September 10, 2009

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## Amendment to the Supporting Statement for the Information Collection Request (ICR):

Title: Tier 1 Screening of Certain Chemi cals 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 to tal 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 c hemicals. This amendment provides an adjustment to the estimated number of pot ential Order recipients and the corresponding

calculations. The chemicals listed in t he 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 re cipients 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 recipi ent has several options for their initial response, which in turn specifically identifie s 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 onl y 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 t he assumption that all Order recipients will participate in the consortium activities. T hese 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 informa tion 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 addi tional orders to recipients not currently identified, the Agency has proj ected 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 mu ltiplier, 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 recipi ents on their individual level of effort for responding to the Order. This feedback woul d facilitate the Agency’s review of the

burden estimates and activities described in t he 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, di saggregated by the labor category listed in Table 4, are presented in Table 6 of the ICR and are not adjusted for purposes of thisSeptember 10, 2009

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### amendment. Using the respondent categor ies and numbers presented in Table 1, Tables 7 & 8 are amended to present t he 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 dis aggregated 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 dis aggregated 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 adjust ed 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 dis aggregated 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 c hemicals 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 annualiz ed 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. Li ne item 11 in both tables represents recordkeeping. (c) For total respondent burden see Table 10, i.e., tota l 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 repres ents 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 year s. 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 es timated 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 res pondent 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 subm ission of other scientifically relevant information to address the Order. The revised forms allow the respondent to provide a separate response to indicate if other scient ifically 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 fo rm that provides the mailing & delivery addresses. The Agency revised the “See atta ched documentation” st atement to clarify

that the check box is intended to serve as a confirmation or reminder for the respondent to attach the required documentation. Previ ously the wording of the check box implied that attaching the required documentati on was optional, which conflicted with the

instructions in the Order that indica ted certain documentation was required to substantiate the response.

Finally, the parenthetical used in the addr ess for the submissions was revised to reflect an internal Agency revision to t he 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. Fo r 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 atta chment 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