Document ID: EPA-HQ-OPP-2007-0923-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-01-16T05:00Z

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-2007- 0923 at   HYPERLINK "http://www.regulations.gov" 
www.regulations.gov .

Attachment G

Office of Pesticide Programs

October 2007

  TOC \o "1-4" \h \z \u  

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

 

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 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 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.
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
re-evaluation 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).  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 (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.  “Burden” means the time, effort, or
financial resources expended by persons to generate, maintain, or
provide information to or for a Federal Agency.” 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 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 data	Assist with search for
existing data

Sign and send initial response forms to EPA

Prepare initial response forms for submission

Oversight of employee activities

PHASE 2(a): DATA GENERATION USING CONTRACT LABORATORY

Planning/oversight of employee and contract activities	Plan the data
collection activities with the laboratory	Complete/file/archive other
required paperwork

Make decisions

Electronic data entry

Secure contract lab services and approve statement of work (SOW)	Create
test protocols for 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 contract activities	Routine contact with
testing laboratory which can include on-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 EPA	Draft summary of the data for cover letter
Prepare submission to EPA

Close-out contract

Oversight of employee activities	Complete other required paperwork
Complete/file/archive 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 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,   SEQ CHAPTER \h \r 1 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.

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.     	



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 1-Response 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 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).

 

Figure - 1 Relationship of Test Costs to Response Phases 

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.

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:

Managerial (20%)

Technical (65%)

Clerical (15%)	   

Labor rates are derived from the parent ICR

Labor rates are “fully loaded”

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 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 estimate 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
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 fully-loaded 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

 	

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:	14.05 hours ($1,417.50)

Technical labor:		71.04 hours ($4,606.88)

Clerical labor:		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. 

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. 2070-0060, (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, 2005, 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. 



Attachment A

Case Studies: Agency Analysis of Response Costs for Phase 1 Responses 

 

In this study, EPA assumes: 

Paperwork activities for applications for registration for “me-too”
pesticides  are similar to paperwork activities for developing a DCI
response that does not entail generating new data or requesting a
waiver. 

Estimated burden and costs listed in Table A are fixed, consistent costs
for every respondent, and are not derived from any test cost estimates.

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. 

The paperwork burden for phase 1 responses that are similar to
activities in developing registration applications may be described as
follows:

read and discuss test requirements (read the DCI letter to understand
what data are to be submitted); 

plan activities (includes time for reviewing internal company
information); 

complete paperwork (prepare necessary correspondence, documents to EPA);

Store/maintain information (maintain information submitted to the Agency
in company files).

Paperwork burden for such activities may be disaggregated by labor
category as follows (percentages are approximations):

Managerial (65%)

Technical (0%)

Clerical (35%)

Labor rates are derived from the parent ICR.

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 do 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	Totals

	Management	Technical	Clerical	Hours	Cost

Read instructions	7	0	0	7	938

Plan activities	0.5	0	0	0.5	67

Complete Paperwork	0	0	3	3	123

Store/maintain data	0	0	1	1	41

Totals	7.5	0	4	11.5	1169

(* Indexed to 2005 dollars)

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.   



In this study EPA assumes:

The total paperwork burden hours and costs for Phase 1 responses are
approximately 7 percent of the estimated average cost to generate new
data.  

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 eligibilitygeneric
data exemption. 

Paperwork activities that do not involve data generation may be
described as follows:

read and discuss test requirements (read the DCI letter to understand
what data are to be submitted); 

plan activities (developing options for not generating new data includes
 reviewing internal company information for existing data); 

complete paperwork (prepare necessary correspondence, documents and/or
waiver requests to avoid having to submitting data to EPA);

record, maintain and file information (maintain information submitted to
the Agency in company files).

Paperwork burden for Phase 1 DCI responses  activities may be
disaggregated by labor category as follows (percentages are
approximations):

Managerial (50%)

Technical (5%) 

Clerical (45%)

Labor rates are derived from the parent ICR 

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,
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:	$708.75 = ($1,417.50 * 0.50)

Technical labor:		  $70.88 = ($1,417.50 * 0.05)

Clerical labor:		$637.87 = ($1,417.50 * 0.45)

Total labor:						$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:	5.45 hours ($708.75 ÷ $130/hr)

Technical labor:	  	0.81 hours ($70.88 ÷ $88/hr)

Clerical labor:		15.95 hours ($637.87 ÷ $40/hr)

Total hours:	      	22.21 hours

 

	

Under 40 CFR 158.45, the Agency may waive data requirements on a
case-by-case 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.  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 searches,  

