LABORATORY CAPACITY AND CAPABILITY Information Collection Request:

Supporting Statement U. S. ENVIRONMENTAL PROTECTION AGENCY Office of Environmental Information April 2003 Table of Contents 1. Identification of the Information Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1( a) Title of the Information Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1( b) Short Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. Need For and Use of the Collection 2( a) Need/ Authority for the Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2( b) Practical Utility/ Users of the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3. Non duplication, Consultations, and Other Collection Criteria . . . . . . . . . . . . . . . . . . . . 2 3( a) Non duplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3( b) Public Notice Required Prior to ICR Submission to OMB . . . . . . . . . . . . . . . . . 2 3( c) Consultations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( d) Effects of Less Frequent Collections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( e) General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( f) Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( g) Sensitive Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4. The Respondents and the Information Requested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4( a) Respondents/ SIC Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4( b) Information Requested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 5. The Information Collected  Agency Activities, Collection Methodology, and Information Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 5( a) Agency Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 5( b) Collection Methodology and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5( c) Small Entity Flexibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 5( d) Collection Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6. Estimating the Burden and Cost of the Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6( a) Estimating Respondent Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6( b) Estimating Respondent Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 6( c) Estimating Agency Burden and Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6( d) Estimating the Respondent Universe and Total Burden and Costs . . . . . . . . . . . . 6 6( e) Bottom Line Burden Hours and Cost Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6( f) Reasons for Change in Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6( g) Burden Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 APPENDIX A Federal Register Notice: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A 1 APPENDIX B Survey of State Laboratories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B 1 1 ICR SUPPORTING STATEMENT OUTLINE Laboratory Capacity and Capability Information Collection Request April 2003 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title and Number of the Information Collection Title: Laboratory Capacity and Capability EPA ICR Number: 2110.01 This Information Collection Request ( ICR) specifies activities applicable to the United States Environmental Protection Agency ( EPA or the Agency) as required by the National Homeland Security Strategic Plan created by the Department of Homeland Security, which addresses laboratory capacity and capability to analyze environmental samples.

1( b) Short Characterization/ Abstract In the aftermath of the response to the September 11 attacks at the World Trade Center, the Pentagon, and in Western Pennsylvania, state, local and federal personnel successfully carried out their missions under trying circumstances and with the challenge of unprecedented demand on response resources. One of the most significant challenges faced was obtaining sufficient laboratory support.

In July 2002, the Office of Homeland Security ( Department of Homeland Security) delineated new responsibilities associated with creating appropriate levels of laboratory support in response to terrorist incidents. The National Homeland Security Strategic Plan directs DHS, HHS and EPA to ensure sufficient capacity and capability to analyze environmental and clinical samples during crises. Moreover, these same agencies and departments are to work toward a network of state, federal and private laboratories capable of analyzing standard chemical and biological analytes as well as chemical warfare, bioterrorism, and radiochemical agents, in support of emergency response.

A necessary first step to assess the Nation's analytical capability is to collect and collate information on federal, state and private laboratories into a compendium of laboratory capabilities relevant to terrorist incidents. This compendium is intended to assist personnel who respond to emergency situations in quickly identifying qualified and appropriate laboratory capabilities and capacities to analyze chemical and biological analytes as well as chemical warfare, bioterrorism, and radiochemical agents.

EPA will collect information from other federal agencies and from State environmental, public health and agriculture laboratories using a common survey instrument. This instrument 2 will identify analytical capabilities and the information collected will be organized in the following manner:

$ Laboratory Profiles $ Points of Contact $ Location $ Analytical Capabilities $ Instrumentation $ Special Sample Handling $ Support Services $ Acreditation, Certification and QA Programs This ICR will result in a one time burden and cost to respondents of 400 hours and $ 30,000. These costs represent the time required to fill out and review the one time survey, photocopying and postage. The estimated burden and cost to EPA is 200 hours and $ 40,000.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection The Homeland Security Act of 2002 ( Public Law 107 296) created the Department of Homeland Security under whose auspices this information is being collected. The collection of laboratory capability information is a necessary step toward ensuring sufficient national laboratory analysis capability in response to terrorist incidents involving chemical, biological or radiological warfare agents. The National Homeland Security Strategic Plan developed by DHS seeks to build sufficient laboratory analysis capability to support incident response across the nation.

