                    SUPPORTING STATEMENT FOR THE RENEWAL OF

               EPA INFORMATION COLLECTION REQUEST NUMBER 1613.03

DATA REPORTING REQUIREMENTS FOR STATE AND LOCAL VEHICLE EMISSION INSPECTION AND MAINTENANCE (I/M) PROGRAMS

                               February 29, 2012

                               TABLE OF CONTENTS

1. 	IDENTIFICATION OF THE INFORMATION COLLECTION ............................ 3
	1(a) Title and Number of the Information Collection ..............................................	3
	1(b) Characterization of the Information Collection ................................................	3

2. 	NEED FOR AND USE OF THE COLLECTION ...................................................	3
	2(a) Need and Authority for the Collection .............................................................	3
	2(b) Use and Users of the Data ................................................................................	4

3. 	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION
      CRITERIA ...............................................................................................................	5
	3(a) Non-Duplication ...............................................................................................	5
	3(b) Public Notice Required Prior to ICR Submission to OMB............................... 5
	3(c) Consultations ....................................................................................................	6
	3(d) Effects of Less Frequent Collection .................................................................	7
	3(e) General Guidelines ...........................................................................................	7
	3(f) Confidentiality ..................................................................................................	7
	3(g) Sensitive Questions ........................................................................................... 7

4. 	THE RESPONDENTS AND THE INFORMATION COLLECTED .....................	7
	4(a) State and Local Respondents.............................................................................	7
	4(b) Information Requested .....................................................................................	8

5. 	THE INFORMATION COLLECTED -- AGENCY ACTIONS, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT .............................	15
	5(a) Federal Agency Activities ................................................................................	15
	5(b) Collection Methodology and Management ......................................................	16
	5(c) Small Entity Flexibility ....................................................................................	16
	5(d) Collection Schedule .........................................................................................	17

6. 	ESTIMATING THE BURDEN AND COST OF THE COLLECTION ..................	17
	6(a) Estimating Respondent Burden ........................................................................	17
	6(b) Estimating Respondent Costs ...........................................................................	18
	6(c) Estimated Agency Burden and Cost .................................................................	20
	6(d) Bottom Line Burden Hours and Costs .............................................................	22
	6(e) Reasons for Change in Burden .........................................................................	22
	6(f) Burden Statement ..............................................................................................	23

APPENDIX A ......................................................................................................................	24

1. 	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) 	Title and Number of the Information Collection

	This information collection request (ICR) renewal is entitled "Data Reporting Requirements for State and Local Vehicle Emission Inspection and Maintenance (I/M) Programs" [EPA ICR Number 1613.03; Office of Management and Budget (OMB) Control Number 2060-0252].

1(b) 	Characterization of the Information Collection

      To provide general oversight and support to state and local I/M programs, the U. S. Environmental Protection Agency (EPA) requires that state or local program management for both basic and enhanced I/M programs compile and submit two different reports to their Regional EPA office.  The first reporting requirement is the submittal of an annual report providing general program operating data and summary statistics, addressing the program's current design and coverage, a summary of testing data, enforcement program efforts, quality assurance and quality control efforts, as well as other miscellaneous information allowing for an assessment of the program's relative effectiveness; the second is a biennial report addressing  any changes to the program over the two-year period prior to the biennial report's submission, including the impact of such changes, any weaknesses discovered during the reporting period, and the corrections made or planned.

      General program effectiveness is determined by the degree to which the operating program compares to the program described in the state's approved State Implementation Plan (SIP), which, in turn, must meet or exceed the minimum requirements for mandatory I/M programs, as promulgated under 40 CFR, Part 5, Subpart S in response to requirements established in section 182 of the Clean Air Act Amendments of 1990 (Act). The information provided by the annual and biennial I/M reports described above are used by the EPA Regional office to determine whether a given I/M program is meeting its obligations under the approved SIP.  The information may also be used by EPA Headquarters to assess national trends in the implementation of both basic and enhanced I/M programs, as well as to help determine when anomalous reporting results are due to national versus local causes.

2. 	Need for and Use of the Collection

2(a)	Need and Authority for the Collection

      The collection of a variety of program operating and summary data is essential to the assessment of an I/M program's overall effectiveness and the degree to which it complies with requirements established in response to sections 182(a)(2)(b)(ii); 182(b)(4); and 182(c)(3) of the Act, under which EPA is authorized to impose these collection and recordkeeping requirements.  The specific program data to be collected are listed under the "Data analysis and reporting" section of EPA's I/M rule (40 CFR Part 51, subpart S, section 51.366).  A list of the required reporting elements is included in section 4(b) of this Information Collection Request (ICR) renewal.

2(b) 	Use and Users of the Data

      There are, in effect, three users of the information required by this collection  -  the  primary user, represented by the state or local agency or department in charge of managing the I/M program itself (hereafter referred to as "the state" and/or "the respondent"), the secondary user, represented by the EPA Regional office (henceforth referred to as "the Region") to help determine the degree to which the program complies with its approved SIP, and finally, EPA Headquarters, to help identify national trends in the implementation of both basic and enhanced I/M programs, as well as to help determine when anomalous results being observed by a State or Region are due to national versus local causes.

      The State

      For the purpose of effectively managing its I/M program, the state must gather a wide range of program data, including data from the testing program, quality control and assurance efforts, and the enforcement program.  For example, sufficient test data must be gathered to unambiguously link specific test results to a specific vehicle, I/M program registrant, test site, and inspector, to help determine whether or not the correct test parameters were observed for the specific vehicle in question.  This programmatic need  -  which is distinct from any need and/or burden imposed by this ICR  -  is reflected in the fact that current testing equipment specifications include extensive data capture requirements to serve just this purpose.  In turn, the state can analyze this data and compare it to the registration database (in programs enforced through registration denial, per the Act) or otherwise use it to establish a vehicle's compliance with program requirements.  Owners of vehicles found to be out-of-compliance are not allowed to register said vehicle(s) (again, in programs enforced through registration denial) or must be otherwise prevented from operating the non-complying vehicle(s) in the program area.  Penalties may also be assessed for non-compliance with program requirements.

      Data collected as part of the testing program can also be used to target audits of inspection stations and inspectors, with irregularities such as unusually high pass or fail rates, mismatched vehicle information, etc. acting as flags to possible problems.  In addition, the state must gather and analyze quality control data to ensure that motorists are given accurate and consistent measurements.  In the interest of effectively managing its enforcement and quality assurance efforts, the program must keep records of such efforts, including the number of investigations conducted (including internal control reviews to detect weaknesses within the program itself, as well as investigations of testing sites and inspectors), the methodology used, and the results of investigations and other enforcement and quality assurance activities.