Calculations & analysis

10

10	1000

Compiling rational 

8

8	800

Review document file and submit	

1

1	

2	

200

Total

20	2000



Attachment B

Chart: FIFRA Estimated Study Costs And Paperwork Burden Hour And Cost
Estimates 



Test Information	Paperwork Burden Totals

(35% of study cost)	 	 

Test Guideline/

Section	Test Name	AverageTest Cost	Total Paperwork Burden Cost	Total
Paperwork Burden Hours	High Test Cost 

(High AVG for 2005 SciReg)	Low Test Cost 

(Low AVG for 2005 SciReg)

 	 	 	 	 	 	 

Product Performance 	 	 	 	 	 	 

810.1000	Overview, Definitions, and General Considerations 	$100,000.0
$35,000.0	443.6	$100,000.0	$100,000.0

810.1550	Product Identity and Disclosure of Ingredients (Composition)
(Chemical Identity)	$223.0	$78.1	1.0	$223.0	$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

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	 	 	 	 

830.1550	Product identity and composition	$233.0	$81.6	1.0	$223.0	 

830.1600	Description of materials used to produce the product	$334.0
$116.9	1.5	$501.0	$167.0

830.1620	Description of production process	$418.0	$146.3	1.9	$167.0
$668.0

830.1650	Description of formulation process	$418.0	$146.3	1.9	$167.0
$668.0

830.1670	Discussion of formulation of impurities	$418.0	$146.3	1.9
$167.0	$668.0

830.1700	Preliminary analysis	$31,715.0	$11,100.3	140.7	$50,054.0
$8,875.0

830.1750	Certified limits	$248.0	$86.8	1.1	$330.0	$165.0

830.1800	Enforcement analytical method	$15,454.0	$5,408.9	68.6	$21,538.0
$9,371.0

830.1900	Submittal of samples	$495.0	$173.3	2.2	$660.0	$330.0

830.6302	Color	$700.0	$245.0	3.1	$1,000.0	$400.0

830.6303	Physical state	$700.0	$245.0	3.1	$1,000.0	$400.0

830.6304	Odor	$700.0	$245.0	3.1	$1,000.0	$400.0

830.6313	Stability to normal and elevated temperatures, metals, and
metal ions	$8,250.0	$2,887.5	36.6	$12,000.0	$4,500.0

830.6314	Oxidation/reduction: chemical incompatibility	$2,994.0	$1,047.9
13.3	$3,044.0	$2,944.0

830.6315	Flammability	$2,000.0	$700.0	8.9	$3,000.0	$1,000.0

830.6316	Explodability	$4,163.0	$1,457.1	18.5	$4,163.0	$4,163.0

830.6317	Storage stability	$11,500.0	$4,025.0	51.0	$15,000.0	$8,000.0

830.6319	Miscibility	$1,100.0	$385.0	4.9	$1,500.0	$700.0

830.6320	Corrosion characteristics	$2,750.0	$962.5	12.2	$3,500.0
$2,000.0

830.6321	Dielectric breakdown voltage	$2,525.0	$883.8	11.2	$2,675.0
$2,375.0

830.7000	pH	$750.0	$262.5	3.3	$1,000.0	$500.0

830.7050	UV/visible light absorption	$2,022.0	$707.7	9.0	$2,072.0
$1,972.0

830.7100	Viscosity	$1,400.0	$490.0	6.2	$2,000.0	$800.0

830.7200	Melting point/melting range	$1,200.0	$420.0	5.3	$1,600.0	$800.0

830.7220	Boiling point/boiling range	$1,500.0	$525.0	6.7	$2,000.0
$1,000.0

830.7300	Density/relative density/bulk density	$1,400.0	$490.0	6.2
$2,000.0	$800.0

830.7370	Dissociation constants in water	$4,845.0	$1,695.8	21.5	$4,845.0
$4,845.0

830.7520	Particle size, fiber length, and diameter distribution	$1,333.0
$466.6	5.9	$1,333.0	$1,333.0

830.7550	Partition coefficient (n-octanol/water) - shake flask method
$6,667.0	$2,333.5	29.6	$7,333.0	$6,000.0

830.7560	Partition coefficient (n-octanol/water) -generator column 
$6,667.0	$2,333.5	29.6	$7,333.0	$6,000.0

830.7570	Partition coefficient (n-octanol/water) -estimation
chromatography	$4,388.0	$1,535.8	19.5	$4,700.0	$4,075.0

830.7840	Water Solubility:  column elution/shake flask	$9,635.0	$3,372.3
42.7	$11,322.0	$7,947.0

830.7860	Water solubility	$9,635.0	$3,372.3	42.7	$11,322.0	$7,947.0

830.7950	Vapor pressure	$15,000.0	$5,250.0	66.5	$20,000.0	$10,000.0

 	 	 	 	 	 	 

