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.
By Lynn L. Bergeson
On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation. Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities:
- Advancing public health by promoting innovation;
- Strengthening public outreach and communication; and
- Increasing engagement with domestic and international partners.
The statement includes an indication that FDA will be seeking public input in the coming year. Once input is received, the first step in implementing the new action plan will be the adoption of “a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them.” According to their statement, this policy framework will be modern and flexible, accompanied by two guidance documents in 2019. The guidance documents are intended to provide greater clarity on how FDA will be applying regulatory oversight in evaluating risk profiles of various products. In addition to these elements, the Action Plan also highlights FDA’s commitment to efforts with both national and international partners in fostering efficiency and cooperation.
By Lynn L. Bergeson
On October 16, 2018, the Office of Information and Regulatory Affairs released the Trump Administration’s Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions (Agenda). The Agenda aims to report on actions that administrative agencies, such as EPA, plan to put forward in the near- and long-terms. As its name implies, the Agenda includes both regulatory and deregulatory actions and attempts to justify any burden associated with these actions. According to its announcement, it should reflect four broad regulatory reform priorities: advancing regulatory reform, public notice of regulatory development, transparency, and consistent practice across the Federal Government.
Included in the Agenda are the Administration’s estimated timelines for the rulemakings on year-round sales of 15 percent ethanol (E15) sales and the Renewable Fuel Standard (RFS) resetting renewable volume obligations (RVO). It is expected that EPA will release a proposed rule on permitting E15 sales year-round in February 2019, with a final rulemaking expected in May 2019. While the final rulemaking on RFS Biomass-Based Diesel (BBD) volume is expected to be announced in November 2018, the rulemaking on the RFS modification of applicable volumes is predicted to be announced in 2019. According to the Agenda, the proposed rule will be announced in January 2019 and the final rule should follow in December 2019.
By Lynn L. Bergeson
On October 15, 2018, U.S. Representatives Ruben Gallego (D-AZ) and Danny Davis (D-IL) submitted a letter to the U.S. Environmental Protection Agency (EPA) expressing concern over President Trump’s issuance of waivers to the Renewable Fuel Standard (RFS). Particularly worried about EPA’s recent actions to waive RFS blending requirements, the letter, signed by 19 members of Congress, urges EPA “to halt the issuance of additional RFS waivers and to reallocate waived gallons in the 2019 Renewable Volume Obligations.” According to the letter, the issuance of these waivers has led to higher gas prices and higher emission levels, particularly, in communities of color that are disproportionately impacted by air pollution. Given the largely negative impacts of these waivers, the letter also highlights the benefits and importance of biofuels in reducing greenhouse gas (GHG) emissions and, consequently, improving public health outcomes. “The Trump administration’s decision to abandon RFS goals has already set back our progress by 5 years,” Representative Gallego expanded in a press release.
By Lynn L. Bergeson
On October 11, 2018, President Trump issued a Presidential Determination that the development and purchase of equipment and materials needed for alane fuel cells are essential to the national defense. Alane fuel cells are, essentially, comprised of aluminum hydride and are possible alternatives to hydrogen fuel cells. According to manufacturers, the only byproducts are water and aluminum, the latter of which can be recycled.
Issuing the determination under Section 303 of the Defense Production Act of 1950, the President stated that “United States industry cannot reasonably be expected to provide the capability for the production of alane fuel cells adequately and in a timely manner. Further, purchases, purchase commitments, or other action pursuant to section 303 of the Act are the most cost effective, expedient, and practical alternative method for meeting the need for this critical capability.”
In general, Section 303 authorities can be used by the President to provide incentives for domestic private industry to produce and supply critical goods that are necessary for the national defense. It vests the President with an array of authorities to create, maintain, protect, expand, or restore domestic industrial base capabilities essential to the national defense. These authorities include purchasing or making purchase commitments of industrial resources or critical technology items; making subsidized payments for domestically produced materials; and installing and purchasing equipment for industrial facilities to expand their productive capacity.
By Lynn L. Bergeson
On October 9, 2018, during a rally in Council Bluffs, Iowa, U.S. President Donald Trump announced that he will order the U.S. Environmental Protection Agency (EPA) to expand its sales of corn ethanol. This action, which farmers across the U.S. have been waiting for, will allow for year-round sales of 15 percent biofuels (E15) ethanol blends. Currently, E15 sales are restricted during the summer months in certain states, limiting the expansion of the market space for biofuels. Well received by many in the industry, the announcement was particularly appreciated by the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, which applauded President Trump’s decision in a press release. Brent Erikson, BIO’s Executive Vice President, emphasized in his statement that “[a]llowing E15 to be sold year-round will help unleash the potential of cellulosic biofuels by creating more demand and marked headroom for the next generation of biofuels.”