Attachment B (revised 2/1/2021)

                         Office of Pesticide Programs
           2015 Revised General Methodology and Assumptions Used to
   Estimate Paperwork Response Burden for Pesticide Data Call-In Recipients
                                 November 2015
Introduction

In 2007, the United States Environmental Protection Agency (EPA or Agency) described the methodology and assumptions the EPA's Office of Pesticide Programs (OPP) uses to calculate the related Paperwork Reduction Act (PRA) burden for industry to respond to Data Call-In (DCI) notices issued pursuant to Section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The methodology is entitled "General Methodology Used to Estimate Paperwork Burden Hours and Costs by the Office of Pesticide Programs for Submission of Required Data/Information for Responding to a Data Call-In Notice" Today, the Agency is redefining some of this methodology by revising the number of DCI recipient groups and calculations for those groups to reassess the PRA burden. This document revises and supplements the 2007 policy.

 Industry Participation

To update the 2007 methodology, OPP conducted a reassessment of the information collection burden associated with the DCI response process. In December 2013, the Agency held a DCI Response Burden Assessment Workshop with industry stakeholders. As part of the reassessment, OPP consulted with industry about the Agency burden assumptions, the methodology used to estimate the burden, the time estimates for conducting PRA activities, and the accuracy of and appropriate distribution of the labor rates.  This document incorporates new burden and cost data obtained in part from workshop participants and other public comments. OPP's burden reassessment of the DCI Information Collection Request (ICR) were limited only to PRA burdens for the following types of DCIs: Reregistration, Registration Review, Endangered Species Protection Program, Special Review Program, and the Tolerance Assessment Program including the Anticipated Residue/Percent Crop Treated Information.

 Burden Assessment for the DCI ICR renewal

The PRA burden hour and cost estimates in this document are new and use the revised methodology. The Agency will use this revised methodology to update the burden and cost estimates in future DCI ICR renewal documents. The estimates in this document were used to update the DCI ICR document that is posted in the Docket EPA-HQ-OPP-2020-0693. The Agency seeks public comment on the new methodology and the new estimates. All public comments received will be posted to the docket for this action.

Section I: Background on Programs Involving Data Call-Ins (DCIs)

EPA uses its DCI authority to acquire the data that has been deemed necessary for the Agency's statutorily mandated review of a pesticide's registration, which require it to assess whether the continued registration of an existing pesticide causes an unreasonable adverse effect on human health or the environment and whether the Agency will pursue appropriate regulatory measures. The key OPP program areas which use the issuance of a DCI under FIFRA §3(c)(2)(B) include:

       A. Reregistration Program

FIFRA §4 requires EPA to re-assess the health and safety data for all pesticide active ingredients registered before November 1, 1984, to determine whether these "older" pesticides meet the criteria for registration that would be expected of a pesticide being registered today for the first time. FIFRA §4 directs EPA to use FIFRA §3(c)(2)(B) authority to obtain the required data. While, the reregistration program reassessment process was completed by 2006 for food-use pesticide ingredients and 2008 for non-food use pesticide ingredients, the Agency may still issue certain types of product-specific PDCIs in the future.

      B. Registration Review Program

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandates the continuous review of existing pesticides (FIFRA §3(g)). All pesticides distributed or sold in the United States must be registered by EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re-evaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided at http://www.epa.gov/pesticide-reevaluation. In 2006, the Agency implemented the registration review program pursuant to FIFRA § 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration (40 CFR Part 155, subpart C). The Pesticide Registration Improvement Act (PRIA) requires EPA to complete registration review decisions by October 1, 2022, for all pesticides registered as of October 1, 2007. Each chemical will need to repeat registration review no later than 15 years following the date of completion of the initial registration review or following the date the chemical was first registered (for chemicals registered after October 1, 2007). FIFRA §3(g) instructs EPA to use the FIFRA §3(c)(2)(B) authority to obtain data determined to be necessary to complete the assessments, reviews, and decisions called for under FIFRA §3(g).

In addition, EPA intends these reviews to involve the review of data related to endangered species and endocrine effects:
       Endangered Species Protection Program (ESPP). EPA conducts effects determinations (risk assessments) to ensure that protections are in place for populations of non-target species including endangered species as required under the Endangered Species Act (ESA), as part of the risk characterization of the pesticide under Registration Review. FIFRA §3(g) instructs EPA to use the FIFRA §3(c)(2)(B) authority to obtain the required data.
 Endocrine Disruptor Screening Program (EDSP). EPA considers potential endocrine effects pursuant to Federal Food, Drug, and Cosmetic Act (FFDCA)§408(p) as part of the risk characterization of the pesticide under Registration Review.  FFDCA §408(p)(5) mandates the issuance of Orders requiring screening of substances for their potential endocrine disruptor effects. FIFRA §3(c)(2)(B) also provides a means of obtaining needed data for pesticides. Under the EDSP program, two types of data collection authorities allow the Agency to address endocrine disruptor screening, and testing data needs for DCIs and §408(p) Orders. In establishing the policy and procedures for issuing §408(p) Orders under the EDSP, EPA will integrate the considerations under the EDSP with the Registration Review activities whenever possible. EPA believes that doing this will provide efficiencies for everyone involved. Please note, however, the information collection activities associated with the issuance of §408(p) Orders are already covered by another ICR, identified under EPA ICR No. 2249 and approved under Office of Management and Budget (OMB) Control No. 2070-0176. As such, the issuance of §408(p) Orders for Registration Review chemicals is not currently covered by EPA ICR No. 2288 approved under OMB control No. 2070-0174.

      C. Maintenance DCIs

Section 3(c)(2)(B) of FIFRA provides a means of obtaining needed additional data "to maintain in effect an existing registration of a pesticide." A need for a data call-in may arise from evolving of scientific understanding and methodologies, changes in the discovery of deficiencies in previously submitted data, or from the new discovery of specific attributes of the pesticide or its ingredients. For example, such data may be needed in support of Agency enforcement cases resulting from consumer complaints about the product, its storage stability, the integrity of its container, or exaggerated advertising claims. A DCI might also be needed to confirm product performance of public health pesticides or a new type of manufacturing process may call into question data submitted for a pesticide registration using older manufacturing technologies no longer used today. These situations may give rise to new concerns such as observed or suspected adverse human health or environmental effects attributed to the use of a pesticide that were not present at the time of the original registration or from unanticipated circumstances such as changes in pathogens of public health concern, new EPA initiatives, or the evolution of scientific test methodologies or manufacturing technologies.

       D. Tolerance Assessment Program (Anticipated Residue/Percent Crop Treated Information)

Under FFDCA §408, before a pesticide may be used on food or feed crops, the Agency must establish a tolerance for the pesticide residues on that crop or establish an exemption from the requirement to have a tolerance. In order to conduct the required evaluation, a Pesticide Registrant may be required to submit specific data necessary to demonstrate that residues do not exceed the residue levels used to establish the tolerance. Under the authority of FIFRA §3(c)(2)(B), the Agency will issue a DCI to obtain any additional data that is determined to be necessary for the decisions that must be made under this program. FFDCA §408(b)(2)(E) and (F) authorize the use of anticipated or actual residue (ARs) data, and percent crop treated (PCT) data to establish, modify, maintain, or revoke a tolerance for a pesticide. FFDCA requires that if AR data are used, data must be reviewed within five years after a tolerance is initially established. If PCT data are used, FFDCA affords EPA the discretion to obtain additional data if any or all of several conditions, including but not limited to the following, are met:
       The existing data have been found unreliable;
       Exposure estimates underestimate exposures for any significant population group; and
       Dietary exposure must be re-evaluated periodically.

 Section II: Data Collections Using a DCI

The data that EPA may collect and review under this ICR will likely vary for each DCI because the DCI is tailored to address the specific needs of the individual chemical or active ingredient under review. However, the data requested will be primarily based on the data requirements that are found in 40 CFR Part 158. In codifying the requirements in 40 CFR Part 158, EPA provided substantiation and support to demonstrate the need and practical utility for the data in terms of its use to assess the risks for particular chemicals based on the different use patterns and pesticides, and in order to make the required registration decisions about those pesticides. 40 CFR Part 158 also includes a provision that allows the Agency to seek additional non-codified data if it is determined to be necessary to make the risk-based decisions mandated by federal law.

