83 FR 5625 - Proposed Information Collection Request (EPA ICR No. 1204.13); Comment Request; Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2)

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 27 (February 8, 2018)

Page Range		5625-5626
FR Document		2018-02547

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.

Federal Register, Volume 83 Issue 27 (Thursday, February 8, 2018)

[Federal Register Volume 83, Number 27 (Thursday, February 8, 2018)]
[Notices]
[Pages 5625-5626]
From the Federal Register Online  [www.thefederalregister.org]
[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 OPP_Docket@epa.gov, 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: 
johnson.amaris@epa.gov.

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]
 BILLING CODE 6560-50-P

Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices 5625

once EPA revisits the original CBI This third alternative approach would ENVIRONMENTAL PROTECTION
claim(s). avoid several problems that EPA has AGENCY
EPA acknowledges that this approach identified with assigning more than one
would occasionally create the [EPA–HQ–OPP–2017–0687; FRL–9971–89]
UID to a single substance (see ‘‘Second
possibility that the application of the Alternative Approach,’’ May 8 Federal Proposed Information Collection
UID to submissions from two or more Register document (at 21389). One such Request (EPA ICR No. 1204.13);
companies may alert each company to problem is that assigning more than one Comment Request; Submission of
the other’s manufacture of the same UID per chemical substance would work Unreasonable Adverse Effects
chemical substance. However, such against one of the purposes of assigning Information Under FIFRA Section
disclosures frequently arise in the UIDs, to ‘‘provide a specific reference 6(a)(2)
normal course of business under TSCA, identifier that protects the
independent of UID. One reason for this confidentiality claim to the specific AGENCY: Environmental Protection
is that a single accession number is chemical identity for the duration of the Agency (EPA).
typically assigned to each Inventory claim, while providing a way for the ACTION: Notice.
substance, and the accession number is public to identify other filings
often used for subsequent reporting, e.g., pertaining to that substance.’’ (See SUMMARY: The Environmental Protection
under the Chemical Data Reporting discussion in EPA’s May 8 Federal Agency is planning to submit an
(CDR) rule. Accession numbers are also Register document (at 21388).) In information collection request (ICR),
included alongside other regulatory addition, it is unclear how multiple ‘‘Submission of Unreasonable Adverse
information, such as relevant section 5 UIDs per chemical can be reconciled Effects Information under FIFRA
significant new use rule (SNUR) with the section 8(b)(7) requirement to Section 6(a)(2)’’ (EPA ICR No. 1204.13,
citations, reported in public databases, publish and keep current a list of each OMB Control No. 2070–0039), to the
such as the Substance Registry Service confidential Inventory chemical, with Office of Management and Budget
(SRS), and in the Inventory file that EPA its UID, accession number, generic (OMB) for review and approval in
makes available to the public name, and PMN number, where accordance with the Paperwork
(confidential inventory chemicals are applicable. Any list that includes all of Reduction Act. Before doing so, EPA is
listed by PMN number, accession this information for each chemical soliciting public comments on specific
number, and generic name). (See would automatically link submissions aspects of the proposed information
https://www.epa.gov/tsca-inventory/ from different companies by including collection as described below. This is a
how-access-tsca-inventory.) Anyone that all of the UIDs and/or by using the same proposed extension of the ICR, which is
has an accession number for a given accession number for multiple listings currently approved through September
confidential inventory substance can on the same chemical. (i.e., if Chemical 30, 2018. An Agency may not conduct
query the CDR database and learn X has three UIDs, assigned to three or sponsor and a person is not required
whether other companies have different company claims, they would to respond to a collection of information
manufactured the chemical in CDR- all be linked on this list, because unless it displays a currently valid OMB
reportable amounts, or query the public Chemical X only has one accession control number.
Inventory to find out the PMN number number, and the list is supposed to DATES: Comments must be submitted on
of the original submission. include both accession number and or before April 9, 2018.
While not every company reports UID.) It is also unclear to EPA how ADDRESSES: Submit your comments,
under the CDR for every chemical that using one UID per chemical, per referencing Docket ID No. EPA–HQ–
they manufacture (for example, company, would operate in the case that
specialty chemical companies may be OPP–2017–0687 online using
a company or parts of a company www.regulations.gov (our preferred
making relatively small quantities of a changes ownership; how such UIDs
substance, for a specialized use, and method), by email to OPP_Docket@
would be applied to EPA-generated epa.gov, or by mail to: EPA Docket
may not meet the reporting thresholds documents that are relevant to more
for CDR), the fact that a chemical Center, Environmental Protection
than one submission; or how the Agency, Mail Code 28221T, 1200
substance is on the Inventory can be multiple UIDs would be handled in the
revealed in other ways. For example, a Pennsylvania Ave. NW, Washington, DC
case that one company withdraws or 20460.
company that intends to manufacture a permits its CBI claim to expire while the
chemical substance for commercial EPA’s policy is that all comments
other does not. Using one UID per received will be included in the public
purposes may file a bona fide chemical, and applying that same UID
submission under 40 CFR 720.25 to docket without change including any
to related documents in all but a very personal information provided, unless
determine whether the chemical few exceptional cases, would avoid
substance is already on the Inventory. the comment includes profanity, threats,
these issues. information claimed to be Confidential
The response to the bona fide inquiry,
where EPA tells the submitter whether C. Opportunity To Comment on Business Information (CBI) or other
a chemical substance is on the Approach to Applying the Unique information whose disclosure is
confidential portion of the Inventory, Identifier restricted by statute.
would indicate whether another FOR FURTHER INFORMATION CONTACT:
EPA invites comment on the possible
company has manufactured the approach outlined above. Amaris Johnson, Field and External
chemical substance for commercial Affairs Division, Office of Pesticide
Authority: 15 U.S.C. 2613. Programs, (7506P), Environmental
purposes in the United States. Also,
daltland on DSKBBV9HB2PROD with NOTICES

