Attachment I

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Response to Comments on the

Public Review Draft of the Renewal for

Information Collection Request (ICR), entitled:

Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)

(77 FR 47640, August 9, 2012)

EPA ICR No.: 2249.03

OMB Control No.: 2070-0176

Docket ID No.: EPA–HQ–OPPT–2011–0966

October 22, 2012

Table of Contents

I. Introduction ..........................................................................................................................................1

II. Commenters..........................................................................................................................................2

III. Comments and Responses....................................................................................................................3

A. General ICR ......................................................................................................................................3

B. Paperwork Related Activities ...........................................................................................................4

C. Calculation Methodologies...............................................................................................................4

D. Other Topics......................................................................................................................................5

I. Introduction

The EPA's Endocrine Disruptor Screening Program (EDSP) was established under §408(p) of the 

Federal Food, Drug, and Cosmetic Act (FFDCA),

1 which required the EPA to develop a chemical 

screening program using appropriate validated test systems and other scientifically relevant information 

to determine whether certain substances may have hormonal effects. The EDSP consists of a two-tiered 

approach to screen chemicals for potential endocrine disrupting effects. The purpose of Tier 1 screening 

is to identify substances that have the potential to interact with the estrogen, androgen, or thyroid 

hormone systems using a battery of assays. Substances that have the potential to interact with estrogen, 

androgen or thyroid systems will proceed on to Tier II, which is designed to identify any adverse 

endocrine-related effects caused by the substance, and establish a quantitative relationship between the 

dose and that endocrine effect for risk assessment. Additional information about the EDSP is available 

through the agency's Web site at http://www.epa.gov/endo.

This "Response to Public Comments" document specifically addresses public comments that the EPA

received on the renewal of the existing information collection request (ICR) (EPA ICR No. 2249.03) 

under the Paperwork Reduction Act (PRA),

2 covering the information collection activities associated 

with Tier 1 screening of chemicals under the EPA's (EDSP) and currently approved through October 31, 

2012.

The ICR renewal addresses the information collection activities only for the initial list of chemicals 

screened under Tier 1 of the EDSP, and covers the full range of information collection activities 

 1 See attachment A to the ICR. 2 44 USC 3501 et seq.
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associated with the issuance of and response to Tier 1 EDSP orders issued by the EPA. The initial list 

was established in 2009, and consists of 67 pesticide active ingredients (PAIs) and pesticide inerts.

As the renewal of an ongoing information collection activity approved under the PRA, the draft ICR

renewal covers the paperwork burden associated with the continuation of these activities over the next 

three (3) years. As such, the paperwork burdens were adjusted to reflect the planned progression 

associated with the information collection activities covered by the ICR.

Under the existing ICR, the EPA issued the Tier 1 EDSP orders to the identified pesticide registrant and 

inert manufacturers, and received the initial responses from those order recipients. However, as stated in 

the EDSP Policies and Procedures (Attachment B), the EPA will continue to issue "catch-up" orders for 

a period of 15 years to companies who enter the marketplace after the issuance of the initial orders in 

2010. An up-to-date matrix with information on the status of the orders issued and responses received 

for those chemicals is available on the agency's Web site at http://www.epa.gov/endo. To facilitate 

consortia formation, the EPA also makes a list of the order recipients for each chemical publicly 

available. It is available at the same web address as above. 

Although the information collection activities were not being changed by this ICR renewal, only limited 

activities remain to be completed at this stage of the program. The limited remaining ongoing 

information collection activities relate primarily to data submission, and to those activities associated 

with "catch-up" orders. In calculating the overall burden, the EPA assumes that all future "catch-up" 

order recipients will join existing data submitters. Therefore, no new data generators will be created. 

Thus, any changes in the calculation of the burdens and costs associated with data generators (IC#1 and 

IC#2) are moot.

II. Commenters

The following four unique entities filed comments on the draft renewal to the ICR:

Commentor #(1) DCN (2) Commenter Name (3) Affiliate

1 EPA-HQ-OPPT2011-0966-0012Bayer CropScience Endocrine Drive 

Team

Bayer CropScience LP

2 EPA-HQ-OPPT2011-0966-0013Clare Thorpe, Senior Director Human 

Health Policy

CropLife America (CLA) and Endocrine 

Policy Forum (EPF)

3 EPA-HQ-OPPT2011-0966-0014Scott Slaughter Center for Regulatory Effectiveness 

(CRE)

4 EPA-HQ-OPPT2011-0966-0015Patricia L. Bishop, Research 

Associate, Regulatory Testing 

Division and Kristie Sullivan, 

Director, Regulatory Testing Issues

People for the Ethical Treatment of 

Animals (PETA) and Physicians 

Committee for Responsible Medicine 

(PCRM)

Key

(1) This is the number that is used in this document to refer to this particular commenter.

