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.
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By Lynn L. Bergeson

From July 23-24, 2019, the Food and Drug Law Institute (FDLI) will be hosting the Introduction to Drug, Biologics, and Biosimilars Law and Regulation conference in Boston, MA. The conference will cover an overview of administrative agencies that impact these industries and how they interact with the U.S. Food and Drug Administration (FDA). It will also include sessions on the development of drug and biological products, FDA’s review and approval of marketing applications, biosimilars and generic drugs, manufacturing issues, and case studies, among other topics.

Tags: FDA, Biobased

 

 
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By Lynn L. Bergeson

On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on the petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim.  Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule:  (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements. 
 
The D.C. Circuit’s order states that only the first claim succeeds past the standard of review required under both the Administrative Procedure Act (APA) and TSCA, however; specifically, EPA acted arbitrarily and capriciously via its “omission of any inquiry into a chemical identity’s susceptibility to reverse engineering [which] effectively excised a statutorily required criterion from the substantiation process.”  Even though EPA included several substantiation questions to address reverse engineering in the proposed rule, EPA did not include any “substantiation questions related to the requirement that a substance’s chemical identity not be susceptible to reverse engineering” and declined altogether to “‘secure answers’ substantiating a company’s ‘assertion’ that its chemical product cannot be reverse engineered.”  The court states that this error was “fatal” and remands this issue back to EPA for EPA to “address its arbitrary elimination of substantiation questions regarding reverse engineering.” For further details, see Bergeson & Campbell, P.C.’s (B&C®) TSCAblog™ article.

Tags: TSCA

 
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By Lynn L. Bergeson

On April 29, 2019, the National Chicken Council submitted a letter to EPA’s Office of Transportation and Air Quality outlining the potentially negative impact of the changes to the biofuels policy on the poultry industry. In his letter to EPA, Mike Brown, President of the National Chicken Council, reported concern with EPA’s proposal on year-round ethanol-15 (E15) use under the Renewable Fuels Standard (RFS) Program. The National Chicken Council believes that EPA has failed to consider the impact of such volume waivers on the boiler industry, and for poultry and livestock feeders generally. Brown assures EPA that a year-round E15 use waiver “will result in a rapid expansion of corn use under the RFS adding the potential for price and supply volatility in the corn market.” Instead of the aforementioned proposed modifications, the National Chicken Council is suggesting that EPA consider a predictable, transparent off-ramp based on the U.S. Department of Agriculture (USDA) stocks-to-use-ratio in the June World Agricultural Supply and Demand Estimates (WASDE) report. Partial waivers would then be structured for the remainder of the year. The structure of the partial waivers is further detailed in the letter.

Tags: E15, RFS, Biofuel

 
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By Lynn L. Bergeson

In April 2019, Navius Research Inc. (Navius Research) published a report titled “Biofuels in Canada 2019: Tracking biofuel consumption, feedstocks and avoided greenhouse gas emissions.” Using public data, the report analyzes the volume of transportation biofuels consumed in each Canadian province and estimates the impact of this consumption on greenhouse gas (GHG) emissions and transportation energy costs. An increase in both ethanol and renewable fuel consumption is noted in the report, which has led to reduced fuel expenditures in Canada by 0.42 percent from 2010 through 2017. This decreased expenditure is relative to a counterfactual scenario without biofuel consumption. Relative to this counterfactual scenario, differences in fuel energy density and fuel costs, Canada has ended up paying more taxes due to biofuel blending and consumption.


 
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By Lynn L. Bergeson

On April 25, 2019, the Environmental Law Institute (ELI) held an event to provide an overview of their latest publication, a book titled Legal Pathways to Deep Decarbonization in the United States. Providing an overview of the book, a few of the authors were part of a panel discussion opened by William K. Reilly, former EPA Administrator under President George H. W. Bush. In his opening remarks, Mr. Reilly emphasized the potential existing with politics to change culture to achieve low-carbon emissions in the near future. Following Mr. Reilly, Commonwealth Professor of Environmental Law and Sustainability Director at Widener University, John C. Dernbach, started the panel discussion by providing an overview of the contents of the book. According to Professor Dernbach, deep decarbonization is defined as achieving at least 80 percent GHG emissions through deep cuts by 2050. The book therefore contains chapters on federal, state, and tribal legal tools that are available to decarbonize the U.S. In the book, the authors present twelve types of legal tools available; some that are regulatory tools, and some that are not. Types of legal tools include, research and development (R&D), market leveraging approaches, removal of incentives for fossil fuels, and infrastructure development, among others. During the event, other authors and co-authors spoke about specific chapters of the book, stating that they were almost certain that the legal tools available would create economic, social, and environmental security. Unfortunately, the event was interrupted by a fire alarm in the building. For further information, the book can be found for purchase here.

Tags: ELI, Carbon

 

 
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By Lynn L. Bergeson

On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  84 Fed. Reg. 16826.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in the Active-Inactive rule.  Comments are due June 24, 2019. See Bergeson & Campbell, P.C.’s (B&C®) full memorandum for more information on the proposed rule.

