Tackling PFAS Must Start at the Source
Melanie Benesh - Environmental Working Group
Environmental Working Group
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The scale of contamination from per- and polyfluoroalkyl substances, or PFAS, is astonishing. PFAS have been identified at more than 2,800 sites in 50 states and contaminates the drinking water of more than 200 million Americans. EPA has taken a critical step to address existing pollution by proposing to designate two notorious PFAS—PFOA and PFOS— as hazardous substances under CERCLA, the Superfund law. By the end of the year, the agency will also propose drinking water limits for the two chemicals.

Unfortunately, we cannot simply clean our way out of the contamination crisis. To effectively address PFAS, it’s imperative that EPA prioritize stopping releases at the source to mitigate future damage.

PFAS are released into the environment from both industrial and consumer sources. Their uses are ubiquitous—a recent analysis identified more than 1,400 PFAS in more than 200 use categories. Experts have identified more than 40,000 potential industrial dischargers of PFAS in the United States.

To tackle PFAS at the source, the government should quickly impose Effluent Limitation Guidelines on PFAS-discharging industries, incorporate PFAS into clean water discharge permits, address releases in air, and eliminate non-essential consumer uses.

EPA has promised to propose ELGs for chemical manufacturers by summer 2023 and for metal finishers and electroplaters by summer 2024. The agency has also committed to detailed studies on electronics manufacturers, textile mills, and landfills, and data reviews on leather tanners, plastics molders, and paint formulators, but has not set deadlines for proposed rules. As a result, it will be years, or even decades, before EPA has effluent limitations for most industrial dischargers. By contrast, Congress has proposed legislation, the Clean Water Standards for PFAS Act 2.0, that would require all nine of the industry categories identified in the agency’s PFAS Roadmap to have discharge limits by the end of 2026.

EPA can and should accelerate its timeframe for restrictions on industrial discharges. But it can also do more to reduce PFAS discharges through permits in the meantime. The agency released new guidance for federal permit writers in April but has been slow to incorporate PFAS into EPA-issued water pollution permits. EPA should immediately start imposing discharge limits and monitoring requirements into these permits. The agency should also impose pretreatment requirements for discharges in the eight states where EPA administers the National Pretreatment Program.

Most discharge permits are handled by state authorities. The agency has committed to release guidance for state permit writers, but states should not wait for EPA. Some states, like Michigan, Colorado, and Alabama, have already started incorporating PFAS requirements into their state-issued permits and more should follow suit.

Air is also an underappreciated source of PFAS in the environment. PFAS released from air stacks contaminates land and water through deposition. EPA has developed a test method to measure 50 PFAS in air and a handful of facilities have had to install thermal oxidizers as a part of legal consent agreements, but there are no federal requirements to monitor or limit emissions. The agency is slated to announce “air mitigation options” but has yet to commit to any regulations.

In addition to discharges from industrial sources, people are regularly exposed to PFAS through consumer products. Household waste also contributes a significant amount of PFAS in influent sent to publicly owned treatment works. Many consumer uses, such as food packaging, cosmetics, and carpeting, are unnecessary uses with safer alternatives already widely available. Several states have banned certain non-essential uses and Maine has banned all non-essential uses by 2030. Federal regulators should restrict or eliminate unnecessary uses wherever possible. The federal government can also influence the marketplace by requiring PFAS-free alternatives in procurement contracts.

New Jersey Will Resolve PFAS Problems
Shawn M. LaTourette - New Jersey Commissioner of Environmental Protection
New Jersey Commissioner of Environmental Protection
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For decades, New Jersey’s textiles, metals, electronics, and chemicals industries powered America, improving quality of life for millions, but leaving later generations to clean up the unintended environmental harm. The birthplace of America’s industrial revolution, our state also has a long, proud, and bipartisan history of national leadership in restoring and improving environmental quality.

That legacy has left us somewhat prescient. Chances are, if you are reckoning with an emerging contaminant, it has already emerged here, and the New Jersey Department of Environmental Protection is busy wrestling it out of the ground. After all, the federal Superfund law was modeled on the earlier New Jersey Spill Act. We boast the most contaminated sites in the country because we seek them out and clean them up—a mark not of indignity, but of our resolve.

So too is the New Jersey story of PFAS now turning up in water supplies across the country, scarring natural resources around the globe, and finally receiving due attention from the U.S. Environmental Protection Agency. New Jersey was home to a manufacturing epicenter that discharged loads of the so-called “forever chemicals” into our surface waters, soil, wetlands, groundwater, and air. As a result, we now find PFAS in our drinking water supplies, our wildlife, and our blood serum.

But we are cleaning up.

When PFAS were initially detected, in 2006, NJDEP got to work on the nation’s first statewide occurrence studies of PFAS in public drinking water, leading analytical efforts and research on the health effects of exposure. Later waterway sampling deepened our understanding of bioaccumulation in fish, triggering consumption advisories.

