[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 [[Page 32043]] 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 (OMB0925-04-06) 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 [[Page 32044]] 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] BILLING CODE 6560-50-P