2018-11802. Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting

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): “Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting” (EPA ICR No. 1693.09, OMB Control No. 2070-0142). This is a request to renew the approval of an existing ICR, which is currently approved through May 31, 2018. EPA did not receive any public comments in response to the previously provided public review opportunity issued in the Federal Register of September 13, 2017. With this submission to OMB, EPA is providing an additional 30 days for public review and comment. 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.

DATES:

Additional comments may be submitted on or before July 2, 2018.

ADDRESSES:

Submit your comments, identified by Docket ID number EPA-HQ-OPP-2017-0440, 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 the 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:

Ryne Yarger, Field and External Affairs Division, 7506P, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 703-605-1193; 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.

Abstract: This ICR addresses the two information collection requirements contained in the regulations codified in 40 CFR part 174 pertaining to pesticidal substances that are produced by plants (plant-incorporated protectants, or PIPs). A PIP is defined as “the pesticidal substance that is intended to be produced and used in a living plant and the genetic material necessary for the production of such a substance.” Many, but not all, PIPs are exempt from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

CBI is protected by FIFRA and generally cannot be released to the public. For most pesticide registration applications, the current CBI regulations at 40 CFR part 2 require that claimants substantiate their CBI claims for their own records when the claim is made, and subsequently provide the substantiation to EPA only if requested. However, under 40 CFR part 174, whenever a registrant claims that information submitted to EPA in support of a PIP registration application contains CBI, the registrant must substantiate such claims to EPA when they are made. In addition, 40 CFR part 174 also requires manufacturers of PIPs that are otherwise exempted from registration requirements to report any adverse effects of the PIP to the Agency within 30 days of when the information is first obtained. Such reporting will allow the Agency to determine whether further action is needed to prevent unreasonable adverse effects to human health or the environment.

Form Numbers: None.

Respondents/affected entities: Entities potentially affected by this ICR include producers and importers of PIPs. The North American Industrial Classification System (NAICS) codes for respondents under this ICR include: 325320 (Pesticide and other Agricultural Chemical Manufacturing), 325414 (Biological Products (except Diagnostic) Manufacturing), 422910 (Farm Supplies Wholesalers), 422930 (Flower, Nursery Stock, and Florist's Suppliers), 541710 (Research and Development in the Physical, Engineering, and Life Sciences), and 611310 (Colleges, Universities, and Professional Schools).

Respondent's obligation to respond: Mandatory.

Estimated number of respondents: 24 (total).

Frequency of response: On occasion.

Total estimated burden: 518 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $41,892 (per year), includes $0 annualized capital or operation and maintenance costs.

Changes in the Estimates: There is an increase of 86 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase reflects EPA's updating of burden estimates for this collection based upon historical information on the number of CBI substantiations per year. Based upon revised estimates, the number of CBI substantiations per year has increased from 20 to 24, with a corresponding increase in the associated burden. This change is an adjustment.

Courtney Kerwin,

Director, Collection Strategies Division.