Federal Agencies Announce Investments and Resources to Advance National Biotechnology and Biomanufacturing Initiative

As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact sheet on the summit, federal departments and agencies, with funding of more than $2 billion, will take the following actions:

  • Leverage biotechnology for strengthened supply chains: The Department of Health and Human Services (DHHS) will invest $40 million to expand the role of biomanufacturing for active pharmaceutical ingredients (API), antibiotics, and the key starting materials needed to produce essential medications and respond to pandemics. The Department of Defense (DOD) is launching the Tri-Service Biotechnology for a Resilient Supply Chain program with a more than $270 million investment over five years to turn research into products more quickly and to support the advanced development of biobased materials for defense supply chains, such as fuels, fire-resistant composites, polymers and resins, and protective materials. Through the Sustainable Aviation Fuel Grand Challenge, the Department of Energy (DOE) will work with the Department of Transportation and the U.S. Department of Agriculture (USDA) to leverage the estimated one billion tons of sustainable biomass and waste resources in the United States to provide domestic supply chains for fuels, chemicals, and materials.
  • Expand domestic biomanufacturing: DOD will invest $1 billion in bioindustrial domestic manufacturing infrastructure over five years to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators. According to the fact sheet, this support will provide incentives for private- and public-sector partners to expand manufacturing capacity for products important to both commercial and defense supply chains, such as critical chemicals.
  • Foster innovation across the United States: The National Science Foundation (NSF) recently announced a competition to fund Regional Innovation Engines that will support key areas of national interest and economic promise, including biotechnology and biomanufacturing topics such as manufacturing life-saving medicines, reducing waste, and mitigating climate change. In May 2022, USDA announced $32 million for wood innovation and community wood grants, leveraging an additional $93 million in partner funds to develop new wood products and enable effective use of U.S. forest resources. DOE also plans to announce new awards of approximately $178 million to advance innovative research efforts in biotechnology, bioproducts, and biomaterials. In addition, the U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge will invest more than $200 million to strengthen America’s bioeconomy by advancing regional biotechnology and biomanufacturing programs.
  • Bring bioproducts to market: DOE will provide up to $100 million for research and development (R&D) for conversion of biomass to fuels and chemicals, including R&D for improved production and recycling of biobased plastics. DOE will also double efforts, adding an additional $60 million, to de-risk the scale-up of biotechnology and biomanufacturing that will lead to commercialization of biorefineries that produce renewable chemicals and fuels that significantly reduce greenhouse gas emissions from transportation, industry, and agriculture. The new $10 million Bioproduct Pilot Program will support scale-up activities and studies on the benefits of biobased products. Manufacturing USA institutes BioFabUSA and BioMADE (launched by DOD) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) (launched by the Department of Commerce (DOC)) will expand their industry partnerships to enable commercialization across regenerative medicine, industrial biomanufacturing, and biopharmaceuticals.
  • Train the next generation of biotechnologists: The National Institutes of Health (NIH) is expanding the Innovation Corps (I-Corps™), a biotech entrepreneurship bootcamp. NIIMBL will continue to offer a summer immersion program, the NIIMBL eXperience, in partnership with the National Society for Black Engineers, which connects underrepresented students with biopharmaceutical companies, and support pathways to careers in biotechnology. In March 2022, USDA announced $68 million through the Agriculture and Food Research Initiative to train the next generation of research and education professionals.
  • Drive regulatory innovation to increase access to products of biotechnology: The Food and Drug Administration (FDA) is spearheading efforts to support advanced manufacturing through regulatory science, technical guidance, and increased engagement with industry seeking to leverage these emerging technologies. For agricultural biotechnologies, USDA is building new regulatory processes to promote safe innovation in agriculture and alternative foods, allowing USDA to review more diverse products.
  • Advance measurements and standards for the bioeconomy: DOC plans to invest an additional $14 million next year at the National Institute of Standards and Technology for biotechnology research programs to develop measurement technologies, standards, and data for the U.S. bioeconomy.
  • Reduce risk through investing in biosecurity innovations: DOE’s National Nuclear Security Administration plans to initiate a new $20 million bioassurance program that will advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks, and will integrate biosecurity into biotechnology development.
  • Facilitate data sharing to advance the bioeconomy: Through the Cancer Moonshot, NIH is expanding the Cancer Research Data Ecosystem, a national data infrastructure that encourages data sharing to support cancer care for individual patients and enables discovery of new treatments. USDA is working with NIH to ensure that data on persistent poverty can be integrated with cancer surveillance. NSF recently announced a competition for a new $20 million biosciences data center to increase our understanding of living systems at small scales, which will produce new biotechnology designs to make products in agriculture, medicine and health, and materials.

A recording of the White House summit is available online.

©2022 Bergeson & Campbell, P.C.

ARPA-E: Biden’s Proposed FY 2023 Budget Boosts Investment in Clean Energy Technologies

On March 28, 2022, the Biden-Harris Administration sent the President’s Budget for Fiscal Year (FY) 2023 to the United States Congress (“Congress”). The President’s proposed $5.8 trillion budget for FY 2023 allocates billions of dollars toward combating climate change and boosting clean energy development. Biden’s budget requests $48.2 billion for the Department of Energy (“DOE”), with $700 million of those funds allocated to the DOE’s Advanced Research Projects Agency-Energy program (“ARPA-E”).[1] With these increased funds, the Biden administration plans for ARPA-E to expand its scope beyond energy technology–focused projects to include climate adaptation and resilience innovations.[2]

What Is ARPA-E?