      A. History of the Methodology Used to Estimate the Paperwork Burden and Costs for DCIs

DCI Test Cost Burden Calculation Assumptions
Prior to 2007, EPA calculated the paperwork burden and costs for the data generation activities as a percentage of the testing costs. This percent-based estimate of paperwork associated with conducting a test was initially established in consultation with OMB in the 1980s in an effort to provide a reasonable estimate of the burden associated with the paperwork component of data generation, which may vary based on the complexity of the test performed. In 2007, EPA solicited public comment on this approach as described in detail in the document entitled "General Methodology Used to Estimate Paperwork Burden Hours and Costs by the Office of Pesticide Programs for Submission of Required Data/Information for Responding to a Data Call-In Notice." Based on feedback received, EPA concluded that this approach appeared to be a reasonable and fair alternative to simply setting a single estimate for data generation burden or using set criteria of high, medium or low burden, neither of which may fairly reflect potential differences in burden.
To calculate the burden and costs associated with the paperwork activities involved in conducting the tests, the Agency starts with the cost of the test, typically the market price for the test as identified by laboratories that offer testing services. The Agency maintains an archive of the basic FIFRA study cost estimates that were developed through surveys of independent testing laboratories, Agency economic analyses, and registrant comments during ICR renewal periods. To the greatest extent possible, EPA uses multiple sources to provide test cost estimates, which are updated as needed.
EPA uses 35% of the estimated total test cost to calculate the total potential cost of the paperwork activities related to data generation. The 35% of test cost is disaggregated by labor category, and then burden hours are extrapolated by using the loaded labor rates. To disaggregate by labor category, the Agency considered the estimated distribution of paperwork activity across the labor categories represented and the existing methodology assumption that paperwork activities for data generation mostly involve the technical staff to perform the tests, with fewer activities related to management and clerical staff.

See Figure 1 for an illustrated outline of the Agency burden calculation process for data generation.

Figure 1  -  Method for Calculating Paperwork Burden from Test Costs
                     Calculate 35% of the Total Test Cost
Divide 35% of the Total Cost into Labor Categories:
20% for Managerial
65% for Technical
15% for Clerical
Divide each by Fully Loaded Labor Wage Rate for that Labor Category
Burden Hours by Labor Category
                     Calculate 35% of the Total Test Cost
Divide 35% of the Total Cost into Labor Categories:
20% for Managerial
65% for Technical
15% for Clerical
Divide each by Fully Loaded Labor Wage Rate for that Labor Category
Burden Hours by Labor Category

This approach assumes and incorporates the following core considerations:
 Recipients generate all of the data as specified in the DCI and without any changes.
 All data generation is performed by an independent laboratory.
 Paperwork burden is disaggregated by labor category as follows:
 Managerial (20%)
 Technical (65%)
 Clerical (15%)
 Labor rates are fully loaded, meaning that they include the estimated costs of wages, overhead, and benefits paid to an employee.

For certain types of DCIs, paperwork burden calculations do not follow the current methodology -- that is, they are not broken out by 20%-65%-15% Managerial-Technical-Clerical as is typically the case. This is because certain types of DCIs have paperwork burden that falls disproportionately on different labor categories and thus do not follow the EPA methodology for estimating paperwork burden hours for DCIs. For more information, see the case studies in the 2007 methodology document. Mailing costs for DCIs are not included in the estimates below as electronic submissions are now accepted, and it is typical practice for registrants to submit data using this method. In the case that DCI submissions are submitted using certified mail, it is estimated that the cost to submit an individual DCI would be no more than $20.

B. Methodology for Calculating Labor Wage Rates

The Agency updates the estimated wages, benefits, and overhead for all labor categories for affected industries, state government, and EPA employees based on publicly available data from the U.S. Bureau of Labor Statistics (BLS). The formulas used to estimate the labor rates and formulas used to derive the fully loaded rates and overhead costs for the new and renewal ICRs are listed in Table 1.

Table 1: EPA Methodology Used to Determine Labor Rates
Methodology
The methodology uses data on each sector and labor type for an Unloaded wage rate (hourly wage rate), and calculates the Loaded wage rate (unloaded wage rate + benefits), and the Fully loaded wage rate (loaded wage rate + overhead). Fully loaded wage rates are used to calculate respondent costs. This renewal uses 2019 base data.
Unloaded Wage Rate
Wages are estimated for labor types (management, technical, and clerical) within relevant sectors. The Agency uses average wage data for the relevant sectors available in the National Industry-Specific Occupational Employment and Wage Estimates from the (BLS) at http://www.bls.gov/oes/current/oes_nat.htm.
Sectors
The specific North American Industry Classification System (NAICS) code and website for each sector is included in that sector's wage rate table. Within each sector, the wage data are provided by Standard Occupational Classification (SOC). The SOC system is used by Federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm).
Loaded Wage Rate
Unless stated otherwise, all benefits represent 46% of unloaded wage rates, based on benefits for all civilian non-farm workers, from http://www.bls.gov/news.release/ecec.t01.htm. However, if other sectors are listed for which 46% is not applicable; the applicable percentage will be stated.
Fully Loaded Wage Rate
We multiply the loaded wage rate by 50% (EPA guidelines 20-70%) to calculate overhead costs and add this to the loaded wage rate to get the fully loaded wage rate.

      C. Information Collection Groups

Information Collection (IC) groups are a way of categorizing similar DCIs into subprogram groupings. EPA projects 13 IC groups for this ICR renewal. The IC groups and subgroups are outlined in Table 2. In the previous DCI ICR, the IC group, "DCIs for Enforcement and Unanticipated Incidents" was included but EPA is removing this group in future ICRs because EPA has not issued, and does not foresee issuing, any DCIs for this category. The Special Review program section is also being removed from this ICR renewal. The program has not conducted a special review in over a decade and does not foresee any new special review program activity being conducted in the near future. Conversely one new IC group is being added, the Maintenance DCI group, which includes the paperwork burden and cost of non-target pollinator insect studies and efficacy studies. Detailed information about the specific IC program groups is in Section 1: Programs Involving Data Call-ins.

Table 2: Information Collection (IC) Groups
IC Group
Activity
    Reregistration: Voluntarily Submitted Data (Low Burden Studies)
                            Reregistration Program
    Reregistration: Voluntarily Submitted Data (High Burden Studies)

    Reregistration DCIs: Product Specific Data

    Maintenance DCIs
                               Maintenance DCIs
    Registration Review DCIs
                              Registration Review
    Resistance Management Plans

    Registration Review: Voluntarily Submitted Data (Low Burden Studies)

    Registration Review: Voluntarily Submitted Data (High Burden Studies)

    Anticipated Residue DCIs: Base Set of Data

    Anticipated Residue DCIs: Verification of Use Data
    Tolerance Assessment Program (Anticipated Residue/Percent Crop Treated)
    Anticipated Residue DCIs: Updated Public Source Monitoring Data

    DCIs for Percent Crop Treated Estimates

 Section III: Redefining the DCI Recipient Groups to Better Define Paperwork Burden

Each IC subprogram group described in Section II, has a unique set of DCI recipients with corresponding burden activities, see Table 3. The Agency is redefining the DCI recipient groups to better classify the activities and burdens associated with each group. These new definitions refine the existing burden methodology and will be used in future DCI PRA burden assessments. While each DCI involves the same basic paperwork activities, the burden associated with each recipient group can be very different. The new DCI recipient groups and their definitions are:
 DCI Recipients
 Data Generators
 Consortium Participants

DCI Recipients - After receiving a DCI, each recipient has 90 days to provide the initial response indicating how the recipient plans to comply with the DCI. A recipient may avoid generating the data if they qualify for a generic data exemption, i.e., they use a registered pesticide as the source of the active ingredient in their own product, cancel the product's registration, submit or cite existing data, or is granted a waiver by EPA in response to their request. Thus, not all DCI recipients will generate data in response to a DCI however, at a minimum, all recipients are assumed to be involved in the four burden activities listed in Table 3.

Data Generators - Regardless of the response option that the DCI recipient might select, the Agency has assumed that some data will be generated for each chemical. The data generator is assumed to be involved in the nine burden activities listed in Table 3. While Agency records indicate that not all the studies requested in a DCI are, in fact, generated (data generators can request waivers, submit or cite existing data like the DCI recipients), for the most part, the Data Generators group will assume the highest DCI response burden among the three respondent groups.

Consortium Participants - The Agency will assume that whenever more than one company receives identical DCIs for the same chemical, the companies will work together and participate in a consortium or task force to generate one set of data to respond to the DCI. Generally, the Agency calculations for DCI response burdens are accounted for as part of the 35% of the cost of generating studies. However, in addition to the burden of creating the DCI response and generating data, consortium participants are subject to the burden associated with operating a consortium or task force (e.g., communication, attending meetings, etc.). The seven additional consortium burden activities are listed in Table 3.

