20
Jan
Apology Issued for Testing Pesticides on Humans
(Beyond Pesticides, January 20, 2023) In late December 2022, the University of California San Francisco made a public apology for the unethical actions of two School of Medicine faculty members who conducted experiments in the 1960s and 1970s on some 2,600 prisoners held at the California Medical Facility at Vacaville. The connection to the work of Beyond Pesticides? The experiments involved exposing male prisoners, by dermal application and via injection, to insecticides and herbicides; this continued until 1977, when the State of California banned all human subject research at state prisons. The investigation and apology — which arose through the work of the UCSF Program for Historical Reconciliation — surface multiple issues surrounding scientific research on human subjects, including ethics and regulations related to consent and to risk of harm. Beyond Pesticides has assiduously chronicled the huge variety of health harms that pesticide use can cause, has reported on many studies evidencing the presence of pesticide residues in human bodies, and in the mid-2000s weighed in on the then-vociferous ethics and regulations controversies surrounding research practices (see more below).
UCSF investigated the case of two dermatology professors who, the university learned, had failed to secure consent from the prisoners — many of whom were then either being evaluated or treated for psychiatric issues. The one surviving professor, Dr. Howard Maibach, wrote in a letter to colleagues: “What I believed to be ethical as a matter of course forty and fifty years ago is not considered ethical today. I regret having participated in research that did not comply with contemporary standards.” He indicated that a former University of San Francisco president had opined to him that the prisoners were ethically able to consent to the experiments. Dr. Maibach has also defended the research, suggesting that it yielded benefits to the prisoners, such as free dermatologic care subsequent to the study, and compensation for their participation (the university has dismissed these “benefits” claims).
The UCSF apology emerges into a landscape in which there is increased public attention in the U.S. on historical (and current) inequities and abuses across institutions, as well as mounting concern about the human and environmental health harms of pesticide use. The medical academy has had its own share of ethical misbehavior, from clinical bias to outright villainy; most notorious among them was the 1930s Tuskegee Institute study on syphilis. In that terrible episode, researchers not only did not secure consent from the study’s 600 Black male subjects, but also, wanting to monitor the disease’s progression, withheld treatment from the 399 subjects who had the disease. Investigators essentially stood by and did nothing as the infected men went blind, had other severe health problems, and/or eventually died.
Informed consent is now ethically central to how scientific research can be conducted in the U.S. Legitimate research abides by federal requirements, which include: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. (See also the U.S. Health and Human Services FAQ on informed consent.)
Intentional dosing of human subjects with pesticides is a different kettle of fish from the current biomonitoring protocols employed in some pesticide research. The role of potential harm caused by pesticides has fueled research for decades, but deliberate testing on humans was the subject of much discussion and argument, most intensively during the 1990s and 2000s.
To wit: should humans be the subjects of research on pesticides at all? If so, under what conditions? Should potentially harmful substances ever be intentionally introduced to research subjects? Can all harms be predicted? How is “harm” defined and by whom? Should there be any “weighing” of potential harms to research subjects against potential direct or indirect benefits to them, to public health, to disease treatment or prevention, et al. (See a multitude of Beyond Pesticides coverage of related developments here and here; see also a 2007 publication of the American Medical Association that parses some of these issues.)
The U.S. Environmental Protection Agency (EPA), and federal agencies broadly, were and are compelled (given their mandates) to address these issues. In 1991, EPA and 14 other federal agencies and departments adopted a set of regulations aimed at creating uniformity in the protection of human research subjects. EPA’s regulation was the “Protections for Subjects in Human Research,” referred to as the Common Rule. In 2006, EPA banned all third-party research (intended for submission to the agency) involving intentional dosing of pregnant or nursing women [or] children with pesticides. The Common Rule has undergone a series of revisions and rulemaking up through 2018, seeking to “modernize, strengthen, and make [it] more effective . . . [and] to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.”
EPA convened a joint meeting, in 1998, of its Scientific Advisory Board and Scientific Advisory Panel on the matter of human pesticide testing. According to an evaluation published in Environmental Medicine, after considerable Sturm und Drang, the committee ultimately “could not agree unanimously whether there are circumstances under which pesticide testing on human subjects can be justified. The final report states, ‘human dosing experiments are not appropriate if the primary intent of the study is to determine or revise a NOEL or NOAEL [types of standardized metrics for symptom levels].’ . . . [I]f the use of human subjects in pesticide testing can be justified, that justification cannot be to facilitate the interests of industry or agriculture, but only to better safeguard the public health.” It is noteworthy that several members objected to the final report because it “minimizes the risks to humans from intentional experimental dosing and deemphasizes the issue that ‘no limited human study will provide information about safe levels of intake of pesticides by humans, especially children.’”
EPA has subsequently adopted several “subparts” to the 2018 Common Rule aimed at increasing protections for participants in human research conducted or supported by EPA, or certain types of third party research. The federal Regulations.gov website notes that “Congress mandated three requirements for EPA’s rule: (1) prohibit the use of pregnant women, infants or children as subjects; (2) be consistent with the principles proposed in the 2004 report of National Academy of Sciences ‘Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues’ and the principles of the Nuremberg Code; and (3) establish an independent Human Subjects Review Board. . . . EPA created [other] regulatory subparts . . . [to] govern research conducted or sponsored by EPA involving . . . intentional exposure to any substance of human subjects who are children or pregnant or nursing women; [additional subparts] provide extra protections for pregnant women and for children who are the subjects of observational research conducted or supported by EPA.”