ARPA-E is a United States federal government agency under the purview of the Department of Energy that funds and promotes the research and development of advanced energy technologies. ARPA-E was recommended to Congress in the 2005 National Academies report Rising Above the Gathering Storm: Energizing and Employing America for a Bright Economic Future, which published recommendations for federal government actions to maintain and expand U.S. competitiveness.[3] In 2007, ARPA-E was officially created after Congress implemented a number of the report’s recommendations by enacting the America COMPETES Act.[4] The 2007 Act was superseded by the America COMPETES Reauthorization Act of 2010, which incorporated much of the original language of the 2007 Act but made some modifications to ARPA-E structure.[5] In 2009, ARPA-E officially commenced operations after receiving its first appropriated funds through the American Recovery and Reinvestment Act of 2009 —$400 million to fund the establishment of ARPA-E.[6]

ARPA-E’s mission is statutorily defined as overcoming “the long-term and high-risk technology barriers in the development of energy technologies.”[7] This involves the development of energy technologies that will achieve various goals, including the reduction of fossil fuel imports, the reduction of energy-related emissions, improvements in energy efficiency, and increased resilience and security of energy infrastructure.[8] The statute directs ARPA-E to pursue these objectives through particular means:

  1. Identifying and promoting revolutionary advances in fundamental and applied sciences;
  2. Translating scientific discoveries and cutting-edge inventions into technological innovations; and
  3. Accelerating transformational technological advances in areas industry is unlikely to undertake because of technical and financial uncertainty.[9]

The Impact of ARPA-E

Since 2009, ARPA-E has provided approximately $3 billion in R&D funding for over 1,294 potentially transformational energy technology projects.[10] Publishing annual reports to analyze and catalog its influence, the agency tracks commercial impact with key early indicators, including private-sector follow-on funding, new company formation, partnership with other government agencies, publications, inventions, and patents.[11]

Many ARPA-E project teams have continued to advance their technologies: 129 new companies have been formed, 285 licenses have been issued, 268 teams have partnered with another government agency, and 185 teams have together raised over $9.87 billion in private-sector follow-on funding.[12] In addition, ARPA-E projects fostered technological innovation and advanced scientific knowledge, as evidenced by the 5,497 peer-reviewed journal articles and 829 patents issued by the U.S. Patent and Trademark Office that sprung from the ARPA-E program.[13] ARPA-E recently announced that it is starting to count exits through public listings, mergers, and acquisitions. As of January 2022, ARPA-E has 20 exits with a total reported value of $21.6 billion.[14]

How Does Biden’s FY 2023 Budget Affect ARPA-E?

Biden has requested a 56% increase for ARPA-E, to $700 million.[15] The budget also proposes expansions of ARPA-E’s purview to more fully address innovation gaps around adaptation, mitigation, and resilience to the impacts of climate change.[16] This investment in research and development of high-potential and high-impact technologies aims to help remove technological barriers to advance energy and environmental missions.[17]

The request provides that ARPA-E shall also expand its scope “to invest in climate-related innovations necessary to achieve net zero climate-inducing emissions by 2050.”[18] Given the increasing bipartisan support for alternative energy funding and ARPA-E’s continuing and rising commercial impact, it is likely that ARPA-E’s funding and support of the research and development of early-stage energy technologies will continue to pave the way for the commercialization of advanced energy technologies.


Endnotes

  1. https://www.law360.com/articles/1478133/biden-budget-provides-billions-for-clean-energy
  2. https://www.energy.gov/articles/statement-energy-secretary-granholm-president-bidens-doe-fiscal-year-2023-budget
  3. https://doi.org/10.17226/24778
  4. Id. at 22
  5. Id.
  6. Id.
  7. 42 U.S.C. § 16538(b)
  8. 42 U.S.C. § 16538(c)(1)(A)
  9. 42 U.S.C. § 16538(c)(2)
  10. https://arpa-e.energy.gov/about/our-impact
  11. Id.
  12. Id.
  13. Id.
  14. Id.
  15. https://www.science.org/content/article/biden-s-2023-budget-request-science-aims-high-again
  16. https://www.whitehouse.gov/wp-content/uploads/2022/03/budget_fy2023.pdf
  17. Id.
  18. https://www.science.org/content/article/biden-s-2023-budget-request-science-aims-high-again
©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Guarding the Grid: DOE Releases 100-Day Cybersecurity Pilot Program

The February 2021 hack into Oldsmar, Florida’s water treatment system is a frightening reminder that critical infrastructure systems can be vulnerable to cyberattacks and that cyberattacks can jeopardize health and safety. In this case, the hack may have spurred government action. On Tuesday, the Biden administration announced a 100-day plan “to advance technologies and systems that will provide cyber visibility, detection, and response capabilities for industrial control of electric utilities.”

In a coordinated effort among the Department of Energy (“DOE”), the Cybersecurity and Infrastructure Security Agency (“CISA”), and the electricity industry, the plan lays out four areas of focus for the next 100 days: (1) enhancement of mechanisms for detection, mitigation, and forensic activities; (2) “concrete milestones” for the industry to develop “situational awareness and response capabilities in critical industrial control systems (ICS) and operational technology networks (OT)”; (3) reinforcement of overall cybersecurity in critical infrastructure information technology networks; and (4) voluntary industry participation programs “to deploy technologies to increase the visibility of threats in ICS and OT systems.”

The plan’s success likely hinges on the government’s ability to develop sustainable, cooperative relationships with the relevant industries. “Public-private partnership is paramount to the Administration’s efforts,” said National Security Council (“NSC”) Spokesperson Emily Horne in response to Tuesday’s announcement, “because protecting our Nation’s critical infrastructure is a shared responsibility of government and the owners and operators of that infrastructure.” It appears that similar plans are being developed for additional critical infrastructure industries, including water, the chemical sector, and natural gas.

The previous administration responded to the escalating threat of cyberattacks from foreign adversaries[1] in part with Executive Order 13920, which declared a national emergency with regard to electric grid security and gave the Secretary of Energy the authority to prohibit certain transactions involving electric equipment potentially controlled by a foreign adversary. Relying on EO 13920, the DOE issued a Prohibition Order in December 2020 barring “Critical Defense Facilities” and any supporting facilities from purchasing or installing electricity generation equipment manufactured in China (“December Prohibition Order”).

On January 20, 2021, President Biden’s DOE issued a 90-day suspension of EO 13920 and the December Prohibition Order to allow the DOE and the Office of Management and Budget to consider methods of “protect[ing] against high-risk electric equipment transactions by foreign adversaries while providing additional certainty to the utility industry and the public.” Tuesday’s announcement from the DOE revoked the December Prohibition Order, effective immediately, but EO 13920 will remain in place until it expires on May 1, 2021.