Our eyes opened to the widespread and persistent environmental and public health risks, New Jersey became the first state to enact a regulatory standard for monitoring and removing a PFAS compound from drinking water. NJDEP has now promulgated health-based drinking water Maximum Contaminant Levels for PFNA, PFOA, and PFOS, as well as groundwater standards governing cleanup of these three if found at contaminated sites. And, most recently, our agency established soil remediation standards for these chemicals.

Today, 76 New Jersey drinking water systems have PFAS at levels that exceed health-based standards, placing a new multi-million-dollar treatment burden on each utility and its ratepayers. PFAS also lurks in wastewater discharged from sewage treatment plants that could similarly require expensive infrastructure improvements. PFAS-contaminated groundwater plumes plague New Jersey, impairing private drinking water wells and complicating brownfields remediation and redevelopment.

Other states are too confronting the PFAS fallout, and its magnitude demands concerted federal legislative action to deliver the financial resources necessary to clean up what is a national mess.

New Jersey refuses to wait. With the resources available, our agency is defraying the cost of PFAS treatment for public utilities and aiding homeowners with contaminated private wells. Our people are working collaboratively with wastewater systems to identify risks, and with licensed “site remediation professionals” to remove PFAS found in soil and groundwater. And, to prevent manufacturers from leaving New Jersey taxpayers to clean up after them, NJDEP is pursuing multiple lawsuits to hold responsible parties accountable.

To discount or leave these threats lying in wait for later generations would be convenient—but unconscionable. We lean instead on the gift left by our industrial legacy and the environmental quality champions who followed—like former Governor Jim Florio, who as a congressman was an author of the Superfund law. New Jersey has resolved to advance the science and regulate accordingly, to make public investments in cleanup solutions, and to hold responsible parties accountable for their pollution. We resolve to leave the place better than we found it.

The Everywhere Chemicals
Alexandra Dapolito Dunn - Baker Botts
Baker Botts
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Person standing in a kitchen, with the microwave popcorn, plastic water bottle, and fire extinguisher highlighted

In one way or another, most of us come into daily contact with a member of the family of chemicals known as PFAS—or more properly, as per- and polyfluoroalkyl substances. Largely due to their unique non-stick and grease-and-oil-resistant properties, PFAS can be found in cookware and household fire extinguishers—and also in food packaging, personal care and hygiene products, plus carpeting, candy wrappers, and paint. In addition to consumer goods, PFAS are also widely used industrially in the aerospace, automotive, construction, electronics, and military sectors.

Due to their widespread deployment across society, PFAS are ever-present in the environment—in drinking water, soil, and air. They are found in the leachate and soil surrounding landfills and disposal sites, around the production facilities that either manufacture or formulate PFAS, and at industrial sites where companies commonly used PFAS, such as metal plating and certain textile and paper mills. PFAS are detectable in drinking water sources in every state, as well as in many biosolids and residuals that leave wastewater treatment plants for land application. EPA and nongovernmental organization estimates of PFAS-contaminated sites nationwide range from 1,200 to nearly 3,000.

Of equally great concern as environmental contamination is the Center for Disease Control’s finding that PFAS have bioaccumulated in detectable levels in the blood of 97 to 99 percent of Americans. The effect of PFAS in the human body—and at various life stages—is under study, with the CDC identifying adverse health impacts that include increased cholesterol levels; decreased vaccine response in children; changes in liver enzymes; increased risk of high blood pressure or pre-eclampsia in pregnant women; small decreases in infant birth weights; and increased risk of kidney or testicular cancer. The millions of people with PFAS in their drinking water, one of the most likely pathways of exposure, are demanding response from manufacturers, water suppliers, and the government.

As with many chemicals in our society, PFAS were developed to address industrial needs, and since those needs still exist, new, generally less-persistent and less-toxic forms of PFAS chemistry are still being authorized today by EPA to enter commerce. Businesses identified this unique chemistry in the 1930s and 1940s—with PFAS taking the supply chain by storm through products like Scotchguard (1956) and Teflon (widespread by the 1960s). PFAS-containing firefighting foams were adopted by the military in the mid-1960s, with use soon to be required by other federal agencies, such as the Federal Aviation Administration.

So how many PFAS are there? The CDC estimates that over 9,000 different substances have entered commerce under that classification. Some of the most persistent forms, based on long chains of eight carbon atoms and known as C8s, were voluntarily phased out by the eight major U.S. manufacturers through an EPA stewardship program that reached its goal in 2015. The chemistry of these long chains is what made them so useful in so many consumer and industrial applications. C8s do not easily break down, which adds to product durability and effectiveness, but problematically they also do not break down in the environment. This was the trait that earned PFAS the shorthand descriptor of “forever chemicals.” While C8s are not made in the United States any longer, there are large stockpiles of C8 foams and other products throughout the nation. Alternative, shorter carbon-chain PFAS products have entered the market as a replacement. These are known as C6s and by other chemical names, and they show slightly less toxicity but continued persistence, including bioaccumulation in the environment, in fish and wildlife, and in the human body. In fact, they are so persistent that a half-life for these chemistries has yet to be determined.

