EPA ICR No. 2195.06					OMB Control No. 2070-0169

Attachment I                                                                                           

Explanation of Methodology and Data Used to Calculate Respondent Burdens and Costs
 
 Burden Hours for Respondents

 As required, EPA sent consultation questions about the burden and cost estimates to three respondents  -  the Agricultural Handler Exposure Task Force (AHETF), the Antimicrobial Exposure Assessment Task Force II (AEATF), and another third-party study sponsor who has conducted human research studies. The three organizations are experienced in submitting human research to the Office of Pesticide Programs (OPP).  The workload of one organization did not allow for a response to EPA's request. Consultation responses were received from AHETF and AEATF and are provided in Attachment H. To calculate new burden and cost estimates for this renewal ICR, EPA relied upon the estimates provided in the two consultation responses and knowledge of the range of protocols/studies to be submitted for review. EPA calculated an average of the different responses, recognizing that some study types are more complicated and costly to conduct than others.

 The respondent burden and cost estimates that appear in Table 1 in the ICR, for research involving intentional exposure of human subjects, are the averages of the values in Table A (burden hour estimates for agricultural handler studies, from the AHETF's consultation response) and Table B (burden hour estimates for antimicrobial exposure studies, from the AEATF's consultation response). For activities where the AHETF did not include a burden estimate because they do not anticipate performing the activity during the next cycle, their response was not included in calculating the average.  The consultation responses influenced the expected annual number of studies used in the calculations.  

 Hourly Rates for Respondents

 The two respondents indicated that the hourly rates used by EPA for calculating the estimated costs are too low.  In determining the rates, OPP uses a single source of data, the Bureau of Labor Statistics' National Industry-Specific Occupational Employment and Wage Estimates and selects the appropriate occupational category.
 Using the BLS data allows EPA to be consistent between across sectors and occupations. If OPP were to separately research wages for each ICR, the methodology in determining the wages would not be consistent and the wage rates could not be compared between sectors and occupations.  Some wages would be biased high, while others would be biased low. The BLS wages are categorized by North American Industry Classification System (NAICS) codes, and therefore are industry specific. They are, however, national averages.  Therefore, some of the high wages earned by specialists in high-cost localities are offset by others who are less specialized in lower cost localities.

 To estimate costs for regulated entities for this renewal ICR, EPA used wage rates from NAICS 541710 (Research and Development in the Physical, Engineering, and Life Sciences). The BLS fully-loaded hourly rates for this industry are $195/hour for management, $99/hour for technical staff, and $59/hour for clerical staff.
 
 Agency Burden and Costs

 The estimated burden and costs to the Agency are derived from input from EPA staff members who have prepared reviews for studies that were presented to the HSRB. Recognizing that some study types are more complicated and time consuming to review that others, EPA calculated a weighted average using the staff time estimates and the expected frequency of receiving different types of studies.  The weighted averages are provided in ICR Tables 3 and 4. The wage rates EPA used to estimate Agency costs for this renewal ICR were from NAICS 999100 (Federal Executive Branch). The BLS fully-loaded hourly rates for Agency staff are $139/hour for management, $92/hour for technical staff, and $51/hour for clerical staff. 

  Number of Transactions
 
  	The estimated number of transactions is based on the responses from the two respondents received during the recent consultation, information on other types of studies received during the previous consultation, EPA's historical experience, and knowledge of upcoming submissions.

                    RESPONDENT BURDEN HOUR ESTIMATES

  Table A. Agricultural Handler Exposure Studies  -  Burden Hour Estimates from AHETF's Consultation Response 




                                  Activities
                           Average Burden Hours Per
                                  Occurrence

       Total Per Response





 Total Hours
                           Cost ($) Estimated by EPA
                            Actual Cost ($) to AHETF

   Mgt
 Technical
 Clerical





  $195
                                      $99
   $59











 Rule familiarization and training (per protocol)

                                       0

                                       0

                                       0

                                       0

   0

   0
 Prepare and submit protocol for IRB review

                                       0

                                       0

                                       0

   0

  0

   0
 Prepare and submit protocol for EPA and HSRB review

                                       0

                                       0

                                       0

  0

  0

  0
 Document ethical conduct of a completed study for which EPA and the HSRB have reviewed the protocol



                                      65



   2,000



                                      60



  2,125



  196,077



  213,661
  
 Store, file, and maintain records

                                       5

                                       5

                                       5

                                      15

   1,412

   1,762

 TOTALS

                                      70

   2,005

                                      65

  2,140

  197,489

  215,424

  Table B. Antimicrobial Exposure Studies  -  Burden Hour Estimates from AEATF's Consultation Response



       Activities
          Average Burden Hours Per Occurrence

      Total Per Response

   Manage- ment



                                  Total Hours
                           Cost ($) Based on EPA Nos.
 Based on Industry Cost ($)


 Technical
 Clerical



 

   $195
                                      $99
   $59



 







