Recordkeeping Requirements for Producers, Registrants, and Applicants of Pesticides and Pesticide Devices under Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (Renewal)

Forms and Documents

Document Name	Status
Form 3540-16 Recordkeeping Requirements for Producers of Pesticides under section 8 of the Federal Insecticide, Fungicide, and Rodenti- cide Act (FIFRA) Form	Modified
0143-11Supporting Statement.doc Supporting Statement A	2010-12-14

IC Document Collections

IC ID	Document Title	Status
24865	Recordkeeping Requirements for Producers of Pesticides under section 8 of the Federal Insecticide, Fungicide, and Rodenti- cide Act (FIFRA) Form	Modified

ICR Details

OMB Control No: 2070-0028	ICR Reference No: 201101-2070-001
Status: Historical Active	Previous ICR Reference No: 200712-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0143.11
Title: Recordkeeping Requirements for Producers, Registrants, and Applicants of Pesticides and Pesticide Devices under Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (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: 06/01/2011
	Date Received in OIRA: 01/26/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for 3 years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	36 Months From Approved	05/31/2011
Responses	11,600	0	13,400
Time Burden (Hours)	23,200	0	26,800
Cost Burden (Dollars)	0	0	0

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Abstract: FIFRA section 8 states that the Administrator of the Environmental Protection Agency may prescribe regulations requiring pesticide producers, registrants and applicants for registration to maintain such records with respect to their operations and the effective enforcement of this Act and to make such records available for inspection and copying as specified in the statute. The regulations at 40 CFR Part 169 (Books and Records of Pesticide Production and Distribution) specify the following records that producers must keep and the disposition of those records. Producers must maintain records on production data for pesticides, devices, or active ingredients (including pesticides produced pursuant to an experimental use permit); receipt by the producer of pesticides, devices, or active ingredients used in producing pesticides; delivery, moving, or holding of pesticides; inventory; domestic advertising for restricted use pesticides; guarantees; exports; disposal; human testing; and tolerance petitions. Additionally, section 8 gives the Agency inspectional authority to monitor the validity of research data (including raw data), developed in accordance with Good Laboratory Practice Standards, and used to support pesticide registration. These records generally consist of the material produced during the course of ordinary business activity, and are maintained in the location, manner, and duration as is generally prudent for such records in the course of ordinary business activity. Respondents are required to maintain records of receipt, production, shipping, and inventory for two years. Records regarding testing of registered pesticides must be maintained for the life of the pesticide registration, as such data are necessary to support the regulatory decision. Approximately 11,600 respondents are currently subject to this requirement, and it is estimated that no additional respondents per year will become subject to this requirement in the next three years. The cost of this ICR to the respondents is estimated to be $1,762,040. The estimate of number of respondents is based on the number of pesticide producers who have responded to the latest mandatory annual reporting response under FIFRA section 7, which defines the entire universe of legal producers of pesticides for sale or distribution in the United States. The estimated change is based on extrapolation from trends in the number of reported producers over the last three years. The estimated cost per producer has been estimated to consist entirely of the cost of preparing records for inspection, as the recordkeeping itself consists of activities that are considered to be customary business practices.

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Authorizing Statute(s): US Code: 7 USC 136f Name of Law: Books and Records
  

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 36651	06/28/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 4654	01/26/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Recordkeeping Requirements for Producers of Pesticides under section 8 of the Federal Insecticide, Fungicide, and Rodenti- cide Act (FIFRA)	3540-16	Pesticide Report for Pesticide-Producing and Device-Producing Establishments

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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	11,600	13,400	0	0	-1,800	0
Annual Time Burden (Hours)	23,200	26,800	0	0	-3,600	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: $2,457

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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