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Docket ID No. EPA-HQ-OPPT-2013-0275

Response to Comments on

the

Public Review Draft of

the

Information Collection Request (ICR) entitled:

“Addendum for the

Second List of Chemicals; Tier 1

Screening of Certain Chemicals Under

the Endocrine Disruptor Screening

Program (EDSP)”

(72 FR 70568, November 17, 2010)

March 7, 2013

Table of Contents

I. Introduction ......................................................................................................................... 2

II. Commenters ....................................................................................................................... 3

III. Comments and Responses.............................................................................................. 4

A. General ICR ................................................................................................................. 4

B. Paperwork Related Activities........................................................................................ 7

C. Calculation Methodologies ........................................................................................... 8

D. SDWA Orders............................................................................................................... 9

E. Data Generation Burden and Cost Estimates............................................................... 9

F. Other Topics................................................................................................................. 9
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I. Introduction

EPA’s Endocrine Disruptor Screening Program (EDSP) was established under section 408(p) 

of the Federal Food, Drug, and Cosmetic Act (FFDCA), which required EPA to develop a 

chemical screening program using appropriate validated test systems and other scientifically 

relevant information (OSRI) 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. Based on a Weight of Evidence (WoE) analysis, substances that have the 

potential to interact with estrogen, androgen or thyroid systems will be considered for Tier 2 

testing. Tier 2 tests are designed to establish dose-response relationships for any potential 

adverse effect to be used in 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 

EPA has received on an addendum to an existing information collection request (ICR) (EPA 

ICR No. 2249.01) under the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., covering 

the information collection activities associated with Tier 1 screening of chemicals under EPA’s 

EDSP and is currently approved through October 31, 2012.

The addendum on which the Agency sought public comments does not change the activities 

covered by the current ICR, and is instead intended to seek approval of additional activities 

related to the Tier 1 screening of certain chemicals under the EDSP unique from the first 

EDSP list. This second list of chemicals to be screened under the EDSP (“EDSP List 2”) 

contains pesticide active ingredients (PAIs) and, more significantly, chemicals that may be 

found in sources of drinking water to which a substantial population may be exposed and 

chemicals that are regulated under the Safe Drinking Water Act (SDWA). This new group of 

chemicals to be screened under SDWA is generally referred to as “SDWA Chemicals” in all 

EDSP documents.

Although the policy and procedures issued in 2009 for the EDSP List 1 (Federal Register 

Notice: April 15, 2009 (74 FR 17559-17579) would clearly apply to the information collection 

activities for the PAIs on the second list, many of the existing policies and procedures reflect 

issues uniquely associated with the pesticide market and the specific regulatory context under 

which EPA regulates pesticide chemicals. EPA therefore determined that some of the existing 

policies and procedures are generally not applicable to non-pesticide chemicals and there 

were competing considerations for SDWA chemicals that warranted a modification to those 

policies and procedures with regard to SDWA chemicals. As such, EPA also sought public 

comment on a draft supplement to the 2009 document that will specifically address polices and 

procedures for SDWA chemicals (Federal Register Notice: November 17, 2010 (75 FR 70558-

70568).

In summary, on November 17, 2010, EPA issued three Federal Register (FR) notices seeking 

public comment on the three documents associated with the additional activities related to the 

Tier 1 screening of certain chemicals under the EDSP for a second list of chemicals with a 

wider range of coverage than that of the initial EDSP List 1:

• The first FR Notice sought public comment on the draft second list of chemicals for 

EDSP Tier 1 Screening (75 FR 70248, Docket ID No. EPA-HQ-OPPT-2009-0477).
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• The second FR Notice sought public comment on the draft addendum to an existing 

Information Collection Request (ICR) that describes the information collection activities

associated with Tier 1 screening of a second group of chemicals under the EDSP and 

provides EPA's estimates for the related paperwork burden and costs (75 FR 70568, 

Docket ID No. EPA-HQ-OPPT-2007-1081).1

• The third FR notice sought public comment on the draft policies and procedures that the 

Agency intends to use for chemicals that will be the second list of chemicals to be 

screened under the EDSP (73 FR 70842, Docket ID No. EPA-HQ-OPPT-2007-1080).