Spray Drift	 	 	 	 	 	 

840.1100	Spray droplet size spectrum	$258,750.0	$90,562.5	1,147.9
$340,000.0	$177,500.0

840.1200	Spray drift field deposition	$16,250.0	$5,687.5	72.1	$25,000.0
$7,500.0

 	 	 	 	 	 	 

Ecological Effects Tests	 	 	 	 	 

850.1000	Use Profile	$251.0	$87.9	1.1	$334.0	$167.0

850.1010	Aquatic invertebrate acute toxicity, freshwater daphnids
$17,000.0	$5,950.0	75.4	$20,000.0	$14,000.0

850.1020	Gammarid acute toxicity test	$0.0	$0.0	0.0	$0.0	$0.0

850.1025	Oyster acute toxicity test	$32,725.0	$11,453.8	145.2	$32,725.0
$7,550.0

850.1035	Mysid acute toxicity test	$32,725.0	$11,453.8	145.2	$32,725.0
$7,550.0

850.1045	Penaeid acute toxicity test	$32,725.0	$11,453.8	145.2	$32,725.0
$7,550.0

850.1055	Bivalve acute tox larval (embryo/larval) 	$32,725.0	$11,453.8
145.2	$32,725.0	$7,550.0

850.1075	Fish acute toxicity (freshwater)	$17,000.0	$5,950.0	75.4
$28,061.0	$10,066.0

850.1075	Fish acute toxicity test (estaurine/marine)	$20,138.0	$7,048.3
89.3	$20,138.0	$20,138.0

850.1300	Daphnid chronic toxicity test	$118,063.0	$41,322.1	523.7
$162,800.0	$73,325.0

850.1350	Mysid chronic tox - aquatic invertebrate life-cycle (saltwater)
$36,333.0	$12,716.6	161.2	$41,000.0	$31,667.0

850.1400	Fish early-life stage toxicity test (freshwater)	$37,279.0
$13,047.7	165.4	$41,379.0	$33,179.0

850.1450	Fish early-life stage toxicity test (saltwater)	$75,000.0
$26,250.0	332.7	$0.0	$0.0

850.1500	Fish life-cycle toxicity	$512,500.0	$179,375.0	2,273.5
$650,000.0	$375,000.0

850.1710	Aquatic Bioavailability/Biomagnification:  Oyster BCF
$123,919.0	$43,371.7	549.7	$143,919.0	$103,919.0

850.1730	Aquatic Bioavailability/Biomagnification:  Fish BCF	$140,452.0
$49,158.2	623.1	$169,279.0	$111,624.0

850.1735	Whole sediment acute toxicity invertebrates (freshwater)
$20,250.0	$7,087.5	89.8	$21,500.0	$26,000.0

850.1740	Whole sediment acute toxicity invertebrates (marine)	$37,500.0
$13,125.0	166.4	$50,000.0	$25,000.0

850.1790	Chironomid sediment toxicity test	$83,000.0	$29,050.0	368.2
$83,000.0	$83,000.0

850.1800	Tadpole/sediment subchronic toxicity test	$195,856.0	$68,549.6
868.9	$195,856.0	$195,856.0

850.1850	Aquatic food chain transfer - Bioavailability	$325,000.0
$113,750.0	1,441.8	$500,000.0	$150,000.0

850.1900	Generic  freshwater microscosm test (laboratory)	$295,000.0
$103,250.0	1,308.7	$360,000.0	$230,000.0

850.1925	Site-specific aquatic microcosm test (laboratory)	$250,000.0
$87,500.0	1,109.0	$250,000.0	$250,000.0

850.1950	Simulated or actual field testing - field animal	$512,500.0
$179,375.0	2,273.5	$650,000.0	$375,000.0

850.1950	Simulated or actual field testing - aquatic	$600,000.0
$210,000.0	2,661.7	$700,000.0	$500,000.0

850.1950	Simulated or actual field testing - insect predators	$87,500.0
$30,625.0	388.2	$100,000.0	$75,000.0

850.1950	Simulated or actual field testing - plants	$62,500.0	$21,875.0
277.3	$75,000.0	$50,000.0

850.2100	Avian acute oral toxicity test	$10,100.0	$3,535.0	44.8
$13,800.0	$6,400.0

850.2200	Avian dietary toxicity test	$6,480.0	$2,268.0	28.7	$6,647.0
$6,313.0

850.2300	Avian reproduction test	$168,250.0	$58,887.5	746.4	$215,500.0
$121,000.0

850.2400	Wild mammal acute toxicity	$35,000.0	$12,250.0	155.3	$50,000.0
