA states that grant applications should focus on at least one of the following P2 priority areas, also referred to as National Emphasis Areas (NEA) that support several of the EPA’s Smart Sectors. Through these grants, technical assistance and projects should encourage businesses to identify, develop, and adopt P2 practices and reduce waste in the following sectors:

  • Food and Beverage Manufacturing and Processing (NEA #1);
  • Chemical Manufacturing, Processing, and Formulation (NEA #2);
  • Automotive Manufacturing and Maintenance (NEA #3);
  • Aerospace Product and Parts Manufacturing and Maintenance (NEA #4); and
  • Metal Manufacturing and Fabrication (NEA #5).

Proposals are due by April 30, 2020. Additional information is available on www.grants.gov, under Funding Opportunity Announcement EPA-HQ-OPPT-2020-002.

EPA Adds Two Microorganisms To List Of Microoganisms Eligible For Exemption From Certain TSCA Reporting Requirements

On March 10, 2020, EPA announced that it issued a final rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under the Toxic Substances Control Act (TSCA). EPA states that manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA’s new chemicals review program with reduced TSCA fees. The final rule is intended to ensure the safety of human health and the environment while reducing regulatory burden for the biotechnology industry.

EPA states that after reviewing all relevant health and safety data, it determined that the two microorganisms can be added to the list of microorganisms eligible for exemption. Under TSCA, manufacturers of a new intergeneric microorganism may be eligible to submit an exemption request in lieu of a microbial commercial activity notice (MCAN) if the organism is on the list of species eligible for an exemption and meets other criteria. EPA is including these two microorganisms on the list because it determined that the microorganisms “will not present an unreasonable risk of injury to health or the environment provided that the other criteria relating to the introduced genetic material and the physical containment of the new microorganisms have been met.”

According to EPA, both microorganisms have a long history of safe use to produce a variety of commercial enzymes used in industrial and food-related industries. Trichoderma reesei is used by the animal feed, baking, beverages, textile processing, detergent, pulp and paper, industrial chemicals, and biofuels industries. Bacillus amyloliquefaciens has been used to produce commercial enzymes for more than 50 years. It produces carbohydrases, proteases, nucleases, xylanases, and phosphatases that have applications in the food, brewing, distilling, and textile industries.

The final rule will be effective April 9, 2020.

EPA Announces SNPRM On Strengthening Transparency In Regulatory Science

On March 3, 2020, EPA announced that a supplemental notice of the proposed rulemaking (SNPRM) titled “Strengthening Transparency in Regulatory Science” will be published in the Federal Register in the near future. While the notice would only modify EPA internal procedures, industry stakeholders are asked to comment on the proposed rule during a 30-day period after the date of publication in the Federal Register. The supplemental notice proposes the following changes to the 2018 proposed rulemaking:

  • A scope that applies to influential scientific information and significant regulatory decisions;
  • A modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions as well as an alternate approach;
  • Clarification on the ability of the EPA Administrator to grant exemptions; and
  • Definitions and clarifications that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science.

These proposed modifications are in response to some of the public comments received by EPA on the 2018 proposed rulemaking. Under the alternate approach to the use of data and models, EPA will also use restricted studies that are not available to the public. The proposal would apply to reviews of data, models, and studies regardless of when the data and models were generated. EPA plans to identify studies that are given greater consideration and provide a short explanation of why greater consideration was given.

EPA is seeking comment on each of the proposed changes. In particular, EPA is asking for feedback on whether this approach may improve consistency between this proposed rulemaking and certain provisions of those statutes that refer to standards for data availability.

EPA’s announcement includes a pre-publication version of the proposed supplemental rulemaking, which can be accessed here. Interested parties may wish to review Bergeson & Campbell, P.C.’s (B&C®) March 9, 2020, memorandum on the SNPRM.

EPA Announces Latest Update To TSCA Inventory

On March 11, 2020, EPA announced the availability of the latest TSCA Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals, of which 41,484 are active in U.S. commerce. Other updates to the TSCA Inventory include:

  • Updates to commercial activity data, or active/inactive status;
  • Updated regulatory flags, such as consent orders and significant new use rules (SNUR); and
  • Additional unique identifiers.

EPA notes that the TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.

DOE Announces Funds Available For Workforce Development At Universities

On March 6, 2020, the U.S. Department of Energy (DOE) announced that up to $20 million in funding is available for workforce development at universities in emerging energy fields. Aiming to prepare the next generation of scientists and engineers, DOE’s investment will fund a land grant university to pursue interdisciplinary research through the support of expansions of existing joint graduate education programs with DOE National Laboratories. This effort will be led by DOE’s Office of Energy Efficiency and Renewable Energy (EERE) as part of the implementation of the “Charting a Course for Success: American’s Strategy for STEM Education” roadmap. The selected project will:

  • Establish a five-year EERE Research, Training and Workforce Development Program that expands existing joint graduate programs, with associated investment in learning and research tools to promote research, entrepreneurship, and technology transfer;
  • Use existing National Laboratory capabilities in key EERE-related areas for training and research that support EERE-funded projects; and
  • Coordinate with other relevant programs, including regional and national fellowship and workforce development efforts, build sustainable alliances, and apply lessons learned and best practices.

Applications for this funding opportunities are due on or prior to April 13, 2020, at 5:00 p.m. (EDT).

EPA Publishes Final Rule Establishing CBI Claims Review For TSCA Inventory

On March 6, 2020, EPA announced via the Federal Register its final rule on requirements for regulated entities to substantiate certain confidential business information (CBI) made under TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities, providing the review criteria and related procedures that EPA will use to complete the reviews within the five-year time frame set in TSCA. The final rule will be effective on May 5, 2020.

Continuing Education

B&C Launches TSCA TutorTM Online And On-Demand Training Courses

B&C has launched the complete suite of TSCA TutorTM regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA TutorTM training platform offers live in-person training at a company’s site and customized live webinar training, so that companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.

TSCA awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how EPA’s ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.

TSCA TutorTM online training courses include:

  • Video lessons.
     
  • Detailed handout materials, including copies of all presentations and relevant course materials from EPA and other sources.
     
  • Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.
     

The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes six former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.

Online courses are offered at $100 for one-hour modules and $200 for two-hour modules, or $1,400 for the full 12-module training. Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.TSCAtutor.com to view sample course segments and purchase modules. Volume discounts are available for companies wishing to purchase courses for multiple employees. Companies interested in live in-person or customized live webinar training should contact [email protected] to schedule.

For more information about TSCA Tutor™, contact Heidi Lewis at [email protected].

Other News
 

EurekAlert!, “A Novel Biofuel System for Hydrogen Production from Biomass
 
Des Moines Register, “Iowans Slam Reported Plan by Trump Administration to Appeal Ruling Against Ethanol Exemptions
 
The Journal Record, “Lee:  Industry Applauds Efforts to Protect Small Refiners
 
the Fence Post, “Reports:  White House to Appeal RFS Decision
 
Forbes, “The Future of Biofuel May Include Shark Liver Oil
 

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