Amendment to the Supporting Statement for the ICR: "Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)" (EPA ICR No.: 2249.01)

September 10, 2009

Amendment to the
Supporting Statement for the Information Collection Request (ICR):
Title: Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor
Screening Program (EDSP)
EPA ICR No.: 2249.01; OMB Control No.: 2070-(tbd)
Docket ID No.: EPA-HQ-OPPT-2007-1081

Overview:
In the current ICR, the estimated total number of potential respondents is 390. In
describing the method for estimating this number, the Agency indicated on page 14 of
the supporting statement that it intended to search external sources to identify other
potential manufacturers and importers of the listed chemicals. Subsequent to
submitting the ICR on April 15, 2009, EPA used a contractor’s assistance to complete
such a search of external public sources of information to identify other potential
manufacturers and importers of the listed chemicals. This amendment provides an
adjustment to the estimated number of potential Order recipients and the corresponding
calculations. The chemicals listed in the April ICR, the activities described,
methodologies used, and per activity burden estimates are not changed in this
amendment.

Amended Potential Number of Respondents:
The estimated number of potential Order recipients identified to date for each of
the 67 chemicals is provided in Attachment A2 to this amendment. The estimated
number of potential respondents for this ICR is assumed to include all of the potential
recipients of an Order. Each Order recipient has several options for their initial
response, which in turn specifically identifies the remaining activities applicable to them.
Although several of those initial response options may be considered satisfaction of
that recipient’s activities under the Order, the ICR assumes that each recipient will
either take the lead to submit the data, or will actively participate in a consortium. In
addition, although the Agency has identified only one Order recipient for 15 of the 67
chemicals, and has identified that a total of 45 of the 67 chemicals have 5 or fewer
Order recipients, the Agency has retained the assumption that all Order recipients will
participate in the consortium activities. These and the other assumptions in the ICR are
intended to ensure that the estimate provided remains conservative. The Agency
expects to be able to amend these assumptions when the ICR is renewed based on its
experience with issuing the Orders, and information on the initial responses provided by
the Order recipients.
As in the original supporting statement, it is important to note that this estimate
for the potential number of order recipients is based on currently available information.
To account for the potential need to issue additional orders to recipients not currently
identified, the Agency has projected the possibility that as many as 20 additional orders
might be issued subsequently. The estimated number of potential “catch-up orders” is
not changed.

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September 10, 2009

The adjusted estimated total number of potential Order recipients is changed
from 390 to 769. To illustrate the change, which carries through to the number of
respondents used in several tables as the multiplier, Table 1 of the ICR is amended as
follows:
Table 1 - Estimated Number of Potential Order Recipients (Respondents)
Estimated Number of Respondents
Potential Respondent Category
Pesticide
Manufacturers/ Catch-Up
Registrants Importers
Orders
Order Recipients
20
207 219
163 530
Data Generators/Submitters
58
9
0
Consortium Participants
20
149 161
154 521

Total
390 769
67
323 702

Added Optional Level of Effort Questionnaire:
During the OMB review of the ICR, it was suggested that the Agency more
actively solicit feedback from the Order recipients on their individual level of effort for
responding to the Order. This feedback would facilitate the Agency’s review of the
burden estimates and activities described in the ICR so that they may be refined when
the ICR is reviewed prior to its scheduled renewal. Table 17 provides an estimated per
respondent burden and costs for the activities associated with responding to this
optional questionnaire.
Table 17 – Estimated per Respondent Burden & Costs for Optional Questionnaire
Activities
Burden (hrs.)
Costs ($)
Technical
(a)
1) Read Questionnaire
0.2
2) Prepare Responses
1.0
3) Submit Questionnaire to EPA
0.0
1.2
Totals:
Hourly rates are based on Table 5 in the ICR.
Total Costs in (f) = (a) x (d) + (b) x (e)

Clerical
(b)

Total
(c)

0.2
0.0
0.5
0.7

0.4
1.0
0.5
1.9

Technical
(d)
$76.92/hr.
15.38
76.92
0
92.30

Clerical
(e)
$33.60/hr.
6.72
0
16.80
23.52

Total
(f)
22.10
76.92
16.80
115.82

Since responding to this questionnaire is completely voluntary for the
respondents, the Agency has assumed that at least half of the Order recipients might
choose to respond. As such, the total potential burden is estimated to be 730 (1.9 hrs x
384), with an estimated cost of $44,475 ($115.82 x 384). Annualized over the three
years of the ICR, the annual potential burden is 243 (730 ÷ 3), with an estimated annual
cost of $14,825 ($44,475 ÷ 3).
These estimates are being added as a separate IC to the total burden, see
revised Table 16 below.

