81 FR 2212 - Imidacloprid Registration Review; Draft Pollinator Ecological Risk Assessment; Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 10 (January 15, 2016)

Page Range		2212-2213
FR Document		2016-00740

This notice announces the availability of EPA's draft pollinator-only ecological risk assessment for the registration review of imidacloprid and opens a public comment period on this document. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed a comprehensive draft pollinator-only ecological risk assessment for all registered agricultural uses of imidacloprid, with focus on agricultural crops that are attractive to pollinators. After reviewing comments received during the public comment period, EPA will issue a revised pollinator risk assessment, explain any changes to the draft risk assessment, and respond to comments and may request public input on risk mitigation before completing a proposed registration review decision for imidacloprid. The revised risk assessment will also address the ecological risks for all other taxa, as well as a comprehensive draft human health risk assessment. Through the registration review program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

Federal Register, Volume 81 Issue 10 (Friday, January 15, 2016)

[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2212-2213]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00740]



[[Page 2212]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0844; FRL-9940-82]


Imidacloprid Registration Review; Draft Pollinator Ecological 
Risk Assessment; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the availability of EPA's draft 
pollinator-only ecological risk assessment for the registration review 
of imidacloprid and opens a public comment period on this document. 
Registration review is EPA's periodic review of pesticide registrations 
to ensure that each pesticide continues to satisfy the statutory 
standard for registration, that is, the pesticide can perform its 
intended function without unreasonable adverse effects on human health 
or the environment. As part of the registration review process, the 
Agency has completed a comprehensive draft pollinator-only ecological 
risk assessment for all registered agricultural uses of imidacloprid, 
with focus on agricultural crops that are attractive to pollinators. 
After reviewing comments received during the public comment period, EPA 
will issue a revised pollinator risk assessment, explain any changes to 
the draft risk assessment, and respond to comments and may request 
public input on risk mitigation before completing a proposed 
registration review decision for imidacloprid. The revised risk 
assessment will also address the ecological risks for all other taxa, 
as well as a comprehensive draft human health risk assessment. Through 
the registration review program, EPA is ensuring that each pesticide's 
registration is based on current scientific and other knowledge, 
including its effects on human health and the environment.

DATES: Comments must be received on or before March 15, 2016.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2008-0844, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For pesticide specific information contact: Kelly Ballard, Chemical 
Review Manager, Pesticide Re-Evaluation Division (7508P), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-8126; 
email address: [email protected].
    For general questions on the registration review program, contact: 
Rich Dumas, Pesticide Re-Evaluation Division (7508P), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8015; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of 
interest to a wide range of stakeholders including environmental, human 
health, farm worker, and agricultural advocates; the chemical industry; 
pesticide users; and members of the public interested in the sale, 
distribution, or use of pesticides. Since others also may be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the Chemical Review Manager listed under FOR FURTHER 
INFORMATION CONTACT.

 B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental 
justice, the fair treatment and meaningful involvement of any group, 
including minority and/or low income populations, in the development, 
implementation, and enforcement of environmental laws, regulations, and 
policies. To help address potential environmental justice issues, the 
Agency seeks information on any groups or segments of the population 
who, as a result of their location, cultural practices, or other 
factors, may have atypical or disproportionately high and adverse human 
health impacts or environmental effects from exposure to the 
pesticide(s) discussed in this document, compared to the general 
population.

II. Authority

    EPA is conducting its registration review of imidacloprid pursuant 
to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) and the Procedural Regulations for Registration Review at 
40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other 
things, that the registrations of pesticides are to be reviewed every 
15 years. Under FIFRA, a pesticide product may be registered or remain 
registered only if it meets the statutory standard for registration 
given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in 
accordance with widespread and commonly recognized practice, the 
pesticide product must perform its intended function without 
unreasonable adverse effects on the environment; that is, without any 
unreasonable risk to man or the environment, or a human dietary risk 
from residues that result from the use of a pesticide in or on food.

III. Registration Reviews

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide 
registration for imidacloprid to ensure that it continues to satisfy 
the FIFRA standard for registration--that is, that imidacloprid can 
still be used without unreasonable adverse effects on human health or 
the environment. Imidacloprid is a neonicotinoid insecticide used for 
the control of sucking insects on a large variety of agricultural and 
non-agricultural sites, including vegetable crops, tree nuts, tree 
fruits, stone fruits,

