[Federal Register Volume 64, Number 114 (Tuesday, June 15, 1999)]
[Notices]
[Pages 32042-32044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15168]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6358-5]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Agricultural Health Study: Pesticide Exposure Study

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.), this notice announces that EPA is planning to submit the 
following proposed Information Collection Request (ICR) to the Office 
of Management and Budget (OMB) entitled: ``Agricultural Health Study: 
Pesticide Exposure Study'' EPA ICR Number: 1906.01. Before submitting 
this

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ICR to OMB for review and approval, EPA is soliciting comments on 
specific aspects of the proposed information collection as described 
below.

DATES: Comments must be submitted on or before August 16, 1999.

ADDRESSES: Public comments should be submitted to: Ms. Dianne Dean, US 
EPA (MD-56), Research Triangle Park, NC 27711.

FOR FURTHER INFORMATION CONTACT: Interested persons may obtain a copy 
of this ICR without charge by contacting Ms. Dianne Dean, 919-541-3085. 
Fax: 919-541-1486. E-mail: [email protected]. For technical 
information on the proposed study, contact Mr. Gary Evans, 919-541-
3124. FAX: 919-541-4046. E-mail: [email protected].

SUPPLEMENTARY INFORMATION:
    Affected entities: Entities potentially affected by this action are 
private pesticide applicators in the Agricultural Health Study 
epidemiological cohort, their spouses, and children.
    Title: Agricultural Health Study: Pesticide Exposure Study, EPA ICR 
Number: 1906.01.
    Abstract: The National Cancer Institute (NCI), the National 
Institute of Environmental Health Sciences (NIEHS) and the U.S. 
Environmental Protection Agency (U.S. EPA) have agreed through a 
Memorandum of Understanding to perform a prospective epidemiological 
study of the risk of cancer and other diseases for 90,000 registered 
pesticide applicators and their spouses in the states of Iowa and North 
Carolina. Information Collection Requests prepared by NCI for survey 
data collection in the AHS epidemiological study have received OMB 
approval (current OMB #0925-04-06, expires November 30, 2001). The U.S. 
EPA will support the AHS by performing an exposure measurement study of 
private pesticide applicators in the cohort. The exposure measurement 
study is the subject of the information collection request cited in 
this notice.
    Study respondents will be registered private pesticide applicators 
in the AHS prospective epidemiological cohort, their spouses, and up to 
two children (between the ages of 3-18 years old) selected from each 
home. An estimated total of 160 applicators will be selected into the 
study. Approximately 24 of these applicators will be asked to 
participate in the exposure study in each of two years. Participation 
will be entirely voluntary.
    Applicator exposures will monitored around their application of a 
target pesticide. Observations of applicator pesticide handling, 
mixing, loading, and application (HMLA) work practices will be 
performed. A sample of the pesticide formulation will be collected. 
Measurements of applicator exposure will be obtained through collection 
of personal, environmental, and urinary biomarker samples. Urine 
samples will be collected from participating spouses and children to 
measure urinary biomarkers of exposure to the applied pesticide.
    A screening questionnaire will be administered to cohort pesticide 
applicators to determine their eligibility for participation in the 
exposure study. A modified version of the NCI AHS Private Pesticide 
Applicator Followup Questionnaire (OMB #0925-04-06) will be 
administered to the applicator immediately after the observed HMLA 
activity. A Biomarker Questionnaire will be administered to the 
applicator at the end of the monitoring period to collect data for 
interpreting the measurements and to provide additional information 
about applicator and farm family exposure to pesticides. Spouse and 
child components of the Biomarker Questionnaire will be administered to 
participating spouses and up to two participating children in the 
applicator's family. The full NCI AHS Private Pesticide Applicator 
Followup Questionnaire (OMB 0925-04-06) will be administered 
to the pesticide applicator several months after the observed 
application event.
    The data will be used by scientists within ORD and the Agencies 
collaborating on AHS. Data will be used to:
    (i) Assess the magnitude of cohort applicator exposures to applied 
target pesticides;
    (ii) Assess the classification of cohort applicator exposures using 
data from AHS epidemiological study questionnaires and provide data for 
refining exposure classification algorithms;
    (iii) Identify key exposure factors;
    (iv) Assess the association between the application of target 
pesticides and potential exposure for the applicator's spouse and 
child.

The information will appear in the form of final EPA reports, journal 
articles, and will also be made publicly available.
    The total cost of the study is estimated to be $1.8 M over a period 
of three years.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15.
    The EPA would like to solicit comments to:
    (i) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden 
of the proposed collection of information, including the validity of 
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information 
to be collected; and
    (iv) Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses.
    Burden Statement: Screening questionnaires will be administered by 
telephone to determine eligibility to participate in the study. It is 
estimated that 800 AHS cohort applicators will be screened to identify 
eligible pesticide applicators. Average respondent burden for screening 
is estimated to be 10 minutes. The total burden for the screening 
questionnaire is estimated to be 133 hours.
    Average respondent burden for applicators participating in the 
exposure measurement study is estimated to be 4 hours for pesticide 
applicators, 60 minutes for applicator spouses and children providing 
urine samples, and 30 minutes for children only responding to the 
questionnaire. This time includes recruitment, training time, time the 
respondent will spend collecting or assisting collection of samples, 
and time spent completing interviewer-administered questionnaires. 
Approximately 24 of the 160 pesticide applicators will be monitored two 
times. It is estimated that 115 spouses and 96 children will provide 
urine samples and answer the questionnaire. An estimated additional 64 
children will participate by answering the questionnaire only. The 
total burden for participating in the exposure study is estimated to be 
983 hours.
    The overall total estimated burden for screening and for 
participation in the exposure study is estimated to be 1116 hours. Data 
collection is scheduled to occur over a two-year period with work 
approximately 60 applicators in the first year, and the remainder of 
the applicators and repeat visits in the second year. Therefore, the 
annual

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burden is estimated to be 410 hours for respondents for the first year, 
and 706 hours in the second year.
    There are no direct respondent costs for this data collection. An 
incentive payment of $100 will be offered to defray the burden for 
pesticide applicators participating in the exposure measurement study. 
An incentive payment of $20 will be offered to spouses and children 
providing urine samples, and $5 to children responding to the 
questionnaire only.
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information.

    Dated: May 27, 1999.
Gary J. Foley,
Director, National Exposure Research Laboratory.
[FR Doc. 99-15168 Filed 6-14-99; 8:45 am]
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