 Rule familiarization and training (per protocol)
                                       8
                                      10
                                       7
                                      25
                                    $2,392
                                    $2,959
 Prepare and submit protocol for IRB review
                                      25
                                      225
                                      30
                                      280
                                    $25,708
                                    $28,851
 Prepare and submit protocol for EPA and HSRB review
                                      100
                                      500
                                      40
                                      640
                                    $61,970
                                    $71,223
 Document ethical conduct of a completed study for which EPA and the HSRB have reviewed the protocol
                                      60
                                     1,000
                                      60
                                     1,120
                                   $103,400
                                   $113,956
 Prepare and submit final report for EPA and HSRB review*
                                       
                                       
                                       
                                       
                                       
                                       
 Store, file, and maintain records
                                      10
                                      40
                                      10
                                      60
                                    $5,583
                                    $6,487
 TOTALS
                                      203
                                     1,775
                                      147
                                     2,125
                                    $199,052
                                   $223,476
  
  Note:  EPA combined the two figures in the shaded rows 4 and 5 above in order to fully reflect the respondent's input.  This was necessary because the respondent added row 5* (above) entitled "prepare and submit final report for EPA and HSRB review." From EPA's perspective, row 4 is the essential activity in light of the required activities encompassed by this ICR and the language in the federal rule on protection of human subjects.  Nonetheless, EPA combined the two figures in the shaded rows 4 and 5 above to fully reflect the respondent's input.  
  
  Table D.  Documentation of Ethical Conduct of a Completed Study for which EPA and HSRB have NOT reviewed the Protocol (per requirements at §26.1303)  -  Using information compiled during previous ICR renewal process

     Activities
           Average Burden Hours Per Occurrence
    Total Per Response

                                  Management
                                     $139
                                   Technical
                                      $92
                                   Clerical
                                      $51
 Hours
   Cost ($)
 Document ethical conduct of a completed study for which EPA and the HSRB have not reviewed the protocol


                                                                              2


                                                                             24


                                                                              2


    28


   2,588
                                                       
  Table 1. Average Burden and Cost Estimates for Respondents  -  Research Involving Intentional Exposure of Human Subjects
  
  Note: This table takes into account the different types of studies submitted for review.
  
                                   Activities
                       Average Burden Hours Per Response
                               Total Per Response
                                        
                                   Management
                                      $195
                                   Technical
                                      $99
                                    Clerical
                                      $59
                                     Hours
                                    Cost ($)
 Rule familiarization and training
                                       6
                                       7
                                       5
                                       18
                                     $2,155
 Prepare and submit protocol for IRB review
                                       18
                                       83
                                       13
                                      114
                                    $12,469
 Prepare and submit protocol for EPA and HSRB review
                                       68
                                      334
                                       28
                                      430
                                    $47,886
 Document ethical conduct of a completed study for which EPA and the HSRB have reviewed the protocol; prepare and submit completed study for IRB, EPA, and HSRB Review
                                       56
                                     1,329
                                       57
                                     1,442
                                    $145,481
 Store, file, and maintain records
                                       7
                                       20
                                       8
                                       35
                                     $3,810
 Total per response
                                      155
                                     1,773
                                      111
                                     2,039
                                    $211,801
  Annual Burden:	2,039 hours per response * 4 responses per year = 8,156 hours Annual Costs:	$211,801 per response * 4 responses per year = $847,205



  Table 2. Respondent Burden and Cost Estimates  -  All Other Submitted Research with Human Subjects
                                   Activities
                       Average Burden Hours Per Response
                               Total Per Response
                                        
                                   Management
                                      $195
                                   Technical
                                      $99
                                    Clerical
                                      $59
                                     Hours
                                    Cost ($)
 Rule familiarization and training
                                       1
                                       1
                                       0
                                       2
                                      $294
 Prepare and Submit Ethics Information of Completed Human Studies to EPA
                                       0
                                       8
                                       1
                                       9
                                      $848
 Store, file, and maintain records
                                       0
                                       0
                                       1
                                       1
                                      $59
 Total per response
                                       1
                                       9
                                       2
                                       12
                                     $1,201
  Annual Burden:  12 hours per study * 10 studies submitted per year = 120 hours Annual Costs:     $1,201 per study * 10 studies submitted per year = $12,010
  
  Agency Burden Hour Estimates

   Table 3.    Weighted average Agency burden and cost estimates for research involving intentional exposure
   
                                  Activities
                       Average Burden Hours Per Response
                              Total Per Response
                                       
                                  Management
                                    $139/hr
                                   Technical
                                    $92/hr
                                   Clerical
                                    $51/hr
                                     Hours
                                   Cost ($)
Rule familiarization and training
                                       1
                                       2
                                       0
                                       3
                                      288
Primary Review of Scientific and Ethical Aspects of a Protocol
                                       3
                                      210
                                       0
                                      213
                                    17,592
Primary Review of Scientific and Ethical Aspects of a Completed Study Report
                                       3
                                      235
                                       0
                                      238
                                    19,642
Secondary Review of Scientific and Ethical Aspects of a Protocol
                                      197
                                    4,694*
Secondary Review of Scientific and Ethical Aspects of a Completed Report
                                      197
                                    4,694*
Store, file, and maintain records
                                       0
                                       0
                                       2
                                       2
                                      102
Total per response
                                       7
                                      841
                                       2
                                      850
                                    51,581

   *	HSRB members are special government employees; their time should be reflected as part of Agency burden. Cost of HSRB members working on the HSRB report (collectively spending 197 hours per HSRB report in FY 2011, compensated at the 2014 rate of $59/hour), plus the cost of EPA Office of the Science Advisor (OSA) technical staff working on the HSRB report (30 hours per report, at the technical staff rate of $82/hour). Each HSRB report covers an average of 3 protocols and/or completed studies per report, so each topic costs an average of $4,694.

