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By Lynn L. Bergeson and Carla N. Hutton
 
The House Energy and Commerce Subcommittee on Environment and Climate Change will hold a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” According to the October 20, 2021, press release issued by the House Committee on Energy and Commerce, Representatives Frank Pallone, Jr. (D-NJ), Chair of the Committee, and Paul Tonko (D-NY), Chair of the Subcommittee, stated that the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) made “crucial” reforms to the Toxic Substances Control Act (TSCA) “that improve how the federal government protects Americans from dangerous chemicals, and now we must ensure those reforms are implemented effectively and honestly.” Pallone and Tonko stated that during the previous administration, “chemical risk evaluations were skewed in favor of industry to the detriment of workers and communities. We must protect consumers from exposure to toxic substances and ensure the Environmental Protection Agency is using the tools Congress granted it to protect public health.” The Subcommittee will discuss the implementation of the Lautenberg Act and the U.S. Environmental Protection Agency’s (EPA) “efforts to get TSCA back on track.”


 

By Lynn L. Bergeson 

On September 20, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Titled “Questions and Answers on Biosimilar Development and the BPCI Act,” the revised guidance aims to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars. The guidance also includes FDA’s interpretation of certain statutory requirements added by the BPCI Act.


 

By Lynn L. Bergeson

On September 15, 2021, the Senate Committee on Environment and Public Works held a hearing on several U.S. Environmental Protection Agency (EPA) nominees, including Amanda Howe, nominated for Assistant Administrator for Mission Support, and David Uhlmann, nominated for Assistant Administrator for Enforcement and Compliance Assurance.

Amanda Howe has a long history of public service, including such roles as the Chief Operating Officer for the now-Vice President, Kamala Harris, for the People Presidential Campaign, Acting Chief of Staff for New York Mayor Bill de Blasio, Assistant Secretary of Commerce and Trade for Virginia’s then-Governor Mark R. Warner (D), and lead planner of Her Majesty Queen Elizabeth II and Prince Phillip’s royal visit to Virginia for then-Governor Tim Kaine (D). Ms. Howe highlighted her extensive career in operations and management during her opening statements to the Committee, noting that if confirmed, she will bring her personal motto of “go for the good” to her position at EPA.

David Uhlmann is the current Director of the Environmental Policy and Law Program at the University of Michigan Law. Prior to academia, Mr. Uhlmann spent 17 years as a federal prosecutor, including seven years with the U.S. Department of Justice’s Environmental Crimes section. During his opening statement, Mr. Uhlmann stressed that his time in academia has strengthened his belief in promoting environmental advocacy, noting that he believes that those companies that display ethics, integrity, and environmental stewardship should not be at a competitive disadvantage to those that do not.

Senator Shelley Moore Capito (R-WV), Ranking Member of the Committee, asked Ms. Howe how she would transition from the political sphere into governmental management, given President Biden’s initiative to bolster EPA staff. Ms. Howe reiterated her operations management background, noting that throughout her career in public service, she has managed large and complex operations and can think of no better way to serve the public than through the EPA. Senator Capito then asked Mr. Uhlmann about a paper he had written for the Obama Administration. The paper addressed the Clean Energy Standard and carbon taxing, but excluded carbon capture and nuclear energy. Senator Capito questioned how Mr. Uhlmann’s stance on the Clean Energy Standard would align with his EPA nominated role. Mr. Uhlmann responded that while he felt that we need to be seriously addressing climate change, it is the role of Congress to decide how. He stated that his role within EPA would be to help companies comply with any laws that Congress passes and any regulations promulgated by EPA, as well as to bring enforcement actions against companies that violate those laws.

Senator Cynthia Lummis (R-WY) questioned Mr. Uhlmann about his stance on a recent series of White House Environmental Justice Advisory Council recommendations that stated that federal support for technologies such as carbon capture, utilization, and storage were not suitable for Environmental Justice (EJ) communities. Mr. Uhlmann responded that both EJ communities and rural communities have been left behind, and that if confirmed, he would work with states to ensure both communities had access to clean air and water. Senator Lummis and Senator Benjamin L. Cardin (D-MD) each probed Mr. Uhlmann about respective projects that their states were working on with EPA, and asked for a commitment from Mr. Uhlmann that those projects would not go to the wayside. Mr. Uhlmann responded that he believed strongly in a state and federal partnership and that he would work to strengthen that relationship.