submitters of section 5 notices that are Dated: January 26, 2018. Protection Agency, 1200 Pennsylvania
subsequently deemed to be invalid Charlotte Bertrand, Ave. NW, Washington, DC 20460;
because the substance is already on the Acting Principal Deputy Assistant telephone number: (703) 305–9542;
Inventory and thus not subject to Administrator, Office of Chemical Safety and email address: johnson.amaris@epa.gov.
section 5 reporting requirements are Pollution Prevention. SUPPLEMENTARY INFORMATION:
informed of the Inventory status and are [FR Doc. 2018–02548 Filed 2–7–18; 8:45 am] Supporting documents which explain
provided the accession number. BILLING CODE 6560–50–P in detail the information that the EPA

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5626 Federal Register / Vol. 83, No. 27 / Thursday, February 8, 2018 / Notices

will be collecting are available in the anyone who holds or has ever held a questions about this ICR or the approval
public docket for this ICR. The docket registration for a pesticide product process, please contact the technical
can be viewed online at issued under FIFRA Section 3 or 24(c). person listed under FOR FURTHER
www.regulations.gov or in person at the The North American Industrial INFORMATION CONTACT.
EPA Docket Center, WJC West, Room Classification System (NAICS) is 325300 Authority: 44 U.S.C. 3501 et seq.
3334, 1301 Constitution Ave. NW, (Pesticide, Fertilizer and Other
Washington, DC. The telephone number Agricultural Chemical Manufacturing). Dated: January 11, 2018.
for the Docket Center is (202) 566–1744. Respondent’s obligation to respond: Charlotte Bertrand,
For additional information about EPA’s Mandatory (FIFRA 6(a)(2)). Acting Principal Deputy Assistant
public docket, visit http://www.epa.gov/ Estimated number of respondents: Administrator, Office of Chemical Safety and
dockets. 1,452 (total). Pollution Prevention.
Pursuant to section 3506(c)(2)(A) of Frequency of response: On occasion. [FR Doc. 2018–02547 Filed 2–7–18; 8:45 am]
the PRA, EPA is soliciting comments Total estimated burden: 301,118 BILLING CODE 6560–50–P
and information to enable it to: (i.) hours (per year). Burden is defined at 5
Evaluate whether the proposed CFR 1320.03(b).
collection of information is necessary Total estimated cost: $19,999,815 (per ENVIRONMENTAL PROTECTION
for the proper performance of the year). AGENCY
functions of the Agency, including Changes in Estimates: There is an
whether the information will have increase of 71,778 hours in the total [EPA–HQ–ORD–2005–0530; FRL–9974–07–
practical utility; (ii.) evaluate the estimated respondent burden compared OEI]
accuracy of the Agency’s estimate of the with the ICR currently approved by
burden of the proposed collection of OMB. This increase is due to the Information Collection Request
information, including the validity of expectation that the number of Submitted to OMB for Review and
the methodology and assumptions used; responses will increase by 16% from Approval; Comment Request;
(iii.) enhance the quality, utility, and 93,000 in the last ICR approval to Application for Reference and
clarity of the information to be approximately 108,000 for this ICR Equivalent Method Determination
collected; and (iv.) minimize the burden renewal. The increase is due to EPA’s (Renewal)
of the collection of information on those revised expectations regarding the
number of incident reports that will be AGENCY: Environmental Protection
who are to respond, including through Agency (EPA).
the use of appropriate automated submitted to the Agency, which reflects
historical information on the number of ACTION: Notice.
electronic, mechanical, or other
technological collection techniques or responses received. The increase in the
SUMMARY: The Environmental Protection
other forms of information technology, number of incident reports has also
Agency (EPA) has submitted an
e.g., permitting electronic submission of prompted the need for additional
information collection request (ICR),
responses. EPA will consider the information discussed in section 4 of
‘‘Application for Reference and