Table 3: New Recipient Groups - Activities and Corresponding Category.
                                 DCI Recipient
Collection Activity
                              Collection Category
    Read Instructions
                                   Reporting
    Plan Activities

    Complete Paperwork

    Store/maintain Data
                                 Recordkeeping
                                Data Generator
Collection Activity
                              Collection Category
    Read and discuss test requirements
                                   Reporting
    Discuss test and protocol with Agency

    Plan activities

    Create information

    Gather information

    Process, compile, review information for accuracy

    Complete written forms

    Record, disclose, display information
                                 Recordkeeping
    Store, file, or maintain information

                            Consortium Activities
    Negotiate/establish consortium/task force agreements/select administrator
            Paperwork burden associated with operating a consortium
    Establish/conduct appropriate technical working groups

    Participate in consortium discussions

    Plan logistics for calls or meetings

    Schedule and participate in discussions with Agency

    Review Agency assessments, participate in public comment activities

    Store, file, or maintain consortium information

 Section IV: Estimating the Burden and Cost for the Redefined DCI Recipient Groups
The estimated paperwork burden and costs for DCI recipients vary from DCI to DCI because of the variations in the individual studies that are part of the DCI and the combination of activities (waivers, exemptions, etc.) each DCI manifests. As discussed, there are multiple ways of responding to a DCI and not all DCI recipients will generate and submit data as part of the DCI response. Until the Agency receives the 90-day response letters to the DCI notice from the registrants indicating what studies, if any, they will conduct, it is not possible to accurately estimate the burden and costs of developing the data. Nor can the Agency accurately predict the number of DCI recipients who will generate data or the amount of data that might be submitted to EPA. The Agency's burden estimates are based on past patterns of DCI response activities.

DCI Recipients - DCI recipients are subject to burden from having to provide an initial response to the EPA for a DCI regardless of whether or not they generate data. The methodology EPA used for calculating the burden for this group is derived from the 2007 Methodology, Phase 1 requirements outlined in Case Study #1, Attachment A, which reflects the activities that all DCI recipients would have to conduct regardless of whether or not they generate data.

Given that a single DCI can be sent to several companies, DCI recipient burden is calculated at the company level -- not at the DCI level. To estimate the number of companies that are DCI recipients, EPA conducted a search of companies that received a DCI in its Pesticide Registration Information System (PRISM) to determine the average annual number of impacted entities. The Agency estimates that 122 companies will receive a DCI annually. For more information on methodologies used in estimating the total number of DCI recipients and burdens to DCI recipients, see Appendix A.

Data Generators  -  Generally, the paperwork burden and costs for data generators are based in part on the average cost of paying a laboratory to conduct the test(s) necessary to generate the data requested in the DCI. To estimate paperwork activities for each type of labor category (e.g., managerial, technical, and clerical), the disaggregated paperwork burden costs are multiplied by their corresponding labor category wage rates ($/hr). However, burden and cost calculations for some DCIs do not follow the Agency's methodology of paperwork burden being categorized as 20%-65%-15% Managerial-Technical-Clerical, as certain Information Collection (IC) Groups have paperwork burden that falls disproportionately on different labor categories. For details regarding the methodology used for calculating data generation paperwork burden for each of the IC Groups, refer to Appendix B.

EPA has also assumed that for each DCI, companies are combining resources when responding to a DCI and data generation is necessary -- thus, it is expected that only one set of data is being submitted to the EPA in response to each DCI. EPA understands that this assumption may not be accurate and solicits industry input to clarify this assumption.

EPA expects to issue approximately 803 DCIs over the next three years that will require data generation. This represents an annual average of 268 DCIs issued. The estimate for data generators does not include voluntarily submitted data, as they are not DCIs (i.e., IC Groups 2, 3, 8, and 9 in Table 4 are excluded from this estimate).

Consortium Participants - Unlike typical data generators, consortiums face additional paperwork burden activities, such as meetings and correspondence to coordinate consortium activities. While consortium members encumber burden from consortium activities, the cost savings incurred by sharing the DCI response and data generation burden provides cost savings to industry. EPA assumes that no business would opt to join a consortium if the cost of consortium activities would result in a higher cost per DCI response. Thus for each consortium member, the upper bound (i.e., maximum) total cost per DCI submitted by a consortium is expected to be less than or equal to the per DCI cost incurred by a recipient who chooses to submit their DCI data independently  -  a.k.a., a Data Generator. Industry provided EPA with information to support that approximately 21 consortiums exist and the typical consortium activities that result in paperwork burden. Details on consortium activities and the methodology used for calculating total consortium paperwork burden are located in Appendix C.

The breakdown of the regulatory decisions for DCIs that EPA expects to make over the next three years (2021  -  2024) is as follows:

Table 4: Estimated Number of DCIs by IC Group
                                   IC Number
                                   IC Group
                           Total DCIs 1-Year Period*
                           Total DCIs 3-Year Period*
                                       1
Reregistration DCIs: Confirmatory Data
                                      0.3
                                       1
                                       2
Reregistration: Voluntarily Submitted Data
(Low Burden Studies)
                                      0.3
                                       1
                                       3
Reregistration: Voluntarily Submitted Data
(High Burden Studies)

                                       4
Reregistration DCIs: Product Specific Data
                                      0.3
                                       1
                                       5
Maintenance DCI[1]
                                  75  -  NTIP
                                 1 - Efficacy
                                 225  -  NTIP
                                 3 - Efficacy
                                       6
Registration Review DCIs
                                     110.7
                                      332
                                       7
Registration Review Resistance Management Plans
                                      79
                                      237
                                       8
Registration Review: Voluntarily Submitted Data (Low Burden Studies)
                                       5
                                      15
                                       9
Registration Review: Voluntarily Submitted Data (High Burden Studies)

                                      10
Anticipated Residue DCIs: Base Set of Data
                                      0.3
                                       1
                                      11
Anticipated Residue DCIs: Verification of Use Data
                                      0.3
                                       1
                                      12
Anticipated Residue DCIs: Updated Public Source Monitoring Data
                                      0.3
                                       1
                                      13
DCIs for Percent Crop Treated Estimates
                                      0.3
                                       1
                                                                    Total DCIs*
                                     267.5
                                      803
                                               Total Voluntarily Submitted Data
                                      5.3
                                      16
1Includes Non-Target Insect Pollinator (NTIP) and Efficacy Studies
* Counts for IC Groups 2, 3, 8, and 9 are for voluntarily submitted data -- i.e., they are not DCIs. Therefore, the total DCI count does not include these estimates.
Numbers may not add due to rounding.

 DCI-Related Respondent Burden and Cost Estimates
 Tables 5 and 6 provide information on the burden and costs faced by DCI recipients, data generators, and consortium participants. Respondent costs are based on managerial, technical and clerical wage rates estimated at $145.34, $76.35, and $49.61 per hour, respectively. These wage rates are based on 2019 wage rates estimated by the Bureau of Labor Statistics (BLS) for the North American Industry Classification System (NAICS) for pesticide registrants (NAICS code 325300).
 Table 5 outlines annual burden and costs to these three groups per company of DCI -- that is, for DCI recipients, burden is estimated by company since companies are responsible for responding to the 90-day notice; for data generators, it is assumed that only one data package is being submitted by one or more (consortium participant) companies for each DCI.
 Table 5: Estimated DCI-Related Annual Respondent Burden and Costs per Company/DCI*
Activity Category
                                   Clerical
                                   Technical
                                    Manager
                                 Burden Totals