      EPA Regional Office

      To comply with this information collection, the state must summarize and report the above data to the EPA Regional Office with jurisdiction over the state in question.  The state will have maximum flexibility to use pre-existing, internal reporting mechanisms to meet these summary data reporting requirements, and may submit the required reports in whatever format is most convenient for the state, including electronically, via hardcopy, or by directing the EPA Regional Office to web resources which include the required information.  The Regional Office will use this information to assess specific state programs and their success in complying with I/M requirements.  This assessment will lead to follow-up conversations with the state to discuss possible program improvements or corrective action necessary to address anomalies, and in some instances may lead to site visits and audits of the programs in question.

	EPA Headquarters

	When anomalies are discovered in the reported summary information and cannot be resolved by the state and Region, EPA Headquarters may be called in to help determine whether a given anomaly is the result of local conditions or is perhaps indicative of a larger, national trend.  In such situations, EPA Headquarters will work with the state and the Region to identify and address the causes of the anomaly.  Information regarding the resolution of such cases  -  to the extent it may be relevant outside the program in question  -  will be made available to other states, Regions, and the public in general through various communication methods, including biweekly conference calls with the EPA Regions, a bimonthly stakeholder call with the I/M states, and the I/M Clearinghouse web site, currently managed by Weber State University under a grant from EPA.

3. 	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)	Non-Duplication

      EPA has made an effort to ensure that the data collection efforts associated with renewal of this ICR are not duplicated.  EPA has consulted with State and Local environmental programs, other Federal agencies (such as EPA's Regional Offices). To the best of EPA's knowledge, data currently required by this information collection are not available from any other source.

3(b)	Public Notice Required Prior to ICR Submission to OMB

      To comply with the 1995 Amendments to the Paperwork Reduction Act (PRA), EPA has solicited public comment on the renewal of this ICR for a 60-day period before the renewal request was submitted to OMB. Specifically, EPA has published a notice in the Federal Register requesting comment on the continued use of the estimated respondent burden and other aspects of this ICR renewal (XX FR XXXX, see Appendix A).  An additional Federal Register notice will be published prior to submission of this request for ICR renewal to OMB.  The public comment period for this additional notice will be 30 days.

3(c)	Consultations

      In an effort to address state concerns regarding a wide-range of environmental reporting requirements, EPA and the Environmental Council of the States (ECOS) launched the Burden Reduction Initiative (BRI) in October 2006.  As part of this initiative, EPA invited states to identify their top five reporting requirements with potential for streamlining or elimination.  A total of 39 states responded to this invitation, identifying more than 200 reporting requirements as candidates for possible burden reduction or elimination.

      Although 33 states plus the District of Columbia currently run I/M programs subject to the reporting requirements covered by the information collection currently up for renewal, only 5 of the 39 states responding to the reporting burden reduction initiative  -  Illinois, Massachusetts, Maryland, New Hampshire, and Virginia  -  identified some aspect of the I/M reporting requirements as potential candidates for burden reduction.  It should be noted, however, that there was no consensus among the 5 states regarding what sort of relief was needed.  EPA has met with ECOS representatives concerning the 5 states commenting on I/M reporting requirements as well as the need for additional program evaluation guidance.  Clarification with regard to the existing reporting requirements satisfied the workgroup.

      For this most recent renewal of the ICR for I/M reporting requirements, EPA has published the first 60 day notice soliciting comments on its proposed renewal of the I/M ICR on February XX, 2012 (XX FR XXXX, see Appendix A).  The public comment period closed on May XX, 2012.  EPA did not receive comments on any portion of its proposal from the states which originally identified I/M reporting requirements as warranting relief under the BRI, nor from any other source.

3(d)	Effects of Less Frequent Collection

      The I/M Rule requires annual and biennial reporting by the I/M programs to ensure that states are achieving the emission reductions claimed by such programs in their approved SIPs.  EPA has considered a range of alternatives for data reporting requirement frequency.  It is EPA's judgment that collecting the required information less frequently would limit its ability to determine a program's progress toward meeting requirements under 40 CFR, Part 51 and would delay its ability to identify and resolve programmatic deficiencies that may negatively impact a program's ability to achieve the needed emission reductions, thus magnifying any potential shortfall.  It may be argued that more frequent reporting would therefore shrink the potential for negative impacts by identifying deficiencies sooner, relative to the current reporting frequency.  In setting the current reporting frequency, EPA has attempted to strike a reasonable balance and believes that more frequent reporting would be unduly burdensome.  To supplement the current reporting cycle and thus ensure that major program deficiencies do not go undetected for an unreasonable period of time, EPA holds bimonthly conference calls with I/M states as a forum for raising, discussing, and resolving implementation issues as they arise.  State participation in these calls is, of course, voluntary.

3(e)	General Guidelines

      This ICR was prepared in accordance with the October 2009 version of EPA's Guide to Writing Information Collection Requests Under the Paperwork Reduction Act (PRA) of 1995 (or "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.

3(f)	Confidentiality

      No confidential information will be collected as a result of this ICR.

3(g)	Sensitive Questions

      No information of a sensitive nature will be collected as a result of this ICR.

 	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	State and Local Respondents

      The respondents to this information collection are the state government agencies or departments responsible for oversight and operation of the I/M programs (SIC# 91).  As of January 2012, thirty-three states plus the District of Columbia are affected by I/M program requirements.  This category of respondent was selected because it represents the entities most comprehensively involved in gathering the information which must be summarized for this collection (i.e., those parties responsible for establishing, maintaining, and analyzing the program's central database, or overseeing contractor personnel responsible for such activities).  Although I/M programs can and do vary by type (i.e., basic I/M programs versus enhanced I/M programs), the data elements to be addressed by this information collection remain consistent across program types, and hence the burden does not vary by program type.

4(b)	Information Requested

      Under current I/M program practice, various internal analyses and reports are routinely generated using the data collected on vehicle tests, as well as quality control, quality assurance, and enforcement efforts.  The information requested in this ICR renewal is, in fact, based upon the data items currently collected in and the reports currently generated by many of the better run I/M programs.  These reports are used primarily as management tools for internal monitoring and evaluation of the program.  Summaries of the information provided in these reports are also currently being used by EPA (primarily the Agency's Regional Offices and, secondarily, EPA Headquarters) to fulfill the Agency's statutory obligation to provide oversight to mandatory I/M programs and to ensure that such programs are achieving the emission reductions claimed in their approved SIPs.  The purpose of this current request is to renew a previously approved information collection (OMB Control Number 2060-0252; EPA ICR Number 1613.03) so that EPA can continue to meet is statutory obligation with regard to providing I/M program implementation guidance and oversight.

(i)	Data items

A.	Recordkeeping Requirements

      In fulfilling the requirements of this information collection, respondents gather and maintain records on the following data items per vehicle inspected as part of the I/M program.  As stated previously, similar information is currently collected by existing I/M programs and is written into the data recording requirements of their testing equipment specifications.  As stated in the introduction to this section, these records represent information which a program needs to gather and maintain as part of the day-to-day administration and enforcement of the program, and, as such, do not constitute an additional burden triggered by this information collection or its renewal.

