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EPA materials from the DCI Response Burden Assessment
Workshop, December 12, 2013
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Agenda
Pesticide Data Call In (DCI) Information Collection Request (ICR)
Industry Consultation Workshop
12/12/13
11:00
•
•
•
•
Introduction
Welcome and introductions
Conduct of workshop
Purpose of workshop
Brief overview of ICRs and consultation process
Martha Shimkin
Angela Hofmann
11:15 Burden methodology, assumptions, and estimates
Elizabeth Hill
• Programs involving DCIs, and DCI response types
• Burden estimation methodology:
o Overview of basic methodology
o Registration Review
DCIs
Voluntarily submitted data (low- and high-burden studies)
o Reregistration
Confirmatory data
Product specific data
Voluntarily submitted data (low- and high-burden studies)
o Tolerance Assessment Program
Anticipated Residue DCIs: Base Set of Data
Anticipated Residue DCIs: Verification of Use Data
Anticipated Residue DCIs: Updated Public Source Monitoring Data
DCIs for Percent Crop Treated Estimates
o Special Review DCIs
o DCI recipients – initial (90-day) response
12:45 Additional questions for participants
Cameo Smoot
1:00
•
•
Wrap-up
Questions and comments from participants
Request for written comments by January 13
Martha Shimkin
1:30
Adjourn
Office of Pesticide Programs
Draft Methodology and Assumptions for Estimating Response Burden for Pesticide Data
Call Ins: Data Call In Response Burden Assessment Workshop
December 12, 2013
Introduction
The Environmental Protection Agency (EPA) through the Office of Pesticide Programs (OPP) is
currently redefining the Data Call-In (DCI) recipient groups and calculations for those groups to
reassess the Paperwork Reduction Act (PRA) burden. Under the PRA, 44 U.S.C. 35, the Agency
is required to ensure that the information collected from the public minimizes the burden and
maximizes the public utility of the information collected. Prior to collecting the information
from the public, EPA must have Office of Management and Budget (OMB) approval. Several
programs under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) authorize EPA
to seek additional data from pesticide registrants to ensure compliance with statutory standards
for the protection of human health and the environment.
The OPP is conducting a reassessment of the information collections obtained through the DCI
process. As part of this reassessment, OPP is consulting 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. The focus of
the DCI Response Burden Assessment Workshop and OPP’s burden reassessment of the DCI
ICR are 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 (Anticipated Residue/Percent Crop Treated Information).
Section I: Background on Programs Involving Data Call-Ins (DCIs)
The following programs involve reviews of existing registrations that could result in a
determination that additional data are necessary for a decision, which would be sought through
the issuance of a DCI under FIFRA §3(c)(2)(B).
A. Reregistration Program
FIFRA §4 1 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 fooduse pesticide ingredients and 2008 for non-food use pesticide ingredients, the Agency will still
issue certain types of product-specific DCIs (PDCIs) in the future.
1
7 USC 136a-1
November 26, 2012
B. Registration Review Program
FIFRA §3(g) 2 directs EPA to establish by regulation procedures for periodically reviewing
pesticide registrations, and to complete each pesticide's registration review at least every 15 years
to assure that the pesticide continues to pose no unreasonable adverse effects on human health or
the environment. The purpose of this review is to assure that a pesticide continues to meet the
FIFRA standard for registration. The procedural regulations were promulgated in 2006 as 40
CFR part 155, subpart C. 3 The Pesticide Registration Improvement Act 4 requires EPA to
complete registration review decisions for all currently-registered pesticides by October 1, 2022.
FIFRA §3(g) instructs EPA to use the FIFRA §3(c)(2)(B) authority to obtain data determined to
be necessary to complete the assessment, 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:
2
3
4
5
6
7
•
Endangered Species Protection Program (ESPP): EPA regards the ESPP, which concerns
endangered species assessments (effects determinations) required under the Endangered
Species Act (ESA) 5, 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 intends to consider endocrine
effects pursuant to FFDCA §408(p) 6 as part of the risk characterization of the pesticide
under Registration Review. 7 FFDCA §408(p) 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. Thus, under the EDSP
program two types of data collection authorities allow the Agency to address endocrine
disruptor screening and testing data needs: 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.
2249.03 and approved under OMB Control No. 2070-0176. As such, the issuance of
408(p) orders for Registration Review chemicals is not currently covered by this ICR.
7 USC 136a(g)
71 FR 45719, August 9, 2006.
Public Law 112-177- September 28, 2012, 112th Congress (126 Stat. 1327)
16 USC 1531 et seq. For information about the ESPP, go to http://www.epa.gov/espp/.
21 USC 346a(p).
For information about the EDSP, go to http://www.epa.gov/scipoly/oscpendo/index.htm.
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November 26, 2012
C. Special Review Program
Though it does not occur often, the Special Review process is set in motion when EPA has
reason to believe that the continued use of a registered pesticide may result in unreasonable
adverse effects to people or the environment. The criteria for initiating a Special Review, which
are found in 40 CFR 154.7, include the following:
• Acute toxicity to humans or domestic animals.
• Potential chronic or delayed toxic effects in humans.
• Potential hazards to non-target organisms.
• Risk to the continued existence of any threatened or endangered species.
• Risk of destruction or other adverse modification of a critical habitat of any threatened or
endangered species.
• Any other adverse effect to humans or the environment which may outweigh the benefits
that justify initial or continued registration.
Should data and information be needed as part of Special Review, EPA may use the authority in
FIFRA §3(c) (2) (B) to issue a DCI to obtain the necessary data. 8
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 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
8
For additional information about Special Review, go to http://www.epa.gov/oppsrrd1/special_review/index.htm.
3
November 26, 2012
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 1980's 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” 9 see Attachment 1). Based on feedback received, EPA concluded that this
approach appears 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.
In summary, 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 for 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.
9 This document was originally published as Attachment G to a DCI ICR renewal document posted under the docket
identification #EPA-HQ-OPP-2007-0923-0005. See Regulations.gov
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November 26, 2012
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
This approach assumes and incorporates the following core considerations:
(1) Recipients generate all of the data as specified in the DCI and without any changes.
(2) All data generation is performed by an independent laboratory.
(3) Paperwork burden is disaggregated by labor category as follows:
a. Managerial (20%)
b. Technical (65%)
c. Clerical (15%)
(4) Labor rates are fully loaded, meaning that they include the estimated costs of wages,
overhead, and benefits paid to an employee.
Note that 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 of such instances, see
Appendix B.
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. The formulas used to estimate the labor rates and formulas
used to derive the fully loaded rates and overhead costs for the new ICR renewal 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 2012 base data.
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November 26, 2012
Unloaded
Wage Rate
Wages are estimated for labor types (management, technical, and clerical)
within applicable sectors. The Agency uses average wage data for the relevant
sectors available in the National Industry-Specific Occupational Employment
and Wage Estimates from the Bureau of Labor Statistics (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 43% 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 43% 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 (ICs) Groups are a way of categorizing similar DCI requests into
subprogram groupings. EPA currently uses 12 IC Groups which are outlined in Table 2. In the
previous DCI ICR, IC Group, “DCIs for Enforcement and Unanticipated Incidents” was included
but EPA plans to remove this group in future ICRs because EPA has not issued and does not
foresee issuing any DCIs for this category. Detailed information about the specific IC program
groups is in Section 1: Programs Involving Data Call-ins.
Table 2: Information Collection (IC) Groups by Program
IC Group
Program
1. Reregistration DCIs: Confirmatory Data
2. Reregistration: Voluntarily Submitted Data
(Low Burden Studies)
3. Reregistration: Voluntarily Submitted Data
(High Burden Studies)
4. Reregistration DCIs: Product Specific Data
5. Special Review DCIs
6. Registration Review DCIs
7. Registration Review: Voluntarily Submitted Data
(Low Burden Studies)
8. Registration Review: Voluntarily Submitted Data
Reregistration Program
Special Review Program
Registration Review
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November 26, 2012
IC Group
(High Burden Studies)
9. Anticipated Residue DCIs: Base Set of Data
Program
10. Anticipated Residue DCIs: Verification of Use Data
11. Anticipated Residue DCIs: Updated Public Source
Monitoring Data
12. DCIs for Percent Crop Treated Estimates
Tolerance Assessment Program
(Anticipated Residue/Percent
Crop Treated)
Section III: Redefining the DCI Recipient Groups to Better Define Paperwork Burden
The Agency is redefining the DCI recipient groups to better classify the activities and burdens
associated with each group. While each DCI involves the same basic paperwork activities, which
are grouped into the following three information collection categories for purposes of presenting
the burden and costs in this ICR, the burden associated with each group can be very different.
The groups are:
1. DCI Recipients
2. Data Generators
3. 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 registrant 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. Not all DCI
recipients will generate data in response to a DCI. The DCI recipient is assumed to be involved
in the four activities listed in Table 3. The burden for dDCI recipients will be lower than the
burden estimates for the data generation group.
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 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 generator
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 to generate one
set of data and participate in a consortium or task force. Generally, the Agency calculations for
these paperwork burdens are accounted for as part of the 35% of the cost of generating studies. 10
10 As part of the 2007 methodology, the Agency identified three response phases: Phase 1: the initial response;
Phase 2: data generation and Phase 3: data submission to EPA. The Phase 1, Phase 2 and Phase 3 response activity
burden hours and costs are accounted for as subsets of the paperwork burden estimates for information collection
activities that are related to generating data to respond to a DCI. These burdens are accounted for as part of the 35%
of the test burden and cost.
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November 26, 2012
However, in addition to the cost of data generation, consortium participants are subject to costs
associated with operating a consortium or task force (e.g., communication, attending meetings,
etc.). Thus, consortium participants are also assumed to be involved in the four consortium
activities listed in Table 3.
Table 3: New Recipient Groups - Collection Activities and Corresponding Collection
Category.
DCI Recipient
Collection Activity
Collection Category
1) Read Instructions
2) Plan Activities
3) Complete Paperwork
4) Store/maintain Data
Reporting
Recordkeeping
Data Generator
Collection Activity
Collection Category
1) Read and discuss test requirements
2) Discuss test and protocol with Agency
3) Plan activities
4) Create information
Reporting
5) Gather information
6) Process, compile, review information for
accuracy
7) Complete written forms
8) Record, disclose, display information
Recordkeeping
9) Store, file, or maintain information
Consortium Participants
Collection Activity
Collection Category
1) Negotiate/establish consortium/task force
agreements
Reporting
2) Participate in consortium discussions
3) Plan logistics for calls or meetings
Recordkeeping
4) Store/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
8
November 26, 2012
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 must 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 request 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 request 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 - The paperwork burden and costs for data generators are based in part on the
average cost for 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
(managerial, technical, and clerical), the disaggregated paperwork burden costs are multiplied by
their corresponding labor wage rates ($/hr). As mentioned previously, some DCIs do not follow
the Agency’s methodology of paperwork being 20%-65%-15% Managerial-Technical-Clerical as
certain 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 request. EPA understands that this assumption
may not be accurate and solicits industry input to clarify this assumption.
EPA expects to issue approximately 120 DCIs annually over the next three years that will require
data generation. This is nearly all of the 122 companies that are data recipients annually. This
estimate for data generators does not include voluntarily submitted data as they are not DCIs
(i.e., IC Groups 2, 3, 7, and 8 in Table 4 are excluded from this estimate).
Consortium Participants - Although consortium members encumber burden from consortium
activities, the cost savings from avoiding study generation are expected to far exceed the burden
from such activities. Furthermore, 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. 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 burden incurred by a recipient who
chooses to submit their DCI data independently. In this case, the burden per consortium member
would be equal to that in Table 5 for DCI Generators. EPA is currently requesting additional
9
November 26, 2012
information from industry to better understand costs incurred by consortium participants and has
left a placeholder for consortium burden in Tables 5 and 6.
The breakdown of the regulatory decisions for DCIs that EPA expects to make over the next
three years is as follows:
Table 4: Estimated Number of DCIs by IC Group
Total DCIs
1-Year
Period*
Total DCIs
3-Year
Period*
Reregistration DCIs: Confirmatory Data
23.7
71
Reregistration: Voluntarily Submitted Data
(Low Burden Studies)
Reregistration: Voluntarily Submitted Data
(High Burden Studies)
0.3
1
4
Reregistration DCIs: Product Specific Data
20.3
61
5
Special Review DCIs
0.3
1
6
Registration Review DCIs
92.3
277
Registration Review: Voluntarily Submitted Data
(Low Burden Studies)
Registration Review: Voluntarily Submitted Data
(High Burden Studies)
0.3
1
Anticipated Residue DCIs: Base Set of Data
0.3
1
0.3
1
0.3
1
0.3
1
119.3
358
0.7
2
IC Number
1
2
3
7
8
9
10
11
12
IC Group
Anticipated Residue DCIs: Verification of Use
Data
Anticipated Residue DCIs: Updated Public
Source Monitoring Data
DCIs for Percent Crop Treated Estimates
Total DCIs*
Total Voluntarily Submitted Data
* Counts for IC Groups 2, 3, 7, and 8 are for voluntarily submitted data—i.e., they are not DCIs.
Therefore, the total DCI count does not include these estimates.
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November 26, 2012
A. DCI-Related Respondent Burden and Cost Estimates
Tables 5 and 6 provide information on the burden and costs faced by DCI recipients, DCI data
generators, and DCI consortiums. Respondent costs are based on managerial, technical and
clerical wage rates estimated at $117.54, $62.58, and $37.33 per hour, respectively. These wage
rates are based on 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 burden and cost to these three groups per company of DCI—that is, for data
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 companies for each DCI. As mentioned, EPA is currently requesting
additional information from industry to better understand costs incurred by consortium
participants and therefore has a placeholder for consortium burden in Tables 5 and 6.
Table 5: Estimated Common DCI-Related Annual Respondent Burden and Costs per
Company/DCI*
Clerical
Activity Category
Hrs.
Technical
$37.33/hr.
Hrs.
Manager
$62.58/hr.
Hrs.
$117.54/hr.
Burden
(hrs)
Totals
Costs ($)
IC Category – DCI Recipients
Reporting
3
$112
0
$0
7.5
$882
11.5
$994
Recordkeeping
1
$37
0
$0
0
$0
1
$37
IC Category – Data Generators
Reregistration Program DCIs
1) Confirmatory DCIs
Reporting
962
$35,909
4,662
$291,760
620
$72,892
6,244
$400,561
Recordkeeping
842
$31,420
0
$0
144
$16,880
985
$48,301
146
$5,458
709
$44,348
93
$10,927
948
$60,734
128
$4,776
$0
23
$2,718
151
$7,494
2) Product Specific DCIs
Reporting
Recordkeeping
0
3) Reregistration: Voluntarily Submitted Low Burden Studies
Reporting
88
$3,300
428
$26,814
57
$6,699
574
$36,813
Recordkeeping
77
$2,888
0
$0
13
$1,551
91
$4,439
4) Reregistration: Voluntarily Submitted High Burden Studies
Reporting
549
$20,495
2,661
$166,523
349
$40,976
3,559
$227,994
Recordkeeping
480
$17,933
0
$0
87
$10,262
568
$28,195
Special Review and Registration Review DCIs
5) Special Review DCIs
Reporting
137
$5,127
666
$41,655
88
$10,295
891
$57,077
4Recordkeeping
120
$4,486
0
$0
21
$2,521
142
$7,007
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November 26, 2012
Clerical
Activity Category
Hrs.
Technical
$37.33/hr.
Manager
Hrs.
$62.58/hr.
Hrs.
$117.54/hr.