The “Response to Public Comments” document provides a summary of the comments 

specifically received on, and related to, the draft addendum to the ICR, and the Agency’s 

responses to those comments applicable to the ICR document. Additional “Response to Public 

Comments” documents have been prepared for the public comments received by the Agency

for the draft proposed EDSP List 2 and the draft proposed Policies and Procedures related to 

the EDSP List 2. These documents are available in the respective dockets associated with 

each item identified above. To view these documents go to www.regulations.gov.

II. Commenters

The following 8 unique entities filed 10 comments on the draft addendum to the ICR:

Commenter #

(1)

DCN

(2)

Commenter Name

(3) Affiliate Notes

37 EPA-HQ-OPPT2007-1081-0037Wendelyn Jones, 

Senior Director, Human 

Health Policy

CropLife America 

(CLA) and the 

Endocrine Policy 

Forum (EPF)

Preliminary Burden 

Report

38 EPA-HQ-OPPT2007-1081-0038Susan Van Volkenburg, 

Director, Product Safety 

and Regulatory Affairs

LANXESS Corporation No Direct ICR 

Questions.

Duplicate of 

Submission Under 

Docket X for Second 

EDSP List

39 EPA-HQ-OPPT2007-1081-0039Bayer CropScience 

Endocrine Drive Team

Bayer CropScience

40 EPA-HQ-OPPT2007-1081-0040Catherine Willett, 

Science Policy Advisor, 

Regulatory Testing 

Division and Kristie 

Sullivan, Science and 

Policy Advisor

People for the Ethical 

Treatment of Animals 

(PETA) and 

Physicians Committee 

for Responsible 

Medicine (PCRM)

41 EPA-HQ-OPPT2007-1081-0041Scott Slaughter Center for Regulatory 

Effectiveness (CRE)

42 EPA-HQ-OPPT2007-1081-0042Richard A. Becker, 

Senior Toxicologist and 

Senior Director, 

Regulatory and 

Technical Affairs 

Department

American Chemistry 

Council (ACC)

 1 Please note that when comments were sought in 2010, the draft ICR was identified under EPA ICR No. 2249.02 

and OMB Control No. 2070-0176, with public comments directed to Docket ID No. EPA-HQ-OPPT-2007-1081. 

That same docket was established for the initial ICR related to List 1 chemicals. Given the resulting confusion in 

finding documents in that docket, EPA has established a new docket for the ICR Addendum submitted to OMB, 

with a link to the old docket. 
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Commenter #

(1)

DCN

(2)

Commenter Name

(3) Affiliate Notes

43 EPA-HQ-OPPT2007-1081-0043Francis X. Sherman, 

Country Director

AkzoNobel No new comments.

Supportive of ACC 

comments submitted 

under Docket # EPAHQ-OPPT-2007-1081-

0042

37 EPA-HQ-OPPT2007-1081-0044Wendelyn Jones, 

Senior Director Human 

Health Policy

CropLife America 

(CLA) and Endocrine 

Policy Forum (EPF)

Cover Letter

37 EPA-HQ-OPPT2007-1081-0045Wendelyn Jones, 

Senior Director Human 

Health Policy

CropLife America 

(CLA) and Endocrine 

Policy Forum (EPF)

Comments

42 EPA-HQ-OPPT2007-1081-0046Susan Ferenc Chemical Producers 

and Distributors 

Association

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 www.regulations.gov

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

Please note that the matrix above excludes any commenters that simply asked for an 

extension of the comment period. Also note that some comments received for the addendum 

to the existing ICR are actually addressing topics included under the public comment 

collections for the EDSP List 2 and the EDSP Policies and Procedures for SDWA chemicals.

Likewise, some comments for the addendum to existing ICR were received under the other 

two public comment collections. In each “Response to Public Comments” document, the 

Agency directs the reader to the appropriate response document.