(2) This is the number that is used to identify this comment in the docket at http://www.regulations.gov.

(3) This is the name of the individual or entity that submitted the comments, along with their affiliation, if provided.

These four commenters provided similar comments that can be grouped into specific topic or subject 

categories. This document is organized according to the topic or subject categories:

A. General ICR

B. Paperwork Related Activities

C. Calculation Methodologies

D. Other Topics
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III. Comments and Responses

A. General ICR

General Comment: The EPA has not followed the OMB terms of clearance the agency agreed to with 

the existing ICR. (Commenters # 1, 2, 3, and 4)

Additional Detail: Commenter 4 stated, "In approving the original ICR for Tier 1 screening of List 1 

chemicals, the OMB, under authority of the PRA, attached a notice of Terms of 

Clearance (TOC) directing the EPA to demonstrate the maximum practical utility 

of the information collection and evaluate the sufficiency of OSRI on these 

chemicals prior to requiring industry to screen additional chemicals. OMB also 

went on to request that the EPA provide a report re‐estimating the burden of this 

information collection based on the responses to the Tier 1 test orders, including 

the use of cost‐sharing and data compensation, the submission and acceptance of 

existing data and OSRI, and description of any instances in which submission of 

OSRI was deemed insufficient to satisfy the testing order."

Agency Response: The EPA fully intends to follow the terms of clearance as additional information 

becomes available. For example, the report on the re-estimation of the burden is 

partly dependent on an optional survey (requested by OMB) of EDSP Tier 1 order 

recipients that were mailed along with the orders the EPA issued for EDSP List 1.

Keep in mind that the EPA is still receiving EDSP List 1 Tier 1 data at the time of 

the writing of this document. This survey is, again, optional and so far, no surveys 

have been returned to the agency with any significant information germane to a 

re-estimation report. This lack of returned surveys notwithstanding, the EPA has 

re-estimated the cost of the EDSP Tier 1 Battery in conjunction with a study of 

laboratory capacity of contract laboratories that conduct the EDSP Tier 1 Battery.

The ICR supporting statement was previously updated to reflect the updated 

burden and cost estimates. A copy of the laboratory capacity study has been 

placed in the docket under Docket ID No. EPA-HQ-OPPT-2007-1081 and is 

available at http://www.regulations.gov.

With regards to submission and acceptance of existing data and OSRI, the EPA

revised the ICR supporting statement to include a line item to estimate the

burdens and costs associated specifically with OSRI submission. The estimated 

burdens and costs associated with this submission of OSRI are based on the report 

submitted during the public comment period by Commenter 2 under Docket ID 

No. EPA-HQ-OPPT-2007-1081-0037 and is available at 

http://www.regulations.gov.

Furthermore, the EPA has developed a guidance document titled, "Weight-ofEvidence Guidance Document: Evaluating Results of EDSP Tier 1 Screening to 

Identify Candidate Chemicals for Tier 2 Testing." The availability of this 

document for public comment was announced in a FR Notice on November 4, 

2010 (FR 75 67963) under Docket ID No. EPA-HQ-OPPT-2010-0877. The 

guidance document was revised based on the public comments received and an 

amended document was placed in the same docket. Standard Evaluation 

Procedures (SEPs) for all 11 EDSP Tier 1 Assays are available at 

http://www.epa.gov/endo/pubs/toresources/seps.htm. These SEPs were internally 

peer reviewed at the agency.
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General Comment: The EPA has not demonstrated practical utility. (Commenters # 1, 2, 3 and 4)

Additional Detail: Commenter 1 stated the EPA should "evaluate whether the proposed collection of 

information is necessary for the proper performance of the functions of the 

agency, including whether the information will have practical utility."

Agency Response: The EPA disagrees with this comment. The draft ICR Renewal Supporting 

Statement explained the utility of the data generated by each assay and its 

intended use in decision-making, as well as the estimated cost and burden for each 

assay. In fact, the EPA has already considered the potential interaction of a 

chemical with the endocrine system in making certain pesticide registration 

decisions. For example, the EPA considered data from prototypes of the assays 

included in the current EDSP Tier 1 screen, along with other existing data, in 

preparing the risk assessments of procymidone3 and vinclozolin4

.