Tags: TSCA, CBI

 
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By Lynn L. Bergeson

On April 25, 2019, EPA issued a proposed rule that would amend the TSCA Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Inventory to report data on chemical manufacturing, processing, and use every four years.  EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce the burden for certain CDR reporters.  Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA Section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements.  Overall, according to EPA, the regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner.  Comments are due by June 24, 2019See B&C’s full memorandum for more information on the proposed rule.

Tags: TSCA

 
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By Lynn L. Bergeson

On April 17, 2019, the Iowa Renewable Fuels Association (IRFA), a Biobased and Renewable Products Advocacy Group (BRAG®) member, spoke at a press conference alongside Iowa Secretary of Agriculture, Mike Naig, on how the approval of small-refinery exemptions (SRE) for the 2018 Renewable Fuel Standard (RFS) blend levels would undermine RFS in an irreversible way.  IRFA’s Executive Director, Monte Shaw, pointed out that under current conditions all a refinery needs to show significant disproportionate economic harm to be granted an SRE is to purchase Renewable Identification Numbers (RIN).  RINs, also known as compliance credits, can be purchased for as little as eight cents, which undermines RFS and breaks President Trump’s promise to protect the 15-billion-gallon RFS.  Shaw concludes:  “[t]he bottom line is this:  If you grant SREs under these circumstances with eight-cent RINs, then what EPA is really saying is that they will always grant SREs and the hope of a true 15-billion-gallon RFS is dead.”

Tags: IRFA, RFS, Biofuel

 
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By Lynn L. Bergeson

On April 17, 2019, Mark Carney, Governor of the Bank of England, Francois Villeroy de Galhau, Governor of the Banque de France, and Frank Edelson, Chair of the Network for Greening the Financial Services (NGFS), published an open letter on the financial implications of global warming.  Co-signed by the NGFS coalition, consisting of 34 central banks, the letter warns of global warming’s potential damage to infrastructure and private property, negative human health effects, decrease in productivity, and wealth destruction.  The letter states that no countries are immune to the effects of climate change and that “if some companies and industries fail to adjust to this new world, they will fail to exist.”  Although the Paris agreement has and continues to promote a low-carbon economy, further measures would be central to achieving zero net zero carbon emissions by 2050.  Key to reaching this goal would be a massive reallocation of capital, the financial experts highlight.
 
Given the challenges associated with achieving zero-carbon emissions, in the letter, Carney, Villeroy de Galhau, and NGFS members propose four recommendations to policymakers and financial firms:

  • The integration of climate-related financial risks into daily work, financial stability monitoring, and board risk management.  Policymakers and financial firms should conduct scenario analyses and take a long-term strategic approach, which considers risks associated with global warming.  These risks should be embedded it into their business-as-usual governance and risk-management frameworks.
  • Leadership by example, particularly by central banks, to integrate sustainability into their own portfolio management.
  • Internal and external collaboration among public authorities to bridge data gaps important to assessments of climate-related risks.
  • In-house capacity building and knowledge sharing with various stakeholders on the financial risks related to climate change.

According to the letter, the successful implementation of these four recommendations would lead to two broader calls for action on disclosure and classification of these risks.  Market and regulators’ support in assessing risks and opportunities from climate change accompanied by consistent international disclosure are critical.  In addition, NGFS members also encourage the development of a classification system to identify economic activities that would contribute to the transition to a low-carbon economy.  In sum, robust leadership and collaboration play a crucial role in identifying global solutions for the financial sector.


 
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By Lynn L. Bergeson

On April 12, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the reopening of the public review and comment period for the draft Environmental Impact Statement (dEIS) and the preliminary Pest Risk Assessment (PRA). These two documents have been prepared in response to a permit application from a company requesting the environmental release of genetically engineered (GE) Citrus tristeza virus (CTV). The reopening of comments is the result of a new research paper released after the initial comment period back in the summer of 2018. The research paper examines the movement of CTV, which could raise questions regarding the transmissibility of GE CTV. Updates to the dEIS and PRA have been made according to the new information obtained. While the dEIS evaluated the environmental impacts that could result from approving the permit application, the preliminary PRA analyzes the GE plant virus as a biological control measure and its potential to pose a risk to plant health. In its announcement, USDA APHIS clearly states that applying GE CTV does not mean that the trees are themselves GE. The permit application requests the approval for the use of GE CTV as a biological control agent that would help manage citrus greening disease. Instead, a gene from spinach is delivered to the tree’s circulatory system. Comments must be submitted on or prior to April 30, 2019.

Tags: USDA, APHIS

 
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By Lynn L. Bergeson

On April 16, 2019, the U.S. Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced the winners of DOE’s Solar Decathlon® Design Challenge, which was held at the National Renewable Energy Laboratory in Golden, CO, from April 12-14, 2019. The Challenge consisted of ten contests in which student teams designed highly efficient and innovative buildings powered by renewable energy.  The winners are teams that best blended architectural engineering excellence with innovation, market potential, smart energy production, and building efficiency.

Tags: DOE, EERE, Solar

 
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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.

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