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.
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.
On November 16, 2016, the White House filed the Mid-Century Strategy for Deep Decarbonization with the United Nations Framework Convention on Climate Change under the Paris climate deal. The strategy highlights the role that U.S. government-funded research, development, and demonstration (RD&D) had on the technological advances of the last century, and the potential to increase the pace and reduce the costs of decarbonization using the full power of U.S. RD&D efforts focused on clean energy technologies.
The strategy states that potentially high impact technologies in early stages of development or commercial deployment, such as carbon capture, utilization, and storage (CCUS), advanced nuclear, and second generation biofuels, can benefit from support programs that drive cost reductions through learning and economies-of-scale. The strategy also states that the cost of decarbonization can likely be lowered by public and private RD&D that covers a wide range of technologies as it is unclear how the technologies will progress over time.
Regarding biofuels, the strategy identified opportunities for RD&D investments to:
|Reduce biofuel production costs;
|Improve production efficiency;
|Develop “drop-in” fuels that require no changes to existing fuel infrastructure;
|Co-optimize engines with low-carbon fuel to maximize performance and greenhouse gas reductions; and
||Ensure biomass production and use methods are carbon beneficial.
On June 15, 2016, H.R. 5489, Agriculture Environmental Stewardship Act of 2016, was introduced to the House Ways and Means Committee on Science, Space, and Technology. The bill would add additional biogas applications to the list of technologies that qualify for the federal Section 45 energy investment tax credit, increasing acceptable biogas technologies from only biogas-based electricity projects to "qualified biogas property" defined as:
property comprising a system which--
(i) uses anaerobic digesters, or other biological, chemical, thermal, or mechanical processes (alone or in combination), to convert biomass (as defined in section 45K(c)(3)) into a gas which consists of not less than 52 percent methane, and
(ii) captures such gas for use as a fuel.
Qualified biogas properties, as well as qualified manure resource recovery properties, will be eligible for a 30 percent tax credit under this bill. H.R. 5489 was introduced with bipartisan support by Representatives Tom Reed (R-NY) and Ron Kind (D-WI), and signed by 12 other House members. A similar bill is expected to be introduced in the Senate,
On May 24, 2016, the U.S. House of Representatives passed H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the long-awaited Toxic Substances Control Act (TSCA) Reform. Senate approval is expected, with the bill being signed into law soon after. The current, and likely final, version of the bill does not contain the sustainable chemistry provision in Section 27 entitled "Development and Evaluation of Test Methods and Sustainable Chemistry" that was in earlier versions of the bill. This provision would have provided funding, research, and support of green chemistry issues through the Office of Science and Technology Policy (OSTP). Renewable chemicals will face the same changes as traditional chemicals, which are covered in detail on Bergeson & Campbell, P.C.'s (B&C®) TSCA Reform News & Information web page.
Chemical Watch is presenting a free webinar on the regulatory changes resulting from TSCA Reform, entitled "'The New TSCA' - What You Need to Know." B&C's Lynn L. Bergeson is participating on the expert panel, along with James V. Aidala, B&C, Charles M. Auer from Charles Auer & Associates LLC, and Richard A. Denison from the Environmental Defense Fund. The webinar will take place on June 13, 2016, at 11:00 a.m. (EDT), 8:00 a.m. (PDT), and 4:00 p.m. (BST)..
On February 18, 2016, at the Advanced Bioeconomy Leadership Conference 2016 (ABLC2016), Dr. Catherine Woteki, Chief Scientist and Undersecretary for Research, Education, and Economics at the U.S. Department of Agriculture (USDA), announced the release of the Federal Activities Report on the Bioeconomy. The report was created to share current federal agency activities that help to develop and support the bioeconomy. The report first introduces the importance of fostering the bioeconomy and the purpose of the Biomass Research & Development Board. From there the report covers all research, loan, and other projects that federal agencies are currently engaged in. The agencies covered in this report are:
- The U.S. Department of Energy (DOE);
- The U.S. Environmental Protection Agency (EPA);
- The U.S. Department of the Interior (DOI);
- The National Science Foundation (NSF);
- The U.S. Department of Defense (DOD);
- The U.S. Department of Transportation (DOT); and
- The Executive Office of the President of the United States.
On December 14, 2015, the U.S. Environmental Protection Agency (EPA) published the Renewable Fuel Standard (RFS) Program: Standards for 2014, 2015, and 2016 and Biomass-Based Diesel Volume for 2017 in the Federal Register. The final rule will become effective on February 12, 2016, and establishes annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel for motor vehicle gasoline and diesel produced or imported in the years 2014, 2015, and 2016 and biomass-based diesel for 2017. More information regarding the RFS final rule is available in the Biobased and Renewable Products Advocacy Group's (BRAG®) article EPA Releases Final Renewable Fuel Standard Rule.
On October 8, 2015, the U.S. Department of Energy's (DOE) Office of Energy Efficiency & Renewable Energy announced the upcoming Bioproducts in the Federal Bioeconomy Portfolio Webinar. Bioenergy Technologies Office Technology Manager Nichole Fitzgerald, U.S. Department of Agriculture (USDA) BioPreferred Deputy Program Manager Kate Lewis, and the Ohio State University Bioproducts Innovation Center's Director Dennis Hall will discuss how the federal government supports bioproducts research, commercialization, and market development as part of the expansion of the U.S. bioeconomy. The webinar is scheduled for October 26, 2015, from 1:00 p.m. to 2:00 p.m. (EDT), and registration is available online.
On September 25, 2015, EPA published Recommendations for Specifications, Environmental Performance Standards, and Ecolabels for Federal Procurement. The notice describes EPA's recommendations for federal agencies that are purchasing environmentally-friendly products. Section 3(i) of Executive Order 13693, Planning for Federal Sustainability in the Next Decade, directs federal agencies to adhere to certain environmental performance and sustainability standards when practicable. The new EPA recommendations list acceptable environmentally sustainable product brands and service providers that require a procurement preference, including EPA's voluntary program Energy Star®, the U.S. Department of Agriculture's (USDA) Certified Biobased label BioPreferred®, and EPA designated recycled content products, among others.
In the October 30, 2014, Federal Register, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued a notice of request for public comments regarding an extension of a previously approved information collection requirement regarding Biobased Procurements. The original notice was published in the Federal Register on August 20, 2014, and no comments were received. Comments are now due on December 1, 2014.
As summarized by the notice, the "Federal Acquisition Regulation clause 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts, requires prime contractors to report annually the product types and dollar values of U.S. Department of Agriculture (USDA)-designated biobased products purchased to the System for Award Management (SAM) Web site. The information reported by prime contractors enables Federal agencies to report annually to the Office of Federal Procurement Policy (OFPP) concerning actions taken to implement and measure progress in carrying out the preference for biobased products required under section 9002 of the Farm Security and Rural Investment Act of 2002, codified at 7 U.S.C. 8102."