	1) Test record number
	2) Inspection station and inspector number
	3) Test system number
	4) Date of the test
            5) Emission test start time and the time final emission scores are determined
	6) Vehicle Identification Number (VIN)
	7) License plate number
	8) Test certificate number
	9) Gross Vehicle Weight Rating (GVWR)
	10) Vehicle model year, make, and type
	11) Number of cylinders or displacement
	12) Transmission type
	13) Odometer reading
	14) Type of test performed (i.e., initial test, first retest, or subsequent retest)
	15) Fuel type of the vehicle (i.e., gas, diesel, or other fuel)
	16) Type of vehicle preconditioning performed (if any)
	17) Emission test sequence(s) used
	18) Hydrocarbon emission scores and standards for each applicable test mode
            19) Carbon monoxide emission scores and standards for each applicable test mode
            20) Carbon dioxide emission scores (CO+CO2) and standards for each applicable        test mode
            21) Nitrogen oxides emission scores and standards for each applicable test mode
            22) Results (Pass/Fail/Not Applicable) of the applicable visual inspections for the catalytic converter, air system, gas cap, evaporative system, positive crankcase ventilation (PCV) valve, and fuel inlet restrictor
            23) Results of the evaporative pressure test expressed as a pass or fail (where applicable)
            24) Results of the evaporative system purge test expressed as a pass or fail along with the total purge flow in liters achieved during the test (where applicable)
            25) Results of the on-board diagnostic check expressed as pass or fail along with the diagnostic trouble codes revealed (where applicable).

      In addition, I/M programs must gather and maintain records on the results of all applicable quality control checks conducted in response to 40 CFR 51, subpart S, section 359, identifying each check by station number, system number, date, and start time.  The record shall also contain the concentration values of the calibration gases used to perform the gas characterization portion of the quality control checks (if applicable).  Raw test data (both vehicle inspections and quality control checks, if applicable) shall be saved for a minimum of two complete inspection cycles (i.e., two years in annual programs, and four years in biennial programs), and submitted to EPA electronically upon request.  Current practice is for states to save data for five to nine years, typically.

B.	Reporting Requirements

	(1) Annual Report

	Internal data analysis and reporting are currently employed in better-run I/M programs as management tools to facilitate the monitoring and evaluation of the program by program management.  Under the ICR EPA proposes to renew, state I/M programs submit summaries of this information to the EPA Regional Office with jurisdiction over the I/M program in question.  To be considered complete, these reports must include information regarding the types of program activities performed and their final outcomes, including summary statistics and effectiveness evaluations of the enforcement mechanism, the quality assurance system, the quality control program, and the testing element.  Under the existing ICR, respondents are required to provide their respective EPA Regional Offices with the following data annually.  Again, as previously stated, these reporting requirements were originally based upon the reporting practices of better-run I/M programs at the time the original information collection was developed, and, as such, do not constitute an additional respondent burden.

	It should be noted that as state programs gradually phase-out tailpipe testing and begin to move toward the exclusive use of onboard diagnostic (OBD) based testing, an added benefit of doing such will be a significant reduction in the number of reporting elements that need to be gathered, summarized, and reported.  For example, all the by-pollutant reporting requirements will no longer apply, and neither will any of the reporting elements that presume dual testing of OBD-equipped vehicles.  Additionally, because OBD-based testing equipment does not need to be calibrated like tailpipe based systems, the need to perform and record calibration results as part of the overt equipment auditing process is likewise eliminated.  Although EPA notes this eventuality, the Agency has not attempted to quantify the impact on respondent burden because individual respondent programs will vary greatly with regard to when such a change to OBD-only testing may be possible and/or desirable.  Because most programs will eventually reach the stage described above (varying only with regard to when) EPA is confident that the respondent burden estimates in this proposed information collection renewal reflect a worst-case scenario and can therefore be characterized as conservative.

	Test Data Summary
	I/M programs are required to submit to their EPA Regional Office by July of each year a report providing basic statistics on the testing program for January through December of the previous year, including:
      (1) The number of vehicles tested by model year and vehicle type;
      (2) By model year and vehicle type, the number and percentage of vehicles:
      (i) Failing initially, per test type;
      (ii) Failing the first retest per test type;
      (iii) Passing the first retest per test type;
      (iv) Initially failed vehicles passing the second or subsequent retest per test type;
      (v) Initially failed vehicles receiving a waiver; and
      (vi) Vehicles with no known final outcome (regardless of reason).
      (vii) - (x) [Reserved]
      (xi) Passing the on-board diagnostic check;
      (xii) Failing the on-board diagnostic check;
            (xiii) Failing the on-board diagnostic check and passing the tailpipe test (if applicable);
            (xiv) Failing the on-board diagnostic check and failing the tailpipe test (if applicable);
            (xv) Passing the on-board diagnostic check and failing the I/M gas cap evaporative system test (if applicable);
            (xvi) Failing the on-board diagnostic check and passing the I/M gas cap evaporative system test (if applicable);
            (xvii) Passing both the on-board diagnostic check and I/M gas cap evaporative system test (if applicable);
            (xviii) Failing both the on-board diagnostic check and I/M gas cap evaporative system test (if applicable);
      (xix) MIL is commanded on and no codes are stored;
      (xx) MIL is not commanded on and codes are stored;
      (xxi) MIL is commanded on and codes are stored;
      (xxii) MIL is not commanded on and codes are not stored;
            (xxiii) Readiness status indicates that the evaluation is not complete for any module supported by on-board diagnostic systems;
      (3) The initial test volume by model year and test station;
      (4) The initial test failure rate by model year and test station; and
      (5) The average increase or decrease in tailpipe emission levels for HC, CO, and NOX (if applicable) after repairs by model year and vehicle type for vehicles receiving a mass emissions test.

	Quality Assurance Summary
	I/M programs are required to submit to their EPA Regional Office by July of each year a report providing basic statistics on the quality assurance program for January through December of the previous year, including:
      (1) The number of inspection stations and lanes:
      (i) Operating throughout the year; and
      (ii) Operating for only part of the year;
      (2) The number of inspection stations and lanes operating throughout the year:
      (i) Receiving overt performance audits in the year;
            (ii) Not receiving overt performance audits in the year;
      (iii) Receiving covert performance audits in the year;
      (iv) Not receiving covert performance audits in the year; and
      (v) That have been shut down as a result of overt performance audits;
      (3) The number of covert audits:
      (i) Conducted with the vehicle set to fail per test type;
            (ii) Conducted with the vehicle set to fail any combination of two or more test types;
      (iii) Resulting in a false pass per test type;
      (iv) Resulting in a false pass for any combination of two or more test types;
      (v) - (viii) [Reserved]
      (4) The number of inspectors and stations:
            (i) That were suspended, fired, or otherwise prohibited from testing as a result of covert audits;
            (ii) That were suspended, fired, or otherwise prohibited from testing for other causes; and
      (iii) That received fines;
      (5) The number of inspectors licensed or certified to conduct testing;
      (6) The number of hearings:
      (i) Held to consider adverse actions against inspectors and stations; and
      (ii) Resulting in adverse actions against inspectors and stations;
      (7) The total amount collected in fines from inspectors and stations by type of violation;
      (8) The total number of covert vehicles available for undercover audits over the year; and
      (9) The number of covert auditors available for undercover audits.