                                     Hrs.
                                   $49.61/hr
                                     Hrs.
                                   $76.35/hr
                                     Hrs.
                                  $145.34/hr
                                     (hrs)
                                   Costs ($)
IC Category  -  DCI Recipients
Reporting
                                                                              0
                                                                            $0
                                                                              7
                                                                          $534
                                                                             12
                                                                        $1,744
                                                                             19
                                                                        $2,278
Recordkeeping
                                                                              1
                                                                           $50
                                                                              0
                                                                            $0
                                                                              0
                                                                            $0
                                                                              1
                                                                           $50
IC Category  -  Data Generators[1]
                          Reregistration Program DCIs
1) Confirmatory DCIs
Reporting
                                                                            724
                                                                       $35,897
                                                                          3,821
                                                                      $291,760
                                                                            501
                                                                       $72,829
                                                                          5,046
                                                                      $400,486
Recordkeeping
                                                                            634
                                                                       $31,432
                                                                              0
                                                                            $0
                                                                            117
                                                                       $16,943
                                                                            750
                                                                       $48,375
2) Product Specific DCIs
Reporting
                                                                            110
                                                                        $5,461
                                                                            581
                                                                       $44,348
                                                                             75
                                                                       $10,866
                                                                            766
                                                                       $60,675
Recordkeeping
                                                                             96
                                                                        $4,773
                                                                              0
                                                                            $0
                                                                             19
                                                                        $2,780
                                                                            115
                                                                        $7,553
3) Reregistration: Voluntarily Submitted Low Burden Studies
Reporting
                                                                             76
                                                                        $3,749
                                                                            396
                                                                       $30,252
                                                                             57
                                                                        $8,274
                                                                            529
                                                                       $42,275
Recordkeeping
                                                                             65
                                                                        $3,232
                                                                              0
                                                                            $0
                                                                              7
                                                                        $1,034
                                                                             72
                                                                        $4,266
4) Reregistration: Voluntarily Submitted High Burden Studies
Reporting
                                                                            414
                                                                       $20,549
                                                                          2,191
                                                                      $167,287
                                                                            284
                                                                       $41,331
                                                                          2,890
                                                                      $229,167
Recordkeeping
                                                                            364
                                                                       $18,056
                                                                              0
                                                                            $0
                                                                             70
                                                                       $10,142
                                                                            434
                                                                       $28,198
                   Maintenance and Registration Review DCIs
5) Maintenance DCIs
Reporting
                                                                            390
                                                                       $19,322
                                                                          2,055
                                                                      $156,889
                                                                            279
                                                                       $40,536
                                                                          2,723
                                                                      $216,747
Recordkeeping
                                                                            340
                                                                       $16,883
                                                                              0
                                                                            $0
                                                                             53
                                                                        $7,737
                                                                            394
                                                                       $24,621
6) Registration Review DCIs
Reporting
                                                                          3,355
                                                                      $166,410
                                                                         17,812
                                                                    $1,359,881
                                                                          2,386
                                                                      $346,734
                                                                         23,552
                                                                    $1,873,026
Recordkeeping
                                                                          2,972
                                                                      $147,408
                                                                              0
                                                                            $0
                                                                            493
                                                                       $71,691
                                                                          3,465
                                                                      $219,099
7) Registration Review Resistance Management Plans
Reporting
                                                                              0
                                                                            $0
                                                                             32
                                                                        $2,407
                                                                              3
                                                                          $481
                                                                             35
                                                                        $2,888
Recordkeeping
                                                                              0
                                                                            $0
                                                                              4
                                                                          $321
                                                                              0
                                                                            $0
                                                                              4
                                                                          $321
8) Registration Review:  Voluntarily Submitted Low Burden Studies
Reporting
                                                                             76
                                                                        $3,749
                                                                            396
                                                                       $30,252
                                                                             57
                                                                        $8,274
                                                                            529
                                                                       $42,275
Recordkeeping
                                                                             65
                                                                        $3,232
                                                                              0
                                                                            $0
                                                                              7
                                                                        $1,034
                                                                             72
                                                                        $4,266
9)  Registration Review:  Voluntarily Submitted High Burden Studies
Reporting
                                                                            414
                                                                       $20,549
                                                                          2,191
                                                                      $167,287
                                                                            284
                                                                       $41,331
                                                                          2,890
                                                                      $229,167
Recordkeeping
                                                                            364
                                                                       $18,056
                                                                              0
                                                                            $0
                                                                             70
                                                                       $10,142
                                                                            434
                                                                       $28,198
                 Anticipated Residue/Percent Crop Treated DCIs
10) AR DCIs: Base Set of Data
Reporting
                                                                              3
                                                                          $128
                                                                         11,173
                                                                      $852,992
                                                                              4
                                                                          $598
                                                                         11,179
                                                                      $853,717
Recordkeeping
                                                                              1
                                                                           $43
                                                                              0
                                                                            $0
                                                                              0
                                                                            $0
                                                                              1
                                                                           $43
11) AR DCIs: Verification-of-use Data
Reporting
                                                                             13
                                                                          $650
                                                                             34
                                                                        $2,590
                                                                             16
                                                                        $2,308
                                                                             63
                                                                        $5,548
Recordkeeping
                                                                              2
                                                                           $82
                                                                              0
                                                                            $0
                                                                              0
                                                                            $0
                                                                              2
                                                                           $82
12) AR DCIs: Updated Public Source Monitoring Data
Reporting
                                                                             12
                                                                          $615
                                                                             95
                                                                        $7,216
                                                                             14
                                                                        $1,977
                                                                            121
                                                                        $9,807
Recordkeeping
                                                                              2
                                                                           $77
                                                                              0
                                                                            $0
                                                                              0
                                                                            $0
                                                                              2
                                                                           $77
13) DCIs for Percent Crop Treated Estimates
Reporting
                                                                              3
                                                                          $125
                                                                             45
                                                                        $3,403
                                                                              1
                                                                          $189
                                                                             48
                                                                        $3,716
Recordkeeping
                                                                              1
                                                                           $64
                                                                              0
                                                                            $0
                                                                              0
                                                                            $0
                                                                              1
                                                                           $64
Consortiums
Paperwork burden associated with operating a consortium
                                                                            510
                                                                       $25,299
                                                                            800
                                                                       $61,078
                                                                            810
                                                                      $117,722
                                                                          2,120
                                                                      $204,098
* Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table.
Note that these estimates reflect burden and costs per company when referring to DCI recipients and per DCI when referring to data generators. Methods used for calculating the cost and burden for cases under each IC Group vary. For a review of methods used in these calculations, refer to Appendix A, B, and C.

Table 6 presents the total respondent burden hours for DCI recipients, data generators, and consortium participants (excluding voluntary data submissions). These calculations reflect recordkeeping, reporting, and total burden numbers for each IC group universe. Refer to Appendices A, B, and C for methodologies and formulas demonstrating how these estimates were calculated. For example, the supporting text under Table A-1 in Appendix A demonstrates how the total burden hours and costs were calculated for DCI recipients. Tables in Appendix B provide the same information for data generators by IC group. The 3-year total bottom-line paperwork burden is estimated at 3,274,852 burden hours which equates to $254,539,344 in paperwork burden costs.

Table 6: Summary of Registrant DCI Paperwork Burdens and Costs (3-year Totals)

                                 Burden Hours
                                     Costs

                                   Reporting
                                Recordkeeping
                                    Total
                                   Reporting
                                Recordkeeping
                                    Total
Data Recipients
                                                                          2,318
                                                                            122
                                                                          2,440
                                                                      $277,971
                                                                        $6,052
                                                                      $284,023
Data Generators
Reregistration Program DCIs

Confirmatory DCIs
                                                                          1,682
                                                                            250
                                                                          1,932
                                                                      $133,495
                                                                       $16,125
                                                                      $149,620

Product Specific DCIs
                                                                            255
                                                                             38
                                                                            294
                                                                       $20,225
                                                                        $2,518
                                                                       $22,743

Voluntarily Submitted Low Burden Studies
                                                                            176
                                                                             24
                                                                            200
                                                                       $14,092
                                                                        $1,422
                                                                       $15,514

Voluntarily Submitted High Burden Studies
                                                                            963
                                                                            145
                                                                          1,108
                                                                       $76,389
                                                                        $9,399
                                                                       $85,788
Maintenance and Registration Review DCIs

Maintenance DCIs
                                                                        199,995
                                                                         28,887
                                                                        228,881
                                                                    $15,918,069
                                                                     $1,805,799
                                                                   $17,723,868

Registration Review DCIs
                                                                      2,606,450
                                                                        383,446
                                                                      2,989,896
                                                                   $207,281,499
                                                                    $24,247,001
                                                                  $231,528,500

Registration Review Resistance Management Plans
                                                                          2,752
                                                                            332
                                                                          3,084
                                                                      $228,160
                                                                       $25,351
                                                                      $253,511

Registration Review:  Voluntarily Submitted Low Burden Studies
                                                                          2,644
                                                                            361
                                                                          3,005
                                                                      $211,374
                                                                       $21,331
                                                                      $232,705

Registration Review:  Voluntarily Submitted High Burden Studies
                                                                         14,449
                                                                          2,169
                                                                         16,618
                                                                    $1,145,834
                                                                      $140,991
                                                                    $1,286,825
Anticipated Residue/Percent Crop Treated DCIs

AR DCIs: Base Set of Data
                                                                          3,726
                                                                            0.3
                                                                          3,727
                                                                      $284,572
                                                                           $14
                                                                      $284,587