comments received and amend the ICR the supporting statement. Since the last
Equivalent Method Determination
as appropriate. The final ICR package ICR was approved, the EPA has found
(Renewal)’’ (EPA ICR No. 0559.13, OMB
will then be submitted to OMB for it necessary to request additional data in
Control No. 2080–0005) to the Office of
review and approval. At that time, EPA certain subject areas under 40 CFR 159.
Management and Budget (OMB) for
will issue another Federal Register First, due to a significant increase in the
review and approval in accordance with
notice to announce the submission of number of adverse incidents for spot-on
the Paperwork Reduction Act. This is a
the ICR to OMB and the opportunity to domestic animal pet products from
proposed extension of the ICR, which is
submit additional comments to OMB. several registrants, EPA began requiring
currently approved through February
Abstract: Section 6(a)(2) of the more standardized post-market
28, 2018. Public comments were
Federal Insecticide, Fungicide and surveillance reporting on adverse effects
previously requested via the Federal
Rodenticide Act (FIFRA) requires and submission of sales information, so
Register on September 6, 2017 during a
pesticide registrants to submit the Agency can better evaluate incident
60-day comment period. This notice
information to the Agency which may rates. Second, the Agency requested
allows for an additional 30 days for
be relevant to the balancing of the risks additional information from the
public comments. A fuller description
and benefits of a pesticide product. The registrant of an herbicide to help
of the ICR is given below, including its
statute requires the registrant to submit explain circumstances for incidents of
estimated burden and cost to the public.
any factual information that it acquires alleged tree and plant damage. Finally,
An agency may not conduct or sponsor
regarding adverse effects associated new concerns about neonicotinoid
and a person is not required to respond
with its pesticidal products, and it is up pesticides and the loss of bee colonies
to a collection of information unless it
to the Agency to determine whether or led to EPA’s request for more
displays a currently valid OMB control
not that factual information constitutes documentation from registrants for these
number.
an unreasonable adverse effect. In order products.
to limit the amount of less meaningful Next Step in the Process for this ICR: DATES: Additional comments may be
information that might be submitted to EPA will consider the comments submitted on or before March 12, 2018.
the Agency, the EPA has limited the received and amend the ICR as ADDRESSES: Submit your comments,
scope of factual information that the appropriate. The final ICR package will referencing Docket ID Number EPA–
registrant must submit. The Agency’s then be submitted to OMB for review HQ–ORD–2005–0530, to (1) EPA online
daltland on DSKBBV9HB2PROD with NOTICES

regulations at 40 CFR part 159 provide and approval pursuant to 5 CFR using www.regulations.gov (our
a detailed description of the reporting 1320.12. EPA will issue another Federal preferred method), or by mail to: EPA
obligations of registrants under FIFRA Register document pursuant to 5 CFR Docket Center, Environmental
section 6(a)(2). 1320.5(a)(1)(iv) to announce the Protection Agency, Mail Code 28221T,
Form Numbers: None. submission of the ICR to OMB and the 1200 Pennsylvania Ave. NW,
Respondents/affected entities: Entities opportunity to submit additional Washington, DC 20460, and (2) OMB via
potentially affected by this ICR include comments to OMB. If you have any email to oira_submission@omb.eop.gov.

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Document Created: 2018-02-08 00:16:11
Document Modified: 2018-02-08 00:16:11

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments must be submitted on or before April 9, 2018.
Contact		Amaris Johnson, Field and External Affairs Division, Office of Pesticide Programs, (7506P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
FR Citation		83 FR 5625