This apparently represents the current EPA stance; Beyond Pesticides research to find evidence of an outright EPA ban on human dosing experiments found none. That said, a digital search also yielded no evidence of any recent or current research that has intentionally dosed people with pesticides. What is far more common, and has been for some years, is a “retrospective” approach in pesticide research — sampling and analysis of the products of the human body (e.g., urine, blood) to determine the presence and concentration of various kinds of pesticides, acquired through vocational exposures, or through food, water, and general environmental exposures.
Such “biomonitoring” is used in academic/scientific research, but it is also used by government agencies (e.g., the CDC [Centers for Disease Control and Prevention]), nonprofit advocate organizations, and others watchdogging impacts of specific contaminants in humans (or other organisms). Beyond Pesticides explains that biomonitoring “is considered to be the most health-relevant assessment of exposure because it ‘measure[s] the amount of the chemical that actually gets into people, not the amount that may get into people.’”
However, Beyond Pesticides has historically criticized EPA and the CDC for conducting human monitoring studies without full disclosure of agency knowledge about known or potential hazards associated with the exposure patterns being monitored. In 2012, the CDC and the Maryland Department of Health and Mental Hygiene enrolled Maryland households in a study that involved spraying the neurotoxic synthetic pyrethroid insecticide bifenthrin on their property to determine the efficacy of this approach in controlling Lyme disease. At the time, Beyond Pesticides voiced concern that study participants, who were given gift cards for their participation, had not been provided complete information about bifenthrin’s potential health risks to people, and requested that the study be halted. [The study was eventually terminated after over a year, when no efficacy was found.]
Similarly, in 2004, EPA launched the two-year Children’s Environmental Exposure Research Study of 60 children in Duval County, Florida to collect information on their exposure to pesticides and household chemicals, such as flame retardants and perfluorinated chemicals, a family of substances in products such as Teflon. Paul Gilman, then-EPA science adviser and assistant administrator, said the study, utilizing chemical industry money, will help the agency conduct “groundbreaking work” on how chemicals are absorbed by infants and children from birth to age three. Participating parents, who were to receive up to $970 and a free video camcorder for participating, had to agree to routinely spray or have pesticides sprayed inside their homes during the two-year study period. Chemical concentrations were to be measured in air, dust, and urine samples of the children, and by analyzing chemicals absorbed in clothing before and after pesticide applications. While the study was derailed by public outrage and press coverage, EPA can still engage in “observational studies” that encourage pesticide use with incentives under federal regulations.
One could credibly argue that pesticide use is a grand human experiment, given that virtually everyone carries hundreds of exogenous chemical compounds in their bodies (and the number continues to rise)—an experiment associated with elevated rates of debilitating and deadly diseases. (See Pesticide-Induced Diseases Database.) These compounds enter human bodies through multiple routes (air, food, water, consumer products, etc.), and some accumulate because they are not readily processed/broken down and excreted; these can sometimes linger for long periods and increase risk for certain diseases. “Body burden” refers to the presence and accumulation of these synthetic chemicals in (generally human) bodies.
Beyond Pesticides reports regularly on emerging research documenting the presence and effects of pesticides in people. A recent example is a study in the Journal of Hazardous Materials that, for the first time, finds a high frequency of eight widely available neonicotinoid insecticides in human bile (which is produced by the liver). Residues in the sampled bile was 86% nitenpyram and dinotefuran; the former is used in flea treatments, and the latter in agriculture and land management. This finding suggests that these compounds are not easily degraded by the liver and represent potential toxicity risks to the organ.
One of the important vectors for exposure to chemical contaminants is the food supply; three federal agencies are involved in understanding and regulating pesticide residues in food. EPA sets “tolerances” for the amount of pesticide residue allowable in foods (though it is also able to establish tolerance exemptions for particular pesticides). The U.S. Food and Drug Administration (FDA) enforces those EPA tolerances for domestic foods shipped in interstate commerce, and for imported foods (except for meat, poultry, catfish, and certain egg products, which are regulated by the U.S. Department of Agriculture). FDA conducts a pesticide residue monitoring program that generates an annual report on results of its evaluation thousands of foods and food products each year; see our coverage of the 2020 report, which found that more than half of food in the U.S. contains pesticide residues.
The ubiquity of synthetic chemicals, including pesticides, is true not only in human bodies; other organisms, ecosystems, natural resources, and the environment broadly are all permeated to greater or lesser degrees.
As Beyond Pesticides reported early in 2022, Professor Sir Ian Boyd (of the University of St. Andrews) wrote in The Guardian, “The rise of the chemical burden in the environment is diffuse and insidious. Even if the toxic effects of individual chemicals can be hard to detect, this does not mean that the aggregate effect is likely to be insignificant. Regulation is not designed to detect or understand these effects. We are relatively blind to what is going on as a result. In this situation, where we have a low level of scientific certainty about effects, there is a need for a much more precautionary approach to new chemicals and to the amount being emitted to the environment.”
Research, regulation, and biomonitoring efforts are certainly an improvement over the pesticide landscape of 40 or more years ago. Given that more than 500 synthetic pesticides are registered for use in the U.S. (and thousands of other synthetic chemicals are used in myriad other sectors), it is helpful to know what is happening in humans and the rest of the living world. But these efforts are not solutions to our chemical problem in agriculture and land management.
Once again, Beyond Pesticides points out that, rather than digging our collective selves into a deeper, synthetic chemical/pesticide-saturated hole, the far wiser path is one of moving to a precautionary approach that would eschew these synthetic and petrochemical inputs. Organic is the path to a healthy and sustainable future; we must advance on that path with extreme urgency.
All unattributed positions and opinions in this piece are those of Beyond Pesticides.
