Flubendiamide; Notice of Intent To Cancel Pesticide Registrations, 11558-11561 [2016-04905]
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[FR Doc. 2016–04833 Filed 3–3–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–0099; FRL–9943–25]
Flubendiamide; Notice of Intent To
Cancel Pesticide Registrations
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
Pursuant to section 6(e) of the
Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), EPA hereby
announces its intent to cancel the
registration of four (4) pesticide
products containing the insecticide
flubendiamide owing to the registrants’
failure to comply with a required
condition of their registrations. This
document identifies the products at
issue, summarizes EPA’s basis for these
actions, and explains how adversely
affected persons may request a hearing
and the consequences of requesting or
failing to request such a hearing.
DATES: Under FIFRA section 6(e),
affected registrants and other adversely
affected persons must request a hearing
within 30 days from the date that the
affected registrant received EPA’s Notice
of Intent to Cancel. Please see Unit
VII.A.2. for specific instructions.
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SUMMARY:
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All persons who request a
hearing must comply with the Agency’s
Rules of Practice Governing Hearings,
40 CFR part 164. Requests for hearing
must be filed with the Hearing Clerk in
EPA’s Office of Administrative Law
Judges (‘‘OALJ’’), in conformance with
the requirements of 40 CFR part 164.
The OALJ uses different addresses
depending on the delivery method.
Please see Unit VII. for specific
instructions.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Executive Summary
A. What action is the Agency taking?
EPA is announcing its intent to cancel
the registration of four (4) pesticide
products containing the insecticide
flubendiamide owing to the registrants’
failure to comply with a required
condition of their registrations.
Specifically, EPA intends to cancel each
of the following pesticide products,
listed in sequence by EPA registration
number.
• EPA Reg. No. 264–1025—BELT SC
Insecticide.
• EPA Reg. No. 71711–26—
FLUBENDIAMIDE Technical.
• EPA Reg. No. 71711–32—VETICA
Insecticide.
• EPA Reg. No. 71711–33—
TOURISMO Insecticide.
The following is a list of the names
and addresses of record for all
registrants of the products listed in this
unit, in sequence by EPA company
number (this number corresponds to the
first part of the EPA registration
numbers of the products).
• EPA Co. No. 264—Bayer
CropScience LP, P.O. Box 12014, 2 T.W.
Alexander Drive, Research Triangle
Park, NC 27709–2014.
• EPA Co. No. 71711—Nichino
America, Inc., 4550 New Linden Hill
Road, Suite 501, Wilmington, DE
19808–2951.
In addition, this document
summarizes EPA’s legal authority for
the proposed cancellation (see Unit II.),
the registrants’ failure to comply with a
required condition of registration (see
Unit III.), EPA’s existing stocks
determination (see Unit IV.), scope of
the ensuing cancellation proceeding if a
hearing is requested (see Unit V.),
timing of cancellation of registration
(see Unit VI.), and procedural matters
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that explain how eligible persons may
request a hearing and the consequences
of requesting or failing to request such
a hearing (see Unit VII.).
B. What is the Agency’s authority for
taking these actions?
The Agency’s authority is contained
in section 6(e) of FIFRA, 7 U.S.C.
136d(e).
C. Who is affected by this action?
This announcement will directly
affect the pesticide registrants listed in
Unit I.A. and others who may distribute,
sell or use the products listed in Unit
I.A. This announcement may also be of
particular 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. EPA
believes the stakeholders described
above encompass those likely to be
affected; however, more remote effects
are possible, and the Agency has not
attempted to describe all the other
specific entities that may be affected by
this action.
II. Legal Authority
FIFRA generally governs pesticide
sale, distribution, and use in the United
States and establishes a federal
registration scheme that generally
precludes distributing or selling any
pesticide that has not been ‘‘registered’’
by EPA. 7 U.S.C. 136a(a). A FIFRA
registration is a license that establishes
the terms and conditions under which
a pesticide may be lawfully sold,
distributed, and used. See id. 7 U.S.C.
136a(c)(1)(A)–(F) and 136a(d)(1).
The flubendiamide products at issue
in this proceeding were conditionally
registered pursuant to FIFRA section
3(c)(7)(C) and EPA’s regulations at 40
CFR 152.114 and 152.115. Those
provisions allow that a conditional
registration of an active ingredient not
contained in any currently registered
products be registered for a reasonably
sufficient time for the registrant to
generate and submit newly-required
data on the condition that by the end of
such time the Administrator determines
the data do not meet or exceed risk
criteria and subject to such other
conditions as the Administrator may
prescribe. The conditional registration
provision was added to FIFRA to
address the inequity created by the
then-existing statutory scheme between
existing registrants and new applicants,
and to provide a ‘‘middle ground’’ in the
registration process between totally
denying registration and granting it. See
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Woodstream Corp. v Jackson, 845 F.
Supp. 2d. 174,181 (D.D.C. 2012).
However, the utility of conditional
registrations depends on affected
registrants’ compliance with the terms
and conditions of their registrations. If
registrants accept registrations subject to
conditions, but then fail to honor those
conditions, EPA could well become
more restrictive in its use of the
conditional registration authority, and
society would lose some of the benefits
offered by a flexible registration process.
FIFRA section 6(e) establishes
procedures for cancellation of
conditional registrations issued
pursuant to FIFRA section 3(c)(7).
Pursuant to FIFRA section 6(e), the
Administrator is required to issue a
notice of intent to cancel a conditional
registration under FIFRA section 3(c)(7)
if (1) during the period provided for the
satisfaction of the condition, the
Administrator determines that the
registrant has failed to initiate and
pursue appropriate action to satisfy any
imposed condition, or (2) at the end of
the period provided for satisfaction of
any condition, the condition has not
been satisfied. The Administrator is
authorized to permit the sale and use of
existing stocks of a pesticide whose
conditional registration has been
canceled to such extent and subject to
such conditions as the Administrator
may specify, if the Administrator
determines that such sale or use is not
inconsistent with the purposes of this
Act and will not have unreasonable
adverse effects on the environment.