The DOE has now opted to revoke the December Prohibition Order in an effort to “create a stable policy environment” while the DOE further develops its cybersecurity strategy for the electricity sector. However, utilities are still encouraged to “act in a way that minimizes the risk of installing electric equipment and programmable components that are subject to foreign adversaries’ ownership, control, or influence” while the DOE develops further recommendations.

To assist in cybersecurity strategy development, along with the DOE’s 100-day plan announcement, the DOE issued a Request for Information (“RFI”) “focused on preventing exploitation and attacks by foreign threats to the U.S. supply chain.” Interested parties are encouraged to submit input to the DOE by June 7, 2021 regarding the development of “a long-term strategy that includes technical assistance needs, supply chain risk management, procurement best practices, and risk mitigation criteria” as well as the “depth and breadth of a future prohibition authority.” Instructions for submitting comments can be found on the DOE’s website.

The DOE is still hammering out many details of the 100-day plan, and some details may never be released to the public – expansions of DOE’s Cyber Testing for Resilient Industrial Control Systems program, for example, will be classified to avoid oversharing with foreign intelligence. While the DOE works to develop its 100-day plan, utilities should evaluate cybersecurity infrastructure within their own systems. For example, utilities could make renewed efforts to take inventory of software and hardware used across any systems touching critical infrastructure, and ensure that all technology is secure and up to date. If defense, detection, and prevention systems do not meet the DOE’s suggested standards, a utility could consider implementing additional measures or strengthening current systems now.

Additionally, a utility could consider whether and how its organization might participate in an information-sharing program. Any thoughts regarding guardrails and disclosure limitations for such a program could be submitted as comments to the RFI. Also, a utility could consider how its current approach to communicating with internal and external stakeholders about cyber issues might impact participation in information sharing.


[1] The new 100-day plan comes not only in the wake of the Oldsmar water system hack but also just days after the administration announced sanctions against Russia for its role in the Solar Winds hack.

© 2021 Bracewell LLP

For more articles on cybersecurity, visit the NLR Communications, Media & Internet section.

BRAG Biobased Products Blog

USDA Requests Input On HBIIP

On January 16, 2020, the U.S. Department of Agriculture (USDA) announced the issuance of a Request for Information (RFI) to assist with the creation of its new program called Higher Blends Infrastructure Incentive Program (HBIIP). A USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. Requesting feedback from all interested parties, this RFI solicits information on options for fuel ethanol and biodiesel infrastructure, innovation, products, technology, and data derived from all HBIIP processes and/or science that drive economic growth, promote health, and increase public benefit. With an approaching deadline for comment submissions by January 30, 2020, thus far, only three parties have submitted comments to USDA.

DOE Announces Launch Of The 2020 Tibbetts Awards Program

On January 21, 2020, the U.S. Department of Energy’s (DOE) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Programs Office announced the launch of the U.S. Small Business Administration’s (SBA) Tibbetts Awards. The Tibbetts Awards recognize companies, organizations, and individuals exemplifying the best of the best in the SBIR and STTR programs. Named after the founder of the SBIR program, Roland Tibbetts, the awards also help DOE to document the economic, technical, and societal benefits from SBIR/STTR funding. Nominees can consist of an individual, a company, or an organization that promotes the mission and goals of the SBIR/STTR programs. The mission and goals include:

  • Stimulation of technological innovation;
  • Work with small businesses to meet federal development needs;
  • Encouragement of diverse participation in innovation and entrepreneurship;
  • Increase of private sector commercialization of innovations derived research and development (R&D); and
  • Foster technology transfer through cooperative R&D between small businesses and research institutions.

Nominations are open through February 21, 2020, and can be submitted via this website.

EU Funds Project To Develop Biobased Ropes For Aquaculture

On January 17, 2020, the European Union (EU) announced a new innovative project called BIOGEARS that will be funded under the European Maritime and Fisheries Fund (EMFF). The project focuses on the development of biobased gear solutions for the creation of an eco-friendly offshore aquaculture sector using a multitrophic approach and new biobased value chains. With the aim to address the gap of biobased ropes for offshore aquaculture, which is currently manufactured with 100 percent non-recyclable plastics, BIOGEARS will create a biobased value chain under the EU Bioeconomy Strategy framework. The European Bioeconomy Strategy aims to accelerate the deployment of a sustainable and circular European bioeconomy to maximize its contribution towards the 2030 Agenda and its Sustainable Development Goals (SDG), as well as the Paris Agreement. With the goal of increasing aquaculture marketable products, BIOGEARS uses an Integrated Multi-Trophic Aquaculture (IMTA) approach by integrating seaweed with mussel production. The BIOGEARS project’s intention is to develop biobased ropes that are tough, durable, and fit-for-purpose while still able to biodegrade in shorter time and managed by local composting facilities.

As part of the project, all project partners will participate in a BLUE LAB to enhance cooperation and enable tracking of innovation of the new biobased materials developed. Project coordinator, Leire Arantzamendi, expressed her hopes of boosting more eco-friendly mussel and seaweed production stating that BIOGEARS “will generate three rope prototypes with a highly reduced carbon footprint along the value chain.” The project will focus on the Atlantic Basin.


©2020 Bergeson & Campbell, P.C.

For more developments in the Biotech sphere, see the National Law Review Biotech, Food & Drug law section.

U.S. Department of Energy Withdraws Expanded General Service Lamp Definition and Refuses to Impose Backstop Efficiency Standard

On September 5, 2019, the U.S. Department of Energy (DOE) published a final rule and proposed rule regarding general service lamps and general service incandescent lamps with far-reaching implications for lamp manufacturers and retailers. DOE is withdrawing the Obama Administration’s revised definitions of general service lamps and general service incandescent lamps, which would have imposed federal efficiency standards on a wide array of lamps. DOE also asserts in the new rule that it has not triggered a statutory “backstop” efficiency standard, which would have prohibited the sale of all non-compliant lamps beginning January 1, 2020. In a separate proposed rule, DOE has initially determined that energy conservation standards for general service incandescent lamps are not justified. DOE’s decisions, which stall what was to be an accelerated transition away from incandescents and toward LEDs, will likely prompt a legal challenge by consumer and environmental groups, as well as a number of states and other interested stakeholders.