PFAS are also referred to as an “emerging contaminant.” However, while our scientific understanding of how to remediate, destroy, and address PFAS due to their prevalence may be emerging, as noted, PFAS have been used for over 70 years, and approaches to mitigate their risk have been the topic of discussion and litigation for decades. For example, one of the first PFAS lawsuits was filed in 1999, Tennan v. DuPont, and EPA’s stewardship program was launched seven years later.

Digging deeper, though, there are aspects of PFAS that align with the more traditional characteristics of emerging contaminants, such as evolving toxicity and exposure data; incomplete risk assessments and confusing risk communication; lack of management tools; undeveloped analytical methods; and a seriously lagging, patchwork regulatory scheme. New toxicology information on members of the PFAS family is released almost weekly; at the same time, new analytical methods are being developed and validated. Importantly, many state and federal PFAS advisory levels are below the detection methods available to laboratories. The ability to replicate scientific testing of a particular contaminant at any laboratory is critical to allowing national assessment, verification of testing results, and even for use in liability litigation. Additionally, while the federal government is working toward developing a comprehensive regulatory framework governing PFAS, there is a lot of work still being done by states, academia, and a variety of stakeholders.

Building on the stewardship program and other EPA actions, the agency released a comprehensive PFAS Action Plan in 2018. EPA held many community forums and made some progress, particularly toward preparing testing for two PFAS family members, PFOA and PFOS, under Unregulated Contaminant Monitoring Rule V, and toward the determination needed to regulate both under the Safe Drinking Water Act. The agency finalized this regulatory determination last April, under its 2021 PFAS Roadmap. The roadmap takes a “whole of agency” approach to these chemicals, and also reaches out to the entire federal scientific and policy family in advancing comprehensive approaches. A final rule to set Maximum Contaminant Levels and Maximum Contaminant Level Goals under the SDWA was expected by late 2022.

In addition to the SDWA actions, EPA articulates other key PFAS goals in its roadmap, including: setting Effluent Limitation Guidelines and using Clean Water Act permitting authority to limit PFAS discharges from industrial sources; and designating two, PFOA and PFOS, as “hazardous substances” under the Superfund law. EPA is well on its way to advancing these goals.

Last June, the agency released four interim drinking water health advisories for PFAS. These advisories replaced the 2016 ones, lowering the safe lifetime exposure from drinking water levels of PFOA to 0.004 parts per trillion, to 0.02 parts per trillion for PFOS, and setting limits for “GenX” at 10 parts per trillion and PFBS at 2,000 parts per trillion. These numbers cannot be measured by current test methods or laboratory techniques.

Further, in September, EPA formally proposed to designate two specific PFOA and PFOS chemicals as “hazardous substances” under Section 102(a) of CERCLA—marking the first time ever that EPA would directly list a hazardous substance through the Superfund law versus taking its list of hazardous substances from other statutes—such as the Resource Conservation and Recovery Act, the Clean Air Act, or the Clean Water Act. If finalized, EPA’s rule would set a reportable quantity of one pound of PFOA or PFOS, meaning that anyone in charge of a vessel or facility who has knowledge of a release of one pound or more within a 24-hour period would be required to immediately report the release to federal, state, tribal, and local authorities. It would also allow for cost recovery and contribution actions for expenses incurred in cleaning up releases of those PFAS. Hundreds of Superfund sites across the country could be reopened to address the presence of PFOA and PFOS at them—chemicals that were never considered when many sites were declared remediated.

Indeed, companies are already being notified that their five-year closure reviews are now going to take PFOA and PFOS into account, while others are receiving CERCLA 104(e) requests for information about PFAS use at sites long complete. Many stakeholders are awaiting EPA’s final PFAS destruction guidance, which will set best practices for managing historic stockpiles of these chemicals and will be needed to manage reopened or new sites.

Other federal agencies are taking action too. Last May, the Department of Defense published a draft Military Specification on new PFAS-free firefighting foam. The draft version of the MILSPEC was released for public comment shortly thereafter. If approved, it is expected that the FAA will adopt the standard for commercial airports. Adoption of this standard would significantly reduce the continued use of PFAS-containing AFFF, aqueous film-forming foam, which is utilized for jet fuel fires—however, an accepted, fully viable substitute for the current formulations of this foam does not exist. This could send these sources into a circular process wherein they are not to use AFFF foams but real alternatives are not available.

DOD and the Department of Homeland Security are also taking action to investigate and remediate PFAS releases from their facilities. At the same time, the Department of Agriculture is working to educate farmers and growers on what PFAS presence in their groundwater or soil may mean; the Food and Drug Administration is rapidly directing a phaseout of food containers with PFAS in them; and agencies like the CDC continue to study various exposure pathways and better characterize the health effects of exposure.

In August, the White House Council on Environmental Quality released a report that encourages EPA to expand its work identifying PFAS-free products in its recommendations on federal procurement standards. The report provides further instructions for implementing Executive Order 14057, which directs federal agencies to find substitutes and have all federal procurement products PFAS-free by 2024.