If a hearing is requested by an
adversely affected party, a hearing shall
be conducted in accordance with FIFRA
section 6(d) and 40 CFR part 164 (the
regulations establishing the procedures
for hearings under FIFRA). The scope of
a hearing under FIFRA section 6(e) is
quite narrow; FIFRA provides that the
only matters for resolution at that
hearing shall be whether the registrant
has initiated and pursued appropriate
action to comply with the condition or
conditions within the time provided or
whether the condition or conditions
have been satisfied within the time
provided, and whether the
Administrator’s determination with
respect to the disposition of existing
stocks is consistent with FIFRA. A
decision after completion of the hearing
is final. Consistent with the narrowness
of the scope of hearing, the statute also
provides that a hearing under FIFRA
section 6(e) shall be held and a
determination made within seventy-five
(75) days after receipt of a request for
hearing.
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III. Registrants’ Failure To Comply
With a Required Condition of
Registration
Flubendiamide is an insecticide
which targets lepidoptera pests
approved for use on corn, cotton,
tobacco, tree fruits, nuts, vegetables, and
vine crops. EPA has determined that the
flubendiamide registrations listed in
Unit I.A. should be cancelled because
the registrants have failed to satisfy a
required condition of their registrations.
EPA issued conditional registrations
for each of the flubendiamide products
identified in Unit I.A., beginning with
the issuance of Flubendiamide
Technical and Belt SC Insecticide on
August 1, 2008. The Notices of
Registration (‘‘NOR’’) issued on August
1, 2008, state that the product is
conditionally registered in accordance
with FIFRA section 3(c)(7),
incorporating by reference conditions of
registration set forth in EPA’s
preliminary acceptance letter (‘‘PAL’’).
Vetica and Tourismo flubendiamide
registrations were issued March 4, 2009,
and the PAL applied to those
registrations as well. The NOR states
that ‘‘release for shipment of these
products constitutes acceptance of the
conditions of registration as outlined in
the preliminary acceptance letter for
flubendiamide, dated July 31, 2008. If
these conditions are not complied with,
the registration will be subject to
cancellation in accordance with section
6(e) of FIFRA.’’ The Registrants
subsequently released each of these
products for shipment, thereby
accepting the specified conditions of
registration.
EPA’s PAL for flubendiamide (which,
as noted previously, included
conditions of registration which were
specifically incorporated into the NORs)
was issued on July 31, 2008, and
specified the conditions under which
EPA would approve registration of the
flubendiamide products. The
flubendiamide registrants, Bayer
CropScience LP, as authorized agent for
Nichino America, Inc., agreed to these
terms by concurring with the
Registration Division’s intended terms
and conditions of registration.
Application for a New Section 3
Registration of Flubendiamide with
Associated Tolerance, July 31, 2008. At
the time of registration, the product was
conditionally registered subject to a
time limit of 5 years. EPA required
flubendiamide to be conditionally
registered because of concerns regarding
flubendiamide’s mobility, stability/
persistence, accumulation in soils,
water columns and sediments, and the
extremely toxic nature of the primary
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degradate NNI–001-des-iodo to
invertebrates of aquatic systems; in light
of these concerns, the conditional
registrations required use of vegetative
filter strips and submission of
additional data to address the concerns.
In addition, instead of the registrations
automatically expiring on a date certain,
a condition was added that obligated the
registrants to expeditiously request
voluntary cancellation of the
registrations if EPA notified them that
EPA determined the registrations did
not meet the FIFRA standard for
registration.
The Registrants understood and
agreed by signing the PAL that if, after
EPA review of the referenced
conditional data, EPA were to make a
determination that continued
registration of flubendiamide products
will result in unreasonable adverse
effects on the environment, EPA would
notify the Registrants, and within one
(1) week of notification of this finding,
the Registrants would submit a request
for voluntary cancellation of all the
flubendiamide registrations. Without
that condition, the registration would
likely not have been approved by EPA.
Moreover, pursuant to the terms of the
NORs for the four flubendiamide
registrations, each Registrant accepted
all conditions of their flubendiamide
registrations—expressly including the
conditions specified in the PAL—upon
sale or distribution of pesticide products
pursuant to those registrations. The
Registrants were notified on January 29,
2016 that EPA had made such a finding
and, under the terms of the timelimited/conditional registration, the
Registrants were obligated to submit an
appropriate request for voluntary
cancellation to EPA by or before
February 5, 2016. Letter to Ms. Nancy
Delaney, Regulatory Manager,
Authorized Agent for Nichino America,
Inc., c/o Bayer CropScience, from Jack
E. Housenger, Director, Office of
Pesticide Programs, January 29, 2016.
On February 5, 2016, Bayer submitted a
letter to EPA on its behalf and as
regulatory agent for Nichino, informing
EPA that neither registrant would
comply with the condition to submit
voluntary cancellation requests for the
flubendiamide registrations. Response
to Request to Submit Voluntary
Cancellation Requests for
Flubendiamide Technical Registration
and Associated End Use Products,
February 5, 2016. Consistent with the
position stated in the February 5, 2016
letter, neither Bayer nor Nichino has
submitted a voluntary cancellation
request in response to EPA’s letter of
January 29, 2016. Once EPA exercised
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the registration condition set forth in the
NOR, the registrants’ failure to comply
with that condition of registration by
submitting requests for voluntary
cancellation makes the flubendiamide
products identified in Unit I.A. subject
to cancellation under FIFRA section
6(e).
