In the late ’90s, following the grand reveal of Dolly the Sheep, there was an uproar about the potential for cloning humans. In response, reproductive cloning—that is, the ability to have a human give birth to a cloned embryo—was essentially prohibited in the U.S.
But the ban wasn’t a result of an act of Congress. Instead, the government body that took action was the Food and Drug Administration. The FDA stepped in by using power Congress had already given it to oversee medical products, and it remains accountable to Congress in how it uses this authority. It’s the same mechanism that has allowed the FDA to evolve and manage many emerging technologies, such as, software as a medical device, advanced reproductive technologies, tobacco products such as e-cigarettes, and even cell-based meats (along with USDA).
But now, the Supreme Court has just made this process of regulating new technologies, even for human cloning, more vulnerable to legal challenges.
In a decision in June, West Virginia v. EPA, the Supreme Court limited the Environmental Protection Agency’s ability to regulate carbon emissions from power plants. Many were quick to point out the obvious setback to climate regulation as well as the court’s perceived power grab in shifting power from agencies to themselves. However, the way the Supreme Court did this—by recognizing and endorsing the “major questions doctrine”—threatens regulation and public policy in the U.S. by allowing judges to pick and choose regulation they think is “major” and then undoing it. Previously, the court deferred to an agency’s interpretation of authority as long as lawmakers had granted them power through legislation and Congress had not previously spoken more specifically on the issue. But this new major questions standard creates some cutting issues around why courts should be so closely involved in policymaking.
The upshot of the major questions doctrine is that it allows courts to strike down regulatory programs they feel are “major,” which in practice seems to mean too costly, too political, or too novel in nature. While this new level of judicial scrutiny is potentially harmful for all kinds of regulatory programs, it is particularly troubling for efforts to strike the right balance between the benefits and risks of new technologies. Regulating the development and use of new tech often requires agencies to use their existing authority from Congress to address unforeseeable concerns created by new technologies. However, because new technology is just that—new—and almost always has economic and political consequences, its regulation could be particularly vulnerable to the major questions doctrine. The Supreme Court’s new deregulatory tool could be used to invalidate regulations for new tech in court as well as make regulators think twice before they even start the process of creating new policy for technology.
That’s particularly alarming because regulatory agencies like the FDA have long been responsible for most of the regulating of new technologies. Congress certainly could set new legislation on emerging tech, practically speaking, but lawmakers rarely prioritize technology policy—which is often difficult for nonexperts to understand, may not get the same media attention or public outcry as other issues, and can be politically tricky to execute. So Congress has generally seemed happy to let regulatory agencies using their existing power to handle new tech issues such as privacy, genetically modified crops, or nanotechnology.
But the major questions doctrine would let courts object to new regulation anyhow, which could ultimately leave federal courts with the final say about how new tech can be regulated to prevent harms to safety, privacy, equity, and so on. This will likely leave regulators with fewer tools to manage the risks associated with new technologies, could be unequally applied to target specific agencies, and may leave the American public with less protection from all kinds of tech-related harms. For example, the EPA has stepped in to regulate how genetically modified insects are released into the environment (for instance, to stop the spread of disease) using its existing authority on “pesticides.” Congress has made no objection to this move but, no matter, the major questions doctrine could allow courts to decide the EPA’s policy is too novel or too political anyway and cut down these efforts to protect human and environmental health.
The major questions doctrine gives courts new tools—or at least new political cover—to question agencies’ authority on new technology. This is happening even though Congress has many tools to oversee agency programs and has already given agencies broader mandates around protecting patients, consumers, and the environment. Because technology can touch every part of our lives, multiple different federal agencies are often involved in managing risk and other policy issues around new technologies. Aside from the FDA or EPA, various regulators use their existing tools and authority from Congress to manage issues like A.I., cryptocurrencies, self-driving cars, and so on. But these uses of authority might not be permitted under the court’s new “major questions” analysis. At bare minimum, agencies may now face a higher bar to justify getting involved in new tech, even when technologies cause problems Congress already told agencies to regulate.
Human reproductive cloning is a good example of why Congress is often hesitant to get caught up in new technological issues. At least a part of the issue in the late ’90s was that Congress got caught up in political hurdles over whether a ban would prevent medical research and other useful kinds of innovation. In this case, the FDA filled the void by prohibiting human reproductive cloning without getting specialized permission from the agency first, under its authority to regulate clinical testing. This effectively banned reproductive cloning, while still allowing for therapeutic applications of the underlying technology to be revisited when appropriate.
At any time, if Congress were to become uncomfortable with the direction of the FDA’s action on cloning, it can still write a law to override the decision. Yet the issue has instead faded from policymaker attention, showing a tacit approval of the FDA’s use of its existing authority. To be fair, it seems unlikely that anyone would file suit to block FDA regulation of cloning, but that doesn’t mean it’s impossible. It is striking that the Supreme Court’s powered-up version of the major questions doctrine could have enabled such a lawsuit to be successful. And it seems likely to chip away at other agencies’ policy efforts now.
Notably, the court might not apply this major questions doctrine equally to all agencies. Practically speaking, the Supreme Court and other appellate courts will not hear every challenge to agency authority, even on intrinsically new, political, and costly agency actions. So, the courts could wield notable power in selecting which cases to hear through their various procedures. At the Supreme Court, the six conservative justices will likely have significant sway over which agencies regulating technology are reviewed under this new standard, since only four justices need to agree to hear a case. If specific agencies that are more often criticized by conservatives, such as the EPA or Securities and Exchange Commission, are more often under review, it could both further politicize the court and leave agencies in a state of uncertainty over their potential vulnerability when trying to regulate new technologies. This targeted power to unequally apply this review just adds to the sheer amount of power the court appears to be building for itself, creating separation of powers and accountability issues that should concern everyone.
This new doctrine shifts power away from agencies empowered and overseen by Congress, and toward courts and industry—potentially through covert means. At a moment when Americans are starting to rethink the kind of future that technologies should usher in, the major questions doctrine could give courts and industry greater veto power over policies set by regulators trying to fulfill policy goals given to them by democratically elected leaders in Congress. The eagerness with which conservative actors have already started using the major questions doctrine since the Supreme Court’s decision this summer offers a hint of what might be coming for technology regulation and beyond.
That is to say, the major questions doctrine could make technology regulation less democratic and enable technologies like genetically modified insects or new reproductive techniques to be developed and introduced into the world without input from the people who will be affected by the benefits and harms of those technologies. While regulation isn’t perfect, it can provide an important check on private power and, at its best, offer spaces for civil society and the public to get involved and make their voices heard on issues of technology policy. Rather than taking a hammer to technology regulation with the major questions doctrine, we should be thinking through new ways to make technology regulation more accountable to and inclusive of the public—the actual people who technology is supposed to be for.