2( b) Practical Utility/ Users of the Data EPA, HHS, DOD, DHS, FEMA and other agencies involved in incident response will use this information to identify laboratory resources which could be applied to support response to known or suspected terrorist events. Once compiled, the information collected can be used to identify and address gaps in the nation's analytical support ability. Only entities designated by DHS and EPA may have access to the laboratory information derived from this collection.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non duplication To the best of the Agency's knowledge, the information to be collected from the State laboratories is not known to be available from another source.

3( b) Public Notice Required Prior to ICR submission to OMB 3 To comply with the 1995 Amendments to the PRA, EPA solicited public comment on this ICR for a 21 day period before it was submitted to OMB.

3( c) Consultations Because of the critical nature of the information to be collected under this ICR ( i. e., ensuring adequate laboratory support for analysis of warfare agent samples), the survey for collecting this information has been developed quickly. However, EPA has consulted with other federal and state entities prior to completion of the survey instrument and this information collection. This consultation included direct engagement with the Environmental Council of States ( ECOS), the umbrella organization representing the Nation's State Environmental Commissioners, as well as the Department of Homeland Security's interagency Health and Biodefense Working Group.

3( d) Effects of Less Frequent Collection This one time information collection is necessary to produce the necessary laboratory information included a compendium of available resources.

3( e) General Guidelines This ICR was developed in accordance with the ICR Handbook prepared by EPA's Office of Environmental Information, Office of Information Collection, Collection Strategies Division. The ICR Handbook provides the most current instructions for ICR preparation to ensure compliance with the 1995 PRA amendments and OMB's implementing guidelines.

Respondents are not required to:

$ Report information to EPA more than once.

$ Prepare a written response to the collection in fewer than 30 days after receipt of a request.

$ Participate in a statistical survey that is not designed as part of this collection.

$ Use a statistical data classification that has not been reviewed and approved by OMB.

3( f) Confidentiality Due to the sensitivity of the information collected, State respondents should submit survey responses to EPA by courier service directly to a receiving location that secures the information, allowing access only to permitted individuals. Each State respondent is expected to retain a copy of the survey and manage that record as sensitive information. 4 3( g) Sensitive Questions The survey collects information about each entity's core analytical abilities, geographic location, and special instrumentation. None of the responses by themselves are sensitive but, collectively, the information could be assembled to disrupt infrastructure potentially needed for response activities.

4. RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ SIC Codes Respondents are State Environmental, Agriculture, and Public Health Laboratories with no SIC codes.

4( b) Information Requested 4 ( i) Data items, including record keeping requirements Each State Laboratory will report through a survey instrument, analytical capabilities, instrumentation, points of contact and special handling support present/ provided at their facility. Each facility will be expected to maintain copies of their survey responses in a place appropriate for maintaining sensitive records.

4 ( ii) Respondent Activities $ Read and understand the survey instrument $ Complete and submit survey to designated EPA location.

$ Maintain appropriate records 5. INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities EPA will conduct the following activities connected to the survey of laboratory capability.

$ Create and field test the survey instrument ( EPA laboratories were asked to complete the survey).

$ Provide assistance in completing the instrument. 5 $ Collect and organize responses into one compendium.

$ Maintain appropriate records.

5( b) Collection Methodology and Management In collecting the information associated with this ICR, EPA will require use of courier services by respondents. EPA will maintain information obtained in such a way as to limit access to authorized individuals and in collaboration with the Department of Homeland Security.

EPA will review the surveys for completeness and quality control purposes and will followup with respondents to clarify, where necessary.

5( c) Small Entity Flexibility Survey respondents are State governments and not jurisdictions with fewer than 50,000 people.

5( d) Collection Schedule The survey will be due thirty days from date of request.

6. ESTIMATING BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden The one time burden to complete and review the survey instrument is estimated to be 400 hours. This work will entail reading the instrument instructions, completing the document and conducting appropriate organizational reviews prior to submission. This estimate was based on EPA's experience in completing the survey for EPA laboratories across the country.

6( b) Estimating Respondent Costs 6 ( i) Estimating Labor Costs The labor costs associated with this one time collection are estimated to be $ 24,000 ( based on $ 60/ hour for Lab Director/ Management).

6( ii) Estimating Capital and Operations and Maintenance Costs The costs for copying, filing and mailing the survey instrument are estimated to be $ 6,000. 6 6 ( iii) Capital/ Start up Operating and Maintenance ( O& M) Costs No start up costs.

6 ( iv) Annualizing Capital Costs N/ A 6( c) Estimating Agency Burden and Cost The estimated burden to EPA for this one time collection is 260 hours. These hours will be devoted to review, compilation and preparation of the compendium of laboratory information.