Burden
(hrs)
Totals
Costs ($)
6) Registration Review DCIs
Reporting
3,688
$137,662
17,873
$1,118,502
2,340
$275,009
23,901
$1,531,173
Recordkeeping
3,227
$120,454
0
$0
588
$69,145
3,815
$189,599
7) Registration Review: Voluntarily Submitted Low Burden Studies
Reporting
88
$3,300
428
$26,814
57
$6,699
574
$36,813
Recordkeeping
77
$2,888
0
$0
13
$1,551
91
$4,439
8) Registration Review: Voluntarily Submitted High Burden Studies
Reporting
549
$20,495
2,661
$166,523
349
$40,976
3,559
$227,994
Recordkeeping
480
$17,933
0
$0
87
$10,262
568
$28,195
Anticipated Residue/Percent Crop Treated DCIs
9) AR DCIs: Base Set of Data
Reporting
2
$75
13,624
$852,590
9
$1,058
13,635
$853,722
Recordkeeping
1
$37
0
$0
0
$0
1
$37
10) AR DCIs: Verification-of-use Data
Reporting
8
$299
32
$2,003
28
$3,291
68
$5,592
Recordkeeping
1
$37
0
$0
0
$0
1
$37
11) AR DCIs: Updated Public Source Monitoring Data
Reporting
8
$299
100
$6,258
28
$3,291
136
$9,848
Recordkeeping
1
$37
0
$0
0
$0
1
$37
12) DCIs for Percent Crop Treated Estimates
Reporting
2
$75
53
$3,317
3
$353
58
$3,744
Recordkeeping
1
$37
0
$0
0
$0
1
$37
IC Category – Consortium Participants
TBD
Reporting
Recordkeeping
Third Party
Disclosure Activities
TBD
Estimates outlined above represent the maximum paperwork burden that a consortium participant is
expected to face.
* 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 and B.
Table 6 presents the total annual respondent burden hours for data recipients, data generators,
and consortium members (excluding voluntary data submissions). These calculations reflect
recordkeeping, reporting, and total burden numbers for each IC group universe. Refer to
Appendices A and B 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 data recipients. Tables in Appendix B
provide the same information for data generators by IC group. Total bottom-line paperwork
12
November 26, 2012
burden is estimated at 2,758,896 burden hours which equates to $171,333,146 in paperwork
burden costs. Of this, 1,403 burden hours ($125,782) are incurred by the entire universe of data
recipients.
13
Table 6: Summary of Annual DCI Paperwork Burdens and Costs
Burden Hours
Data Recipients (Table A-1_
Data Generators
Reregistration Program DCIs
Confirmatory DCIs (Table B-1)
Product Specific DCIs (Table B-4)
Voluntarily Submitted Low Burden Studies (Table B-2)
Voluntarily Submitted High Burden Studies (Table B-3)
Special Review and Registration Review DCIs
Special Review DCIs (Table B-5)
Registration Review DCIs (Table B-6)
Registration Review: Voluntarily Submitted Low
Burden Studies (Table B-7)
Registration Review: Voluntarily Submitted High
Burden Studies (Table B-8)
Anticipated Residue/Percent Crop Treated DCIs
AR DCIs: Base Set of Data (Table B-9)
AR DCIs: Verification-of-use Data (Table B-10)
AR DCIs: Updated Public Source Monitoring Data
(Table B-11)
DCIs for Percent Crop Treated Estimates (Table B-12)
DCI Data Generator Total
Costs
Reporting
Recordkeeping
1,281
122
1,403
$121,227
$4,554
$125,782
147,781
19,273
191
1,186
23,319
3,072
30
189
171,100
22,345
221
1,375
$9,479,935
$1,234,916
$12,271
$75,998
$1,143,113
$152,387
$1,480
$9,398
$10,623,048
$1,387,303
$13,751
$85,396
297
2,206,818
47
352,252
344
2,559,070
$19,026
$141,378,303
$2,336
$17,506,330
$21,361
$158,884,633
191
30
221
$12,271
$1,480
$13,751
1,186
189
1,375
$75,998
$9,398
$85,396
4,545
23
0.3
0.3
4,545
23
$284,574
$1,864
$12
$12
$284,587
$1,877
45
0.3
46
$3,283
$12
$3,295
19
2,378,801
0.3
378,691
20
2,757,493
$1,248
$152,403,149
$12
$18,804,215
$1,260
$171,207,364
TBD
TBD
2,758,896
$152,524,376
Consortium Members
TBD
Total Annual Burden
2,380,082
TBD
378,813
Total
Reporting
Recordkeeping
TBD
$18,808,769
Total
TBD
$171,333,146
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 A and 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 are
expected for 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 2014 to 2017.
EPA has made the assumption that the annual average is the three-year average of
companies receiving DCIs with a final due date in 2014-2016, which is 215 annually.
Annual burden and costs is estimated at 11.5 hours or $1,031 for each DCI recipient; with
122 companies receiving DCIs annually, the total annual burden is 1,403 hours or
$125,782.
Table A-1: Annual Burden and Costs per DCI Recipients
Burden Hours
Total
Mgmt.
Tech.
Cler.
Hours Costs
Activity
($117.54) ($62.58) ($37.33)
7.0
0.0
0.0
7.0
$822
1) Read
Instructions
0.0
0.0
0.5
$59
2) Plan Activities 0.5
0.0
0.0
3.0
3.0
$111
3) Complete
Paperwork
0.0
1.0
1.0
$37
4) Store/maintain 0.0
Data
7.5
0.0
4.0
11.5
$1,031
5) Totals
Estimated Total Burden & Costs Across all DCI Recipients:
Reporting (Collection Activities 1-3):
Burden: 10.5 hours per response x 122 responses = 1,281 burden hours.
Costs: $993.67 per response x 122 responses = $121,227
Recordkeeping (Collection Activity 4):
Burden: 1 hour per response x 122 responses = 122 burden hours
Costs: $37.33 per response x 122 responses = $4,554
Total (Reporting + Recordkeeping):
Burden: 11.5 hours per response x 122 responses = 1,403 burden hours
Costs: $1,031 per response x 122 responses = $125,782
* 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 Respondent Burden – Reregistration
Over the next three years, EPA expects to issue 123 reregistration DCIs and 9 import
tolerances for confirmatory and product specific data; a maximum of one voluntarily data
submission is expected to be received by the Agency. This is a substantial decrease from
previous DCI estimates as the reregistration process is switching over to registration
review; however, EPA’s Antimicrobials Division in the Office of Pesticide Programs still
has several chemicals that are subject to reregistration which accounts for a majority of
the reregistration DCIs to be issued.
Section B-1.1: Paperwork Burden Related to the Submission of Confirmatory Data
Reregistration
Confirmatory data are required of registrants to complete registrant databases and to
assist in the evaluation of risk findings. For DCIs involving confirmatory studies, EPA
assumes that only one respondent will provide the data requested. The total cost for the
most burdensome confirmatory data DCI that the EPA has issued in the past three years
was $1,282,460. The paperwork cost associated with this (35% of the total cost) is
$448,861 or 7,230 total burden hours. EPA expects to issue 71 confirmatory DCIs over
the next three years, which is an average of 23.7 confirmatory DCIs annually. Total
annual burden across all Confirmatory Data DCIs is 171,100 burden hours or
$10,623,048. See Table B-1 below for burden activity details.
Table B-1: Annual Respondent Burden per DCI Involving Confirmatory Studies
Collection Activity
1. Read and discuss test
requirements
2. Discuss test and protocol
with Agency
3. Plan activities
4. Create information
5. Gather information
6. Process, compile, review
information for accuracy
Mgmt.
($117.54)
Tech.
Cler.
($62.58) ($37.33)
78
0
0
39
157
118
0
72
72
3,584
360
0
0
721
0
228
575
0
Total
Hours
78
Costs
$9,207
111
$9,104
229 $22,915
4,422 $265,000
360 $22,501
804
$62,856
16
Collection Activity
7. Complete written forms
8. Record, disclose, display
information
9. Store, file, or maintain
information
Total
Mgmt.
($117.54)
Tech.
Cler.
($62.58) ($37.33)
Total
0
0
240
Hours
240
72
0
481
553
72
764
0
4,662
361
1,804
Costs
$8,977
$26,395
433 $21,906
7,230 $448,861
Estimated Total Annual Burden & Costs Across All Confirmatory Study DCI Data
Generators:
Reporting (Collection Activities 1-7):
Burden: 6,244 hours per response x 1 response per DCI x 23.7 DCIs = 147,781 burden hours.
Costs: $400,561 per response x 1 response per DCI x 21.7 DCIs = $9,479,935.
Recordkeeping (Collection Activities 8-9):
Burden: 985 hours per response x 1 response per DCI x 23.7 DCIs = 23,319 burden hours.
Costs: $48,301 per response x 1 response per DCI x 23.7 DCIs = $1,143,113.
Total (Reporting + Recordkeeping):
Burden: 7,230 hours per response x 1 response per DCI x 23.7 DCIs = 171,100 burden hours.
Costs: $448,861 per response x 1 response per DCI x 23.7 DCIs = $10,623,048.
* 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
Submission of voluntary data consist of studies not required by the Agency but are
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 low 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.
Given that there have been no recent voluntary submissions under reregistration, the
Agency used the burden hour cost calculated in the previous DCI ICR—adjusted for
wage rate changes—to back 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 estimate. Updating
for 2012 labor wage rates, the 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 664 to 4,126 burden hours, or $41,252 to $256,189
per voluntary submission. Since only one submission is expected every three years, the
expected range of potential annual burden from a voluntary submission is 221 to 1,375
burden hours or $13,751 to $85,396 in burden cost.
17
Table B-2. Annual Respondent Burden per Submission of Voluntary Studies (Low
Burden)
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54) ($62.58) ($37.33)
Hours
Costs
1. Read and discuss test
requirements
7
0
0
7
$846
2. Discuss test and
protocol with Agency
4
7
0
10
$837
3. Plan activities
14
7
0
21 $2,106
4. Create information
11
329
66
406 $24,355
5. Gather information
0
33
0
33 $2,068
6. Process, compile,
review information for
accuracy
21
53
0
74 $5,777
7. Complete written
forms
0
0
22
22
$825
8. Record, disclose,
display information
7
0
44
51 $2,426
9. Store, file, or maintain
information
7
0
33
40 $2,013
Total
70
428
166
664 $41,252
Estimated Total Annual Burden & Costs Across All Voluntary Low Burden Studies:
Reporting (Collection Activities 1-7):
Burden: 574 hours per response x 1 response per DCI x 0.33 DCIs = 191 burden hours.
Costs: $36,813 per response x 1 response per DCI x 0.33 DCIs = $12,271.
Recordkeeping (Collection Activities 8-9):
Burden: 91 hours per response x 1 response per DCI x 0.33 DCIs = 30 burden hours.
Costs: $4,439 per response x 1 response per DCI x 0.33 DCIs = $1,480.
Total (Reporting + Recordkeeping):
Burden: 664 hours x 1 response x 0.33 submissions = 221 hours
Costs: $41,252 x 1 response x 0.33 submissions = $13,751
* Numbers may not add due to rounding. Please refer to text for information on calculations
presented in this table.
Table B-3. Annual Respondent Burden per Submission of Voluntary Studies (High
Burden)
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54) ($62.58) ($37.33)
Hours
Costs
1. Read and discuss test
requirements
44
0
0
44
$5,131
2. Discuss test and
protocol with Agency
22
41
0
63
$5,134
3. Plan activities
87
41
0
128 $12,830
18
Collection Activity
4. Create information
5. Gather information
6. Process, compile,
review information for
accuracy
7. Complete written
forms
8. Record, disclose,
display information
9. Store, file, or maintain
information
Total
Total
Hours
Costs
2,523 $151,064
205 $12,842
Mgmt.
($117.54)
65
0
Tech.
($62.58)
2,045
205
Cler.
($37.33)
412
0
130
328
0
459
$35,869
0
0
137
137
$5,124
44
0
275
318
$15,378
44
436
0
2,661
206
1,029
250 $12,817
4,126 $256,189
Estimated Total Annual Burden & Costs Across All Voluntary High Burden Studies:
Reporting (Collection Activities 1-7):
Burden: 3,559 hours per response x 0.33 submissions = 1,186 burden hours.
Costs: $227,994 per response x 0.33 submissions = $75,998.
Recordkeeping (Collection Activities 8-9):
Burden: 568 hours per response x 0.33 submissions = 189 burden hours.
Costs: $28,195 per response x 0.33 submissions = $9,398.
Total (Reporting + Recordkeeping):
Burden: 4,126 hours x 1 response x 0.33 submissions = 1,375 hours
Costs: $256,189 x 1 response x 0.33 submissions = $85,396
* 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 61 Product-Specific DCIs (PDCIs) will be called-in over the next
three years (20.3 annually) and that each PDCI 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 updated 2007 EPA
burden estimate methodology, the paperwork cost associated with this (35% of the total
cost) is $68,228 or 1,099 burden hours. Total annual paperwork burden across all
PDCI’s is 22,345 burden hours or $1,387,303. See Table B-4 below for burden activity
details.
19
Table B-4. Annual Respondent Burden Estimates per Product Specific DCI
Collection Activity
Mgmt.
Tech.
Cler.
Total
($117.54)
($62.58) ($37.33) Hours
Costs
1. Read and discuss test 12
0
0
12
$1,359
requirements
2. Discuss test and
6
11
0
17
$1,377
protocol with Agency
3. Plan activities
23
11
0
34
$3,402
4. Create information
17
545
110
672
$40,234
5. Gather information
0
55
0
55
$3,420
6. Process, compile,
35
87
0
122
$9,577
review information for
accuracy
7. Complete written
0
0
37
37
$1,365
forms
8. Record, disclose,
12
0
73
85
$4,088
display information
9. Store, file, or
12
0
55
66
$3,406
maintain information
Total
116
709
274
1,099
$68,228
Estimated Total Annual Burden & Costs Across All Product-Specific DCI Data
Generators:
Reporting (Collection Activities 1-7):
Burden: 948 hours per response x 1 response per DCI x 20.3 DCIs = 19,273 burden hours.
Costs: $60,734 per response x 1 response per DCI x 20.3 DCIs = $1,234,916.
Recordkeeping (Collection Activities 8-9):
Burden: 151 hours per response x 1 response per DCI x 20.3 DCIs = 3,072 burden hours.
Costs: $7,494 per response x 1 response per DCI x 20.3 DCIs = $152,387.
Total (Reporting + Recordkeeping):
Burden: 1,099 hours per response x 1 response per DCI x 20.4 DCI = 22,345 burden hours.
Costs: $68,228 per response x 1 response per DCI x 20.3 DCI = $1,387,303.
Numbers may not add due to rounding. Please refer to text for information on calculations
presented in this table.
Section B-2: Estimating Respondent Burden – Special Review
Special Reviews, though rare, are conducted when the Agency determines such a review
is warranted. In the Special Review Program, EPA focuses on specific hazards or uses of
a pesticide. Special Reviews are not intended to be comprehensive evaluations of the
pesticide; instead, the DCIs address specific hazard or exposure concerns.
Over a three-year ICR approval period, one response is expected. Since the Agency has
not requested a Special Review in recent history, no high-end estimates could be obtained
to represent the upper bound burden estimate for a DCI associated with this IC Group.
Instead, the Agency used the burden hour cost calculated in the previous DCI ICR—
20
adjusted for wage rate changes—to back out the proportional burden hour estimates for
each of the three labor groups (i.e., 20% managerial, 65% technical, 15% clerical). Total
DCI test cost is estimated at $183,097 when adjusting for 2012 wage rates, making the
total DCI paperwork burden $64,084 (1,032 burden hours) per DCI when assuming
paperwork burden is 35% of total DCI burden. With only one DCI expected every three
years, this equates to a total annual paperwork burden of 344 burden hours or
$21,361annually across all Special Review DCIs. Table B-6 details the estimated annual
respondent burden hours and costs for Special Review DCIs.