$20,000.0

850.2500	Simulated or actual field testing terrestrial wildlife
$527,502.0	$184,625.7	2,340.1	$552,000.0	$502,000.0

850.2500	Simulated or actual field testing - birds	$600,000.0	$210,000.0
2,661.7	$700,000.0	$500,000.0

850.3020	Honey bee acute contact toxicity	$3,175.0	$1,111.3	14.1
$3,175.0	$3,175.0

850.3030	Honey bee toxicity of residues on foliage	$13,368.0	$4,678.8
59.3	$16,670.0	$10,065.0

850.3040	Field testing for pollinators	$47,500.0	$16,625.0	210.7
$65,000.0	$30,000.0

850.4000	Background - Nontarget plant testing	$0.0	$0.0	0.0	$0.0	$0.0

850.4025	Target area phytotoxicity	$0.0	$0.0	0.0	$0.0	$0.0

850.4100	Terrestrial plant toxicity (seedling emergence, Tier I)
$14,625.0	$5,118.8	64.9	$15,625.0	$13,625.0

850.4150	Terrestrial plant toxicity (vegetative vigor, Tier I)	$14,625.0
$5,118.8	64.9	$15,625.0	$13,625.0

850.4200	Seed germination/root elongation toxicity test	$10,292.0
$3,602.2	45.7	$15,875.0	$4,709.0

850.4200	Seed germination/root elongation toxicity test	$25,602.5
$8,960.9	113.6	$30,930.0	$20,275.0

850.4230	Early seed growth toxicity test	$0.0	$0.0	0.0	$0.0	$0.0

850.4225	Seedling emergence, Tier II	$20,375.0	$7,131.3	90.4	$22,000.0
$18,750.0

850.4250	Vegetative vigor, Tier II	$24,500.0	$8,575.0	108.7	$26,500.0
$22,500.0

850.4300	Terrestrial plants field study, Tier III	$111,863.0	$39,152.1
496.2	$126,863.0	$26,500.0

850.4400	Aquatic plant toxicology test using Lemna spp., Tier I
$35,155.0	$12,304.3	156.0	$39,525.0	$18,750.0

850.4400	Aquatic plant toxicology test using Lemna spp., Tier II
$35,155.0	$18,632.2	236.2	$35,155.0	$35,155.0

850.4450	Aquatic plants field study, Tier III	$0.0	$0.0	0.0	$0.0	$0.0

850.5400	Algal Toxicity Tier I and Tier II	$35,155.0	$12,304.3	156.0
$35,155.0	$35,155.0

na	Acute toxicity to aquatic insects	$0.0	$0.0	0.0	$0.0	$0.0

na	Aquatic insect life-cycle study	$0.0	$0.0	0.0	$0.0	$0.0

na	Simulated or actual field testing for aquatic insects	$0.0	$0.0	0.0
$0.0	$0.0

na	Nontarget insect testing - predators and parasites	$0.0	$0.0	0.0	$0.0
$0.0

na	Nontarget insect testing - predators and parasites	$0.0	$0.0	0.0	$0.0
$0.0

 	 	 	 	 	 	 

Health Effects	 	 	 	 	 	 

870.1100	Acute oral toxicity (rat)	$3,473.0	$1,215.6	15.4	$4,015.0
$2,932.0

870.1200	Acute dermal toxicity	$2,000.0	$700.0	8.9	$3,000.0	$1,000.0

870.1300	Acute inhalation toxicity (rat)	$2,000.0	$700.0	8.9	$3,000.0
$1,000.0

870.1300	Acute inhalation tox (microbials)	$12,000.0	$4,200.0	53.2
$20,000.0	$4,000.0

870.2400	Acute eye irritation (rabbit)	$2,000.0	$700.0	8.9	$3,000.0
$1,000.0

870.2500	Acute dermal irritation	$2,000.0	$700.0	8.9	$3,000.0	$1,000.0

870.2600	Skin (dermal) sensitization	$8,000.0	$2,800.0	35.5	$10,000.0
$6,000.0

870.3100	90-day oral toxicity in rodents	$138,106.0	$48,337.1	612.7
$142,517.0	$133,695.0

870.3150	90-day oral toxicity in non-rodents	$221,047.0	$77,366.5	980.6
$221,047.0	$221,047.0

870.3200	21/28-day dermal toxicity	$83,240.0	$29,134.0	369.3	$84,681.0
$81,798.0

870.3250	90-day dermal toxicity	$137,094.0	$47,982.9	608.2	$138,114.0
$137,094.0

870.3465	90-day inhalation toxicity (rat)	$300,000.0	$105,000.0	1,330.9
$350,000.0	$300,000.0

