Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting

Forms and Documents

Document Name	Status
Attachment D_Record of Consultations.pdf Supplementary Document	2014-01-16
Attachment G_OMB_Display.doc Supplementary Document	2014-01-16
Attachment E_Worksheets Used to Calculate Labor Costs.pdf Supplementary Document	2014-01-16
Attachment C_FFDCA section 408(a).pdf Supplementary Document	2014-01-16
Attachment B_FIFRA section 25(b).pdf Supplementary Document	2014-01-16
Attachment A_40 CFR 174.pdf Supplementary Document	2014-01-16
1693ss08.docx Supporting Statement A	2014-06-12

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: 201406-2070-003
Status: Historical Active	Previous ICR Reference No: 201101-2070-004
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1693.08
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: 05/06/2015
	Date Received in OIRA: 06/30/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	21	0	19
Time Burden (Hours)	432	0	389
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:
	78 FR 59014	09/25/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 36314	06/26/2014
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	21	19	0	0	2	0
Annual Time Burden (Hours)	432	389	0	0	43	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: There is increase of 43 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is reflects EPA's updating of burden estimates for this collection based upon historical information on the number of CBI substantiations per year. Based upon revised estimates, the number of CBI substantiations per year has increased from 18 to 20, with a corresponding increase in the associated burden. The number of adverse effect reporting submissions remains the same. The increase in the expected number of responses is primarily driven by an expected increase in the number of applications for registration requiring CBI substantiation. This change is an adjustment.

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Annual Cost to Federal Government: $16,612

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: 06/30/2014

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