[[Page 2213]]

cotton, tobacco, grapes, citrus, turf, and ornamentals. EPA has 
completed a comprehensive draft pollinator-only ecological risk 
assessment for all registered agricultural uses of imidacloprid, with 
focus on agricultural crops that are attractive to pollinators.
    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, 
through this notice of availability, for interested parties to provide 
comments and input concerning the Agency's draft pollinator-only 
ecological risk assessment for imidacloprid. Such comments and input 
could address, among other things, the Agency's risk assessment 
methodologies and assumptions, as applied to this draft pollinator-only 
risk assessment. The Agency will consider all comments received during 
the public comment period and make changes, as appropriate, to the 
draft pollinator-only risk assessment. EPA will then issue a revised 
pollinator risk assessment, explain any changes to the draft risk 
assessment, and respond to comments. In the Federal Register notice 
announcing the availability of the revised risk assessment, if the 
revised risk assessment indicates risks of concern, the Agency may 
provide a comment period for the public to submit suggestions for 
mitigating the risk identified in the revised risk assessment before 
developing a proposed registration review decision on imidacloprid. 
Additionally, the revised risk assessment will also address ecological 
risks for all other taxa, as well as a comprehensive draft human health 
risk assessment.
    1. Other related information. Additional information on 
imidacloprid is available on the Pesticide Registration Review Status 
Web page. Information on the Agency's registration review program and 
its implementing regulation is available at http://www.epa.gov/oppsrrd1/registration_review.
    2. Information submission requirements. Anyone may submit data or 
information in response to this document. To be considered during a 
pesticide's registration review, the submitted data or information must 
meet the following requirements:
     To ensure that EPA will consider data or information 
submitted, interested persons must submit the data or information 
during the comment period. The Agency may, at its discretion, consider 
data or information submitted at a later date.
     The data or information submitted must be presented in a 
legible and useable form. For example, an English translation must 
accompany any material that is not in English and a written transcript 
must accompany any information submitted as an audiographic or 
videographic record. Written material may be submitted in paper or 
electronic form.
     Submitters must clearly identify the source of any 
submitted data or information.
     Submitters may request the Agency to reconsider data or 
information that the Agency rejected in a previous review. However, 
submitters must explain why they believe the Agency should reconsider 
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for 
each pesticide case will remain publicly accessible through the 
duration of the registration review process; that is, until all actions 
required in the final decision on the registration review case have 
been completed.

    Authority:  7 U.S.C. 136 et seq.

    Dated: January 8, 2016.
Michael Goodis,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2016-00740 Filed 1-14-16; 8:45 am]
 BILLING CODE 6560-50-P