870.3700	Prenatal developmental toxicity study (rat and rabbit,
preferred)	$76,844.0	$26,895.4	340.9	$77,037.0	$76,844.0

870.3800	Reproduction and fertility effects (multigeneration) 
$378,479.0	$132,467.7	1,679.0	$381,233.0	$378,479.0

870.4100	Chronic tox (rodent and non-rodent)	$950,000.0	$332,500.0
4,214.4	$1,100,000.0	$950,000.0

870.4200	Carcinogenicity (rat and mouse, preferred)	$1,730,000.0
$605,500.0	7,674.6	$2,060,000.0	$1,730,000.0

870.4200	Carcinogenicity (microbials)	$922,244.0	$322,785.4	4,091.2
$925,806.0	$922,244.0

870.5100	Bacterial reverse mutation assay  	$4,057.0	$1,420.0	18.0
$4,457.0	$4,057.0

870.5300	In vitro mammalian cell gene mutation test	$18,654.0	$6,528.9
82.8	$19,767.0	$18,654.0

870.5375	In vitro mammalian chromosomal aberration test	$0.0	$0.0	0.0
$0.0	$0.0

870.5380	Mammalian spermatogonial chromosomal aberration test	$19,382.0
$6,783.7	86.0	$19,382.0	$19,382.0

870.5385	Mammalian bone marrow chromosomal aberration test	$30,004.0
$10,501.4	133.1	$30,004.0	$30,004.0

870.5395	Mammalian erthrocyte micronucleus test	$20,477.0	$7,167.0	90.8
$20,594.0	$20,477.0

none	Reference list of all studies/papers known to the applicant
concerning mutagenicity	$418.0	$146.3	1.9	$418.0	$418.0

870.5450	Rodent dominant lethal assay	$0.0	$0.0	0.0	$0.0	$0.0

870.5500	Bacterial DNA damage or repair tests	$0.0	$0.0	0.0	$0.0	$0.0

870.5550	Unscheduled DNA synthesis in mammalian cells in culture
$30,000.0	$10,500.0	133.1	$0.0	$0.0

870.6100	Acute and 28 day delayed neurotoxicity organophosphorus
substances (hen)	$79,375.0	$27,781.3	352.1	$80,625.0	$72,125.0

870.6200	Acute neurotoxicity (rat)	$89,596.0	$31,358.6	397.5	$91,680.0
$87,513.0

870.6200	90-day Neurotoxicity (rat)	$184,039.0	$64,413.7	816.4
$186,410.0	$181,668.0

870.6300	Developmental neurotoxicity study	$406,904.0	$142,416.4	1,805.1
$417,135.0	$396,904.0

870.6500	Schedule-controlled operant behavior 	$164,000.0	$57,400.0
727.5	$164,000.0	$164,000.0

870.6850	Peripheral nerve function 	$110,000.0	$38,500.0	488.0
$110,000.0	$110,000.0

870.6855	Neurophysiology: sensory evoked potentials	$110,000.0	$38,500.0
488.0	$110,000.0	$110,000.0

870.7200	Companion animal safety	$156,000.0	$54,600.0	692.0	$167,667.0
$144,333.0

870.7485	Metabolism and pharmacokinetics	$182,729.0	$63,955.2	810.6
$217,729.0	$147,729.0

870.7600	Dermal penetration	$147,529.0	$51,635.2	654.5	$175,346.0
$119,711.0

870.7800	Immunotoxicity 	$56,648.0	$19,826.8	251.3	$57,731.0	$55,565.0

 	 	 	 	 	 	 

Occupational and Residential Exposure	 	 	 	 	 

875.1100	Dermal outdoor exposure	$167,857.0	$58,750.0	744.6	$192,143.0
$143,571.0

875.1200	Dermal indoor exposure	$126,429.0	$44,250.2	560.9	$150,714.0
$102,143.0

875.1300	Inhalation outdoor exposure	$164,286.0	$57,500.1	728.8
$181,429.0	$147,143.0

875.1400	Inhalation indoor exposure	$126,429.0	$44,250.2	560.9
$150,714.0	$102,143.0

875.1500	Biological monitoring 	$188,393.0	$65,937.6	835.7	$219,256.0
$157,500.0

875.1600	Application exposure data reporting and calculations	$7,500.0
$2,625.0	33.3	$10,000.0	$5,000.0

875.1700	Product use information 	$3,000.0	$1,050.0	13.3	$4,000.0
$2,000.0

875.2100	Dislodgeable foliar residue dissipation and turf transferable
residues	$55,100.0	$19,285.0	244.4	$56,100.0	$54,100.0

