Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting

Forms and Documents

Document Name	Status
Attachment_G_OMB_Display.doc Supplementary Document	2010-12-14
PIP_ICR_Attachment E_Labor worksheet.doc Supplementary Document	2010-07-26
Attachment_D_Record_of_Consultations.pdf Supplementary Document	2010-07-26
PIP_ICR_Attachment_C_FFDCA_408(a).doc Supplementary Document	2010-07-26
PIP_ICR_Attachment_B_FIFRA_25(b).doc Supplementary Document	2010-07-26
PIP_ICR_Attachment A_40CFR174.pdf Supplementary Document	2010-07-26
PIP_ICR_Supporting_Statement_2010-12-14.doc Supporting Statement A	2010-12-14

IC Document Collections

IC ID	Document Title	Status
24963	Plant-Incorporated Protectants - Substantiation of Confidential Business Information Claims	Modified
182391	Plant-Incorporated Protectants - Adverse Effects Reporting	Modified

ICR Details

OMB Control No: 2070-0142	ICR Reference No: 201101-2070-004
Status: Historical Active	Previous ICR Reference No: 200710-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1693.07
Title: Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting
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: 06/07/2011
	Date Received in OIRA: 01/26/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for 3 years. It is suggested the agency pay close attention to any rulemakings regarding the treatment or enforcement of CBI claims that may affect this collection and submit revisions accordingly.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	36 Months From Approved	06/30/2011
Responses	19	0	15
Time Burden (Hours)	389	0	303
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR addresses the two information collection requirements described in regulations pertaining to pesticidal substances that are produced by plants (plant-incorporated protectants aka "PIPs") and which are codified in 40 CFR part 174. A PIP is defined as "the pesticidal substance that is intended to be produced and used in a living plant and the genetic material necessary for the production of such a substance." Many, but not all, PIPs are exempt from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). When registering a PIP, an applicant may sometimes include information that they claim to be confidential business information (CBI). CBI is protected by FIFRA and generally cannot be released to the public. Under 40 CFR part 174, whenever an applicant claims that information submitted to EPA in support of a registration application for a PIP contains CBI, the applicant must substantiate such claims when they are made. In addition, manufacturers of PIPs that are otherwise exempted from the requirements of registration must report subsequent adverse effects information (i.e., risk/benefit information under FIFRA section 6(a)(2))of the PIP to the Agency. Such reporting will allow the Agency to determine whether further action is needed to prevent unreasonable adverse effects to public health or the environment.

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Authorizing Statute(s): US Code: 7 USC 136-136y Name of Law: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
   US Code: 21 USC 346a Name of Law: 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:
	75 FR 24691	05/05/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 4657	01/26/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Plant-Incorporated Protectants - Substantiation of Confidential Business Information Claims
Plant-Incorporated Protectants - Adverse Effects Reporting

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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	19	15	0	0	4	0
Annual Time Burden (Hours)	389	303	0	0	86	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $13,610

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: 01/26/2011

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