2212 Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices

ENVIRONMENTAL PROTECTION • Hand Delivery: To make special public docket. Information so marked
AGENCY arrangements for hand delivery or will not be disclosed except in
delivery of boxed information, please accordance with procedures set forth in
[EPA–HQ–OPP–2008–0844; FRL–9940–82]
follow the instructions at http://www. 40 CFR part 2.
Imidacloprid Registration Review; epa.gov/dockets/contacts.html. 2. Tips for preparing your comments.
Draft Pollinator Ecological Risk Additional instructions on When preparing and submitting your
Assessment; Notice of Availability commenting or visiting the docket, comments, see the commenting tips at
along with more information about http://www.epa.gov/dockets/
AGENCY: Environmental Protection dockets generally, is available at comments.html.
Agency (EPA). http://www.epa.gov/dockets. 3. Environmental justice. EPA seeks to
ACTION: Notice. FOR FURTHER INFORMATION CONTACT: achieve environmental justice, the fair
For pesticide specific information treatment and meaningful involvement
SUMMARY: This notice announces the contact: Kelly Ballard, Chemical Review of any group, including minority and/or
availability of EPA’s draft pollinator- Manager, Pesticide Re-Evaluation low income populations, in the
only ecological risk assessment for the Division (7508P), Office of Pesticide development, implementation, and
registration review of imidacloprid and enforcement of environmental laws,
Programs, Environmental Protection
opens a public comment period on this regulations, and policies. To help
Agency, 1200 Pennsylvania Ave. NW.,
document. Registration review is EPA’s address potential environmental justice
Washington, DC 20460–0001; telephone
periodic review of pesticide issues, the Agency seeks information on
number: (703) 305–8126; email address:
registrations to ensure that each any groups or segments of the
ballard.kelly@epa.gov.
pesticide continues to satisfy the For general questions on the population who, as a result of their
statutory standard for registration, that registration review program, contact: location, cultural practices, or other
is, the pesticide can perform its factors, may have atypical or
Rich Dumas, Pesticide Re-Evaluation
intended function without unreasonable disproportionately high and adverse
Division (7508P), Office of Pesticide
adverse effects on human health or the human health impacts or environmental
Programs, Environmental Protection
environment. As part of the registration effects from exposure to the pesticide(s)
Agency, 1200 Pennsylvania Ave. NW.,
review process, the Agency has discussed in this document, compared
Washington, DC 20460–0001; telephone
completed a comprehensive draft to the general population.
number: (703) 308–8015; email address:
pollinator-only ecological risk
dumas.richard@epa.gov. II. Authority
assessment for all registered agricultural
uses of imidacloprid, with focus on SUPPLEMENTARY INFORMATION: EPA is conducting its registration
agricultural crops that are attractive to I. General Information review of imidacloprid pursuant to
pollinators. After reviewing comments section 3(g) of the Federal Insecticide,
received during the public comment A. Does this action apply to me? Fungicide, and Rodenticide Act (FIFRA)
period, EPA will issue a revised This action is directed to the public and the Procedural Regulations for
pollinator risk assessment, explain any in general, and may be of interest to a Registration Review at 40 CFR part 155,
changes to the draft risk assessment, and wide range of stakeholders including subpart C. Section 3(g) of FIFRA
respond to comments and may request environmental, human health, farm provides, among other things, that the
public input on risk mitigation before worker, and agricultural advocates; the registrations of pesticides are to be
completing a proposed registration chemical industry; pesticide users; and reviewed every 15 years. Under FIFRA,
review decision for imidacloprid. The members of the public interested in the a pesticide product may be registered or
revised risk assessment will also sale, distribution, or use of pesticides. remain registered only if it meets the
address the ecological risks for all other Since others also may be interested, the statutory standard for registration given
taxa, as well as a comprehensive draft Agency has not attempted to describe all in FIFRA section 3(c)(5) (7 U.S.C.
human health risk assessment. Through the specific entities that may be affected 136a(c)(5)). When used in accordance
the registration review program, EPA is by this action. If you have any questions with widespread and commonly
ensuring that each pesticide’s regarding the applicability of this action recognized practice, the pesticide
registration is based on current to a particular entity, consult the product must perform its intended
scientific and other knowledge, Chemical Review Manager listed under function without unreasonable adverse
including its effects on human health FOR FURTHER INFORMATION CONTACT. effects on the environment; that is,
and the environment. without any unreasonable risk to man or
DATES: Comments must be received on
B. What should I consider as I prepare
the environment, or a human dietary
or before March 15, 2016. my comments for EPA?
risk from residues that result from the
ADDRESSES: Submit your comments, 1. Submitting CBI. Do not submit this use of a pesticide in or on food.
identified by docket identification (ID) information to EPA through
regulations.gov or email. Clearly mark III. Registration Reviews
number EPA–HQ–OPP–2008–0844, by
one of the following methods: the part or all of the information that As directed by FIFRA section 3(g),
• Federal eRulemaking Portal: http:// you claim to be CBI. For CBI EPA is reviewing the pesticide
www.regulations.gov. Follow the online information in a disk or CD–ROM that registration for imidacloprid to ensure
instructions for submitting comments. you mail to EPA, mark the outside of the that it continues to satisfy the FIFRA
Do not submit electronically any disk or CD–ROM as CBI and then standard for registration—that is, that
mstockstill on DSK4VPTVN1PROD with NOTICES

information you consider to be identify electronically within the disk or imidacloprid can still be used without
Confidential Business Information (CBI) CD–ROM the specific information that unreasonable adverse effects on human
or other information whose disclosure is is claimed as CBI. In addition to one health or the environment. Imidacloprid
restricted by statute. complete version of the comment that is a neonicotinoid insecticide used for
• Mail: OPP Docket, Environmental includes information claimed as CBI, a the control of sucking insects on a large
Protection Agency Docket Center (EPA/ copy of the comment that does not variety of agricultural and non-
DC), (28221T), 1200 Pennsylvania Ave. contain the information claimed as CBI agricultural sites, including vegetable
NW., Washington, DC 20460–0001. must be submitted for inclusion in the crops, tree nuts, tree fruits, stone fruits,

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Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices 2213