875.2200	Soil residue dissipation	$83,125.0	$29,093.8	368.8	$85,000.0
$81,250.0

875.2300	Indoor surface residue dissipation 	$35,000.0	$12,250.0	155.3
$35,000.0	 

875.2400	Dermal exposure	$125,500.0	$43,925.0	556.7	$133,000.0
$118,000.0

875.2500	Inhalation exposure	$73,000.0	$25,550.0	323.8	$81,000.0
$65,000.0

875.2600	Biological monitoring 	$166,875.0	$58,406.3	740.3	$191,667.0
$142,083.0

875.2700	Product use information 	$3,000.0	$1,050.0	13.3	$4,000.0
$2,000.0

875.2800	Description of human activity	$3,000.0	$1,050.0	13.3	$4,000.0
$2,000.0

875.2900	Data reporting and calculations	$3,000.0	$1,050.0	13.3	$4,000.0
$2,000.0

875.3000	Nondietary ingestion exposure 	$75,000.0	$26,250.0	332.7
$83,333.0	$66,667.0

 	 	 	 	 	 	 

Environmental Fate	 	 	 	 	 	 

none	Use Profile	$251.0	$0.0	0.0	$334.0	$167.0

835.1230	Sediment and soil adsorption/desorption	$23,750.0	$8,312.5
105.4	$24,583.0	$22,917.0

835.1240	Leaching and adsorption/desorption	$46,780.0	$16,373.0	207.5
$51,880.0	$41,680.0

835.1410	Laboratory volatility	$45,000.0	$15,750.0	199.6	$5,000.0
$40,000.0

835.2120	Hydrolysis	$25,230.0	$8,830.5	111.9	$29,900.0	$20,560.0

835.2240	Photodegradation in water	$46,875.0	$16,406.3	207.9	$47,875.0
$47,875.0

835.2370	Photodegradation in air	$110,000.0	$38,500.0	488.0	$120,000.0
$100,000.0

835.2410	Photodegradation on soil	$42,350.0	$14,822.5	187.9	$45,183.0
$39,517.0

835.4100	Aerobic soil metabolism	$94,375.0	$33,031.3	418.7	$98,625.0
$90,125.0

835.4200	Anaerobic soil metabolism	$71,300.0	$24,955.0	316.3	$71,300.0
$71,300.0

835.4300	Aerobic aquatic metabolism	$44,475.0	$15,566.3	197.3	$47,350.0
$41,600.0

835.4400	Anaerobic aquatic metabolism	$80,900.0	$28,315.0	358.9
$86,525.0	$72,275.0

835.6100	Terrestrial field dissipation	$317,767.0	$111,218.5	1,409.7
$366,067.0	$269,467.0

835.6200	Aquatic field dissipation	$267,250.0	$93,537.5	1,185.6
$354,000.0	$180,500.0

835.6300	Forestry dissipation	$275,500.0	$96,425.0	1,222.2	$362,500.0
$188,500.0

835.6400	Combination and tank mixes	$219,200.0	$76,720.0	972.4
$219,200.0	 

835.8100	Field volatility	$230,900.0	$80,815.0	1,024.3	$230,900.0	 

835.7100	Groundwater Monitoring	$1,225,000.0	$428,750.0	5,434.3
$2,000,000.0	$450,000.0

none	Monitoring of representative U.S. waters	$215,833.0	$75,541.6	957.5
$263,333.0	$168,333.0

none	Leaching study	$43,000.0	$15,050.0	190.8	$48,000.0	$38,000.0

 	 	 	 	 	 	 

