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Attachment H

EDSP ICR Renewal Consultation

In addition to the notice and comment requirement, agencies are also required 

under 5 CFR 1320.8(d)(1) to consult with potential respondents and data users 

about specific aspects of an ICR before submitting it to OMB for review and

approval, regardless of whether changes have or have not been made to the

collection activity. 

■ Consultation Participants

EPA consulted with a variety of respondents regarding the information collection 

activities for this ICR during the renewal and consolidation process. A list of the 

respondents contacted is below:

1. American Chemistry Council (Stakeholder) 

700 Second St., NE

Washington, DC 20002 [directions]

Fax: (202) 249-6100

Contact: Sylvia Palmer

 Director, Regulatory and Technical Affairs

 Telephone: (202) 249-6425

 Sylvia_palmer@americanchemistry.com

2. CropLife America (CLA)/Endocrine Policy Forum (EPF) (Stakeholder) 

1156 15th St., NW

Washington, DC 20005 

Contact: Barbara P. Glenn, Ph.D.

 Senior Vice President, Science and Regulatory Affairs

 desk (202) 833-4474

 bglenn@croplifeamerica.org 

3. Natural Resources Defense Council (NRDC) (Stakeholder) 

40 West 20th Street

New York, NY 10011

Fax: (212) 727-1773

Contact: Mr. Michael Wall

 Telephone: (212) 727-2700

 mwall@nrdc.org
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4. Acetone Consortium (Pesticide Inert) 

700 Second St., NE

Washington, DC 20002 [directions]

Phone: (202) 249-7000

Fax: (202) 249-6100

Contact: Jonathon T. Busch

 Manager, Acetone EDSP Testing Consortium

 Director, Chemical Products & Technology Division

 Telephone: (202) 249-6725

 jon_busch@americanchemistry.com

5. 2,4-D Consortium (Pesticide Active Ingredient) 

2862 Jeremy Court

Carmel, IN 46033-8757

Contact: Larry Hammond

 Chairman, Technical Committee

 2,4-D Task Force

 317-517-9442

 lhammond@indy.rr.com

6. Atrazine EDSP Consortium (Pesticidal Inert) 

Atrazine EDSP Consortium

c/o Syngenta Crop Protection

P.O. Box 18300

Greensboro, NC 27419

Contact: Dan Campbell

 (336) 632-7627

 dan.campbell@syngenta.com

7. Carbaryl (Sole Data Doer) 

Bayer Cropscience

108 Alexander Avenue 

Durham, NC

Contact: Mike Gorrell

 Office Phone (919) 549-2423

 mike.gorrell@bayer.com 
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8. Propargite (Sole Data Doer) 

Chemtura Corporation

199 Benson Road

Middlebury, CT 06749 USA

Fx: (203) 573-2958

Contact: Robert "Tim" Weiland

 Registration Specialist, North America

 (203) 573-2027

 tim.weiland@chemtura.com

■ Survey Questions

A. Publicly Available Data 

1. Is the data that the Agency seeks available from any public source, or 

already collected by another office at EPA or by another agency?

2. If yes, where can you find the data?

B. Frequency of Collection

1. Can the Agency collect the information less frequently and still 

produce the same outcome?

C. Clarity of Instructions 

1. Based on the instructions, is it clear to the respondents what they may 

be required to do and how to submit such data? If not, what 

suggestions do they have to clarify the instructions?

2. Did you understand what was required, where applicable, to submit or 

maintain in your records?

3. Is the format of any reporting forms is clear, logical, and easy to 

complete? 

D. Electronic Reporting and Record Keeping 

1. Would electronic alternatives to paper-based records and data 

submissions be preferred?

E. Burden and Costs 

1. Are the labor rates EPA used to estimate burdens and costs accurate?
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2. Are there other costs that should be accounted for that may have 

been missed, such as capital/start-up/Management & Overhead

expenditures/etc.? 
Appendix 1 

Written Response From Bayer CropScience, LP
EPA SHORT ICR SURVEY FOR EDSP – October 4, 2012 

(A) Publicly Available Data 

Is the data that the Agency seeks available from any public source, or already collected by 

another office at EPA or by another agency? 

Yes 

If yes, where can you find the data? 