AR DCIs: Verification-of-use Data
                                                                             21
                                                                            0.5
                                                                             22
                                                                        $1,849
                                                                           $27
                                                                        $1,877

AR DCIs: Updated Public Source Monitoring Data
                                                                             40
                                                                            0.5
                                                                             41
                                                                        $3,269
                                                                           $26
                                                                        $3,295

DCIs for Percent Crop Treated Estimates
                                                                             16
                                                                            0.4
                                                                             17
                                                                        $1,239
                                                                           $21
                                                                        $1,260

                           DCI Data Generator Total
                                                                      2,814,937
                                                                        412,955
                                                                      3,227,892
                                                                   $223,872,378
                                                                    $26,096,882
                                                                  $249,969,260

                       Operating Activities Burden Hours
                           Operating Activities Cost
                              Consortium Members
                                       -
                                       -
                                                                         44,520
                                       -
                                       -
                                                                    $4,286,061
                              Total Annual Burden
                                                                      2,817,255
                                                                        413,077
                                                                      3,274,852
                                                                  $224,150,350
                                                                   $26,102,934
                                                                  $254,539,344
Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table. Methods used for calculating the cost and burden for cases under each IC Group vary. For a review of methods used in these calculations, refer to Appendices A, B, and C.

Section V: Agency Activities and Estimated Costs

After initiating a statutorily mandated pesticide review, if additional data are needed, the Agency will issue a DCI when the need for additional data has been identified.

The functions and responsibilities associated with the EDSP under FFDCA §408(p) have been assigned to EPA's Office of Chemical Safety and Pollution Prevention (OCSPP). Within OCSPP, OPP will be responsible for the administrative functions related to the issuance of the §408(p) Orders, receiving, processing, and maintaining records of responses to the §408(p) Orders, as well as, other administrative functions related to the §408(p) Orders for pesticide chemicals. The technical review of the data will reside with OPP and include consultation and coordination on an as-needed basis with staff from within OCSPP and other EPA offices (e.g., Office of Science Coordination and Policy, OSCP; Office of Water, OW; Office of Research and Development, ORD) as appropriate.

The Pesticide Registration Information System (PRISM) software application has been developed in OPP to integrate functionality necessary to support the Registration Review and EDSP (Endocrine Disrupter Screening Program) programs. PRISM supports many of the Registration Review and EDSP processes associated with tracking, including DCIs, §408(p) orders, and data submissions. PRISM serves as a replacement for the equivalent functionality provided by the Office of Pesticide Programs Information Network (OPPIN) application. PRISM was enhanced to accept electronic registration (e-Registration) documents. The e-Submission module of PRISM supports the processing of a number of specific application documents (FIFRA §3 new applications, §3 amendments, experimental use permits, petitions for tolerances, and applications for supplemental distributor products) required for pesticide applications. OPP continues to track Reregistration program information, including DCIs, registrant responses, and reregistration data submissions through OPPIN. Also currently, OPPIN lists the bibliography of data submitters for all the DCIs. All correspondence associated with the issuance and response to the DCI is filed in the master registration file or `registration jacket' of affected products. Failures to comply with DCI requirements are referred to EPA's Office of Enforcement and Compliance Assurance for appropriate follow-up actions.

Although the Agency does not publish the submitted information, public access to the OPPIN bibliography is made through the National Pesticides Information Retrieval System (NPIRS). NPIRS supports searches of the OPPIN database by chemical, subject, submission date, laboratory, guideline number, and document type. The public may request copies of non-confidential studies through the Freedom of Information Act (FOIA).

In September 2015, OPP debuted a new electronic system for pesticide applications, the Pesticide Submission Portal (PSP).  In February 2016, EPA began to accept DCI response packages through the PSP. The electronic submission process is a combination of document file uploads and providing information online that is equivalent to existing OMB-approved forms that would otherwise be filled out, printed, and mailed to EPA. The current PSP leverages the Agency's existing Central Data Exchange (CDX) to provide a secure method of submitting these documents and information within a secure online environment. CDX does require initial user registration for which the paperwork burden estimate is covered under "Cross-Media Electronic Reporting Rule" ICR, OMB No. 2025-0003; EPA No. 2002.26.

 DCI-Related Agency Burden and Cost Estimates
 Tables 7 and 8 provide information on the burden and costs faced by the Agency in requesting DCIs. Agency costs are based on managerial, technical and clerical wage rates estimated at $108.45, $79.61, and $46.10 per hour, respectively. These wage rates are based on 2019 wage rates estimated by the U.S. Bureau of Labor Statistics (BLS) for the North American Industry Classification System (NAICS) for the federal government (NAICS code 999100).
 Table 7 outlines Agency burden and cost per DCI. Overall, average reporting hours range from 40 to 326 hours per DCI ($3,064 to $25,956), depending on the type of DCI. Average recordkeeping hours per DCI range from 2 to 5 hours ($104 to $244).

Table 7: Estimated DCI-Related Annual Agency Burden and Costs per DCI*
Category
                                   Clerical
                                   Technical
                                    Manager
                                    Totals

                                     Hrs.
                                   $46.10/hr
                                     Hrs.
                                   $79.61/hr
                                     Hrs.
                                  $108.45/hr
                                 Burden (hrs)
                                   Costs ($)
Reregistration
Reporting
                                                                            2.0
                                                                           $92
                                                                          321.1
                                                                       $25,566
                                                                            2.8
                                                                          $298
                                                                            326
                                                                       $25,956
Recordkeeping
                                                                            4.5
                                                                          $207
                                                                            0.0
                                                                            $0
                                                                            0.0
                                                                            $0
                                                                              5
                                                                          $207
Maintenance DCIs
Reporting
                                                                            1.0
                                                                           $46
                                                                          160.6
                                                                       $12,783
                                                                            1.4
                                                                          $149
                                                                            163
                                                                       $12,978
Recordkeeping
                                                                            2.3
                                                                          $104
                                                                            0.0
                                                                            $0
                                                                            0.0
                                                                            $0
                                                                              2
                                                                          $104
Registration Review DCIs
Reporting
                                                                            7.2
                                                                          $332
                                                                           28.6
                                                                        $2,277
                                                                            4.2
                                                                          $456
                                                                             40
                                                                        $3,064
Recordkeeping
                                                                            5.3
                                                                          $244
                                                                            0.0
                                                                            $0
                                                                            0.0
                                                                            $0
                                                                              5
                                                                          $244
Anticipated Residue/Percent Crop Treated DCIs
Reporting
                                                                            7.2
                                                                          $332
                                                                           28.6
                                                                        $2,277
                                                                            4.2
                                                                          $456
                                                                             40
                                                                        $3,064
Recordkeeping
                                                                            5.3
                                                                          $244
                                                                            0.0
                                                                            $0
                                                                            0.0
                                                                            $0
                                                                              5
                                                                          $244
* Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table. Methods used for calculating the cost and burden for cases under each IC Group vary. For a review of methods used in these calculations, refer to Appendix B.

Table 8 presents the total annual Agency burden hours. These calculations reflect recordkeeping, reporting, and total burden numbers for each type of DCI. Refer to Appendix B for methodologies and formulas demonstrating how these estimates were calculated for each type of DCI. Total bottom-line Agency paperwork burden is estimated at 21,538 burden hours which equates to $1,652,342 in paperwork burden costs.

Table 8: Summary of Agency DCI Paperwork Burdens and Costs (3-year Totals)

                                 Burden Hours
                                     Costs

                                   Reporting
                                 Recordkeeping
                                     Total
                                   Reporting
                                 Recordkeeping
                                     Total
Reregistration Program DCIs
                                                                            326
                                                                              5
                                                                            330
                                                                        $25,956
                                                                           $207
                                                                        $26,164
Maintenance DCI
                                                                         12,384
                                                                            171
                                                                         12,555
                                                                       $986,347
                                                                         $7,883
                                                                       $994,230
Registration Review DCIs
                                                                          7,587
                                                                          1,005
                                                                          8,592
                                                                       $581,194
                                                                        $46,343
                                                                       $627,537
Anticipated Residue and Percent Crop Treated DCIs
                                                                             53
                                                                              7
                                                                             60
                                                                         $4,086
                                                                           $326
                                                                         $4,412
Total Annual Agency Burden
                                                                         20,350
                                                                          1,188
                                                                         21,538
                                                                     $1,597,583
                                                                        $54,760
                                                                     $1,652,342
Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table. Methods used for calculating the cost and burden vary for each type of DCI. For a review of methods used in these calculations, refer to Appendices B.