Background

As defined by Congress in the Energy Policy and Conservation Act of 1975 (EPCA), general service incandescent lamps (GSILs) are any “standard incandescent or halogen type lamp . . . intended for general service applications,” that “has a medium screw base,” that fits within statutorily defined lumen and operating voltage ranges, and that is not one of twenty-two exempted lamp types. General service lamps (GSLs), in turn, are GSILs or “any other lamps that the Secretary [of Energy] determines are used to satisfy lighting applications traditionally served by general service incandescent lamps.” With the Energy Independence and Security Act of 2007 (EISA), Congress directed DOE to initiate rulemaking procedures to determine whether efficiency standards for GSLs should be amended to be “more stringent” than those that currently apply to fluorescent lamps and incandescent reflector lamps and whether existing exemptions for “certain incandescent lamps should be maintained or discontinued.”

The EISA sought to prod DOE into moving quickly to establish GSL/GSIL efficiency standards. First, Congress provided that if DOE “determines that the standards in effect for general service incandescent lamps should be amended, the Secretary shall publish a final rule not later than” January 1, 2017. Second, Congress included a “backstop” measure: if the Secretary of Energy “fails to complete a rulemaking” as directed, “the Secretary shall prohibit the sale of any general service lamp that does not meet a minimum efficacy standard of 45 lumens per watt,” effective January 1, 2020. The 45-lumen standard is generally understood to be unachievable for many incandescents, and would, therefore, hasten an ongoing transition to LED lamps. The backstop standard is also unusual to the extent that it would apply as a prohibition on sale, while most other appliance and equipment standards enforced by DOE apply to import and manufacture, rather than sale. As a result, the backstop not only impacts lamp manufacturers, but also the retailers who market such lamps.

The Obama Administration in January 2017 promulgated final rules revising the GSL and GSIL definitions to no longer exempt five categories of specialty incandescent lamps (rough service lamps, shatter-resistant lamps, 3-way incandescent lamps, high lumen incandescent lamps, and vibration service lamps), incandescent reflector lamps, or a variety of decorative lamps (T-Shape, B, BA, CA, F, G16-1/2, G25, G30, S, M-14, and candelabra base lamps). Effective January 1, 2020, these lamp categories would be subject to the relevant efficiency standards. The Obama Administration, however, did not initiate rulemaking with regard to the efficiency standards themselves because an appropriations rider prevented it from doing so.

The Trump Administration’s recent move withdraws these revised definitions to maintain the current efficiency regulatory scheme. Without deciding whether or not to amend the efficiency standards themselves, DOE’s new rule prevents those standards from applying to the specialty, decorative, and reflector lamps identified under the earlier rule. Some commenters argue that the new rule violates the EPCA’s “anti-backsliding” provision, while DOE asserts that the provision applies only to efficiency standards and not to the categories to which those standards apply.

Regulatory Uncertainty Regarding “Backstop” Standards

With the new rule, DOE concludes that the backstop will not take effect on January 1 and so will not prohibit the sale of GSLs not meeting the 45 lumens per watt standard. DOE agreed with electrical and lighting trade associations and manufacturers that the backstop would only be triggered if DOE had actually determined to maintain, amend, or eliminate GSL and GSIL efficiency standards but failed to do so, whereas to date, DOE had determined only to maintain the currently effective list of exemptions from the GSL and GSIL definitions. Additionally, DOE states that the backstop is not self-executing but rather requires the Secretary to take action to prohibit the sale of less efficient lamps. DOE asserts that this interpretation of the backstop provision prevents the Secretary of Energy from having to enforce a more stringent efficiency standard that he has not yet determined to be necessary or unnecessary.

A variety of environmental commenters, utility companies, and state attorneys general disagree with DOE’s reading and argue that, without further action, the backstop provision will indeed be triggered on January 1, 2020, because DOE has “fail[ed] to complete” the congressionally directed rulemaking to determine the need for amended efficiency standards. These commenters argue that the backstop is self-executing and requires no further DOE action to go into effect.

Preemption

In recent years, states have begun to enact their own lamp efficiency standards in line with the Obama Administration’s proposal and Congress’ “backstop” standard, in part out of concern that DOE might seek to delay or reverse the federal standard. More states are likely to do so in light of DOE’s latest move, creating the possibility that lamp manufacturers, importers, and retailers will have to navigate a patchwork of state regulations. Such state regulations will likely be subject to litigation, as DOE asserts that even though it has not yet promulgated an efficiency standard, state standards for covered products are preempted.

Next Steps

DOE’s withdrawal of the revised GSL/GSIL definitions or its interpretation of the backstop provision has not yet prompted a legal challenge. Some environmental advocates, however, have raised the possibility of bringing suit to force implementation of the lamp efficiency standards.

 


© 2019 Beveridge & Diamond PC

ARTICLE BY Daniel A. Eisenberg and Jack Zietman of Beveridge & Diamond PC.

Department of Education Unveils Proposed Title IX Regulations

On Friday, November 16, 2018, the Department of Education (DOE) released proposed Title IX regulations dictating the process by which colleges and universities must handle allegations of sexual misconduct.

Institutions of higher education have been in limbo since September 2017 when the DOE rescinded Obama-era guidance that called for hard-hitting enforcement of Title IX and issued interim guidance as a placeholder until they could engage in the formal rulemaking process. Today’s proposed regulations, if enacted, will take the place of the DOE’s September 2017 interim guidance.  According to the DOE, the new regulations would substantially decrease the number of investigations into complaints of sexual misconduct and save institutions millions over the next decade.

Many of the new regulations deviate significantly from prior guidance. The most significant changes increase the discretion given to universities in crafting procedures for adjudicating Title IX claims within their institutions.  The proposed guidance allows universities to choose the applicable evidentiary standard (either “preponderance of the evidence” or “clear and convincing evidence”) in determining responsibility, as long as it is consistent with the standard used in other student disciplinary matters.  The new regulations also permit the use of informal resolution processes to resolve sexual misconduct allegations if the parties agree.