EPA will have data in its own files that should be re-evaluated, just as is done for problem 

formulation at the beginning of registration review, before deciding which Tier 1 studies should 

be requested in a test-order. EPA holds the data that companies have submitted to the Agency to 

support the safety of their products (e.g., data required for pesticide registration) which contains 

many studies which include evaluations of estrogen, androgen and thyroid activity. In addition, 

screening programs and relevant research studies are performed or funded by EPA (e.g., HPV 

screens, ToxCast, positive control work for EDSP studies, ORD research, etc.). EPA could also 

search the peer reviewed literature for additional OSRI; although not all of the data may be 

relevant and reliable for Tier 1 data purposes, EPA could critically evaluate publications as to 

whether they have value in the Tier 1 process. The Agency should at a minimum re-evaluate and 

issue a transparent “OSRI opinion” of the studies it already has in house rather than placing the 

burden on industry to explain data that EPA is already familiar with. 

In the List 1, Tier 1 process, test order recipients provided OSRI (other scientifically relevant 

information) which included a review of the existing pesticide safety data submitted to EPA. We 

feel this information was underutilized by EPA in the process, which is a concern for the 

upcoming List 2 pesticides. Our opinion is that EPA’s OSRI evaluation for List 1 was too strict; 

EPA appeared focused on receiving the exact assays prescribed in the guidelines rather than 

acknowledging other types of data might provide equivalent or even superior data. While it is 

understandable that EPA wanted to receive a significant body of data for every List 1 Tier 1 

screening study to help it determine the strengths and weaknesses of each assay, moving forward 

EPA should place higher weight on 40CFR part 158 studies, also drawing from the lessons that 

will have been learned from the List 1 Tier 1 results. EPA should also be better able to determine 

the utility of ToxCast assays once all List 1 Tier 1 data has been evaluated and results measured 

against those obtained from ToxCast screening. 

(B) Frequency of Collection 

Can the Agency collect the information less frequently and still produce the same outcome? 

As indicated above, EPA may already have sufficient information to evaluate endocrine activity 

and would eliminate the need to collect additional information. A thorough review of existing 

data should be initiated by EPA before test orders are issued. 

If studies are determined to be necessary, the Agency could eliminate the 1 year interim report 

requirement; this requirement was a paperwork burden on test order recipients and EPA without 

bringing any information value. Also, based upon our List 1 Tier 1 experience, EPA should 
EPA SHORT ICR SURVEY FOR EDSP – October 4, 2012 

extend the duration of the Tier 1 program to allow test-order recipients at least 2.5 years 

(preferably 3) to fulfill the requirements; this would ensure that all test order recipients that file 

an OSRI report at 90 or 150 days and request waivers from some or all data requirements have 

enough time after receiving OSRI feedback from the Agency to provide both their studies and 

weight of evidence (WoE) summaries in a single submission package (assuming EPA continues 

to provide its OSRI feedback within 3-6 months). This would greatly reduce the need for the 

multiple study deadline extension requests that were burdensome to List 1 recipients and 

presumably to EPA as well. Finally, even in cases where study deadline extensions are 

necessary, EPA should still accept a single submission of all required data to reduce the burden 

on both industry and EPA associated with multiple submissions. Since all studies are needed for 

the Agency to make a WoE determination, this should not significantly delay EPA in its decision 

making process.

(C) Clarity of Instructions

Based on the instructions, is it clear to the respondents what they may be required to do 

and how to submit such data? If not, what suggestions do they have to clarify the 

instructions? 

The test order itself is not easily digested by the receiving registration manager in one reading. If 

the purpose is to readily understand what procedures need to be followed to respond rather than 

data related details, the document would benefit from some re-ordering (e.g., options for 

responding would be better early in the document so the reader can view the bulk of the 

information from the category he believes applies to him) and making some sections information 

related appendices (e.g. section III.A The Tier 1 battery along with Table 1 in III C could form 

an appendix) . 

There is considerable mention in the test order about citing OSRI but we still have little insight 

on how EPA has and will in future review and determine OSRI acceptability. EPA indicated to 

industry that the Agency used a WoE approach for OSRI; a description of the OSRI WoE 

process would be greatly appreciated. 