Congress is exploring many of the same areas as the federal agencies and, in some cases, seeking to accelerate their actions. Both chambers are active, though their respective bills will have to be reintroduced in the new Congress. For example, the Clean Water Standards for PFAS 2.0 Act, introduced in both chambers last session, would require EPA to publish human health water criteria for each measurable PFAS and class of PFAS within three years. It also would set deadlines for EPA to publish Effluent Limitations Guidelines and standards for certain industrial point source categories pursuant to the CWA.

Other bills in various stages of activity include the PFAS Intergovernmental Coordination Act, a Senate bill that would establish a working group of federal, state, local, and tribal government representatives to coordinate a holistic response to contamination. The PFAS Firefighter Protection Act, in both chambers, would prohibit PFAS-containing firefighting foam from being used in training and action within two years and would prohibit its use at airports by October 2024. The carefully named PROTECT Act, standing for Prevent Release of Toxics Emissions, Contamination, and Transfer Act, in both chambers, would require EPA to list the entire class of PFAS as hazardous air pollutants under the CAA and would create CERCLA liability for PFAS contamination. Finally, the Senate-passed Preventing PFAS Runoff at Airports Act would raise the federal cost share for PFAS testing at airports.

The Infrastructure Investment and Jobs Act, signed in 2021, contains $10 billion to address PFAS contamination in drinking water, while the National Defense Authorization Act for fiscal 2022 contains PFAS provisions that are focused on the Department of Defense. The fiscal 2023 NDAA, when passed, is expected to contain additional PFAS provisions.

It is extremely common that when federal regulation lags, states step into the gap if their residents are at risk. And step into this gap they have indeed. For example, according to the National Conference of State Legislatures, in 2021 states considered 196 bills related to PFAS. Many states are setting soil and groundwater cleanup standards, consumer product phaseouts, and taking other actions that are well ahead of the federal government.

While EPA works on its drinking water contaminant levels and goals, according to the nonprofit Safer States, 12 states—Alaska, California, Connecticut, Hawaii, Massachusetts, Michigan, Minnesota, New Hampshire, New Jersey, New York, Oregon, Vermont—have set action levels for where PFAS in public drinking water exceed permissible state levels. Four states—Delaware, New Hampshire, Rhode Island, and Wisconsin—are codifying state Maximum Contaminant Levels. Seven states—Maine, Massachusetts, Michigan, New Hampshire, New Jersey, New York, and Vermont—have enforceable MCLs for PFAS. The use of certain PFAS-containing firefighting foams in training and testing is banned in Colorado, Georgia, Illinois, Indiana, Washington, and Wisconsin.

Some states have passed regulations requiring studies and monitoring of PFAS bioaccumulation. Florida, Hawaii, and South Carolina passed regulations monitoring PFAS bioaccumulation in fish. Michigan, Montana, Tennessee, and Utah implemented their own state action plans to better grasp the impact of PFAS on their water and soil. These action plans involve steps like computer mapping of contaminated sites, expanding monitoring efforts for known PFAS sources, and community outreach to educate the public about potential exposure.

Some states have taken the added step of creating specific PFAS remediation and mitigation procedures. For example, the Vermont legislature codified Act 55, which requires parties that contaminate groundwater with PFAS to connect affected residents to a clean municipal water supply; Michigan created a PFAS Action Response Team, which works with federal and local partners to rapidly remediate contaminated sites; and Colorado and New Hampshire created grant programs to support PFAS remediation efforts.

States are also branching out from more traditional approaches to addressing PFAS issues. For example, Maine recently became the first state to prohibit the land application of biosolids and the sale of compost or similar products containing sludge and septage due to PFAS concerns. Under An Act to Prohibit the Contamination of Clean Soils With So-Called Forever Chemicals, biosolids can only be applied to land if they can be shown to be essentially PFAS-free. The result is that for the foreseeable future, some Maine wastewater utilities are exporting their biosolids to Canada while others are landfilling at high cost; the sustainability of both is questionable. Massachusetts proposed a bill establishing a moratorium on procuring new structures that generate PFAS emissions or modifying existing uses or structures that may generate PFAS. If ever passed, the bill would effectively halt the construction of new sewage sludge incinerators or improvements for existing incinerators. Other states have adopted programs for PFAS testing before biosolids can be land applied and are using a variety of approaches to determine what is “safe”—most of which are derived from a combination of scientific studies and policy choices.

In 2018, California became the first state to target the phasing out of PFAS used for stain resistance from carpets and rugs. Final regulations effective in 2021 list rugs and carpets containing PFAS as Priority Products under the state’s Safer Consumer Products Program. Under the regulation, domestic and foreign manufacturers whose rugs and carpets contain PFAS are required to submit a Priority Product Notification and thereafter are required to submit to the state a chemical removal notification, a product removal notification, a product-chemical replacement notification, a preliminary alternatives analysis report, or satisfy other similar reporting obligations. And Washington state, having issued two reports finding that ample alternatives exist, has embarked on a two-year process to ban PFAS-containing food packaging.