Table B-6: Estimated Annual Burden Hours and Cost Estimates for Special Review
DCIs per Respondent
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54)
($62.58)
($37.33) Hours Costs
1. Read and discuss test
requirements
11
0
0
11 $1,261
2. Discuss test and protocol
with Agency
5
10
0
16 $1,273
3. Plan activities
0
10
0
10
$642
4. Create information
22
512
103
637 $38,454
5. Gather information
17
51
0
68 $5,173
6. Process, compile, review
information for accuracy
0
82
0
82 $5,140
7. Complete written forms
33
0
34
67 $5,134
8. Record, disclose, display
information
0
0
69
69 $2,563
9. Store, file, or maintain
information
21
0
52
73 $4,444
109
665
258 1,032 $64,084
Total
Estimated Total Annual Burden & Costs Across All Special Review DCI Data Generators:
Reporting (Collection Activities 1-7):
Burden: 891 hours per response x 1 response per DCI x 0.33 DCIs = 297 burden hours
Costs: $57,077 per response x 1 response per DCI x 0.33 DCIs = $19,026
Recordkeeping (Collection Activities 8-9):
Burden: 142 hours per response x 1 response per DCI x 0.33 DCIs = 47 burden hours
Costs: $7,007 per response x 1 response per DCI x 0.33 DCIs = $2,336
Total (Reporting + Recordkeeping):
Burden: 1,032 hours per response x 1 response per DCI x 0.33 DCI = 344 burden hours
Costs: $64,084 per response x 1 response per DCI x 0.33 DCI = $21,361
* Numbers may not add due to rounding.
21
Section B-3: Estimating the Respondent Burden – Registration Review Program
Data that is submitted under the Registration Review Program includes that 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 estimated total cost for all studies requested under the most burdensome registration
review DCI that EPA has issued in the past three years was $4,916,432. The paperwork
cost associated with this (35% of the total cost) was $1,720,772 or 27,716 total burden
hours. EPA expects to issue 277 Registration Review DCIs over the next three years,
which equals an average of 92 registration review DCIs annually. See Table B-7 below
for burden activity details. Across all Registration Review DCIs, this would be
$158,884,633 annually or 2,559,070 burden hours.
Table B-7: Estimated Annual Respondent Burden Hours and Costs for Registration
Review DCIs
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54)
($62.58)
($37.33) Hours
Costs
1. Read and discuss test
requirements
294
0
0
294
$34,573
2. Discuss test and
protocol with Agency
147
276
0
423
$34,538
3. Plan activities
588
276
0
864
$86,397
4. Create information
441
13,738
2,766 16,945 $1,014,828
5. Gather information
0
1,378
0 1,378
$86,260
6. Process, compile,
review information for
accuracy
869
2,205
0 3,074
$240,162
7. Complete written
forms
0
0
922
922
$34,415
8. Record, disclose,
display information
294
0
1,844 2,138
$103,403
9. Store, file, or maintain
information
294
0
1,383 1,677
$86,196
2,928
17,873
6,914 27,716 $1,720,772
Total
Estimated Total Annual Burden & Costs Across All Registration Review DCI Data
Generators:
Reporting (Collection Activities 1-7):
Burden: 23,901 hours per response x 1 response per DCI x 92.33 DCIs = 2,206,818 burden hours
Costs: $1,531,173 per response x 1 response per DCI x 92.3 DCIs = $141,378,303
Recordkeeping (Collection Activities 8-9):
Burden: 3,815 hours per response x 1 response per DCI x 92.33 DCIs = 352,252 burden hours
Costs: $189,599 per response x 1 response per DCI x 92.3 DCIs = $17,506,330
22
Total (Reporting + Recordkeeping):
Burden: 27,716 hours per response x 1 response per DCI x 92.33 DCIs = 2,559,070 burden hours
Costs: $1,720,772 per response x 1 response per DCI x 92.33 DCIs = $158,884,633
* Numbers may not add due to rounding.
Section B-3.2: Estimating the Respondent Burden – Registration Review: Voluntary
Submission of Data
Given that the Agency has completed all Reregistration Eligibility Decisions (REDs),
voluntary data submissions to the EPA are now being received under the Registration
Review Program. The Agency has provided high and low burden estimates as the
expected cost of voluntarily submitted data is variable in nature.
Since no data is available on the burden per submission for voluntary data under
Registration Review, burden hours and cost were adopted from estimates for voluntary
data under Reregistration Review. The method used for Reregistration Review burden
calculations used the burden hour cost calculated in the previous DCI ICR—adjusted for
wage rate changes—to back out the proportional burden hour estimates for each of the
three labor groups (i.e., 20% managerial, 65% technical, 15% clerical). Updating for
2012 labor wage rates, the total test 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 664 to 4,126 burden hours, or $41,252 to $256,189 per
voluntary submission. This method was used both for low and high burden voluntary
submission burden hour estimates. See Tables B-8 and B-9 for details.
Table B-8: Estimated Annual Respondent Burden Hours and Costs for Registration
Review: Voluntarily Submitted Data (Low Burden)
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54)
($62.58)
($37.33) Hours Costs
1. Read and discuss test
requirements
7
0
0
7
$846
2. Discuss test and protocol
with Agency
4
7
0
10
$837
3. Plan activities
14
7
0
21 $2,106
4. Create information
11
329
66
406 $24,355
5. Gather information
0
33
0
33 $2,068
6. Process, compile, review
information for accuracy
21
53
0
74 $5,777
7. Complete written forms
0
0
22
22
$825
8. Record, disclose, display
information
7
0
44
51 $2,426
9. Store, file, or maintain
information
7
0
33
40 $2,013
70
428
166
664 $41,252
Total
23
Estimated Total Annual Burden & Costs Across All Registration Review Voluntary Low
Burden Studies:
Reporting (Collection Activities 1-7):
Burden: 574 hours per response x 0.33 submissions = 191 burden hours.
Costs: $36,813 per response x 0.33 submissions = $12,271.
Recordkeeping (Collection Activities 8-9):
Burden: 91 hours per response x 0.33 submissions = 30 burden hours.
Costs: $4,439 per response x 0.33 submissions = $1,480.
Total (Reporting + Recordkeeping):
Burden: 664 hours x 0.33 submissions = 221 hours
Costs: $41,252 x 0.33 submissions = $13,751
* Numbers may not add due to rounding.
Table B-9: Estimated Annual Respondent Burden Hours and Costs for Registration
Review: Voluntarily Submitted Data (High Burden)
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54)
($62.58)
($37.33) Hours
Costs
1. Read and discuss test
requirements
44
0
0
44
$5,131
2. Discuss test and
protocol with Agency
22
41
0
63
$5,134
3. Plan activities
87
41
0
128 $12,830
4. Create information
65
2,045
412 2,523 $151,064
5. Gather information
0
205
0
205 $12,842
6. Process, compile,
review information for
accuracy
130
328
0
459 $35,869
7. Complete written forms
0
0
137
137
$5,124
8. Record, disclose,
display information
44
0
275
318 $15,378
9. Store, file, or maintain
information
44
0
206
250 $12,817
436
2,661
1,029 4,126 $256,189
Total
Estimated Total Annual Burden & Costs Across All Registration Review Voluntary High
Burden Studies:
Reporting (Collection Activities 1-7):
Burden: 3,559 hours per response x 0.33 submissions = 1,186 burden hours.
Costs: $227,994 per response x 0.33 submissions = $75,998.
Recordkeeping (Collection Activities 8-9):
Burden: 568 hours per response x 0.33 submissions = 189 burden hours.
Costs: $28,195 per response x 0.33 submissions = $9,398.
Total (Reporting + Recordkeeping):
Burden: 4,126 hours x 0.33 submissions = 1,375 hours
Costs: $256,189 x 0.33 submissions = $85,396
* Numbers may not add due to rounding.
24
Section B-4: Estimating Respondent Burden – Anticipated Residues/Percent Crop
Treated DCIs (AR/PCT)
The Anticipated Residue and Percent Crop Treated (AR/PCT) review programs requires
the Agency to reevaluate of previous Agency decisions regarding the establishment of a
tolerance (maximum residue limit) for pesticide residues on food or feed crops. The law
also requires that tolerance decisions based on ARs or PCT data be verified to ensure that
residues in or on food are not above the residue levels relied on for establishing the
tolerance.
Section B-4.1: Estimating Respondent Burden - Anticipated Residues/Percent Crop
Treated DCIs
There are four IC groups associated with AR/PCT, including:
•
•
•
•
DCI for anticipated residues requiring a base set of data,
DCI for anticipated residues for verification of use data
DCI for anticipated residues collected from publicly available sources, and
DCI for percent crop treated using existing information.
After reevaluating the burden hours from the last DCI ICR, the Agency is not changing
the burden hour estimates. Thus, it does not follow the 20%-65%-15% ManagerialTechnical-Clerical breakout assumption as is typically the case. This is because given the
nature of data requests that occur in an AR/PCT DCI, paperwork burden falls
disproportionately on technical labor, i.e., 72%-99% technical labor versus the standard
65% technical labor—with the exception of anticipated residues verification of use data,
where paperwork burden disproportionately falls on management (approximately 40%
managerial labor versus the standard 20% managerial labor).
Furthermore, the previous collection activities associated with the AR/PCT DCIs are less
detailed than collection activities associated with different IC groups. The Agency has
altered these less defined groupings to coordinate with the collection activities associated
with other IC groups. Table B-11 provides a breakdown of how these categories
compare.
Table B-11: Change in Collection Activity Groupings for Anticipated
Residues/Percent Crop Treated DCIs
Previous Collection Activity Groupings
New Collection Activity Groupings for
for AR/PCT DCI IC Groupings
AR/PCT DCI IC Groupings
1. Read and discuss test requirements
1. Read Instructions
2. Discuss test and protocol with Agency
2. Plan Activities
3. Plan activities
3. Create Information
4. Create information
4. Gather Information
5. Gather information
25
Previous Collection Activity Groupings
for AR/PCT DCI IC Groupings
5. Compile and Review
6. Complete Paperwork
7. Maintain and file
New Collection Activity Groupings for
AR/PCT DCI IC Groupings
6. Process, compile, review information for
accuracy
7. Complete written forms
8. Record, disclose, display information
9. Store, file, or maintain information
The following presents the Agency’s burden estimates for each type of DCI.
Section B-4.2: Anticipated Residue DCIs: Base Set of Data
As explained in Section B-4.1, the Agency is not changing the burden hour estimates for
any of the AR/PCT DCIs from the original (20%-65%-15% Managerial-TechnicalClerical) paperwork burden breakouts breakout. For base set of data, the ManagerialTechnical-Clerical paperwork burden breakout for each type of labor is 0.07%
managerial, 99.91% technical, and 0.02% clerical.
The total test cost for an anticipated residue DCI requiring a base set of data is estimated
at $2,439,314. Respondent burden hours for generating and submitting data in response
to a DCI for anticipated residues requiring a base set of data to be submitted are estimated
at 13,636 burden hours, or $853,760, per response.
In most cases, registrants will be able to get the information from federal and state
monitoring programs, thus the Agency estimates that no more than one registrant might
generate their own monitoring data in response to the DCI every three years which would
result in 4,545 burden hours or $284,587 in costs annually, as shown in B-12.
Table B-12: Anticipated Residue DCIs: Base Set of Data Annual Burden/Cost
Estimates, per DCI
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54)
($62.58)
($37.33) Hours
Costs
1. Read and discuss test
requirements
2. Discuss test and
protocol with Agency
2
0
0
2
$235
3. Plan activities
4
0
0
4
$470
4. Create information
0
13,600
0 13,600 $851,088
5. Gather information
0
16
0
16
$1,001
6. Process, compile,
review information for
accuracy
1
8
0
9
$618
7. Complete written forms
2
0
2
4
$310
26
Collection Activity
8. Record, disclose,
display information
9. Store, file, or maintain
information
Total
Mgmt.
($117.54)
Tech.
($62.58)
0
0
9
13,624
Cler.
($37.33)
1
Total
Hours
Costs
1
$37
3 13,636 $853,760
Estimated Total Annual Burden & Costs Across All Anticipated Residue (Base Set of Data)
DCIs:
Reporting (Collection Activities 1-7):
Burden: 13,635 hours per response x 1 response per DCI x 0.33 DCIs = 4,545 burden hours.
Costs: $853,722 per response x 1 response per DCI x 0.33 DCIs = $284,574.
Recordkeeping (Collection Activities 8-9):
Burden: 1 hour per response x 1 response per DCI x 0.33 DCIs = 0.3 burden hours.
Costs: $37 per response x 1 response per DCI x 0.33 DCIs = $12.
Total (Reporting + Recordkeeping):
Burden: 13,636 hours per response x 1 response per DCI x 0.33 DCIs = 4,545 burden hours.
Costs: $853,760 per response x 1 response per DCI x 0.33 DCIs = $284,587.
* Numbers may not add due to rounding.
Section B-4.3: Anticipated Residue DCIs: Verification of Use Data
As explained in Section B-4.1, the Agency is not changing the burden hour estimates for
any of the AR/PCT DCIs from the original (20%-65%-15% Managerial-TechnicalClerical) paperwork burden breakouts breakout. For verification of use data, the
Managerial-Technical-Clerical paperwork burden breakout for each type of labor is 41%
managerial, 46% technical, and 13% clerical.
The total test cost for an anticipated residue DCI requiring a verification of use data is
estimated at $16,085. The Agency estimates that the verification for updating use
information is 69 burden hours or $5,630 per response and that no more than one
respondent every three years will comply with a DCI by submitting a base set of data for
updating use information, which equates to 23 burden hours annually ($1,877). Refer to
Table B-13 for details.
Table B-13: Anticipated Residue DCIs: Verification of Use Data Annual
Burden/Cost Estimates, per DCI
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54)
($62.58)
($37.33) Hours Costs
1. Read and discuss test
requirements
2. Discuss test and protocol
with Agency
8
0
0
8
$940
3. Plan activities
16
0
0
16 $1,881
27
Collection Activity
4. Create information
5. Gather information
6. Process, compile, review
information for accuracy
7. Complete written forms
8. Record, disclose, display
information
9. Store, file, or maintain
information
Total
Mgmt.
($117.54)
Tech.
($62.58)
Total
Cler.
($37.33) Hours Costs
0
0
$0
0
16 $1,001
0
0
0
16
2
2
16
0
0
8
18 $1,236
10
$534
0
28
0
32
1
9
1
$37
69 $5,630
Estimated Total Annual Burden & Costs Across All Anticipated Residue (Verification of
Use) DCIs:
Reporting (Collection Activities 1-7):
Burden: 68 hours per response x 1 response per DCI x 0.33 DCIs = 23 burden hours.
Costs: $5,592 per response x 1 response per DCI x 0.33 DCIs = $1,864.
Recordkeeping (Collection Activities 8-9):
Burden: 1 hour per response x 1 response per DCI x 0.33 DCIs = 0.3 burden hours.
Costs: $37 per response x 1 response per DCI x 0.33 DCIs = $12.
Total (Reporting + Recordkeeping):
Burden: 69 hours per response x 1 response per DCI x 0.33 DCIs = 23 burden hours.
Costs: $5,630 per response x 1 response per DCI x 0.33 DCIs = $1,877.
* Numbers may not add due to rounding.
Section B-4.4: Anticipated Residue DCIs: Updated Public Source Monitoring Data
As explained in Section B-4.1, the Agency is not changing the burden hour estimates for
any of the AR/PCT DCIs from the original (20%-65%-15% Managerial-TechnicalClerical) paperwork burden breakouts breakout. For updated public source monitoring
data, the Managerial-Technical-Clerical paperwork burden breakout for each type of
labor is 20% managerial, 73% technical, and 7% clerical.
The total test cost for an anticipated residue DCI requiring public source monitoring data
is estimated at $28,242. The average respondent burden for submitting a base set of data
for updating monitoring information is estimated at 137 burden hours or $9,885 per year.
The Agency estimates that an average of one respondent every three years is likely to be
able to comply with a DCI by submitting data from publicly available sources. As such,
the total annual respondent burden for this type of DCI is estimated to be 46 burden hours
($3,295). See Table B-14.
