By Lauren M. Graham, Ph.D.
On March 23, 2017, the California Environmental Protection Agency’s Air Resources Board (ARB) announced the release of new carbon intensity pathways for fuels certified under the low carbon fuel standard (LCFS) using the CA-GREET 2.0 model. Of the 18 pathways approved in March, eight are first generation biodiesel carbon intensity pathways and four are second generation renewable diesel carbon intensity pathways. A pathway for biodiesel produced from used cooking oil has been provisionally certified, as well. The approved pathways can be used for credit reporting purposes beginning with reports for Q1 2017. The LCFS regulation aims to reduce the carbon intensity of fuels sold in California by 10 percent by 2020 in line with the California Health and Safety Code mandate to reduce greenhouse gases in California.
By Lauren M. Graham, Ph.D.
On March 24, 2017, the California Energy Commission (CEC) published a notice on the proposed recipients of up to $23 million in Electric Program Investment Charge (EPIC) funding for applied research and development (AR&D) and technology demonstration and development (TD&D) activities focused on advancing bioenergy electricity generation. The funding opportunity is focused on three main bioenergy applications, including:
||Efficient, Sustainable and Lower-Cost Bioenergy: Innovations to Improve Woody Biomass-to-Electricity Systems ($5,000,000);
||Demonstration and Evaluation of Environmentally and Economically Sustainable Woody Biomass-to-Electricity Systems ($10,000,000); and
||Demonstration and Evaluation of Environmentally and Economically Sustainable Food Waste Biomass-to-Electricity Systems ($8,000,000).
Of the 57 abstracts submitted, 28 passed Phase 1 screening. All of the 23 proposals received during Phase 2 passed the administrative screening process. CEC published the recommended funding and score for each of the 23 proposed projects. The funding recommendations will be approved during the Energy Commission Business meeting, at which time the Energy Commission can add, remove, or shift funding to make additional awards and negotiate with applicants to modify the project scope, schedule, or funding level.
On March 13, 2017, the South Dakota Farmers Union announced that the National Farmers Union had passed a resolution calling for the U.S. Environmental Protection Agency (EPA) to open the market to higher blends of ethanol during its annual meeting in San Diego. The resolution, which was brought forward by the South Dakota Farmers Union delegation, promotes the use of higher blended fuels, such as E30, as a way to expand the retail fuels infrastructure and support the Renewable Fuel Standard (RFS).
In addition to passing the resolution, the National Farmers Union filed legal comments regarding EPA’s overreach in its interpretation of the Clean Air Act (CAA), which limits ethanol content to 15 percent. Doug Sombke, President of South Dakota Farmers Union, called on EPA and all government regulators to reverse statements and policies that unfairly limit the amount of ethanol in fuel and stated that both the state and national organization continue to seek greater market access for higher blended fuels.
On February 21, 2017, USDA announced in the Federal Register that the comment period for the Designation of Product Categories for Federal Procurement proposed rule had been extended. The proposed rule aims to amend the Guidelines for Designating Biobased Products for Federal Procurement to add 12 product categories composed of intermediate ingredient and feedstock materials and to propose a minimum biobased content for each category. In addition to the product categories and biobased content, USDA is seeking comments on appropriate performance standards for each product category, the positive environmental and human health attributes of biobased products within the proposed categories, and how small businesses may be affected by the proposed rule. Comments are now due by April 13, 2017.
On February 9, 2017, Illinois State Senators Andy Manar and Chapin Rose introduced legislation aimed at growing Illinois’ biobased economy by providing incentives under the Renewable Chemical Production Tax Credit Program Act. The program would provide credit against taxes for eligible Illinois businesses that produce renewable chemicals within the state using biomass feedstock and other renewable sources. The legislation defines a renewable chemical as a building block with a biobased content of at least 50 percent. According to the legislation, eligible businesses will be required to submit to the Department of Commerce and Economic Opportunity an application for the tax credit that includes the amount of renewable chemical produced during the calendar year and any other information needed to verify eligibility as identified by the Department. The proposed tax credit will not exceed $1 million for businesses that have been in operation in Illinois for five years or less, and $500,000 for businesses that have been in operation longer than five years.
Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Charles M. Auer, Senior Regulatory and Policy Advisor with B&C, have published “An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders,” in Industrial Biotechnology. This article discusses how the “New [Toxic Substances Control Act (TSCA)] fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of changes, the careful balancing of countless competing needs and interests, and artful drafting yield a statute that has been greatly strengthened and addresses virtually all of the deficiencies that have impeded TSCA's effectiveness over the years. The changes are consequential, and stakeholders in the industrial biotechnology community could be greatly impacted by them, depending upon how EPA interprets and discharges its new authorities. This article highlights key changes of which stakeholders should be aware, sets forth the law's schedule by which EPA is to implement the changes, and identifies opportunities for stakeholders to engage in rulemaking or other activities to help influence the implementation process to ensure that it is firmly rooted in a clear understanding of the science, and of the risks and benefits offered by products of industrial biotechnology.”
On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology.
The New York State Clean Heating Fuel Tax Credit has been extended through 2020. The personal income tax credit, which was initially authorized in 2006, is provided to eligible taxpayers for biodiesel purchases used for residential space and water heating. For each percent of biodiesel blended with conventional home heating oil, a tax credit of $0.01/gallon is available up to a maximum of $0.20/gallon. A partial credit will be calculated for buildings with a shared oil storage tank for residential and non-residential space that is based on the percentage of residential square footage. A refund will be provided to taxpayers whose allowable credit exceeds their liability for that year.
On December 22, 2016, the California Department of Toxic Substances Control (DTSC) announced that the public comment period for the draft Alternatives Analysis (AA) Guide for the Safer Consumer Products (SCP) program has been extended to February 3, 2017. The guide, which was released on December 19, 2016, aims to help relevant stakeholders navigate all phases of the SCP AA process and provide useful approaches, methods, resources, tools and examples of how to fulfill SCP's regulatory requirements. The draft AA Guide is available through the Safer Consumer Products Information Management System (CalSAFER). The SCP program aims to reduce toxic chemicals in consumer products using a four step process that identifies specific products that contain potentially harmful chemicals and asks manufacturers to assess whether the chemical is necessary and whether a safer alternative can be used.
By Lynn L. Bergeson and Carla N. Hutton
On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:
- Graphics that illustrate agency-specific overviews of regulatory roles;
- Case studies that demonstrate how a product developer might navigate the regulatory framework; and
- A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.
In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.” EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities. In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products. When completed, the agencies will consider the study’s findings, as well as the comments. More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology.