Election Will Be Critical for Biden’s National Climate Emergency Effort
Author
David P. Clarke - Writer & Editor
Writer & Editor
Current Issue
Issue
6
David P. Clarke

In August, President Biden said that “practically speaking,” he already had declared a national climate emergency, although not formally, as some want. The Inflation Reduction Act’s $369 billion in climate and clean energy funding was a good start, he said. And certainly EPA’s proposed rule for controlling power plant greenhouse gas emissions also counts as a salient administration bid to deal with what Biden calls an “existential threat.”

While the IRA is still in its early stages and faces significant hurdles, such as massive transmission needs, the law could go a long way toward achieving Biden’s goal of net-zero GHG emissions by 2050. In August, the American Clean Power Association—representing 750 large wind, solar, and other clean energy companies—issued a report finding that over the prior 12 months federal support had spurred $271 billion in clean energy and manufacturing investment—exceeding total investment over the previous eight years. But as the presidential election moves forward, an effort called Project 2025 is hoping a GOP president will repeal the IRA and eliminate all GHG-reducing regulations.

EPA’s power plant proposal, expected to be final in June 2024, isn’t even out of the gate and already is facing strong GOP opposition. In an August letter to EPA administrator Michael Regan, 39 senators called for withdrawing the proposal. They invoked the Supreme Court’s West Virginia v. EPA ruling to argue that the agency must have clear authorization from Congress to regulate a “fundamental sector of the economy,” and said EPA had “overstepped its authority.” Likewise, House GOP critics denounced the agency’s proposal as an effort to restructure the U.S. power sector and a threat to the electricity system’s reliability.

Among the more than one million public comments EPA received on its proposal, commissioner James Danly of the Federal Energy Regulatory Commission suggested that the rule, together with “numerous other public policies,” would increasingly jeopardize the bulk power system. At FERC’s scheduled annual Reliability Technical Conference this fall, the proposal’s potentially “substantial consequences” for reliability will be considered, Danly wrote, and urged EPA to include the conference proceedings in its record.

Although conceding the necessity for GHG reductions, large business interests nevertheless disagree with EPA’s proposed pathways to that goal. The Edison Electric Institute, representing all U.S. investor-owned electric companies, commented that it supports EPA’s decarbonization goal, but added that the technologies the agency is promoting to clean up new and existing fossil-based power generation, such as carbon capture and storage (CCS) and hydrogen blending, are still unproven. Six major industrial trade groups echoed EEI’s views, warning that EPA’s rule, in directly and indirectly reshaping the power sector, could impact reliability and damage U.S. manufacturers’ competitiveness.

Tackling claims that CCS is unproven, the Clean Air Task Force and the Natural Resources Defense Council in their comments argue that since 2015 CCS has been increasingly tested and proven and is “ripe” for certain coal-fired plants to adopt for compliance by 2030 with an EPA performance standard and is the best control system for large, existing gas-fired plants. Blending low-GHG hydrogen in new natural gas units is also “adequately demonstrated,” they note, and urge even stricter performance standards for such units. Although CCS remains highly controversial, the groups argue that IRA’s substantial CCS and clean hydrogen tax credits will certainly lower costs.

CATF and NRDC also dispute claims that the agency’s proposal runs counter to the West Virginia ruling. Rather, the ruling endorses the source-specific, technological approaches under the Clean Air Act’s Section 111 that EPA is relying on. The Union of Concerned Scientists comments that EPA in its proposal “diligently attended to constraints” the ruling imposed.

UCS, CATF, and NRDC insist that the agency’s proposal won’t undermine grid reliability, noting, for example, the extensive network of procedures and organizations, including the North American Electric Reliability Corporation, grid operators, and others, that ensure reliability. Further, EPA’s rule allows that some gas generators may be needed during peak electricity demand periods.

As emphasized by the New York State Reliability Council, however, many in the electric industry want EPA’s rule to provide greater authority to extend generation facilities’ operation if needed for reliability. With many sectors rapidly electrifying, requirements for reliable electrical systems will increase, with “severe societal consequences” if power failures occur.

Legal and political battles will likely ensue over EPA’s proposal, but, as CATF and NRDC underscore, the worsening climate crisis necessitates the “fastest possible” power plant GHG reductions.

Election Will Be Critical for Biden’s National Climate Emergency Effort.

Behind EPA’s Cancer Alley Pullback
Author
Lylla Younes - Grist
Grist
Current Issue
Issue
5
In Cancer Alley, huge chemical plants often have citizens as neighbors. Getty Images.

Pastor Philip Schmitter waited more than 20 years for the Environmental Protection Agency to do its job. In 1992, he’d filed a civil rights complaint to halt the construction of a power station that would spew toxic lead into the air of his predominantly Black community in Flint, Michigan. Decades passed without a response, so he joined four other groups around the country in a lawsuit to compel the agency to address their concerns.

The case hinged on the EPA’s duty to enforce Title VI, a provision of the landmark Civil Rights Act of 1964. Title VI allows federal agencies to take action against state policies that discriminate by disproportionately harming groups protected by the act—the discriminatory policy being, in this case, Michigan’s permitting of a plant that would pollute Black neighborhoods. After EPA lost the suit in 2020, agency officials finally began timely investigations of civil rights complaints and made some of EPA’s first-ever findings of discrimination.

That progress, however, could be short-lived.

This summer, EPA abruptly terminated three of its highest-profile open civil rights complaints. The move deals a major blow not only to the majority-Black communities that filed them but also to EPA’s own authority to enforce Title VI in places with some of the nation’s worst air quality. The cases originated in the region widely known as Cancer Alley, an 85-mile industrial corridor in southeast Louisiana, and were voluntarily closed after the state’s Republican attorney general sued the federal government for alleged abuses of power during the complaint negotiations.

Grist obtained copies of two draft agreements from the now-defunct negotiations, which reveal efforts by EPA officials to institute profound changes to Louisiana’s permitting process, which has historically concentrated chemical plants near Black communities. One of the most substantial terms of the resolution would have required state regulators to assess whether a community is already exposed to disproportionately high levels of pollution before permitting new plants there. With the cases closed, the prospect of those changes has all but vanished.

“This is basically the EPA not using the full power of its environmental laws,” said Adam Kron, a senior attorney at Earthjustice who worked on the case. He described Title VI as one of the clearest ways to advance environmental justice, a goal that the Biden EPA has repeatedly called a priority. “It’s disappointing to see EPA acquiesce to what seems like a lawsuit that really doesn’t have much grounding to it.”

The Title VI statute states that no person should, on the basis of race, color, or national origin, be subject to discrimination under any program that receives federal funding. The provision is wide-reaching, covering hundreds of thousands of programs across the country and governing decisions as diverse as where a road can go or who can get treatment at a hospital. But in the environmental space, it’s been largely underutilized, with EPA routinely failing to respond to dozens of cases within the 180-day period required by the law.