28
Table B-14: Anticipated Residue DCIs: Updated Public Source Monitoring Data
Annual Burden/Cost Estimates, per DCI
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54)
($62.58)
($37.33) Hours Costs
1. Read and discuss test
requirements
2. Discuss test and protocol
with Agency
8
0
0
8
$940
3. Plan activities
16
0
0
16 $1,881
4. Create information
0
0
0
0
$0
5. Gather information
0
60
0
60 $3,755
6. Process, compile, review
information for accuracy
2
40
0
42 $2,738
7. Complete written forms
2
0
8
10
$534
8. Record, disclose, display
information
9. Store, file, or maintain
information
0
0
1
1
$37
28
100
9
137 $9,885
Total
Estimated Total Annual Burden & Costs Across All Anticipated Residue (Public Source
Monitoring Data) DCIs:
Reporting (Collection Activities 1-7):
Burden: 136 hours per response x 1 response per DCI x 0.33 DCIs = 45 burden hours
Costs: $9,848 per response x 1 response per DCI x 0.33 DCIs = $3,283
Recordkeeping (Collection Activities 8-9)
Burden: 1 hour per response x 1 response per DCI x 0.33 DCIs = 0.3 burden hours
Costs: $37 per response x 1 response per DCI x 0.33 DCIs = $12
Total (Reporting + Recordkeeping):
Burden: 137 hours per response x 1 response per DCI x 0.33 DCIs = 46 burden hours
Costs: $9,885 per response x 1 response per DCI x 0.33 DCIs = $3,295
* Numbers may not add due to rounding.
Section B-4.5: DCIs for Percent Crop Treated Estimates
As explained in Section B-4.1, the Agency is not changing the burden hour estimates for
any of the AR/PCT DCIs from the original (20%-65%-15% Managerial-TechnicalClerical) paperwork burden breakouts breakout. For percent crop treated estimates, the
Managerial-Technical-Clerical paperwork burden breakout for each type of labor is 5%
managerial, 90% technical, and 5% clerical.
The estimated total test cost for a DCI requiring percent crop treated estimates is $10,802.
The annual per respondent burden for generating percent crop treated estimates using
existing information is estimated to be 59 burden hours ($3,781). Percent crop treated
estimates are generally conducted within the Agency, and only in rare instances would a
29
registrant need to gather the information; one DCI every three years impacting one
respondent is likely an overestimation. If this were the case, however, the annual burden
estimates is 20 hours or $1,260 in paperwork burden cost. The estimated costs assume
that the cost of purchasing or obtaining percent crop treated information is obtaining data
from existing, contracted data sources. See Table B-15.
Table B-15: DCIs for Percent Crop Treated Estimates Annual Respondent
Burden/Cost Estimates, per DCI
Total
Mgmt.
Tech.
Cler.
Collection Activity
($117.54)
($62.58)
($37.33) Hours Costs
1. Read and discuss test
requirements
2. Discuss test and protocol
with Agency
1
1
0
2
$180
3. Plan activities
0
2
0
2
$125
4. Create information
0
8
0
8
$501
5. Gather information
0
22
0
22 $1,377
6. Process, compile, review
information for accuracy
1
20
0
21 $1,369
7. Complete written forms
1
0
2
3
$192
8. Record, disclose, display
information
9. Store, file, or maintain
information
0
0
1
1
$37
3
53
3
59 $3,781
Total
Estimated Total Annual Burden & Costs Across All Anticipated Residue (Public Source
Monitoring Data) DCIs:
Reporting (Collection Activities 1-7):
Burden: 58 hours per response x 1 response per DCI x 0.33 DCIs = 19 burden hours.
Costs: $3,744 per response x 1 response per DCI x 0.33 DCIs = $1,248.
Recordkeeping (Collection Activities 8-9):
Burden: 1 hour per response x 1 response per DCI x 0.33 DCIs = 0.3 burden hours.
Costs: $37 per response x 1 response per DCI x 0.33 DCIs = $12.
Total (Reporting + Recordkeeping):
Burden: 59 hours per response x 1 response per DCI x 0.33 DCIs = 20 burden hours.
Costs: $3,781 per response x 1 response per DCI x 0.33 DCIs = $1,260.
* Numbers may not add due to rounding.
30
Attachment 1
(Originally Attachment G)
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
Draft Document for Public Review - EPA is releasing this draft document
solely for the purpose of public review and comment. This draft document is
not now, and has not yet been, formally disseminated by EPA. It does not
represent and should not be construed to represent any Agency policy or
determination. Please submit comments to Docket ID # EPA-HQ-OPP-20070923 at www.regulations.gov.
Office of Pesticide Programs
October 2007
31
Contents
SECTION I ............................................................................................................ 3
BACKGROUND .................................................................................................... 3
I. What is the purpose of this document? ........................................................... 3
II. Why does EPA issue DCIs? ........................................................................... 3
III. How do PRA requirements relate to DCIs? ..................................................... 4
IV. How does a DCI recipient respond to a DCI? ................................................. 5
V. DCI burden activities tables ............................................................................ 6
Table 1 ............................................................................................................ 6
Table 2 ............................................................................................................ 7
VI. Variations of the response to a DCI ................................................................ 8
a. Data generation in response to a DCI ..................................................... 8
b. Non-data generation in responses a DCI ................................................ 9
SECTION II ......................................................................................................... 10
ESTIMATING PAPERWORK ACTVITIES OF DATA GENERATION .................. 10
I. What are the key assumptions when estimating PRA burden hours and costs
for data generation? ............................................................................................ 10
a. Paperwork burden is generally 35% of the cost of the study................. 10
b. All registrants generate all DCI data .................................................... 12
II. How are test cost estimates developed? ....................................................... 12
III. What if test cost estimates are unavailable? ................................................. 12
IV. What if the available test cost estimates vary? ............................................. 13
V. What are the steps in calculating the paperwork burden (hours and costs)? 13
a. Calculate test costs. .............................................................................. 13
b. Distribute paperwork activities among labor categories. ....................... 13
c. Calculate paperwork burden hours from labor cost distribution............. 14
VI. Is the burden for those not generating data covered?. ................................ 15
Attachment A: Case Studies: Agency analysis of response costs of non-data
generation .......................................................................................................... 17
1. Study #1 Review of the Application for New and Amended Pesticide
Registration, OMB No. 2070-0060, (EPA ICR No. 0277.14) for non-data
generated burden hours and costs. ........................................................... 17
2. Study #2 Data Generation for Pesticide Reregistration ICR, OMB No.
2070-0107, (EPA ICR No. 1504.05)........................................................... 19
3. Study #3 Economic Analysis for Proposed Changes in Data
Requirements Rule for Biochemical and Microbial Pesticides – Cost
Estimates for Data Waivers........................................................................ 21
Attachment B: FIFRA estimated test cost chart and PRA cost estimates .......... 22
32
Article I.
Section I. Background
I. What is the purpose of this document?
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires federal
agencies to estimate the “paperwork burden” for “information collection”
activities. Under the PRA, “paperwork burden” means the total time, effort, or
financial resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal Agency. Under the PRA, an
“information collection” means any request for information made by a federal
agency of ten or more respondents, and may include a request to report, retain
records, or disclose information to third parties.
This document describes the methodology used by the Environmental Protection
Agency’s (EPA) Office of Pesticide Programs (OPP) to estimate the paperwork
burden hours and costs for stakeholders responding to Data Call-In (DCI)
Notices issued by OPP under section 3(c)(2)(B) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). The methodology is intended to
provide a description of the process used by EPA to derive the estimated
paperwork burden hours and costs associated with submitting a response to EPA
under a DCI. The methodology presented in this document should also enable
stakeholders to reproduce the burden estimates made by the Agency for DCI
related collection activities. This increased transparency will enable the public to
provide more substantive and meaningful feedback during public comment
periods. This feedback will better enable the Agency to periodically amend the
burden estimates. In addition, since the methodology presented here will be
used by the Agency to estimate the paperwork burden for DCI requests, this
document will serve as a reference for such calculations in the future.
•
II. Why does EPA issue DCIs?
With few exceptions, FIFRA requires EPA to evaluate all pesticides marketed
and used in the United States to ensure that they will not pose unreasonable
risks to human health and the environment. Pesticides that meet the
requirements are granted a license or “registration” that permits their distribution,
sale, and use according to specific use directions and requirements identified on
the label. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA
establishes tolerances (defined as maximum allowed pesticide residue levels) to
specify the amount of the pesticide residue that can legally remain in or on food
or animal feed, using a safety standard of a “reasonable certainty of no harm.”
EPA’s review and evaluation of a new, amended, or existing pesticide
registration or tolerance require data of sufficient quality and quantity to
characterize the pesticide’s hazards and the potential risk from its intended uses.
The data requested by the Agency, including the data requested in the DCI, allow
EPA to evaluate whether a pesticide meets the statutory standard for registration,
and allow the Agency to establish the appropriate tolerance(s) for the pesticide
33
under section 408 of the FFDCA.
Under section 3(c) (2) (B) of FIFRA EPA can require pesticide registrants to
generate and submit data to the Agency, when such data are required to
maintain an existing registration of a pesticide. EPA’s determination that
additional data are needed could occur for various reasons, with the following
four reasons being the most common:
•
•
•
•
•
The Reregistration Program: Section 4 of FIFRA requires EPA to reassess 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. Section 4 directs EPA to
use section 3(c) (2) (B) authority to obtain the required data.
The Registration Review Program: Section 3(g) of FIFRA contains
provisions to ensure that each pesticide will be reviewed every 15 years to
ensure that the pesticide continues to pose no risk of unreasonable
adverse effects on human health or the environment. Section 3(g)
instructs EPA to use the section 3(c) (2) (B) authority to obtain the
required data.
The Special Review Program: Though rare, EPA may conduct a Special
Review if EPA believes that a registered pesticide poses risks of
unreasonable adverse effects on human health or the environment.
Section 3(c) (2) (B) of FIFRA provides a means of obtaining any needed
data.
Anticipated Residue/Percent Crop Treated Information: Under
FFDCA, EPA can consider information on the anticipated levels of
pesticide residues in food (the actual levels of pesticide residues that have
been measured in food) and data on the actual percent of food treated
with the pesticide chemical. The Agency must also provide for periodic reevaluation of this information. Under FFDCA section 408(b)(2)(E), EPA
can issue a DCI for information relating to anticipated residues, and under
section 408(b)(2)(F) EPA can issue a DCI for percent crop treated
estimates.
III. How do the PRA requirements relate to DCIs?
The PRA states, “An agency may not conduct or sponsor, and a person is not
required to respond to a “collection of information,” as defined at 5 CFR
1320.3(c), unless the “collection” displays a currently valid control number issued
by the Office of Management and Budget (OMB). 11 EPA’s issuance of a DCI
under FIFRA section 3(c) (2) (B) is subject to the PRA requirements because the
DCI is considered a “collection of information” under the PRA. To comply with
the PRA requirements, EPA must submit an Information Collection Request
11 OMB is part of the Executive Office of the President.
34
(ICR) that provides specific information to OMB about the data that EPA intends
to call in for a given pesticide, including: a list of required studies, the practical
utility of the data, the estimated testing costs, and the estimated paperwork
burden.
Under the PRA, “practical utility” means the actual, not merely the theoretical or
potential, usefulness of information to or for an agency, taking into account its
accuracy, validity, adequacy, and reliability, and the agency's ability to process
the information it collects in a useful and timely fashion. 12 “Burden” means the
time, effort, or financial resources expended by persons to generate, maintain, or
provide information to or for a Federal Agency. 13” including resources to:
•
•
•
•
•
•
•
•
review instructions;
develop, acquire, install, and use technology and systems;
search data sources;
collect, review, validate, and verify information/data;
process and maintain information/data;
disclose and transmit/submit information/data;
change/adjust the existing ways of complying with any previously
applicable instructions and requirements to comply with new
requirements; and/or
train personnel.
IV. How does a DCI recipient respond to a DCI?
Response to a DCI can generally be divided into three phases.
•
•
•
•
Phase 1: Initial response: After receiving a DCI, the recipient has 90
days to provide the initial response, which states how the recipient plans
to comply with the DCI. A registrant may avoid generating the data if he
qualifies for a generic data exemption (i.e., he uses a registered pesticide
as the source of the active ingredient in his own product), cancels the
product’s registration, submits or cites existing data, or requests a waiver.
Phase 2: Data generation: Unless the DCI recipient can cite existing
studies or is granted a waiver by the Agency, the DCI recipient must then
generate the required data.
Phase 3: Data submission: DCI recipient submits the
studies/information to EPA.
V. DCI burden activities tables
Table 1 illustrates the paperwork activities that would typically be performed by a
DCI recipient during each of the three phases. Note that the activities that are
12 5 CFR 1320.3(l)
13 5 CFR 1320.3(b)
35
likely to occur have been divided into three categories of duties: managerial,
technical and clerical. For this table, it was assumed that the data generation
was performed at the request of the DCI recipient by a contract laboratory.
Although DCI recipients can certainly choose to generate the data themselves,
the Agency believes that the assumption used provides a sufficiently
conservative estimate, and does not expect the burden estimate for DCI
recipients to be more than the estimate. Table 1 includes only those duties
performed directly by the DCI recipient.
Table 1 – Response Phases
Managerial Duties
Technical Duties
Clerical Duties
PHASE 1: INITIAL RESPONSE
Read regulations
Read regulations
Complete other
required paperwork
Review EPA’s DCI notice
Review EPA’s DCI
notice
Communicate with EPA
Assist with review of
internal company
information
Plan DCI response
Search for existing
Assist with search for
data
existing data
Sign and send initial
Prepare initial
response forms to EPA
response forms for
submission
Oversight of employee
activities
PHASE 2(a): DATA GENERATION USING CONTRACT LABORATORY
Planning/oversight of
Plan the data collection Complete/file/archive
employee and contract
activities with the
other required
activities
laboratory
paperwork
Make decisions
Electronic data entry
Secure contract lab services Create test protocols
and approve statement of
for SOW
work (SOW)
Communicate with EPA
Ensures contract
laboratory maintains
records and
procedures during
testing period in
accordance with the
Good Laboratory
Practices (GLPs)
Oversight of employee and
Routine contact with
contract activities
testing laboratory
which can include on36
site visits
Analyze interim report
and/or monthly report
Proof draft final report
Generate acceptance
report
PHASE 3: DATA SUBMISSION TO EPA
Sign-off on submission to
Draft summary of the
Prepare submission to
EPA
data for cover letter
EPA
Close-out contract
Oversight of employee
Complete other
Complete/file/archive
activities
required paperwork
other required
paperwork
Table 2 represents the PRA activities conducted at a contract laboratory. Data
are generated by following standard operating procedures, which involve mostly
technical duties. As part of their duties under Good Laboratory Practices (GLP),
the scientists and technicians maintain logbooks and other records from which
the final report is written. This table lists activities that occur in the conduct of
studies where the test subjects are animals. Activities associated with animal
care would not occur in studies where the test subject is inanimate, such as
product chemistry studies, environmental fate studies or residue chemistry
studies.
• Table 2
PHASE 2(b): PRA DATA GENERATION ACTIVITIES CONDUCTED AT THE
CONTRACT LABORATORY*
Technical Duties
Individual animal care records
Records on the rooms in which animals are housed and procedures are
performed
Necropsy records
Equipment logbooks and computer-generated records such as chromatograms
Records on preparation of analytical standards
Freezer and storage area logbooks
Chain-of-custody forms
Quality control/quality assurance forms and review checks for accuracy
Archive and transmittal of data forms
*The Agency recognizes that in certain instances these activities might be
conducted “in-house.”
•
VI. Variations of the response to a DCI
Because there are multiple ways of responding to a DCI, not all DCI recipients
participate in all three phases. A registrant would participate only in phase 1 if
37
they:
•
•
•
•
•
Voluntarily cancel the pesticide registration
Delete the uses of the product to which the requirements apply
Qualify for a generic data exemption
Request and receive a data waiver
Purchase/cite existing data
A registrant who purchases/cites existing data performs Phase 1 Initial response
and Phase 3 Data Submission activities only. The initial response phase and the
data submission phase are considered to have more-or-less fixed hours and
costs since reading the regulations and preparing submissions to the Agency are
independent of the type of information submitted.