The 890 guidelines as issued contained numerous errors and misinformation. Industry 

appreciated the efforts of EPA to address the questions (EPA response to the EPF 2-7-2011 FAQ 

at EPA-HQ-OPP-2009-0634-0240). However, industry believes series 890 needs to be reissued 

in corrected form (after the decision is made on the utility of every screen in the battery and/or 

possible additions). 

 In some cases guidance was received late in the process, and therefore was not as useful as it 

should have been (SEPs, study profile templates, electronic data forms). In other cases, the 

guidance was insufficient (OSRI, Weight of Evidence). In at least one case, guidance has yet to 

be received (triggers for Tier 2 testing). Moving forward on List 2 Tier 1 and List 1 Tier 2, EPA 

needs to release guidance earlier in the process and solicit comments prior to finalization in order 

to maximize the usefulness and the compliance of test order recipients. 
EPA SHORT ICR SURVEY FOR EDSP – October 4, 2012 

Did you understand what was required, where applicable, to submit or maintain in your 

records? 

There was a level of clarity due to the fact that the test orders were issued under FIFRA. 

However, EPA will have to take additional steps to ensure the process is equally understood for 

test orders issued under alternate legislative mandates. 

One point that did involve significant time and communication, both verbal and written, was the 

issue of adverse effect reporting, where there was uncertainty brought about by the 1998 Federal 

Register Notice on the proposed EDSP policy which stated in vitro assays would not be subject 

to FIFRA 6(a)(2) or TSCA 8(e) reporting requirements. The ultimate decision issued by EPA in 

response to the EPF’s final written communication on April 29, 2011 was not received until July 

2011, well after study results had begun to become available. 

There is still the issue of conflicting requirements in the test guidelines/SEP/Study profile 

templates/DEST; is certain information truly required or is it viewed as “nice to have” and at the 

discretion of the lab/registrant whether to provide it (e.g., proficiency work, saturation binding). 

These discrepencies should be cleared up before the next test order issues. 

Is the format of any reporting forms clear, logical, and easy to complete?

 Once received, the forms were clear. The major issue was that forms generally came late in the 

process; in future, it would be preferred if everything is made available up front.

D) Electronic Reporting and Record Keeping

Would electronic alternatives to paper-based records and data submissions be preferred? 

We did make electronic submissions, although our first e-submission was rejected necessitating 

some back and forth with the Agency and cost to resolve the problem. Values for certain ePrism 

fields were added to fill in EDSP specific information (i.e. Consortia information, EDSP 

number); internal effort to problem solve in addition to software development costs to adapt 

existing tools cost approximately $20K in one off costs. Once the needed modifications were 

made electronic submissions went smoothly. 

(E) Burden and Costs 

Are the labor rates EPA used to estimate burdens and costs accurate? 

Clerical help is not widely available in many companies, including BCS, so clerical tasks are 

generally performed by managerial and technical staff except in the case of e-submissions, which 

involve documentation specialists whose hourly costs are more in line with the managerial costs 

suggested by EPA. The managerial and technical labor rates that EPA is applying in its ICR are 

considerably lower than those of BCS, particularly in the case of technical staff. It’s possible that 
EPA SHORT ICR SURVEY FOR EDSP – October 4, 2012 

general overhead costs for office space and systems and support that are part of labor costs (and 

will vary by company) are not taken into account in EPA estimates. Also, time and labor rates 

associated with legal and consulting services, both particularly important for consortia, are not 

represented. 

Over the past year we have often heard that EPA has found certain steps/review to be more 

resource intensive or more complicated than they had anticipated. BCS is interested in whether 

EPA estimates of Agency burden have been accurate. In the interest of transparency, will the 

Agency be furnishing an accounting of their burden in comparison to what was predicted for the 

first 3 years? 

Are there other costs that should be accounted for that may have been missed, such as 

capital/start-up/M&O expenditures/etc.? 

Start-up costs and capital expenditures are a consideration for every lab when implementing new 

testing designs. In addition, the costs of developing OSRI were not included in EPA’s burden 

estimates. The Endocrine Policy Forum has developed cost-burden information for the test order 

to OSRI phase of the program (and are working on estmates that would encompass from OSRI to 

submission including testing and data interpretation) and these reflect the real burden to industry 

for this phase of the EDSP. 