A hallmark of a patchwork and evolving domestic regulatory structure for a chemical is that litigation will fill the gap for redress much like state legislation does. Indeed, in the past few decades there have been thousands of state and federal lawsuits filed against PFAS manufacturers, PFAS users, and even municipalities. A recent litigation survey revealed that of 60 reviewed cases, 42 were brought in or removed to federal court, while 18 were pursued in state court. Of these sampled cases, plaintiff groups fell into three primary categories: state and local governments; individual and class-action suits; and private water utilities.

These cases show that the plaintiffs are primarily looking to common law for relief. (This is unsurprising given the current absence of environmental statutory language providing causes of action against PFAS manufacturers and users.) Among the claims, nuisance was the most common, followed by trespass and product liability—citing a failure to warn or a defective design. Meanwhile, state and local governments primarily sought to recover response costs for remediation efforts; individuals and class action plaintiffs sought damages for personal injury and property damage and ongoing health monitoring; and private water utilities, much as did the states, sought to recover response costs from PFAS manufacturers associated with needed remediation.

States and localities across the country are also bringing suit against PFAS manufacturers and users. These suits often are rooted in common-law product liability theories or allege consumer fraud or misrepresentation and generally seek to recover costs related to remediation, restoration of damaged infrastructure and natural resources, or long-term monitoring. Several states—including Alaska, Delaware, Michigan, Minnesota, New Hampshire, New Jersey, New York, Ohio, and Vermont—are also pursuing natural resource damage claims. While many of these state cases remain pending, noteworthy settlements include a Minnesota agreement in 2018 with 3M for $850 million and a 2021 Delaware settlement with DuPont, Chemours, and Corteva for $50 million—the latter subject to escalation as legal precedent grows. States are retaining private firms to bring PFAS litigation on their behalf, for natural resource damages, some even on contingency. This reflects the limited resources of states to pursue the volume of PFAS cases before them, and the need for creative approaches to recover damages caused by PFAS manufacture and use.

So many cases have been brought against manufacturers or formulators of AFFF, aqueous film-forming foam, used for fire-fighting and which contains PFAS, by water utilities and other users for contamination of surface and groundwater, that the suits are being moved into a massive multi-district litigation based in the federal court in South Carolina. This MDL was consolidated by a federal judge in 2018 and in fall 2022 included over 3,019 cases. The 12,000-plus plaintiffs—individuals, local governments, states, tribes, water districts, airports, companies, and colleges—allege harm from AFFF contamination and exposure. Defendants (nearly 200 of them) span the supply chain (i.e., manufacturers of AFFF and its component chemicals and distributors) and also include AFFF users, including the Air Force, Army, and Navy.

These cases all generally allege that AFFF containing certain PFAS contaminated groundwater near military bases, airports, and other industrial sites where the foam was used to extinguish liquid fuel fires. And while the specific causes of actions vary, they generally fall into the following categories: claims for property damage asserted by water providers; claims for property damage asserted by property owners; bodily injury claims; and claims for medical monitoring for potential future injury. In September, the court designated City of Stuart v. 3M Company, et al. as the lead case for the bellwether trial and set the start date for this coming June. This first case will allow the parties’ executive committees to test legal theories in a trial setting, discern potential trends, gauge the potential success of future trials, and possibly foster settlements.

Plaintiff groups are also increasingly pursuing class action lawsuits for PFAS in products, alleging false and misleading labeling claims against companies whose products allegedly contain PFAS, and suits against PFAS manufacturers alleging that they knowingly distributed PFAS for decades despite concerns that they were likely associated with a wide variety of serious health risks. One such example of the former category is& Brown v. Cover Girl Cosmetics, wherein plaintiffs allege that the makeup manufacturer’s representation that its products are safe and appropriate for use on consumers’ eyelashes is misleading and fraudulently advertised because the products contain PFAS. An example of the latter category is Hardwick v. 3M Company, which involves a putative class of roughly 11.8 million Ohio residents with a blood concentration of 0.5 parts per trillion of any PFAS, which is currently against PFAS manufacturers but could draw in others if it progresses.

As is typically the case when an entire industry finds itself in the cross-hairs of new regulations and massive litigation exposure, an entire ecosystem around PFAS has blossomed into existence. Not only are law firms and private consultants directly representing corporations in lawsuits, they are also working with companies proactively to identify possible historic uses of PFAS and to identify potential insurance coverage for PFAS-related litigation and judgments. Scientists and toxicologists continue to refine what we know about PFAS contamination and its effects on the human body. And companies and researchers alike are pouring massive resources into identifying viable PFAS alternatives in anticipation of sweeping regulations that may direct them to do so.

PFAS are understandably on the minds of many. From chemical manufacturers, to regulators, to scientists, to lawyers, to everyday citizens who see PFAS in the news and worry about the health and safety of their families. There are environmental justice issues associated with these chemicals, and it will be worthy to watch how EPA’s newly formed Office of Environmental Justice and External Civil Rights takes up the PFAS issue.

It is conceivable that PFAS may one day be regulated and litigated out of use. It is also conceivable that science could someday advance to the point of being able to break down and eliminate these wildly persistent chemicals. Modern medicine may even develop to the point that it can counteract the known (and unknown) effects of PFAS exposure, aiding people already impacted.