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 predict the total cost and burden of developing the data.
This methodology was prepared so that an average burden could be presented
for a DCI recipient, regardless of the response they choose. Clearly, by
assuming that all DCI recipients engage in all three activities the Agency has
chosen to overestimate the burden for a DCI recipient who may not engage in
any activities beyond Phase 1. The cost for DCI recipients who engage in a
taskforce for data generation, voluntarily cancel the product or affected uses,
submit or cite existing data, or are granted a waiver incur fewer burden hours and
costs.
• a. Data generation in response to a DCI
A registrant who chooses to generate data in response to the DCI may either:
•
•
generate and submit the required data on their own, or
generate and submit the required data as part of a taskforce.
Data generation is considered the most expensive of the three phases.
However, the amount of the expense is highly dependent on the type of data
required. Therefore, it is logical to assume that the more expensive the study,
the greater the paperwork burden hours and costs. For a DCI recipient to
generate and submit the required data on their own is the most expensive of the
response scenarios. However, the cost for DCI respondents who pool their
resources for data generation with other stakeholders is less than those who
engage in data generation activities on their own. Therefore, the Agency
encourages cost-sharing agreements among manufacturers of specific pesticide
chemicals to minimize the duplication of laboratory tests conducted in response
to a DCI. DCI notices explain the statutory provisions for cost sharing
agreements for FIFRA.
38
• b. Phase 1 and Phase 3 response activities for data
generaters
Phase I and Phase 3 DCI response activities are a subset of the paperwork
burden hours and costs estimates related to generating data to respond to a DCI
notice. Unlike the wide variation of the costs for data generation, Phase 1 and
Phase 3 response costs are more or less fixed costs. Generally, less than
twenty-five (25) burden hours are spent on these activities at a cost of around
$2,000 (indexed to 2006 dollars). Section II of this document presents a
discussion of these burden hours and costs.
39
Section 1.01
Generation
•
Section II. Estimating Paperwork Activities Of Data
I. What are the key assumptions when estimating PRA burden hours
and costs for data generation?
• a. Paperwork activities are generally 35% of the cost of the
study.
For more than a decade, EPA has been estimating all the paperwork burden
hours and costs of responding to a DCI notice as approximately 35% of the cost
of the study, see Figure - 1 Relationship of Test Costs to Response Phases.
This formula allows the Agency to derive a reasonable estimate of for PRA
activities (Phases 1, 2, and 3) by using the average estimated cost of specific
tests. This approach was adopted because it allows the Agency to consider the
potential for there to be more burdens related to a more complex study. The
premise is that a more expensive test may cause the respondent to incur more
burden hours and costs than a less expensive test would. This estimate is only
applicable to DCI-related data generation. This percentage was developed from
numerous sources of information including agency expertise, industry
consultation, and repeated review by the public, industry, key stakeholders, and
OMB on the Agency’s information collection activities.
EPA assumes that 35% of the cost of any given test reflects all burdens and
costs necessary for the completion of the paperwork activities. The paperwork
burden and cost fall into two general categories of activity burden, administrative
and technical:
Administrative Paperwork Burden is defined as the labor time spent
communicating and working with the Agency and planning a response to the DCI
and the planning of data collection and submittal activities. Generally, the
respondent will conduct collection activities listed in the Section 1, Table 1Response Phases (Phase 1 and Phase 3). The labor cost related to the
Administrative category of paperwork burden is assumed to equal 2% of the total
test cost (2% of total test cost = Administrative Paperwork Burden Cost).
Technical Paperwork Burden is the labor time needed to complete the paperwork
associated with the initiation of testing, collecting and maintaining data, use of
laboratory standards, data analysis, data compiling, data entry, oversight of
contractor or employee activities, and decision-making. Generally, the
respondent will conduct collection activities listed in Table 1-Response Phases
(Phase 2(a)). This contract laboratory will conduct collection activities listed in
Table 2 (Phase 2(b)). The labor cost for the technical category of paperwork
burden is assumed to equal 33% of the total test cost. (33% of total test cost =
Technical Paperwork Burden Cost)
Thus, [Administrative paperwork (2% of total test cost)] + [Technical paperwork
(33% of total test cost)] = total test-related paperwork burden hours and costs
(35% of total test cost). This aggregate paperwork burden and cost estimate of
35% for data generation activities is used in a number of DCI-related Agency
40
information collection activities, including:
•
Data Acquisition for Registration (OMB #2070-0122; EPA #1503);
•
Data Generation for Pesticide Reregistration (OMB #2070 - 0107; EPA
#1504);
•
Data Call-Ins for Special Review and Registration Review Programs (OMB
#2070-0057; EPA #0922); and
•
Anticipated Residue/Percent Crop Treated (OMB #2070-0164; EPA
#1911).
Phase 1:
Initial
Response to
DCI
Phase III:
Data
Submission
to EPA
35% of test
cost covers
the PRA
burden hours
and costs of
all three
Phase II
(a&b)
Data
Generation
including
technical
Figure - 1 Relationship of Test Costs to Response Phases
41
•
• b. All registrants generate all DCI data
The paperwork activity estimates are based on the average cost of generating
new data. The total cost of the paperwork burden hours and costs is equal to
approximately 35% of the total costs to generate new data. This approach
assumes:
•
•
•
•
•
•
Registrants generate all of the data as specified in the DCI notice. 14
All data generation was performed by an independent laboratory.
Paperwork burden consists of an administrative (2%) and technical (33%)
burden. These two categories relate to office and laboratory activities,
respectively.
Paperwork burden is disaggregated by labor category as follows: 15
a. Managerial (20%)
b. Technical (65%)
c. Clerical (15%)
Labor rates are derived from the parent ICR
Labor rates are “fully loaded 16”
To estimate paperwork activities for each type of labor category (managerial,
technical, and clerical), the disaggregated paperwork burden costs are divided by
their corresponding labor rates ($/hr). EPA assumes that DCI respondents who
generate all requested data on their own is the most expensive of the response
options considered and represents the maximum potential estimate of overall
burden.
•
II. How are test cost estimates developed?
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 extent possible, EPA uses multiple sources to provide test cost estimates,
which are updated as needed. Attachment B contains a listing of the FIFRA study
cost estimates currently on file with the Agency. The chart also provides the
paperwork burden hour and cost estimates for specific studies.
•
III. What if test cost estimates are unavailable?
The Agency may request certain special studies or non-guideline studies that
have not been previously required, and for which test cost estimates have not yet
14 Assumes registrants perform most of the PRA activities highlighted in, Section I-V, “DCI
burden activity tables;” Table 1 – Response Phases
15 See Section I-V, “DCI burden activity tables;” Table 1 – Response Phases; which lists specific
managerial, technical, and clerical duties.
16 “Fully loaded” labor rates are meant to be the estimated costs of wages, overhead, and
benefits paid to an employee.
42
been calculated. If the estimated test cost is not readily available to the Agency
at the time that a particular test is requested, EPA will estimate the cost on the
basis of:
•
•
•
•
•
EPA staff expertise and experience;
similarity with another study protocol for which cost estimates are
available;
type of study requested (e.g., animal studies, field monitoring, and other
possible test parameters);
level of work that EPA expects will be involved in generating the data (high
medium, or low effort required); and/or
time required to complete the test.
The Agency’s estimate would then serve as the default test cost for use in
calculating the paperwork burden. EPA will update and revise these default test
costs as more reliable estimates are obtained.
•
•
IV. What if the available test cost estimates vary?
To the extent possible, EPA uses multiple sources to provide test cost estimates.
If several cost estimates exist for a particular study, but the differing estimates fall
within an acceptable range, EPA will use the average estimate as its estimate.
For example, if test cost estimates for a study were quoted at $20,000, $30,000,
and $40,000, these estimates would be considered to fall within an acceptable
range, and the average of $30,000 would be used in EPA’s estimation of
paperwork burden. If EPA finds that the quoted test costs for a given test varies
widely among sources (i.e., the variation is not within a reasonable range), then
EPA will make a case-by-case decision on how to estimate an average test cost
using the criteria listed in section II-III (What if tests costs are unavailable).
•
V. What are the steps in calculating the paperwork burden (hours
and costs)?
• a. Calculate test costs
Using the EPA archive information of FIFRA study cost estimates, the Agency
calculates the total paperwork burden hours and costs for a test as 35% of the
total test cost (administrative paperwork burden as 2% and technical paperwork
burden as 33% of the total test cost). This percent-based estimate of paperwork
burden is reflective of expert opinion, information from industry, various
proprietary information/data, and a general assessment of test costs.
• b. Distribute paperwork activities among labor categories.
As an entity prepares a data generating response to the DCI notice, EPA
43
assumes managerial, technical, and clerical staff will undertake certain activities.
Paperwork burden costs are divided among managerial, technical, and clerical
staff labor categories (see Table 3, below) to reasonably reflect, on average, the
percent of work performed.
Table 3: Distribution of Paperwork Activities Across Labor Categories*
Labor category
% of Paperwork Activities Performed
Managerial
20%
Technical
65%
Clerical
15%
Using this percentage system, EPA can assign a paperwork activity cost to each
labor category.
For example, study guideline 850.1735, Whole Sediment Acute Toxicity,
has an estimated cost of $20,250. To assign a paperwork activity cost to
each labor category, and to eventually arrive at a total estimate of
paperwork burden in hours and costs, the steps below are taken.
Labor category activities:
Managerial labor:
$1,417.50 = ($7,087.50 * 0.20)
Technical labor:
$4,606.88 = ($7,087.50 * 0.65)
Clerical labor:
$1,063.12 = ($7,087.50 * 0.15)
Total paperwork activities cost:
= $7,087.50
EPA would estimate that $7,087.50 or 35% of the total test cost represents the
cost of the total paperwork burden activities.
• c. Calculate paperwork burden hours from labor cost
distribution.
The second component for estimating DCI PRA activities is to estimate the
average amount of time required to complete activities such as obtaining,
compiling, preparing and submitting information to EPA. After distributing the
paperwork costs among the managerial, technical and clerical labor categories,
the paperwork burden hours are then derived by dividing the costs using fullyloaded wage rates ($/hour) compiled from the Department of Labor’s Bureau of
Labor Statistics which are shown in Table 4.
Table 4: Fully-Loaded Hourly Wage Rates, by Labor Category*
Labor category
Rate ($/hour)
Managerial
$100.86
Technical
$64.80
Clerical
$33.05
44
To estimate paperwork burden in hours, using the hourly wage rates listed in
Table 4, the steps below are taken.
Distribution of paperwork burden hours and costs for labor categories:
Managerial labor:
Technical labor:
Clerical labor:
14.05 hours ($1,417.50)
71.04 hours ($4,606.88)
32.17 hours ($1,063.12)
Total paperwork burden hours = 117.31 hours
•
•
VI. Is the burden for those not generating data covered?
As discussed in Section 1-VI, (Variations of the response to a DCI), 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 predict the burden and costs of
developing the data. Since the Agency cannot predict the number of DCI
recipients who will actually generate data or the amount of data that might be
submitted, EPA submits paperwork burden estimates to OMB for DCI response
activities under all three Phases (1, 2, and 3). Therefore the Agency uses a
default assumption that all DCI recipients will need to generate all of the data
requested. The Agency recognizes that using this default assumption inflates the
paperwork burden estimates associated with the DCI and renders an
overstatement of the burden and cost. The Phase I and Phase 3 response
activity burden hours and costs are accounted for in the existing DCI ICRs as a
subset of the paperwork burden estimates for information collection activities that
are related to generating data to respond to a DCI notice. 17
In 2006, the Agency conducted a preliminary analysis of existing information from
certain collections to estimate the PRA burden of paperwork activities that do not
involve data generation, such as Phase 1 responses to DCIs. For the study, the
Agency chose two ICRs in which PRA burden hours and costs for paperwork
activities that do not involve data generation are clearly defined. The first, the
Application for New and Amended Pesticide Registration ICR, OMB No. 20700060, (EPA ICR No. 0277.14) represents the majority of paperwork activities that
do not involve data generation for applications for pesticide registration and the
second ICR, the Data Generation for Pesticide Reregistration ICR, OMB No.
2070-0107, (EPA ICR No. 1504.05) represents all DCI related PRA burden and
costs. The subset of paperwork activities that do not involve data generation was
tallied and the burden hours and costs from both ICRs were estimated. Finally,
information from the Economic Analysis of the Proposed Change to Data
Requirements Rule for Biochemical and Microbial Pesticides, September 2,
17 See Section 1-V “DCI burden activity tables;” Table 1 – Response Phases.
45
2005, 18 was also used to extract costs for activities that do not involve data
generation. Of these three studies, the estimates of costs of paperwork that do
not involve data generation were 1) $1169.00; 2) $1417.00 and 3) $2000.00 per
response respectively. The Agency believes these costs generally represent the
range for paperwork burden and cost that registrants who are not generating
data might be incur when creating Phase 1 responses. These analyses are
discussed in detail in Attachment A.
18 See Environmental Protection Agency proposed rule 40 CFR parts 158 and 172, Subparts
L&M: Data Requirements for Registration of Biochemical and Microbial Pesticides, (45 FR 12072
Wednesday March 8, 2006), section XVII Regulatory Assessment. For specific information refer
to the docket EPA-HQ-OPP-2004-0415, document 6, U.S. EPA, 2005, “Economic Analysis of the
Proposed Change to Data Requirements Rule for Biochemical and Microbial Pesticides,”
FEAD/OPP/U.S. EPA, Washington, DC.
46
Attachment A
Case Studies: Agency Analysis of Response Costs for
Phase 1 Responses
1. Study #1: Review of the Application for New and Amended
Pesticide Registration, OMB No. 2070-0060, (EPA ICR No.
0277.14) representing burden hours and costs for paperwork
activities that do not involve data generation for applications
for pesticide registration
In this study, EPA assumes:
1. Paperwork activities for applications for registration for “me-too”
pesticides 19 are similar to paperwork activities for developing a DCI
response that does not entail generating new data or requesting a waiver.
2. Estimated burden and costs listed in Table A are fixed, consistent costs
for every respondent, and are not derived from any test cost estimates.
3. Technical labor efforts are not calculated because the Agency assumes
no technical burden would be involved in developing a DCI response that
does not entail generating new data or requesting a waiver. 20
4. The paperwork burden for phase 1 responses that are similar to activities
in developing registration applications may be described as follows:
a. read and discuss test requirements (read the DCI letter to
understand what data are to be submitted);
b. plan activities (includes time for reviewing internal company
information);
c. complete paperwork (prepare necessary correspondence,
documents to EPA);
d. Store/maintain information (maintain information submitted to the
Agency in company files).
5. Paperwork burden for such activities may be disaggregated by labor
19 “Me too” pesticides are pesticides that are substantially similar to an existing pesticide. When
applying for a “me-too” registration, a registrant would either cite existing data or claim eligibility
for a formulator’s exemption. A registrant is eligible for a formulators exemption if he uses a
registered pesticide product as the source of the active ingredient in his product. Little or no
technical labor is involved for this type of response.
20 As an example, consider the DCI respondent who claims a generic data exemption (GDE) as
their response to a DCI. A generic data exemption is the same as a formulator’s exemption. Little
or no technical labor burden is involved for this type of response.
47
category as follows (percentages are approximations):
a. Managerial (65%)
b. Technical (0%)
c. Clerical (35%)
6. Labor rates are derived from the parent ICR.
7. Labor rates are fully loaded.
The supporting statement of the Application for New and Amended Pesticide
Registration ICR characterizes the activities that would be needed for an
application/notification. These activities are substantially similar to those of
Phase 1: Initial Response that does not involve generating data or requesting a
data waiver. The applicable activities are reproduced in Table A below:
Table A: Estimated Burden/Cost for Phase 1 Response*
Collection Activity
Burden Hours
Management Technical Clerical
Read instructions
7
0
0
Plan activities
0.5
0
0
Complete Paperwork
0
0
3
Store/maintain data
0
0
1
Totals
7.5
0
4
(* Indexed to 2005 dollars)
Totals
Hours Cost
7
938
0.5
67
3
123
1
41
11.5
1169
After distributing the paperwork costs among the managerial and clerical staff
labor categories, the paperwork burden hours are then derived by dividing the
costs using the fully-loaded wage rates ($/hour) compiled in the parent ICR,
Review of the Application for New and Amended Pesticide Registration, OMB
No. 2070-0060, (EPA ICR No. 0277.14) approved by Office of Management and
Budget, November 8, 2005.