Another consideration is the accuracy of the costs that EPA put forward in 2009, which were 

well below the estimate EPA has in its current ICR renewal request. The estimates that EPA has 

recently put forward regarding the cost burden to test order recipients has come closer to the 

costs that industry expects to bear to comply with the EDSP than were reflected in the original 

ICR. If one considers the difference between the data generation activity estimates EPA put 

forward in 2009 (approximately $540,000) as compared to today’s estimates (approximately 

$860,000) there was close to a 40% underestimation made in the initial ICR. It is understandable 

that at the beginning of a program estimates must be based on hypotheses and/or less robust 

information, increasing the likelihood that estimates will be significantly skewed. Looking ahead 

to List 2 Tier 1 and especially List 1 Tier 2, EPA should consider the difference between the 

2009 and 2012 estimates as other ICRs are developed for the endocrine program and determine 

an uncertainty factor to apply that would better predict the actual costs when the program 

matures. Perhaps cooperative consultation between industry and EPA could help determine some 

reasonable uncertainty factors. 
Appendix 2 

Written Response From ACC Acetone EDSP Testing Consortium
EPA ICR Renewal Survey 

Response of the ACC Acetone EDSP Testing Consortium 

October 12, 2012 

(A) Publicly Available Data 

Is the data that the Agency seeks available from any public source, or already collected by 

another office at EPA or by another agency? 

Please see the response of the American Chemistry Council (ACC) submitted separately. 

(B) Frequency of Collection

Can the Agency collect the information less frequently and still produce the same outcome? 

Please see the response of the American Chemistry Council (ACC) submitted separately. 

(C) Clarity of Instructions

Based on the instructions, is it clear to the respondents what they may be required to do 

and how to submit such data? If not, what suggestions do they have to clarify the 

instructions? 

Please see the response of the American Chemistry Council (ACC) submitted separately. 

Did you understand what was required, where applicable, to submit or maintain in your 

records?

 

Please see the response of the American Chemistry Council (ACC) submitted separately. 

Is the format of any reporting forms clear, logical, and easy to complete? 

Is there any information on the initial response form, the 1 year progress that we can relate from 

Panels? 

Please see the response of the American Chemistry Council (ACC) submitted separately. 

(D) Electronic Reporting and Record Keeping

Would electronic alternatives to paper-based records and data submissions be preferred? 

Please see the response of the American Chemistry Council (ACC) submitted separately. 

(E) Burden and Costs
Are the labor rates EPA used to estimate burdens and costs accurate?

Depending on the experience of the Consortium manger and dynamics of the particular industry 

Consortium, a typical trade association rate for management services of $150 to $250 per hour 

would apply to the EDSP. Typically, the same hourly rate ($150 to 250 per hour) also would 

apply to a PhD scientific consultant retained by a Consortium. The hourly rates for both 

management and consultant fees for the Acetone EDSP Testing Consortium fit within the ranges 

presented here. 

Are there other costs that should be accounted for that may have been missed, such as 

capital/start-up/M&O expenditures/etc.? (Management and Overhead) 

For the Acetone EDSP Testing Consortium:

--Laboratory Costs: The assay-by-assay break down is provided in the attachment. The EPA 

table that was sent as part of the survey did not allow input for analytical costs, range-finding 

study costs, or for GLP purity assessment costs. These are significant costs. When you take 

these three costs, and the total assay-by-assay costs for testing at a commercial laboratory, the 

total laboratory costs thus far for acetone testing are $666,615.

--Scientific Consulting Costs: To assist the acetone Consortium for such activities as protocol 

and report review, lab site visits, and communications with lab and sponsors on technical issues, 

the scientific consulting costs are approximately: $85,000

--Trade Association Management Costs (for a 2 year testing program): $80,000—This 

approximate figure covers in part such items as: the manager’s direct time on the project; time 

of administrative assistant; and legal and accounting services. 

--OSRI Costs for Acetone: $0 (no OSRI data were submitted for acetone) 

--Estimated Archiving Cost of Study Materials for 15-year FIFRA Period: These are estimated 

costs because they have not been incurred yet: (a) $15,000 (or $1,000 per year x 15 years for the 

four mammalian studies = $15,000), plus (b) $800 per year for the seven non-mammalian/in 

vitro studies ($800 per year x 15 years = $12,000). Total estimated archiving cost = $27,000 for 

the 15-year required FIFRA retention. 