The 2020 federal court ruling on Schmitter’s case gave communities in Louisiana’s St. James and St. John the Baptist parishes hope that Title VI could finally help limit pollution in their backyards. Together, their complaints alleged a number of negligent actions by state regulators, including a failure to curb cancer-causing emissions that violate federal safety standards, and to consider pre-existing pollution when permitting new industrial plants. A formal resolution of their cases would have likely addressed these concerns.

The draft agreements that Grist obtained include sweeping measures to change the way the state of Louisiana approves new industrial facilities, like folding community involvement into critical moments of the decisionmaking process and requiring officials to prove, both before and after plants begin operating, that their emissions will not disproportionately harm people of color. In Louisiana, majority-Black communities are exposed to at least seven times the emissions, on average, as predominantly White communities in industrial areas.

“We were hoping to get systemic change,” said Kimberly Terrell, a research scientist at the Tulane Environmental Law Clinic, who worked on the complaints. “For decades, people have been fighting against individual polluters and individual facilities, but when the decisionmaking process itself is flawed, you need something that seeks to improve it.” Louisiana officials did not respond to a request for comment.

Despite progress with the agreements, testimony in Louisiana’s legal filings suggests that, at some point during the negotiation process, things between state and federal officials began to sour. Then, in late May, the state’s attorney general, Jeff Landry, sued EPA.

The case hinged on EPA’s ability to pursue actions based on “disparate impacts,” or the idea that a policy or agency decision can disproportionately harm a specific group of people, regardless of whether or not that harm is intentional. These standards have always been unpopular with some state officials who view them as evidence of federal agencies meddling in matters beyond their authority. The Supreme Court’s conservative majority is sympathetic to these concerns, ruling in numerous landmark cases over the past few years to vastly restrict the powers of federal regulators.

But multiple lawyers whom Grist interviewed argued that Louisiana’s legal arguments would have ultimately been unlikely to undermine Title VI, raising the question of why EPA appears to have preemptively conceded on the matter. “It was unripe—there was no action by the EPA that Louisiana could challenge,” said Kron. “So it seems like a strange lawsuit for [the federal government] to take as a serious enough threat to just undo this whole process that’s been going on for over a year.”

Environmental advocates and residents in Louisiana also decried the decision to close the complaints.

“I often feel like our communities are left to fight on our own,” said Joy Banner, an activist and long-time resident of the region. “It’s disappointing when we have organizations at the federal level who aren’t willing to step in to fight along with us for our basic human right to survive.”

EPA spokesperson Khanya Brann told Grist that the agency remains “fully committed” to improving the environmental conditions in the communities that filed the complaints.

“Community participation has been critical to identifying both problems and solutions, and we look forward to our continued partnership with the residents in both parishes as we continue our joint efforts to improve public health and the environment,” she said.

The Environmental Protection Agency wrote in its letters announcing the closure of the complaints that it would address residents’ concerns through other means, like its pending litigation against one of the region’s most infamous chemical plants and its proposed rules for tightening standards for certain types of facilities operating in the region. But residents told Grist that those measures do not cover the totality of their concerns, and that a major benefit of the Title VI process is its speedy timeline: While court cases can drag on and emissions standards can take years to implement, a resolution of the complaints may have granted communities much faster relief from toxic emissions.

Claire Glenn, a criminal defense attorney with a background in civil rights law, compared EPA’s use of Title VI to other federal agencies’ more robust implementation of the law. The Department of Transportation, for example, requires regulators to consider whether a project will disproportionately impact a group of people before it’s ever constructed. However, she added, deciding where a transit line goes is often less controversial than approving a multi-billion dollar company’s new industrial complex. “I think the reason EPA’s Title VI program is so hamstrung is because it is so directly butting up against corporate interests,” she said.

Advocates told Grist that they are exploring other options to advance residents’ concerns, and called EPA’s actions this week a setback but not a roadblock. Residents said that they are determined not to give up.

“We come from a long line of people who fought,” said Banner. “This is just one little hill that we have to overcome—but ultimately I see us heading to the mountain, and victory is the mountain.”

This story was originally published by Grist.

TESTIMONY The agency was on the cusp of cleaning up Cancer Alley. Then it backed down. Documents obtained by the online publication Grist reveal the sweeping changes that EPA was negotiating before giving in to GOP pressure.

Seeing Green: Can EPA Effectively Manage Its Billions for Grants?
Author
David P. Clarke - Writer & Editor
Writer & Editor
Current Issue
Issue
2
David P. Clarke

During the Biden presidency, Congress has appropriated billions of dollars for EPA to award as grants supporting clean water, environmental justice, climate action, and other priorities. While many are elated at the funding, some observers suggest the agency will be highly challenged to spend it all effectively.

Last November, EPA released a “Year One Anniversary Report” describing its activities so far under the 2021 Bipartisan Infrastructure Law, which provides the agency’s largest-ever appropriation: $60B over five years to support environmental projects. The BIL expanded EPA’s traditional role from conducting scientific research and writing regulations to now serving as “a large-scale funder of critical infrastructure,” the agency says.

In its first year, EPA awarded only $6.4B in grants of the $14.1B that Congress appropriated for fiscal year 2022. But states, tribes, or territories can receive distributions from the FY22 appropriation “on a rolling basis” until the end of FY23 in line with their Clean Water State Revolving Fund timeline, an agency spokesperson says. Since November an additional $7.1B has been distributed.

The BIL appropriation, while far-reaching in itself, was followed by the 2022 Inflation Reduction Act, which created a $27B Greenhouse Gas Reduction Fund as a new Clear Air Act section. Until the end of FY24, EPA can award GHGRF grants, including $7B for zero-emission technologies in disadvantaged communities, and the rest for “green banks” that will invest in clean technologies for reducing GHGs and other pollution, especially (once again) in “low-income and disadvantaged communities.” With the 2024 deadline, EPA will have about a year “to dole out $27B,” notes one observer.

After IRA passage, the massive new funding led EPA Administrator Michael Regan to write, “This is a moment unlike any other in our history.” Also, after years of shrinking budgets, the agency’s 2023 appropriations included $575 million in new funding. The EPA spokesperson adds that the agency “is committed to distributing the funds equitably, responsibly, and impactfully,” working closely with regions, states, tribes, and territories. EPA’s new technical assistance programs will identify infrastructure needs and help applicants navigate federal funding processes to give everyone “their fair share” and unlock the IRA’s possibilities.

According to the Natural Resources Defense Council—which responded to EPA’s request for public comments on how it should design and implement the GHGRF—the $20B reserved for green banks and other “nonprofit lenders” could produce up to 80,000 investments. While recognizing the $27B total as a “critical down payment” on an equitable, low-carbon future, NRDC notes that the agency faces “a clear challenge” in designing a program that can efficiently and equitably deploy the money. A key decision will be to accurately define “low-income and disadvantaged communities” whose benefit the law emphasizes, NRDC and others note. The definition will shape how grant recipients spend funds to achieve the law’s goals.

A second core question concerns which technologies to direct funds toward. NRDC suggests that the law’s goals would be best met by funding “distributed” technologies to cut carbon, such as decarbonizing buildings, moving to electric vehicles, and the like. Another commenter, the Center for Biological Diversity, urges EPA to devote “a large portion” of its GHG grants to support EV charging stations to enable widespread adoption.