These 8 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. SDWA Orders

E. Data Generation Burden and Cost Estimates

F. Other Topics

III. Comments and Responses

A. General ICR

General Comment: EPA was inconsistent within the draft ICR Supporting Statement in its 

use of language describing the purpose EDSP Tier 1 data and its use in risk assessments.

(Commenter #’s 39, 41)

Additional Detail: Commenter 39 specifically stated, “EPA states in the notice for the 

proposed addendum, that the purpose of Tier 2 is to “establish a dose-response 

relationship for any adverse effects that might result from the interactions identified through 

the Tier 1 assays.” Tier 1 screening only determines the potential for interaction with the 

estrogen, androgen and thyroid (EAT) systems. Potential for interaction with EAT systems 

is not an adverse effect. Tier 2 tests, however, are designed to identify any adverse effect 
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on endocrine systems and to establish a relationship between dose and the effect. EPA

should ensure that the description of the EDSP found in the Draft Phase 2 Policies and 

Procedures is correctly captured in its Phase 2 ICR. This clarity is important to prevent the 

incorrect impression from the Phase 2 ICR that the Tier 1 screens determine adverse 

endocrine effects.”

Commenter 41 stated “EPA‘s Supporting Statement for the ICR addendum states that EPA 

will use the Tier 1 data to perform risk assessments. Those risk assessments should not be 

performed because the Tier 1 data are neither an accurate nor reliable enough to support 

risk assessments.”

Agency Response: EPA agrees that the language should be consistent. Commenter 39 is 

correct, EDSP Tier 1 data does not identify adverse endocrine effects of a chemical. EDSP 

Tier 1 data only identifies the potential for that chemical to interact with the endocrine 

system. EPA has modified all documents to make this concept clear and consistent. As for 

the use of EDSP Tier 1 data in risk assessments, this data will have the potential to be 

used as information to inform any future risk assessments on a chemical. This data, 

however, will not be the sole basis for any such risk assessment, but will be used in 

conjunction with other chemical specific data (i.e., EDSP Tier 2 data, OSRI, Part 158 

Guideline data, etc.) as part of the WoE to inform a risk assessment.

General Comment: EPA has not followed the OMB terms of clearance the Agency agreed 

to with the existing ICR. (Commenter #’s 40, 37,42)

Additional Detail: Commenter 40 quoted the OMB terms of clearance for the existing 

ICR, "OMB requests that EPA provide a report re-estimating the burden of this information 

collection based on responses to the Tier I 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. OMB requests this report prior to or at the time of submission of 

revision of this information collection to cover additional chemicals. In addition, in order to 

ensure that EPA has maximized the practical utility of the Tier I assays as the program 

moves forward, EPA should ensure sufficient opportunity prior to submission of any 

revision to this collection for public comment and peer review of the EPA tools to be 

developed to guide agency decisions on whether a chemical must proceed to Tier II, 

including the Weight of the Evidence Approach and Standard Evaluation Procedures.”

Agency Response:

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 was mailed 

along with the orders EPA issued for EDSP List 1. Keep in mind that 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, 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 has been updated to reflect the updated burden and 
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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 www.regulations.gov.

With regard to submission and acceptance of existing data and OSRI, EPA has also 

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 37 under Docket ID No. 

EPA-HQ-OPPT-2007-1081-0037 and is available at www.regulations.gov.

Furthermore, EPA has developed a guidance document titled, "Weight-of-Evidence 

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 for all 11 EDSP Tier 1 are available at 

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

reviewed at the Agency.

General Comment: EPA has rejected most OSRI submissions submitted for EDSP List 1 

Chemicals. (Commenter # 41)

Additional Detail: Commenter 41 stated “EPA is violating these Terms because EPA is 

summarily denying the vast majority of OSRI applications. EPA is also violating OMB‘s 

Terms because EPA‘s OSRI denials are not based on any Weight of the Evidence 

Approach (WOE) or on any Standard Evaluation Procedures that have been subject to 

public comment and peer review. EPA‘s current draft WOE Guidance is subject to public 

comment only after EPA has already denied many OSRI petitions. It has not been peer 

reviewed, and EPA has not mentioned any possibility of peer review. The draft guidance 

also lacks utility because it is vague, too general, and too lacking in substantive content to 

provide any useful guidance for its intended users.”