IV. EPA’s Existing Stocks
Determination
Existing stocks of cancelled pesticides
are those products that were ‘‘released
for shipment’’ before the effective date
of cancellation. FIFRA sections 6(a)(1)
and 6(e) allow the Agency to permit the
continued sale and use of existing
stocks of pesticides that have been
cancelled, to the extent that the
Administrator determines that such sale
or use would not be inconsistent with
the purposes of this Act. 7 U.S.C.
136d(a)(1). FIFRA section 6(a)(1)
authorizes the Administrator to ‘‘permit
the continued sale and use of existing
stocks of a pesticide whose registration
is suspended or canceled . . . under
such conditions, and for such uses as
the Administrator determines that such
sale or use is not inconsistent with the
purposes of this Act.’’
EPA’s policy in regard to the
disposition of existing stocks of
cancelled pesticides appears in a policy
statement issued in 1991 and amended
in 1996. (56 FR 29362, June 26, 1991
(FRL–3846–4) and 61 FR 16632, April
16, 1996 (FRL–5363–8)). The existing
stocks policy indicates that although
registrants who fail to satisfy a general
condition (i.e., one which requires a
registrant to submit required data when
all other registrants of the similar
product are required to do so) would
typically be allowed to distribute and
sell existing stocks of the cancelled
pesticide for one year,
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On the other hand, if a registrant of a
conditional registration fails to comply with
a specific condition identified at the time the
registration was issued, the Agency does not
believe it is generally appropriate to allow
any sale and use of existing stocks if the
registration is cancelled. Accordingly, the
Agency does not anticipate allowing a
registrant to sell or distribute existing stocks
of cancelled products that were conditionally
registered if the registrant fails to
demonstrate compliance with any specific
requirements set forth in the conditional
registration. 56 FR at 29366–67.
The registration condition in the
instant case is specific and was
identified at the time the registration
was issued, so the Agency does not
intend to allow any sale or distribution
of existing stocks.
Neither FIFRA nor any other law
gives the registrant or anyone else a
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right to continue to distribute or sell
existing stocks of a cancelled pesticide.
Per FIFRA section 6(a)(1), the
disposition of existing stocks of
cancelled pesticides is at the discretion
of the Administrator. Inasmuch as the
disposition of existing stocks of a
cancelled pesticide is at EPA’s
discretion, EPA considers it
inappropriate to reward registrants who
disregard the terms and conditions of
registration, like the condition at issue
here, by allowing any distribution or
sale of existing stocks. This is not a case
where the registrants have made a
diligent effort to comply with the
condition of registration, only to fail
through circumstances beyond their
control. Rather, they simply refuse to
comply with a condition they earlier
chose to accept in order to obtain the
registration initially. Their refusal to
comply with the condition will likely
delay the cancellation for a number of
months, during which time they may
not only continue to sell and distribute
the previously-produced product that
should by the terms and conditions of
registration now be cancelled, but also
to continue to produce, sell and
distribute additional quantities until
cancellation through the FIFRA section
6(e) proceeding. For these reasons, and
consistent with EPA’s existing stocks
policy, EPA has determined that it
would not be appropriate to allow any
further sale or distribution, by any
person, of existing stocks of the
products identified in Unit I.A. after
those registrations are cancelled, except
to the extent that distribution is for
purposes of returning material back up
the channels of trade, for purposes of
disposal, or for purposes of lawful
export.
EPA has determined that use of
existing stocks of the technical
flubendiamide registration (EPA Reg.
No. 71711–26) should be prohibited
upon the cancellation of that
registration. Technical products are
used solely for the purpose of
manufacturing other pesticide products.
For the same reason discussed above
with respect to sale and distribution of
cancelled products, EPA believes it
would be inappropriate to allow use of
existing stocks of EPA Reg. No. 71711–
26 to produce additional flubendiamide
pesticide products unless those
products are clearly designated solely
for lawful export.
EPA believes it would be appropriate
to allow continued use of existing stocks
of the cancelled end-use flubendiamide
products EPA Reg. Nos. 264–1025,
71711–32, and 71711–33, currently held
by end users, provided that such use is
consistent with the previously
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approved-labeling accompanying the
product. The quantity of existing stocks
of these products currently in the hands
of end users is expected to be
sufficiently low that the costs and risks
associated with collecting them for
disposal would be high compared to
those associated with the use of the
cancelled product in accordance with
its labeling. When containers of
flubendiamide have already been
opened, transporting them can create a
greater risk of spillage. Open containers
also create additional burden when sent
for disposal because proper disposal
may require that the content be verified,
adding additional expense. Because of
the probable wide dispersal of product
in user’s hands, notification and
subsequent supervision of users
imposes significant costs on state and/
or federal authorities. EPA may amend
its position regarding use of existing
stocks of end-use flubendiamide
products at hearing if the quantity of
those products in the hands of end users
increases prior to cancellation. For these
reasons, EPA intends to allow existing
stocks of the end-use flubendiamide
products EPA Reg. Nos. 264–1025,
71711–32, and 71711–33, in the hands
of end users to be used until exhausted.
V. Scope of Proceeding
The scope of a hearing under FIFRA
section 6(e) is quite narrow; FIFRA
provides that the only matters for
resolution at that hearing shall be
whether the registrant has initiated and
pursued appropriate action to comply
with the condition or conditions within
the time provided or whether the
condition or conditions have been
satisfied within the time provided, and
whether the Administrator’s
determination with respect to the
disposition of existing stocks is
consistent with FIFRA. The Statute also
provides that a hearing under FIFRA
section 6(e) shall be held and a
determination made within seventy-five
days after receipt of a request for
hearing.