Closing the nominations hearing, Committee Chair Thomas Carper (D-DE) asked each nominee a series of questions, including his standard “what question were you not asked that you wish you had been?” Senator Carper posed three questions to Ms. Howe: what attributes of Governor Mark Warner and Governor Tim Kaine did you witness and learn during your time as a public servant; how would you plan on safely bringing the EPA workforce back into the office; and given EPA’s prior cybersecurity breaches, how would you lead EPA’s cybersecurity efforts? Ms. Howe reflected on her time serving each Governor and noted that Mark Warner had the ability to pay attention to detail while still maintaining an eye on the big picture. In her role as EPA Assistant Administrator for Mission Support, she would work to incorporate these lessons by building strong relationships regardless of political party, so that common ground can be found for the common good. From Tim Kaine, Ms. Howe observed that kindness is a strength, and that challenges should be approached with openness, kindness, and integrity.

Ms. Howe expressed concern for the EPA workforce and the challenges they face in keeping themselves and their families safe during Covid. When considering bringing EPA staff back to the office, Ms. Howe stressed the importance of following the science and following Centers for Disease Control and Prevention (CDC) guidelines. In considering how to move forward, Ms. Howe stated she would use EPA as the resource that it is and consult with staff to understand what aspects of teleworking have been successful. She noted that people’s lives have changed, and reintegrating back to the office will take empathy, openness, and a willingness to listen to concerns. In her response to cybersecurity concerns, Ms. Howe stated that this is an issue that has been and will continue to be a top priority for Mission Support. If confirmed, she plans to work directly with the EPA’s Chief Information Officer (CIO) and Chief Operating Officer (COO) to identify and sharpen cybersecurity. She also noted that she has no reservations in speaking openly with Congress and to ask for the resources and tools that she needs to tighten EPA cybersecurity measures. The question Ms. Howe would have liked to be asked was “how do you feel about your nomination to the role of Assistant Administrator for Mission Support?” She feels excited. She is looking forward to recruiting new staff to EPA and feels that it is a vibrant and exciting place to work.

Senator Carper’s closing questions to Mr. Uhlmann included: what in your extensive experience prosecuting environmental crimes and enforcement actions can you bring to this position in helping EPA identify and prevent violations before they occur; and what question were you not asked that you wish you had been? Mr. Uhlmann discussed his long history as a prosecutor working with the career staff of EPA in trials, as well as his collaborative work alongside EPA civil attorneys. Mr. Uhlmann emphasized his deep appreciation for the career staff at EPA, highlighting that unlike his predecessors, he is not new to this area and can “hit the ground running.” Overall, Mr. Uhlmann focused on the need for response. The most salient lesson he observed from his time as a prosecutor is that pollution has real consequences on the lives of Americans and their communities.

Mr. Uhlmann would have liked to have been asked what his top priorities would be as Assistant Administrator for Enforcement and Compliance Assurance. He focused on the threat of climate change and the effects that environmental harms have on communities, stating that these concerns should be at the root of enforcement and compliance actions. He went on to address staffing issues within EPA enforcement and compliance regional offices, and the advocacy he would engage in to procure the necessary resources to strengthen those offices. Maintaining that we cannot regulate our way out of every environmental problem, Mr. Uhlmann focused on the importance of promoting ethics, integrity, and environmental stewardship within the business community to help solve these problems. Rounding out his list of priorities, Mr. Uhlmann stated that there is no room for politics in enforcement, rather it is about the law and the facts.

Commentary

The hearing proceeded with a jovial atmosphere and at times felt almost routine in nature. There were no real surprises or hard hitting questions posed to either nominee. Senator Mark Kelly (D-AZ) posed only one question to Mr. Uhlmann, centered on the niche issue of Clean Air Act (CAA) violations for modifying street vehicle emissions systems to convert them to racing vehicles. Senator Kelly expressed concern over how this statutory prohibition hampered the sport of street racing in Arizona. Mr. Uhlmann pivoted to his work on the VW emissions case and the environmental consequences of that scandal, but did not commit to a stance on Senator Kelly’s proposed amendments to the CAA. The line of questioning then diverted towards Senator Kelly’s wife, Gabby Gifford, and her love of street motorcycle racing. The hearing itself incorporated a decent amount of story-telling on behalf of the Committee members, adding to a sense of collegiality. Throughout the hearing, both nominees emanated passion for their possible future roles within EPA and focused on collaboration as a necessary element moving forward.