But for now, much remains unclear. What we do know is that states and private parties will continue to flood the legal system with lawsuits against PFAS manufacturers and users. We also know that the science will continue to develop and that state and federal governments will continue to increasingly monitor and regulate PFAS. What’s more, as state and federal environmental structures evolve to provide clearer recourse against PFAS manufacturers and users, we will almost certainly see much more enforcement activity.

There is certainly more to come, and as this piece shows, there are more than enough opportunities for environmental lawyers, policymakers, scientists, legislators, jurists, and thought leaders to contribute to solving the “everywhere chemicals” challenge. TEF

The author wishes to thank Jeff Wettengel and Cameron Hughes for their assistance with this article.

OPENING ARGUMENT PFAS are potentially harmful chemical substances that can be found throughout industry and commerce; in almost all homes; in the air, water, and soil; in the bodies of over 97 percent of Americans—and they can last forever. How is the U.S. managing them?

Poison Politics: Trouble Banning Harmful Lead Ammunition
Lynn Scarlett - Former Deputy Secretary of the Interior
Former Deputy Secretary of the Interior
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Pulling the Trigger on Hunting Regulations for Lead Ammunition,” Lydia Shields, 33 Villanova Environmental Law Journal 85 (2022) and “Silent Spring Revisited—Is It Time to Ban Lead?” Jaclyn McBain Cohen, 39 Pace Environmental Law Review 31 (2022).

While serving as deputy secretary of the interior, I attended an event held by the Fish and Wildlife Service on testing condors for lead. This magnificent bird, brought back from the brink of extinction, still faces perils. Lead poisoning from ingesting ammunition fragments and other foreign sources remains a significant culprit threatening not only the condor but other wildlife populations as well.

Lead poisoning, including from ammunition, is not a newly identified danger. It had been flagged as a central threat in the 1980s, when the last two dozen condors were brought into captivity to launch a captive-breeding program deemed the bird’s only hope for survival. The program succeeded in breeding condors and releasing them back into the wilds. Of the 550 or so birds bred through this process, over half now fly free in California, Utah, Arizona, and Mexico.

But this is not an unmitigated success story. Lead poisoning from ammunition persists and still imperils condors and other creatures. Some sampling in condors has shown measures 80 times the “at risk” level (though no level is considered “safe”).

After several decades, acknowledging the threat the heavy metal poses to wildlife and people, California banned all use of lead ammunition beginning in 2019. A 2012 study by Myra Finkelstein and others had concluded “that the prevalence of lead poisoning in California condors is of epidemic proportion and that the principle (sic) source of lead poisoning is lead-based ammunition.” Drawing upon such research, the state took legislative action.

But California’s move, pioneering though it is, does not begin to address the problem of poisoning associated with use of lead bullets. A few statistics illustrate the ubiquity of the problem. The FWS estimates hunters put some 14,000 tons of lead ammunition into the environment each year, poisoning 10-20 million animals and affecting some 130 animal species.

Building from these data, the FWS promulgated policies last September whereby various wildlife refuges will require use of non-lead ammunition by fall 2026. Noting this effort, two law journal articles trace the regulatory and legislative history of federal and state efforts to ban or significantly curtail use of lead ammunition. In “Silent Spring Revisited—Is It Time to Ban Lead?” Jaclyn McBain Cohen argues for a federal ban on lead ammunition under provisions of the Endangered Species Act. Meanwhile, Lydia Shields makes a case for congressional action to ban use of lead ammunition in “Pulling the Trigger on Hunting Regulations for Lead Ammunition.” Though exploring different options for addressing the lead ammunition challenge, both articles end up in a similar place, arguing that an outright ban would be commensurate with the extent of poisoning of wildlife and people from lead ammunition.

As both authors note, the evidence is substantial. Studies of lead poisoning show effects such as increased lethargy, weakness, organ failure, and nerve disorders. In humans, lead is linked to anemia and adverse cognitive impacts. As both authors note, these effects in humans have resulted in bans of lead in gasoline, paint, toys, and other products. Lead ammunition, as far back as 1986, was banned from use in hunting of waterfowl under the Migratory Bird Treaty Act. But attempts over 30 years to expand this ban beyond waterfowl have met concerted resistance, despite extensive evidence of harm to wildlife and people.

Though opponents of banning lead ammunition, including the National Rifle Association and some hunting groups, contest the science and role of lead ammunition in wildlife deaths, the scientific evidence on the adverse impacts of lead ammunition is in fact extensive. In a literature search of 570 peer-reviewed studies from 1975-2016 on health and environmental risks from lead ammunition, Jon Armeno and others find that “more than 99% of [the studies] raised concerns over use of lead-based ammunition.”

The pushback against banning lead ammunition has a familiar ring, paralleling other environmental debates that highlight costs of alternatives, debate the science, link proposed regulations to larger agendas—in this case, to being a precursor to banning hunting and undermining fundamental freedoms to hunt anchored in American traditions. The opponents’ arguments are not compelling and, in some cases, are misleading, inaccurate, and alarmist. California’s experiences with banning lead ammunition have not shown declines in hunting; alternative forms of ammunition have costs similar to premium lead ammunition and, in any case, comprise a very small portion of hunting costs. And the science showing harms to people and wildlife associated with lead ammunition is unequivocal.