	Quality Control Summary
	I/M programs are required to submit to their EPA Regional Office by July of each year a report providing basic statistics on the quality assurance program for January through December of the previous year, including:
      (1) The number of emission testing sites and lanes in use in the program;
      (2) The number of equipment audits by station and lane;
      (3) The number and percentage of stations that have failed equipment audits; and
      (4) Number and percentage of stations and lanes shut down as a result of equipment audits.

	Enforcement Summary

      (1) All varieties of enforcement programs shall, at a minimum, submit to their EPA Regional Office by July of each year a report providing basic statistics on the enforcement program for January through December of the previous year, including:
            (i) An estimate of the number of vehicles subject to the inspection program, including the results of an analysis of the registration data base;
            (ii) The percentage of motorist compliance based upon a comparison of the number of valid final tests with the number of subject vehicles;
      (iii) The total number of compliance documents issued to inspection stations;
      (iv) The number of missing compliance documents;
      (v)  The number of time extensions and other exemptions granted to motorists; and
            (vi) The number of compliance surveys conducted, number of vehicles surveyed in each, and the compliance rates found.
      (2) Registration denial based enforcement programs shall provide the following additional information:
            (i) A report of the program's efforts and actions to prevent motorists from falsely registering vehicles out of the program area or falsely changing fuel type or weight class on the vehicle registration, and the results of special studies to investigate the frequency of such activity; and
            (ii) The number of registration file audits, number of registrations reviewed, and compliance rates found in such audits.
      (3) Computer-matching based enforcement programs shall provide the following additional information:
            (i) The number and percentage of subject vehicles that were tested by the initial deadline, and by other milestones in the cycle;
            (ii) A report on the program's efforts to detect and enforce against motorists falsely changing vehicle classifications to circumvent program requirements, and the frequency of this type of activity; and
            (iii) The number of enforcement system audits, and the error rate found during those audits.
      (4) Sticker-based enforcement systems shall provide the following additional information:
            (i) A report on the program's efforts to prevent, detect, and enforce against sticker theft and counterfeiting, and the frequency of this type of activity;
            (ii) A report on the program's efforts to detect and enforce against motorists falsely changing vehicle classifications to circumvent program requirements, and the frequency of this type of activity; and
            (iii) The number of parking lot sticker audits conducted, the number of vehicles surveyed in each, and the noncompliance rate found during those audits.

	(2) Biennial Report
	In addition to the annual reports identified above, programs shall submit to their EPA Regional Office by July of every other year, biennial reports addressing:
      (1) Any changes made in program design, funding, personnel levels, procedures, regulations, and legal authority, with detailed discussion and evaluation of the impact on the program of all such changes; and
      (2) Any weaknesses or problems identified in the program within the two-year reporting period, what steps have already been taken to correct those problems, the results of those steps, and any future efforts planned.

	(ii)	Respondent Activities

	When responding programs were originally preparing to submit the first round of the above-listed summary data for this approved information collection, the respondents had to pursue the activities identified below.  Several of these activities were essentially one-time efforts (such as pursuing legal authority and constructing testing sites) required to comply with the Act's mandate that such programs be implemented in the first place, while others are activities that are currently conducted in better-run I/M programs for the sake of program implementation, management, and enforcement, and would therefore be pursued regardless of this information collection.  Such activities have been identified here as common business practice (CBP), even though, properly speaking, the respondent entities are representatives of state government agencies or departments.  Respondent activities have been separated for the annual and biennial reports, and separate burden estimates are provided for each in section 6 of this submittal.

	Annual Report

   * Read the I/M regulation (CBP)
   * Review the regulatory provisions addressing the annual reporting requirement and assess respondent responsibility
   * Prepare a State Implementation Plan (SIP) and submit to EPA (CBP)
   * Secure necessary legal authority to establish program (CBP)
   * Develop regulatory basis for program (CBP)
   * Receive appropriate training relative to program operation (CBP)
   * Begin program implementation (i.e., establish testing sites, begin testing, etc.) (CBP)
   * Gather test and quality control information and review for accuracy (CBP)
   * Analyze the test and quality control data (CBP)
   * Based upon analysis of data, begin enforcement efforts against motorists, stations, and inspectors (CBP)
   * Complete written or electronic "paperwork" associated with enforcement and program oversight efforts (CBP)
   * Store, file, and maintain all relevant program records and information (CBP)
   * Assemble existing reports in preparation for summarization
   * Prepare annual summaries of program operating statistics for the enforcement mechanism, the quality assurance system, the quality control program, and the testing element based upon existing, internal reports
   * Review summary information for accuracy
   * Prepare and submit annual report to EPA (or otherwise provide EPA access to the required information)

	Biennial Report

	In addition to the above activities associated with the submittal of the annual information collection, I/M programs must also submit a biennial report that addresses program changes since the last reporting period, including any program weaknesses identified and improvements made.  Again, many of these activities, given their importance in the areas of effective program management and helping to ensure that program resources are not wasted or abused, will need to be pursued internally regardless of this external reporting requirement.  As such, many of these activities are designated as CBP.

   * Track and record all changes made in program design, funding, personnel levels, procedures, regulations, and legal authority
   * Conduct an evaluation of the impact on the program of all such changes (CBP)
   * Conduct periodic internal investigations to discover and correct weaknesses (CBP)
   * Track and record all such weaknesses or problems identified in the program within the two-year reporting period, and the steps taken to correct those problems
   * Evaluate the results of those steps (CBP)
   * Assemble and report the above required information, including any future efforts planned

5.  	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

5(a)	Federal Agency Activities

	In executing the original information collection, EPA had to (and, in some instances, still needs to) do the following:

         * Develop regulations (one-time activity)
         * Prepare initial ICR (one-time activity)
         * Renew initial ICR (periodic)
         * Answer respondent questions
         * Review individual annual and biennial reports
         * Meet with its Regional Offices to review and discuss collective findings, trends
         * Through its Regional Offices, communicate the findings of individual reviews to individual responding states

5(b)	Collection Methodology and Management

	A portion of this information has been assembled in one form or another since the inception of I/M programs as a result of the Clean Air Act Amendments of l977 which required urban areas failing to meet the National Air Quality Standards to implement in-use vehicle I/M programs.  Historically, the sources of this information have included, among other things, on-site audits by EPA personnel, internal program data reports courtesy-copied to EPA, raw program data submitted to EPA for analysis, and, since it was originally approved, the responses to this existing information collection.

	Respondents have the option to supply their data in either hardcopy or electronically, and are free to adopt whatever reporting format results in the least burden for the respondent, while also addressing the data elements listed in this ICR.  EPA is aware of at least one Regional Office which has been granted limited, online access to a state's I/M database so the Region itself may generate the required data summary reports when they are due.