The American Water Works Association—representing more than 4,300 drinking water utilities—points to numerous GHG-reduction opportunities at water facilities and makes a case that its members should be eligible to receive GHGRF funds. Likewise, the American Chemistry Council, representing 190 chemical manufacturing companies located in communities nationwide, calls on EPA to allow fund leveraging for public-private partnerships involving communities, businesses, manufacturers, and industrial facilities.

The nonprofit Coalition for Green Capital, a green-bank leader, notes that its members, along with private-sector investors, have funded more than $9B in clean energy projects. Citing a letter from congressional GHGRF authors calling for that fund to capitalize a single “national climate bank,” the coalition comments to EPA that it intends to seek GHGRF funds to capitalize a national green bank.

To achieve President Biden’s goal of reducing GHG emissions 50-52 percent by 2030, the coalition writes, in the coming decade “at least $1 trillion” must be invested, with disadvantaged communities needing at least one fifth of that amount.

Clearly, EPA has an opportunity to turbocharge decarbonization across the economy. With so much at stake, and so many watching critically, transparency and accountability will be crucial.

Seeing Green: Can EPA Effectively Manage Its Billions for Grants?

A Valuable Tool—If It Is Used Carefully
Author
Gregory Jaffe - Center for Science in the Public Interest
Center for Science in the Public Interest
Current Issue
Issue
6
Parent Article

Agricultural biotechnologies are important tools that can help mitigate and adapt to climate change, and improve nutrition security. However, the products of those technologies must be safe for humans and the environment and be utilized sustainably.

The first generation of engineered products—soybeans, corn, cotton, and canola resistant to herbicides or that produce their own pesticides—have been regulated by a system that can be described as “case by case.” Depending on the organism and the introduced trait, one, two, or three agencies (USDA, FDA, or EPA) review each individual product using existing laws to ensure it does not have an adverse impact on food safety and nutrition, agricultural interests, or the environment. Some federal oversight is mandatory (registration at EPA for pesticide-producing plants) while other procedures are voluntary (FDA’s oversight of biotech plants). Some procedures are transparent and allow for public input (USDA deregulation of engineered plants) while others are not (FDA’s approval of engineered animals as new animal drugs).

More importantly, the regulatory system focuses more on the requirements of the law being applied than the potential risks and impacts of the product. Recent changes to USDA’s oversight now remove large categories of products from oversight, but without the necessary scientific evidence to justify those exemptions.

The federal government needs to institute science-based and proportionate oversight that ensures biotech plants and animals are safe and do not adversely affect the environment. FDA’s oversight for biotech plants should be mandatory, and the agency needs to confirm that products are safe. USDA should not allow developers to self-determine whether their products meet one of the agency’s exempt categories and it should base any exemptions on the organism and introduced trait, not solely on the type of genetic change. FDA should establish proportionate regulatory procedures for animals with genomic changes so that it does not require the same degree of oversight for a gene-edited animal that introduces an existing gene from the same species (a dehorned cow) as it does for adding a gene from an unrelated species (salmon engineered to grow faster).

Engineered and edited products need to be used sustainably and provide benefits, both of which only can be determined case by case. While insect-resistant crops have been associated with significant reductions in chemical insecticidal sprays, overuse of Bt corn has led to resistant pest populations. Crops engineered to withstand herbicides (glyphosate-tolerant corn, cotton, and soybeans) have increased use of certain herbicides but also replaced others—for other examples, see the CSPI Report, “In the Weeds.” Depending on the crop and chemical, the net result of such substitutions can be increases in different herbicides but not necessarily increased toxicity.

Overall, glyphosate use has increased significantly, but the net result is lower acute toxicity for corn, cotton, and soybeans and increases in chronic toxicity for corn and cotton (with a reduction for soybeans). As has Bt corn, glyphosate overuse with herbicide-tolerant crops has led to resistant weeds, requiring farmers to go back to spraying chemicals that those crops were designed to eliminate.

EPA rightly requires farmers growing Bt crops to take steps to delay the development of resistant pests, but the agency should strengthen those requirements to address resistant insects that have developed. In addition, if a chemical will be sprayed on a herbicide-tolerant crop, EPA should impose conditions that delay development of resistant weeds.

With a regulatory system that is science-based, proportionate, transparent, and timely, genetically engineered and gene-edited products could more easily reach the market in the United States. Then advantageous traits such as drought tolerance, nitrogen fixation, and nutritional enhancement could impact the major food and agricultural challenges our country and world face.

A Bounty of Benefits
Author
Stanley Abramson - ArentFox Schiff
Karen Carr - ArentFox Schiff
ArentFox Schiff
ArentFox Schiff
Current Issue
Issue
6
Bounty of Benefits

Nearly 70 years have passed since the world was introduced to DNA, the molecule that encodes heredity. And it is 35 years since the first experiment with a genetically engineered organism in a strawberry patch in California. Since then, field tests with GE plants have been conducted 20,000 times in the United States, under the watchful eye of agencies acting under the Coordinated Framework for Regulation of Biotechnology. Over 200 GE food and agricultural products have been cleared for commercialization following review by one or more of the three agencies involved in the framework—the U.S. Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency.

In contrast to most new technologies, opposition to the use of genetic engineering and calls for regulation developed well before any products were on the market or even tested in the open. Some in the expert community, including academics and NGO scientists, demanded to know more about the potential ecological effects of growing GE crops and potential health effects of consuming food from those crops. Even after science-based protocols were put in place, and premarket review regulations adopted under USDA, FDA, and EPA statutes to ensure GE products would be as safe to grow and eat as their conventionally bred counterparts, a number of public interest groups and European governments were still opposed. Some remain so still.

In the meantime, with GE crops grown and consumed globally since 1996 on 7 billion acres in up to 29 countries, there are unprecedented amounts of peer-reviewed safety data—and no evidence that GE crops or foods have caused any adverse health or environmental effects, nor has any court ever found that to be the case in spite of dozens of legal challenges. GE crops have allowed farmers to realize such benefits as higher yields (growing more food per acre), a significant reduction in pesticide application using insect-resistant crops coupled with a corresponding reduction in worker exposure in the field, and the ability to fight weeds well into the growing season with herbicide-tolerant crops. Newer plants with consumer and health benefits have begun to further diversify this mix. As a result, GE crops support sustainable development in numerous ways, including food security—providing a safe, nutritious, and affordable supply for all consumers—while contributing to a reduction in food waste and minimization of agriculture’s environmental footprint, importantly its climate impacts.

Under intensive regulatory, commercial, and academic oversight, and notwithstanding its widespread and rapid rate of adoption, biotechnology has produced benefits that have flowed to society without any evidence of adverse health or environmental effects. It is a fair question to ask how many other new technologies can point to such an enviable track record. However, biotechnology has not been without its skeptics.