Both Cohen and Shields, in their respective articles, contest the counterclaims. But Shields is more insightful in understanding the debate as a fundamentally sociopolitical one and in delineating the regulatory, judicial, and congressional constraints, to date, on efforts to ban lead ammunition.

Shields summarizes several efforts to use the Toxic Substances Control Act, administered by the Environmental Protection Agency, to ban lead ammunition. Both the agency itself and the Court of Appeals for the D.C. Circuit have found that EPA does not have the statutory authority to regulate lead ammunition.

As Shields notes, though TSCA provides the agency with authority to regulate chemical substances that present “an unreasonable risk of injury to health or the environment,” it excludes certain substances, including shells and cartridges. Shields observes that this exclusion is not perfectly clear, since House report language on the bill states: “Although the language of the bill is clear on its face as to the exemption for pistols, revolvers, firearms, shells, and cartridges, . . . the committee does not exclude from regulation under the bill chemical components of ammunition.” Shields notes similar Senate report language. Yet attempts to use TSCA to ban lead ammunition by focusing on the content of ammunition rather than the ammunition itself have failed.

Other decisions have also hampered efforts to ban lead ammunition. The 2016 National Defense Authorization Act, Shields notes, “contained a provision to exclude shot shells and cartridges, as well as their components, from the term ‘chemical substance’ in the TSCA.” This language, Shields writes, “prevents the EPA from regulating the lead in ammunition under the TSCA, but it does not preclude other agencies or Congress from exercising their authority to implement a ban on lead ammunition.”

Rather than focusing on TSCA possibilities for banning lead ammunition, Cohen strives to make a case for using Endangered Species Act authorities for such a ban. But this approach also confronts limitations that Cohen does not probe. While I do not attempt a legal assessment here, among the numerous challenges is that of determining whether lead poisoning is the proximate cause of death of specific endangered species. Critics of bans on lead ammunition argue that the lead does not directly cause death, even if it results in weakness, disorientation, or other effects that may impact species survival. Or they argue that lead effects are insignificant.

Three decades of attempts to ban lead ammunition beyond the ban applicable to waterfowl hunting using various regulatory or legislative approaches have failed nationally and, with the exception of California, within states. Summarizing state efforts, Shields describes a focus on education, incentives to use non-lead alternatives, and some restrictions applicable to public lands. None has meaningfully curbed the use of lead ammunition for hunting. “Although lead poses an undeniable risk to the health of humans, plants, and animals, ninety five percent of the ten to thirteen billion rounds of ammunition that hunters purchase each year contain lead,” writes Shields.

Reiterating the compelling science and probing the legal tools and their history in attempts to ban lead ammunition, as both authors do, reinforce why such a ban may be warranted and illuminate the limitations of existing legal tools for accomplishing one. Above all, this history suggests that the real obstacles are socio-political barriers. Therein lies the challenge.

Shields ends her treatise by writing: “The scientific evidence and data surrounding lead ammunition and lead poisoning demonstrate the need for a federal ban on lead ammunition” and “Congress should implement meaningful and comprehensive hunting legislation to ban the use of lead ammunition.” Cohen similarly sees the need for a ban, stating that “the only thing that stands in the way of a nationwide ban is opposition by lobbying groups.”

This is a big barrier. In recent years, the Congress, pressed by those lobbying groups, has acted in precisely the opposite direction, inserting language into the defense bill against considering lead ammunition as a chemical substance under TSCA, preventing spending to implement bans, or failing to consider proposed legislation to advance bans on lead ammunition in hunting. The step-by-step approach of the FWS to apply bans in particular refuges, paired with reaffirming hunting opportunities, may be a more realistic pathway. Such an approach could build, through experience, better understanding by relevant stakeholders that alternative forms of ammunition are effective, affordable, and consistent with sustained opportunities for hunting.

Lynn Scarlett on Trouble Banning Lead Ammunition

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

Performing at the Speed of Science Yields Complex Covid-19 Vaccine
Sally R. K. Fisk - Pfizer Inc.
Pfizer Inc.
Current Issue
Sally R.K. Fisk

When the pandemic began, the challenge for Pfizer and our partner BioNTech wasn’t just developing a vaccine—we also had to make it, and by the billions. This was no small feat—especially when you consider that the companies were looking to do what would normally take five years in less than one. Until the very end of 2020, no mRNA vaccine had ever been authorized and thus, one had never been manufactured at scale by any company. Pfizer invested more than $2 billion at risk on our Covid-19 vaccine development program—with $500 million of that spent on scaling up our manufacturing capabilities, before we knew the results of our clinical trials. There were no guarantees. But, with 172 years of experience on our side, we’ve arguably developed the most efficient vaccine manufacturing machine that the pharmaceutical industry has seen.