--Consortium Funding Agreement: $10,000 must be retained by Consortium after completion of 

testing program in event the trade association must assist with data compensation issues. 

--Quality assurance costs (budgeted): $65,000 

....................................................................... 

TOTAL of all of the above for the acetone EDSP costs: $933,615. The acetone testing is 

currently in progress, so there is always the chance that costs could increase. 
Information provided by: 

Jonathon T. Busch 

Manager, ACC Acetone EDSP Testing Consortium 

Director, Chemical Products & Technology Division 

American Chemistry Council (ACC)

700 – 2nd Street NE 

Washington, DC 20002 

Office: (202) 249-6725 | Cell: (703) 439-7076 

Email: jon_busch@americanchemistry.comm

www.americanchemistry.comm

 
Appendix 3 

Written Response From American Chemistry Council
EPA List 1 ICR Renewal Survey 

American Chemistry Council Response 

October 15, 2012 

(A) Publicly Available Data 

Is the data that the Agency seeks available from any public source, or already collected by 

another office at EPA or by another agency? 

For a number of substances, the data from substantially similar assays to the Tier 1 screening and 

Tier 2 testing assays may be available in the scientific literature.

For some substances, the data from substantially similar assays to the Tier 2 test assays may be 

available as information EPA has already collected for pesticide registrations, for the HPV 

Challenge program and from TSCA test rules, TSCA enforceable consent agreements and other 

submissions in accordance with TSCA rules and requirements. 

For the substances selected for List 1 Tier 1 screening, there was data available therefore from 

public sources that EPA had access to. The Agency did not perform adequate due diligence in 

determining what was available, before asking industry to provide it. In addition, the OSRI process 

was so strict that the available data was often rejected or under-utilized. EPA should have evaluated 

the information available before requesting all 11 screens. 

If yes, where can you find the data? 

• Data required for pesticide registration

• Data collected under the HPV Challenge program

• TSCA test rules, consent agreements and other TSCA submissions 

• ToxCast results, if such methods can be shown to meet the requisite validation benchmarks 

of “relevant, reliable, sensitive and specific for the intended purpose of use.” At present, we 

are not in support of using assays such as these until they have been shown to be valid for 

their intended use. 

• Positive/negative controls in development and validation work for EDSP Tier 1 and Tier 2 

Test guidelines. 

• Scientific literature

Many 870 series test guideline studies required for pesticide registration of active ingredients 

include evaluations of endpoints that are sensitive to effects on E, A, T and can also be used in 

weight of evidence evaluations. 

(B) Frequency of Collection

Can the Agency collect the information less frequently and still produce the same outcome? 

EPA asked for too much "other" information that was not needed as part of the test order. This took 

additional time and resources, and increased the paper-work burden on industry 
There were several tasks for the information collection requirements that required time and effort 

but added very little value e.g. the interim report which was of limited value due to the fact that 

most respondents simply stated that testing and responses were in progress. 

The agency can collect information less frequently and still produce the same outcome by giving 

industry the ability to submit all studies at once. This would allow the results to be understood in the 

context of the full battery and any positive response in a particular assay would be potentially 

tempered by the overall results of the entire battery. This would also enable companies to make a 

WoE determination. 

(C) Clarity of Instructions

Based on the instructions, is it clear to the respondents what they may be required to do and 

how to submit such data? If not, what suggestions do they have to clarify the instructions? 

The 890 guidelines contained numerous errors and misinformation, and there is still no guidance 

available to industry on what will trigger Tier 2 testing. 

Filling out Study templates wasn't completely clear because there are discrepancies between the test 

guidelines, Standard Evaluation Procedures (SEP) and Data Entry Spreadsheet Templates (DEST) 

and guidance was received late in the process.

It is not clear what data should be submitted for OSRI and the form such submissions should take. 

Despite repeated requests, EPA has still not provided guidance on development of OSRI. 

Experience with OSRI for EDSP List 1 substances shows that a lack of guidance leads to 

considerable transaction costs by test order recipients. The lack of uniformity in what is submitted 

and the level of documentation required causes major delays in reviews of OSRI submissions and 

decisions from the Agency as to whether to grant a waiver from 1 or more EDSP Tier 1 assays for a 

given substance. The lack of guidance and thus the lack of uniformity in what is submitted increases 

the burden for the Agency. 