	The information received from the I/M programs has been used by EPA Regional Offices to assess specific state programs and their success in complying with the I/M rulemaking requirements as well as their approved SIPs.  As part of this assessment, EPA's Regional Offices conduct follow-up conversations with their states to discuss possible program improvements or corrective actions necessary to address anomalies (if found).  When an anomaly discovered in the reported summary information cannot be resolved by the state and/or Region, EPA Headquarters has been called in to help determine whether the anomaly is the result of local conditions or is perhaps indicative of a larger, national trend.  In such situations, EPA Headquarters has worked with the state and the Region to identify and address the causes of the anomaly.  Information regarding the resolution of such cases  -  to the extent it may be relevant outside the program in question  -  are made available to other states, Regions, and the public in general through various communication vehicles, including biweekly conference calls with the EPA Regions, a bimonthly stakeholder call with the I/M states, and the I/M Clearinghouse web site, currently managed by Weber State University under a grant from EPA.  The last of these may be accessed at the following:

		http://www.obdclearinghouse.com/

5(c)	Small Entity Flexibility

	This section is not applicable.  Our respondents are not small business entities but state governments and their representatives.

5(d)	Collection Schedule

	Under the original 1992 I/M rulemaking, basic I/M programs were required to begin reporting by July 1995, with the first biennial report coming due in July 1996.  Enhanced I/M programs were required to begin reporting by July 1996, with the first biennial report coming due in July 1997.  Currently  -  and for simplicity sake  -  the reporting schedule is as follows: all required I/M programs must submit their annual I/M summary data reports by July of each year.  Basic I/M programs must submit the required biennial report in even numbered years, and enhanced I/M programs must submit the biennial report in odd numbered years.  If, for administrative reasons, it is easier for a given program to combine its biennial report with its annual report and submit the combined report annually, EPA will accommodate the state's preference in this regard.

 6. 	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

 	In simple terms, EPA calculated the burden and cost estimates for this ICR using
 the following equation:

Number of states        X	Number of burden hours 	      X 	Cost per hour
implementing I/M 		for each state to comply
				with I/M ICR

Section 6(a) describes the information used to develop numbers for the first two variables above.  Section 6(b) describes how the last variable above  -  state and local costs per hour  -  were estimated.  Section 6(c) describes federal burden hours and costs for managing this information collection activity.

6(a)	Estimating Respondent Burden

	The burden estimates for both the recordkeeping and annual reporting requirements were made using professional judgment.  Recordkeeping activities are assumed to be routine, automated, and conducted primarily for the effective management of the program.  Nonetheless, an hour of burden has been assumed for this category.  The estimate of the burden for information gathering by technical staff for the annual report is a conservative one based upon EPA's previous experience working with states as they respond to the I/M reporting requirements.

	Estimates of respondent burden for the biennial report are based upon OTAQ program management staff experience with the assemblage and compilation of materials for the office's annual Assurance Letter under the Federal Managers Financial Integrity Act (FMFIA).  In many ways, the biennial report most resembles the Assurance Letter in its requirement that program changes and internal control activities be tracked, evaluated, and reported.

6(b)	Estimating Respondent Costs

	Since the information gathering and recordkeeping requirements costs for the I/M rule are very minor compared with other costs for this rule, no estimates of information collection labor costs were made in the original Regulatory Impact Analysis.  Given that the respondents to this ICR are state government employees, in managerial, technical, and clerical positions, the General Schedule was adopted as a yardstick for estimating hourly labor rates.  To ensure that our estimates are conservative, only the higher ranges of these categories were used.  For the clerical category, GS-8 was used, while GS-13 was selected to represent the technical position, and GS-15 was used as the base for calculating management labor rates.  First, EPA is assuming that state and local burden hours would be completed by an experienced staff person being paid hourly rates at a GS-8, step 3, GS-13, step 3 and GS-15, step 3 of federal government employee salary.  Second, EPA multiplied these hourly rates by the standard government overhead factor of 1.6.  This calculation results in a state and local cost of $30.77/burden hour, $58.61/burden hour, and $81.47/burden hour, respectively.  Calendar year 2012 was chosen as the base year.  The resulting labor rates are shown in the table below:

    Table 1.  Hourly Labor Rates, By Category, Adjusted for Overhead Factor

Hours Rates
Clerical (GS-8.3)
Technical (GS-13.3)
Managerial (GS-15.3)
2012 base year
                                     19.23
                                     36.63
                                     50.92
Adjusted by the overhead factor 1.6
                                     30.77
                                     58.61
                                     81.47

Table 2. 	Respondent Burden Hours & Cost for Annual Report

Collection Activity
Managerial Hours
Technical Hours
Clerical Hours
Burden Hours
Annual Costs
1. Read regulatory provisions
                                       1
                                       1

                                       2
                                    $140.08
2. Assess data requirements

                                       8

                                       8
                                    $468.88
3. Assemble reports & data

                                      16

                                      16
                                    $937.76
4. Review information for accuracy

                                       8

                                       8
                                    $468.88
5. Summarize information

                                       4

                                       4
                                    $234.44
6. Prepare and submit report

                                       4
                                       1
                                       5
                                    $265.21
7. Record, store, & maintain files

                                       1

                                       1
                                    $58.61
Total
                                       1
                                      42
                                       1
                                      43
                                    $2,574

Table 3. 	Respondent Burden Hours & Cost for Biennial Report

Collection Activity
Managerial Hours
Technical Hours
Clerical Hours
Burden Hours
Annual Costs
1. Track/record program change

                                      16

                                      16
                                    $937.76
2. Track/record weakness/correction

                                      16

                                      16
                                    $937.76
3. Assemble/report findings/future plans
                                      16
                                      32
                                       4
                                      52
                                   $3,302.12
Total
                                      16
                                      64
                                       4
                                      84
                                    $5,178

Annual burden hours
per respondent		= (Hr. of annual report) + (Hr of biennial report)/2
			=  43 + 84/2
			=  85

Annual burden cost
per respondent 		=  $2,574 + ($5,178) / 2
			=  $5,163

Annual total burden hours for all respondents:
                     =  (annual burden hours per respondent) x (total number of respondents)
			=   85 x 28
			=   2,380

Annual total burden costs for all respondents
			=   (annual burden cost per respondent) x (total number of respondent)
			=   $5,163 X 28
			=   $ 144,564

6(c)	Estimating Agency Burden and Cost

	The estimates of each class of hours needed to handle the burdens associated with this ICR are based upon the experience EPA has had in handling similar tasks such as assembling and processing pre-audit information from individual states on an as-needed basis.  The labor categories and hourly labor rates are the same as those used for the respondent burden estimates, and are decidedly conservative.

