By Lynn L. Bergeson
On April 30, 2019, 15 U.S. Senators signed and submitted a letter to the U.S. Environmental Protection Agency (EPA) Administrator, Andrew Wheeler, urging him to protect U.S. consumers and account for the ethanol blend wall when setting annual target volumes under the Renewable Fuel Standards (RFS) requirements. According to the letter, a decrease in consumer demand for gasoline has occurred since the RFS Program was passed into law. Instead of the original 170 billion gallons projected, now, the U.S. Energy Information Administration (EIA) projects a gasoline demand for 2020 to be closer to 142 billion gallons and to decrease to 137 billion gallons by 2022. Therefore, in the letter, the Senators request that EPA acknowledge the “market reality when resetting the statutory targets such that the contribution of conventional biofuel is set below an implied 10 percent level for 2020.” They also emphasize that, should EPA fail to reset the volume below the blend wall, EPA would be violating the Congressional intent set forth under RFS, harming both consumers and refiners
By Lynn L. Bergeson
On April 15, 2019, U.S. Senator Elizabeth Warren (D-MA) wrote an article for Medium Politics, titled “My plan for public lands.” In the article, Warren highlights the importance and value of U.S. public lands and the need to make them part of the climate solution rather than the issue. Emphasizing her position on corporate profits and how they should not be prioritized over local communities’ health and safety, Warren states that on her first day in office as President, she will “sign an executive order that says no more drilling—a total moratorium on all new fossil fuel leases, including for drilling offshore and on public lands.” Furthermore, she vows to set a goal of providing ten percent of the U.S.’s electricity generation from renewable sources offshore or on public lands.
By Lynn L. Bergeson
On February 27, 2019, Senators Rand Paul (R-KY) and Chuck Grassley (R-IA) introduced the Fuel Choice and Deregulation Act of 2019 (S. 581). The legislation would remove “burdensome” regulations on domestic energy production. The bill “provides new economic opportunity for Kentucky farmers by allowing fuel producers and automobile manufacturers to innovate and bring new products to market that will lower costs for consumers, increase domestic energy production, and protect the environment,” said Senator Paul. The Fuel Choice and Deregulation Act would remove regulations blocking higher ethanol blends, such as gasoline blended with up to fifteen percent ethanol (E15), from entering the marketplace. It also removes the requirement for EPA certifications on aftermarket vehicle conversions. The bill specifically would reform Reid Vapor Pressure (RVP) requirements by allowing higher blend levels of ethanol to exceed the current 9.0 pounds per square inch (psi) standard, and it prevents EPA from regulating biomass fuel. RVP is a measure of how quickly fuel evaporates into the atmosphere. EPA regulates RVP in conjunction with ozone emissions in the summer months. Congress previously directed EPA to issue a “one pound waiver” for ethanol blends of ten percent, allowing E10 to be sold at 10.0 psi. Last year, President Trump signed an executive order directing EPA to look into the possibility of allowing year-round sales of E15. This bill extends the Congressional waiver to higher blends of ethanol, including E15.
By Lynn L. Bergeson
On February 15, 2019, U.S. President Donald Trump signed into law a bill originally introduced in early 2017 by Representative Nita Lowey (D-NY) titled the Consolidated Appropriations Act, 2019 (2019 Appropriations Act). Of interest to stakeholders in the biobased sector is Section 428, which covers policies relating to biomass energy. In this section, responsibilities assigned to the U.S. Secretary of Energy, Secretary of Agriculture, and EPA Administrator are outlined in support of the key role forests play in addressing U.S. energy needs. Among these responsibilities are the establishment of clear and simple policies for forest biomass solutions to the U.S. carbon footprint and the encouragement of private investment throughout the forest biomass supply chain. Government stakeholders should be consistent across all federal departments and agencies and recognize the full benefits of the use of forest biomass for energy, conservation, and responsible forest management.
By Lynn L. Bergeson
On February 7, 2019, Representative Ocasio-Cortez (D-NY), in partnership with Senator Ed Markey (D- MA), released the outline for the Green New Deal, a policy package designed to reduce greenhouse gas (GHG) emissions through the transformation of the U.S. economy. The outline includes highlights on the systemic impact from climate change, particularly on women, indigenous populations, deindustrialized and migrant communities, the poor, communities of color, depopulated rural communities, low-income workers, the elderly, the unhoused, people with disabilities, and youth. Stating that climate change poses a direct threat to the U.S. national security, the outline of the Deal makes it the federal government’s duty to pass its measures. These duties include transitioning to 100 percent renewable energy; creating millions of high-wage jobs; ensuring economic security for everyone; investing in infrastructure and industry; ensuring clean air and water, climate and community resiliency, access to healthy food, and a sustainable environment; and promoting justice and equity that currently prevent oppression repair. According to Ocasio-Cortez’s outline, all Green New Deal goals should be addressed in ten years through:
- Resiliency building against climate change-related disasters;
- Pollution elimination;
- Expansion of renewable and zero-emission energy sources;
- Spurring growth in clean manufacturing;
- Promoting sustainable farming;
- Building a sustainable food system;
- Provision of resources, training, and education; and
- Public investment in research and development (R&D), among other measures.
