The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

On October 20, 2020, Senator Jeff Merkley (D-OR) and Representative Mike Levin (D-CA) introduced in the U.S. Senate and the U.S. House of Representatives the Zero-Emission Vehicles At of 2020 (the Act). The Act would amend Part A of Title II of the Clean Air Act (CAA) to create a federal national zero-emission vehicle (ZEV) standard and address climate change by ending U.S. sales of new gasoline-powered vehicles in 2035. Senator Merkley and Representative Levin’s standard aims to boost the market for battery electric vehicles and hydrogen fuel cell vehicles. Sponsored by four other Senators and an additional 15 Representatives, the ZEV standard has also been criticized by conservatives and biofuels industry stakeholders. Senator Chuck Grassley (R-IA) stated that Iowans should not “allow coastal state lawmakers to dictate to Middle America how to live [their] lives or take away the freedom to choose what kind of car to buy.”


 

By Lynn L. Bergeson

On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Under BsUFA, FDA collects user fees to support its process for the review of biosimilar and biological products and the current legislative authority is set to expire in September 2022. At the aforementioned time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA requests public comments as it begins the process to reauthorize the BsUFA program and invites stakeholders to participate in its virtual public meeting on November 19, 2020, from 9:00 a.m. to 12:30 p.m. (EST). Registration to participate in the virtual meeting is available here. After the meeting, written comments must be submitted on or prior to December 19, 2020.


 

By Lynn L. Bergeson

On October 8, 2020, Secretary of Agriculture, Sonny Perdue, announced that the U.S. Department of Agriculture (USDA) has made $22 million available in grants to increase sales of ethanol and biodiesel. The funds are coming out of the $100 million in grants available through the Higher Blends Infrastructure Incentive Program (HBIIP) and have been disbursed to 14 states. USDA predicts that the investments will increase ethanol demand by approximately 150 million gallons annually.

HBIIP aims to assist biodiesel distribution facilities and transportation fueling facilities with the conversion to higher ethanol and biodiesel blends by sharing costs related to installing fuel pumps and related equipment and infrastructure. Eligible grant applicants are vehicle fueling facilities, including, but not limited to:

  • Local fueling stations and locations;
  • Vehicle fueling facilities;
  • Hypermarket fueling stations;
  • Convenience stores;
  • Fuel terminal operations;
  • Fleet facilities;
  • Midstream partners; and
  • Distribution facilities.

Higher fuel blends mean fuels that contain ethanol over ten percent by volume and/or fuels containing biodiesel blends higher than five percent by volume. More information on USDA’s HBIIP can be found here.

Tags: USDA, Biofuel

 

By Lynn L. Bergeson

On October 15, 2020, the U.S. Department of Energy (DOE) announced the availability of over $27 million in funding for 12 projects supporting research and development (R&D) efforts toward advanced plastics recycling technologies and new recyclable plastics. These efforts are part of DOE’s Plastics Innovation Challenge, which aims to improve existing recycling processes that break plastics down into chemical building blocks that can be used to make new products. The 12 projects selected will address highly recyclable or biodegradable plastics, novel methods for deconstructing and upcycling existing plastics, and collaborations to tackle challenges in plastic waste.


 

By Lynn L. Bergeson

On October 19, 2020, the U.S. Energy Information Administration (EIA) announced that, in 2019, renewable energy consumption levels in the United States increased for the fourth year in a row, reaching a record 11 percent of total energy consumption. Wood and waste energy, wood pellets, and biomass waste from landfills accounted for approximately 24 percent of U.S. renewable energy use. According to EIA, industrial, commercial, and electric power facilities use wood and waste as fuel to generate electricity, manufacture goods, and produce heat. Biofuels, which includes fuel ethanol, biodiesel, and other renewable fuels, accounted for approximately 20 percent of U.S. renewable energy consumption in 2019. A detailed chart prepared by EIA further outlines the breakdown, including percentages for hydropower, solar, and wind energy consumption in 2019.


 

After reading the article below by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), we were inspired to post it. We appreciate having the opportunity to share his analysis with our audience.