Agency Response: EPA disagrees with this comment. In more than half of all the 

instances where OSRI was submitted for a chemical (27 of 47 or ~57.4%), EPA determined 

that the requirement for one or more EDSP Tier 1 study had been met an because the 

OSRI submitted was determined to be sufficient. All EDSP List 1 Tier 1 OSRI submissions 

and EPA’s review of the submissions can be accessed at 

http://www.epa.gov/endo/pubs/EDSP_OSRI_Response_Table.pdf. 

As for the WoE Guidance, this document has been revised based on the public comments 

received and an amended document has been placed in the docket at www.regulations.gov

under Docket ID No. EPA-HQ-OPPT-2010-0877.

General Comment: EPA has not demonstrated practical utility. (Commenter #s 40, 41, 

37,42)

Additional Detail: Commenter 41 stated “EPA’s addition of new tests demonstrates that 

the EDSP Tier 1 Test Battery which OMB approved is inadequate, lacks practical utility, 

and should never been approved to begin with.”
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Agency Response: EPA disagrees with this comment. The draft ICR Addendum

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, EPA has already considered the potential interaction of a chemical with the 

endocrine system in making certain pesticide registration decisions. For example, 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 procymidone2 and 

vinclozolin.

3

General Comment: EPA has added new test to the EDSP Tier 1 Battery. (Commenter # 

41)

Additional Detail: Commenter 41 stated “EPA’s addition of new tests demonstrates that 

the EDSP Tier 1 Test Battery which OMB approved is inadequate, lacks practical utility, 

and should never been approved to begin with.”

Agency Response: EPA disagrees with this comment. EPA has not added any new 

assays to the EDSP Tier 1 Battery. The same 11 assays that were listed in the existing ICR 

are the same 11 assays that were listed in draft ICR Addendum Supporting Statement.

General Comment: Requiring EDSP Tier 1 Screening data is duplicative, unnecessary, 

and requires unnecessary animal testing. (Commenter #s 40, 37,42)

Additional Detail: Commenter 41 stated “Given that the current focus of the EDSP 

program is on well studied substances, including pesticides, the Agency is needlessly 

expending resources and requesting unnecessary animal testing.”

Agency Response: EPA disagrees with this comment. If any EDSP Tier 1 order recipient

believes data exists that is duplicative of data required by an EDSP Tier 1 Order, they are 

entitled to submit the data as OSRI along with a clear rationale why it would suffice for the 

required data. EPA will review all OSRI submitted. Implicit in the comment is the idea that 

EPA should bear the responsibility for making a determination of whether existing data are 

adequate for the EDSP prior to issuing an order. However, both FIFRA and FFDCA clearly 

indicate that it is the responsibility of the manufacturer and/or registrant to demonstrate that 

their chemical and/or product can be used safely. In addition, SDWA does not require the 

Agency to make that determination prior to providing for testing under Section 1457. 

Moreover, EPA believes that manufacturers/registrants are better placed to identify data 

specific to their chemical/product that addresses the chemical’s potential to interact with the 

endocrine system.

B. Paperwork Related Activities

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

the submission of OSRI. (Commenter #s 37,39, 42)

 2 To access the documents related to the procymidone decision, go to 

http://www.epa.gov/pesticides/reregistration/procymidone/.

3 To access the documents related to the vinclozolin decision, go to 

http://www.epa.gov/pesticides/reregistration/vinclozolin/.
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Additional Detail: Commenter 37 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.”