                                   Appendix A
              Estimated Burden Hours and Costs for DCI Recipients

This Appendix outlines the burden hours and costs for DCI recipients. The methodology EPA used for calculating the burden for this group is derived from the 2007 document entitled General Methodology Used to Estimate Paperwork Burden Hours and Costs by the Office of Pesticide Programs for Submission of Required Data/Information for Responding to a Data Call-In Notice, see Attachment 1, Case Study #1, Attachment A.

To calculate the universe of DCI recipients, EPA conducted a search of its Pesticide Registration Information System (PRISM) for all companies that received DCI requests in 2013. This number was 82; however, an influx of DCIs under reregistration began antimicrobials starting in 2014, with an estimated average of 20 confirmatory and 20 product-specific DCIs being sent out annually for the next three years. This would result in 122 DCIs being expected annually from 2021 to 2024.

Annual burden and costs is estimated at 20 hours or $2,328 for each DCI recipient; with 122 companies receiving DCIs annually, the total annual burden is 2,440 hours and $284,023.

Table A-1: Annual Burden and Costs per DCI Recipient
Activity
                                 Burden Hours
                                     Total

Management
Technical
Clerical
Hours
Costs
    Read Instructions
                                                                              7
                                                                              2
                                                                              0
                                                                              9
                                                                         $1,170
    Plan Activities
                                                                              3
                                                                              3
                                                                              0
                                                                              6
                                                                           $665
    Complete Paperwork
                                                                              2
                                                                              2
                                                                              0
                                                                              4
                                                                           $443
    Store/maintain Data
                                                                              0
                                                                              0
                                                                              1
                                                                              1
                                                                            $50
                                                                         Totals
                                                                             12
                                                                              7
                                                                              1
                                                                             20
                                                                         $2,328
Estimated Total Burden & Costs Across all DCI Recipients:
Reporting (Collection Activities 1-3):
Burden: 19 hours per response x 122 responses = 2,318 burden hours
Costs: $2,278 per response x 122 responses = $277,971
Recordkeeping (Collection Activity 4):
Burden: 1 hour per response x 122 responses = 122 burden hours
Costs: $50 per response x 122 responses = $6,052
Total (Reporting + Recordkeeping):
Burden: 20 hours per response x 122 responses = 2,440 burden hours
Costs: $2,328 per response x 122 responses = $284,023
* Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table.

                                  Appendix B:
 Estimated Burden Hours and Costs for DCI Collection Activities for Data Generators, by IC Group

The estimated burden hours, collection activity costs, and total cost per DCI by IC Group using loaded labor rates for the labor categories are outlined in this Appendix. Please see Section 1(b)(i): Methodology Used to Estimate the Paperwork Burden and Costs for DCIs for an overview of how paperwork burden estimates in this section were calculated.

Section B-1: Estimating Paperwork Burden  -  Reregistration

Over the next three years, EPA expects to issue one reregistration DCI for product specific data. This is a substantial decrease from previous DCI estimates as the reregistration process is transitioning to registration review.  However, EPA's Antimicrobials Division in the Office of Pesticide Programs still has one chemical that may need a reregistration DCI to be issued.

Section B-1.1: Paperwork Burden Related to the Submission of Confirmatory Data Reregistration

Confirmatory data are required to complete registrant databases and to assist in the evaluation of risk findings. For DCIs involving confirmatory studies, EPA assumes that only one DCI recipient will provide the data requested. The total cost for the most burdensome confirmatory data DCI that the EPA has issued in recent years was $1,282,460. The paperwork cost associated with this (35% of the total cost) is $448,861 and 5,796 total burden hours. EPA expects to issue 1 confirmatory DCIs over the next three years, which is an average of 0.3 confirmatory DCIs annually. Total annual burden across all Confirmatory Data DCIs is 1,932 burden hours or $149,620. See Table B-1 below for burden activity details.

Table B-1: Annual Respondent Paperwork Burden per DCI Involving Confirmatory Studies
                              Collection Activity
                                 Burden Hours
                                     Total

Management
Technical
Clerical
                                     Hours
                                     Costs
    Read and discuss test requirements
                                                                             63
                                                                              0
                                                                              0
                                                                             63
                                                                         $9,104
    Discuss test and protocol with Agency
                                                                             31
                                                                             59
                                                                              0
                                                                             90
                                                                         $9,068
    Plan activities
                                                                            127
                                                                             59
                                                                              0
                                                                            186
                                                                        $22,976
    Create information
                                                                             96
                                                                          2,937
                                                                            543
                                                                          3,575
                                                                       $265,063
    Gather information
                                                                              0
                                                                            295
                                                                              0
                                                                            295
                                                                        $22,509
    Process, compile, review information for accuracy
                                                                            184
                                                                            471
                                                                              0
                                                                            656
                                                                        $62,791
    Complete written forms
                                                                              0
                                                                              0
                                                                            181
                                                                            181
                                                                         $8,974
    Record, disclose, display information
                                                                             58
                                                                              0
                                                                            362
                                                                            420
                                                                        $26,420
    Store, file, or maintain information
                                                                             58
                                                                              0
                                                                            272
                                                                            330
                                                                        $21,954
                                                                          Total
                                                                            618
                                                                          3,821
                                                                          1,357
                                                                          5,796
                                                                       $448,861
Estimated Total Annual Burden & Costs Across All Confirmatory Study DCI Data Generators:
Reporting (Collection Activities 1-7):
Burden: 5,046 hours per response x 1 response per DCI x 0.3 DCIs = 1,682 burden hours
Costs: $400,486 per response x 1 response per DCI x 0.3 DCIs = $133,495
Recordkeeping (Collection Activities 8-9):
Burden: 750 hours per response x 1 response per DCI x 0.3 DCIs = 250 burden hours
Costs: $48,375 per response x 1 response per DCI x 0.3 DCIs = $16,125
Total (Reporting + Recordkeeping):
Burden: 5,796 hours per response x 1 response per DCI x 0.3 DCIs = 1,932 burden hours
Costs: $448,861 per response x 1 response per DCI x 0.3 DCIs = $149,620
* Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table.

Section B-1.2: Paperwork Burden Related to Voluntarily Submitted Data - Reregistration

Voluntary data consist of studies not required by the Agency. Instead voluntary data is submitted by registrants to supplement a pesticide database. The Agency does not expect to receive more than one voluntary data submission over the next three years under the reregistration program. Despite the small chance of such an occurrence, the Agency has provided high and low burden estimates given the variable nature of the expected cost of voluntarily submitted data.

In the last several years, no voluntary submissions have been received for the reregistration program. Therefore, the Agency used the burden hour cost calculated in the previous DCI ICR -- adjusted for wage rate changes -- and backed out the proportional burden hour estimates for each of the three labor groups (i.e., 20% managerial, 65% technical, 15% clerical). This method was used both for low and high burden voluntary submission burden hour estimates. The labor wage rates were updated and indexed to 2019, thus, for the new ICR (2021  -  2024) the Agency is projecting a total data cost per voluntary submission is expected to range from $117,862 to $731,969. This translates to paperwork burden estimates for voluntary submissions ranging from 583 to 3,622 burden hours, or $41,252 to $256,189 per voluntary submission. EPA adopted industry recommended adjustments to the burden hour estimates, which puts the range of possible paperwork burden per voluntary submission at 601 to 3,324 hours, or $46,541 to $257,365. Since only one submission is expected every three years, the expected range of potential annual burden from a voluntary submission is 200 to 1,108 burden hours or $15,514 to $85,788 in burden cost.