                Table 4.  Agency Burden for One Time ICR Costs

One- time  Activity
Managerial Hours
Technical Hours
Clerical Hours
 Burden Hours
Annual Costs
Reg Development
                                       4
                                      20

                                      24
                                   $1,498.08

ICR development
                                       2
                                      80
                                       1
                                      83
                                   $4,882.51
Database Set Up
                                       2
                                      40

                                      42
                                   $4,835.74
Total
                                       8
                                      136
                                       1
                                      149
                                    $11,216

  Table 5.  Agency Burden Hours & Cost per Annual & Biennial Report

Collection Activity
Managerial Hours
Technical Hours
Clerical Hours
 Burden Hours
Annual Costs
1.Answer  questions
                                       4
                                      34

                                      38
                                   $2,318.62
2. Review data submissions

                                      34

                                      34
                                   $1,992.74
3. Record data submission

                                      34
                                      34
                                   $1,046.18
4. Analyze data and store

                                       4

                                       4
                                    $234.44
5.Summarize data & report
                                       8
                                      68
                                       8
                                      84
                                   $4,637.24
Total
                                      12
                                      140
                                      42
                                      194
                                    $10,229

Annual total burden hours for agency
	= (annual agency burden hours) +  (Average start up hours over 3 years)
	= 194 + 149/3
	= 244

Annual total burden cost for agency
	=  (annual agency burden costs) +  (Average start up cost over 3 years)
	= $11,216 + $10,229/3
	= $14,626

6(d)  Bottom Line Burden Hours and Costs

	The bottom line burden hours and costs appear in Table 6.  Total annual respondent burden associated with this ICR is estimated to be approximately 2,380 burden hours.  The corresponding total annual respondent costs are estimated to be $144,564.  Total national burden, including respondent burden and EPA burden, is estimated to be 2,624 hours annually.  The total national cost, for respondents and EPA, is estimated to be $159,190 annually.

                 Table 6.  Bottom Line Annual Burden and Cost

number of respondents
                                      28
27 states plus D. C.
total annual respondents
                                      28
one response per respondent
hours per respondent
                                      85
table 2 and 3
cost per respondent
                                    $5,163
table 2 and 3
total respondent hours
                                     2,380
hours per resp. x 28
total respondent cost
                                   $144,564
cost per resp. x 28
total agency hours
                                      244
table 5
total agency cost
                                    $14,626
table 5
total burden hours (resp. + agency)
                                     2,624
total respondent hours + total EPA hours
total burden cost (resp. + agency)
                                   $159,190
total respondent cost + total EPA cost

6(e)	Reasons for Change in Burden

	The total annual burden estimated in 1992, I/M Program Proposed Rule ICR, approved by OMB, was 2,282 hours.  The annual burden hours per respondent was 85 hours.  When the original ICR was subsequently renewed, the annual burden hours per respondent was retained at 85 hours, but the estimate of total respondents' burden was changed to 2,890 hours.  The reason for that change was that the number of states (respondents) implementing the I/M program had increased to 34.  During the current renewal, the total burden hours and costs associated with this ICR are going down due to the fact that now, only 28 states (respondents) are covered by mandatory I/M reporting requirements.  This is due to areas redesignating to attainment for the criteria pollutant(s) that triggered the original I/M program requirement and either dropping the program, or continuing a revised version of the program for maintenance purposes only.  At the same time, however, the individual cost per respondent has risen, due to increases in the Office of Personnel Management's hourly wage estimates for clerical, technical, and managerial positions used to estimate the cost of the respondent's burden.

6(f)	Burden Statement

	Public reporting burden for collections included in this ICR is detailed above.  The annual burden per respondent is estimated to be 85 hours, and the total annual respondent burden imposed by these collections is estimated to be 2,380 hours (28 respondents). These estimates include time for summarizing data as well as reporting summaries.  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 number for this ICR is OCN # 2060-0252.

 	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. EPA-HQ-OAR-2008-0707: Notice-3, which is available for online viewing at www.regulations.gov, or in person viewing at the Air Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA/DC 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_NUMBER>, and the telephone number for the Air Docket is<PHONE_NUMBER>.

	Use www.regulations.gov to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the 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 in this document.
APPENDIX A


Page 1 of 12 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D. C., 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES August 8, 2005 MEMORANDUM Subject: Transmission of the Preliminary Cumulative Risk Assessment for the NMethyl Carbamate Pesticides for review by the FIFRA Scientific Advisory Panel.

To: Myrta Christian, Designated Federal Official FIFRA SAP Office of Science Coordination and Policy ( 7101C)

From: Anna B. Lowit and David J. Miller Office of Pesticide Programs, Health Effects Division ( 7509C)

Through: George Herndon, Associate Director Office of Pesticide Programs, Health Effects Division ( 7509C)

A meeting of the FIFRA SAP is scheduled for August 23 26, 2005. This meeting will focus on the Preliminary Cumulative Risk Assessment for the N Methyl Carbamate Pesticides. This memo provides the charge questions to the Panel. Page 2 of 12 Questions for the SAP HAZARD EPA's hazard and dose response chapter ( I. B) and associated appendices ( II. B. 1 6) of the Preliminary Cumulative Risk Assessment describe the application of the Relative Potency Factor ( RPF) method to the N methyl carbamate pesticides. These documents a) outline the steps in developing the dose response relationships for each pesticide and its capacity to inhibit AChE in rats; b) describe the data used in the assessment; c) summarize the empirical dose response modeling which provides the basis for the relative potency factors ( RPFs), points of departure ( PoDs), and estimates of AChE inhibition half life; and d) provide the rationale for selecting oxamyl as the index chemical.

HAZARD QUESTION # 1 Empirical Dose Response and Time Course Modeling At the February, 2005 meeting of the FIFRA SAP, EPA proposed an empirical model for use in the cumulative risk assessment of the N methyl carbamates. This model contains a dose response and a time to recovery component. Based on the comments from the Panel and following experience with its application EPA made some modifications to this proposed model. EPA has applied this revised empirical model to the available RBC and brain cholinesterase data for the N methyl carbamates. BMD and BMDL estimates provided in the preliminary assessment were derived from cholinesterase data from multiple studies and in some cases, using different cholinesterase measurement techniques.

H1a. Please comment on the mathematical/ statistical approach to modeling cholinesterase data used to estimate benchmark dose values and time to half life recovery in the preliminary cumulative risk assessment. Please address biological and mathematical/ statistical considerations in your response.

H1b. Please comment on the adequacy, clarity, and transparency of the documentation provided for the empirical dose response and time course modeling. Page 3 of 12 HAZARD QUESTION # 2 Selection of the Index Chemical EPA's cumulative risk assessment guidance indicates that the index chemical should be selected based on the availability of high quality toxicity database for the common mechanism endpoint. The selection of the index chemical is an important step in the cumulative risk assessment; the BMD for oxamyl was used to calculate RPFs and the BMDL for oxamyl was used as the PoD for extrapolating cumulative risk.

H2. Please comment on the rationale provided for the selection of the index chemical. Should any additional factors be included in the rationale for the selection of oxamyl as the index chemical?