Other notable provisions of the proposed regulations include the following:

  • The definition of “sexual harassment” has been more narrowly defined as “unwelcome conduct on the basis of sex that is so severe, pervasive and objectively offensive that it denies a person access to the school’s education program or activity.”
  • For purposes of administrative enforcement, universities would be held to a “deliberately indifferent” standard. In other words, to avoid liability, a university with “actual knowledge” of sexual harassment need only respond in a manner that is not “deliberately indifferent.” An institution would be found deliberately indifferent “only if its response to sexual harassment is clearly unreasonable in light of the known circumstances.”
  • “Actual knowledge” is defined in the proposed regulations as notice of sexual harassment or allegations of sexual harassment provided to an official of the institution “who has the authority to institute corrective measures on behalf of the [institution].” In contrast to prior guidance, this definition excludes most professors, administrators, and staff.
  • Under the proposed regulations, universities would no longer be allowed to investigate allegations of sexual harassment that occurred off-campus.
  • The proposed regulations would require universities to provide written notice to a respondent upon receipt of a complaint, which would include a statement that the responding party is presumed to be not responsible for the alleged conduct and that a determination of responsibility will be made at the end of the grievance process.
  • Live fact-finding hearings would be mandatory for universities under the new regulations. Investigators would also be precluded from serving as factfinders.  This would eliminate the use of the single investigator model currently used by many universities.
  • Universities must permit cross-examination of any party or witness by the opposing party’s advisor, but not by the party him/herself.  If a party or witness refuses to submit to cross-examination, that person’s testimony could not be relied on by the fact-finder. The party’s choice of advisor could not be limited by the institution of higher education.
  • Religious institutions of higher education would no longer be required to seek assurances of exemption from Title IX regulations in advance of a DOE investigation. Under the new regulations, a religious institution of higher education could invoke an exemption to Title IX’s requirements at any time during the investigation.

The new regulations address other topics such as constitutional issues and the intersection between Title IX and Title VII of the Civil Rights Act. They also clarify that, just as an institution’s treatment of a complaining party may constitute discrimination based on sex, an institution’s treatment of the responding party may also constitute discrimination based on sex. Institutions of higher education must continue to comply with all applicable state laws regarding sexual misconduct and sexual misconduct investigations.

Now that the proposed regulations have been published, the public has sixty days to submit comments before the regulations go into effect. The final regulations, however, are likely to closely mirror what has been proposed today, and colleges and universities should act immediately to carefully review their sexual misconduct policies and practices for compliance.

 

Jackson Lewis P.C. © 2018
This post was written by Susan D. Friedfel, Monica H. Khetarpal Marla N. Presley Crystal L. Tyler and Hobart J. Webster.

DOE Announces $8.8 Million In Funding For Algae Technology Innovation Projects

On September 8, 2017, the U.S. Department of Energy (DOE) selected an additional four Productivity Enhanced Algae and Toolkits (PEAK) projects to receive up to $8.8 million.  The projects aim to develop high-impact tools and techniques that will increase the productivity of algae organisms to reduce the costs of producing algal biofuels and bioproducts.  In total, DOE has awarded over $16 million in funding to the initiative.

The project winners include:

  • Colorado School of Mines, in partnership with Global Algae Innovations, Pacific Northwest National Laboratory, and Colorado State University, which will use advanced directed evolution approaches in combination with high-performance, custom-built, solar simulation bioreactors to improve the productivity of robust wild algal strains;
  • University of California, San Diego, which will work with Triton Health and Nutrition, Algenesis Materials, and Global Algae Innovations on the development of genetic tools, high-throughput screening methods, and breeding strategies for green algae and cyanobacteria, targeting robust production strains;
  • University of Toledo, in partnership with Montana State University and the University of North Carolina, which will cultivate microalgae in high-salinity and high-alkalinity media to achieve productivities without needing to add concentrated carbon dioxide, and deliver molecular toolkits, including metabolic modeling combined with targeted genome editing; and
  • Lawrence Livermore National Laboratory, which will ecologically engineer algae to encourage growth of bacteria that efficiently remineralize dissolved organic matter to improve carbon dioxide uptake and simultaneously remove excess oxygen.
This post was written by  Kathleen M. Roberts of Bergeson & Campbell, P.C. ©2017
For more Environmental & Energy legal analysis go to The National Law Review

DOE Releases $7 Million Funding Opportunity Announcment For Co-Optimization Of Fuels And Engines Initiative

Funding Opportunity Announcement, FOAOn August 1, 2016, DOE released a Funding Opportunity Announcement (FOA) for $7 million to research fuel and engine co-optimization technologies. Funding will be provided through the Co-Optimization of Fuels and Engines (Co-Optima) initiative, a collaboration between DOE’s Bioenergy Technologies Office (BETO) and Vehicle Technologies Office (VTO), bringing together national laboratories and industry to conduct tandem fuel and engine research, development, and deployment assessments. This initiative works to improve near-term conventional spark-ignition engine efficiency and enable full operability of advanced compression ignition engines. Research cycles include identifying fuel candidates, understanding their characteristics, and determining market transformation requirements. This FOA is restricted to U.S. Institutions of Higher Education and nonprofit research institutions operating under U.S. Institutions of Higher Education. Proposals should address one or more of the following sub-topics:

  • Fuel characterization and fuel property prediction;
  • Kinetic measurement and mechanism development;
  • Emissions and environmental impact analysis;
  • Impact of fuel chemistry and fuel properties on particulate emissions;
  • Small-volume, high-throughput fuel testing; and
  • Additional barriers.

Concept papers are due by August 15, 2016, at 5:00 p.m. (EDT), with full applications due on September 18, 2016, at 5:00 p.m. (EDT).

©2016 Bergeson & Campbell, P.C.