48
(i) 2. Study #2: Data Generation for Pesticide Reregistration ICR, OMB
No. 2070-0107, (EPA ICR No. 1504.05).
In this study EPA assumes:
1) The total paperwork burden hours and costs for Phase 1 responses are
approximately 7 percent of the estimated average cost to generate new
data.
2) Registrant responses to the DCI notice that do not involve data generation
include voluntary cancellation, submitting or citing existing data,
requesting a data waiver, or claiming eligibility generic data exemption.
3) Paperwork activities that do not involve data generation may be described
as follows:
a. read and discuss test requirements (read the DCI letter to
understand what data are to be submitted);
b. plan activities (developing options for not generating new data
includes reviewing internal company information for existing data);
c. complete paperwork (prepare necessary correspondence,
documents and/or waiver requests to avoid having to submitting
data to EPA);
d. record, maintain and file information (maintain information
submitted to the Agency in company files).
4) Paperwork burden for Phase 1 DCI responses activities may be
disaggregated by labor category as follows (percentages are
approximations):
e. Managerial (50%)
f. Technical (5%)
g. Clerical (45%)
5) Labor rates are derived from the parent ICR
6) Labor rates are fully loaded.
a. Calculate Cost of Paperwork. Using the EPA maintained database of test cost
estimates, the Agency calculates the total paperwork burden cost for a test as
7% of the total test cost because based on the percentage breakdown for
paperwork burden applicable to non-data generation activities for this ICR. This
percent-based estimate of paperwork burden is reflective of expert opinion,
information from industry, various proprietary information/data, and a general
assessment of test costs. These activities represent the Phase I DCI response
activities discussed in section IV.
b. Distribute Paperwork Costs Among Labor Categories. As an entity prepares a
response of non-data generation in response to the DCI notice, EPA assumes
certain activities will be conducted by managerial, technical, and clerical staff.
Paperwork activities are divided among these labor categories (see Table B
below) to reasonably reflect, on average, the percent of work performed. These
percentage breakdowns by labor category, derived from the parent ICR Data
Generation for Pesticide Reregistration ICR, OMB No. 2070-0107, (EPA ICR No.
1504.05), are consistent for burden activities associated with confirmatory DCIs,
49
product specific DCIs, and submission of voluntary studies cited within the parent
ICR.
Table B: Distribution of Burden Across Labor Categories
Labor category
% of Paperwork Burden Activities Performed
Managerial
50%
Technical
5%
Clerical
45%
For example the study guideline 850.1735, Whole Sediment Acute
Toxicity, has an estimated cost of $20,250. Estimates for paperwork cost
for these non-data generation activities would be:
Managerial labor:
Technical labor:
Clerical labor:
Total labor:
$708.75 = ($1,417.50 * 0.50)
$70.88 = ($1,417.50 * 0.05)
$637.87 = ($1,417.50 * 0.45)
$1,417.50
EPA would estimate that $1,417.50 or 7% of the total test cost represents the
cost of the total paperwork burden activities.
c. Calculate Paperwork Burden Hours From Labor Cost Distribution. After
distributing the paperwork costs among the managerial, technical and clerical
staff labor categories, the paperwork burden hours are then derived by dividing
the costs using fully-loaded wage rates ($/hour) cited in the parent ICR and listed
in Table C.
Table C: Fully-Loaded Hourly Wage Rates, by Labor Category*
Labor category
Rate ($/hour)
Managerial
$130
Technical
$88
Clerical
$40
(Labor costs cited in the parent ICR - Indexed to 2004 dollars)
To estimate paperwork burden in hours, using the hourly wage rates listed
in Table C, the steps below are taken.
Managerial labor:
Technical labor:
Clerical labor:
Total hours:
5.45 hours ($708.75 ÷ $130/hr)
0.81 hours ($70.88 ÷ $88/hr)
15.95 hours ($637.87 ÷ $40/hr)
22.21 hours
(ii) 3. Study #3: Economic Analysis for Proposed Changes in Data
Requirements Rule for Biochemical and Microbial Pesticides – Cost
Estimates for Data Waivers.
50
Under 40 CFR 158.45, the Agency may waive data requirements on a case-bycase basis in response to specific requests by applicants. The Agency believes
the paperwork burden and cost for developing a data waiver request is a
relatively fixed cost. When the Agency analyzed burden and cost for data waivers
in the Economic Analysis for Proposed Changes in Data Requirements Rule for
Biochemical and Microbial Pesticides in 2005, the cost of applying for waivers
was estimated to be approximately $2,000 per firm per registration action,
regardless of the number of tests a waiver is applied for, if at least one waiver
was granted. 21 EPA believes this unit of cost/burden may be applicable to the
data waivers submitted to the Agency in response to a DCI. Under this
assumption, all non-data generation paperwork activities would be placed at a
fixed burden of 20 hours and the burden hours would be distributed as
represented in Table D below.
Table D: Industry Estimated Burden/Cost Submitting a Data Waivers
Response*
Collection Activity
Burden Hours
Totals
Management Technical Clerical Hours Cost
Research, Literature
10
1000
searches,
Calculations & analysis
10
Compiling rational
8
8
800
Review document file and
submit
1
1
2
200
Total
20
2000
21 The Biopesticide Industry Alliance Regulatory Committee provided additional
informal cost estimates to EPA. Burden breakdown and costs estimates would
be: Research, literature searches, calculations, analysis etc. = 10 hours = $1000
writing; compiling the rationale = 8 hours = $800; and managerial/clerical = 2
hours = $200. For a total of $2,000.00 for each waiver. A general $100.00 per
hour for consultant costs was provided to EPA.
51
Attachment B
Chart: FIFRA Estimated Study Costs And Paperwork
Burden Hour And Cost Estimates
52
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Test Name
Total Paperwork Burden Hours
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
Product Performance
810.1000
Overview, Definitions, and General Considerations
$100,000.0
$35,000.0
443.6
$100,000.0
810.1550
Product Identity and Disclosure of Ingredients (Composition) (Chemical Identity)
$223.0
$78.1
1.0
$223.0
$100,000.0
$223.0
810.2100
Products for hard surfaces -EPA Disinfectant test
$6,600.0
$2,310.0
29.3
$7,200.0
$6,000.0
810.2100
Products for hard surfaces - AOAC Fungicide test
$1,600.0
$560.0
7.1
$2,000.0
$1,200.0
810.2100(b)&(i)
Chemical Analysis
$5,339.0
$1,868.7
23.7
$6,701.0
$3,976.0
810.2100(m)(2)
Products for hard surfaces - AOAC Germicidal, detergent sanitizers
$3,500.0
$1,225.0
15.5
$4,000.0
$3,000.0
810.21000(j)
Products for hard surfaces -Sanitizer test non food
$4,000.0
$1,400.0
17.7
$5,000.0
$3,000.0
810.2100b,c,d or i
Products for hard surfaces -AOAC use dilution test, germicidal
$6,000.0
$2,100.0
26.6
$7,000.0
$5,000.0
810.2100c,d,e
Products for hard surfaces -AOAC Use dilution/germicidal spray/carrier
$6,000.0
$2,100.0
26.6
$7,000.0
$5,000.0
810.2100(f)
Products for hard surfaces - Fungicidal test
$1,600.0
$560.0
7.1
$2,000.0
$1,200.0
810.2100(g)
Products for hard surfaces - Virucidal activity method
$4,000.0
$1,400.0
17.7
$6,000.0
$2,000.0
810.2100(g)
Products for hard surfaces -AOAC Tuberculocidal test
$3,250.0
$1,137.5
14.4
$5,000.0
$1,500.0
810.2100(l)
Products for hard surfaces - Hard inanimate surface non food
$4,000.0
$1,400.0
17.7
$5,000.0
$3,000.0
810.2200
Products for hard surfaces - AVG
$6,187.0
$2,165.5
27.4
$6,187.0
$6,187.0
810.2200 - itemized
Limited disinfectant
$4,201.0
$1,470.4
18.6
$5,010.0
$3,391.0
810.2200 - itemized
Broad spectrum disinfectant
$5,763.0
$2,017.1
25.6
$6,720.0
$4,806.0
810.2200 - itemized
Hospital disinfectant
$5,993.0
$2,097.6
26.6
$7,000.0
$4,986.0
810.2200 - itemized
Fungicidal disinfectant
$4,219.0
$1,476.7
18.7
$4,865.0
$3,572.0
810.2200 - itemized
Virucidal disinfectant
$13,068.0
$4,573.8
58.0
$19,574.0
$6,561.0
810.2200 - itemized
Tuberculocidal disinfectant
$4,691.0
$1,641.9
20.8
$5,633.0
$6,748.0
53
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Test Name
Total Paperwork Burden Hours
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
810.2200 - itemized
Additional bacteria
$4,082.0
$1,428.7
18.1
$4,803.0
$3,361.0
810.2200 - itemized
Non-food contact
$5,198.0
$1,819.3
23.1
$6,026.0
$4,370.0
810.2200 - itemized
Food contact - Halide products
$4,455.0
$1,559.3
19.8
$5,195.0
$3,714.0
810.2200 - itemized
Food contact - Non-halide products
$6,086.0
$2,130.1
27.0
$7,301.0
$4,870.0
810.2200 - itemized
Sanitizers for urinal and toilet bowl water and in-tank sanitizers
$5,672.0
$1,985.2
25.2
$6,902.0
$4,441.0
810.2200 - itemized
Residual self-sanitizing - wet surfaces
$5,210.0
$1,823.5
23.1
$3,969.0
$6,451.0
810.2200 - itemized
Sterilants
$11,803.0
$4,131.1
52.4
$11,936.0
$11,669.0
810.2300b
Products for fabrics/textiles -EPA Carpet Sanitizer
$3,250.0
$1,137.5
14.4
$5,000.0
$1,500.0
810.2400
Products for air sanitizers
$5,500.0
$1,925.0
24.4
$6,500.0
$4,500.0
810.2400(b)(j)
Chemical Analysis
$175.0
$61.3
0.8
$350.0
$0.0
810.2400(b)(l)
Chemical Analysis
$4,000.0
$1,400.0
17.7
$4,000.0
$4,000.0
810.2600
Products for microbial pests associated with human and animal waste
$5,720.0
$2,002.0
25.4
$5,720.0
$5,720.0
810.2700(d)
Products for treating water systems AOAC- water disinfectants pools
$7,500.0
$2,625.0
33.3
$10,000.0
$5,000.0
810.3000
General considerations for Efficacy of invertebrate control agents
$600.0
$210.0
2.7
$600.0
$600.0
810.3100
Soil treatments for imported fire ants
$140,000.0
$49,000.0
621.1
$200,000.0
$80,000.0
810.3200
Livestock,poultry,fur and wool bearing animal treatments
$30,000.0
$10,500.0
133.1
$50,000.0
$10,000.0
810.3300
Treatments to control pests of human and pets
$50,000.0
$17,500.0
221.8
$60,000.0
$40,000.0
810.3400
Mosquito,blackfly and biting midge treatments
$140,000.0
$49,000.0
621.1
$200,000.0
$80,000.0
810.3500
Premises Treatments
$700,000.0
$245,000.0
3,105.3
$800,000.0
$600,000.0
810.3600
Structural Treatments
$1,200.0
$420.0
5.3
$1,200.0
$1,200.0
810.3700
Insect repellants for human skin and outdoor premises
$5,000.0
$1,750.0
22.2
$5,000.0
$5,000.0
810.3800
Methods for efficacy testing of termite baits
$60,000.0
$21,000.0
266.2
$100,000.0
$20,000.0
Product Chemistry
54
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.1900
830.6302
830.6303
830.6304
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7200
830.7220
830.7300
830.7370
830.7520
Product identity and composition
Description of materials used to produce the product
Description of production process
Description of formulation process
Discussion of formulation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Submittal of samples
Color
Physical state
Odor
Stability to normal and elevated temperatures, metals, and metal ions
Oxidation/reduction: chemical incompatibility
Flammability
Explodability
Storage stability
Miscibility
Corrosion characteristics
Dielectric breakdown voltage
pH
UV/visible light absorption
Viscosity
Melting point/melting range
Boiling point/boiling range
Density/relative density/bulk density
Dissociation constants in water
Particle size, fiber length, and diameter distribution
$233.0
$334.0
$418.0
$418.0
$418.0
$31,715.0
$248.0
$15,454.0
$495.0
$700.0
$700.0
$700.0
$8,250.0
$2,994.0
$2,000.0
$4,163.0
$11,500.0
$1,100.0
$2,750.0
$2,525.0
$750.0
$2,022.0
$1,400.0
$1,200.0
$1,500.0
$1,400.0
$4,845.0
$1,333.0
$81.6
$116.9
$146.3
$146.3
$146.3
$11,100.3
$86.8
$5,408.9
$173.3
$245.0
$245.0
$245.0
$2,887.5
$1,047.9
$700.0
$1,457.1
$4,025.0
$385.0
$962.5
$883.8
$262.5
$707.7
$490.0
$420.0
$525.0
$490.0
$1,695.8
$466.6
1.0
1.5
1.9
1.9
1.9
140.7
1.1
68.6
2.2
3.1
3.1
3.1
36.6
13.3
8.9
18.5
51.0
4.9
12.2
11.2
3.3
9.0
6.2
5.3
6.7
6.2
21.5
5.9
$223.0
$501.0
$167.0
$167.0
$167.0
$50,054.0
$330.0
$21,538.0
$660.0
$1,000.0
$1,000.0
$1,000.0
$12,000.0
$3,044.0
$3,000.0
$4,163.0
$15,000.0
$1,500.0
$3,500.0
$2,675.0
$1,000.0
$2,072.0
$2,000.0
$1,600.0
$2,000.0
$2,000.0
$4,845.0
$1,333.0
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Total Paperwork Burden Hours
Test Name
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
$167.0
$668.0
$668.0
$668.0
$8,875.0
$165.0
$9,371.0
$330.0
$400.0
$400.0
$400.0
$4,500.0
$2,944.0
$1,000.0
$4,163.0
$8,000.0
$700.0
$2,000.0
$2,375.0
$500.0
$1,972.0
$800.0
$800.0
$1,000.0
$800.0
$4,845.0
$1,333.0
55
Spray Drift
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Test Name
Total Paperwork Burden Hours
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
830.7550
830.7560
830.7570
830.7840
830.7860
830.7950
Partition coefficient (n-octanol/water) - shake flask method
Partition coefficient (n-octanol/water) -generator column
Partition coefficient (n-octanol/water) -estimation chromatography
Water Solubility: column elution/shake flask
Water solubility
Vapor pressure
$6,667.0
$6,667.0
$4,388.0
$9,635.0
$9,635.0
$15,000.0
$2,333.5
$2,333.5
$1,535.8
$3,372.3
$3,372.3
$5,250.0
29.6
29.6
19.5
42.7
42.7
66.5
$7,333.0
$7,333.0
$4,700.0
$11,322.0
$11,322.0
$20,000.0
$6,000.0
$6,000.0
$4,075.0
$7,947.0
$7,947.0
$10,000.0
840.1100
840.1200
Spray droplet size spectrum
Spray drift field deposition
$258,750.0