A FIFRA section 6(e) proceeding is
intended only to address whether
conditions of registration have been
met, not to assess the merits of
conditions or whether the registrants
disagree with the conditions of their
approved registration. Similarly, the
FIFRA section 6(e) proceeding is limited
to whether the Agency’s existing stocks
determination ‘‘is consistent’’ with
FIFRA, not whether the existing stock
provisions of the NOIC strike an optimal
balance between the risks and benefits
associated with the distribution, sale
and use of existing stocks of a cancelled
pesticide. FIFRA section 6(e)(2)
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provides that where a FIFRA section
6(e) cancellation hearing is requested,
the scope of the hearing and the
standard of review in regard to the
Administrator’s determination with
respect to the disposition of existing
stocks is limited to whether that
determination is consistent with FIFRA.
Congress mandated a final decision
within seventy-five (75) days, and a
broader or more complex hearing could
not reasonably be completed in such a
limited timeframe. Accordingly, the
only matters for resolution in any
hearing requested regarding this matter
shall be whether the registrants satisfied
the condition of registration requiring
them to submit timely requests for
voluntary cancellation when notified by
EPA of its determination that the
registrations caused unreasonable
adverse effects on the environment, and
whether the proposed existing stocks
provision is consistent with FIFRA.
VI. Timing of Cancellation of
Registration
The cancellation of registration of
each of the specific products identified
in Unit I.A. will be final and effective
thirty (30) days after the date of receipt
by the registrant, unless a valid hearing
request is received regarding that
specific flubendiamide product.
In the event a hearing is held
concerning a particular product, the
cancellation of the registration for that
product will not become effective
except pursuant to a final order issued
by the Environmental Appeals Board or
(if the matter is referred to the
Administrator pursuant to 40 CFR
164.2(g)) the Administrator, or an initial
decision of the presiding Administrative
Law Judge that becomes a final order
pursuant to 40 CFR 164.90(b). Pursuant
to FIFRA section 6(e)(2), such order
shall issue within seventy-five (75) days
after receipt of a request for hearing.
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VII. Procedural Matters
This unit explains how eligible
persons may request a hearing and the
consequences of requesting or failing to
request such a hearing.
A. Requesting a Hearing
1. Who can request a hearing? A
registrant or any other person who is
adversely affected by a cancellation as
described in this document may request
a hearing.
2. When must a hearing be requested?
A request for a hearing by a registrant
or other adversely affected person must
be submitted in writing within thirty
(30) days after the date of the registrant’s
receipt of the Notice of Intent to Cancel.
Under FIFRA section 6(e), the time
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period for requesting a hearing is
calculated from the date the affected
registrant receives the Notice of Intent to
Cancel, without regard to the date of
issuance or publication in the Federal
Register. EPA issued this Notice of
Intent to Cancel and promptly sent it to
each registrant by certified mail on
February 29, 2016. Registrants will be
able to calculate the deadline for their
request based on their receipt of the
Notice of Intent to Cancel. In order to
assure that any requests for hearing from
persons other than the registrants are
received in a timely manner, persons
other than the registrants who wish to
submit a request for hearing are urged
to assume that the registrants received
the Notice of Intent to Cancel on March
1, 2016, and make sure that a request for
hearing is received by EPA’s Office of
Administrative Law Judges on or before
March 31, 2016.
3. How must a hearing be requested?
All persons who request a hearing must
comply with the Agency’s Rules of
Practice Governing Hearings under
FIFRA, 40 CFR part 164. Among other
requirements, these rules include the
following requirements:
a. Each hearing request must
specifically identify by registration or
accession number each individual
pesticide product concerning which a
hearing is requested, 40 CFR 164.22(a);
b. Each hearing request must be
accompanied by a document setting
forth specific objections which respond
to the Agency’s reasons for proposing
cancellation as set forth in this
document and state the factual basis for
each such objection, 40 CFR 164.22(a);
and
c. Each hearing request must be
received by the OALJ within the
applicable 30-day period (40 CFR
164.5(a)).
Failure to comply with any one of
these requirements will invalidate the
request for a hearing and, in the absence
of a valid hearing request, result in final
cancellation of registration for the
product in question by operation of law.
4. Where does a person submit a
hearing request? Requests for hearing
must be submitted to the OALJ. The
OALJ uses different addresses
depending on the delivery method.
Please note that mail deliveries to
federal agencies are screened off-site,
and this security procedure can delay
delivery. Documents that a party sends
using the U.S. Postal Service must be
addressed to the following OALJ
mailing address: U.S. Environmental
Protection Agency, Office of
Administrative Law Judges, Mail Code
1900R, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460.
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11561
Documents that a party hand delivers
or sends using a courier or commercial
delivery service (such as Federal
Express or UPS) must be addressed to
the following OALJ hand delivery
address: U.S. Environmental Protection
Agency, Office of Administrative Law
Judges, Ronald Reagan Building, Rm.
M1200, 1300 Pennsylvania Ave. NW.,
Washington, DC 20460.
B. The Hearing
If a hearing concerning any product
affected by this document is requested
in a timely and effective manner, the
hearing will be governed by the
Agency’s Rules of Practice Governing
Hearings under FIFRA, 40 CFR part 164,
and the procedures set forth in Unit VII.
Any interested person may participate
in the hearing, in accordance with 40
CFR 164.31.
Documents and transcripts will be
available in the Administrative Law
Judges’ Electronic Docket Database
available at https://yosemite.epa.gov/
oarm/alj/alj_web_docket.nsf. The
physical public docket for the hearing is
located at the U.S. Environmental
Protection Agency, Office of
Administrative Law Judges, Ronald
Reagan Building, Rm. M1200, 1300
Pennsylvania Ave. NW., Washington,
DC 20460 and documents can be viewed
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, except federal holidays.
List of Subjects
Environmental protection, Pesticides
and pests, Cancellation.