cotton, tobacco, grapes, citrus, turf, and written transcript must accompany any With this submission, EPA is providing
ornamentals. EPA has completed a information submitted as an an additional 30 days for public review.
comprehensive draft pollinator-only audiographic or videographic record. DATES: Comments must be received on
ecological risk assessment for all Written material may be submitted in or before February 16, 2016.
registered agricultural uses of paper or electronic form. ADDRESSES: Submit your comments,
imidacloprid, with focus on agricultural • Submitters must clearly identify the identified by docket identification (ID)
crops that are attractive to pollinators. source of any submitted data or number EPA–HQ–OPP–2015–0231, to
Pursuant to 40 CFR 155.53(c), EPA is information. both EPA and OMB as follows:
providing an opportunity, through this • Submitters may request the Agency • To EPA online using http://
notice of availability, for interested to reconsider data or information that www.regulations.gov (our preferred
parties to provide comments and input the Agency rejected in a previous method) or by mail to: EPA Docket
concerning the Agency’s draft review. However, submitters must Center, Environmental Protection
pollinator-only ecological risk explain why they believe the Agency Agency, Mail Code 28221T, 1200
assessment for imidacloprid. Such should reconsider the data or Pennsylvania Ave. NW., Washington,
comments and input could address, information in the pesticide’s DC 20460.
among other things, the Agency’s risk registration review. • To OMB via email to oira_
assessment methodologies and As provided in 40 CFR 155.58, the submission@omb.eop.gov. Address
assumptions, as applied to this draft registration review docket for each comments to OMB Desk Officer for EPA.
pollinator-only risk assessment. The pesticide case will remain publicly EPA’s policy is that all comments
Agency will consider all comments accessible through the duration of the received will be included in the docket
received during the public comment registration review process; that is, until without change, including any personal
period and make changes, as all actions required in the final decision information provided, unless the
appropriate, to the draft pollinator-only on the registration review case have comment includes profanity, threats,
risk assessment. EPA will then issue a been completed. information claimed to be Confidential
revised pollinator risk assessment, Business Information (CBI), or other
Authority: 7 U.S.C. 136 et seq.
explain any changes to the draft risk information whose disclosure is
assessment, and respond to comments. Dated: January 8, 2016.
restricted by statute. Do not submit
In the Federal Register notice Michael Goodis,
electronically any information you
announcing the availability of the Acting Director, Pesticide Re-Evaluation
consider to be CBI or other information
revised risk assessment, if the revised Division, Office of Pesticide Programs.
whose disclosure is restricted by statute.
risk assessment indicates risks of [FR Doc. 2016–00740 Filed 1–14–16; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
concern, the Agency may provide a BILLING CODE 6560–50–P
comment period for the public to submit Scott Drewes, Field and External
suggestions for mitigating the risk Affairs, (7506P), Office of Pesticide
identified in the revised risk assessment ENVIRONMENTAL PROTECTION Programs, Environmental Protection
before developing a proposed AGENCY Agency, 1200 Pennsylvania Ave. NW.,
registration review decision on Washington, DC 20460–0001; telephone
[EPA–HQ–OPP–2015–0231; FRL–9936–04– number: (703) 347–0107; email address:
imidacloprid. Additionally, the revised OEI]
risk assessment will also address drewes.scott@epa.gov.
ecological risks for all other taxa, as well SUPPLEMENTARY INFORMATION:
Information Collection Request
as a comprehensive draft human health Submitted to OMB for Review and Docket: Supporting documents,
risk assessment. Approval; Comment Request; Foreign including the ICR that explains in detail
1. Other related information. Purchaser Acknowledgement the information collection activities and
Additional information on imidacloprid Statement of Unregistered Pesticides the related burden and cost estimates
is available on the Pesticide Registration that are summarized in this document,
Review Status Web page. Information on AGENCY: Environmental Protection are available in the docket for this ICR.
the Agency’s registration review Agency (EPA). The docket can be viewed online at
program and its implementing ACTION: Notice. http://www.regulations.gov or in person
regulation is available at http://www. at the EPA Docket Center, West William
epa.gov/oppsrrd1/registration_review. SUMMARY: EPA has submitted the Jefferson Clinton Bldg., Rm. 3334, 1301
2. Information submission following information collection request Constitution Ave. NW., Washington,
requirements. Anyone may submit data (ICR) to the Office of Management and DC. The telephone number for the
or information in response to this Budget (OMB) for review and approval Docket Center is (202) 566–1744. For
document. To be considered during a in accordance with the Paperwork additional information about EPA’s
pesticide’s registration review, the Reduction Act (PRA): ‘‘Foreign public docket, visit http://www.epa.gov/
submitted data or information must Purchaser Acknowledgement Statement dockets.
meet the following requirements: of Unregistered Pesticides’’ (FPAS) and ICR status: This ICR is currently
• To ensure that EPA will consider identified by EPA ICR No. 0161.13 and scheduled to expire on January 31,
data or information submitted, OMB Control No. 2070–0027. The ICR, 2016. Under OMB regulations, the
interested persons must submit the data which is available in the docket along Agency may continue to conduct or
or information during the comment with other related materials, provides a sponsor the collection of information
mstockstill on DSK4VPTVN1PROD with NOTICES

period. The Agency may, at its detailed explanation of the collection while this submission is pending at
discretion, consider data or information activities and the burden estimate that OMB.
submitted at a later date. is only briefly summarized in this Under PRA, 44 U.S.C. 3501 et seq., an
• The data or information submitted document. EPA has addressed the agency may not conduct or sponsor, and
must be presented in a legible and comments received in response to the a person is not required to respond to,
useable form. For example, an English previously provided public review a collection of information, unless it
translation must accompany any opportunity issued in the Federal displays a currently valid OMB control
material that is not in English and a Register on May 8, 2015 (80 FR 26554). number. The OMB control numbers are

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Document Created: 2018-02-02 12:32:19
Document Modified: 2018-02-02 12:32:19

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 received on or before March 15, 2016.
Contact		For pesticide specific information contact: Kelly Ballard, Chemical Review Manager, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-8126;
FR Citation		81 FR 2212