(Washington, D.C.-January 26, 2006) Under new rules announced today, all
third-party intentional dosing research on pesticides involving children and
pregnant women intended for submission to EPA is banned, and EPA will neither
conduct nor support any intentional dosing studies that involve pregnant women or
children for all substances EPA regulates. These final new rules also establish
stringent enforceable ethical safeguards to protect individuals who volunteer to
participate in third-party intentional dosing research.
"These final rules will protect pregnant women and children from unethical human
research involving pesticides and other environmental substances," said Susan B.
Hazen, acting assistant administrator in EPA's Office of Prevention, Pesticides and
Toxic Substances. "Pregnant women and children should never be involved in these
types of studies. Now adult volunteers (non-pregnant) will have the highest level of
ethical safeguards available if they choose to participate in research studies."
These final regulations adopt and implement many of the recommendations from the
prestigious National Academy of Sciences, have benefited from public comments, and
adhere to the legislation passed by Congress in August 2005. Under the new rules,
the provisions of the Federal Policy for the Protection of Human Subjects of
Research (the Common Rule) are extended to cover all third-party intentional dosing
studies submitted to EPA under the pesticide laws. Third party studies are those
studies not conducted or supported by a federal agency. EPA is also establishing a
Human Studies Review Board to obtain independent scientific and ethical review on
whether to accept certain existing human studies as well as review all new study
protocols before the studies are started.
This rule makes it clear that all pregnant women and all children are excluded from
all such studies involving intentional exposure. For any new, intentional dosing
studies with pesticides, this final rule requires researchers to do the following:
(1) assure that pregnant women and children are not participants, (2) comply with
the requirements of the Common Rule (current ethical standards for research
conducted or supported by the federal government); (3) submit detailed study
protocols to EPA prior to initiation so that EPA can review to ensure the study
meets the new ethical protections and is scientifically sound; and (4) once the
study is conducted, provide detailed information to EPA describing how the study met
the necessary ethical protections.
The sweeping requirements of this final rule will lay the groundwork and provide an
important foundation for the Agency to build upon in future actions that may be
determined necessary to provide further protections to public health. For more
information on today's announcement, visit:
http://www.epa.gov/oppfead1/guidance/human-test.htm