In addition to the technical aspects of making a complex mRNA vaccine while moving at the speed of science, we focused on always prioritizing quality, safety, and compliance; keeping colleagues in our research and manufacturing plants safe; and continuing to protect the environment. That message has been consistently reinforced by our CEO and leaders and includes amplified messaging about our Open Door policy, office of the Ombuds, and anonymous Compliance Hotline, to encourage our colleagues to speak up. And when issues or concerns are raised, we listen and respond.

Our speed was driven by working on activities in parallel, being flexible, and adding extra resources and innovative thinking. For example, in 2020 our manufacturing facility in Kalamazoo, Michigan, designed two separate vaccine manufacturing lines, one in an existing production area while the second was being designed as a prefabricated modular system constructed at an off-site facility and transported and placed in existing space at the Pfizer site. That meant two separate environmental permitting scenarios, two separate safety profiles, and the need to have both designs completed and constructed more quickly than we ever had before—because that is what patients around the world needed. This generated financial risk for the company, and our teams worked incredibly hard, but it enabled Pfizer to be ready with manufacturing capability if, and immediately when, we received emergency use authorization from the FDA.

We eliminated hierarchy in internal reporting and made meetings more efficient. The right subject matter experts and decisionmakers were in daily core meetings, irrespective of titles or reporting lines, to assure that all colleagues involved in the process design, construction, and startup stayed connected. We redesigned our processes to enhance efficiencies and drive effectiveness. That does not mean we eliminated critical decisionmaking processes; in fact, it was streamlined processes that enabled us to move fast with confidence, ensuring we maintained our high standards for quality, safety, and integrity.

We established a risk management framework specific to the vaccine project to ensure that we were developing mitigation strategies for existing and emerging risks. Elevated risks were escalated to leadership to enable the rapid deployment of resources and support so identified risks could be proactively mitigated and not become roadblocks. For example, relative to process safety and environmental risks, we implemented an OSHA Process Hazard Assessment approach for all steps in the production process regardless of whether the step used flammable or hazardous materials. And we repeated the PHA at key phases of design, construction, and startup.

We established open, transparent, and cooperative lines of communication with the government, including environmental agencies. We needed new authorizations for air emissions from state agencies and for wastewater discharges from local publicly owned treatment works. Having authorizations timely issued and compliance at all stages was of paramount importance, so we developed detailed environmental data in advance to cover multiple potential operating scenarios. Our facilities established early lines of communication with their regulators, who recognized the urgency of our mission and our commitment to environmental compliance. They were flexible when we presented multiple scenarios for operation while we awaited the decision on final design. With this common purpose, the agencies were able to prioritize and expedite our applications while maintaining their rigorous and robust review processes.

These were important aspects of our ability to deliver the vaccine in unprecedented time. However, the most important factor was ultimately our colleagues and the individuals employed by our partners and government who, working collectively with shared purpose, delivered breakthroughs and innovation in record time—proving that when humanity works toward common goals with urgency and focus, we can address the world’s greatest challenges.

Performing at the Speed of Science Yields Complex Covid-19 Vaccine

Time for Environmental Crimes
Rena Steinzor - University of Maryland Carey Law School
University of Maryland Carey Law School
Current Issue

Criminal prosecution for major regulatory offenses, for a while the norm and then the exception, is once again on the rise. Government officials, facing dwindling enforcement budgets, are hauling malfeasant corporations and their executives into court to face charges.

The Debate: Dangerous Intersection: Climate Change and National Security
Francesco Femia - The Center for Climate and Security
Leo Goff - Center for Naval Analyses
Alice Hill - National Security Council
Thilmeeza Hussain - Voice of Women -- Maldives
Marcus King - George Washington University
Maureen Sullivan - Department of Defense
The Center for Climate and Security
Center for Naval Analyses
National Security Council
Voice of Women -- Maldives
George Washington University
Department of Defense
Current Issue

The dangers of climate change are not usually couched in terms of national security, but awareness of the issue is growing rapidly. What could be more basic to security than a climate conducive for agriculture, abundant water supplies, ecosystem health, industrial production, biodiversity, and human comfort? What could be more threatening than extreme weather events or mass migrations because of rising seas and crop failures? The annual ELI-Miriam Hamilton Keare Policy Forum brought together top experts on the topic.

Climate Canaries
Barry E. Hill - Vermont Law School
Caitlin O'Sullivan -
Vermont Law School
Current Issue

The people of Bangladesh are already suffering from the effects of global warming, serving as an early-warning indicator of its ultimate imprint on humanity as a whole. But for right now, the developed world owes the poor countries assistance in their struggle.

Artisanal and Small-Scale Gold Mining in Nigeria: Recommendations to Address Mercury and Lead Exposure - Executive Summary
Environmental Law Insitute
Date Released
November 2014

This executive summary introduces ELI’s assessment of legal and policy challenges underpinning the informal artisanal and small-scale gold mining (ASGM) sector in Nigeria. The assessment presents legal, institutional, and financial recommendations designed to improve long-term health and environmental outcomes from the ASGM process. These recommendations are intended to accelerate the formalization of artisanal miners in order to encourage the development and dissemination of best mining practices.