Document ID: EPA-HQ-OPP-2017-0687-0001
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Submission of Unreasonable Adverse Effects Information
Posted Date: 2018-02-08T05:00Z

[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Notices]
[Pages 5625-5626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02547]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0687; FRL-9971-89]

Proposed Information Collection Request (EPA ICR No. 1204.13); 
Comment Request; Submission of Unreasonable Adverse Effects Information 
Under FIFRA Section 6(a)(2)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an 
information collection request (ICR), ``Submission of Unreasonable 
Adverse Effects Information under FIFRA Section 6(a)(2)'' (EPA ICR No. 
1204.13, OMB Control No. 2070-0039), to the Office of Management and 
Budget (OMB) for review and approval in accordance with the Paperwork 
Reduction Act. Before doing so, EPA is soliciting public comments on 
specific aspects of the proposed information collection as described 
below. This is a proposed extension of the ICR, which is currently 
approved through September 30, 2018. 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: Comments must be submitted on or before April 9, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OPP-
2017-0687 online using www.regulations.gov (our preferred method), by 
email to [email protected], or by mail to: EPA Docket Center, 
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania 
Ave. NW, Washington, DC 20460.
    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: Amaris Johnson, Field and External 
Affairs Division, Office of Pesticide Programs, (7506P), Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; 
telephone number: (703) 305-9542; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Supporting documents which explain in detail the information that 
the EPA

[[Page 5626]]

will be collecting are available in the public docket for this ICR. The 
docket can be viewed online at www.regulations.gov or in person at the 
EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, 
Washington, DC. The telephone number for the Docket Center is (202) 
566-1744. For additional information about EPA's public docket, visit 
http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting 
comments and information to enable it to: (i.) Evaluate whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the Agency, including whether the 
information will have practical utility; (ii.) evaluate the accuracy of 
the Agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (iii.) enhance the quality, utility, and clarity of the 
information to be collected; and (iv.) minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses. EPA 
will consider the comments received and amend the ICR as appropriate. 
The final ICR package will then be submitted to OMB for review and 
approval. At that time, EPA will issue another Federal Register notice 
to announce the submission of the ICR to OMB and the opportunity to 
submit additional comments to OMB.
    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: Entities potentially affected by 
this ICR include anyone who holds or has ever held a registration for a 
pesticide product issued under FIFRA Section 3 or 24(c). The North 
American Industrial Classification System (NAICS) is 325300 (Pesticide, 
Fertilizer and Other Agricultural Chemical Manufacturing).
    Respondent's obligation to respond: Mandatory (FIFRA 6(a)(2)).
    Estimated number of respondents: 1,452 (total).
    Frequency of response: On occasion.
    Total estimated burden: 301,118 hours (per year). Burden is defined 
at 5 CFR 1320.03(b).
    Total estimated cost: $19,999,815 (per year).
    Changes in Estimates: There is an increase of 71,778 hours in the 
total estimated 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. The increase is 
due to EPA's revised expectations regarding the number of incident 
reports that will be submitted to the Agency, which reflects historical 
information on the number of responses received. The increase in the 
number of incident reports has also prompted the need for additional 
information discussed in section 4 of the supporting statement. Since 
the last ICR was approved, the EPA has found it necessary to request 
additional data in certain subject areas under 40 CFR 159. First, due 
to a significant increase in the number of adverse incidents for spot-
on domestic animal pet products from several registrants, EPA began 
requiring more standardized post-market surveillance reporting on 
adverse effects and submission of sales information, so the Agency can 
better evaluate incident rates. Second, the Agency requested additional 
information from the registrant of an herbicide to help explain 
circumstances for incidents of alleged tree and plant damage. Finally, 
new concerns about neonicotinoid pesticides and the loss of bee 
colonies led to EPA's request for more documentation from registrants 
for these products.
    Next Step in the Process for this ICR: EPA will consider the 
comments received and amend the ICR as appropriate. The final ICR 
package will then be submitted to OMB for review and approval pursuant 
to 5 CFR 1320.12. EPA will issue another Federal Register document 
pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the 
ICR to OMB and the opportunity to submit additional comments to OMB. If 
you have any questions about this ICR or the approval process, please 
contact the technical person listed under FOR FURTHER INFORMATION 
CONTACT.

    Authority:  44 U.S.C. 3501 et seq.

    Dated: January 11, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical 
Safety and Pollution Prevention.
[FR Doc. 2018-02547 Filed 2-7-18; 8:45 am]
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