 

By Lynn L. Bergeson

On July 2, 2021, U.S. Representatives Angie Craig (D-MN) and Randy Feenstra (R-IA) introduced a bill called the Small Refinery Exemption Clarification Act of 2021. The bill clarifies that only oil refineries that have been continuously receiving small refinery exemptions (SRE) since 2011 should be eligible to petition for extensions of renewable fuel blending requirement exemptions. The SRE Clarification Act follows the Supreme Court’s decision in late June 2021 that, according to Representatives Craig and Feenstra, could negatively influence the biofuels industry by making it easier for oil refineries to avoid Renewable Fuel Standard (RFS) blending requirements. Representative Craig stated that “[‌i]t is vital that we continue to support the clean biofuels industry as we reduce the carbon intensity of our transportation sector and make important investments across rural America.” Representative Feenstra emphasized that “we must erase ambiguities and ensure oil refineries are not able to take shortcuts when it comes to blending biofuels.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 14, 2021, the Senate confirmed by voice vote Michal Freedhoff to be the Assistant Administrator for Chemical Safety and Pollution Prevention of the U.S. Environmental Protection Agency (EPA). As reported in our January 22, 2021, blog item, Freedhoff was onboarded in January 2021 as Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention. On April 14, 2021, President Joseph Biden nominated Freedhoff for Assistant Administrator for Chemical Safety and Pollution Prevention. According to Biden’s announcement, Freedhoff has more than 20 years of government experience, most recently as the Minority Director of Oversight for the Senate Environment and Public Works Committee. She began her Congressional service in 1996 in then-Representative Ed Markey’s (D-MA) office as a Congressional Science and Engineering fellow after receiving a Ph.D. in physical chemistry at the University of Rochester. Freedhoff also served on the staffs of the House Science Committee, the House Select Committee on Energy Independence and Global Warming, the House Energy and Commerce Committee, and the House Natural Resources Committee. The announcement states that Freedhoff’s legislative work includes the 2016 re-authorization of the Toxic Substances Control Act (TSCA), 2019 legislation to address per- and polyfluoroalkyl substances (PFAS) contamination, the fuel economy provisions in the 2007 Energy Independence and Security Act, and a law requiring the creation of an online database of potential consumer product safety defects.


 

By  Lynn L. Bergeson

On May 28, 2021, the Biden-Harris Administration submitted President Joseph Biden’s budget for fiscal year 2022 (FY 2022) to Congress. According to EPA’s May 28, 2021, press release, the budget request advances “key EPA priorities, including tackling climate change, advancing environmental justice, protecting public health, improving infrastructure, creating jobs, and supporting and rebuilding the EPA workforce.” The President’s FY 2022 budget request supports:

  • Rebuilding Infrastructure and Creating Jobs: The budget provides $882 million for the Superfund Remedial program to clean up some of the nation’s most contaminated land, reduce emissions of toxic substances and greenhouse gases (GHG) from existing and abandoned infrastructure, and respond to environmental emergencies, oil spills, and natural disasters;
     
  • Protecting Public Health: The budget includes $75 million to accelerate toxicity studies and fund research to inform the regulatory developments of designating per- and polyfluoroalkyl substances (PFAS) as hazardous substances while setting enforceable limits for PFAS. In FY 2022, EPA will advance public health by providing an additional $15 million and 87 full-time equivalent employees (FTE) to build agency capacity in managing chemical safety and toxic substances under the Toxic Substances Control Act (TSCA);
     
  • Tackling the Climate Crisis with the Urgency Science Demands: The FY 2022 budget recognizes the opportunity in tackling the climate crisis by developing the technologies and solutions that will drive new markets and create good paying jobs. The budget restores the Air, Climate, and Energy Research Program and increases base funding by more than $60 million, including $30 million for breakthrough research through the Advanced Research Projects Agency-Climate (ARPA-C) with DOE. The budget provides an additional $6.1 million and 14 FTEs to implement the recently enacted American Innovation and Manufacturing (AIM) Act and reduce potent GHGs while supporting new manufacturing in the United States;
     
  • Advancing Environmental Justice and Civil Rights: The budget includes more than $900 million in investments for environmental justice-related work, collectively known as EPA’s Accelerating Environmental and Economic Justice Initiative, elevating environmental justice as a top priority across the agency. The budget also proposes a new national program dedicated to environmental justice to further that goal;
     
  • Supporting States, Tribes, and Regional Offices: Almost half of the total budget, $5.1 billion, will support states, tribes, and localities through the State and Tribal Assistance Grants account;
     
  • Prioritizing Science and Enhancing the Workforce: The FY 2022 budget includes an increase of 1,026 FTEs “to stop the downward slide in the size of EPA’s workforce in recent years to better meet the mission.” Within this increase are 114 FTEs to propel and expand EPA’s research programs to ensure the agency has the science programs that communities demand from EPA. Also included are 86 additional FTEs to support the criminal and civil enforcement programs to ensure that environmental laws are followed.