Biomass Research And Development Initiative Provides Seven Projects With Up To $10 Million In Funding

On May 9, 2016, the U.S. Department of Energy (DOE), the U.S. Department of Agriculture (USDA), and the National Institute of Food and Agriculture (NIFA) announced the recipients of up to $10 million in funding through the Biomass Research and Development Initiative (BRDI). BRDI is a joint program through DOE and USDA that helps develop sustainable sources of biomass and increase the availability of biobased fuels and products. DOE selected two of the grant winners to receive between $1 million and $2 million: the Ohio State University (OSU) project is “Biomass Gasification for Chemicals Production Using Chemical Looping Techniques,” and the Massachusetts Institute of Technology (MIT) project is “Improving Tolerance of Yeast to Lignocellulose-derived Feedstocks and Products.”

USDA then selected five grant winners to receive a total of $7.3 million in funding:

  • University of California-Riverside, to convert poplar to ethanol and polyurethane via pretreatment and lignin polymer synthesis;

  • University of Montana, to quantify ecological and economic opportunities of various forest types and to quantify benefits of replacing fossil fuel with forest-based bioenergy;

  • North Carolina Biotechnology Center, to optimize production of educational resources on biomass sorghum production in the Mid-Atlantic region;

  • Dartmouth College, to overcome the lignocellulosic recalcitrance barrier; and

  • State University of New York College of Environmental Science and Forestry, to provide life cycle understanding for the production of willow and forest biomass to mitigate investment risk.

©2016 Bergeson & Campbell, P.C.

U.S. DOE Disclaims Jurisdiction over Canadian Gas and Authorizes LNG Exports to Non-FTA Nations from Bear Head LNG Project

On February 5, 2016, the U.S. Department of Energy’s Office of Fossil Energy (“DOE/FE”) issued two orders to Bear Head LNG Corporation and Bear Head LNG (USA), LLC (together, “Bear Head LNG”),1 formally announcing DOE’s comprehensive policy for considering applications involving liquefied natural gas (“LNG”) exports from Eastern Canada to global markets.

  • In Order 3769 (“In-Transit Order”), DOE/FE determined that it lacks jurisdiction under Section 3 of the Natural Gas Act (the “NGA”) over Bear Head LNG’s proposed imports of Canadian natural gas travelling by pipeline through the United States on its way back to Canada (i.e., in‑transit shipments).2  In this regard, DOE/FE dismissed Bear Head LNG’s application seeking authorization to access Western and Central Canadian natural gas supplies that necessarily must cross the U.S.-Canada border (due to transportation pipeline configurations), en route to the proposed Bear Head LNG project.

  • In Order 3770 (the “Non-FTA Order”), DOE/FE granted Bear Head LNG long-term, multi‑contract authorization under Section 3(a) of the NGA to export U.S. natural gas by pipeline to Canada for subsequent liquefaction and export (i.e., re-export) to nations with which the United States does not have a free trade agreement (“FTA”) requiring the national treatment of natural gas (“non-FTA nations”).3

The Bear Head LNG proceedings presented legal issues of first impression4 and “an unusual factual circumstance,”5 as DOE/FE stated.  Certainly, as discussed below, DOE/FE’s legal determinations in the Bear Head LNG proceedings were significant.6  However, the legal significance of the Bear Head LNG Orders is dwarfed by the political implications of DOE/FE’s announced policies of (i) adopting a laissez-faire approach to applications for Canadian gas in-transit through the U.S., and (ii) giving the green light to natural gas exports of U.S. natural gas to Canada for liquefaction and export to non-FTA nations.

The Legal Standard:  FTA or Non-FTA

Specifically, DOE/FE was called upon to determine which of the two legal standards found in Section 3 of the NGA (i.e., FTA or non-FTA) properly applied to Bear Head LNG’s applications filed for the purpose of securing gas supply for the Bear Head LNG project.  For diversity of supply, Bear Head LNG sought authorizations for in-transit shipments of Canadian natural gas, as well as pipeline exports of U.S. natural gas to Canada.  As described in Bear Head LNG’s applications, LNG produced at the project is intended for export to FTA and non-FTA nations.

In addressing this issue, DOE/FE opted to apply the discretionary, non-FTA standard (i.e., the NGA Section 3(a) public interest standard), inasmuch as LNG produced at the Bear Head LNG project is intended for delivery and end-use in non-FTA nations.  DOE/FE reiterated the rationale supporting its determination, previously unveiled in the FTA Order, in the Non-FTA Order.  It explained that its decision is rooted in Congressional intent that all exports destined for non-FTA nations be reviewed for their consistency with the U.S. public interest.  To do otherwise, DOE/FE reasoned, would permit potential exporters to evade the non-FTA public interest analysis simply by transiting natural gas and LNG through an FTA nation.7

Balancing NGA Mandates with U.S. International Trade Obligations

Undoubtedly, Bear Head LNG’s proceedings presented DOE/FE with the challenge of discharging its statutory mandate under the NGA, without violating U.S. obligations under NAFTA or trampling on an already strained U.S.-Canada energy relationship suffering from the highly politicized discord over the Keystone XL Pipeline.8

As a starting point, consider that DOE/FE’s decision to exercise its NGA Section 3(a) jurisdiction in effect extends beyond the U.S.-Canada border (where the export of U.S. natural gas by pipeline will occur) and follows the gas into Canada (where the export of LNG by vessel will occur).  In this regard, the Non-FTA Order arguably is an exercise of extraterritorial jurisdiction by DOE/FE—which is not to say it is impermissible.9  To further complicate matters, prior to DOE/FE’s issuance of the In-Transit Order, there was uncertainty regarding which NGA Section 3 standard DOE/FE would apply to in-transit shipments of Canadian gas, and whether DOE/FE would be consistent in its view of in-transit gas when Canadian gas was in question, as opposed to U.S. gas in transit for delivery to the Bear Head LNG project.10

Then consider that the NEB has authorized (without restriction) the export of Canadian gas intended for liquefaction and export from U.S. West Coast projects.11

With the lawsuits stemming from U.S. decision to reject the Keystone XL Pipeline as a backdrop, and a newly elected Canadian government looking for a fresh start with the Obama Administration, particularly in energy and climate change, DOE/FE’s favorable determinations in the Bear Head LNG proceedings mark a positive step in strengthening ties between the two nations.