Dated: February 29, 2016.
Louise P. Wise,
Acting Assistant Administrator, Office of
Chemical Safety and Pollution Prevention.
[FR Doc. 2016–04905 Filed 3–3–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9943–37-Region 1]
Proposed Cercla Administrative Cost
Recovery Settlement: Former Athol
Rod and Gun Club Superfund Site,
Athol, Massachusetts
Environmental Protection
Agency (EPA).
ACTION: Notice of proposed settlement;
request for public comments.
AGENCY:
Notice is hereby given of a
proposed administrative cost settlement
for recovery of response costs
concerning the Former Athol Rod and
Gun Club Superfund Site, located in
Athol, Worcester County, Massachusetts
with the Settling Party the Town of
SUMMARY:
E:\FR\FM\04MRN1.SGM
04MRN1
Agencies
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11558-11561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04905]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0099; FRL-9943-25]
Flubendiamide; Notice of Intent To Cancel Pesticide Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Pursuant to section 6(e) of the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA), EPA hereby announces its intent to cancel
the registration of four (4) pesticide products containing the
insecticide flubendiamide owing to the registrants' failure to comply
with a required condition of their registrations. This document
identifies the products at issue, summarizes EPA's basis for these
actions, and explains how adversely affected persons may request a
hearing and the consequences of requesting or failing to request such a
hearing.
DATES: Under FIFRA section 6(e), affected registrants and other
adversely affected persons must request a hearing within 30 days from
the date that the affected registrant received EPA's Notice of Intent
to Cancel. Please see Unit VII.A.2. for specific instructions.
ADDRESSES: All persons who request a hearing must comply with the
Agency's Rules of Practice Governing Hearings, 40 CFR part 164.
Requests for hearing must be filed with the Hearing Clerk in EPA's
Office of Administrative Law Judges (``OALJ''), in conformance with the
requirements of 40 CFR part 164. The OALJ uses different addresses
depending on the delivery method. Please see Unit VII. for specific
instructions.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. What action is the Agency taking?
EPA is announcing its intent to cancel the registration of four (4)
pesticide products containing the insecticide flubendiamide owing to
the registrants' failure to comply with a required condition of their
registrations. Specifically, EPA intends to cancel each of the
following pesticide products, listed in sequence by EPA registration
number.
EPA Reg. No. 264-1025--BELT SC Insecticide.
EPA Reg. No. 71711-26--FLUBENDIAMIDE Technical.
EPA Reg. No. 71711-32--VETICA Insecticide.
EPA Reg. No. 71711-33--TOURISMO Insecticide.
The following is a list of the names and addresses of record for
all registrants of the products listed in this unit, in sequence by EPA
company number (this number corresponds to the first part of the EPA
registration numbers of the products).
EPA Co. No. 264--Bayer CropScience LP, P.O. Box 12014, 2
T.W. Alexander Drive, Research Triangle Park, NC 27709-2014.
EPA Co. No. 71711--Nichino America, Inc., 4550 New Linden
Hill Road, Suite 501, Wilmington, DE 19808-2951.
In addition, this document summarizes EPA's legal authority for the
proposed cancellation (see Unit II.), the registrants' failure to
comply with a required condition of registration (see Unit III.), EPA's
existing stocks determination (see Unit IV.), scope of the ensuing
cancellation proceeding if a hearing is requested (see Unit V.), timing
of cancellation of registration (see Unit VI.), and procedural matters
that explain how eligible persons may request a hearing and the
consequences of requesting or failing to request such a hearing (see
Unit VII.).
B. What is the Agency's authority for taking these actions?
The Agency's authority is contained in section 6(e) of FIFRA, 7
U.S.C. 136d(e).
C. Who is affected by this action?
This announcement will directly affect the pesticide registrants
listed in Unit I.A. and others who may distribute, sell or use the
products listed in Unit I.A. This announcement may also be of
particular 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. EPA
believes the stakeholders described above encompass those likely to be
affected; however, more remote effects are possible, and the Agency has
not attempted to describe all the other specific entities that may be
affected by this action.
II. Legal Authority
FIFRA generally governs pesticide sale, distribution, and use in
the United States and establishes a federal registration scheme that
generally precludes distributing or selling any pesticide that has not
been ``registered'' by EPA. 7 U.S.C. 136a(a). A FIFRA registration is a
license that establishes the terms and conditions under which a
pesticide may be lawfully sold, distributed, and used. See id. 7 U.S.C.
136a(c)(1)(A)-(F) and 136a(d)(1).
The flubendiamide products at issue in this proceeding were
conditionally registered pursuant to FIFRA section 3(c)(7)(C) and EPA's
regulations at 40 CFR 152.114 and 152.115. Those provisions allow that
a conditional registration of an active ingredient not contained in any
currently registered products be registered for a reasonably sufficient
time for the registrant to generate and submit newly-required data on
the condition that by the end of such time the Administrator determines
the data do not meet or exceed risk criteria and subject to such other
conditions as the Administrator may prescribe. The conditional
registration provision was added to FIFRA to address the inequity
created by the then-existing statutory scheme between existing
registrants and new applicants, and to provide a ``middle ground'' in
the registration process between totally denying registration and
granting it. See
[[Page 11559]]
Woodstream Corp. v Jackson, 845 F. Supp. 2d. 174,181 (D.D.C. 2012).
However, the utility of conditional registrations depends on affected
registrants' compliance with the terms and conditions of their
registrations. If registrants accept registrations subject to
conditions, but then fail to honor those conditions, EPA could well
become more restrictive in its use of the conditional registration
authority, and society would lose some of the benefits offered by a
flexible registration process.
FIFRA section 6(e) establishes procedures for cancellation of
conditional registrations issued pursuant to FIFRA section 3(c)(7).