TSCA as a Gap-Filling Statute: Potentially Exposed and Susceptible Subpopulations

By Jeffery Morris, PhD

In its response to public comments on the scope documents for its next twenty chemical risk evaluations conducted under the Toxic Substances Control Act (TSCA), the US Environmental Protection Agency (EPA) has asserted that TSCA is a “gap-filling statute” for the regulation of chemical substances in the United States (US EPA, Summary of Public Comments Received on the Draft Scopes of the Risk Evaluations for Twenty Chemical Substances Under the Toxic Substances Control Act (TSCA), August 2020, p. 13). This assertion relates to the regulatory nexus between TSCA and other federal statutes. At issue regarding regulatory nexus is whether TSCA’s role is to: (1) fill gaps where issues are not addressed by other laws that regulate chemicals1, (2) serve as the nation’s primary and preeminent statute for chemicals, or (3) operate somewhere between these two positions. Inherent in the TSCA-as-gap-filler position is the view that federal laws should work together to advance the public welfare, and that different environmental statutes have their own strengths in how they govern the impact of chemicals on people and the environment.

TSCA requires the consideration of potentially exposed or susceptible subpopulations in the EPA’s evaluation of chemicals. While TSCA is not the only environmental law with provisions for susceptible or vulnerable subpopulations, the direct, repeated emphasis across multiple sections of the law that the EPA consider potentially exposed or susceptible subpopulations may be unique in US environmental law. Therefore, how the EPA meets this requirement with respect to other laws’ treatment of such populations is an important consideration for regulatory nexus. Key questions regarding regulatory nexus and TSCA’s role are how to go about identifying whether other statutes leave gaps in this area for TSCA to fill and if they do, how those gaps should be filled in the EPA’s chemical evaluations.

The recently released final scope documents and the accompanying response-to-comments document do not fully answer these questions, including regarding comments that have been raised about how the EPA will apply exposure and susceptibility considerations to people living in communities located near high concentrations of chemicals-related activity. My hope is that exploring these questions now can help inform a path forward for further addressing comments the EPA has received on potentially exposed or susceptible subpopulations as the twenty draft risk evaluations are developed, as well as in scope documents for future chemicals brought into the TSCA prioritization process.

In its response to scope document comments, the EPA makes two important statements regarding the regulatory nexus issue as applied to potentially exposed or susceptible subpopulations. The first, on page 13, is that “EPA believes that coordinated action on exposure pathways and risks addressed by other EPA-administered statutes and regulatory programs is consistent with statutory text and legislative history, particularly as they pertain to TSCA’s function as a ‘gap-filling’ statute ….” In the second statement, also on page 13, the EPA adds that “[t]o the extent that specific exposure pathways are not under the jurisdiction of other EPA-administered statutes and associated regulatory programs, EPA plans to evaluate those exposures in the risk evaluations for the individual substances.”

The first statement’s focus on “coordinated action” between laws and regulations with respect to chemical evaluation and management is a crucial consideration for regulatory nexus. Coordination by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), which administers TSCA, with other EPA offices that manage statutes that address chemicals, as well as with other federal agencies that implement laws impacting chemicals, is good government practice. What is missing from the final scope documents, and therefore would be a valuable addition to the chemical-specific dockets, is a detailed description of the type of coordination cited in the response to comments. Ideally, this description would appear in the scope documents, but for these twenty chemicals an addition to the dockets would be helpful. For example, the EPA could strengthen its explanation of whether potential exposures or susceptibilities are based on geography (e.g., exposures are higher in a particular location), biology (e.g., a particular population has a genetic or otherwise biologically based predisposition to suffer adverse effects from exposure to a chemical), or cultural/societal factors (e.g., a cultural or community practice results in exposure potential greater than in the general population, or an attribute of the subpopulation’s location in society, such as having low income or poor access to health care, creates susceptibilities to adverse effects from chemical exposure).

Because some comments on community exposures refer specifically to 1,3-butadiene, it is a useful example to illustrate the challenges and opportunities presented by the coordination the EPA is conducting within the regulatory nexus construct; it also can illustrate what I mean by a detailed description of cross-office coordination on potentially exposed or susceptible subpopulations. This example looks at just one of 1,3-butadiene’s uses: in the production of tires. Under its Clean Air Act (CAA) authority, the EPA’s Office of Air and Radiation (OAR) conducted a Residual Risk Assessment for the Rubber Tire Manufacturing Source Category in Support of the 2020 Risk and Technology Review Final Rule (EPA-HQ-OAR-2019-0392-0047, February 2020) that includes 1,3-butadiene within this source category, among numerous other chemical substances designated as hazardous air pollutants (HAP). This assessment supports a July 24, 2020, final rule, National Emission Standards for Hazardous Air Pollutants: Rubber Tire Manufacturing Residual Risk and Technology Review (EPA-HQ-OAR-2019-0392; FRL 10008-48-OAR, 85 FR 44752, July 24, 2020).