Agency Response: EPA agrees with the comment and has revised the ICR Addendum 

Supporting Statement to break out the costs and burdens associated with the submission 

of OSRI. This is reflected as a “line item” in the Information Categories (ICs) that are 

related to the generation of data. Furthermore, the estimated burdens and costs for OSRI 

are based on the report submitted during the public comment period by Commenter 37 

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

www.regulations.gov. The revised cost of the submission of OSRI is now estimated to be 

$34,486 per chemical based on the average cost per chemical calculated in the report 

mentioned above.

C. Calculation Methodologies

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

submission of EDSP Tier 1 data. (Commenter # 37, 39, 42)

Additional Detail: Commenter 37 stated, “CLA/EPF is disappointed that EPA has not 

taken the opportunity to realign, update and correct activity burden tables in their public 

review draft supporting statement for an ICR (dated Sept 23rd 2010) using the experience 

they have gained in the first year of the EDSP program. Tables from the supporting 

statement for an ICR dated April 15th 2009 have not been revised at all in the statement to 

support the Draft ICR. Examples of simple achievable updates are in Table 2 'Expected 

Order Recipient Activities by Labor Categories Activities.' In Table 2, activities 3 and 4 are 

misaligned. Activity 4 must be submitted in the timeframe of activity 3 as EPA will only 

accept such documentation during the initial response period as evidenced by Table 3. It 

should be made clear that in subsequent dependant tables (6, 11, 18, 19) in the draft 

document that the creation of OSRI is now a significant burden against activity 3 as well as 

activity 4 for both order recipients and data submitters.”

Agency Response: EPA concurs with the commenters. The Agency has revised all 

estimates based on current information.

The re-estimation started with a revision to the costs for conducting the 11 EDSP Tier 1 

Battery. EPA has based the re-estimation from median assay costs obtained from one

report generated in conjunction with a study of laboratory capacity of contract laboratories 

that conduct the EDSP Tier 1 Battery. The ICR supporting statement has been revised 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 www.regulations.gov.

The overall cost for all eleven assays (including analytical chemistry costs and adjusted for 

inflation) is now estimated to be $579,345.
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EPA has also responded to concerns from stakeholders that the Agency did not include the 

burdens and costs associated with the submission of Data Entry Spreadsheet Templates 

(DESTs) for EDSP Tier 1 Assays. Test Order recipients may choose to use DESTs as a 

method for reporting all raw data in an electronic format for the 890 Guideline Series for the 

EDSP Tier 1 battery. There is a DEST for each of the eleven 890 Guideline Series EDSP 

Tier 1 assays that comprise the battery. EPA is encouraging Test Order recipients to use 

the DEST as a method for standardizing raw data reporting and to assist EPA reviewers in 

the comprehensive and consistent evaluations of the raw data. DESTs are available at 

http://www.epa.gov/endo/pubs/toresources/seps.htm#dests. EPA agrees and has added 

40 hours of burden per chemical to the technical labor category under Activity 6 “Generate 

the data” in Table 6-B.

It should also be noted that all labor rates and cost increases due to inflation as well are up 

to date (June 2012) in the revised supporting statement.

D. SDWA Orders

No comments were received on SDWA orders directly related to the ICR.

E. Data Generation Burden and Cost Estimates

Please see comments Section C (Calculation Methodologies) of this document.

F. Other Topics

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

(Commenter # 40)

Additional Detail: Commenter 40 stated, “For registration, pesticides currently are often 

subject to dozens of separate animal tests, including reproductive and chronic/lifecycle 

studies in rodents, fish and birds, as well as metabolism and pharmacokinetics studies.

These tests kill thousands of animals and include many of the same endpoints addressed 

in the presumptive EDSP Tier 2 tests.”

Agency Response: This issue is related to the selection of the assays and the final Tier 1 

battery. As explained in the ICR, the selection of the final Tier 1 battery was a scientifically 

rigorous process that involved extensive scientific review and public participation from the 

very beginning in 1996. These issues are therefore more appropriately addressed in that 

process, and not as part of the ICR, whose focus is solely on the paperwork activities 

related to the issuance of Tier 1 Orders for the EDSP List 2 Chemicals identified.