Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting (Renewal)

Forms and Documents

Document Name	Status
1693.09_ss_Attachment F_OMB_Display.pdf Supplementary Document	2018-05-31
1693.09_ss_Attachment E_Worksheets Used to Calculate Labor Costs.pdf Supplementary Document	2018-05-31
1693.09_ss_Attachment D_PIPs ICR_1693.09_Consultations Responses_2017-11-28.pdf Supplementary Document	2018-05-31
1693.09_ss_Attachment C_FFDCA section 408(a).pdf Supplementary Document	2018-05-31
1693.09_ss_Attachment B_FIFRA section 25(b).pdf Supplementary Document	2018-05-31
1693.09_ss_Attachment A_40 CFR 174.pdf Supplementary Document	2018-05-31
1693.09_ss_2018-05-21.docx Supporting Statement A	2018-05-31

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	Unchanged

ICR Details

OMB Control No: 2070-0142	ICR Reference No: 201805-2070-001
Status: Active	Previous ICR Reference No: 201406-2070-003
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1693.09
Title: Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting (Renewal)
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: 09/09/2019
	Date Received in OIRA: 05/31/2018
Terms of Clearance: Upon re-submission, EPA needs to consolidate all the OMB control numbers associated with the PSP Portal (2070-0040, 2070-0142, 2070-0039, 2070-0182, 2070-0060, 2070-0044, and 2070-0024). The agency is reminded to include a burden statement on the initial online screen for all collection activities within the PSP Portal and to provide updated screen shots of the PSP Portal and associated form questions.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	36 Months From Approved	09/30/2019
Responses	25	0	21
Time Burden (Hours)	518	0	432
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) and which are codified in 40 CFR part 174. A plant-incorporated protectant (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). Registrants sometimes include in a submission to EPA for registration of PIPs information that they claim to be CBI. CBI is protected by FIFRA and generally cannot be released to the public. For most pesticide registration applications, the current CBI regulations at 40 CFR part 2 require that claimants substantiate their CBI claims for their own records when the claim is made, and subsequently provide the substantiation to EPA only if requested. However, under 40 CFR part 174, whenever a registrant claims that information submitted to EPA in support of a PIP registration application contains CBI, the registrant must substantiate such claims to EPA when they are made. In addition, 40 CFR part 174 also requires manufacturers of PIPs that are otherwise exempted from registration requirements to report any adverse effects of the PIP to the Agency within 30 days of when the information is first obtained. Such reporting will allow the Agency to determine whether further action is needed to prevent unreasonable adverse effects to human health or the environment.

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Authorizing Statute(s): US Code: 21 USC 346a Name of Law: Federal Food, Drug, and Cosmetic Act (FFDCA)
   US Code: 7 USC 136-136y Name of Law: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
  

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:
	82 FR 43008	09/30/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 43008	09/30/2017
Did the Agency receive public comments on this ICR? No

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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	25	21	0	0	4	0
Annual Time Burden (Hours)	518	432	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: There is an increase of 86 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase 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 20 to 24, with a corresponding increase in the associated burden. 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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 05/31/2018

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