Pursuant to FIFRA section 6(e), the Administrator is required to issue
a notice of intent to cancel a conditional registration under FIFRA
section 3(c)(7) if (1) during the period provided for the satisfaction
of the condition, the Administrator determines that the registrant has
failed to initiate and pursue appropriate action to satisfy any imposed
condition, or (2) at the end of the period provided for satisfaction of
any condition, the condition has not been satisfied. The Administrator
is authorized to permit the sale and use of existing stocks of a
pesticide whose conditional registration has been canceled to such
extent and subject to such conditions as the Administrator may specify,
if the Administrator determines that such sale or use is not
inconsistent with the purposes of this Act and will not have
unreasonable adverse effects on the environment.
If a hearing is requested by an adversely affected party, a hearing
shall be conducted in accordance with FIFRA section 6(d) and 40 CFR
part 164 (the regulations establishing the procedures for hearings
under FIFRA). The scope of a hearing under FIFRA section 6(e) is quite
narrow; FIFRA provides that the only matters for resolution at that
hearing shall be whether the registrant has initiated and pursued
appropriate action to comply with the condition or conditions within
the time provided or whether the condition or conditions have been
satisfied within the time provided, and whether the Administrator's
determination with respect to the disposition of existing stocks is
consistent with FIFRA. A decision after completion of the hearing is
final. Consistent with the narrowness of the scope of hearing, the
statute also provides that a hearing under FIFRA section 6(e) shall be
held and a determination made within seventy-five (75) days after
receipt of a request for hearing.
III. Registrants' Failure To Comply With a Required Condition of
Registration
Flubendiamide is an insecticide which targets lepidoptera pests
approved for use on corn, cotton, tobacco, tree fruits, nuts,
vegetables, and vine crops. EPA has determined that the flubendiamide
registrations listed in Unit I.A. should be cancelled because the
registrants have failed to satisfy a required condition of their
registrations.
EPA issued conditional registrations for each of the flubendiamide
products identified in Unit I.A., beginning with the issuance of
Flubendiamide Technical and Belt SC Insecticide on August 1, 2008. The
Notices of Registration (``NOR'') issued on August 1, 2008, state that
the product is conditionally registered in accordance with FIFRA
section 3(c)(7), incorporating by reference conditions of registration
set forth in EPA's preliminary acceptance letter (``PAL''). Vetica and
Tourismo flubendiamide registrations were issued March 4, 2009, and the
PAL applied to those registrations as well. The NOR states that
``release for shipment of these products constitutes acceptance of the
conditions of registration as outlined in the preliminary acceptance
letter for flubendiamide, dated July 31, 2008. If these conditions are
not complied with, the registration will be subject to cancellation in
accordance with section 6(e) of FIFRA.'' The Registrants subsequently
released each of these products for shipment, thereby accepting the
specified conditions of registration.
EPA's PAL for flubendiamide (which, as noted previously, included
conditions of registration which were specifically incorporated into
the NORs) was issued on July 31, 2008, and specified the conditions
under which EPA would approve registration of the flubendiamide
products. The flubendiamide registrants, Bayer CropScience LP, as
authorized agent for Nichino America, Inc., agreed to these terms by
concurring with the Registration Division's intended terms and
conditions of registration. Application for a New Section 3
Registration of Flubendiamide with Associated Tolerance, July 31, 2008.
At the time of registration, the product was conditionally registered
subject to a time limit of 5 years. EPA required flubendiamide to be
conditionally registered because of concerns regarding flubendiamide's
mobility, stability/persistence, accumulation in soils, water columns
and sediments, and the extremely toxic nature of the primary degradate
NNI-001-des-iodo to invertebrates of aquatic systems; in light of these
concerns, the conditional registrations required use of vegetative
filter strips and submission of additional data to address the
concerns. In addition, instead of the registrations automatically
expiring on a date certain, a condition was added that obligated the
registrants to expeditiously request voluntary cancellation of the
registrations if EPA notified them that EPA determined the
registrations did not meet the FIFRA standard for registration.
The Registrants understood and agreed by signing the PAL that if,
after EPA review of the referenced conditional data, EPA were to make a
determination that continued registration of flubendiamide products
will result in unreasonable adverse effects on the environment, EPA
would notify the Registrants, and within one (1) week of notification
of this finding, the Registrants would submit a request for voluntary
cancellation of all the flubendiamide registrations. Without that
condition, the registration would likely not have been approved by EPA.
Moreover, pursuant to the terms of the NORs for the four flubendiamide
registrations, each Registrant accepted all conditions of their
flubendiamide registrations--expressly including the conditions
specified in the PAL--upon sale or distribution of pesticide products
pursuant to those registrations. The Registrants were notified on
January 29, 2016 that EPA had made such a finding and, under the terms
of the time-limited/conditional registration, the Registrants were
obligated to submit an appropriate request for voluntary cancellation
to EPA by or before February 5, 2016. Letter to Ms. Nancy Delaney,
Regulatory Manager, Authorized Agent for Nichino America, Inc., c/o
Bayer CropScience, from Jack E. Housenger, Director, Office of
Pesticide Programs, January 29, 2016. On February 5, 2016, Bayer
submitted a letter to EPA on its behalf and as regulatory agent for
Nichino, informing EPA that neither registrant would comply with the
condition to submit voluntary cancellation requests for the
flubendiamide registrations. Response to Request to Submit Voluntary
Cancellation Requests for Flubendiamide Technical Registration and
Associated End Use Products, February 5, 2016. Consistent with the
position stated in the February 5, 2016 letter, neither Bayer nor
Nichino has submitted a voluntary cancellation request in response to
EPA's letter of January 29, 2016. Once EPA exercised
[[Page 11560]]
the registration condition set forth in the NOR, the registrants'
failure to comply with that condition of registration by submitting
requests for voluntary cancellation makes the flubendiamide products
identified in Unit I.A. subject to cancellation under FIFRA section
6(e).
