Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)

Forms and Documents

Document Name	Status
Form EPA Form No. 6300- Order Recipients - Manufacturers and Importers of Pesticide Inert Ingredients Form and Instruction	New
Form 6300-05 Data Submitters Form	Removed
Form 6300-05-Q Optional Questionnaire Form	Removed
Form EPA Form No. 6300- Order Recipients - Registrants of Pesticide Active Ingredients Form and Instruction	Modified
2249.03_Attachment_I.pdf Supplementary Document	2012-10-23
2249.03_Attachment_H.pdf Supplementary Document	2012-10-23
2249.03_Attachment_G.pdf Supplementary Document	2012-10-23
2249.03_Attachment_F.pdf Supplementary Document	2012-10-23
2249.03_Attachment_E.pdf Supplementary Document	2012-10-23
2249.03_Attachment_D-2.pdf Supplementary Document	2012-10-23
2249.03_Attachment_D-1.pdf Supplementary Document	2012-10-23
2249.03_Attachment_B.pdf Supplementary Document	2012-10-23
2249.03_Attachment_C-2.pdf Supplementary Document	2012-10-23
2249.03_Attachment_A.pdf Supplementary Document	2012-10-23
2249.03_Attachment_C-1.pdf Supplementary Document	2012-10-23
2249.03_Attachment_B.pdf Supplementary Document	2012-10-24
2249.03_Attachment_B.pdf Supplementary Document	2012-10-24
2249.03_Attachment_B.pdf Supplementary Document	2012-10-24
2249.03_Attachment_B.pdf Supplementary Document	2012-10-24
2249.03_Attachment_B.pdf Supplementary Document	2012-10-24
2249.03_Attachment_B.pdf Supplementary Document	2012-10-23
2249.03_Attachment_B.pdf Supplementary Document	2012-10-24
2249.03_ss_2012-10-25.docx Supporting Statement A	2012-10-25

IC Document Collections

IC ID	Document Title	Status
204655	Consortium Participants - Manufacturers and Importers of Pesticide Inert Ingredients Instruction	New
204654	Consortium Participants - Registrants of Pesticide Active Ingredients Instruction	New
204653	Data Generators and Submitters - Manufacturers and Importers of Pesticide Inert Ingredients Instruction	New
204652	Data Generators and Submitters - Registrants of Pesticide Active Ingredients Instruction	New
204651	Order Recipients - Manufacturers and Importers of Pesticide Inert Ingredients Form and Instruction	New
190887	Data Submitters Form	Removed
190886	Optional Questionnaire Form	Removed
188816	Order Recipients - Registrants of Pesticide Active Ingredients Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0176	ICR Reference No: 201210-2070-003
Status: Historical Active	Previous ICR Reference No: 200904-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2249.03
Title: Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/03/2013
	Date Received in OIRA: 10/30/2012
Terms of Clearance: In accordance with 5 CFR 1320, this information collection has been approved for an additional 3 years for the 67 chemicals published by EPA at 74 Fed. Reg. 17579 (April 15, 2009). OMB supports the EPA’s efforts to 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, when they are determined sufficient to satisfy the test orders. OMB still 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 the issuance of the test orders for additional chemicals in Tier I. OMB acknowledges the EPA’s outreach to the public and peer reviewers and encourages continuous efforts for stakeholder involvement while developing the protocols on whether a chemical must proceed to Tier II, including the Weight of the Evidence Approach and Standard Evaluation Procedures.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2016	36 Months From Approved	07/31/2013
Responses	385	0	1,287
Time Burden (Hours)	98,403	0	161,415
Cost Burden (Dollars)	190	0	0

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Abstract: This renewal ICR covers the information collection activities associated with Tier 1 screening of 67 chemicals identified on List 1 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 the EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. This ICR addresses the information collection activities for the initial list of chemicals screened under Tier 1 of the EDSP, and covers the full range of information collection activities associated with the issuance of and response to Tier 1 EDSP orders issued by the EPA. The initial list was established in 2009, and consists of 67 pesticide active ingredients (PAIs) and pesticide inerts. As the renewal of an ongoing information collection activity approved under the PRA, this ICR addresses the paperwork burden associated with the continuation of these activities over the next three (3) years. As such, the paperwork burdens are adjusted to reflect the planned progression associated with the information collection activities covered by the ICR, which are unchanged from the approved ICR. Please note, however, that the structure of the ICR has been changed to incorporate a more logical IC break-out that would match that used in the ICR submission system.

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Authorizing Statute(s): US Code: 21 USC 346a(p) Name of Law: section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 47640	08/09/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 65682	10/30/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Order Recipients - Registrants of Pesticide Active Ingredients	EPA Form No. 6300-05, EPA Form No. 6300-05-C	Initial Response Form for Individual Order Recipients (As of April 3, 2009) ,   Initial Response Form for Consortium/Task Force (As of April 3, 2009)
Order Recipients - Manufacturers and Importers of Pesticide Inert Ingredients	EPA Form No. 6300-05, EPA Form No. 6300-05-C	Initial Response Form for Individual Order Recipients (As of April 3, 2009) ,   Initial Response Form for Consortium/Task Force (As of April 3, 2009)
Data Generators and Submitters - Manufacturers and Importers of Pesticide Inert Ingredients
Data Generators and Submitters - Registrants of Pesticide Active Ingredients
Consortium Participants - Registrants of Pesticide Active Ingredients
Consortium Participants - Manufacturers and Importers of Pesticide Inert Ingredients
Optional Questionnaire	6300-05-Q	Optional Questionnaire Level of Effort for Recipients of Tier 1 Screening Orders
Data Submitters	6300-05, 6300-05-C	Initial Response Form for Individual Order Recipients ,   Initial Response Form for Consortium/ Task Force

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	385	1,287	0	-527	-375	0
Annual Time Burden (Hours)	98,403	161,415	0	-139,370	76,358	0
Annual Cost Burden (Dollars)	190	0	0	0	190	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This request represents a decrease of the annualized burden by 63,012 hours from that currently in the OMB inventory (from 161,415 hours to 98,403 hours). This change is an adjustment in burden estimates due to the planned progression of the collection activities associated with the initial list of chemicals to be screened under the EDSP. This change is an adjustment.

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Annual Cost to Federal Government: $889,148

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/30/2012

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