The fears and concerns initially raised with genetic engineering were based largely on uncertainty and lack of experience at a point at which any GE products were still in the R&D stage and there was an absence of any significant educational effort regarding the underlying science. This was particularly true with respect to the novel use of recombinant DNA techniques, which allow genetic material to be joined from organisms that would not share their genes in nature. Unlike the well-recognized risks associated with certain existing products that gave rise to many of our health and environmental regulatory programs in the 20th century, any risks that might be associated with biotechnology were purely speculative and hypothetical.

Did the Coordinated Framework and the health and environmental statutes at its core help facilitate the unprecedented adoption of products of this new technology by the food and agriculture sectors? Without question. Was the lack of any evidence that these products have caused adverse health or environmental effects a key factor as well? Absolutely. Is it time to take a close look at the science and the experience gained over the past 35 years and adjust our regulatory oversight accordingly? Positively.

In 1990, FDA completed premarket review for the first GE food product under the Coordinated Framework. It cleared the path to commercialization for the first GE food ingredient, the chymosin enzyme, for use in cheese and other dairy products. Fast forward to 2019, when GE crops were grown commercially on over 176 million acres in the United States, with soybeans, corn, and cotton making up the bulk of these acres, followed by canola, sugar beets, alfalfa, potatoes, papaya, squash, and apples. In the same year, an estimated 17 million farmers planted GE crops on a total of 470.5 million acres. From 1996 to 2019, GE crops were grown worldwide on an aggregate 6.7 billion acres, providing food, feed, fuel, and shelter to a global population that reached 7.7 billion, with estimated economic benefits of over $225 billion.

Nobel Laureate Norman Borlaug believed that genetic engineering was the only way to increase food production in a world with rapidly growing population and disappearing arable land, and that GE organisms were not inherently dangerous because society has been genetically modifying organisms for a long time. The use of yeast microbes in baking and brewing as early as 6000 B.C. was the earliest practical use of genetics that we know of, followed by the centuries-old crossbreeding of plants and animals for desirable traits. But as Borlaug knew from his own research, crossbreeding could take decades before a useful new variety was created. Other breeding methods, used successfully since the 1950s to develop new crop varieties with chemicals and irradiation, also require multiple generations of plant selection and backcrossing. From the relative randomness of those techniques, many of which are still in use today, researchers have added the more recently developed molecular biology methods, referred to here as genetic engineering, which are far more precise and sophisticated, allowing scientists to develop and test new products safely and expeditiously.

To the extent that the regulatory processes put in place for GE products were able to allay the fears of the general public and scientific community by identifying and avoiding any potential hazards associated with the technology, the pre-implementation vantage point has been an advantage. But it has simultaneously been a burden because it requires decisionmaking in the early years in the face of a significant degree of uncertainty about both risks and benefits. Fortunately, that uncertainty motivated scientists and regulators to develop and utilize risk assessment techniques for evaluating the safety of GE products and risk management methods to address any concerns that may be identified, all of this prior to commercialization.

Looking back, it is easy to question the need for rigorous premarket review of many food and agricultural biotechnology products. At the outset, however, considerable political pressure was brought to bear on the government to do just that for all biotechnology products and particularly for microbes and other products that would be tested and ultimately put to work in the open environment. With the near unanimous support of the scientific community, the National Institutes of Health issued “Guidelines for Research Involving Recombinant DNA Molecules” in 1976, which rapidly established the de facto standard for recombinant DNA research in the public and private sectors.

Acting under those guidelines, NIH approved what would have been the first “deliberate release” experiment of a GE microbe in the open environment. The approval was challenged in federal court by the Foundation on Economic Trends, a nonprofit established by Jeremy Rifkin, an American economic and social theorist, writer, and activist, who took an early interest in biotechnology and was its primary, self-appointed watchdog for many years. The suit against NIH was the first of many to be brought by FOET and others.

Based on his finding that NIH had failed to meet its obligations under the new National Environmental Policy Act, Judge John Sirica enjoined both the experiment and NIH approval of any future deliberate-release experiments. On appeal, the injunction was affirmed as to the proposed experiment, but vacated as to NIH approval of future experiments. In an insightful concurring opinion with respect to scientific experimentation, public interest, and government oversight, Senior Circuit Judge George MacKinnon stated that he could understand how scientists knowledgeable in the field would approve the experiment, particularly when, in his view, “It would seem an experiment that releases into the environment organisms substantially the same as some already living there, and subject to the same naturally occurring controls, would present no risk.” He went on to say, however, that “the general public and those who have to pass on this action are not knowledgeable in this field and they are easily frightened by new scientific experiments and their possible consequences. It is such lay concerns that must here be satisfied by Environmental Assessments and Environmental Impact Statements,” under NEPA.

The injunction against NIH approval of this experiment on procedural grounds and subsequent challenges against EPA, albeit unsuccessful, signaled an abrupt end to any perceived honeymoon period for experiments in the environment, sent shockwaves through the burgeoning agricultural biotechnology research community, and caught the interest of many in the public-interest field as well. A report on the environmental implications of genetic engineering issued in 1984 by a House oversight subcommittee concluded that “the current regulatory framework does not guarantee that adequate consideration will be given to the potential environmental effects of a deliberate release” and recommended a moratorium. The Congressional Office of Technology Assessment warned of threats to the initial preeminence of U.S. biotechnology companies. Right on cue, draft biotechnology oversight legislation began to surface on Capitol Hill.

The growing public and political uneasiness with biotechnology research, including field tests of recombinant DNA organisms, and the inherent delays, costs, and unpredictability of litigation, were particularly concerning at a time when the R&D landscape had changed dramatically. Now, in addition to experiments being conducted in laboratories and greenhouses at numerous public and private research institutes, significant investments were being made by major corporations in the development of new biotechnology-derived products to be tested in the field. Fears of stifled innovation and a loss of the competitiveness of U.S. producers were raised at the highest levels of government and, in April 1984, the Reagan White House established an interagency working group to study and coordinate development of a regulatory policy.

When developers produce a new technology with applications in multiple different areas, it should come as no surprise that the authority to regulate products of that technology will rest with several overlapping government units. In the case of biotechnology, nine departments and eight agencies were tasked to undertake a top-to-bottom review and then develop recommendations for additional regulatory oversight, if warranted, while maintaining flexibility to accommodate new developments. Although both administrative and legislative actions were nominally on the table, there was a strong incentive to avoid any new law that might end up limiting progress rather than promoting it.

One of the key tasks in drafting what became the Coordinated Framework was to identify an existing statute that was best suited for regulation of each category of products for which biotechnology was being or could be applied. While acknowledging that the then-existing, product-based statutes were not drafted with biotechnology in mind, legal support for relying on those laws was based, at least in part, on Diamond v. Chakrabarty, a 1980 Supreme Court decision which upheld the patentability of a GE microorganism under the Patent Act—a law originally drafted by inventor Thomas Jefferson. The framework incorporated statutes that could address virtually every conceivable product category, although none had the pedigree of the Patent Act. The wisdom of using existing risk assessment statutes to review the safety of GE organisms would be recognized in 1987 when the National Academy of Sciences issued the first of several reports finding that any risks posed by such organisms were the “same in kind” as those associated with unmodified organisms and organisms modified by conventional means and, further, that the properties of a GE organism should be the focus of risk assessments, not the process used to produce the organism.

