EDSP: TIER 1 TESTING INFORMATION COLLECTION

ISRTP 2010 Endocrine Workshop

EDSP ComplianceDecember 13, 2010

Susan Ferenc, DVM, Ph.D

Information Collection Request (ICR)

• Agencies requesting submission of information by the public must demonstrate the “practical utility,” or benefit, of the information and enumerate the public “burden,” or cost, of the collection– The Tier 1 data and OSRI are needed and will

be used to provide information that will allow EPA to determine “that a chemical does, or is not likely to, have the potential to interact with the endocrine system.”

ICR• Practical Utility: Means “the actual not merely

theoretical or potential, usefulness of information to or for an agency, taking into account its accuracy, validity, adequacy, and reliability, and the agency’s ability to process the information it collects in a useful and timely fashion…”

• Burden: Means “the total time, effort or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency, including:

• Developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information;

• Searching data sources.”

EDSP Information Collection RequestOMB Action: Approved with Change

“Terms of Clearance”

• “…under the principles of the PRA, EPA should promote and encourage test order recipients to submit Other Scientifically Relevant Information (OSRI) in lieu of performing all or some of the Tier I assays, and EPA should accept OSRI as sufficient to satisfy the test orders to the greatest extent possible.”

• “…to further validate EPA’s burden estimates, 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.”

• “… in order to ensure that EPA has maximized the practical utility of the Tier I assays…, 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 the agency decisions on whether a chemical must proceed to Tier II, including the Weight of Evidence Approach and Standard Evaluation Procedures.”

Status of List 1 Activity• All responses to List 1 Test Orders have been submitted• EPA has made OSRI decisions on 15 chemicals• Of the 58 List 1 pesticide active ingredients:

• 30 are being “supported” in consortia• 143 members in total, 4-5 members per consortia on average, range of 2-17

members• 21 are being “supported” by a single company• 7 are not being “supported”• 20 registrations have been voluntarily cancelled

• Of the 9 List 1 pesticide inert ingredients:• 2 inerts are being “supported” in consortia

• One consortium of 2 companies, the other of 7 (so far)• Data Submission

• OSRI submitted for 46 actives• New Data generated for 5 actives and 2 inerts

• 769 Test Orders sent out:• 173 responses to “support,” • 596 “other” responses (e.g., formulators exemption, opt-out of pesticide

market, not subject to test order, response outstanding)• There will be only one final response for each “supported”

chemical

Table 10 – Estimated Total Respondent Burden Hours by Activity Activity (a) Estimated

Burden (b) Estimated #

Respondents (c)

Total Burden Hours (d)

1) Read instructions 24 769 18,456 2) Plan activities 90 769 69,210 3) Submit an initial response to EPA (b) 47 769 36,143 4) Read and discuss the protocol 181 67 12,127 5) Participate in Consortium 171 702 120,042 6) Generate the data (c) 2,101 67 140,767 7) Submit Progress Report 32 67 2,144 8) Compile and review the final data for submission 239 67 16,013 9) Complete paperwork to assemble the submission package

32 67 2,144

10) Submit final data to EPA 5 67 335 11) Maintain records 86 769 66,134

Total burden: 3,008

483,515

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category. (b) Per chemical burden taken from the total column in Table 6. (c) Number of potential respondents from Table 1. (d) Total = (a) x (b)

.

Table 12 – Estimated Total Respondent Costs by Activity

Activity Estimated Costs ($)

Estimated Respondents

Total $ (rounded)

1) Read instructions 2,166.48 769 1,666,023 2) Plan activities 8,204.40 769 6,309,184

3) Submit an initial response to EPA (b) 4,169.40 769 3,206,269 4) Read and discuss the protocol 14,883.72 67 997,209

5) Participate in Consortium 13,707.48 702 9,622,651 6) Generate the data (c) 141,511.00 67 9,481,237

7) Submit Progress Report 2,291.70 67 153,544 8) Compile and review the final data for submission 18,825.24 67 1,261,291 9) Complete paperwork to assemble the submission

package 2,291.70 67 153,544

10) Submit final data to EPA 378.06 67 25,330 11) Maintain records 3,929.28 769 3,021,616 12) Delivery Costs 10.55 67 25,330

Total costs: $212,369.0 1

$ 35,923,228

ASSAYS Code Avg

     In Vitro Assays:    Androgen Receptor Binding (Rat Prostate) 890.1150 $21,035Aromatase (Human Recombinant) 890.1200 $10,060Estrogen Receptor Binding (Rat Uterine) 890.1250 $21,035ER Transcriptional Activation 890.1300 $15,113Steroidogenisis (Human Cell Line) 890.1550 $16,222     In Vivo Assays:    Fish Sort Term Reproduction 890.1350 $114,767Hershberger (Rat) 890.1400 $30,190Female Pubertal (Rat) 890.1450 $76,770Male Pubertal (Rat) 890.1500 $77,740Amphibian Metamorphosis (Frog) 890.1350 $106,087Uterotrophic (Rat) 890.1600 $32,140     TOTAL $521,158

Total Cost of OSRI (46 chemicals) *$1,584,000

Per Chemical Submission $34,435

Per Test Order Recipient *$8,909

Estimated Costs for Generation and Submission of OSRI

ASSAYS Code Avg OSRI Savings         In Vitro Assays:        

Androgen Receptor Binding 890.115

0 $21,035 2 $42,070

Aromatase (Human Recombinant)890.120

0 $10,060 0 $0

Estrogen Receptor Binding 890.125

0 $21,035 2 $42,070

ER Transcriptional Activation890.130

0 $15,113 2 $30,227

Steroidogenisis (Human Cell Line)890.155

0 $16,222 0 $0         In Vivo Assays:        

Fish Sort Term Reproduction890.135

0 $114,767 0 $0

Hershberger (Rat)890.140

0 $30,190 4 $120,760

Female Pubertal (Rat)890.145

0 $76,770 2 $153,540

Male Pubertal (Rat)890.150

0 $77,740 4 $310,960

Amphibian Metamorphosis (Frog)890.135

0 $106,087 2 $212,173

Uterotrophic (Rat)890.160

0 $32,140 2 $64,280         TOTAL $521,158 $976,080

Total Burden

EPA CPDA

List 1 Tier 1 Program $35,923,228 $70,840,814

List 2 Tier 1 Program $52,071,780 $121,906,952

Battery Costs for List 1 $34,917,586Battery Costs for List 2 $69,835,172

Thank you!