The NEPA Challenge

A secondary, but very significant legal issue, arose under the National Environmental Policy Act (“NEPA”), which requires DOE/FE to consider the environmental impacts of its decisions on applications seeking authorization to export natural gas.  In the past, DOE/FE could meet its NEPA obligations as a cooperating agency in the NEPA review process led by the Federal Energy Regulatory Commission (“FERC”) for U.S. LNG terminal facilities.  In the case of the Bear Head LNG project, the environmental and safety review would be conducted by Canadian federal, provincial and local authorities.

At the time Bear Head LNG filed its applications, relevant DOE/FE non-FTA precedent could be summarized in a single bullet:12

  • Applications involving the construction of new, or the modification of existing, LNG facilities subject to FERC jurisdiction:  DOE/FE acts as cooperating agency in the NEPA review process led by FERC.13  DOE/FE then adopts the NEPA documentation prepared by FERC (be it an environmental assessment (“EA”) or environmental impact statement (“EIS”)), provided DOE/FE has conducted an independent review of such NEPA documentation and determined its comments and suggestions have been satisfied.  In those instances that an EA is prepared, DOE/FE issues a finding of no significant impact (“FONSI”).  In other instances that an EIS is prepared, DOE/FE issues a record of decision.

Since then, relevant DOE/FE non-FTA precedent has evolved as follows, culminating with the most recent decisions issued on February 5, 2016:

  • Applications involving existing LNG facilities not subject to FERC jurisdiction: DOE/FE grants categorical exclusion under its regulations at 10 C.F.R. Part 1021, Subpart D, Appendix B5.

  • Application involving the construction of new CNG facilities not subject to FERC jurisdiction: DOE conducts NEPA review process and prepares NEPA documentation.14

  • Applications involving the construction of new LNG facilities in Canada (i.e., not subject to FERC jurisdiction):  DOE/FE grants categorical exclusion in accordance with its regulations at 10 C.F.R. Part 1021, Subpart D, Appendix B5, with authorized export volume in proportion with level of existing U.S. pipeline capacity.15

New Rules for In-Transit Canadian Gas Shipments

DOE/FE dismissed Bear Head LNG’s in-transit application on the grounds that in-transit shipments returning to the country of origin are not “imports” or “exports” within the meaning of NGA Section 3, such that they fall outside of DOE/FE’s NGA Section 3 jurisdiction.  In reaching this conclusion, DOE/FE noted Congress’ likely intention that the terms “import” and “export” apply only to those categories of shipments that, by their nature, could have a material effect on the U.S. public interest.  Shipments of Canadian-sourced natural gas between Canadian points, according to DOE/FE, are “categorically unlikely” to have a material impact on the U.S. public interest and are, therefore, outside of DOE/FE’s NGA Section 3 purview.

In further support of its jurisdictional determination, DOE/FE cited a 1977 agreement, the Agreement Between the Government of the United States of America and the Government of Canada Concerning Transit Pipelines, which espouses a laissez-faire policy for in-transit shipments of hydrocarbons between the two countries.

Definition of “In-Transit Shipment Returning to the Country of Origin.”

DOE/FE explained these are shipments of natural gas through the U.S. between points of a single foreign nation that are physical and direct.  “Physical” means transportation between two cross-border points, and excludes “exchanges by backhaul, displacement or other virtual shipments.” “Direct” means that the natural gas travels a commercially reasonable path between foreign points consistent with an intention merely to transit through the U.S. without being diverted for another purpose.  Lastly, citing U.S. Customs and Border Protection regulations, DOE/FE noted that the natural gas must enter and exit the U.S. within a 30-day period to qualify as “in-transit.”

Filing and Recordkeeping Requirements.

Despite dismissing the application and disclaiming jurisdiction, DOE/FE drew on its authority under Section 16 of the NGA to direct Bear Head LNG to file monthly reports.  When in-transit shipments occur, Bear Head LNG is to report:  (1) the volumes of natural gas delivered into the U.S., (2) the entity that has title to the natural gas on first entry into the U.S., (3) the points of entry into the U.S., (4) the name of the U.S. pipelines used at the points of entry to and exit from the U.S., (5) the points of exit from the U.S., (6) the entity that has title to the natural gas at the point of exit from the U.S., and (7) the volumes of natural gas delivered to the points of exit.  Lastly, in the event of any discrepancy in volumes, Bear Head LNG must show that no deliveries into U.S. commercial markets occurred.

The In-Transit Order further directs Bear Head LNG to maintain “records of the pipelines used for each in-transit shipment for a period of one year after completion of each in-transit shipment.”  These records are to be provided to DOE/FE upon request.

In Conclusion

DOE/FE rendered Bear Head LNG’s Non-FTA Order in under 12 months.  Certainly, that processing time very likely would have been cut by more than half had DOE/FE applied the FTA standard instead.  Nonetheless, given the complexity of the legal issues and the political implications affecting the Bear Head LNG proceedings, having the benefit of a thoughtful and deliberate analysis carries many tangible benefits.

As to intangible benefits, considering that Bear Head LNG was the second applicant raising issues of first impression before DOE/FE, its chances of achieving timely resolution were not very high.16  Recognizing this, Bear Head LNG pulled together an experienced team of advisors to forge and implement a permitting strategy to improve its odds.  In the end, whether by fortune, miracle or design, Bear Head LNG managed to walk by the awakened snake without getting bitten.  It did not suffer the deluge of public comments that most proponents of LNG exports experience, and it did so in record time.

DOE/FE also is to be commended for resolving Bear Head LNG’s applications in a manner that preserves each sovereign’s interests in its natural resources, but also is consistent with international principles of free trade, reciprocity and comity.  To the extent the Bear Head LNG Orders may be viewed as bringing North American LNG a step closer to serving global demand, consider the words of President Dwight D. Eisenhower:  “Accomplishment will prove to be a journey, not a destination.”

© Copyright 2016 Cadwalader, Wickersham & Taft LLP


1 Bear Head LNG is developing the proposed natural gas liquefaction terminal to be located on the Strait of Canso in Cape Breton, Nova Scotia, Canada.