Residue Chemistry	 	 	 	 	 	 

860.1100	Chemical identity	$1,250.0	$437.5	5.5	$2,000.0	$500.0

860.1200	Directions for use	$4,000.0	$1,400.0	17.7	$5,000.0	$3,000.0

860.1300	Nature of the residue in plants	$100,000.0	$35,000.0	443.6
$105,000.0	$95,000.0

860.1300	Nature of the residue in livestock	$105,833.0	$37,041.6	469.5
$118,333.0	$93,333.0

860.1340	Residue analytical method - plants	$22,125.0	$7,743.8	98.2
$23,250.0	$19,000.0

860.1340	Residue analytical method - livestock	$65,500.0	$22,925.0	290.6
$76,800.0	$54,200.0

860.1360	Multiresidue method	$24,000.0	$8,400.0	106.5	$25,667.0
$22,333.0

860.1380	Storage stability data 	$18,500.0	$6,475.0	82.1	$18,500.0
$18,500.0

860.1400	Water	$53,750.0	$18,812.5	238.4	$55,000.0	$52,500.0

860.1400	Fish	$104,000.0	$36,400.0	461.4	$130,000.0	$78,000.0

860.1400	Irrigated crops (one-crop)	$18,000.0	$6,300.0	79.9	$20,500.0
$15,500.0

860.1460	Food handling	$205,000.0	$71,750.0	909.4	$230,000.0	$180,000.0

860.1480	Meat/milk/poultry/eggs	$149,000.0	$52,150.0	661.0	$152,333.0
$145,667.0

860.1500	Crop field trials	$163,667.0	$57,283.5	726.1	$177,000.0
$150,333.0

860.1520	Processed food/feed	$35,000.0	$12,250.0	155.3	$37,333.0
$32,667.0

860.1540	Reduction of Residues    	$15,000.0	$5,250.0	66.5	$20,000.0
$10,000.0

860.1550	Proposed tolerance	$5,363.0	$1,877.1	23.8	$6,600.0	$4,124.0

860.1560	Reasonable grounds in support of the petition	$10,000.0
$3,500.0	44.4	$15,000.0	$5,000.0

860.1650	Submittal of analytical reference standards	$334.0	$116.9	1.5
$501.0	$167.0

860.1850	Confined accumulation in rotational crops	$249,845.0	$87,445.8
1,108.4	$269,845.0	$229,845.0

860.1900	Field accumulation in rotational crops 	$137,500.0	$48,125.0
610.0	$125,000.0	$150,000.0

none	Migration Studies	$105,000.0	$36,750.0	465.8	$120,000.0	$90,000.0

 	 	 	 	 	 	 

Microbial Pesticides	 	 	 	 	 	 

880.1100	Product identity	$233.0	$81.6	1.0	$300.0	$165.0

880.1200	Description materials, production, formulation	$908.0	$317.8
4.0	$1,650.0	$165.0

880.1400	Discussion of formation of impurities	$330.0	$115.5	1.5	$495.0
$165.0

880.3800	Immune Response	$85,000.0	$29,750.0	377.1	$100,000.0	$70,000.0

880.4350	Non-target insect testing	$15,000.0	$5,250.0	66.5	$18,000.0
$12,000.0

880.4425	Dispenser - water leaching	$25,000.0	$8,750.0	110.9	$30,000.0
$20,000.0

 	Hypersensitivity incidents	$825.0	$288.8	3.7	$1,320.0	$330.0

885.1100	Product Identity	$5,000.0	$1,750.0	22.2	$8,000.0	$2,000.0

885.1200a	Manufacturing process	$3,500.0	$1,225.0	15.5	$5,000.0	$2,000.0

885.1200b	Deposition of samples	$3,500.0	$1,225.0	15.5	$5,000.0	$2,000.0

885.1300	Discussion of formulation of unintentional ingredients	$3,500.0
$1,225.0	15.5	$5,000.0	$2,000.0

885.1400	Analysis of samples	$74,500.0	$26,075.0	330.5	$145,000.0
$4,000.0

885.1500	Certification of limits	$350.0	$122.5	1.6	$500.0	$200.0

885.2000	Background for residue analysis of microbial pest control
agents	$0.0	$0.0	0.0	$0.0	$0.0

885.2100	Chemical identity	$660.0	$231.0	2.9	$825.0	$495.0

885.2200	Nature of the residue in plants	$108,333.0	$37,916.6	480.6
$108,333.0	$108,333.0

885.2250	Nature of the residue in animals	$117,144.0	$41,000.4	519.7
$123,750.0	$110,538.0

885.2300	Analytical method - plants	$26,540.0	$9,289.0	117.7	$34,040.0
$19,040.0

885.2350	Analytical method - animals	$43,908.0	$15,367.8	194.8	$56,325.0
$31,492.0

885.2400	Storage stability, plants	$31,017.0	$10,856.0	137.6	$32,683.0
$29,350.0

885.2500	Magnitude of residue in plants	$137,160.0	$48,006.0	608.5
$137,587.0	$136,733.0

885.2550	Magnitude of residue in meat/milk/poultry	$157,663.0	$55,182.1
699.4	$162,425.0	$152,900.0

885.2600	Magnitude of residue in potable water, fish, and irrigated
crops	$221,442.0	$77,504.7	982.4	$245,225.0	$197,658.0