As the federal government wrestled with the challenge of how best to regulate biotechnology, it was confronted with two opposing schools of thought. Some promoted what would come to be associated with the Precautionary Principle, arguing that unless and until all questions and doubts about a new technology have been satisfactorily answered, it could not be trusted and had to be held in abeyance. Others argued for no new regulation based on the fact that GE techniques were simply an extension of conventional breeding. It was also argued that, even without new legislation, regulation could inhibit research and innovation, delay realization of significant societal benefits, and adversely impact American competitiveness.

In the end, the working group established by President Reagan took a middle ground. Products of biotechnology would be regulated based on existing safety standards and would be expected to be just as safe as their conventional counterparts. The public could be assured that a new fruit or vegetable product would be as safe to grow and produce and as safe and nutritious to eat as its conventional counterpart. This approach to regulation was applied regardless of the type of product (chemical, microbial, plant, or animal) or its intended use (agriculture, food, feed, fuel, forestry, medical, industrial, or consumer). With one notable exception, GE products intended for food and agricultural use would be subject to premarket review to the same extent and under the same standards as their conventional counterparts. The exception was USDA’s decision to review all GE organisms premarket based on a determination that they posed a potential “plant pest” risk. These fundamental concepts were incorporated when the White House issued the Coordinated Framework.

Regulation, of course, cannot remain static and, as a 2000 NAS report made clear, “Regulations should be considered flexible and open to change so that agencies can adapt readily to new information and improved understanding of the science that underlies regulatory decisions.” In this area, EPA, FDA, and USDA have each issued new or amended regulations, policy statements, or guidance documents when deemed appropriate. The agencies have also taken steps to identify individual products or categories of products that either no longer warrant premarket review or qualify for a reduced level of oversight based on experience. The key elements that allow agencies to make these determinations are familiarity with the product category and a history of safe use. Agencies have also moved to increase their oversight of certain product categories when warranted based on a review of product characteristics, exposure scenarios, and other data.

Regulation also has to be able to respond to new scientific developments and, for biotechnology, regulators must now address relatively new genome-editing techniques such as CRISPR-Cas9 that can be used to modify an organism’s DNA by insertion, deletion, or substitution of nucleotides at a specific site in the genome. EPA, FDA, and USDA have each taken preliminary steps to engage with the public and various stakeholders as part of the evaluation process for these new techniques. Just as recombinant DNA technology allows for valuable new traits such as disease resistance and enhanced yield to be added to a variety of plants and animals more rapidly and with greater precision than with conventional techniques, there is strong evidence that genome editing will dramatically improve breeding.

Given the anticipated benefits of genome editing in enabling scientists to tackle the spread of new pathogens, the need to feed a growing world population, and the adverse effects of climate change, the pressure to establish a clear, science-based path to commercialization will surely continue to mount. Once again, cautionary arguments have been made and voices have been raised in opposition. This time around, however, we are no longer at the dawn of the genetic engineering age. Scientists and regulators have a wealth of studies—and experience—to draw on in charting a path forward.

So what have we learned in over 45 years operating under the NIH Guidelines and over 35 years under the Coordinated Framework? Researchers developing GE food and agricultural products have carried out many thousands of controlled laboratory and greenhouse experiments and thousands more of controlled field trials without any reported harm to health, safety, or the environment. Hundreds of beneficial new GE products have successfully completed premarket review and are in widespread use, again without any evidence of having caused adverse effects. Notwithstanding the advanced state of the science and the enviable safety record for these products, court challenges against the regulatory agencies have continued over the past 35 years. Even in those few cases that succeeded, no court has ever found that a GE food or agricultural product was harmful.

Certainly, a legitimate argument can be made that, based on the science alone, there has been no demonstrated need for premarket review of most categories of biotechnology products. So, for example, the closer a GE product comes to its conventionally bred counterpart, the stronger that argument becomes. If the conventional product is regulated solely post-market, then the same should apply to a GE product that meets specified criteria. Like products should be treated the same under the law. This is particularly relevant for gene-editing applications where the resultant products are similar or indistinguishable from conventional counterparts.

Exemptions from premarket review will likely trigger public and political pushback given the puzzling persistence of anti-biotechnology sentiment in some quarters, which is all the more reason for transparency in the risk assessment process. The regulatory agencies have managed to thread this needle for decades and can be expected to continue to find a path forward that respects both the science and the nature of our democratic system of government—including the desire for transparency. Thus, as in the past, each agency should remain open to the identification of individual products or categories of products, regardless of the method of production, that either no longer warrant premarket review or qualify for a reduced level of oversight. While some have called for totally new models and types of regulation for biotechnology, that would almost certainly require authorizing legislation with its inherent risks to future scientific advances.

Perhaps the most persuasive remaining justification for continued premarket oversight is the need to increase public acceptance, particularly with regard to food safety, where some still harbor unfounded fears of effects on nutrition and health. Concerned citizens have not hesitated over the years to demonstrate against the technology, boycott producers, retailers, and restaurants that sell GE food products, and campaign for consumer choice. The message to the regulatory agencies from the continued legal challenges and public opposition seems clear. As Judge MacKinnon advised in 1985, there are “lay concerns that must here be satisfied.” Continued emphasis on public education and outreach through all available means with respect to biotechnology, including genome editing, may ultimately help turn the tide.

An encouraging step was recently taken to facilitate consumer choice by food and biotechnology industries and virtually all other stakeholders when agreement was reached on legislation to create a National Bioengineered Food Disclosure Standard. The statute, which had bipartisan support on Capitol Hill, was signed into law by President Obama in 2016, and directs USDA to establish a mandatory, uniform national disclosure standard for human food that is or may be bioengineered. USDA promulgated establishing regulations in 2018. Disclosure of bioengineered content in covered food products became mandatory through labeling or other approved means just this year, adding a useful counterpart to labeling standards under USDA’s National Organic Program.

While consumers acquaint themselves with disclosure under the new standard, one can certainly argue that it is time for USDA, EPA, and FDA to revisit their current premarket review programs with an eye toward using the extensive experience gained over the past 35 years and the enviable safety record of existing biotechnology products to identify appropriate, science-based opportunities for product exemptions and reduced premarket oversight. There is no need for new legislation. Each of the programs that cover food and agricultural products is science-based, and the governing statutes provide the authority to update policies, guidelines, and regulations, as needed, to reflect current scientific understanding and real-world experience.

Regulation exists to meet government’s responsibility toward society. At this time the federal government is faced with the need to meet several challenging health and environmental concerns that can be addressed using the techniques of modern biotechnology to develop valuable and, in some cases, desperately needed new products. A transparent, science-based regulatory process that recognizes the need for flexibility and the willingness to use it would best meet this objective. TEF

OPENING ARGUMENT Under intensive regulatory, commercial, and academic oversight, and notwithstanding its widespread and rapid rate of adoption, biotechnology has produced huge gains in well-being that have flowed to society without any evidence of adverse health or environmental effects.