   Annual Burden:  	850 hours per response x 4 per year = 3,400 hours plus 30 for OSA review of HSRB report = 3,430 hours
   Annual Costs:	$51,581 x 4 responses/year = $206,324
   
   Please note that the estimated 4 "responses" per year include 4 protocols plus 4 studies.  This definition of responses is consistent with that used and approved for this ICR in previous years.


  Table 4. Weighted Average Burden and Cost Estimates for Agency  -  Research Involving Intentional Exposure  -  All Other Submitted Research with Human Subjects
   
                                  Activities
                       Average Burden Hours Per Response
                              Total Per Response
                                       
                                  Management
                                    $139/hr
                                   Technical
                                    $92/hr
                                   Clerical
                                    $51/hr
                                     Hours
                                   Cost ($)
Rule familiarization and training
                                       0
                                       0
                                       0
                                       0
                                       0
Primary Review of Ethical Aspects of a Completed Study Report
                                       0
                                       6
                                       0
                                       6
                                      552
Store, file, and maintain records
                                       0
                                       0
                                       0
                                       0
                                       0
Total per response
                                       0
                                       6
                                       0
                                       6
                                      552

   Annual Burden:  	6 hours per study x 20 per year = 120 hours
   Annual Costs:	492 x 20 responses/year = $11,038

   Please note that, as discussed in section 6(c), for the pre-rule human research which does not require HSRB review, EPA assumes that 10 of the 20 studies will be located at the Agency's own initiative and therefore will not be subject to 40 CFR 26.1303. This approach is consistent with that used previously for this ICR.


    Table 5.  Total Annual Bottom Line Burden and Costs/Master Table
                              Collection Activity
                              Annual Burden Hours
                                 Annual Costs
                      Annual Respondent Burden and Costs
Research Involving Intentional 	Exposure of Human Subjects (Table 1)
                                     8,156
                                   $847,205
All Other Submitted Research with Human Subjects (Table 2)
                                      120
                                    $12,010
Respondent Total
                                     8,276
                                   $859,215
                             Annual Agency Burden
Research Involving Intentional 	Exposure of Human Subjects (Table 3)
                                     3,430
                                   $206,324
All Other Submitted Research with 	Human Subjects (Table 4)
                                      120
                                      $11,038
Agency Total
                                     3,550
                                   $217,362
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             
             Number of Transactions: September 2012  -  August 2015

Intentional Exposure Studies
 AHETF Monitoring Program
 See the consultation responses in Attachment H.
 In Table 2 of consultation responses, AHETF estimates 2 completed studies per year for FY 17 and FY 18.
 Figures used in ICR: 2 "transactions" per year 
             
 AEATF Monitoring Program
 See the consultation responses in Attachment H.
 In Table 2 of consultation responses, AEATF estimates 4 protocols in FY 2017, 3 studies in FY 2017, and 1 study in FY 2018, for a total of 8 over 3 years.
 Figures used in ICR: 2 "transactions" per year (2 protocols + 2 completed study reports)

 Insect Repellent Efficacy Testing
 Figures used in ICR: 2 "transactions" per year (2 protocols + 2 completed study reports)

 Other Post-Rule Studies
 These could include exposure studies from sources other than the task forces, ADME studies, skin patch tests of irritation or sensitization, systemic toxicity tests, or others.
 All would require submission of a protocol before execution and of a completed report after execution; both the protocol and the report would require EPA and HSRB review.
 Estimate: 1 protocol and 1 completed study per year. (This is likely an over-estimate)

Studies which are Not Intentional Exposure
 Pre-Rule Completed Studies which do not measure or identify a toxic effect
 These studies do not go to the HSRB, but they do require an EPA ethics review. Historical level: 20 reviews per year.
 Assume workload to remain constant over the time period of the ICR
 Estimate: 20 per year (estimated that 10 studies/year are submitted from outside parties, and therefore subject to the requirements of 40 CFR 26.1303 requiring submitters to document the ethical conduct; estimated that 10 studies/year are located by the Agency at its own initiative, and therefore not subject to 40 CFR 26.1303)


 TOTAL RESPONSES PER YEAR TO BE USED IN ICR ESTIMATES:
 7 intentional exposure human studies (rule familiarization + protocol stage where applicable + completed report stage + records storage)
 20 studies/year requiring EPA ethics review, but not HSRB review (pre-rule studies that do not measure or identify a toxic effect)
