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### 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 70 568

, November 17 , 20 10 )

M a r c h 7 , 201 3

Table of Contents

I. Introduction

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II. Commenters

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III. Commen t s and Responses

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A. General ICR

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B. Paperwork Related Activities

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C. Calculation Methodologies

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D. SDWA Orders

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E. Data Generation Burden and Cost Estimates

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F. Other Topics

................................ ................................ ................................ ................. 9Page 2 of 9 I. Introduction

EPA’s Endocrine Disruptor Screening Program ( EDSP ) wa s established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which require d 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, s ubstances 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 A gency ’s Web site at http://www.epa.gov/endo

.
This “Response to Public Comments” document specifically addresses public com ments 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 screeni ng of chemicals under EPA’s EDSP and is currently approved through October 31, 2012.

Th e addendum on which the A gency 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 s creening of c ertain c hemicals u nder 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 u nder 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 L ist 1 ( Federal Register Notic e: April 15, 2009 ( 74 F R 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 mar ket 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 consideration s 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 F R 70558

- 70568 )

. In summary, o n November 17, 2010, EPA is s ued three Federal Re g i st er (FR) notices seeki n g public comment on the three documents associated with the additional activities related to the Tier 1 s creening of c ertain c hemicals u nder the EDSP for a second list of chemicals with a wider range of coverage than that of the initial EDSP L ist 1 :

• The first FR Notice sought public comment on the draft s econd l ist of c hemicals for EDSP Tier 1 Screening ( 75 FR 70248, Docket ID No. EPA

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.Page 3 of 9 • The second FR Notice sought public comment on the draft a ddendum to an existing Information Colle c tion Request (ICR) that describes the information collection activities associated with Tier 1 screening of a second group of chemicals under the EDSP and provides E PA's estimates for the related paperwork burden and costs (7 5 FR 70 568

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• The third FR notice sought public comment on the draft policies and p r ocedures that the A gency intends to use for chemicals that will be the second list of chemicals to be screened under the EDSP (73 FR 70842, D ocket ID No. EPA

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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 appli c able to the ICR document. Additional “ Response to Public Comments ” documents have been prepared f or 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.reg u lations.gov

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II. Commenters

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

Comment e r # (1) DCN (2) Commenter Name (3) Affiliate Notes 37 EPA

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- 0037 Wendelyn Jones, Senior Director, Human Health Policy CropLife America (CLA) and the Endocrine Policy Forum (EPF) Preliminary Burden Report

38 EPA

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- 0038 Susan 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

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- 0039 Bayer CropScience Endocrine Drive Team Bayer CropScience

40 EPA

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- 0040 Catherine 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

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- 0041 Scott Slaughter Center for Regulatory Effectiveness (CRE) 42 EPA

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- 0042 Richard 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 p ublic comments directed to Docket ID No. EPA

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. 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 n ew docket f o r t h e I C R A d d e n d u m s u b m i t t e d t o O M B

, w i t h a link to the old docket.Page 4 of 9 Comment e r # (1) DCN (2) Commenter Name (3) Affiliate Notes 43 EPA

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- 0043 Francis X. Sherman, Country Director AkzoNobel No new comments. Supportive of ACC comments submitted under Docket # EPA

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- 0042 37 EPA

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- 0044 Wendelyn Jones, Senior Director Human Health Policy CropLife America (CLA) and Endocrine Policy Forum (EPF) Cover Letter

37 EPA

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- 0045 Wendelyn Jones, Senior Director Human Health Policy CropLife America (CLA) and Endocrine Policy Forum (EPF) Comments

42 EPA

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- 0046 Susan 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 simil a r 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. Commen t s 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. (Commente r #’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, an drogen and thyroid (EAT) systems. Potential for i nteraction with EAT systems is not an adverse effect. Tier 2 tests , however, are designed to identify any adverse effectPage 5 of 9 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 determin e 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 a ccurate nor reliable enough to support risk assessments. ”

Agency Response: EPA agre es that the language should be consistent. C ommenter 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 Ti er 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 co mpensation, 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 revisi on 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 w as 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 retu rned 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 la boratories that conduct the EDSP Tier 1 Battery. The ICR supporting statement has been updated to reflect the updated burden andPage 6 of 9 cost estimates. A copy of the laboratory capacity study has been placed in the docket under Docket ID No. EPA

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. 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

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- 0037 an d is available at www.regulations.gov

. Furthermore, EPA has developed a guidance document titled, "Weight

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- Evidence Guidance Document: Evaluating Results of EDSP Tier 1 Screening to Identify Candidate Chemicals fo r 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

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. 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 inter nally peer reviewed at the Agency

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

. ( Commenter # 41 )

Additional Detail : Commenter 4 1 stated “E PA is violating these T erms 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. E PA‘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 stud y had been met a n 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

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As for the W o E 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

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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 T est B attery which OMB approved is inadequate, lacks practical utility, and should never been approved to begin with .”Page 7 of 9 Agency Response: EPA disagrees with this comment. The draft ICR Ad dendum 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 chemi cal 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 o f procymidone 2 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 T ier 1 T est B attery 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 exis ting ICR are the same 1 1 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 De tail : 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 EDS P 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

r equired 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 F FDCA 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 Act ivities

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/.Page 8 of 9 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 beli eve 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 t he generation of data. Furthermore, the estimated burde ns and costs for OSRI are based on the report submitted during the public comment period by Commenter 37 under Docket ID No. EPA

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- 0037 and is available at www.regulations.gov

. The revised cost of t he 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 b een 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 submi tted 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 o f 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 on e report generated in conjunction with a study of laboratory capacity of contract laborat ories 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

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The overall cost for all eleven assays (including analytical chemistry costs and adjusted for inflation) is now estimated to be $579,34 5

.Page 9 of 9 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
m ethod 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 rec ipients 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

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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 relat ed to the ICR.

E. Data Generation Burden and Cost Estimates

Please see comments Se ction 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 4 0 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 foc us is solely on the paperwork activities related to the issuance of Tier 1 Orders for the EDSP List 2 C hemicals identified

.