$16,250.0
$90,562.5
$5,687.5
1,147.9
72.1
$340,000.0
$25,000.0
$177,500.0
$7,500.0
Use Profile
Aquatic invertebrate acute toxicity, freshwater daphnids
Gammarid acute toxicity test
Oyster acute toxicity test
Mysid acute toxicity test
Penaeid acute toxicity test
Bivalve acute tox larval (embryo/larval)
Fish acute toxicity (freshwater)
Fish acute toxicity test (estaurine/marine)
Daphnid chronic toxicity test
Mysid chronic tox - aquatic invertebrate life-cycle (saltwater)
Fish early-life stage toxicity test (freshwater)
Fish early-life stage toxicity test (saltwater)
Fish life-cycle toxicity
Aquatic Bioavailability/Biomagnification: Oyster BCF
Aquatic Bioavailability/Biomagnification: Fish BCF
$251.0
$17,000.0
$0.0
$32,725.0
$32,725.0
$32,725.0
$32,725.0
$17,000.0
$20,138.0
$118,063.0
$36,333.0
$37,279.0
$75,000.0
$512,500.0
$123,919.0
$140,452.0
$87.9
$5,950.0
$0.0
$11,453.8
$11,453.8
$11,453.8
$11,453.8
$5,950.0
$7,048.3
$41,322.1
$12,716.6
$13,047.7
$26,250.0
$179,375.0
$43,371.7
$49,158.2
1.1
75.4
0.0
145.2
145.2
145.2
145.2
75.4
89.3
523.7
161.2
165.4
332.7
2,273.5
549.7
623.1
$334.0
$20,000.0
$0.0
$32,725.0
$32,725.0
$32,725.0
$32,725.0
$28,061.0
$20,138.0
$162,800.0
$41,000.0
$41,379.0
$0.0
$650,000.0
$143,919.0
$169,279.0
$167.0
$14,000.0
$0.0
$7,550.0
$7,550.0
$7,550.0
$7,550.0
$10,066.0
$20,138.0
$73,325.0
$31,667.0
$33,179.0
$0.0
$375,000.0
$103,919.0
$111,624.0
Ecological Effects Tests
850.1000
850.1010
850.1020
850.1025
850.1035
850.1045
850.1055
850.1075
850.1075
850.1300
850.1350
850.1400
850.1450
850.1500
850.1710
850.1730
56
850.1735
850.1740
850.1790
850.1800
850.1850
850.1900
850.1925
850.1950
850.1950
850.1950
850.1950
850.2100
850.2200
850.2300
850.2400
850.2500
850.2500
850.3020
850.3030
850.3040
850.4000
850.4025
850.4100
850.4150
850.4200
850.4200
850.4230
850.4225
$20,250.0
$37,500.0
$83,000.0
$195,856.0
$325,000.0
$295,000.0
$250,000.0
$512,500.0
$600,000.0
$87,500.0
$62,500.0
$10,100.0
$6,480.0
$168,250.0
$35,000.0
$527,502.0
$600,000.0
$3,175.0
$13,368.0
$47,500.0
$0.0
$0.0
$14,625.0
$14,625.0
$10,292.0
$25,602.5
$0.0
$20,375.0
$7,087.5
$13,125.0
$29,050.0
$68,549.6
$113,750.0
$103,250.0
$87,500.0
$179,375.0
$210,000.0
$30,625.0
$21,875.0
$3,535.0
$2,268.0
$58,887.5
$12,250.0
$184,625.7
$210,000.0
$1,111.3
$4,678.8
$16,625.0
$0.0
$0.0
$5,118.8
$5,118.8
$3,602.2
$8,960.9
$0.0
$7,131.3
89.8
166.4
368.2
868.9
1,441.8
1,308.7
1,109.0
2,273.5
2,661.7
388.2
277.3
44.8
28.7
746.4
155.3
2,340.1
2,661.7
14.1
59.3
210.7
0.0
0.0
64.9
64.9
45.7
113.6
0.0
90.4
$21,500.0
$50,000.0
$83,000.0
$195,856.0
$500,000.0
$360,000.0
$250,000.0
$650,000.0
$700,000.0
$100,000.0
$75,000.0
$13,800.0
$6,647.0
$215,500.0
$50,000.0
$552,000.0
$700,000.0
$3,175.0
$16,670.0
$65,000.0
$0.0
$0.0
$15,625.0
$15,625.0
$15,875.0
$30,930.0
$0.0
$22,000.0
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Total Paperwork Burden Hours
Test Name
Whole sediment acute toxicity invertebrates (freshwater)
Whole sediment acute toxicity invertebrates (marine)
Chironomid sediment toxicity test
Tadpole/sediment subchronic toxicity test
Aquatic food chain transfer - Bioavailability
Generic freshwater microscosm test (laboratory)
Site-specific aquatic microcosm test (laboratory)
Simulated or actual field testing - field animal
Simulated or actual field testing - aquatic
Simulated or actual field testing - insect predators
Simulated or actual field testing - plants
Avian acute oral toxicity test
Avian dietary toxicity test
Avian reproduction test
Wild mammal acute toxicity
Simulated or actual field testing terrestrial wildlife
Simulated or actual field testing - birds
Honey bee acute contact toxicity
Honey bee toxicity of residues on foliage
Field testing for pollinators
Background - Nontarget plant testing
Target area phytotoxicity
Terrestrial plant toxicity (seedling emergence, Tier I)
Terrestrial plant toxicity (vegetative vigor, Tier I)
Seed germination/root elongation toxicity test
Seed germination/root elongation toxicity test
Early seed growth toxicity test
Seedling emergence, Tier II
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
$26,000.0
$25,000.0
$83,000.0
$195,856.0
$150,000.0
$230,000.0
$250,000.0
$375,000.0
$500,000.0
$75,000.0
$50,000.0
$6,400.0
$6,313.0
$121,000.0
$20,000.0
$502,000.0
$500,000.0
$3,175.0
$10,065.0
$30,000.0
$0.0
$0.0
$13,625.0
$13,625.0
$4,709.0
$20,275.0
$0.0
$18,750.0
57
Health Effects
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Total Paperwork Burden Hours
Test Name
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
850.4250
850.4300
850.4400
850.4400
850.4450
850.5400
na
na
na
na
na
Vegetative vigor, Tier II
Terrestrial plants field study, Tier III
Aquatic plant toxicology test using Lemna spp., Tier I
Aquatic plant toxicology test using Lemna spp., Tier II
Aquatic plants field study, Tier III
Algal Toxicity Tier I and Tier II
Acute toxicity to aquatic insects
Aquatic insect life-cycle study
Simulated or actual field testing for aquatic insects
Nontarget insect testing - predators and parasites
Nontarget insect testing - predators and parasites
$24,500.0
$111,863.0
$35,155.0
$35,155.0
$0.0
$35,155.0
$0.0
$0.0
$0.0
$0.0
$0.0
$8,575.0
$39,152.1
$12,304.3
$18,632.2
$0.0
$12,304.3
$0.0
$0.0
$0.0
$0.0
$0.0
108.7
496.2
156.0
236.2
0.0
156.0
0.0
0.0
0.0
0.0
0.0
$26,500.0
$126,863.0
$39,525.0
$35,155.0
$0.0
$35,155.0
$0.0
$0.0
$0.0
$0.0
$0.0
$22,500.0
$26,500.0
$18,750.0
$35,155.0
$0.0
$35,155.0
$0.0
$0.0
$0.0
$0.0
$0.0
870.1100
870.1200
870.1300
870.1300
870.2400
870.2500
870.2600
870.3100
870.3150
870.3200
870.3250
870.3465
870.3700
870.3800
870.4100
Acute oral toxicity (rat)
Acute dermal toxicity
Acute inhalation toxicity (rat)
Acute inhalation tox (microbials)
Acute eye irritation (rabbit)
Acute dermal irritation
Skin (dermal) sensitization
90-day oral toxicity in rodents
90-day oral toxicity in non-rodents
21/28-day dermal toxicity
90-day dermal toxicity
90-day inhalation toxicity (rat)
Prenatal developmental toxicity study (rat and rabbit, preferred)
Reproduction and fertility effects (multigeneration)
Chronic tox (rodent and non-rodent)
$3,473.0
$2,000.0
$2,000.0
$12,000.0
$2,000.0
$2,000.0
$8,000.0
$138,106.0
$221,047.0
$83,240.0
$137,094.0
$300,000.0
$76,844.0
$378,479.0
$950,000.0
$1,215.6
$700.0
$700.0
$4,200.0
$700.0
$700.0
$2,800.0
$48,337.1
$77,366.5
$29,134.0
$47,982.9
$105,000.0
$26,895.4
$132,467.7
$332,500.0
15.4
8.9
8.9
53.2
8.9
8.9
35.5
612.7
980.6
369.3
608.2
1,330.9
340.9
1,679.0
4,214.4
$4,015.0
$3,000.0
$3,000.0
$20,000.0
$3,000.0
$3,000.0
$10,000.0
$142,517.0
$221,047.0
$84,681.0
$138,114.0
$350,000.0
$77,037.0
$381,233.0
$1,100,000.0
$2,932.0
$1,000.0
$1,000.0
$4,000.0
$1,000.0
$1,000.0
$6,000.0
$133,695.0
$221,047.0
$81,798.0
$137,094.0
$300,000.0
$76,844.0
$378,479.0
$950,000.0
58
870.4200
870.4200
870.5100
870.5300
870.5375
870.5380
870.5385
870.5395
none
870.5450
870.5500
870.5550
870.6100
870.6200
870.6200
870.6300
870.6500
870.6850
870.6855
870.7200
870.7485
870.7600
870.7800
Dermal outdoor exposure
Dermal indoor exposure
Inhalation outdoor exposure
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Total Paperwork Burden Hours
Test Name
Carcinogenicity (rat and mouse, preferred)
Carcinogenicity (microbials)
Bacterial reverse mutation assay
In vitro mammalian cell gene mutation test
In vitro mammalian chromosomal aberration test
Mammalian spermatogonial chromosomal aberration test
Mammalian bone marrow chromosomal aberration test
Mammalian erthrocyte micronucleus test
Reference list of all studies/papers known to the applicant concerning mutagenicity
Rodent dominant lethal assay
Bacterial DNA damage or repair tests
Unscheduled DNA synthesis in mammalian cells in culture
Acute and 28 day delayed neurotoxicity organophosphorus substances (hen)
Acute neurotoxicity (rat)
90-day Neurotoxicity (rat)
Developmental neurotoxicity study
Schedule-controlled operant behavior
Peripheral nerve function
Neurophysiology: sensory evoked potentials
Companion animal safety
Metabolism and pharmacokinetics
Dermal penetration
Immunotoxicity
Occupational and Residential Exposure
875.1100
875.1200
875.1300
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
$1,730,000.0
$922,244.0
$4,057.0
$18,654.0
$0.0
$19,382.0
$30,004.0
$20,477.0
$418.0
$0.0
$0.0
$30,000.0
$79,375.0
$89,596.0
$184,039.0
$406,904.0
$164,000.0
$110,000.0
$110,000.0
$156,000.0
$182,729.0
$147,529.0
$56,648.0
$605,500.0
$322,785.4
$1,420.0
$6,528.9
$0.0
$6,783.7
$10,501.4
$7,167.0
$146.3
$0.0
$0.0
$10,500.0
$27,781.3
$31,358.6
$64,413.7
$142,416.4
$57,400.0
$38,500.0
$38,500.0
$54,600.0
$63,955.2
$51,635.2
$19,826.8
7,674.6
4,091.2
18.0
82.8
0.0
86.0
133.1
90.8
1.9
0.0
0.0
133.1
352.1
397.5
816.4
1,805.1
727.5
488.0
488.0
692.0
810.6
654.5
251.3
$2,060,000.0
$925,806.0
$4,457.0
$19,767.0
$0.0
$19,382.0
$30,004.0
$20,594.0
$418.0
$0.0
$0.0
$0.0
$80,625.0
$91,680.0
$186,410.0
$417,135.0
$164,000.0
$110,000.0
$110,000.0
$167,667.0
$217,729.0
$175,346.0
$57,731.0
$1,730,000.0
$922,244.0
$4,057.0
$18,654.0
$0.0
$19,382.0
$30,004.0
$20,477.0
$418.0
$0.0
$0.0
$0.0
$72,125.0
$87,513.0
$181,668.0
$396,904.0
$164,000.0
$110,000.0
$110,000.0
$144,333.0
$147,729.0
$119,711.0
$55,565.0
$167,857.0
$126,429.0
$164,286.0
$58,750.0
$44,250.2
$57,500.1
744.6
560.9
728.8
$192,143.0
$150,714.0
$181,429.0
$143,571.0
$102,143.0
$147,143.0
59
875.1400
875.1500
875.1600
875.1700
875.2100
875.2200
875.2300
875.2400
875.2500
875.2600
875.2700
875.2800
875.2900
875.3000
Environmental Fate
none
835.1230
835.1240
835.1410
835.2120
835.2240
835.2370
835.2410
835.4100
835.4200
835.4300
835.4400
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Total Paperwork Burden Hours
Test Name
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
Inhalation indoor exposure
Biological monitoring
Application exposure data reporting and calculations
Product use information
Dislodgeable foliar residue dissipation and turf transferable residues
Soil residue dissipation
Indoor surface residue dissipation
Dermal exposure
Inhalation exposure
Biological monitoring
Product use information
Description of human activity
Data reporting and calculations
Nondietary ingestion exposure
$126,429.0
$188,393.0
$7,500.0
$3,000.0
$55,100.0
$83,125.0
$35,000.0
$125,500.0
$73,000.0
$166,875.0
$3,000.0
$3,000.0
$3,000.0
$75,000.0
$44,250.2
$65,937.6
$2,625.0
$1,050.0
$19,285.0
$29,093.8
$12,250.0
$43,925.0
$25,550.0
$58,406.3
$1,050.0
$1,050.0
$1,050.0
$26,250.0
560.9
835.7
33.3
13.3
244.4
368.8
155.3
556.7
323.8
740.3
13.3
13.3
13.3
332.7
$150,714.0
$219,256.0
$10,000.0
$4,000.0
$56,100.0
$85,000.0
$35,000.0
$133,000.0
$81,000.0
$191,667.0
$4,000.0
$4,000.0
$4,000.0
$83,333.0
$102,143.0
$157,500.0
$5,000.0
$2,000.0
$54,100.0
$81,250.0
Use Profile
Sediment and soil adsorption/desorption
Leaching and adsorption/desorption
Laboratory volatility
Hydrolysis
Photodegradation in water
Photodegradation in air
Photodegradation on soil
Aerobic soil metabolism
Anaerobic soil metabolism
Aerobic aquatic metabolism
Anaerobic aquatic metabolism
$251.0
$23,750.0
$46,780.0
$45,000.0
$25,230.0
$46,875.0
$110,000.0
$42,350.0
$94,375.0
$71,300.0
$44,475.0
$80,900.0
$0.0
$8,312.5
$16,373.0
$15,750.0
$8,830.5
$16,406.3
$38,500.0
$14,822.5
$33,031.3
$24,955.0
$15,566.3
$28,315.0
0.0
105.4
207.5
199.6
111.9
207.9
488.0
187.9
418.7
316.3
197.3
358.9
$334.0
$24,583.0
$51,880.0
$5,000.0
$29,900.0
$47,875.0
$120,000.0
$45,183.0
$98,625.0
$71,300.0
$47,350.0
$86,525.0
$167.0
$22,917.0
$41,680.0
$40,000.0
$20,560.0
$47,875.0
$100,000.0
$39,517.0
$90,125.0
$71,300.0
$41,600.0
$72,275.0
$118,000.0
$65,000.0
$142,083.0
$2,000.0
$2,000.0
$2,000.0
$66,667.0
60
835.6100
835.6200
835.6300
835.6400
835.8100
835.7100
none
none
Residue Chemistry
860.1100
860.1200
860.1300
860.1300
860.1340
860.1340
860.1360
860.1380
860.1400
860.1400
860.1400
860.1460
860.1480
860.1500
860.1520
860.1540
860.1550
860.1560
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Total Paperwork Burden Hours
Test Name
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
Terrestrial field dissipation
Aquatic field dissipation
Forestry dissipation
Combination and tank mixes
Field volatility
Groundwater Monitoring
Monitoring of representative U.S. waters
Leaching study
$317,767.0
$267,250.0
$275,500.0
$219,200.0
$230,900.0
$1,225,000.0
$215,833.0
$43,000.0
$111,218.5
$93,537.5
$96,425.0
$76,720.0
$80,815.0
$428,750.0
$75,541.6
$15,050.0
1,409.7
1,185.6
1,222.2
972.4
1,024.3
5,434.3
957.5
190.8
$366,067.0
$354,000.0
$362,500.0
$219,200.0
$230,900.0
$2,000,000.0
$263,333.0
$48,000.0
$269,467.0
$180,500.0
$188,500.0
Chemical identity
Directions for use
Nature of the residue in plants
Nature of the residue in livestock
Residue analytical method - plants
Residue analytical method - livestock
Multiresidue method
Storage stability data
Water
Fish
Irrigated crops (one-crop)
Food handling
Meat/milk/poultry/eggs
Crop field trials
Processed food/feed
Reduction of Residues
Proposed tolerance
Reasonable grounds in support of the petition
$1,250.0
$4,000.0
$100,000.0
$105,833.0
$22,125.0
$65,500.0
$24,000.0
$18,500.0
$53,750.0
$104,000.0
$18,000.0
$205,000.0
$149,000.0
$163,667.0
$35,000.0
$15,000.0
$5,363.0
$10,000.0
$437.5
$1,400.0
$35,000.0
$37,041.6
$7,743.8
$22,925.0
$8,400.0
$6,475.0
$18,812.5
$36,400.0
$6,300.0
$71,750.0
$52,150.0
$57,283.5
$12,250.0
$5,250.0
$1,877.1
$3,500.0
5.5
17.7
443.6
469.5
98.2
290.6
106.5
