Pesticides Data Call In Program (Renewal)

Forms and Documents

Document Name	Status
Form See List #13- DCIs for Percent Crop Treated Estimates Form and Instruction	New
Form See List #12- Anticipated Residue DCIs: Updated Public Source Monitoring Data Form and Instruction	New
Form See List #11- Anticipated Residue DCIs: Updated Verification of Use Data Form and Instruction	New
Form See List #10- Anticipated Residue DCIs: Base set of Data Form and Instruction	New
Form See List #9- Reregistration Review: Voluntarily Submitted Data (High Burden Studies) Form and Instruction	New
Form See List #8- Reregistration Review: Voluntarily Submitted Data (Low Burden Studies) Form and Instruction	New
Form See List #7- Registration Review Resistance Management Plans Form and Instruction	New
Form See List #6- Registration Review DCIs Form and Instruction	New
Form See List #5- Maintenance DCI Form and Instruction	New
Form See List #4- Reregistration DCIs: Product Specific Data Form and Instruction	New
Form See List #3- Reregistration: Voluntarily Submitted Data (High Burden Studies) Form and Instruction	New
Form See List #2- Reregistration: Voluntarily Submitted Data (Low Burden Studies) Form and Instruction	New
Form See List #1- Reregistration DCIs: Confirmatory Data Form and Instruction	New
2288ss04.docx Supporting Statement A	2021-11-18
Attachment F- 18 Qs Supporting Statement.docx Supplementary Document	2021-11-12
Attachment E- Consultations.docx Supplementary Document	2021-11-12
Attachment D- Labor Rates.docx Supplementary Document	2021-11-12
Attachment C- Non-Codified Studies.docx Supplementary Document	2021-11-12
Attachment B- Assumptions.docx Supplementary Document	2021-11-12
Attachment A.pdf Supplementary Document	2021-11-12

IC Document Collections

IC ID	Document Title	Status
250269	#13- DCIs for Percent Crop Treated Estimates Form and Instruction	New
250268	#12- Anticipated Residue DCIs: Updated Public Source Monitoring Data Form and Instruction	New
250267	#11- Anticipated Residue DCIs: Updated Verification of Use Data Form and Instruction	New
250266	#10- Anticipated Residue DCIs: Base set of Data Form and Instruction	New
250265	#9- Reregistration Review: Voluntarily Submitted Data (High Burden Studies) Form and Instruction	New
250264	#8- Reregistration Review: Voluntarily Submitted Data (Low Burden Studies) Form and Instruction	New
250263	#7- Registration Review Resistance Management Plans Form and Instruction	New
250262	#6- Registration Review DCIs Form and Instruction	New
250261	#5- Maintenance DCI Form and Instruction	New
250260	#4- Reregistration DCIs: Product Specific Data Form and Instruction	New
250259	#3- Reregistration: Voluntarily Submitted Data (High Burden Studies) Form and Instruction	New
250258	#2- Reregistration: Voluntarily Submitted Data (Low Burden Studies) Form and Instruction	New
249971	#1- Reregistration DCIs: Confirmatory Data Form and Instruction	New

ICR Details

OMB Control No: 2070-0174	ICR Reference No: 202106-2070-001
Status: Received in OIRA	Previous ICR Reference No: 201801-2070-003
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2288.04
Title: Pesticides Data Call In Program (Renewal)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/30/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2021
Responses	283	472
Time Burden (Hours)	3,274,852	58,206
Cost Burden (Dollars)	0	0

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Abstract: This ICR covers the information collection activities associated with the issuance of DCIs under section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA regulates the use of pesticides under the authority of two federal statutes: FIFRA (7.U.S.C. 136 et seq.) and the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346). In general, before manufacturers can sell pesticides in the United States, EPA must evaluate the pesticides thoroughly to ensure that they meet federal safety standards to protect human health and the environment. EPA grants a "registration" or license that permits a pesticide's distribution, sale, and use only after the company meets the scientific and regulatory requirements. In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with the use of the product. Applicants, or potential registrants, must generate or provide the scientific data necessary to address concerns pertaining to the identity, composition, potential adverse effects, and environmental fate of each pesticide. The data allow EPA to evaluate if a pesticide has the potential to cause harmful effects on certain non-target organisms and endangered species, and on surface or ground water. Through a scientific and public process, EPA specifies the kinds of data and information necessary to make regulatory judgments about the risks and benefits of pesticide products under FIFRA sections 3, 4 and 5, as well as the data and information needed to determine the safety of pesticide chemical residues under FFDCA section 408. The regulations in 40 CFR part 158 describe the minimum data and information EPA typically requires in an application for pesticide registration or amendment; reregistration of a pesticide product; maintenance of a pesticide registration by means of the DCI process (e.g., as used in the registration review program); or to establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue. EPA uses the DCIs issued under this ICR to acquire the data necessary for its statutorily mandated review of a pesticide’s registration, which assess if the continued registration of a pesticide causes an unreasonable adverse effect on human health or the environment.

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Authorizing Statute(s): US Code: 7 USC 136 et seq. Name of Law: FIFRA
   US Code: 21 USC 346a Name of Law: 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:
	86 FR 16718	03/31/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 67460	11/26/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
#1- Reregistration DCIs: Confirmatory Data	See List	See List
#10- Anticipated Residue DCIs: Base set of Data	See List	See List
#11- Anticipated Residue DCIs: Updated Verification of Use Data	See List	See List
#12- Anticipated Residue DCIs: Updated Public Source Monitoring Data	See List	See List
#13- DCIs for Percent Crop Treated Estimates	See List	See List
#2- Reregistration: Voluntarily Submitted Data (Low Burden Studies)	See List	See List
#3- Reregistration: Voluntarily Submitted Data (High Burden Studies)	See List	See List
#4- Reregistration DCIs: Product Specific Data	See List	See List
#5- Maintenance DCI	See List	See List
#6- Registration Review DCIs	See List	See List
#7- Registration Review Resistance Management Plans	See List	See List
#8- Reregistration Review: Voluntarily Submitted Data (Low Burden Studies)	See List	See List
#9- Reregistration Review: Voluntarily Submitted Data (High Burden Studies)	See List	See List

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ICR Summary of Burden

	Total Request	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	283	472	0	0	-189	0
Annual Time Burden (Hours)	3,274,852	58,206	0	0	3,216,646	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: Estimates of burden hours and costs are substantially larger than in the most recent ICR. This is primarily due to an error in past ICRs where annual totals were misreported as 3-year totals underestimating the total approved burden hours and costs by a factor of 3. The Agency has corrected this error and is now reporting annual total burden hours and costs throughout this ICR. Additionally, due to a clerical error, a burden of 58,206 hours was approved rather than the submitted 625,669 burden hours from the currently approved ICR by OMB. The Agency has corrected these errors and this ICR represents an increase of 2,649,183 hours (3,274,852 – 625,669) in the total estimated annualized burden compared with what is currently approved by OMB. The burden increase is a result of several factors, including an increase in DCIs issued annually (Previous to Current Numbers), the addition of high-test costs for certain DCIs, and an increase in non-government wage rates. All these activities have contributed to the significant increase in burden.

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Annual Cost to Federal Government: $1,652,342

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? No

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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: 11/30/2021

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