Amended Respondent Burden Estimates:
The estimated respondent burden for each of the paperwork activities described
in Table 2 in section 4(b) of the ICR, disaggregated by the labor category listed in Table
4, are presented in Table 6 of the ICR and are not adjusted for purposes of this
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amendment. Using the respondent categories and numbers presented in Table 1,
Tables 7 & 8 are amended to present the adjusted estimated respondent burden for
each category of respondent.
Table 7 – Estimated Burden Hours by Activity for Pesticide Registrant
Activity (a)

1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission
package
10) Submit final data to EPA
11) Maintain records
Total burden:

Estimated
Burden
(b)
24
90
47
181
171
2,101
32
239
32

Estimated #
Respondents
(c)
219
219
219
58
161
58
58
58
58

5
86
3,008

58
219

Total Burden
Hours
(d)
5,256
19,710
10,293
10,498
27,531
121,858
1,856
13,862
1,856
290
18,834
231,844

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.
(b) Per chemical burden taken from the total column in Table 6.
(c) Number of potential respondents from Table 1, pesticide registrant column.
(d) Total = (b) x (c)

Table 8 – Estimated Burden Hours by Activity for Manufacturers/Importers
Activity (a)

1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission
package
10) Submit final data to EPA
11) Maintain records
Total burden:

Estimated
Burden
(b)
24
90
47
181
171
2,101
32
239
32

Estimated #
Respondents
(c)
530
530
530
9
521
9
9
9
9

5
86
3,008

9
530

Total Burden
Hours
(d)
12,720
47,700
24,910
1,629
89,091
18,909
288
2,151
288
45
45,580
243,311

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.
(b) Per chemical burden taken from the total column in Table 6.
(c) Number of potential respondents from Table 1, manufacturer/importer column.
(d) Total = (b) x (c)

As indicated previously, EPA’s estimate for “catch-up” Orders as presented in
Table 9 remains unchanged.
Table 10 is amended to present the adjusted total estimated respondent burden.

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Table 10 – Estimated Total Respondent Burden Hours by Activity
Activity (a)

1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission
package
10) Submit final data to EPA
11) Maintain records
Total burden:

Estimated
Burden
(b)
24
90
47
181
171
2,101
32
239
32

Estimated #
Respondents
(c)
769
769
769
67
702
67
67
67
67

5
86
3,008

67
769

Total Burden
Hours
(d)
18,456
69,210
36,143
12,127
120,042
140,767
2,144
16,013
2,144
335
66,134
483,515

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.
(b) Per chemical burden taken from the total column in Table 6.
(c) Number of potential respondents from Table 1.
(d) Total = (a) x (b)

Amended Respondent Cost Estimates:
The estimated respondent cost for each of the paperwork activities is presented in
Table 11 and remains unchanged. The estimated costs for delivering the data to the
Agency are also unchanged. Table 12 is amended to present the estimated total
respondent costs for the initial group of chemicals expected to undergo Tier 1 screening
under the EDSP.
Table 12 – Estimated Total Respondent Costs by Activity
Activity
1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission
package
10) Submit final data to EPA
11) Maintain records
12) Delivery Costs
Total costs:

Estimated
Costs ($)
2,166.48
8,204.40
4,169.40
14,883.72
13,707.48
141,511.00
2,291.70
18,825.24
2,291.70

Estimated
Respondents
769
769
769
67
702
67
67
67
67

Total $
(rounded)
1,666,023
6,309,184
3,206,269
997,209
9,622,651
9,481,237
153,544
1,261,291
153,544

378.06
3,929.28
10.55
$212,369.0
1

67
769
67

25,330
3,021,616
25,330
$ 35,923,228

Amended Total Burden and Cost Estimates:
Table 16 provides a breakdown of the total annualized burden and cost estimate
in terms of the grouping required by OMB, i.e., distinct information collections (ICs).
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Table 16 – Annualized Information Collections (ICs) for this ICR (a)
ICs
Reporting
Recordkeeping (d)
Sub-total EDSP:
Optional Questionnaire (e)
Total:

Per Chemical (b)
Burden Hrs.
Costs $
974
$69,480
29
$1,310
1003
$70,790
0.63
$39
1004
$70,829

