September 10, 2009 

Page 1 of 6 

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. 
September 10, 2009 

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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 

Registrants 

Manufacturers/ 

Importers 

Catch-Up 

Orders Total 

Order Recipients 207 219 163 530 20 390 769

Data Generators/Submitters 58 9 0 67 

Consortium Participants 149 161 154 521 20 323 702

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

Burden (hrs.) Costs ($) 

Technical 

(d) 

Clerical 

(e) 

Activities 

Technical 

(a) 

Clerical 

(b) 

Total 

(c) 

$76.92/hr. $33.60/hr. 

Total 

(f) 

1) Read Questionnaire 0.2 0.2 0.4 15.38 6.72 22.10 

2) Prepare Responses 1.0 0.0 1.0 76.92 0 76.92 

3) Submit Questionnaire to EPA 0.0 0.5 0.5 0 16.80 16.80 

Totals: 1.2 0.7 1.9 92.30 23.52 115.82 

Hourly rates are based on Table 5 in the ICR. 

Total Costs in (f) = (a) x (d) + (b) x (e) 

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 
September 10, 2009 

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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) Estimated 

Burden 

(b) 

Estimated # 

Respondents 

(c) 

Total Burden 

Hours 

(d) 

1) Read instructions 24 219 5,256

2) Plan activities 90 219 19,710

3) Submit an initial response to EPA (b) 47 219 10,293

4) Read and discuss the protocol 181 58 10,498

5) Participate in Consortium 171 161 27,531

6) Generate the data (c) 2,101 58 121,858

7) Submit Progress Report 32 58 1,856

8) Compile and review the final data for submission 239 58 13,862

9) Complete paperwork to assemble the submission 

package 

32 58 1,856

10) Submit final data to EPA 5 58 290

11) Maintain records 86 219 18,834

Total burden: 3,008 231,844

(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) Estimated 

Burden 

(b) 

Estimated # 

Respondents 

(c) 

Total Burden 

Hours 

(d) 

1) Read instructions 24 530 12,720

2) Plan activities 90 530 47,700

3) Submit an initial response to EPA (b) 47 530 24,910

4) Read and discuss the protocol 181 9 1,629

5) Participate in Consortium 171 521 89,091

6) Generate the data (c) 2,101 9 18,909

7) Submit Progress Report 32 9 288

8) Compile and review the final data for submission 239 9 2,151

9) Complete paperwork to assemble the submission 

package 

32 9 288

10) Submit final data to EPA 5 9 45

11) Maintain records 86 530 45,580

Total burden: 3,008 243,311

(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. 
September 10, 2009 

Page 4 of 6 

Table 10 – Estimated Total Respondent Burden Hours by Activity 

Activity (a) Estimated 

Burden 

(b) 

Estimated # 

Respondents 

(c) 

Total Burden 

Hours 

(d) 

1) Read instructions 24 769 18,456

2) Plan activities 90 769 69,210

3) Submit an initial response to EPA (b) 47 769 36,143

4) Read and discuss the protocol 181 67 12,127

5) Participate in Consortium 171 702 120,042

6) Generate the data (c) 2,101 67 140,767

7) Submit Progress Report 32 67 2,144

8) Compile and review the final data for submission 239 67 16,013

9) Complete paperwork to assemble the submission 

package 

32 67 2,144

10) Submit final data to EPA 5 67 335

11) Maintain records 86 769 66,134

Total burden: 3,008 483,515

(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 Estimated 

Costs ($) 

Estimated 

Respondents 

Total $ 

(rounded) 

1) Read instructions 2,166.48 769 1,666,023

2) Plan activities 8,204.40 769 6,309,184

3) Submit an initial response to EPA (b) 4,169.40 769 3,206,269

4) Read and discuss the protocol 14,883.72 67 997,209

5) Participate in Consortium 13,707.48 702 9,622,651

6) Generate the data (c) 141,511.00 67 9,481,237

7) Submit Progress Report 2,291.70 67 153,544

8) Compile and review the final data for submission 18,825.24 67 1,261,291

9) Complete paperwork to assemble the submission 

package 

2,291.70 67 153,544

10) Submit final data to EPA 378.06 67 25,330

11) Maintain records 3,929.28 769 3,021,616

12) Delivery Costs 10.55 67 25,330

Total costs: $212,369.0

1

$ 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). 
September 10, 2009 

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Table 16 – Annualized Information Collections (ICs) for this ICR (a)

Per Chemical (b) Totals (c) ICs Burden Hrs. Costs $ Burden Hrs. Costs $ 

Reporting 974 $69,480 139,127 $10,967,204

Recordkeeping (d) 29 $1,310 22,045 $1,007,205

Sub-total EDSP: 1003 $70,790 161,172 $ 11,974,409

Optional Questionnaire (e) 0.63 $39 243 $14,825

Total: 1004 $70,829 161,415 $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). 
September 10, 2009 

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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 Description

A2 Updated Estimate for Number of Potential Recipients of EDSP Tier 1 Orders/DCIs as of 

September 3, 2009 

B2 Amended Initial Response Form for Individual Order Recipients (As of September 8, 2009).

C2 Amended Initial Response Form for Consortium/ Task Force (As of September 8, 2009).

D2 Amended FFDCA 408(p) Order Template for Pesticide Inert Ingredients (As of September 8, 

2009).

E2 Amended FFDCA 408(p) Order Template for Pesticide Registrants (As of September 8, 2009).

F2 Optional Level of Effort Questionnaire