Table B-2. Annual Respondent Paperwork Burden per Submission of Voluntary Studies (Low Burden)
                              Collection Activity
                                 Burden Hours
                                     Total

Management
Technical
Clerical
                                     Hours
                                     Costs
    Read and discuss test requirements
                                                                              4
                                                                              0
                                                                              0
                                                                              4
                                                                           $517
    Discuss test and protocol with Agency
                                                                              3
                                                                              7
                                                                              0
                                                                              9
                                                                           $890
    Plan activities
                                                                              8
                                                                              7
                                                                              0
                                                                             15
                                                                         $1,665
    Create information
                                                                              6
                                                                            304
                                                                             56
                                                                            367
                                                                        $26,932
    Gather information
                                                                             22
                                                                             30
                                                                              0
                                                                             52
                                                                         $5,526
    Process, compile, review information for accuracy
                                                                             12
                                                                             49
                                                                              0
                                                                             60
                                                                         $5,408
    Complete written forms
                                                                              3
                                                                              0
                                                                             19
                                                                             22
                                                                         $1,336
    Record, disclose, display information
                                                                              4
                                                                              0
                                                                             37
                                                                             41
                                                                         $2,370
    Store, file, or maintain information
                                                                              4
                                                                              0
                                                                             28
                                                                             31
                                                                         $1,896
                                                                          Total
                                                                             64
                                                                            396
                                                                            141
                                                                            601
                                                                        $46,541
Estimated Total Annual Burden & Costs Across All Voluntary Low Burden Studies:
Reporting (Collection Activities 1-7):
Burden: 529 hours per response x 1 response per DCI x 0.33 DCIs = 176 burden hours
Costs: $42,275 per response x 1 response per DCI x 0.33 DCIs = $14,092
Recordkeeping (Collection Activities 8-9):
Burden: 72 hours per response x 1 response per DCI x 0.33 DCIs = 24 burden hours
Costs: $4,266 per response x 1 response per DCI x 0.33 DCIs = $1,422
Total (Reporting + Recordkeeping):
Burden: 601 hours x 1 response x 0.33 submissions = 200 burden hours
Costs: $46,541 x 1 response x 0.33 submissions = $15,514
* Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table.

Table B-3. Annual Respondent Paperwork Burden per Submission of Voluntary Studies (High Burden)
                              Collection Activity
                                 Burden Hours
                                     Total

Management
Technical
Clerical
                                     Hours
                                     Costs
    Read and discuss test requirements
                                                                             35
                                                                              0
                                                                              0
                                                                             35
                                                                         $5,071
    Discuss test and protocol with Agency
                                                                             17
                                                                             34
                                                                              0
                                                                             51
                                                                         $5,116
    Plan activities
                                                                             69
                                                                             34
                                                                              0
                                                                            103
                                                                        $12,596
    Create information
                                                                             51
                                                                          1,684
                                                                            311
                                                                          2,047
                                                                       $151,497
    Gather information
                                                                              8
                                                                            169
                                                                              0
                                                                            177
                                                                        $14,042
    Process, compile, review information for accuracy
                                                                            104
                                                                            270
                                                                              0
                                                                            374
                                                                        $35,729
    Complete written forms
                                                                              0
                                                                              0
                                                                            103
                                                                            103
                                                                         $5,116
    Record, disclose, display information
                                                                             35
                                                                              0
                                                                            208
                                                                            243
                                                                        $15,389
    Store, file, or maintain information
                                                                             35
                                                                              0
                                                                            156
                                                                            191
                                                                        $12,809
                                                                          Total
                                                                            354
                                                                          2,191
                                                                            778
                                                                          3,324
                                                                       $257,365
Estimated Total Annual Burden & Costs Across All Voluntary High Burden Studies:
Reporting (Collection Activities 1-7):
Burden: 2,890 hours per response x 0.33 submissions = 963 burden hours
Costs: $229,167 per response x 0.33 submissions = $76,389
Recordkeeping (Collection Activities 8-9):
Burden: 434 hours per response x 0.33 submissions = 145 burden hours
Costs: $28,198 per response x 0.33 submissions = $9,399
Total (Reporting + Recordkeeping):
Burden: 3,324 hours x 1 response x 0.33 submissions = 1,108 burden hours
Costs: $257,365 x 1 response x 0.33 submissions = $85,788
* Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table.

Section B-1.3: Paperwork Burden Related to the Submission of Product-Specific Data  -  Reregistration

The Agency projects one Product-Specific DCI (PDCI) will be called-in over the next three years (0.3 annually) that will generate one response. Table B-4 provides details for each burden activity. Although a PDCI has not been issued recently, total test cost estimates are available from 2011 for four product chemicals. The average total test cost for each of these chemicals is $194,937. Using the 2015 revised general methodology and assumptions burden estimate methodology, the paperwork cost associated with this (35% of the total cost) is $68,228 or 881 burden hours. Total annual paperwork burden across all PDCI's is 294 burden hours or $22,743. See Table B-4 below for burden activity details.

Table B-4. Annual Respondent Burden Estimates per Product Specific DCI
                              Collection Activity
                                 Burden Hours
                                     Total

Management
Technical
Clerical
                                     Hours
                                     Costs
    Read and discuss test requirements
                                                                             10
                                                                              0
                                                                              0
                                                                             10
                                                                         $1,390
    Discuss test and protocol with Agency
                                                                              5
                                                                              9
                                                                              0
                                                                             15
                                                                         $1,473
    Plan activities
                                                                             18
                                                                              9
                                                                              0
                                                                             28
                                                                         $3,369
    Create information
                                                                             14
                                                                            446
                                                                             82
                                                                            542
                                                                        $40,155
    Gather information
                                                                              0
                                                                             45
                                                                              0
                                                                             45
                                                                         $3,433
    Process, compile, review information for accuracy
                                                                             28
                                                                             71
                                                                              0
                                                                             99
                                                                         $9,479
    Complete written forms
                                                                              0
                                                                              0
                                                                             28
                                                                             28
                                                                         $1,376
    Record, disclose, display information
                                                                             10
                                                                              0
                                                                             55
                                                                             64
                                                                         $4,099
    Store, file, or maintain information
                                                                             10
                                                                              0
                                                                             42
                                                                             51
                                                                         $3,454
                                                                          Total
                                                                             94
                                                                            581
                                                                            206
                                                                            881
                                                                        $68,228
 Estimated Total Annual Burden & Costs Across All Product-Specific DCI Data Generators:
 Reporting (Collection Activities 1-7):
 Burden: 766 hours per response x 1 response per DCI x 0.3 DCIs = 255 burden hours
 Costs: $60,675 per response x 1 response per DCI x 0.3 DCIs = $20,255
 Recordkeeping (Collection Activities 8-9):
 Burden: 115 hours per response x 1 response per DCI x 0.3 DCIs = 38 burden hours
 Costs: $7,553 per response x 1 response per DCI x 0.3 DCIs = $2,518
 Total (Reporting + Recordkeeping):
 Burden: 881 hours per response x 1 response per DCI x 0.3 DCI = 294 burden hours
 Costs: $68,228 per response x 1 response per DCI x 0.3 DCI = $22,743
 Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table.

Section B-1.4: Estimating Agency Paperwork Burden  -  Reregistration

The Agency's annual burden hours and costs for developing DCI correspondence, communication with registrants, developing documents, tracking and storing the evaluation of the data submissions, and other DCI processing activities are detailed in Table B-5 below. Overall, the average annual Agency paperwork burden is 330 hours ($26,164) per DCI.

Table B-5: Annual Agency Paperwork Burden  -  Reregistration
                             Collection Activities
                                 Burden Hours
                                     Total

                                  Management
                                   Technical
                                   Clerical
                                     Hours
                                     Costs

    Develop DCI correspondence
                                      2.0
                                     20.0
                                      2.0
                                      2.0
                                                                         $1,901
    Answer DCI questions from registrants
                                      0.3
                                     10.0
                                      0.0
                                      0.3
                                                                           $823
    Review, evaluate data submission
                                      0.5
                                     291.1
                                      0.0
                                      0.5
                                                                        $23,232
    Record DCI submissions
                                      0.0
                                      0.0
                                      4.0
                                      0.0
                                                                           $184
    Store data
                                      0.0
                                      0.0
                                      0.5
                                      0.0
                                                                            $23
                                                     Total Annual Agency Burden
                                       3
                                      321
                                       7
                                      330
                                                                        $26,164
 Estimated Total Annual Agency Burden & Costs Across All Reregistration:
 Reporting (Collection Activities 1-3):
 Burden: 326 hours per response x 1 response per DCI x 1 DCIs = 326 burden hours
 Costs: $25,956 per response x 1 response per DCI x 1 DCIs = $25,956
 Recordkeeping (Collection Activities 4-5):
 Burden: 5 hours per response x 1 response per DCI x 1 DCIs = 5 burden hours
 Costs: $207 per response x 1 response per DCI x 1 DCIs = $207
 Total (Reporting + Recordkeeping):
 Burden: 330 hours per response x 1 response per DCI x 1 DCIs = 330 burden hours
 Costs: $26,164 per response x 1 response per DCI x 1 DCIs = $26,164
 Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table. Note that the number of reregistration DCIs for reregistration reported here do not include voluntarily submitted data.