82.1
238.4
461.4
79.9
909.4
661.0
726.1
155.3
66.5
23.8
44.4
$2,000.0
$5,000.0
$105,000.0
$118,333.0
$23,250.0
$76,800.0
$25,667.0
$18,500.0
$55,000.0
$130,000.0
$20,500.0
$230,000.0
$152,333.0
$177,000.0
$37,333.0
$20,000.0
$6,600.0
$15,000.0
$500.0
$3,000.0
$95,000.0
$93,333.0
$19,000.0
$54,200.0
$22,333.0
$18,500.0
$52,500.0
$78,000.0
$15,500.0
$180,000.0
$145,667.0
$150,333.0
$32,667.0
$10,000.0
$4,124.0
$5,000.0
$450,000.0
$168,333.0
$38,000.0
61
860.1650
860.1850
860.1900
none
Microbial Pesticides
880.1100
880.1200
880.1400
880.3800
880.4350
880.4425
885.1100
885.1200a
885.1200b
885.1300
885.1400
885.1500
885.2000
885.2100
885.2200
885.2250
885.2300
885.2350
885.2400
885.2500
885.2550
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Total Paperwork Burden Hours
Test Name
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
Submittal of analytical reference standards
Confined accumulation in rotational crops
Field accumulation in rotational crops
Migration Studies
$334.0
$249,845.0
$137,500.0
$105,000.0
$116.9
$87,445.8
$48,125.0
$36,750.0
1.5
1,108.4
610.0
465.8
$501.0
$269,845.0
$125,000.0
$120,000.0
$167.0
$229,845.0
$150,000.0
$90,000.0
Product identity
Description materials, production, formulation
Discussion of formation of impurities
Immune Response
Non-target insect testing
Dispenser - water leaching
Hypersensitivity incidents
Product Identity
Manufacturing process
Deposition of samples
Discussion of formulation of unintentional ingredients
Analysis of samples
Certification of limits
Background for residue analysis of microbial pest control agents
Chemical identity
Nature of the residue in plants
Nature of the residue in animals
Analytical method - plants
Analytical method - animals
Storage stability, plants
Magnitude of residue in plants
Magnitude of residue in meat/milk/poultry
$233.0
$908.0
$330.0
$85,000.0
$15,000.0
$25,000.0
$825.0
$5,000.0
$3,500.0
$3,500.0
$3,500.0
$74,500.0
$350.0
$0.0
$660.0
$108,333.0
$117,144.0
$26,540.0
$43,908.0
$31,017.0
$137,160.0
$157,663.0
$81.6
$317.8
$115.5
$29,750.0
$5,250.0
$8,750.0
$288.8
$1,750.0
$1,225.0
$1,225.0
$1,225.0
$26,075.0
$122.5
$0.0
$231.0
$37,916.6
$41,000.4
$9,289.0
$15,367.8
$10,856.0
$48,006.0
$55,182.1
1.0
4.0
1.5
377.1
66.5
110.9
3.7
22.2
15.5
15.5
15.5
330.5
1.6
0.0
2.9
480.6
519.7
117.7
194.8
137.6
608.5
699.4
$300.0
$1,650.0
$495.0
$100,000.0
$18,000.0
$30,000.0
$1,320.0
$8,000.0
$5,000.0
$5,000.0
$5,000.0
$145,000.0
$500.0
$0.0
$825.0
$108,333.0
$123,750.0
$34,040.0
$56,325.0
$32,683.0
$137,587.0
$162,425.0
$165.0
$165.0
$165.0
$70,000.0
$12,000.0
$20,000.0
$330.0
$2,000.0
$2,000.0
$2,000.0
$2,000.0
$4,000.0
$200.0
$0.0
$495.0
$108,333.0
$110,538.0
$19,040.0
$31,492.0
$29,350.0
$136,733.0
$152,900.0
62
885.2600
885.3000
885.3050
885.3150
885.3200
885.3200
885.3400
885.3500
885.3550
885.3600
885.3650
885.4050
885.4100
885.4150
885.4200
885.4240
885.4280
885.4280
885.4300
885.4380
885.4600
885.4650
885.4700
885.4750
885.5200
885.5300
885.5400
$221,442.0
$250,000.0
$33,500.0
$37,500.0
$37,500.0
$12,500.0
$800.0
$30,000.0
$21,500.0
$150,000.0
$162,500.0
$15,000.0
$16,000.0
$65,000.0
$37,500.0
$37,500.0
$40,000.0
$40,000.0
$30,000.0
$4,250.0
$175,000.0
$75,000.0
$250,000.0
$350,000.0
$95,000.0
$0.0
$95,000.0
$77,504.7
$87,500.0
$11,725.0
$13,125.0
$13,125.0
$4,375.0
$280.0
$10,500.0
$7,525.0
$52,500.0
$56,875.0
$5,250.0
$5,600.0
$22,750.0
$13,125.0
$13,125.0
$14,000.0
$14,000.0
$10,500.0
$1,487.5
$61,250.0
$26,250.0
$87,500.0
$122,500.0
$33,250.0
$0.0
$33,250.0
982.4
1,109.0
148.6
166.4
166.4
55.5
3.5
133.1
95.4
665.4
720.9
66.5
71.0
288.4
166.4
166.4
177.4
177.4
133.1
18.9
776.3
332.7
1,109.0
1,552.7
421.4
0.0
421.4
$245,225.0
$250,000.0
$41,000.0
$50,000.0
$50,000.0
$18,000.0
$1,300.0
$35,000.0
$40,000.0
$200,000.0
$20,000.0
$18,000.0
$20,000.0
$80,000.0
$45,000.0
$45,000.0
$48,000.0
$48,000.0
$40,000.0
$5,000.0
$200,000.0
$1,000.0
$300,000.0
$400,000.0
$150,000.0
$0.0
$150,000.0
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Total Paperwork Burden Hours
Test Name
Magnitude of residue in potable water, fish, and irrigated crops
Background Mammalian Infectivity/pathogenicity analysis
Acute oral toxicity/pathogenicity
Acute pulmonary toxicity/pathogenicity
Acute injection toxicity/pathogenicity (intravenous)
Acute injection toxicity/pathogenicity (intraperitoneal)
Hypersensitivity incidents
Cell Culture
Acute toxicity, TI
Subchronic toxicity/pathogenicity
Reproductive/fertility effects
Avian Oral, TI
Avian Inhalation toxicity/pathogenicity, TI
Wild mammal toxicity/pathogenicity,TI
Freshwater fish toxicity/pathogenicity,TI
Freshwater invertebrate toxicity/pathogenicity,TI
Estuarine/marine animal testing, TI
Estuarine/marine invertebrate testing,TI
Nontarget plant studies, TI
Honey bee testing
Avian chronic pathogenicity and reproduction, TIII
Aquatic invertebrate range testing,TIII
Fish life cycle studies,TIII
Aquatic ecosystem test
Terrestrial environmental expression tests
Freshwater environmental expression test
Marine or estaurine environmental expression tests
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
$197,658.0
$250,000.0
$25,000.0
$25,000.0
$25,000.0
$7,000.0
$300.0
$25,000.0
$3,000.0
$100,000.0
$125,000.0
$12,000.0
$12,000.0
$50,000.0
$30,000.0
$30,000.0
$32,000.0
$32,000.0
$20,000.0
$3,500.0
$150,000.0
$50,000.0
$200,000.0
$300,000.0
$40,000.0
$0.0
$40,000.0
63
Notes:
Low Test Cost
(Low AVG for 2005 SciReg)
High Test Cost
(High AVG for 2005 SciReg)
Total Paperwork Burden Hours
Test Name
AverageTest Cost
Test Guideline/
Section
Total Paperwork Burden Cost
Paperwork Burden Totals
(35% of study cost)
Test Information
Labor Rates in 2003 dollars, but data collected represents 2003 -2007
Clerical: $40/hr
Technical: $88/hr
Management: $130/hr
Color Code:
Study has no cost estimate, source or year
Test cost estimate has no source or year
64
65
Office of Pesticide Programs
Questions for DCI Response Burden Assessment Workshop Participants
Response to questions due to OPP by January 13, 2014
The list of questions below relate to the OPP discussion paper presented to
the participants of the DCI Response Burden Assessment Workshop held
December 12, 2013. During the DCI ICR renewal process, OPP will assess
responses received from Workshop participants and, if rational and sufficient data
is provided, modify the agency’s estimates of the paperwork burden and cost of
responding to a DCI as necessary. After the consultation period is complete,
Industry will have two more opportunities to comment on the methodology as it
is being developed in conjunction with the new DCI ICR. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted by statute.
Non CBI materials submitted to OPP will be placed in the docket for the DCI ICR
renewal when the docket is created. Data estimates or data stated in ranges or
other summary statements are acceptable. If you feel you must submit CBI or
other information whose disclosure is restricted by statute, please contact one of
the program contacts below to assist you with the CBI data submission.
Burden Questions
Consortium participants
1. The EPA encourages companies/registrants to combine resources when
responding to a DCI—thus it is assumed that only one set of data (a.k.a. “data
set,”) and all of the data requested is submitted to the EPA in response to each
DCI. However, this is not always the case.
o The agency is interested in obtaining estimates of and a basis for
supporting:
How many datasets are typically submitted per DCI [for each
Information Collection (IC) group, if possible—see Table 2 for a list
of IC groups].
The typical number of participants in the consortium that your
company participates in (by IC group, if possible).
The total number of consortiums your company has participated
in on an annual basis.
Office of Pesticide Programs
Questions for DCI Response Burden Assessment Workshop Participants
Response to questions due to OPP by January 13, 2014
Any other information you feel would support the EPA in
estimating consortium participant burden.
o Since waiver requests and other exemptions are not data sets can
you estimate the percentage of the DCI response that will be
generated studies?
1a. *Trade Associations
Does your Trade Association track membership participation in a number of
consortiums? Can you provide information on the total number of
consortiums your membership has participated in on an annual basis?
2. Does your company track the activities and costs for consortium participation?
EPA would like to derive an estimate for the average cost for participating in a
consortium (e.g., communication, meetings, and any other activities needed to
coordinate the consortium), in addition to the cost of, data
generation/purchasing (e.g., communication, meetings, and any other
activities needed to coordinate the consortium). If possible, please provide
data on the typical per entity annual cost of consortium participation.
3. When participating in a consortium, EPA is assuming that the cost for
participating varies among involved entities. Do you have any information
supporting how costs are distributed among participants and their typical
variation?
Office of Pesticide Programs
Questions for DCI Response Burden Assessment Workshop Participants
Response to questions due to OPP by January 13, 2014
DCI recipients
4. Are the types of initial DCI burden response activities correct? (See Table 3).
5. Are the initial response activities to the DCI (e.g., 90 day response) for
planning, generating and submitting data in response to a DCI correct? Are the
total burden and breakout percentages of the Industry labor force used to
respond to a DCI (i.e., managerial, technical and clerical) correct? (See Table
A-1, Appendix A).
6. Do you have information to support a different estimate for the expected
number of DCIs recipients? By IC group, if possible.
Data generators
7. Are the types of initial DCI burden response activities correct? (See Table 3).
8. Are the total burden and breakout percentages of the Industry labor force
used to respond to a DCI (i.e., managerial, technical and clerical) correct?
9. Do you have information to support a different estimate for the expected
number of DCIs for which data generation will be necessary? By IC group, if
possible. For example: Your company receives a DCI request. The request
suggests that a total of 10 studies are to be submitted to OPP. You believe
that your company will only have to generate 8 studies (data generation) and
will seek waivers (or other non-data generating actions) for the other two
Office of Pesticide Programs
Questions for DCI Response Burden Assessment Workshop Participants
Response to questions due to OPP by January 13, 2014
studies. In this example your company only anticipates generating 80% of the
requested studies for this DCI request.
Consultation activities
10.Does your company track time and labor estimates for consultation activities?
How would you define the burden activities (i.e., meeting logistics, meeting
preparation, travel, meeting follow-up including debriefing management)?
General Questions:
11.When you receive a DCI, are the instructions and process for responding
understandable? Do you clearly know what is required of you?
12. If there are records to maintain, are you familiar with your record keeping
requirements?
13.Are the forms that are used to report the data gaps, clear, logical, and easy to
comprehend and/or complete?
14.Do you normally submit your response as part of a DVD or other electronic file
only? Or is your response a mix of electronic media and paper?
15.Do you have any suggestions to offer to the Agency to clarify the instructions
or the forms?
Office of Pesticide Programs
Questions for DCI Response Burden Assessment Workshop Participants
Response to questions due to OPP by January 13, 2014
Response to OPP
Thank you for your participation in the DCI Response Burden Assessment
Workshop. We would like to receive your comments by January 13, 2014. We
ask that each company submit one set of consolidated comments. Please forward
your non-CBI responses via email to Cameo Smoot, Field and External Affairs
Division, OPP [email protected], phone (703)305-5454.
If you have additional questions, or would like to follow-up with OPP staff. Staff
contact numbers are as follows:
BEAD – Elizabeth Hill, 703-308-8150
PRD – Joe Nevola, 703-308-8037
AD – Rose Kyprianou, 703-305-5354
Pesticide Data Call In (DCI) Information Collection Request (ICR)
Industry Consultation Workshop
December 12, 2013, 11:00am – 1:30pm
List of Participants
Industry
EPA
David Swayne – Scientific and Reg Consultant (SRC)
Lily Negash
Erin Ahlers – Monsanto
Joe Hogue
Erin Tesch – Tech Sciences Group
Martha Shimkin
Abigail
Elizabeth Hill
– Tech Sciences
Abbey Trubblewood – Dow
Michelle Ranville
Janelle Kay – Texas Reg Consulting
Tim Kiely
John Abbot –
Mike Goodis
Charlotte Sanson – BASF
Angela Hoffman
Kristy Keating – BASF
Joe Nevola
Robert Butz –
Cameo Smoot
Rachel Calliers – SC Johnson
Rose Kyprianou
Seth Goldberg – Steptoe
Rich Dumas
Elizabeth Brown – Steptoe
Kathryn Boyle
Mike Kelly –
Stephen Smearman
Has Shah – American Chemistry Council (ACC)
Lance Wormel
Kathryn Boyle
Steve Smearman
| File Type | application/pdf |
| Author | Smoot, Cameo |
| File Modified | 2016-04-01 |
| File Created | 2016-03-24 |