The coordination challenge, therefore, is to crosswalk the CAA review, which covers numerous HAPs within one sector, with a TSCA risk evaluation covering the conditions of use of a single HAP chemical across multiple sectors. On page 49 of the 1,3-butadiene TSCA scope document, the EPA states that air emission pathways are covered under the CAA (Final Scope of the Risk Evaluation for 1,3-Butadiene, EPA Document # EPA-740-R-20-011, August 2020). It would be useful for the 1,3-butadiene record to include a table and/or narrative that describes how, for its TSCA coordination on the consideration of potentially exposed or susceptible subpopulations, OCSPP evaluated the 1,3-butadiene conditions of use against the respective source category-based and any other analyses conducted by OAR that included 1,3-butadiene. Such a crosswalk could serve as a best practice for application of regulatory nexus analysis in the implementation of TSCA. It would also aid in transparency to the public around a very complex but important concept: that although different environmental statutes may use different approaches (e.g., sector or source category versus individual chemical analysis), it is possible to coordinate their respective contributions to chemical evaluation and management so that, if gaps exist, TSCA can play its appropriate role in health and environmental protection.

For instance, OAR’s 2020 final rule states that “the percentage of the population potentially impacted by Rubber Tire Manufacturing emissions is greater than its corresponding nationwide percentage for: African Americans (25 percent for the source category compared to 12 percent nationwide) and below the poverty level (21 percent for the source category compared to 14 percent nationwide)” (page 44759). Strong coordination between TSCA and the CAA would suggest that such information obtained through CAA activities would be helpful to OCSPP in determining how to address the “potentially exposed or susceptible subpopulations” considerations required under TSCA section 6, including as they may apply to TSCA’s gap-filler role in addressing comments to the 1,3-butadiene scope document concerning disproportionate exposure to communities located near high concentrations of chemicals-related activity.

This consideration leads to the EPA’s statement in its response-to-comments document that where there is not overlap with another regulatory jurisdiction, the EPA will evaluate the exposures. Using the above TSCA-CAA coordination example for 1,3-butadiene, a question for OCSPP could be whether the TSCA requirement that the EPA consider potentially exposed or susceptible subpopulations in its risk evaluations is covered by the work done by OAR on 1,3-butadiene, specifically with respect to commenters’ input on community-based impacts. One would assume “covered” to mean that this particular aspect of TSCA’s potentially exposed or susceptible subpopulations requirement has been evaluated and addressed in OAR’s CAA activities, and therefore can be excluded from the 1,3-butadiene risk evaluation. However, if the CAA has not addressed this particular TSCA requirement in a manner or to an extent intended by the best read of TSCA’s language regarding the consideration of those potentially exposed or susceptible subpopulations in a particular chemical risk evaluation, then there exists a gap that TSCA, as a gap-filling statute, should address.

The manner in which a TSCA risk evaluation fills any identified gaps is also important. This again will require careful and transparent coordination and analysis between statutes. In its chemical risk evaluations, EPA would presumably want to fill gaps in ways that meet the specific requirements of TSCA for potentially exposed or susceptible subpopulations, without doing so in a manner that is at odds with other statutes’ treatment of a chemical substance under TSCA evaluation. Not only would this careful gap filling be in general sound government practice, but it also would help avoid difficulties if the risk evaluation identifies unreasonable risks that the EPA determines, under TSCA section 9, should be addressed under a law other than TSCA.

The 1,3-butadiene example shows how greater explanation, preferably in scoping documents, on how the EPA coordinates among its offices and other agencies to make regulatory nexus decisions for TSCA risk evaluations can not only provide greater transparency to the public on individual chemical evaluations, but also can inform broader discussions on regulatory nexus by showing how such coordination can identify gaps that TSCA is best situated to fill. For some chemicals, it may be the case that other statutes have already adequately assessed the risks to potentially exposed or susceptible subpopulations, obviating the need for additional analysis in a TSCA risk evaluation. However, the mere existence of another statute with jurisdiction over a particular environmental pathway or human exposure scenario for a chemical substance subject to TSCA review should not lead to an a priori assumption that there is not an evaluation gap for TSCA to fill. Any assumptions about other statutes’ coverage of TSCA’s chemical evaluation requirements should be explored, tested, and fully described in TSCA chemical scope documents or elsewhere in the risk evaluation record. This is particularly important with potentially exposed or susceptible subpopulations, given TSCA’s unique approach to requiring their consideration in chemical prioritization, evaluation, and management. I would argue that a good starting point for articulating TSCA’s gap-filling role is in the application of these requirements to people living near high concentrations of chemicals-related activity.