 

By  Lynn L. Bergeson 
 
On May 25, 2021, U.S. Senators Deb Fischer (R-NE) and Tammy Duckworth (D-IL) introduced the bipartisan Renewable Fuel Standard (RFS) Integrity Act of 2021. Aiming to provide more certainty to rural America, this legislation would require that small refineries petition for RFS hardship exemptions by June 1 of each year. According to Senator Fischer, the RFS Integrity Act of 2021 would ensure that the U.S. Environmental Protection Agency (EPA) properly accounts for exempted gallons in the annual Renewable Fuel Obligations (RVO) it sets every November. The legislation would also require that EPA publish the name of the refinery and volume that is exempted at the same time that the refiner receives the exemption.


 

By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
 
On May 25, 2021, U.S. Senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) and House Representatives Randy Feenstra (R-IA), Ashley Hinson (R-IA), and Mariannette Miller-Meeks (R-IA) joined forces in a letter to urge President Biden to uphold his promise to support biofuels in the next four years. Criticizing President Biden’s efforts under the American Jobs Plan for failing to include investments in biofuels, the letter states that “advancements in biofuels can drive biofuels towards being carbon neutral or even carbon negative – something electric vehicles cannot achieve.” According to the representatives, President Biden’s American Jobs Plan focuses on investments in electric vehicles rather than supporting biofuels as a solution to reduce carbon emissions. The letter also urges President Biden to support the biofuels industry through strong Renewable Volume Obligations (RVO) for 2021, 2022, and beyond under the Renewable Fuel Standard (RFS). The letter concludes with the following statement: “Biofuels should not be treated as a transition fuel, but prioritized as a fuel of the future.”


 

By  Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 5, 2021, U.S. Senators Amy Klobuchar (D-MN) and Joni Ernst (R-IA), introduced a $500 million bill on biofuels infrastructure.  The bill, titled the Renewable Fuel Infrastructure Investment and Market Expansion Act, would create a grant program to aid fuel retailers in streamlining sales of fuels with higher ethanol blends.  These infrastructure grants would be available for five years.  Senator Klobuchar highlighted that "[d]iversifying our fuel supply and introducing higher blends of biofuels in the market are great steps forward as we work to promote clean energy technologies and invest in transportation infrastructure.”  She also stated that this legislation would highly benefit the economy and the environment by making cleaner fuels more accessible.


 

March 31, 2021
1:30 p.m. - 3:00 p.m. EDT
Register here

The COVID-19 global pandemic has had far-reaching impacts on business operations. While we are all eager to put the pandemic behind us, other catastrophic events will inevitably occur. To strengthen organizational resilience going forward, we must examine lessons learned and position product stewardship as a key player in business continuity and crisis management.

This complimentary future-focused webinar, hosted by the Product Stewardship Society (PSS), will identify the broad range of complex, unresolved, and evolving issues product stewards have faced and continue to face because of the pandemic.

SPEAKERS:

 

Tina Armstrong, Ph.D., Principal Scientist and Vice President at the global consultancy firm Arcadis

 

 Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (moderator)

 

Jon Hellerstein, CIH, CSP, a career environmental health professional 

 

Al Iannuzzi, Ph.D., Vice President, Sustainability, The Estée Lauder Companies

 

Louise Proud, leader of the Environment, Health, and Safety program for Pfizer Inc.

 

In addition to receiving 1.5 contact hours, participants will learn:

  • How product stewards can integrate product stewardship into business continuity and crisis management.
     
  • What issues a product steward needs to address when a COVID-19 outbreak occurs in a workplace, retail space, or upstream/downstream in the supply chain.
     
  • How to leverage the experiences of the COVID-19 pandemic to influence senior leaders to think differently about product stewardship and environment, health, and safety in general.

Make sure to register now for what promises to be a timely, resourceful, and interesting event!


 
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