Section B-2: Estimating Respondent Burden  -  Maintenance DCIs

Section 3(c)(2)(B) of FIFRA provides a means of obtaining needed additional data "to maintain in effect an existing registration of a pesticide." A need for a data call-in may arise from evolving of scientific understanding and methodologies, changes in the discovery of deficiencies in previously submitted data, or from the new discovery of specific attributes of the pesticide or its ingredients. For example, such data may be needed in support of Agency enforcement cases resulting from consumer complaints about the product, its storage stability, the integrity of its container, or exaggerated advertising claims. A DCI might also be needed to confirm product performance of public health pesticides or a new type of manufacturing process may call into question data submitted for a pesticide registration using older manufacturing technologies no longer used today. These situations may give rise to new concerns such as observed or suspected adverse human health or environmental effects attributed to the use of a pesticide that were not present at the time of the original registration. Therefore, the need for data arise not from a mandated review program like the programs described in paragraphs above, but from unanticipated circumstances such as changes in pathogens of public health concern, new EPA initiatives, or the evolution of scientific test methodologies or manufacturing technologies.

The Agency projects 225 Non-Target Insect Pollinator (NTIP) studies and 3 Efficacy Studies will be called-in over the next three years (75 and 1 studies, respectively annually) and that each study DCI will generate one response. Table B-6 combines the studies (burden hours and costs) and provides details for each burden activity. The average combined total study cost is $689,623 (NTIP = $675,000 and Efficacy = $14,623). Using the 2015 revised general methodology and assumptions burden estimate methodology, the paperwork cost associated with this (35% of the total cost) is $241,368 or 3,117 burden hours. Total annual paperwork burden across all Maintenance DCIs is 228,881 burden hours or $17,723,868. See Table B-6 below for burden activity details.

Table B-6: Estimated Annual Paperwork Burden Hours and Cost Estimates for Maintenance DCIs per Respondent
                             Collection Activities
                                 Burden Hours
                                     Total

                                  Management
                                   Technical
                                   Clerical
                                     Hours
                                     Costs

1. Read and discuss test requirements
                                                                           26.7
                                                                            0.0
                                                                            0.0
                                                                             27
                                                                         $3,877
2. Discuss test and protocol with Agency
                                                                           13.3
                                                                           31.8
                                                                            0.0
                                                                             45
                                                                         $4,368
3. Plan activities
                                                                           54.0
                                                                           31.8
                                                                            0.0
                                                                             86
                                                                        $10,278
4. Create information
                                                                           40.7
                                                                        1,579.3
                                                                          291.9
                                                                          1,912
                                                                       $140,969
5. Gather information
                                                                           64.9
                                                                          158.3
                                                                            0.0
                                                                            223
                                                                        $21,515
6. Process, compile, review information for accuracy
                                                                           79.3
                                                                          253.7
                                                                            0.0
                                                                            333
                                                                        $30,900
7. Complete written forms
                                                                            0.0
                                                                            0.0
                                                                           97.6
                                                                             98
                                                                         $4,840
8. Record, disclose, display information
                                                                           26.6
                                                                            0.0
                                                                          194.4
                                                                            221
                                                                        $13,511
9. Store, file, or maintain information
                                                                           26.6
                                                                            0.0
                                                                          146.0
                                                                            173
                                                                        $11,110
                                                                          Total
                                                                            332
                                                                          2,055
                                                                            730
                                                                          3,117
                                                                       $241,368
Estimated Total Annual Burden & Costs Across All Maintenance DCI Data Generators:
Reporting (Collection Activities 1-7):
Non-Target Pollinator Burden: 2,666 hours per response x 1 response per DCI x 75 DCIs = 199,937 burden hours
Non-Target Pollinator Costs: $212,180 per response x 1 response per DCI x 75 DCIs = $15,913,502
Efficacy Burden: 58 hours per response x 1 response per DCI x 1 DCI = 58 burden hours
Efficacy Costs: $4,567 per response x 1 response per DCI x 1 DCI = $4,567
Recordkeeping (Collection Activities 8-9):
Non-Target Pollinator Burden: 385 hours per response x 1 response per DCI x 75 DCIs = 28,878 burden hours
Non-Target Pollinator Costs: $24,070 per response x 1 response per DCI x 75 DCIs = $1,805,248
Efficacy Burden: 9 hours per response x 1 response per DCI x 1 DCI = 9 burden hours
Efficacy Costs: $551 per response x 1 response per DCI x 1 DCI = $551
Total (Reporting + Recordkeeping):
Non-Target Pollinator Burden: 3,051 hours per response x 1 response per DCI x 75 DCIs = 228,815 burden hours
Non-Target Pollinator Costs: $236,250 per response x 1 response per DCI x 75 DCIs = $17,718,750
Efficacy Burden: 66 hours per response x 1 response per DCI x 1 DCI = 66 burden hours
Efficacy Costs: $5,118 per response x 1 response per DCI x 1 DCI = $5,118
* Numbers may not add due to rounding.

Section B-2.1: Estimating Agency Paperwork Burden  -  Maintenance DCIs

The Agency's annual burden hours and costs for developing DCI correspondence, communication with registrants, developing documents, tracking and storing the evaluation of the data submissions, and other DCI processing activities are detailed in Table B-7 below. Overall, average annual Agency paperwork burden is 165 hours ($13,082) per DCI or 12,555 burden hours ($994,230) annually.

Table B-7: Annual Agency Burden  -  Maintenance DCIs
                             Collection Activities
                                 Burden Hours
                                     Total

                                  Management
                                   Technical
                                   Clerical
                                     Hours
                                     Costs

    Develop DCI correspondence
                                                                            1.0
                                                                           10.0
                                                                            1.0
                                                                             12
                                                                           $951
    Answer DCI questions from registrants
                                                                            0.1
                                                                            5.0
                                                                            0.0
                                                                              5
                                                                           $412
    Review, evaluate data submission
                                                                            0.3
                                                                          145.6
                                                                            0.0
                                                                            146
                                                                        $11,616
    Record DCI submissions
                                                                            0.0
                                                                            0.0
                                                                            2.0
                                                                              2
                                                                            $92
    Store data
                                                                            0.0
                                                                            0.0
                                                                            0.3
                                                                              0
                                                                            $12
Total Annual Agency Burden
                                                                              1
                                                                            161
                                                                              3
                                                                            165
                                                                        $13,082
 Estimated Total Annual Agency Burden & Costs Across All Maintenance DCIs:
 Reporting (Collection Activities 1-3):
 Burden: 163 hours per response x 1 response per DCI x 76 DCIs = 12,384 burden hours
 Costs: $12,978 per response x 1 response per DCI x 76 DCIs = $986,347
 Recordkeeping (Collection Activities 4-5):
 Burden: 2 hours per response x 1 response per DCI x 76 DCIs = 171 burden hours
 Costs: $104 per response x 1 response per DCI x 76 DCIs = $7,883
 Total (Reporting + Recordkeeping):
 Burden: 165 hours per response x 1 response per DCI x 76 DCIs = 12,555 burden hours
 Costs: $13,082 per response x 1 response per DCI x 76 DCIs = $994,230
 Numbers may not add due to rounding. Please refer to text for information on calculations presented in this table.

Section B-3: Estimating the Respondent Burden  -  Registration Review Program

Data that is submitted under the Registration Review Program includes those submitted through DCIs for Registration Review, and Voluntarily Submitted Data. As the burden associated with Voluntarily Submitted Data can be highly variable, low and high burden estimates are provided.

Section B-3.1: Estimating Respondent Burden  -  Registration Review

The annual total estimated cost for all studies requested under the most burdensome registration review DCI that EPA has issued in the past three years was $5,977,500. This DCI took two years for completion and had a total cost of $11,955,000  There was an additional registration review with a higher cost of $27,652,500, but it is not representative of trends in registration review costs found in EPA analysis. The paperwork cost associated with this (35% of the annual total cost) was $2,092,125 or 27,017 total burden hours. EPA expects to issue 332 Registration Review DCIs over the next three years, which equals an average of 110.7 registration review DCIs annually. These DCIs are also to include requests for the new suite of non-target insect pollinator studies that EPA plans to codify in the coming year.

Table B-8: Estimated Annual Respondent Paperwork Burden Hours and Costs for Registration Review DCIs
                             Collection Activity
                                 Burden Hours
                                    Total

Management
Technical
Clerical
                                    Hours
                                     Costs
1. Read and discuss test requirements
                                                                            334
                                                                              0
                                                                              0
                                                                            334
                                                                       $48,521
2. Discuss test and protocol with Agency
                                                                            167
                                                                            369
                                                                              0
                                                                            536
                                                                       $52,456
3. Plan activities
                                                                            667
                                                                            369