1 By “chemicals” I refer in this article to chemicals regulated under TSCA, and not to chemicals that are regulated under other federal statutes, such as pesticides, drugs, and food additives.


 

By Lynn L. Bergeson

The government of Manitoba, Canada, is currently working to amend three regulations under the Biofuels Act. The amendments will update Manitoba’s clean fuel standards by increasing the ethanol and renewable fuel content in gasoline. The proposed amendments include:

  • “Ethanol General Regulation is amended to:
     
    • Include the latest fuel standards for ethanol blended gasoline;
       
    • Remove the quarterly reporting requirements of obligated entities; and
       
    • Increase ethanol content from 8.5% to 10%.
       
  • Biodiesel Mandate for Diesel Fuel Regulation is amended to:
     
    • Increase renewable fuel content of diesel from 2% to 5%;
       
    • Adjust the compliance formula to reflect the 5% blending requirement; and
       
    • Adjust the shortfall calculation to reflect the 5% blending requirement, and to increase the penalty amount from $0.45 to $1.50 per litre.
       
  • Biodiesel (General) Regulation is amended to:
     
    • Repeal the definition of “non-commercial licence;
       
    • Include the latest fuel standards for biodiesel and renewable diesel sold or offered for sale in Manitoba;
       
    • Include the latest fuel standards for biodiesel blends eligible under the Biodiesel Mandate;
       
    • Remove the non-commercial biodiesel manufacturing licence class;
       
    • Clarify the conditions required to hold a commercial biodiesel manufacturing licence; and
       
    • Remove references to the non-commercial licence class.”
       

The primary public policy objective of Manitoba’s government is to reduce greenhouse gas (GHG) emissions while increasing renewable fuels use. The regulatory amendments will come into force on January 1, 2021.


 

By Lynn L. Bergeson

On October 8, 2020, the European Commission (EC), under the European Union (EU) State aid rules, approved the prolongation of tax exemptions for biofuels in Sweden. Having exemptions for liquid biofuels from energy and carbon emissions taxation since 2002, Sweden’s scheme aims to increase biofuels use while reducing the fossil fuels use in transport. With EC’s decision, the tax exemption has now been prolonged by one year from January 1, 2021, until December 31, 2021. EC stated that the tax exemptions are not only appropriate, but necessary for stimulating the production and consumption of domestic and imported biofuels in Sweden. In addition, EC found that the Swedish scheme will contribute to the delivery of the EU’s goals in the Paris Agreement and EU’s move towards its 2030 renewables and carbon emissions targets.


 

By Lynn L. Bergeson

In early September, the U.S. Department of Energy (DOE) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs Office announced that from December 14 to 17, 2020, the Brookhaven National Laboratory will host a virtual workshop for industry researchers to showcase the capabilities and expertise available at DOE’s Office of Science User Facilities. Designed to benefit researchers who have either previously used the Brookhaven facilities and researchers with an interest in learning about accessing the Brookhaven facilities, the workshop program will focus on researchers working in all major industry sectors. Some of these industry sectors include petrochemicals, energy storage, advanced materials, pharmaceuticals, microelectronics, and advanced manufacturing, and DOE believes that companies will benefit from learning how Brookhaven facilities can impact their research and development (R&D) mission.

The workshop will be formatted so that attendees can spend time remotely observing the labs and Brookhaven’s capabilities in action, while engaging in technical discussions with the lab experts. As a virtual “facilities open house,” the workshop will also allow attendees to measure remotely their own samples and collect data. In addition, presentations from industry users of Brookhaven facilities, question and answer sessions, and opportunities to engage directly with DOE program managers will be featured. The workshop is open to the public, and interested parties may register here.


 

By Lynn L. Bergeson

On September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance. EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document. EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents. The final rule will be effective 30 days after the publication in the Federal Register. Further details and a Bergeson & Campbell, P.C. (B&C®) commentary are available here.


 
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