Data Requirements for Antimicrobial Pesticides (Proposed Rule)

Forms and Documents

Document	Type	Status	Availability
2318ss01-NPRM-2008-09-09.pdf	Supporting Statement A	Uploaded 2008-09-11	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
187711	Data Submission Activities		New

ICR Details

OMB Control No: 2070-0172	ICR Reference No: 200901-2070-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2318.01
Title: Data Requirements for Antimicrobial Pesticides (Proposed Rule)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 04/21/2009
	Date Received in OIRA: 01/05/2009
Terms of Clearance: THis ICR is not approved at this time. EPA should reconsider the recordkeeping and reporting requirements as it develops the final rule in order to ensure that they have practical utility and reduce to the extent practicable and appropriate the burden on the public, as required by 5 CFR 1320.9.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR covers the information collection activities contained in the proposed rule in which EPA proposes to revise and update the existing data requirements for antimicrobial pesticides. The proposed revisions to the existing data requirements are needed to reflect current scientific knowledge and current Agency regulatory practices, and to improve protection of the general population as well as sensitive subpopulations. Data requirements are necessary to ensure that the Agency has the ability to make regulatory decisions about the human health and environmental fate and effects of antimicrobial pesticide products as mandated by law.

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Authorizing Statute(s): US Code: 21 USC 346 et seq Name of Law: Federal Food, Drug, and Cosmetic Act (FFDCA)
   US Code: 7 USC 136 et seq. 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:
2070-AD30	Proposed rulemaking	73 FR 59381	10/08/2008

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Federal Register Notices & Comments

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
Data Submission Activities

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The proposed revisions to the data requirements for antimicrobial pesticides are needed to reflect current scientific knowledge and current Agency regulatory practices, and to improve protection of the general population as well as sensitive subpopulations. The revised data requirements are necessary to ensure that the Agency has the ability to make regulatory decisions about the human health and environmental fate and effects of antimicrobial pesticide products as mandated by law.

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Annual Cost to Federal Government: $397,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 01/05/2009

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