View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Plant-Incorporated Protectants - Adverse Effects Reporting
Plant-Incorporated Protectants - Substantiation of Confidential Business Information Claims
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.
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
Agency Contact:
Angela Hofmann
Common Form ICR:
No
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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