885.3000	Background Mammalian Infectivity/pathogenicity analysis
$250,000.0	$87,500.0	1,109.0	$250,000.0	$250,000.0

885.3050	Acute oral toxicity/pathogenicity	$33,500.0	$11,725.0	148.6
$41,000.0	$25,000.0

885.3150	Acute pulmonary toxicity/pathogenicity	$37,500.0	$13,125.0
166.4	$50,000.0	$25,000.0

885.3200	Acute injection toxicity/pathogenicity (intravenous)	$37,500.0
$13,125.0	166.4	$50,000.0	$25,000.0

885.3200	Acute injection toxicity/pathogenicity (intraperitoneal)
$12,500.0	$4,375.0	55.5	$18,000.0	$7,000.0

885.3400	Hypersensitivity incidents	$800.0	$280.0	3.5	$1,300.0	$300.0

885.3500	Cell Culture	$30,000.0	$10,500.0	133.1	$35,000.0	$25,000.0

885.3550	Acute toxicity, TI	$21,500.0	$7,525.0	95.4	$40,000.0	$3,000.0

885.3600	Subchronic toxicity/pathogenicity	$150,000.0	$52,500.0	665.4
$200,000.0	$100,000.0

885.3650	Reproductive/fertility effects	$162,500.0	$56,875.0	720.9
$20,000.0	$125,000.0

885.4050	Avian Oral, TI	$15,000.0	$5,250.0	66.5	$18,000.0	$12,000.0

885.4100	Avian Inhalation toxicity/pathogenicity, TI	$16,000.0	$5,600.0
71.0	$20,000.0	$12,000.0

885.4150	Wild mammal toxicity/pathogenicity,TI	$65,000.0	$22,750.0	288.4
$80,000.0	$50,000.0

885.4200	Freshwater fish toxicity/pathogenicity,TI	$37,500.0	$13,125.0
166.4	$45,000.0	$30,000.0

885.4240	Freshwater invertebrate toxicity/pathogenicity,TI	$37,500.0
$13,125.0	166.4	$45,000.0	$30,000.0

885.4280	Estuarine/marine animal testing, TI	$40,000.0	$14,000.0	177.4
$48,000.0	$32,000.0

885.4280	Estuarine/marine invertebrate testing,TI	$40,000.0	$14,000.0
177.4	$48,000.0	$32,000.0

885.4300	Nontarget plant studies, TI	$30,000.0	$10,500.0	133.1	$40,000.0
$20,000.0

885.4380	Honey bee testing	$4,250.0	$1,487.5	18.9	$5,000.0	$3,500.0

885.4600	Avian chronic pathogenicity and reproduction, TIII	$175,000.0
$61,250.0	776.3	$200,000.0	$150,000.0

885.4650	Aquatic invertebrate range testing,TIII	$75,000.0	$26,250.0
332.7	$1,000.0	$50,000.0

885.4700	Fish life cycle studies,TIII	$250,000.0	$87,500.0	1,109.0
$300,000.0	$200,000.0

885.4750	Aquatic ecosystem test	$350,000.0	$122,500.0	1,552.7	$400,000.0
$300,000.0

885.5200	Terrestrial environmental expression tests	$95,000.0	$33,250.0
421.4	$150,000.0	$40,000.0

885.5300	Freshwater environmental expression test	$0.0	$0.0	0.0	$0.0
$0.0

885.5400	Marine or estaurine environmental expression tests	$95,000.0
$33,250.0	421.4	$150,000.0	$40,000.0

 	 	 	 	 	 	 

 	 	 	 	 	 	 

Notes:

	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	 	 	 	 	 

 OMB is part of the Executive Office of the President.

 5 CFR 1320.3(l)

 5 CFR 1320.3(b)

 Assumes registrants perform most of the PRA activities highlighted in,
Section I-V, “DCI burden activity tables;” Table 1 – Response
Phases 

 See Section I-V, “DCI burden activity tables;” Table 1 – Response
Phases; which lists specific managerial, technical, and clerical duties.

 “Fully loaded” labor rates are meant to be the estimated costs of
wages, overhead, and benefits paid to an employee. 

 See Section 1-V “DCI burden activity tables;” Table 1 – Response
Phases. 

 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.      

 “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. 

 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. 

 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. 

    

 PAGE   

		Page   PAGE  30  of   NUMPAGES  30 					

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35% of test cost covers the PRA burden hours and costs of all three
phases of a DCI response  

Phase 1:

Initial Response to DCI

Phase II (a&b)

Data Generation including technical duties conducted at Laboratories

Phase III:

Data Submission to EPA

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

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   

Section I.  Background	

2.  Study #2: Data Generation for Pesticide Reregistration ICR, OMB No.
2070-0107, (EPA ICR No. 1504.05).  

3.  Study #3:  Economic Analysis for Proposed Changes in Data
Requirements Rule for Biochemical and Microbial Pesticides – Cost
Estimates for Data Waivers. 

Section II.  Estimating Paperwork Activities Of Data Generation

Contents