Water Officer of the United States
Author
Akielly Hu - Environmental Law Institute
Environmental Law Institute
Current Issue
Issue
3
 Radhika Fox smiling at the camera and wearing a white blazer and black shirt

In a political climate marked by polarization and division, sometimes you need a tangible reminder of how interconnected we are. For Radhika Fox, this uniter comes in the shape of one of our most important, yet underappreciated resources: water. Even when we are unable to come to terms with our interdependence, the evidence is plain to see. “If there’s somebody upstream, there’s always somebody else downstream. That’s the nature of the water cycle,” says the country’s most senior water policy official.

A day-one appointee in the Biden administration, Fox was officially sworn in as assistant administrator for water at the U.S. Environmental Protection Agency on June 16, 2021. She is the first woman of color and the first person of Asian American heritage to ever hold the position—a historic moment for the water office.

It’s also “a historic moment for water,” as Fox says. Half a year after her confirmation, the bipartisan infrastructure law injected into the economy more than $50 billion for clean water—the greatest single federal investment in water in the nation’s history. As new infrastructure funds flow through the country, all eyes are on EPA and its Office of Water to tackle some of the most complex and important issues facing this vital resource.

On the most basic level, Fox and her team’s job is to keep the nation’s surface waters clean and its drinking water safe. These Herculean tasks require implementing an alphabet soup of regulations and statutes, most importantly the federal Clean Water Act and the Safe Drinking Water Act. Policymakers at the water office draw out rules to regulate the filling of wetlands and the discharge of pollutants, among other duties.

The water team is also taking on many of the nation’s most pernicious environmental injustices, including lead, per- and polyfluoroalkyl substances, or PFAS, and other toxics in drinking water. Fox has named these issues as top priorities for her tenure. “There’s nothing more fundamental and more essential than equity in the context of water management,” she says.

“I mean, just think about your day, right? You can’t get through your day without access to clean, safe water, whether that’s having that cup of coffee or a glass of water, or being able to provide safe water for your children. Unfortunately, millions of people in this country and all around the world don’t have that fundamental, basic security,” Fox says.

Crises like the lead poisoning in Flint and Benton Harbor, Michigan, have made clear the urgent need for improved, equitable water management. Exposure to lead, particularly in drinking water, disproportionately affects low-income communities and communities of color. The contaminant impairs neural development in children and causes greater risk of kidney failure and stroke, among other health conditions. According to the White House, lead pipes run through an estimated 6 to 10 million homes, plus another 400,000 schools and child care centers.

Early on in his presidency, President Biden announced a goal to replace all lead service lines in the United States. The directive relies heavily on the Office of Water’s regulatory muscles, particularly when it comes to tightening protections under the Lead and Copper Rule, a Safe Drinking Water Act-related regulation published by EPA to limit these substances.

LCR has spun through a turnstile of revisions over the years. In December 2021, EPA announced the office would develop new revisions to the rule, to make the regulation more protective than its current version. “We had a huge, robust public engagement process last year with communities who are on the front lines of the lead crisis, tribal nations, co-regulators, and national associations,” Fox says of the upcoming rule.

In an earlier E&E News interview, Fox clarified that these roundtables would help close a crucial gap in understanding. “We know historically that we haven’t really considered enough the way in which the Lead and Copper Rule impacts people of color,” she said. EPA expects to finalize the new revisions by October 2024.

Concurrently, the water office is moving forward on policies to limit PFAS. These so-called “forever chemicals” are found in the bodies of virtually all Americans, and are associated with cancer, immune disorders, and developmental issues, among a host of other health harms. Fox co-chairs the EPA Council on PFAS, along with the agency’s Region 1 Deputy Regional Administrator Deborah Szaro. The group coordinates agency-wide efforts on PFAS according to a timeline in the council’s strategic roadmap. Targeted actions include regulating PFAS under the SDWA and minimizing chemical discharges in wastewater.

Although many of these rulemakings are still in progress, Fox says she is already “incredibly honored to be in this role as assistant administrator for water to continue the journey toward water equity and justice.” Growing up, her understanding of the disparities between communities and countries developed on an intuitive level, rather than as a conscious awakening.

“My commitment to equity and justice and opportunity for all comes from my upbringing, first and foremost. I am the child of immigrants who came to this country searching for economic opportunity, and I very much stand on their shoulders,” she says.

Fox’s parents grew up in rural India, and her grandparents worked as small farmers, growing rice, lemons, and bananas. Water was essential to her family’s agricultural livelihood. At the same time, their village lacked tap water or flush toilets; the family relied on drinking wells and pit latrines.

Her family regularly traveled back to her grandparents’ village during the summers of her childhood, an experience that allowed her to “see how infrastructure, especially water systems that we didn’t have at my grandmother’s village, can create these communities of opportunity.”

“I think equity is deeply ingrained in who I am because of my background, and from recognizing that the opportunities afforded to you are often random—like from whom and where you were born. I have always felt a desire to give back because I have been given so much opportunity by my family,” she says.

As an undergraduate student at Columbia University, Fox volunteered in Harlem and “saw firsthand how there are so many systems and structures that afford opportunity to some, but not to others.” The experience affirmed a lifelong commitment to equity and justice. Even in her earlier work on infrastructure, housing, and transportation, environmental justice served as “a thread through all of those experiences.”

Fox describes her career trajectory as “grounded in infrastructure.” After more than a decade as the federal policy director at PolicyLink, a research institute dedicated to racial and economic equity, she joined the San Francisco Public Utilities Commission as director of policy and government affairs, helping to provide water and wastewater services to more than 2.6 million Bay Area residents.

“What drew me to the SFPUC was their infrastructure work. The biggest tributary to infrastructure investment in San Francisco is actually the water department. People don’t realize that, so although I went there for infrastructure, I fell in love with working on all kinds of water issues,” Fox says.

She continued to make her mark on the water world as CEO of the national nonprofit U.S. Water Alliance. There her stature began to be generally acknowledged. “Radhika Fox is a significant figure in the water sector—a woman with tremendous respect and standing in the community,” says Tracy Mehan, former assistant administrator for water under the George W. Bush administration. At the Water Alliance, Fox worked to find common ground between water utilities, businesses, nonprofits, and other water sector stakeholders for more than five years before joining EPA.

What sets Fox apart from other bureaucrats is a grounding of policies in the lived, on-the-ground experience of everyday people. Fox has frequently mentioned in public statements that her team’s policymaking will be guided by a principle of “listening to all sides to find enduring solutions.” The philosophy has been a “through line” in her career, and will be put to the ultimate test for reaching consensus on one of water’s most contentious policy issues—the Waters of the United States rule.

Under written law, Clean Water Act jurisdiction extends to any area designated as “Waters of the United States.” What exactly these include is something policymakers have failed to achieve consensus on since the 1980s. A confusing definition of WOTUS jeopardizes the ability of governments at every level to protect the nation’s waters, for a simple reason—whatever doesn’t count, doesn’t get regulated under the federal law.