IV. EPA's Existing Stocks Determination
Existing stocks of cancelled pesticides are those products that
were ``released for shipment'' before the effective date of
cancellation. FIFRA sections 6(a)(1) and 6(e) allow the Agency to
permit the continued sale and use of existing stocks of pesticides that
have been cancelled, to the extent that the Administrator determines
that such sale or use would not be inconsistent with the purposes of
this Act. 7 U.S.C. 136d(a)(1). FIFRA section 6(a)(1) authorizes the
Administrator to ``permit the continued sale and use of existing stocks
of a pesticide whose registration is suspended or canceled . . . under
such conditions, and for such uses as the Administrator determines that
such sale or use is not inconsistent with the purposes of this Act.''
EPA's policy in regard to the disposition of existing stocks of
cancelled pesticides appears in a policy statement issued in 1991 and
amended in 1996. (56 FR 29362, June 26, 1991 (FRL-3846-4) and 61 FR
16632, April 16, 1996 (FRL-5363-8)). The existing stocks policy
indicates that although registrants who fail to satisfy a general
condition (i.e., one which requires a registrant to submit required
data when all other registrants of the similar product are required to
do so) would typically be allowed to distribute and sell existing
stocks of the cancelled pesticide for one year,
On the other hand, if a registrant of a conditional registration
fails to comply with a specific condition identified at the time the
registration was issued, the Agency does not believe it is generally
appropriate to allow any sale and use of existing stocks if the
registration is cancelled. Accordingly, the Agency does not
anticipate allowing a registrant to sell or distribute existing
stocks of cancelled products that were conditionally registered if
the registrant fails to demonstrate compliance with any specific
requirements set forth in the conditional registration. 56 FR at
29366-67.
The registration condition in the instant case is specific and was
identified at the time the registration was issued, so the Agency does
not intend to allow any sale or distribution of existing stocks.
Neither FIFRA nor any other law gives the registrant or anyone else
a right to continue to distribute or sell existing stocks of a
cancelled pesticide. Per FIFRA section 6(a)(1), the disposition of
existing stocks of cancelled pesticides is at the discretion of the
Administrator. Inasmuch as the disposition of existing stocks of a
cancelled pesticide is at EPA's discretion, EPA considers it
inappropriate to reward registrants who disregard the terms and
conditions of registration, like the condition at issue here, by
allowing any distribution or sale of existing stocks. This is not a
case where the registrants have made a diligent effort to comply with
the condition of registration, only to fail through circumstances
beyond their control. Rather, they simply refuse to comply with a
condition they earlier chose to accept in order to obtain the
registration initially. Their refusal to comply with the condition will
likely delay the cancellation for a number of months, during which time
they may not only continue to sell and distribute the previously-
produced product that should by the terms and conditions of
registration now be cancelled, but also to continue to produce, sell
and distribute additional quantities until cancellation through the
FIFRA section 6(e) proceeding. For these reasons, and consistent with
EPA's existing stocks policy, EPA has determined that it would not be
appropriate to allow any further sale or distribution, by any person,
of existing stocks of the products identified in Unit I.A. after those
registrations are cancelled, except to the extent that distribution is
for purposes of returning material back up the channels of trade, for
purposes of disposal, or for purposes of lawful export.
EPA has determined that use of existing stocks of the technical
flubendiamide registration (EPA Reg. No. 71711-26) should be prohibited
upon the cancellation of that registration. Technical products are used
solely for the purpose of manufacturing other pesticide products. For
the same reason discussed above with respect to sale and distribution
of cancelled products, EPA believes it would be inappropriate to allow
use of existing stocks of EPA Reg. No. 71711-26 to produce additional
flubendiamide pesticide products unless those products are clearly
designated solely for lawful export.
EPA believes it would be appropriate to allow continued use of
existing stocks of the cancelled end-use flubendiamide products EPA
Reg. Nos. 264-1025, 71711-32, and 71711-33, currently held by end
users, provided that such use is consistent with the previously
approved-labeling accompanying the product. The quantity of existing
stocks of these products currently in the hands of end users is
expected to be sufficiently low that the costs and risks associated
with collecting them for disposal would be high compared to those
associated with the use of the cancelled product in accordance with its
labeling. When containers of flubendiamide have already been opened,
transporting them can create a greater risk of spillage. Open
containers also create additional burden when sent for disposal because
proper disposal may require that the content be verified, adding
additional expense. Because of the probable wide dispersal of product
in user's hands, notification and subsequent supervision of users
imposes significant costs on state and/or federal authorities. EPA may
amend its position regarding use of existing stocks of end-use
flubendiamide products at hearing if the quantity of those products in
the hands of end users increases prior to cancellation. For these
reasons, EPA intends to allow existing stocks of the end-use
flubendiamide products EPA Reg. Nos. 264-1025, 71711-32, and 71711-33,
in the hands of end users to be used until exhausted.
V. Scope of Proceeding
The scope of a hearing under FIFRA section 6(e) is quite narrow;
FIFRA provides that the only matters for resolution at that hearing
shall be whether the registrant has initiated and pursued appropriate
action to comply with the condition or conditions within the time
provided or whether the condition or conditions have been satisfied
within the time provided, and whether the Administrator's determination
with respect to the disposition of existing stocks is consistent with
FIFRA. The Statute also provides that a hearing under FIFRA section
6(e) shall be held and a determination made within seventy-five days
after receipt of a request for hearing.
