Testing: Advance Notice of Public Rulemaking
Farmworker Justice Fund Comments to EPA
and Records Integrity Branch (PIRIB)
Office of Pesticide Programs (OPP)
Environmental Protection Agency
1200 Pennsylvania Ave., NW.
Washington, DC 20460-0001
RE: Docket ID number
We, the undersigned
organizations dedicated to promoting and protecting human health and safety,
are pleased to have the opportunity to comment on potential U.S. Environmental
Protection Agency (EPA) criteria and standards relating to research involving
This issue is of the
highest import. Protection of human subjects and support of ethically-
and scientifically-conducted studies should be an Agency-wide goal and
Over the years, many
organizations representing pediatrics, health, the faith community and
other public interests have urged the Agency to assure protections for
human test subjects, especially those who were being intentionally dosed
with pesticides with the purpose of eliminating or lessening regulatory
safety margins. It is distressing that the EPA is in the situation where
on one hand it has no policies or oversight system to protect human subjects
in tests (theoretically discouraging such tests on humans), while on the
other hand accepting such experimental studies when submitted in the course
of pesticide regulation. We commend the Agency for proceeding with rulemaking
on this topic and urge expeditious action.
urge the Agency to follow these principles in setting these guidelines
- Any policy adopted
by the Agency should reflect the highest standards of respect for human
subjects and should prohibit research protocols that override the interests
of subjects in order to obtain useful data.
- Any policy adopted
by the Agency must reflect a special concern for the interests of vulnerable
populations, such as fetuses, children, 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., the fetus, infant, young children, or adolescents)
be exposed to toxic chemicals. There are currently too many unknown
dangers to justify such studies, even under the most extraordinary circumstances.
- Children should
not be subjects of studies involving intentional dosing.
- The Agency's criteria
and standards must consider the implications of all studies for a variety
of different populations, from all children, to children with disabilities,
to children in minority and/or farmworker communities, to farmworkers
and others. If the EPA does not assure adequate protection from exposure
to toxicants in the environment, there are groups that will be more
affected; most often these are low income or minority communities. These
same communities are also the ones that most likely would be tempted
by large incentives to participate in human studies that are of no benefit
to them personally or to their communities. This critical issue must
- The EPA should
take whatever administrative action is necessary to extend the protections
of the Common Rule (40 CFR Part 26) to all human research activities
whose results will be submitted to the Agency.
- Bad science is
always unethical. Research protocols that are fundamentally flawed,
such as those with sample sizes inadequate to support reasonable inferences
about the matter in question, are unjustifiable.
- Studies that involve
dosing people orally with organophosphate pesticides to determine acute
"no effect" levels (the human oral pesticide toxicity studies
that were the genesis of this controversy) are not ethical in that they
serve no purpose in improving our ability to diagnose, treat, or understand
the etiology of disease nor do they provide information sufficient to
overcome the risks to individual subjects, and thus the EPA should not
allow or accept such third-party studies.
- Additionally, conducting
such human oral pesticide toxicity studies in adult volunteers provides
limited or no information that protects children. The Agency cannot
assume that such tests are going to prove protective of children.
- If it can be justified
at all to expose human subjects intentionally to toxic substances, the
threshold of justification for such action should be very high. Pesticide
exposure to human subjects must be approached with the greatest degree
of caution. If studies are to be accepted by the Agency, the Agency
has the obligation to assure that the studies have been conducted with
the very highest of scientific and ethical standards.
- In considering
research protocols, it is not enough to determine a risk/benefit ratio;
it is important also to consider the distribution of risks and of benefits,
and to ensure that risks are not imposed on one population for the sake
of benefits to be enjoyed by another. It is also important to be sensitive
to the difference between a reversible risk and one that may be irreversible,
such as possible interference with normal neurological development.
In implementing these
- The Agency must
adopt strong and enforceable standards with regards to all regulatory
data submissions for human testing of pesticides and other chemicals,
based on the principles listed above. Food and Drug Administration (FDA)
policy provides a number of safeguards and the Agency should follow
FDA's lead and promulgate enforceable regulations for third parties
that clearly articulate policies and expectations. However, the FDA
standards should be viewed as a starting point. Clearly, we should have
even stronger standards for pesticides and industrial chemicals than
for drugs and medical devices.
- The Agency must
delegate the responsibility for this task to one strong central authority,
such as the Office of General Counsel, and provide adequate resources
and training for this effort. This includes cleaning its house with
regards to its own internally conducted and funded research to train
its scientists and to assure that the highest ethical standards are
followed there as well.
- The Agency must
move forward with alacrity.
Thank you for your
consideration of these vital issues. For more information please contact
Daniel Swartz, Executive Director of the Children's Environmental Health
Network at 202-543-4033, extension 16.