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Agency Information Collection Activities; Submission To OMB for Review and Approval; Comment Request; Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP); EPA ICR No. 2249.01, OMB Control No. 2070-New

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Information about this document as published in the Federal Register.

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Environmental Protection Agency (EPA).




In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This request involves a new collection activity. The ICR, which is abstracted in this document, describes the nature of the information collection activity and its expected burden and costs.


Additional comments may be submitted on or before May 15, 2009.


Submit your comments, referencing docket ID Number EPA-HQ-OPPT-2007-1081: (1) to EPA online using (our preferred method) or by mail to: Document Control Office (DCO), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) to OMB at: Office of Start Printed Page 17478Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

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William Wooge, Office of Science Coordination and Policy (OSCP), Mailcode 7201M, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8476; fax number: (202) 564-8482; e-mail address:

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EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On December 13, 2007 (72 FR 70839), EPA sought comments on the draft ICR pursuant to 5 CFR 1320.8(d), and received several comments during the comment period. EPA has responded to the comments on the ICR by incorporating changes into the ICR and has also prepared a separate response to comment document that is available in the docket for this ICR. Any additional comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice.

Docket Information: EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2007-1081, which is available for online viewing at, or in person at the OPPT Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is 202-566-1744, and the telephone number for the OPPT Docket is 202-566-0280.

Use EPA's electronic docket and comment system at to submit or view public comments, access the index listing the contents of the docket, and to access those documents in the docket that are available electronically. Please note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in as EPA receives them and without change, unless the comment contains copyrighted material, Confidential Business Information (CBI), or other information whose public disclosure is restricted by statute. For further information about the electronic docket, go to

Title: Tier 1 Screening of Certain Chemicals under the Endocrine Disruptor Screening Program (EDSP).

ICR Numbers: EPA ICR No. 2249.01, OMB Control No. 2070-new.

ICR Status: This ICR is for a new information collection activity that is not contained in a regulation. Under the PRA, an Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control number for this ICR will appear in the Federal Register when approved, and will be displayed on the related collection instruments, i.e., the Tier 1 Order and Initial Response Forms.

Abstract: This ICR covers the information collection activities associated with Tier 1 screening of the first group of chemicals under the Endocrine Disruptor Screening Program (EDSP). The EDSP is established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires endocrine screening of all pesticide chemicals. The Agency established the EDSP in 1998 (63 FR 71541, December 28, 1998) to consist of a two-tiered approach for evaluating all pesticide chemicals for potential endocrine disrupting effects. The purpose of Tier 1 screening (referred to as “screening”) is to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems using a battery of assays. The purpose of Tier 2 testing (referred to as “testing”), is to identify and establish a dose-response relationship for any adverse effects that might result from the interactions identified through the Tier 1 assays. Additional information about the EDSP is available through the Agency's Web site at​scipoly/​oscpendo/​index.htm.

The focus of this ICR is on the information collection activities associated with the Tier 1 screening of the first group of chemicals identified for initial screening under the EDSP. After an opportunity for public comment on a draft list, the Agency has identified a final list of chemicals to be the first to undergo Tier 1 screening. (This list appears in a separate notice published in today's Federal Register.) This list should not be construed as a list of known or likely endocrine disruptors. Nothing in the approach for generating the initial list provides a basis to infer that by simply being on this list these chemicals are suspected to interfere with the endocrine systems of humans or other species, and it would be inappropriate to do so. The first group of chemicals identified for testing includes pesticide active ingredients and High Production Volume (HPV) chemicals used as pesticide inerts. More information on the EPA's priority setting approach and the list of chemicals is available at​scipoly/​oscpendo/​prioritysetting.

This ICR does not cover the information collection activities related to Tier 2 testing because that testing is not expected to occur until the Tier 2 tests complete validation as required by FFDCA. EPA will prepare a separate ICR to address the information collection activities associated with Tier 2 testing. In addition, subsequent Tier 1 screening of additional chemicals not selected for the initial round will be addressed separately, either in a separate ICR or in an amendment to this ICR. In either case, EPA will follow the notice and comment process prescribed by the Paperwork Reduction Act (PRA) to first seek public comment on the new or revised ICR before submitting it to OMB for review and approval under the PRA.

Burden Statement: The annualized public reporting and recordkeeping burden for this collection of information is estimated to average 1003 hours per response, although individual respondent burden varies based on their individual activities. 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. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The ICR, a copy of which is available in the docket, provides a detailed explanation of this estimate, which is only briefly summarized here:

Respondents/Affected Entities: Entities potentially affected by this ICR are those entities that may receive an EDSP test order issued by the Agency. Under FFDCA section 408(p)(5)(A), EPA “shall issue” EDSP test orders “to a registrant of a substance for which testing is required * * * or to a person who manufactures or imports a substance for which testing is required.” Using the North American Industrial Start Printed Page 17479Classification System (NAICS) codes, the Agency has determined that potential respondents to this ICR may include, but is not limited to:

  • Chemical manufacturing (NAICS code 325), e.g., persons who manufacture, import or process chemical substances.
  • Agricultural chemical manufacturing (NAICS code 3253), e.g., persons who manufacture, import or process pesticide, fertilizer and agricultural chemicals.
  • Scientific research and development services (NAICS code 5417), e.g., persons who conduct testing of chemical substances for endocrine effects.

Estimated Total Number of Potential Respondents: 390.

Frequency of Response: On occasion.

Estimated Total Average Number of Responses for Each Respondent: Two or three responses per chemical: An initial response, an interim study report, if applicable, and the final data submission. All respondents will provide an initial response. Some respondents may form a consortium to provide the data, in which case the consortium will also provide an initial response. Only those respondents that generate the data, either individually or through the consortium, will complete an interim study report and the final data submission.

Estimated Total Annual Burden Hours: 108,364 hours.

Estimated Total Annual Costs: $7,478,116. This includes an estimated annualized cost of $236 for non-burden hour or delivery costs.

Changes in Burden Estimates: This is a new collection.

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Dated: April 8, 2009.

Robert Gunter,

Acting Director, Collection Strategies Division.

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[FR Doc. E9-8676 Filed 4-14-09; 8:45 am]