A FIFRA section 6(e) proceeding is intended only to address whether
conditions of registration have been met, not to assess the merits of
conditions or whether the registrants disagree with the conditions of
their approved registration. Similarly, the FIFRA section 6(e)
proceeding is limited to whether the Agency's existing stocks
determination ``is consistent'' with FIFRA, not whether the existing
stock provisions of the NOIC strike an optimal balance between the
risks and benefits associated with the distribution, sale and use of
existing stocks of a cancelled pesticide. FIFRA section 6(e)(2)
[[Page 11561]]
provides that where a FIFRA section 6(e) cancellation hearing is
requested, the scope of the hearing and the standard of review in
regard to the Administrator's determination with respect to the
disposition of existing stocks is limited to whether that determination
is consistent with FIFRA.
Congress mandated a final decision within seventy-five (75) days,
and a broader or more complex hearing could not reasonably be completed
in such a limited timeframe. Accordingly, the only matters for
resolution in any hearing requested regarding this matter shall be
whether the registrants satisfied the condition of registration
requiring them to submit timely requests for voluntary cancellation
when notified by EPA of its determination that the registrations caused
unreasonable adverse effects on the environment, and whether the
proposed existing stocks provision is consistent with FIFRA.
VI. Timing of Cancellation of Registration
The cancellation of registration of each of the specific products
identified in Unit I.A. will be final and effective thirty (30) days
after the date of receipt by the registrant, unless a valid hearing
request is received regarding that specific flubendiamide product.
In the event a hearing is held concerning a particular product, the
cancellation of the registration for that product will not become
effective except pursuant to a final order issued by the Environmental
Appeals Board or (if the matter is referred to the Administrator
pursuant to 40 CFR 164.2(g)) the Administrator, or an initial decision
of the presiding Administrative Law Judge that becomes a final order
pursuant to 40 CFR 164.90(b). Pursuant to FIFRA section 6(e)(2), such
order shall issue within seventy-five (75) days after receipt of a
request for hearing.
VII. Procedural Matters
This unit explains how eligible persons may request a hearing and
the consequences of requesting or failing to request such a hearing.
A. Requesting a Hearing
1. Who can request a hearing? A registrant or any other person who
is adversely affected by a cancellation as described in this document
may request a hearing.
2. When must a hearing be requested? A request for a hearing by a
registrant or other adversely affected person must be submitted in
writing within thirty (30) days after the date of the registrant's
receipt of the Notice of Intent to Cancel. Under FIFRA section 6(e),
the time period for requesting a hearing is calculated from the date
the affected registrant receives the Notice of Intent to Cancel,
without regard to the date of issuance or publication in the Federal
Register. EPA issued this Notice of Intent to Cancel and promptly sent
it to each registrant by certified mail on February 29, 2016.
Registrants will be able to calculate the deadline for their request
based on their receipt of the Notice of Intent to Cancel. In order to
assure that any requests for hearing from persons other than the
registrants are received in a timely manner, persons other than the
registrants who wish to submit a request for hearing are urged to
assume that the registrants received the Notice of Intent to Cancel on
March 1, 2016, and make sure that a request for hearing is received by
EPA's Office of Administrative Law Judges on or before March 31, 2016.
3. How must a hearing be requested? All persons who request a
hearing must comply with the Agency's Rules of Practice Governing
Hearings under FIFRA, 40 CFR part 164. Among other requirements, these
rules include the following requirements:
a. Each hearing request must specifically identify by registration
or accession number each individual pesticide product concerning which
a hearing is requested, 40 CFR 164.22(a);
b. Each hearing request must be accompanied by a document setting
forth specific objections which respond to the Agency's reasons for
proposing cancellation as set forth in this document and state the
factual basis for each such objection, 40 CFR 164.22(a); and
c. Each hearing request must be received by the OALJ within the
applicable 30-day period (40 CFR 164.5(a)).
Failure to comply with any one of these requirements will
invalidate the request for a hearing and, in the absence of a valid
hearing request, result in final cancellation of registration for the
product in question by operation of law.
4. Where does a person submit a hearing request? Requests for
hearing must be submitted to the OALJ. The OALJ uses different
addresses depending on the delivery method. Please note that mail
deliveries to federal agencies are screened off-site, and this security
procedure can delay delivery. Documents that a party sends using the
U.S. Postal Service must be addressed to the following OALJ mailing
address: U.S. Environmental Protection Agency, Office of Administrative
Law Judges, Mail Code 1900R, 1200 Pennsylvania Avenue NW., Washington,
DC 20460.
Documents that a party hand delivers or sends using a courier or
commercial delivery service (such as Federal Express or UPS) must be
addressed to the following OALJ hand delivery address: U.S.
Environmental Protection Agency, Office of Administrative Law Judges,
Ronald Reagan Building, Rm. M1200, 1300 Pennsylvania Ave. NW.,
Washington, DC 20460.
B. The Hearing
If a hearing concerning any product affected by this document is
requested in a timely and effective manner, the hearing will be
governed by the Agency's Rules of Practice Governing Hearings under
FIFRA, 40 CFR part 164, and the procedures set forth in Unit VII. Any
interested person may participate in the hearing, in accordance with 40
CFR 164.31.
Documents and transcripts will be available in the Administrative
Law Judges' Electronic Docket Database available at https://yosemite.epa.gov/oarm/alj/alj_web_docket.nsf. The physical public
docket for the hearing is located at the U.S. Environmental Protection
Agency, Office of Administrative Law Judges, Ronald Reagan Building,
Rm. M1200, 1300 Pennsylvania Ave. NW., Washington, DC 20460 and
documents can be viewed from 8:30 a.m. to 4:30 p.m., Monday through
Friday, except federal holidays.
List of Subjects
Environmental protection, Pesticides and pests, Cancellation.
Dated: February 29, 2016.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2016-04905 Filed 3-3-16; 8:45 am]
BILLING CODE 6560-50-P