B. Paperwork Related Activities

General Comment: The EPA should better calculate the costs and burdens associated with the 

submission of OSRI and the data entry spreadsheet templates (DESTs).

(Commenters # 1, 2, 3 and 4)

Additional Detail: Commenter 3 stated, "CLA/EPF notices that the activities associated with 

evaluating regulatory and literature data in the context of endocrine disruption 

potential and providing justifications for waivers based upon OSRI were not 

specifically included in EPA's request. We believe that this information should be 

included in detail because it represents a significant effort by test order recipients. 

In addition, this information was specifically requested by OMB." Commenter 2 

specifically added "while the Supporting Statement does mention the study profile 

templates, it does not appear that the burden estimates included in the ICR 

account for Data Entry Spreadsheet Templates (DESTs)."

Agency Response: The EPA agrees with the comment. However, as the EDSP List 1 order cycle is 

nearing its final phases, the agency does not expect any additional OSRI or DEST 

submissions (one of the base assumptions in the ICR renewal). The EPA will

revise the costs and burdens associated with the submission of OSRI and DESTs 

in future EDSP ICR Supporting Statements using properly vetted supporting 

information.

C. Calculation Methodologies

General Comment: The EPA should re-estimate the costs and burdens associated with the submission 

of EDSP Tier 1 data specifically related to the base cost of the 11 assays 

contained in the EDSP Tier 1 Screening Battery. (Commenters # 1, 2, 3 and 4)

Additional Detail: Commenter 2 noted an improvement in the agency's estimation of the cost of the 

11 assays that comprise the EDSP Tier 1 Screening Battery but stated the "EPA's 

estimate of the costs is still too low." Commenter 2 went on to add, "The EPF has 

 3 To access the documents related to the procymidone decision, go to http://www.epa.gov/pesticides/reregistration/procymidone/. 4 To access the documents related to the vinclozolin decision, go to http://www.epa.gov/pesticides/reregistration/vinclozolin/.
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recently collected available time and cost estimates from many of its members, 

for the conduct of individual studies as well as the technical, managerial and 

clerical activities related to preparing, submitting and archiving the studies and 

associated documents such as Weight-of-Evidence papers, submission letters and 

transmittal documents. Recognizing that some of the EDSP List 1 work is still 

ongoing, we plan to make the industry data collection and analysis available to the 

EPA when the collection and analysis is complete. At completion of this exercise, 

we will be better able to comment on the accuracy of the EPA's current estimates; 

the EPF burden information should be available in time for the EPA to take them 

into account before issuing a List 2 ICR. While this collection effort is incomplete 

and there is a range of cost per chemical experienced by test order recipients, 

enough information is available to state that the EPF estimates the cost per 

chemical to be approximately $1 million. The EPA's estimate is approximately 

15% too low."

Agency Response: The EPA will review and consider any detailed information related to this issue

when it is submitted. The agency has based all estimates on currently vetted 

information. All estimates are adjusted for inflation and represent an average.

D. Other Topics

General Comment: Enhance the quality, utility and clarity of the information collected.

(Commenters # 1, 2, 3 and 4)

Additional Detail: Commenter 1 specifically added, "on a technical level, the quality of information 

collected depends heavily on the clarity and/or transparency of the EPA protocols 

and standard evaluation procedures (SEPs) and the timeliness of communicating 

these to respondents."

Agency Response: The EPA agrees and will make every effort to improve clarity and timeliness.

General Comment: The current battery does not take into account animal welfare.

(Commenters # 3 and 4)

Additional Detail: Commenter 3 stated, "Continuing with the current EDSP tests would be a waste 

of time, money and animal lives." Commenter 4 added their organization and 

membership shared a "common goal of promoting reliable and relevant regulatory 

testing methods and strategies that protect human health and the environment 

while reducing, and ultimately eliminating, the use of animals."

Agency Response: The agency is currently working diligently to move towards the use of 

computational techniques to reduce our reliance on animal testing. The EDSP has 

prepared a workplan entitled, "Endocrine Disruptor Screening Program for the 

21st Century: (EDSP21 Work Plan)" which goes into further detail regarding the 

EPA's strategy to move towards use of validated 21st Century toxicology tools.

The EDSP21 plan can be found on the EDSP website at 

http://www.epa.gov/endo/pubs/edsp21_work_plan_summary%20_overview_final

.pdf. Until the agency has new validated tools to use, we must rely on the current 

EDSP Tier 1 Screening Battery.