04-26816. Agency Information Collection Activities: Proposed Collection; Comment Request; Detroit Children's Health Study: Health Effects of Environmental Exposures Among Children Living in the Detroit, Michigan Area, EPA ICR Number 2167.01

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 a proposed Information Collection Request (ICR) to the Office of Management and Budget (OMB). This is a request for a new collection. Before submitting the 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 February 7, 2005.

ADDRESSES:

Submit your comments, referencing docket ID number ORD-2004-0019, to EPA online using EDOCKET (our preferred method), by e-mail to [e-mail], or by mail to: EPA Docket Center, Environmental Protection Agency, Office of Environmental Information Docket, Mail Code 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT:

Susan Auby, Environmental Protection Agency, Office of Information Collection, Office of Environmental Information, 1200 Pennsylvania Ave., NW., Mail Code 28221T, Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

EPA has established a public docket for this ICR under Docket ID number ORD-2004-0019, which is available for public viewing at the Office of Research and Development Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is [phone], and the telephone number for the Office of Research and Development Docket is [phone]. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/​edocket. Use EDOCKET to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA within 60 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 (May 31, 2002), or go to http://www.epa.gov./​edocket.

Affected entities: Entities potentially affected by this action are school officials, parents and children in the Detroit and Dearborn Public Schools.

Title: Detroit Children's Health Study: Health Effects of Environmental Exposures among Children Living in the Detroit, Michigan Area.

Abstract: 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 in 40 CFR are listed in 40 CFR part 9. The proposed study will be conducted by the Epidemiology and Biomarkers Branch, Human Studies Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, U.S. EPA. The purpose of this study is to examine the respiratory health effects in school-age children of mobile and point source air pollutants. Further knowledge regarding the respiratory health effects of airborne particulate matter is required to reduce scientific uncertainties in the development of an Air Quality Criteria for Particulate Matter under the Clean Air Act (42 U.S.C. 7403(d)). The National Academy of Science's Committee on Research Priorities for Airborne Particulate Matter has identified several issues of scientific uncertainty in health effects of airborne particulate matter exposures, including the role of particle size and the role of particulate matter constituents and co-pollutants. The Detroit Children's Health Study will contribute to our understanding of whether long-term, early-life exposures to mobile source emissions, particularly diesel exhaust particles, play a key role in the initiation of allergic asthma in schoolchildren.

A similar NHEERL research project, the El Paso Children's Health Study, was conducted among nearly 9,000 schoolchildren with a collaboration on exposure assessment with scientists from EPA's National Exposure Research Laboratory (NERL). The border cities of Detroit, Michigan and El Paso, Texas share common characteristics such as major diesel truck routes and vehicle idling at international borders, but the two areas have great climatic differences. The ORD Multi-Year Plan for Particulate Matter includes the Detroit Children's Health Study as an integral component of ORD's research on the adverse health effects of long-term air pollutant exposures in susceptible populations.

The parents of children enrolled in fourth and fifth grades of selected Detroit and Dearborn Public Schools will receive a twenty-page respiratory health questionnaire along with a written request for permission for their children to participate in a pulmonary function examination at their school. Participation in the study is entirely voluntary. The respiratory health questionnaire conforms to the ATS/DLD standard respiratory symptom questionnaire and consists of questions specific to the child such as general demographic information, childhood respiratory illness and history of asthma, and current respiratory health conditions. There also are questions regarding household characteristics and family history of smoking, asthma, and respiratory illnesses. One parent from each family will be asked to complete the questionnaire, seal the completed form in the provided envelope, and send the envelope back to the teacher with the child.

Ambient air pollutants will be measured at twenty-five elementary schools in the Detroit metropolitan area. These twenty-five schools were selected to represent areas close to and far away from Detroit roadways and the international border crossings as well as those areas in between. Once explicit permission has been received from both the parent and the child, the children from the selected schools will attempt to perform a routine pulmonary function examination and an exhaled nitric oxide (NO) exam. The pulmonary function exam consists of blowing three to eight times into a tube connected to a spirometer. During the pulmonary function examination, a field technician will record each child's height and weight, and coach the child to perform the breathing tests. A new, sterile, disposable mouthpiece will be used for each child in each test. The pulmonary function examination will be conducted according to guidelines developed by the American Thoracic Society and will be conducted in the child's elementary school during normal school hours with an school nurse on site during the examinations. The exhaled nitric oxide exam consists of exhaling into a bag made of clear polyvinyl film, fitting the child's nostrils with a stopper attached to an NO sampling line, and measuring the NO emitted through the nostrils and from the mouth. Neither exam is any more stressful than blowing out the candles on a birthday cake.

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: The public reporting and recordkeeping burden for this collection of information is estimated to average 33 minutes per response or to range from 0.4-1.5 hours per respondent annually. This survey will not be repeated. 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. 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.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. ORD-2004-0019, which is available for public viewing at the Office of Research and Development Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is [phone], and the telephone number for the Office of Research and Development Docket is [phone]. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/​edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. ORD-2004-0019 and OMB control number (20XX-XXXX) [insert the appropriate OMB #] in any correspondence.

Type of respondent	Respondent activities	Estimated number of respondents	Burden hours	Frequency	Total burden hours	Total burden cost
Adult	Complete Questionnaire	15,000	0.40	1	6000	a $88,320
Child	Perform Pulmonary Function Exam	3,500	0.50	1	1750	b 9,013
Child	Perform Exhaled NO Exam	2,000	0.25	1	500	2,575
Total		20,500			8250	99,908
a $14.72/hour.
b $5.15/hour (minimum wage).

There are no direct respondent costs for this data collection.

No Annual Record Keeping Burden: 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.

Dated: November 30, 2004.

John Creason,

Acting Director, Human Studies Division.