HAZARD QUESTION # 3 Selection of Brain ChE data for developing RPFs and PoDs EPA has used data for brain ChE as the basis for the RPFs and PoDs. The rationale for this selection was provided in I. B.

H3. Please comment on the rationale provided for the selection of the brain ChE as the basis for RPFs and PoDs in the preliminary cumulative risk assessment. Should any additional factors be considered? Page 4 of 12 WATER WATER QUESTION # 1 Revised Conceptual Model for Ground Water Based on recommendations of the February 2005 SAP, OPP revised its ground water modeling approach to estimate pesticide concentrations in the upper meter of a fixed saturated zone ( ground water) that starts at 3.5 m below the surface. The Agency has included two additional adjustments to the original conceptual model since the earlier SAP. The models consider variable degradation rates with depth and account for setback distances between the well and the application area by using lateral velocity to estimate the additional travel time for a pesticide to reach the well.

W1. Please comment on the Agency's revisions to the ground water modeling approach to account for variable degradation rates with depth and varying setback distances between the well and treated fields.

WATER QUESTION # 2 Comparisons of the Three Models The three models used by the Agency ( PRZM, RZWQM, and LEACHP) provided predicted concentrations that were similar on average, but short term concentration differences among the models varied considerably. Differences in peak concentration estimates ranged from a factor of 2 to 5 in Florida to as much as a factor of 20 in North Carolina; however, there was no consistency with regard to which model gave the highest or lowest predictions. Some of these differences may due to differences in the way the models handle degradation temperature relationships, evapotranspiration, and weather generation.

W2. Given that no model stands out as superior when compared to the monitoring data evaluated so far, can the SAP suggest criteria for further evaluation of the models? Page 5 of 12 WATER QUESTION # 3 Evaluation of the Ground Water Model Estimates The Agency compared NMC concentrations in ground water estimated with the three models ( PRZM, RZWQM, LEACHP) to results of available prospective ground water monitoring studies ( oxamyl in NC and MD and methomyl in GA), two well monitoring studies along the central ridge of FL, and published literature on in field monitoring studies. Using the FL well monitoring data, known fate characteristics of the NMC pesticides, and soil and hydrologic data, the Agency identified the conditions under which exposures similar to that estimated in the NMC CRA may occur: private wells drawing from shallow, acidic ground water with high to very high saturated hydraulic conductivities in the soil and vadose zone. This has allowed the Agency to move toward a spatially explicit characterization of potential high exposure areas.

W3. Please comment on the performance of the models against the available monitoring data. What additional considerations should be taken when applying modeled estimates to risk assessments for areas where monitoring data are not available? Page 6 of 12 FOOD FOOD QUESTION # 1 The food portion of the N methyl carbamate cumulative risk assessment used similar data sources and techniques to those used for the organophosphate pesticide for estimating cumulative risk from food. This included use of both the USDA's Continuing Survey of Food Intakes by Individuals ( CSFII) as a data source for food consumption and Pesticide Data Program Data ( PDP) as a data source for food residues.

F1. Please comment on the planned intermediate and longer term activities associated with sensitivity analyses identified in Section I of the document. Does the Panel have any suggestions for other or additional activities which the Agency should consider? Page 7 of 12 RESIDENTIAL RESIDENTIAL QUESTION # 1 Use of REJV Data and Professional Judgment To generate estimates of exposure from residential use of NMC pesticides, the probabilistic models use a variety of inputs to address potential exposure from multiple use scenarios. Critical inputs include the percent of households applying the various pesticide products, and the timing of those applications. These two inputs, coupled with potential exposure from pesticide residues in drinking water and the diet, directly impact per capita estimates of cumulative exposure. In its February Case Study, the Agency presented background information on the Residential Exposure Joint Venture ( REJV) survey. The Agency used this database as the primary source for data on the inputs relating to timing of applications and percent of households using NMC products. Details regarding the empirical details of the REJV survey are presented in Appendix II. E. 1.

In February 2005, the SAP expressed reservations regarding the REJV data. In response to SAP concerns, EPA used other non survey information in this preliminary CRA, in addition to estimates from REJV, to develop use/ usage inputs and seasonal timelines of pesticide use which were representative of the Southern region of the U. S.

As previously mentioned, the REJV survey can be used to generate empirically based estimates of percent of household use and the frequency of product specific applications. But, because the REJV did not collect information regarding the reason for the reported pesticide use ( pest treated) or how much of the product was used, the empirical timing and frequency information ( based on a national survey) may not provide a clear picture of regional use. Therefore, to establish the timing of pesticide applications for the scenarios likely to result in the highest exposure, OPP made these estimates based on a combination of REJV data, product label information, professional judgment, and pest pressure information available from the Cooperative State Extension Services. Specific examples of how these sources were used to determine timing and frequency of pesticide use for PNMC residential assessment are presented in Section E of the preliminary NMC CRA document.

R1. Please comment on the use of information sources other than REJV to establish periods of pesticide use and other use/ usage information. Does the Panel suggest an alternative method to improve the use of REJV in the NMC assessment? Does the Panel know of other data sources that may be available? Page 8 of 12 RESIDENTIAL QUESTION # 2 Uncertainties Associated with the Hand To Mouth Assessment To assess non dietary ingestion ( mg/ day), the following four key factors are used in the models:

Residue Concentration ( turf residues, pet fur residues, and residues from hard indoor surfaces)

Hand to mouth frequency ( number of events per hour)

Surface area of the inserted hand parts ( cm2)

Exposure time ( hours/ day)

Other factors include both saliva extraction efficiency and wet hand adjustment factor. This exposure estimate is then used along with the Relative Potency Factor ( RPF) and Benchmark Dose to estimate risk. In the Preliminary N methyl carbamate assessment, risk estimates for non dietary oral exposure result in the lowest Margins of Exposure ( MOEs), and would therefore be of greatest concern to the Agency; however, these low MOEs appear to be due in part to the incorporation of micro activity data into our macro activity models. As a result, the non dietary ingestion scenarios in the Preliminary Nmethyl carbamate cumulative risk assessment are the least refined.

