EPA Proposes Stronger Protections for People in Pesticide Experiments

It will be harder for the chemical industry to use people as test
subjects in pesticide research sent to the U.S. Environmental
Protection Agency, based on an expanded "human testing rule."

EPA has proposed dramatic changes in how studies that intentionally
expose people to pesticides can be conducted and in what studies it will
accept. These proposed changes should force the chemical industry to
avoid these types of studies altogether.

The proposed rule, now open for a 60-day public comment period,
results from a 2010 court settlement between the agency, the Natural
Resources Defense Council and other public health and farmworker
advocacy groups represented by NRDC and Earthjustice. The lawsuit was
filed to prohibit EPA's reliance on these unethical experiments that
often led to weakened pesticide safety standards.

"With this new proposal, EPA has cut the incentive for pesticide
manufacturers to conduct unethical, and often unscientific, human
experiments," said NRDC Senior Attorney Michael Wall. "While it does not
ban human testing outright, it sets the bar high enough that studies on
people should not be an attractive option as evidence submitted to EPA.
We don't want to see anyone getting paid to dose themselves with toxic
pesticides, but if EPA is going to continue to consider studies that use
humans when it regulates pesticides, the research needs to adhere to
these stricter rules," Wall said.

The existing human testing rule, in place since 2006, allows parents
or other authority figures to allow pesticide testing on their children
in some circumstances. The proposed rule closes that loophole. The
existing rule also only applies to pesticide studies conducted with the
intention of being submitted to EPA. With today's proposal, the human
testing rule will apply to all studies EPA reviews, whether or not the
researchers intended for the study to go to EPA.

The new standards are drawn from National Academy of Sciences
recommendations and the Nuremberg Code. Under these new standards, EPA
expects the number of such experiments to fall dramatically.

Background:
In 2006, EPA lifted a moratorium on its use of experiments in which
people are purposely dosed with pesticides to assess toxic effects. In
some studies, public records show that researchers paid people to eat or
drink pesticides, to enter pesticide vapor "chambers," or to have
pesticides sprayed into their eyes or rubbed onto their skin. The
pesticide industry submitted results of such tests to EPA to use as part
of its review on pesticide safety.

"Some of the worst scientific reports I have read are these
industry-funded pesticide studies where no more than a handful of adults
are dosed with a toxic pesticide, and then the companies try to argue
away complaints of headaches, nausea, and even vomiting," said NRDC
Senior Scientist Jennifer Sass. "In one experiment, the people tested
were even told that the chemical was a medicine instead of a pesticide."

A coalition of health and environmental advocates, and farmworker
protection groups filed the lawsuit against EPA in 2006, claiming that
its rule violated a law requiring strict ethical and scientific
protections for pesticide testing on humans.

The coalition argued in the U.S. Court of Appeals for the Second
Circuit that the rule ignored scientific criteria proposed by the
National Academy of Sciences, did not prohibit testing on pregnant women
and children, and even violated the Nuremberg Code, including the
requirement of fully informed consent. The Nuremberg Code is a set of
standards governing medical experiments on humans that was put in place
after World War II, following criminal medical experiments performed by
Nazi doctors.

The 2006 lawsuit was brought by the Farm Labor Organizing Committee,
Migrant Clinicians Network, NRDC, Pesticide Action Network North
America, United Farm Workers, Pineros y Campesinos Unidos del Noroeste
(Northwest Treeplanters and Farmworkers United) and the San Francisco
Bay Area Physicians for Social Responsibility. Attorneys with NRDC,
Earthjustice and Farmworker Justice served as legal counsel for the
coalition.