2 Bear Head LNG Corporation & Bear Head LNG (USA), LLC, DOE/FE Order No. 3769, FE Docket No. 15-14-NG (Feb. 5, 2016), available here.

3 Bear Head LNG Corporation & Bear Head LNG (USA), LLC, DOE/FE Order No. 3770, FE Docket No. 15-33-LNG (Feb. 5, 2016), available here. DOE/FE previously granted Bear Head LNG authorization under Section 3(c) of the NGA to export U.S. natural gas by pipeline to Canada for subsequent liquefaction and export to FTA nations.  See Bear Head LNG Corporation & Bear Head LNG (USA), LLC, DOE/FE Order No. 3681, FE Docket No. 15-33-LNG (Jul. 17, 2015) (the “FTA Order”), available here.

4 See Non-FTA Order at 155.  DOE/FE further stated, “[t]his is among the first two proceedings in which DOE/FE has been asked to review an application to export U.S.-sourced natural gas by pipeline to Canada for liquefaction in Canada, for subsequent re-export of that natural gas in the form of LNG to non-FTA countries” (emphasis added).  Concurrent with Bear Head LNG’s Non-FTA and In-Transit Orders, DOE/FE issued an order to Pieridae Energy (USA), Ltd. granting it similar long-term authority for Non-FTA exports of U.S. natural gas.  See Pieridae Energy (USA) Ltd., DOE/FE Order No. 3768, FE Docket No. 14-179-LNG, available here.

5 IdSee also id. at 156 (“Most applications to DOE/FE for authority to export natural gas to non-FTA countries involve the ready availability of natural gas through an integrated grid of multiple interstate natural gas pipelines. This Application, by contrast, calls for the transportation of U.S.-sourced natural gas through a single interstate natural gas pipeline.”).

6 As U.S. regulatory counsel to Bear Head LNG, we express no view herein on the merits of DOE/FE’s legal determinations.

7 Significantly, the transiting concept is not ingrained in NGA jurisprudence, but it does arise in the context of marking rules and country of origin rules under the North American Free Trade Agreement (“NAFTA”), and in U.S. Customs and Border Protection regulations, as referenced below . Unlike the U.S. legal framework, the Canadian National Energy Board Act and its implementing regulations specifically address gas that is in transit.  But even in instances involving National Energy Board (“NEB”) “in transit” orders, the recently issued corresponding DOE/FE orders have been silent on the “in transit” concept. See, e.g., Terasen Gas Inc., Order Authorizing the Exportation of Gas for Subsequent Import, NEB Order GOL-07-2010, File OF-EI-Gas-GOL-T101 01 (Jun. 7, 2010) and corresponding Terasen Gas Inc., Order Granting Blanket Authorization to Import and Export Natural Gas from and to Canada, DOE/FE Order 2619, FE Docket No. 09-11-NG (Feb. 19, 2009).

8 See Maritimes & Northeast Pipeline, L.L.C., Order Amending Presidential Permit and Authorization Under Section 3 of the Natural Gas Act, 128 FERC ¶ 61,070, P10 (Jul. 21, 2009) (stating that approving exports in addition to imports on the Maritimes & Northeast Pipeline would “promote national economic policy by reducing barriers to foreign trade and stimulating the flow of goods and services between the United States and Canada, both of which are signatories to the North American Free Trade Agreement, providing for fewer restrictions on natural gas imports and exports.”).

9 While there is an extensive body of domestic and international law instructive on this issue, our discussion herein—like DOE/FE’s analysis in the Non-FTA Order—is controlled by the NGA.

10 See Notice of Application, Bear Head LNG Corporation and Bear Head LNG (USA), LLC; Application for Long-Term, Multi-Contract Authorization To Import Natural Gas From, for Subsequent Export to, Canada for a 25 Year Term, 80 Fed. Reg. 20,484 (Apr. 16, 2015)  In an unprecedented move, DOE/FE requested comments on whether section 3(c) of the NGA, 15 U.S.C. § 717b(c), or section 3(a) of the NGA, 15 U.S.C. § 717b(a), provides the appropriate standard for review of Bear Head LNG’s in-transit application.

11 See e.g., Jordan Cove LNG L.P., DOE/FE Order No. 3412, FE Docket No. 13-141-NG (Mar. 18, 2014) (granting long-term, multi-contract authorization to import natural gas from Canada); Jordan Cove Energy Project, L.P., DOE/FE Order No. 3413, FE Docket No. 12-32-LNG (Mar. 24, 2014) (granting long-term, multi-contract authorization to export LNG to Non-FTA nations); LNG Development Company LLC (d/b/a Oregon LNG), DOE/FE Order No. 3465, FE Docket No 12-77-LNG (Jul. 31, 2014) (granting long-term, multi-contract authorization to export LNG to Non-FTA nations).

12 In reviewing potential environmental impacts of a proposal to export natural gas, DOE/FE considers both its obligations under NEPA and NGA Section 3(a).

13 While DOE/FE authorizes the export of LNG pursuant to NGA Section 3, under the same section, FERC exercises exclusive jurisdiction over the siting and construction of LNG terminal facilities (to be located onshore or in state waters). Under the NGA, FERC also serves as the lead federal agency for conducting NEPA analysis for LNG terminal facilities.

14 To date, DOE (through its National Energy Technology Laboratory) has issued only one EA. The final EA, FONSI and order granting export authorization were issued contemporaneously.

15 In denying a motion filed by Pieridae Energy (USA) Ltd., DOE/FE affirmed well-established NEPA precedent.  DOE/FE stated, “we must deny Pieridae US’s Motion to Lodge because the Goldboro Project, to be located in Nova Scotia, Canada, is outside the scope of our environmental review under NEPA in this proceeding, which necessarily focuses on potential environmental impacts within the United States.”  See Pieridae Energy (USA) Ltd., DOE/FE Order No. 3768 at 190.

16 By way of illustration, consider the two-year gap (minus three days) between the issuance of the first Non-FTA LNG export authorization from the Lower-48 and the second one. Applications for the two projects were filed 3 months and 10 days apart.