sign on comments concerning EPA proposal

[Guest guest]

I am not sure that I fully understand your letter but. I would like to respond to it if i am off the record please disregard this email.My husband is a native of Mexico we have been married 18 yrs. and have a daughter 17.We Worked in apple and other fruit Orchards from the 80s to 1993 my husband is iliterate both in English and Spanish he has no education.His only knowledge is farmworking.In 1993 in early Spring he was asked to be the foreman which consisted of driving tractor and spraying of pesticide among other Chemicals some known and others unknown.He began to be ill almost immediatley with flu like symptoms,bleeding from his nostrils,eyes urine infections and the list goes on, When I asked our Employer if my husband was maybe working with a harmful agent she answered not hardly we would not hurt our workers excpecially ,She went to the drug store and purchased him eye wash and over the counter pain releiver.She said she thought he had developed a sensitivity to the cut grass.This went on for 4 months he continued to spray Chemicals he got worse and worse our son began to become ill as well our dogs died etc.our son worked in the orchard as well along with my husband ,he was 14.Until one day there were about 28 farmworkers taken to ER for ( exposure) It was awful and my husband was still trusting his employer our son was one of the 28 taken to the hospital my husband remained in the orchard until the Dept.EPA and the Dept. of Labor removed him and brought him home and convinced him that he was ill and it was not the flu.it has now been 10 yrs and he is still sick ,our daughter who is 17 she was diagnosed at the age of 13 she had been sick 3 yrs prior to being diagnosed she suffers from Indocrine problem such as she no longer has a Thyroid due to Graves Disease.The list goes on and on If this sounds like something you may be interested in please email me or call us 812-949-1490 ask for Dixie

[Guest guest]

In an Advance Notice of Public Rulemaking (ANPRN), the U.S. Environmental

Protection Agency (EPA) has asked for public comment on a multiplicity of

questions to assist it in determining whether and under what circumstances and

subject to what standards, the EPA should accept, consider and rely on studies

involving the intentional dosing of human subjects with pesticides or other

toxic environmental agents. This issue came to the fore in the mid 1990’s

when

pesticide manufacturers submitted a number of human subject tests in order to

establish the “No Observeable Adverse Effect Level” which is the dose below

the

one at which adverse effects are noted. The NOAEL is very important

because it

is the basis from which EPA makes regulatory decisions. When the NOAEL is

derived from animal studies, the Agency adds a 100-fold margin of safety for

evaluating effects on humans (i.e., 10x to account for interspecies variation

and 10x to account for intraspecies variability). If the NOAEL were derived

from a human study, the Agency would only add a 10-fold margin of safety. This

would make a big difference in which products were registered and what worker

protections were required.

These human subject studies, however, present both ethical and scientific

concerns. They don’t meet ethical standards because (among other things):

they

don’t benefit the volunteer test subjects, they don't provide information that

which is unobtainable by other means, and they were not conducted in

accordance

with the Common Rule. They are also scientifically unsound because they use

groups of 10-50 healthy young volunteers, so that the results lack the

statistical power to provide useful information about the effects of these

products on the highly diverse US population, including its most vulnerable

members (e.g., infants, children, the elderly, those with compromised immune

systems, etc.)

Comments on this ANPR are due on Tuesday, Aug 5th. Below is a brief excerpt

from my comments. Anyone interested in signing on to my comments, should

email

me directly at sdavis@... and I will send you the complete draft. If you

would like to sign on, please let me know by Monday, Aug 4th and give me a

brief

paragraph about your organization to include in the comments.

Excerpt from Comments:

These comments address the EPA’s Advance Notice of Public Rulemaking on

concerning the standards to be applied in determining whether to accept

pesticide studies conducted by intentional dosing human subjects.

We urge the EPA to:

(1) categorically reject any study using the intentional, non-therapeutic

dosing

of human subjects with toxic pesticides for the primary purpose of

establishing

a No Observeable Adverse Effect Level (NOAEL) or a No Observeaable Effect

Level

(NOEL) on the grounds that any such study is unethical and inconsistent with

accepted national and international legal standards;

(2) determine that it will not accept, consider or continue to rely upon

previously submitted human subject studies for purposes of setting pesticide

NOAEL/NOELs because they are scientifically and ethically flawed and do not

meet applicable legal standards; and

(3) Only accept, consider or rely upon a Third Party study or Agency-

supported

research, using the intentional dosing of human subjects, in limited

circumstances where (i) the principles established by the Common Rule and

other

nationally and internationally recognized ethical standards are met; (ii) the

data to be derived is essential and adequate data could not be obtained by

other means and (iii)the resulting data will have adequate statistical power

to provide useful information concerning our highly diverse population,

including those who are most vulnerable (e.g., fetuses, infants, children,

adolescents, pregnant women, the elderly and those with compromised immune

systems)..

Prior to the publication of the ANPR, the EPA had convened a Joint

Subcommittee

of its Science Advisory Board (SAB) and the FIFRA Scientific Advisory Panel

(SAP). In a Report entitled Comments on the Use of Data from the Testing of

Human Subjects (SAB/SAP Report), the Joint SAB/SAP Subcommittee found, nter

alia, that the intentional testing of pesticides on human subjects should be

subject to limitations “ranging from ‘rigorous’ to ‘severe,’ that such

studies

should not be conducted if data is available from other sources (e.g., animal

studies, models or unintentional human exposures) or if the resulting data

will

lack adequate statistical power and that such studies should never involve

children, pregnant women or other vulnerable populations.. SAB/SAP Report at

3. Further, the SAB/SAP Report stated that the “Subcommittee, in general,

would not support human experimentation primarily to determine a No

Observeable

Adverse Effect Level.” (SAB/SAP Report at 11). While we do not endorse

all of

the Majority Report’s findings, these conclusions of the Joint SAB/SAP

Committee are sound and should be adopted by EPA..

The ethical concerns raised by the intentional non-therapeutic testing of

toxic

pesticides on human subjects should be informed by the international and

national standards established to regulate human experimentation of these

kinds. The applicable standards include: 1) The Nuremberg Code, which was

adopted by the United States after revelations about the heinous Nazi

experiments on humans, conducted during World War II, came to light. It

establishes minimum ethical standards for human testing, which include the

requirement that the study be expected to “yield fruitful results for the good

of society, unprocurable by other methods or means of study. " 2) The Helsinki

Declaration, which was adopted by the World Medical Association to govern

medical testing of humans. It requires, inter alia¸ that there be a

“reasonable

likelihood” that the test subjects would benefit from the study. 3) FIFRA,

which prohibits the " use [of] any pesticide in tests on human beings unless

such human beings (i) are fully informed of the nature and purposes of the

tests and of any physical and mental health consequences which are reasonably

foreseeable therefrom, and (ii) freely volunteer to participate in the test. "

4) The Common Rule, adopted by EPA at 40 CFR part 26, which in addition to

requiring oversight by an Institutional Review Board and the informed consent

of participants, establishes the principle that the " risks to subjects be

reasonable in relation to anticipated benefits, if any, to subjects, and the

importance of the knowledge that may reasonably be expected. " 40 C.F.R. Part

26. Applying these standards, it is clear that the EPA should establish a

policy of refusing to accept human studies for purposes of setting

NOELs/NOAELs

and that it should refuse to accept or rely on the human studies which

registrants previously submitted to it for this purpose. By contrast, the

intentional dosing of human subjects with pesticides should be allowed in very

limited circumstance to establish adequate protections for workers and

handlers

who are occupationally exposed to pesticides, for the purpose of establishing

adequate protections.