Data Requirements for Antimicrobial Pesticides

Docket ID: EPA-HQ-OPP-2008-0110
Agency: Environmental Protection Agency (EPA)
In 2008, EPA proposed revisions to its pesticide data requirements for antimicrobial pesticide products. The existing antimicrobial data requirements are in 40 CFR part 161. This action will revise the existing data requirements to reflect current regulatory and scientific standards. The data requirements will cover all scientific disciplines for antimicrobial pesticides, including product chemistry and residue chemistry, toxicology, and environmental fate and effects. In general, pesticide data requirements are codified in 40 CFR part 158, which describes the minimum data and information EPA typically requires to support an application for pesticide registration or amendment; support the maintenance of a pesticide registration by means of the data call-in process (e.g., as used in the registration review program); or establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue. This part also establishes procedures and other general requirements associated with the submission of data in support of a pesticide regulatory action. It does not, however, include study protocols, methodology, or standards for conducting or reporting test results; nor does this part describe how the Agency uses or evaluates the data and information in its risk assessment and risk management decisions, or the regulatory determinations that may be based upon the data. Once this regulatory change takes effect, data requirements for antimicrobial pesticides will be set forth in subpart W of 40 CFR part 158, and part 161 will be removed.
RIN: 2070-AD30
Impacts and Effects: None
CFR Citation: 40 CFR 158 and 161
Priority: Other Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Spring 2013
Agenda Stage of Rulemaking: Completed Action
Major Rule: No
Legal Authorities: 7 USC 136 to 136(y)
Legal Deadlines: None
Government Levels Affected: Federal
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: No
Small Entities Affected: No
International Impacts: No
Energy Effects: No
Included in Regulatory Plan: No
ActionDateFR Citation
NPRM10/08/200873 FR 59381
Final Rule05/08/201378 FR 26936
Final Rule Effective07/08/2013
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: EPA-HQ-OPP-2015-0302
Type: Rulemaking
Location: HQ-OPP

Primary Documents

View All  (6)
Comment Period Closed
Apr 06, 2009 11:59 PM ET
Proposed Rule
Posted: 12/12/2008
ID: EPA-HQ-OPP-2008-0110-0056
Comment Period Closed
Jan 06, 2009 11:59 PM ET
Proposed Rule
Posted: 10/08/2008
ID: EPA-HQ-OPP-2008-0110-0001
Comment Period Closed
Posted: 05/08/2013
ID: EPA-HQ-OPP-2008-0110-0111
Comment Period Closed
Posted: 04/20/2011
ID: EPA-HQ-OPP-2008-0110-0105
Comment Period Closed
Proposed Rule
Posted: 10/23/2008
ID: EPA-HQ-OPP-2008-0110-0049

Supporting Documents

View All  (96)
Comments Not Accepted
Supporting & Related Material
Posted: 03/06/2015
ID: EPA-HQ-OPP-2008-0110-0139
Comments Not Accepted
Supporting & Related Material
Posted: 05/17/2013
ID: EPA-HQ-OPP-2008-0110-0138
Comments Not Accepted
Supporting & Related Material
Posted: 05/08/2013
ID: EPA-HQ-OPP-2008-0110-0127


View All  (37)

Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Current Stage
Agency Contact
Kathryn Boyle
703 305-6304
703 305-5884 (Fax)
7506P, Washington, DC 20460
Washington, DC 20460
Scott Drewes
703 347-0107
7506P, Washington, DC 20460
Washington, DC 20460
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.