One sticking point is whether ephemeral or intermittent streams should be covered. The issue has significant implications for the arid Southwest, where water levels tend to fluctuate much more than other areas of the United States. Relentless back-and-forth between administrations, and court decisions over the decades that have introduced even more confusion, has left a patchwork of jurisdictional definitions operating in the country.

Fox describes the last decade of the WOTUS debacle as a “constant ping-pong.” In 2015, the Obama administration issued a Clean Water Rule to define WOTUS. That definition was later rescinded by the Trump administration and replaced with the Navigable Waters Protection Rule in 2020, a regulation that High Country News said would potentially “exclude as many as 94 percent of Arizona’s and 66 percent of California’s streams and rivers from federal oversight, depending on how regulators interpret it.” The rule was eventually vacated by a federal district court in Arizona in 2021.

Overhauling WOTUS is a focal point for Fox’s tenure in the Office of Water. In her Senate confirmation hearing, Fox affirmed, “Administrator [Michael] Regan and I want an enduring definition of Waters of the U.S., one that can withstand administration changes.” So far, the agency has initiated a two-part rulemaking process that first restores a version of the pre-2015 WOTUS definition. Next, the office will establish a brand new definition, potentially settling the matter once and for all.

Establishing a lasting rule won’t be easy. In a podcast interview with Fox, David Ross, the former assistant administrator for water under the Trump administration, delivers brief advice that sounds more like an inside joke: “I’m just going to say: ‘Good luck.’”

Fox and her team have committed to a system of robust public engagement to guide the office’s decisionmaking. The process involves a series of stakeholder meetings and 10 regional roundtables to be held over the coming spring and summer. Roundtable discussions will include representatives from water and wastewater service providers, agriculture, environmental justice communities, tribal nations, and state and local governments, among other groups.

“It’s an issue where there is so much division. What we have been focused on is: how do we get to a durable definition of waters of the United States, one that tries to balance the very diverse perspectives that have a stake in this definition? I believe that we’re not going to be able to do that unless we listen to all sides,” she says.

Believing that different sides can reach consensus feels radical nowadays, especially in a country with as entrenched social and political chasms as the United States. But Fox believes in the power of hearing from someone you may have never otherwise crossed paths with—and she’s seen it in practice.

In her first year as CEO of the U.S. Water Alliance, Fox helped create the Water Equity Network, a program that guides utilities in building equitable water systems. The idea was borne from a desire to act on the severe human health issues faced in the Flint water crisis and beyond, as well as lessons learned at the San Francisco Public Utilities Commission.

“My experience at the SFPUC proved that water agencies can be community anchor institutions. We were the first utility in the nation to adopt a community benefits and environmental justice policy, and I saw how water agencies are fundamental to the solution,” she says. The organization invited cities like Atlanta, Buffalo, Cleveland, Camden, Milwaukee, and Pittsburgh, among others to participate. It gathered water agencies, local officials, and frontline community organizations most impacted by water-related challenges—including lead, contaminated water, PFAS, and flooding—and forced everybody to listen to all sides.

“The water managers—these technical leaders—heard firsthand from people whose water had been shut off. They learned what that meant for them, and what that meant for their children. These were people who had their basements flooded, and were just living in conditions that no one should have to live in,” she recounts. “The water managers heard directly from those communities, and in turn, the communities heard about the constraints that water managers face. There were so many breakthrough solutions that happened because we created a space for a deliberate, thoughtful airing of all of the issues.”

To Fox, public engagement is not just a box to be checked off. She believes that centering these lived experiences strengthens decisionmaking in a substantial way. “When we listen to all sides—when we embrace the complexity of the issues that we’re tackling in the water sector—we can actually reach better outcomes because of that listening. It leads to a different set of solutions,” she says. “That’s why this principle is so foundational to how I think about the work that I do every day."

Fox's leadership, woven with a philosophy that aligns with the Biden administration’s investments in environmental justice, comes at an opportune time. Yet the choice is deliberate: diversity within the country’s top political officials is a minimum requirement for more representative, people-first policies. As Fox puts it in a Politico interview, “I think selecting somebody like me—frankly, as a woman of color in this leadership role—is also part of the Biden-Harris commitment to building a federal team that reflects the diversity of this nation.”

In the coming years, the Office of Water’s responsibilities will only grow, particularly when it comes to ensuring that new funds under the bipartisan infrastructure law go to those who need it most. About 85 percent of those funds will flow through State Revolving Funds, or SRFs, the main channel for distributing money for water infrastructure and projects. The infrastructure law mandates that 49 percent of this money must go to disadvantaged communities as grants and forgivable loans. But what exactly constitutes a disadvantaged community is under the discretion of states.

On March 8, the water office released a 56-page memo to state SRF program managers and EPA regional water division directors to provide guidance on stewarding these funds and clarify responsibilities states have to disadvantaged communities. “The memo encourages states to look at their definition of disadvantaged communities to make sure it’s consistent with statutes, and provides guidance on preferred factors that should be considered when making the investments in disadvantaged communities,” Fox says.

“The water sector can and must do better to steer all kinds of investments, whether it’s the bipartisan infrastructure law money or other infrastructure funding programs, to these communities,” she says. “With so much money on the table, and so many challenges that we see around the country, I think this is the moment to meet the needs of all communities.”

She emphasizes that the memo is only the first step in EPA’s work to ensure that the historic investments in water don’t leave anyone behind. “One exciting thing that is coming later this year is a very robust technical assistance strategy to help disadvantaged communities build their technical, financial, and managerial capacity to receive these funds. We’re quite excited to work with states, tribes, and territories in that next phase.”

This year marks the 50th anniversary of the Clean Water Act, a law passed during a time when rivers caught on fire from unchecked pollution. Fox says there is still much work to be done. Today, many of the most insidious water issues are invisible, even though their effects may not be. Millions of Americans depend on the work of the Office of Water and its ongoing rulemakings. The stakes are high, and so is the pressure on Fox’s team.

Nonetheless, Fox’s optimism remains grounded in the importance of this work, and the power of water to connect us.

“I think that one of our foundational principles as a nation should be to recognize that water is essential to everyone—to every business, to every community, to every person, and to use that as our north star as we develop future policies.” TEF

PROFILE EPA Assistant Administrator Radhika Fox speaks on her journey to water, the historic infrastructure law investments, and her team’s approach to managing the country’s most essential resource.

False Promise of Cost-Benefit Analysis
Author
Amy Sinden - Temple University School of Law
Temple University School of Law
Current Issue
Issue
2
Parent Article
Amy Sinden headshot

Making decisions is hard in environmental policy. It requires grappling with controversial value choices, complex systems, and vast uncertainties about future outcomes. Perhaps it’s no surprise then that the promise of cost-benefit analysis—the idea that we can just plug numbers into a mathematical formula that will spit out objectively determined, welfare-maximizing public policy prescriptions—is almost irresistibly alluring.