6( d) Estimating the Respondent Universe and Total Burden and Costs The estimated cost to EPA for survey review, compilation and compendium development is $ 40,000.

6( e) Bottom Line Burden Hours and Cost Tables 6 ( i) Respondent Tally Activity Burden Hours Cost Read/ Review Survey 200 $ 12,000 Complete/ Submit Instrument 200 $ 12,000 Mailing/ filing/ copying $ 6,000 6 ( ii) The Agency Tally Activity Burden Hours Cost Create Survey 20 $ 1,200 Assist States 50 $ 3,000 Collect and Compile 130 $ 7,800 Create Compendium 60 $ 28,000 TOTAL 660 $ 70,000 6( f) Reasons for Change in Burden New ICR with no change in previous burden estimates. 7 6( g) Burden Statement Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2 hours per response. 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. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

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. OEI 2003 0027 , which is available for public viewing at the Office of Environmental Information 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 ( 202) 566 1744, and the telephone number for the Office of Environmental Information Docket is ( 202) 566 1752. 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. ( OEI 2003 0027) in any correspondence.

Part B of Supporting Statement Part B. This information collection does not involve statistical sampling or a survey used to make inferences about a population. 8 APPENDIX A Federal Register Notice 9 ENVIRONMENTAL PROTECTION AGENCY [ OEI 2003 0027, FRL ]

Agency Information Collection Activities: Proposed Collection; Comment Request; State Laboratory Capacity and Capability AGENCY: Environmental Protection Agency ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) will be forwarded to the Office of Management and Budget ( OMB) for review and approval: State Laboratory Capacity and Capability ( EPA ICR No. 2110.01). 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. EPA also solicits comment on its intention to seek an emergency clearance from OMB to begin collecting data from State Environmental Laboratories and select State Agriculture and State Public Health Laboratories.

DATES: Comments must be submitted on or before [ INSERT DATE 21 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. If EPA does not receive adverse comments on or before this date regarding EPA's request for emergency clearance, EPA intends to seek a 180

day emergency clearance from OMB to begin collecting information from State Laboratories.

ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Don Flattery, US EPA, Office of Environmental Information ( 2810 A), 1200 Pennsylvania Ave, NW; Washington DC 20460. Phone: ( 202) 564

4677; fax ( 202) 501 1622; E mail: flattery. don@ epa. gov. 10 SUPPLEMENTARY INFORMATION: EPA has established a public docket for this ICR under Docket ID number OEI 2003 0027, which is available for public viewing at the Office of Environmental Information 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 ( 202) 566 1744, and the telephone number for the Office of Environmental Information Docket is ( 202) 566 1752. 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 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 and OMB within 21 days of this notice, and according to the following detailed instructions: 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by email to oei. docket@ epa. gov, or by mail to:

EPA Docket Center, Environmental Protection Agency, Office of Environmental Information Docket, 28221T, 1200 Pennsylvania Ave., NW, Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.

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 11 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 www. epa. gov/ edocket.

Title: State Laboratory Capacity and Capability, EPA ICR Number 2110.01. This is a request for a new information collection, and a notification that EPA will seek an emergency clearance from OMB to begin collecting information.

Abstract: In early 2003, EPA completed a compendium of Laboratory Capability and Capacity. The compendium, available to EPA's emergency response community and select managers and staff, is contained in a data base that allows queries based on analytical capabilities,

instrumentation, special handling abilities and location. This useful information was developed through a survey issued to EPA's thirty four fixed and two mobile laboratories.

EPA has been asked by the Department of Homeland Security to pursue development of subsequent phases of this compendium to collect identical information from State laboratory sources. When complete, this information will result in a resource available to select State, local and federal entities involved in response to terrorist incidents involving unknown or suspected chemical, biological or radiological agents. 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 12 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: The one time public reporting and recordkeeping burden for this collection of information is estimated to average 4.0 hours per response. 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 13 otherwise disclose the information.

Respondents/ Affected Entities: 50 States Estimated Number of Respondents: 100 Frequency of Response: Two per State Estimated Total Annual Hour Burden: 400 hours Estimated Total Annual Cost: $ 30,000; includes $ 6,000 O& M costs and $ 0 capital and startup costs.

Dated: ________________

E. Ramona Trovato, Deputy Assistant Administrator,

Office of Environmental Information 14 APPENDIX B Survey of State Laboratories