September 10, 2003
Public Information and Records Integrity Branch (PIRIB)
Office of Pesticide Programs (OPP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., N.W.
Washington, DC 20460-0001
RE: Docket ID number OPP-2003-0132
On behalf of the United States Conference of Catholic Bishops (USCCB), I appreciate the opportunity to comment on potential U.S. Environmental Protection Agency (EPA) criteria and standards relating to research involving human subjects.
A central role of government is to protect the dignity of the human person and foster the common good of society. In fulfilling this obligation, it is necessary for the state to establish regulations to ensure adequate protection of life and health. The regulatory function of government should protect the health of all individuals equally, if it is to protect human dignity and promote the common good of society.
We understand that the Environmental Protection Agency's legal authority over pesticides is to ensure the protection of public health and the environment. The Food Quality Protection Act of 1996 (FQPA) was intended to reform pesticide regulation in response to a 1993 National Academy of Sciences report concluding that the pesticide regulatory framework did not provide adequate health protection, especially for children. As the EPA considers regulations that will govern human testing, we would oppose any attempts (administrative in this case) to undermine or weaken the health protections set forth by the FQPA. Instead, we urge the Administrator to implement and enforce these current protections.
We are particularly concerned with how the new regulations might affect the protection of humans. In our view, human life deserves full respect and protection at every stage and in every condition, particularly those who may be very young, very old or very disabled. Especially at risk are those who are very powerless and marginalized in our society, such as children. Therefore, we support the adoption of special protections for children. From their conception, unborn children face a disproportionate threat to their neurological development from environmental toxins. The ability of children's bodies to cope with harmful substances is also significantly less than that of adults. In addition, we have a special concern for low income families and low wage workers, who share a disproportionate risk and burden from harmful exposure. Farmworkers in particular, are often exposed to dangerous pesticides which undermine their health and their ability to continue to provide for their families.
Accepted codes of conduct for testing, such as the Nuremberg Code and all standards based on it, are very insistent on the principle of informed consent. Since each human being must be treated as an end in him- or herself and not just as a means to benefits for others, exposure even to a risk of harm should only be by the person's own volunteering (after receiving full information about the possible risks). A corollary is that no research posing a significant risk of harm should be conducted on an individual who cannot give informed consent. So, in addition to their special vulnerability, born and unborn children should be excluded because they cannot give such consent. Even parents do not have the right to give proxy consent for research that cannot benefit the child but may pose serious harm to him or her. Similarly, exposing farmworkers to these risks is a concern because they are likely to have literacy and language problems that would compromise the ability to obtain fully informed consent. There should be extra safeguards when dealing with these populations, including materials in the appropriate language and the availability of trained interpreters.
We are very concerned about using humans for the direct testing of pesticides under any conditions, particularly when they will not receive any direct or immediate health benefit, but in fact may be harmed. However, if any such testing were to be permitted, we would urge the Agency to follow the principles below in setting its guidelines and standards:
- Any policy adopted by the Agency should reflect the highest standards of respect for the human dignity of people who might participate in such tests. Research protocols that could significantly harm the people tested in order to obtain useful data should be prohibited.
- Any policy adopted by the Agency must reflect a special concern for the interests of vulnerable populations, such as unborn children, infants and toddlers, adolescents, pregnant women, the elderly and those with fragile health due to compromised respiratory function or other reasons.
- In no case should developing humans (i.e., children in utero, infants, young children, or adolescents) deliberately be exposed to toxic chemicals. There are currently too many unknown dangers to justify such studies, even under the most extraordinary circumstances.
- Pregnant women should be specially protected from any intentional exposure. The burden is on those conducting the study to ensure that any adult women involved in it are not pregnant.
- The Agency's criteria and standards must consider the implications of all studies for a variety of different populations, including children, children with disabilities, children in minority and/or farmworker communities, and farmworkers and others. If the EPA does not ensure adequate protection from exposure to environmental toxins, these groups could be more affected, especially if they live in low income or minority communities. It is important that vulnerable persons, including poor people, not be offered large financial incentives to participate in studies that may harm their health.
- Conducting pesticide toxicity studies in adult volunteers provides limited information to assess the risk for children. The Agency cannot assume that such tests may be used to determine with accuracy a safe level for children.
- If it can be justified at all to expose humans intentionally to toxic substances even with their fully informed consent, the threshold of justification for such action should be very high. Human exposure to pesticides must be approached with the greatest degree of caution. If studies are to be accepted by the Agency, the Agency has the obligation to ensure that the studies are conducted only if absolutely necessary and with the very highest of scientific and ethical standards.
John L. Carr
Department of Social Development & World Peace
United States Conference of Catholic Bishops