Did you understand what was required, where applicable, to submit or maintain in your 

records?

There was much confusion on 6(a)(2) and 8(e) adverse reporting requirements and on April 29, 

2011, the Endocrine Policy Forum sent a letter to the Agency requesting clear guidance on whether 

the results of Tier 1 screening must be reported pursuant to TSCA § 8(e) and FIFRA § 6(a)(2). 

Because the EDSP Tier 1 screening battery does not determine adverse effects, the EPF believes the 

results of Tier 1 screening (both the in vitro and in vivo assays) should not be subject to TSCA § 

8(e) or FIFRA § 6(a)(2) reporting obligations. EPA eventually provided some clarification in a 

July15, 2011 response. 
Is the format of any reporting forms clear, logical, and easy to complete? 

EPA did not develop and disseminate all the Standard Evaluation Procedures/Data Entry Reports 

(SEP/DER) and Data Entry Spreadsheet Templates on time after the test orders were released. The 

SEPs were critical for reviewing results generated by each of the 11 EDSP screens. It would have 

been helpful to have had the DESTs at the beginning of the program so that data could have been 

collected and then submitted electronically.

(D) Electronic Reporting and Record Keeping

Would electronic alternatives to paper-based records and data submissions be preferred? 

Yes, but with some caveats as some test order recipients did encounter problems related to 

electronic submissions. At least one Consortium prepared several reports prior to EPA’s guidance 

on reporting results and then had to spend resources to amend three reports. 

(E) Burden and Costs

Are the labor rates EPA used to estimate burdens and costs accurate?

EPA’s process in the ICR supporting document for calculating the labor rate to arrive at the hourly 

rate figures for managerial, technical and clerical duties is difficult to follow. There are several 

layers of estimations and assumptions being factored into the equation, thus the method for arriving 

at the estimated respondent burden and costs is not readily apparent from the document. Labor 

categories appear to be missing (e.g. legal, accounting). Consultants are likely included in the 

technical category, suggesting that what is there is a significant underestimate. It would be good to 

get some greater accuracy and transparency about how the labor rates are generated.

Depending on the experience of a consortium manager and the dynamics of the particular industry 

consortium, a typical trade association rate for management services in the range of $150 to $250 

per hour would be expected for the EDSP testing consortia activities. Typically, the same hourly 

rate ($150 to 250 per hour) also would apply to a PhD scientific consultant retained by a 

consortium. The hourly rates for both management and consultant fees for the Acetone EDSP 

Testing Consortium fit within these ranges. (See specific survey responses of the Acetone 

Consortium.) 

Are there other costs that should be accounted for that may have been missed, such as 

capital/start-up/M&O expenditures/etc.? (Management and Overhead)

The one big item that EPA does not take into account is the initial cost to the consortia of screening 

the companies that received test orders but who may or may not ultimately join a consortium. 

Numerous test orders were issued for several of the inert substances, and a significant total time 

burden resulted- several hundred hours were spent tracking down all the companies receiving test 

orders.
As the EDSP moves onto List 2 chemicals, there will likely be considerable additional costs for 

setting up and managing consortia for the greater number of commodity chemicals that will likely 

be on EPA’s final List 2. For example, toluene, which was added to EPA’s proposed List 2 when it 

was proposed as an inert utilized in pesticide formulation, had a total of 308 test orders issued. This 

is at least an order of magnitude larger than the maximum number of test orders issued for a 

pesticide active ingredient.

Acetone EDSP testing and ACC management together cost around $933,615 for the entire 11 

assays. No OSRI was submitted for acetone, so there was no cost related to that. Because there are 

some acetone assays still in progress, the total cost of $933,615 could eventually climb higher. The 

Isophorone Consortium did prepare an OSRI document initially which cost about $25,000. 

Overall, EPA significantly under-estimated the Tier 1 costs in the List 1 Tier 1 ICR. See 

comments1 submitted to the List 1 ICR Renewal by the Endocrine Policy Forum on October 9, 

2012. 

 

1

 Comments of the Endocrine Policy Forum on List 1 ICR Renewal, October 9, 2012 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2011-0966-0013