The residue concentration values are derived from individual residue dissipation or deposition studies which are discussed in the Residential Chapter ( Section E) of the Cumulative Risk Assessment document. The exposure durations are taken from the Agency's Exposure Factors Handbook. The hand to mouth frequencies and hand surface areas come from behavior studies relying either on observational data of young children using video tape analysis, trained observers, or parental observers. However, study data that evaluated hand to mouth frequency and surface area mouthed is difficult to interpret. Specifically, comparison of study results can be difficult due to differences in study practices and methodologies. For example, there are no standard definitions of mouthing ( superficial contact, licking, biting, fraction of hand inserted) and thus the data for these behaviors likely differs among studies as a result of the investigators definitions. In addition, the degree to which ancillary data ( such as surface area of hand contacted or inserted, the duration of contact, and the length of videotaping) are collected and reported differ among studies. This makes broad based and generallyapplicable interpretation difficult. Nevertheless, Drs. Zartarian and Xue allowed us the use their preliminary distributional analyses of these children's video data in this assessment. The studies used in the hand to mouth frequency analysis performed by Zartarian and Xue are briefly summarized in a table provided in a memorandum dated August 8, 2005 and provided to the Panel under separate cover. Page 9 of 12 The distributions of hand to mouth frequencies and surface area mouthed used in the Preliminary NMC CRA were based on the analysis performed by Zartarian and Xue ( as detailed above). In the aggregate models used in the NMC cumulative assessment, each separate iteration selects a single value for the hand to mouth events variable from a distribution of hand to mouth frequency values. Also, each separate iteration of the model selects a single surface area from a distribution of the fraction of hand mouthed. These values are multiplied by the residues and exposure durations which are similarly selected from a distribution of residue and exposure durations as described above. This relatively simple selection process, however, ignores the numerous complexities and interrelationships involved in this critical behavior pattern. ( For example, the fraction of a hand which is mouthed during each mouthing event may be inversely correlated with the frequency with which the hand is mouthed. Specifically, a high frequency of hand to mouth events may be associated with a smaller fraction of the hand which is mouthed. The algorithms used in the NMC CRA however, ( as established by the OPP Residential Standard Operating Procedures ( SOP's)) assume independence between these two parameters. This assumption likely leads to overestimates of exposures when upper percentiles of the hand to mouth frequency and area of hand mouthed distributions are combined. In addition, the macroactivity approach used in the NMC CRA aggregate models is based on the following assumptions:

The mouthing frequency ( events per hour), as recorded during the course of observational studies, continue at the same rate for the entire exposure duration selected; in reality, a high end mouthing frequency recorded over a short time interval ( e. g., one hour) may not be likely to continue at the same intensity over a longer time period ( e. g., 6 or 8 hours)

The hand is fully replenished with residues from a contaminated surface ( e. g., the lawn, pet or hard flooring) between each hand to mouth event

The contact frequency and surface area data used in this assessment are taken from observational studies in which all hand contacts were recorded as hand tomouth events, regardless of the fraction of hand mouthed. Additionally, no adjustment was made for the duration of time the hand remained in the mouth.

R2a. The methodology used in the NMC CRA in which micro activity data are used in macro activity approach likely leads to systematic overestimates of exposure when upper percentiles of mouthing frequency and surface area of hand mouthed are combined. Does the Panel agree that this methodology does indeed overestimate exposure? Can the Panel suggest improvements to this methodology to further refine exposure estimates?

R2b. Does the Panel have suggestions for an alternative approach than the one used to estimate the non dietary oral exposure pathway in the Preliminary NMC CRA? For example, would the use of a time weighted frequency value based on random hourly draws of hand frequency distributions more accurately estimate hand to mouth exposures? Page 10 of 12 RESIDENTIAL QUESTION # 3 Distributional Analysis Assessing residential exposure to pesticides is a complex process that must consider exposure from a variety of sources via multiple routes. To account for exposure from different sources, the PNMC residential exposure assessment identifies scenarios where significant exposure may occur. Each of these scenarios is defined by a specific type of activity or set of activities that may result in exposure. Generally the relationships between these activities and the resulting exposures are well defined in that algorithms, equations, and standard operating procedures exist for calculating exposure based on the activity being performed. However the supporting data sets used to estimate exposure for various residential scenarios range from robust ( e. g. unit exposure values) to limited or sparse ( e. g. lawn sizes, area treated, duration of exposure, and saliva extraction factors). Additionally, information characterizing the extent to which each activity contributes to exposure for a particular scenario does not always exists ( e. g. the amount of time spent in home gardens performing activities such as hand weeding versus staking tomatoes or harvesting sweet corn).

In general, the Agency has attempted to fit distributions ( as described in Appendix II. E. 2 of the NMC CRA) to the exposure measurements for residential activities when supporting information exists to characterize the extent to which the activity contributes to exposure for the residential scenario of interest. However, the Agency has employed uniform distributions to the data sets for which such supporting information does not exist, ( e. g. lawn sizes, area treated, duration of exposure, and saliva extraction factors). The Agency has elected to create such distributions when the available data are limited to such an extent that it is uncertain how well they represent national variability. The Agency believes use of uniform distributions to be conservative in estimating potential exposure since uniform distributions tend to overestimate exposure.

R3a. Please comment specifically on the Agency's use of lognormal distributions to estimate residential exposure and the statistical methods and procedures by which the Agency has selected particular distributions ( e. g. probability plots and goodness of fit statistics).

R3b. Does the Panel agree that the Agency's approach to creating and using of uniform distributions ( i. e. ranges of values) for residential scenarios lacking adequate supporting information tends to overestimate exposure? Is the Panel aware of other data sources that may be better suited for assessing residential exposure scenarios of interest? Does the Panel have any suggestions regarding alternative distributions to use for scenarios where supporting exposure information is inadequate? To what extent should sensitivity analyses be used to assess the appropriateness of alternative distributions? Page 11 of 12 R3c. When the Agency fits distributions to various exposure values, the maximum value entered into the probabilistic models for a particular distribution is usually defined to be an upper percentile value such as the 99th percentile in order to ensure realistic input parameters. Recognizing that the Agency intends to perform sensitivity analyses to evaluate the effects of this truncation, please comment on the Agency's approach of truncating distributions that are input to the probabilistic models. Please comment on any other approaches that the Agency might use to evaluate uncertainties associated with choices about whether and where to truncate distributions. Page 12 of 12 INTEGRATION INTEGRATION QUESTION # 1 The cumulative risk assessment guidance describes key principles for conducting these risk assessments. One such principle is the need to consider the time frame of both the exposure ( e. g., When does exposure occur? What is the exposure duration?) and of the toxic effect ( e. g., What are the time to peak effects and the time to recovery? How quickly is the effect reversed?). EPA's Preliminary Cumulative Risk Assessment for the N methyl carbamates describes the current limitations in data and software to fully characterize the dynamic nature of exposure, effect, and recovery for this common mechanism group. In order to address these limitations, OPP performed an examination of the exposure patterns for records from the high end of exposure distribution and found that that a large fraction (~ 70%) of daily records contributing to the upper tail of the food exposure distribution represent single eating occasions. Regarding drinking water and residential/ nonoccupational exposure, EPA's preliminary assessment provided a characterization of the current availability regarding datasets and models and a description of the impact of these limitations on the risk estimates from specific exposure pathways ( i. e., drinking water, residential).

I1a. Please comment on clarity and adequacy of the risk characterization provided in the preliminary cumulative risk assessment. Are there important aspects with respect to the strengths and weaknesses of the risk characterization other than the ones we identified?

I1b. Is the Panel aware of additional data which would aid the Agency in its cumulative risk characterization for the N methyl carbamate pesticides? For example, is the Panel aware of any available data on the timing of water consumption events or can the Panel make any recommendations regarding reasonable assumptions that could be made to help characterize the estimated risk? Are there other sensitivity analyses and further investigations that would be equally or more important than the ones we identified?