This information
collection request is approved for the purposes of exploratory
research intended for use in either: (1) evaluating the exposure
algorithms used to translate the AHS survey data into exposure
estimates, or (2) formulating hypotheses that will be tested in
later, statistically generalizable studies based on the collection
of further data. The large number of potential biases render this
data incapable of being the sole or primary support for generalized
conclusions or policy. These biases include, but are not limited
to, the substantial opportunities for selection bias inherent in
the study design, the likelihood that participants who know that
their movements are being observed will act differently than
unobserved members of the same cohort, and a low expected response
rate. OMB would like to place emphasis on the explicit limitations
of the data described by the Agency on page six of the supporting
statement. The data collected by this study cannot support any
attempt to generalize the results of this study beyond the farmers
and their families who were actually tested. OMB, in conjunction
with the Agricultural Health Study researchers from the EPA
National Exposure Research Laboratory, NCI, and NIEHS, have
determined that this study will not yeild results that can be used
to establish the validity or accuracy of the AHS questionnaire.
Both OMB and the National Exposure Research Laboratory researchers
agree that the data are not sufficiently generalizable to support
appropriate conclusions relating to the goals of the Food Quality
Protection Act for anyone other than those individuals who are
actually observed. The data will be used to evaluate AHS exposure
algorithms used to translate AHS survey data into exposure
estimates and for formulating hypotheses for testing in later,
statistically generalizable studies based on the collection of
additional data.
Inventory as of this Action
Requested
Previously Approved
02/28/2003
02/28/2003
1,674
0
0
349
0
0
0
0
0
NCI, NIEHS, and EPA have agreed
through a Memorandum of Under- standing of perform a prospective
epidemiological study of the risk of cancer and other diseases
associated with usage and exposure to pesticides of registered
pesticide applicators and their spouses in the states of Iowa and
North Carolina. The Agricultural Health Study (AHS) will evaluate
whether those applicators with the greatest usage history and
potential expo- sures to pesticides are at greater risk of cancer
or other diseases than those applicators with lowest usage history
and re- duced potential exposures to pesticides. ...
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.