2018-20638. Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA) has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): “Submission of Unreasonable Adverse Effects Information under FIFRA Section 6(a)(2)” (EPA ICR No. 1204.13, OMB Control No. 2070-0039). This is a request to renew the approval of an existing ICR, which is currently approved through September 30, 2018. EPA received several comments in response to the previously provided public review opportunity issued in the Federal Register of April 4, 2018. With this submission to OMB, EPA is providing an additional 30 days for public review and comment.

DATES:

Comments must be received on or before October 24, 2018.

ADDRESSES:

Submit your comments, referencing Docket ID Number Docket ID No. EPA-HQ-OPP-2017-0687, to both EPA and OMB as follows:

• To EPA online using http://www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460, and
• To OMB via email to [e-mail]. Address comments to OMB Desk Officer for EPA.

EPA's policy is that all comments received will be included in the public docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT:

Prasad Chumble, Field and External Affairs Division, Office of Pesticide Programs, (7506P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: [phone]; fax number: 703-305-5884; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

Docket: Supporting documents, including the ICR that explains in detail the information collection activities and the related burden and cost estimates that are summarized in this document, are available in the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is [phone]. For additional information about EPA's public docket, visit http://www.epa.gov/​dockets.

ICR status: This ICR is currently scheduled to expire on September 30, 2018. Under OMB regulations, an agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Under PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: Section 6(a)(2) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires pesticide registrants to submit information to the Agency which may be relevant to the balancing of the risks and benefits of a pesticide product. The statute requires the registrant to submit any factual information that it acquires regarding adverse effects associated with its pesticidal products, and it is up to the Agency to determine whether or not that factual information constitutes an unreasonable adverse effect. In order to limit the amount of less meaningful information that might be submitted to the Agency, the EPA has limited the scope of factual information that the registrant must submit. The Agency's regulations at 40 CFR part 159 provide a detailed description of the reporting obligations of registrants under FIFRA section 6(a)(2).

Form Numbers: None.

Respondents/affected entities: Anyone who holds or has ever held a registration for a pesticide product issued under FIFRA Sections 3 or 24(c). The North American Industrial Classification System (NAICS) code for most respondents is 325300 (Pesticide, Fertilizer and Other Agricultural Chemical Manufacturing).

Respondent's obligation to respond: Mandatory under FIFRA section 6(a)(2).

Estimated number of respondents: 1,452 (total).

Frequency of response: On occasion.

Total estimated annual burden: 301,118 hours. Burden is defined at 5 CFR 1320.03(b).

Total estimated annual cost: $19,999,815, which includes $0 annualized capital investment or maintenance and operational costs.

Changes in the Estimates: There is a net increase of 71,778 hours in the total estimated annual respondent burden compared with the ICR currently approved by OMB. This increase is due to the expectation that the number of responses will increase by 16% from 93,000 in the last ICR approval to approximately 108,000 for this ICR renewal, and the number of times those incidents might necessitate a request for additional data pursuant to 40 CFR part 159 . The increase reflects consideration of historical information on the number of responses received. There is also an estimated decrease associated with training, which results from a decrease in the number of registrants. This is discussed in more detail in the supporting statement, and represents an adjustment.

Courtney Kerwin,

Director, Collection Strategies Division.