Totals (c)
Burden Hrs.
Costs $
139,127
$10,967,204
22,045
$1,007,205
161,172
$ 11,974,409
243
$14,825
161,415
$11,989,230

(a) Burden hours and costs are annualized by dividing them by 3.
(b) For per chemical burden see Table 6, i.e., total burden minus line item 11 (3,008-86) ÷ 3, and for costs see Table
11, i.e., total cost minus line item 11 (212,369 – 3,929) ÷ 3. Line item 11 in both tables represents recordkeeping.
(c) For total respondent burden see Table 10, i.e., total burden minus line item 11 (483,515-66,134) ÷ 3, and for
costs see Table 12, i.e., total cost minus line item 11 (35,923,228-3,021,616) ÷ 3.
(d) For per chemical see Table 6, for totals see line item 11 in both table 10 & 12 represents recordkeeping, which is
÷ 3.
(e) Per chemical burden & costs comes from Table 17 (1.9 ÷ 3) and ($115.82 ÷ 3), and total burden & costs come
from the text below Table 17.

The total burden hours for respondents calculated for this ICR involves activities
that are expected to occur over the next 3 years. Since the timing of these activities is
not specific enough to accurately divide them by year, the Agency has assumed a 3
year duration of equal effort to calculate the annual burden and costs for this ICR. As
such, the total annual respondent burden and costs for this ICR is simply divided by 3 to
get an estimated annualized burden of approximately 161,415 hours and an annualized
cost of approximately $ 11,989,230.

Amended Burden Statement for this ICR:
The estimated per respondent paperwork burden to comply with this information
collection activity is 3,008 hours, with an estimated cost of $212,369. The optional
questionnaire is estimated to be an additional burden of 1.9 hours and $115.82 per
questionnaire.
Annualized over three years, the respondent burden is 1,003 hours, and the cost
is $70,790. The total annualized estimated paperwork burden for this ICR is 161,415
hours (which includes the questionnaire) and an annualized cost of approximately $
11,989,230 (with the questionnaire).

Minor Amendments to the Initial Response Forms:
The Agency has amended both of the Initial Response Forms to include a
separate line item to reflect a response option discussed in the final Procedures
document and Order template regarding the submission of other scientifically relevant
information to address the Order. The revised forms allow the respondent to provide a
separate response to indicate if other scientifically relevant information is cited or
submitted to address (A) a particular assay (i.e., in part 2.1. of the revised form), or (B)
to satisfy the Order as a whole (i.e., in part 2.2. of the revised form).

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The last sentence in the “Paperwork Reduction Act Notice” was amended on
both forms to reference the part on the form that provides the mailing & delivery
addresses. The Agency revised the “See attached documentation” statement to clarify
that the check box is intended to serve as a confirmation or reminder for the respondent
to attach the required documentation. Previously the wording of the check box implied
that attaching the required documentation was optional, which conflicted with the
instructions in the Order that indicated certain documentation was required to
substantiate the response.
Finally, the parenthetical used in the address for the submissions was revised to
reflect an internal Agency revision to the name of the Division, i.e., “SRRD” was
changed to “PRD,” and to make other minor wording changes.
The revised Forms are in Attachments B2 and C2.

Minor Amendments to the Order Templates:
Corresponding revisions have also been made to the Order Templates that were
attached to the ICR dated April 15, 2009. For example, revisions to the templates
include inserting the citation for the published List of Chemicals, adding a reference to
the new optional survey, and cleaning up internal references to sections within the
Order and phrasing in the ICR.
The revised Templates appear in Attachments D2 and E2.

Attachments to this Amendment:
This amendment and the accompanying attachment listed below can be found in
the docket for this ICR and are accessible electronically through www.Regulations.gov,
under Docket ID Number: EPA-HQ-OPPT-2007-1081.
Attachment
A2
B2
C2
D2

Description
Updated Estimate for Number of Potential Recipients of EDSP Tier 1 Orders/DCIs as of
September 3, 2009
Amended Initial Response Form for Individual Order Recipients (As of September 8, 2009).
Amended Initial Response Form for Consortium/ Task Force (As of September 8, 2009).
Amended FFDCA 408(p) Order Template for Pesticide Inert Ingredients (As of September 8,

E2
F2

Amended FFDCA 408(p) Order Template for Pesticide Registrants (As of September 8, 2009).
Optional Level of Effort Questionnaire

2009).

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