But it’s a false promise. EPA regulates literally hundreds of pollutants that we know cause serious harm to human health and the environment. But knowing something is one thing; being able to quantify it is another. For the vast majority of these pollutants, the agency simply doesn’t have the fine-grained data necessary to put a dollar figure on the benefits of controlling them. These data gaps are so pervasive that most of the time, they prevent EPA’s cost-benefit analyses from monetizing whole categories of benefits the agency itself views as significant. A study I published in 2019 showed that happening in 80 percent of the agency’s major rulemakings issued between 2002 and 2015. Indeed, the problem is so severe that in many instances, EPA is entirely unable to quantify any of the impacts associated with the pollutants a regulation is designed to control.

And all of this is to say nothing of values—like dignity, equity, or human suffering—that resist quantification altogether.

If a CBA can’t put a dollar figure on all the significant categories of benefit, it can’t calculate net benefits. And if it can’t calculate net benefits, formal CBA really doesn’t tell you much. It certainly can’t lead you to the Shangri-La of net benefits maximization promised by its proponents. The result is that the CBA requirement effectively ends up imposing a burden of proof on agencies that is in many instances insurmountable, putting a chilling effect on the implementation of regulatory safeguards. EPA personnel are afraid to propose rules with unquantifiable benefits that prevent the cost-benefit math from coming out right—for fear of reprimand by the bean counters at the White House’s Office of Information and Regulatory Affairs. Under a set of executive orders dating back to President Reagan, that little-known but powerful office houses a small group of economists responsible for ensuring that federal regulations pass the CBA test.

It was worries about precisely this kind of dynamic that led Congress to largely avoid formal CBA in crafting the statutes from which most of our biggest and most contentious environmental regulations originate. Instead, lawmakers came up with a lot of creative ways to make sure costs are kept in check and are not disproportionate to benefits, without requiring them to be directly weighed against each other. In this way, they avoid the need to express regulatory benefits—things like saving lives or preventing neurological damage to kids—in monetary terms.

These are the scrappy, street-smart tools of regulatory decisionmaking—tools like feasibility analysis, cost-effectiveness analysis, and multi-factor balancing. In contexts in which significant benefits (or costs) can’t be quantified, these tools can often provide a more useful framework for rational decisionmaking. And while they may look less elegant in theory, they have a proven track record of actually reducing pollution levels in the real world. But the current hyper-formalistic approach to CBA that has become de rigueur under the regulatory review executive orders is often in tension with these statutory requirements.

In reforming the regulatory review process, President Biden should resist the false allure of CBA and instead reaffirm the primacy of federal agencies and their statutory mandates in regulatory decision-making. He should dispense with the CBA mandate, directing the agencies to instead use the context-specific methods set out in their authorizing statutes for considering the costs and benefits of regulations. These tools are pragmatic, effective, and tailored to specific contexts and information constraints—designed to take advantage of the information we have rather than the information we wish we had.

Illuminating PFAS Risks Among EPA Program's Top Challenges
Author
David P. Clarke - Writer
Writer
Current Issue
David P. Clarke

Ignorance is not bliss when it comes to exposure to PFAS, known to scientists as per- and poly-fluoroalkyl substances and to activists as “forever chemicals.” Six North Carolina environmental groups say they will be kept in the dark after EPA’s “inadequate” response to a petition requesting health studies to understand the risks their communities face from a Chemours plant that manufactured the substances. The agency says it “granted” their petition, reversing a Trump EPA denial, but the “deeply disappointed” activists disagree and have decided to sue.

The petitioners’ concerns may be a harbinger of a broader hue and cry as national concerns rise over PFAS—comprising some 4,700 chemicals that break down slowly and are found in drinking water supplies across the United States as well as in the air, food, and soil. As a result, “PFAS are present in the bodies of nearly all people living in the U.S., Europe, and most of the world,” according to a letter over a dozen scientists sent EPA supporting the petition.

PFAS are ubiquitous because they have been used in industrial and consumer products since the 1940s. They are used in fast-food containers, stain repellants, and electronics. EPA cites diverse health concerns from certain exposure levels, including increased prostate, kidney, and other cancer risks, developmental delays in children, and reduced immune system effectiveness.

Activists demanding EPA action know about PFAS discharges into the Cape Fear River, a drinking water source for about 400,000 people, since they led to a $12 million fine by the N.C. Department of Environmental Quality—then led by Michael Regan, who heads the federal EPA today. Rather, their concern is not knowing “what they’ve done to us,” says Bob Sussman, a former EPA deputy administrator representing the local groups. [Disclosure: Sussman is the Forum’s climate change columnist—Ed.] They have asked for comprehensive testing on 54 PFAS to understand the health risks and medical markers that should be monitored.

EPA claims that Biden’s National PFAS Testing Strategy, released last October, meets the petition’s goals. “But it really doesn’t,” Sussman says. The strategy will test 24 chemicals the agency says are representative of various PFAS categories, but it includes only seven of the 54 requested. Moreover, EPA declined to require an epidemiology study using extensive available exposure data—“the most important thing we asked for,” he adds. The agency also did not require testing of mixtures the communities are exposed to, saying testing individual components is the best approach. But EPA is not testing individual components the petitioners want to understand, either, Sussman says.

The communities’ dispute is occurring as the Biden administration unfolds a program involving eight federal agencies in combatting PFAS pollution. The Defense Department, for example, is cleaning up 700 of its sites where PFAS were used, and the Food and Drug Administration is expanding its testing to calculate food supply exposures. The bipartisan infrastructure law enacted in November also included $10 billion in state and local grants to address PFAS pollution.

The cornerstone of the White House plan is EPA’s three-year PFAS Roadmap, a “whole of agency” approach—published together with the testing strategy. It is aimed at tackling multiple routes of exposure to the chemicals through their full lifecycle. In the roadmap’s prefatory note, Regan called out the “decades of unchecked devastation” in the Cape Fear River area, raising petitioners’ hopes that the agency would pursue more aggressive policies.

The agency’s testing strategy notes that limited or no toxicity data is available for most of the hundreds of PFAS currently in commerce. Expeditiously understanding or addressing PFAS risks would be impossible if EPA tried to research the chemicals one at a time, the strategy says.

Adding to the gargantuan PFAS challenge confronting the agency are broader problems facing its chemicals program. During a House Energy and Commerce subcommittee hearing on Toxic Substances Control Act implementation, EPA’s Office of Chemical Safety and Pollution Prevention assistant administrator, Michael Freedhoff, recalled his shock after learning the program is “incredibly underfunded,” despite new responsibilities added by TSCA’s 2016 overhaul. Freedhoff says the agency has less than 50 percent of the resources needed to implement the new chemicals program as Congress intended. Additionally, EPA’s chemicals office is “hamstrung” by shortages of scientific specialists and high staff attrition from a “toxic workplace,” according to the nonprofit watchdog group Public Employees for Environmental Responsibility.

Citizens don’t know the degree of their exposure, and policymakers don’t know if EPA can handle the new toxics law’s program to evaluate the risks of thousands of chemicals in commerce.

Illuminating PFAS Risks Among EPA Program's Top Challenges