Scholar calls for Congress to empower regulators to limit exposure to cancer-causing chemicals.
Approximately 2 million people in the United States are expected to be diagnosed with cancer in 2024. When environmental and lifestyle factors are known to exert a significant influence on the risk of developing cancer, should regulators intervene?
In a forthcoming article, Daniel G. Aaron, an associate professor at the University of Utah S.J. Quinney College of Law, argues that they must. Aaron warns that carcinogen exposure has become deregulated, leading to a rise in cancer rates with each generation. He recommends that the U.S. Congress strengthen the current cancer-targeted statutes in place to facilitate federal agency enforcement.
Cancer is often caused by “systemic problems,” Aaron explains. Some of the most common forms of cancer, such as lung, colorectal, and breast, can be linked to air pollution, poor diet, smoking, and other exposures to cancer-causing chemicals.
Aaron argues that current federal statutes designed to address systemic sources of carcinogen exposure, which Aaron describes as his “Cancer Framework,” leave these sources of exposure underregulated. Aaron describes his framework as the “federal structure” Congress created when it passed statutes to address “carcinogens with powerful new legal authorities,” but the regulatory schemes these statutes govern have weakened over time.
Aaron’s Cancer Framework includes statutes that regulate consumer products, such as the Food Additives Amendment of 1958 to the Federal Food, Drug, and Cosmetic Act. Through this amendment, any substance that is added to food, unless it is “generally recognized as safe” (GRAS), is subject to pre-market approval from the U.S. Food and Drug Administration (FDA) before it can be sold.
The GRAS exemption, however, has made the requirement of pre-market review defunct, Aaron argues. Because manufacturers can “self-certify” their additives as GRAS, new products can enter the market with minimal FDA oversight, eroding the agency’s authority.
Although Aaron acknowledges that the GRAS exemption allows FDA to avoid the expenses of regulating each individual additive, he describes the regulatory scheme as “toothless” in practice when he asks “how can an additive be generally recognized as safe if it was just invented?”
FDA has also left the cosmetics industry unregulated, argues Aaron. For example, he cites the Modernization of Cosmetics Regulation Act of 2022, which expanded FDA’s regulatory authority over cosmetics but came with no corresponding increase in funding.
Aaron also argues that statutes regulating environmental carcinogens, such as the Toxic Substances Control Act (TSCA), are ineffective. He explains that TSCA gave the U.S. Environmental Protection Agency (EPA) the authority to regulate harmful chemicals, but it limited EPA’s power to issuing only “the least burdensome requirements.”
Congress later removed the strict “least burdensome” standard, but Aaron still characterizes recent regulatory actions under TSCA as “mostly superficial.” For example, EPA issued a rule banning 329 forms of per- and polyfluoroalkyl substances (PFAS), but none of the banned substances were even in use at the time. EPA also issued a rule outlining recordkeeping and reporting requirements for PFAS manufacturers, but Aaron argues that this rule is one of “mere information gathering” and missing substance.
To reach the “optimal regulation” of cancer-causing chemicals, Aaron argues, Congress must make systemic changes to how it delegates regulatory authority to federal agencies and how it oversees the executive and judicial branches of government.
Aaron proposes that Congress is the “dominant problem” preventing the optimal regulation of carcinogens because Congress overuses product exemptions and fails to provide sufficient agency funding. Regulatory authority often goes unexercised due to budget constraints, and Aaron urges Congress to not only provide agencies with the “clear statutory authority” to regulate carcinogens, but also the necessary funding for agencies to exercise it.
Otherwise, he argues, it may be better to have no federal scheme regulating toxic exposure at all—leaving this authority to the states—than to have one with insufficient funding.
Aaron also recommends that Congress avoid statutory exemptions that bypass agency review for new products entering the market, as these exemptions can engulf the entire statute over time. States should also retain the power to pass more stringent laws on carcinogens to cover any “unanticipated holes” in the federal regulatory framework, he argues.
Congress’s failure to oversee other branches of government furthered the deregulation of carcinogens, Aaron contends. Because the public perceives Congress as dysfunctional, Aaron continues, the executive and judicial branches have stepped in to “poach congressional power.”
Presidential and judicial intervention can impede the regulation of cancer, Aaron explains. He argues that presidential control over federal agencies can provide a useful form of accountability, but it can also lead to “over-accountability”: Federal agencies may prefer to make decisions that conform to presidential expectations rather than benefit the public.
Agencies may also act with the threat of judicial scrutiny in mind, Aaron argues, which could lead to a delay in the regulatory process and lower risk-taking.
Aaron notes that legal scholars often focus on the executive and judicial causes of deregulation, but he emphasizes the importance of acknowledging Congress’s “dominant” role in deregulating sources of carcinogen exposure. Aaron concludes by encouraging Congress to address the current statutory shortcomings and to facilitate federal agencies’ efforts to reduce the public’s exposure to cancer-causing chemicals.