By Lynn L. Bergeson
On January 10, 2019, more than 600 environmental groups signed a letter submitted to U.S. Representatives urging them to consider certain principles on climate change as a Green New Deal is developed. As the 116th Congress begins to take into account climate change legislation, environmental groups would like to see affirmative actions focused on six key areas:
- Fossil fuel phase-out;
- Transition into renewable energy;
- The role of public transportation;
- The power of the Clean Air Act (CAA);
- Community-led transitions; and,
- The importance of indigenous rights.
Tying together these six concepts, the environmental groups’ letter highlights the role played by legislators and day-to-day community leaders/workers in integrating a 100 percent renewable energy system in the U.S. The suggested principles call for the expansion of public transportation as a means to phase out fossil fuel vehicles, as well as the prioritization of support for communities that have been historically most harmed by the dirty energy economy. In addition, a reference to the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) is made to emphasize Indigenous Peoples’ rights to receive remedies of losses or damages of their property. The signatory environmental groups also explicitly oppose rollbacks of existing environmental and human health protection policies, legislation that protects the fossil fuels industry, and policies that promote corporate profits over community burdens.
On January 8, 2019, B&C and its consulting affiliate The Acta Group (Acta®) published the 2019 Forecast. The document details the legal, scientific, and regulatory trends in U.S. and global chemical law, providing informed judgment as to the shape of key developments we are likely to see in 2019. Sections on biobased products and biotechnology are included in the document. The full document can be accessed here.
By Lynn L. Bergeson
On December 6, 2018, U.S. Senator Charles E. Schumer (D-NY) wrote a letter to President Donald Trump requesting that, in 2019, any infrastructure package to be considered include a focus on the clean energy economy to address climate change. Emphasizing that climate change is, in fact, real and caused by humans, Senator Schumer refers to the Administration’s recent National Climate Assessment report and the drastic need to reduce emissions. In the letter, Senator Schumer outlines a number of policies that must be included in an infrastructure package in the next Congress. Among these policies are the need to:
- Invest in research, development, and deployment of clean energy, energy efficiency, carbon reduction, and energy storage technologies;
- Provide permanent tax incentives and investments for domestic production of clean energy and renewable power; and
- Invest in upgrades in clean energy for public schools, buildings, and other infrastructure.
Senator Schumer concludes his letter to President Trump highlighting that “[t]he challenge is immense, but so is the opportunity to revitalize and modernize our infrastructure, create new jobs and economic opportunities, and position the United States as a leader in clean energy innovation.”
By Kathleen M. Roberts
Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA).
ISSUE: While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the Toxic Substances Control Act (TSCA) mean that many novel, sustainable technologies are considered “new chemicals” requiring EPA to conduct new chemical assessments. If these new chemicals are converted to other substances by downstream customers, those substances are likely also new, requiring additional new chemical submissions and assessments. Each new chemical submission and assessment represents a cost and a commercial delay and each is a barrier to adoption of what may be a promising sustainable technology. These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of the novel, renewable chemicals -- restrictions that may not apply to older chemistries even though they may be functionally identical in performance, hazard, and risk. Ironically, the new chemical may offer a more benign environmental footprint but nonetheless be subject to stricter controls.
POTENTIAL SOLUTION: To address these issues, the Biobased and Renewable Products Advocacy Group (BRAG®) has submitted to EPA, in partnership with the Biotechnology Innovation Organization (BIO), a BRAG member, a White Paper proposing a TSCA Inventory representation and equivalency determinations for renewable and sustainable biobased chemicals. EPA’s initial response to the White Paper has been positive and staff has indicated a willingness to conduct equivalency determinations if submitted.
REQUEST: BRAG is now seeking companies interested in participating in a pilot project to prepare and submit such requests. Specifically, we are looking for companies that manufacture or plan to manufacture a Class 2 chemical substance that is functionally equivalent to another Class 2 chemical, but due to existing naming conventions, the two chemicals are not listed as equivalent. If your company fits this description and you wish to support an effort to alleviate commercial burden for yourself and others in the future, please consider working with BRAG on this important project so we present impactful equivalency cases to EPA.
BRAG and Bergeson & Campbell, P.C. (B&C®) are committed to this project. As such, we will evaluate all candidate chemicals submitted, select what we believe is a good test case for the project, and prepare as a courtesy the necessary submission paperwork and equivalency arguments, in conjunction with the nominating company.
By Lynn L. Bergeson
On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act through the addition of Section 351(k). The BPCI Act also amended the Federal Food, Drug, and Cosmetic Act to include Section 351(k) under human drug applications for prescription drug user fees provisions. The Program is meant to “create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. This allows a company to apply for licensure of a biosimilar or interchangeable biological product.” In 2012, the Biosimilar User Fee Act (BsUFA) allowed FDA to assess and collect user fees for activities connected with biosimilar biological product development (BPD). Some of these activities include the submission and review of forms, as well as an annual survey of all BsUFA participants.
The information collection proposal estimates an annual reporting burden of 57 hours, based on the number of respondents, the number of responses per respondent, the total annual responses, and the average burden per response. OMB will be accepting comments on FDA’s collection of information proposal until December 5, 2018.