[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: [email protected].

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 http://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