[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8123-8128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02500]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2013-0049; FRL-9377-7]
Rodenticides; Notice of Intent To Cancel Registrations of, and
Notice of Denial of Applications for, Certain Rodenticide Bait Products
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Pursuant to section 6(b) of the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA), EPA hereby announces its intent to cancel
the registration of 12 rodenticide products identified in this Notice.
Pursuant to section 3(c)(6) of FIFRA, EPA hereby announces the denial
of applications for registration of 2 products identified in this
Notice. This Notice summarizes EPA's basis for these actions, and
explains how eligible persons may request a hearing and the
consequences of requesting or failing to request such a hearing.
DATES: Affected registrants must request a hearing within 30 days of
receiving EPA's Notice of Intent to Cancel, or on or before March 7,
2013, whichever occurs later. Other adversely affected parties must
request a hearing on or before March 7, 2013.
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 VI. for specific
instructions.
FOR FURTHER INFORMATION CONTACT: Neil Anderson, Pesticide Re-evaluation
Division, Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
telephone number: (703) 308-8187; 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 each of
the pesticide products listed in Table 1:
Table 1--Pesticide Products Subject to Cancellation
----------------------------------------------------------------------------------------------------------------
EPA Reg.
Product No. Registrant Active ingredient Deficiency
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D-Con Concentrate Kills Rats & 3282-3 Reckitt Benckiser, Warfarin........... Consumer product in a
Mice. Inc. powder form and
packaged without a
protective bait
station.
D-Con Ready Mixed Kills Rats & 3282-4 Reckitt Benckiser, Warfarin........... Consumer product in a
Mice. Inc. pelleted form and
packaged without a
protective bait
station.
D-Con Mouse Prufe Kills Mice.... 3282-9 Reckitt Benckiser, Warfarin........... Consumer product in a
Inc. pelleted form and
packaged without a
protective bait
station.
D-Con Pellets Kills Rats & Mice. 3282-15 Reckitt Benckiser, Warfarin........... Consumer product in a
Inc. pelleted form and
packaged without a
protective bait
station.
D-Con Mouse Prufe II............ 3282-65 Reckitt Benckiser, Brodifacoum........ Consumer product: (1) In
Inc. a pelleted form and
packaged without a
protective bait
station, and (2)
contains a second
generation
anticoagulant
rodenticide (SGAR).
D-Con Pellets Generation II..... 3282-66 Reckitt Benckiser, Brodifacoum........ Consumer product: (1) In
Inc. a pelleted form and
packaged without a
protective bait
station, and (2)
containing a SGAR.
D-Con Bait Pellets II........... 3282-74 Reckitt Benckiser, Brodifacoum........ Consumer product: (1) In
Inc. a pelleted form and
packaged without a
protective bait
station, and (2)
containing a SGAR.
D-Con Ready Mixed Generation II. 3282-81 Reckitt Benckiser, Brodifacoum........ Consumer product: (1) In
Inc. a pelleted form and
packaged without a
protective bait
station, and (2)
containing a SGAR.
D-Con Mouse-Prufe III........... 3282-85 Reckitt Benckiser, Difethialone....... Consumer product: (1) In
Inc. a pelleted form and
packaged without a
protective bait
station, and (2)
containing a SGAR.
D-Con Bait Pellets III.......... 3282-86 Reckitt Benckiser, Difethialone....... Consumer product: (1) In
Inc. a pelleted form and
packaged without a
protective bait
station, and (2)
containing a SGAR.
D-Con II Ready Mix Baitbits III. 3282-87 Reckitt Benckiser, Difethialone....... Consumer product: (1) In
Inc. a pelleted form and
packaged without a
protective bait
station, and (2)
containing a SGAR.
D-Con Bait Packs III............ 3282-88 Reckitt Benckiser, Difethialone....... Consumer product: (1) In
Inc. a pelleted form and
packaged without a
protective bait
station, and (2)
containing a SGAR.
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[[Page 8124]]
EPA is also announcing its denial of the applications for
registration of the pesticide products listed in Table 2:
Table 2--Pesticide Product Registrations Subject to Denial
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Product EPA Application No. Registrant Active ingredient Deficiency
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D-Con Bait Station XV Kills Mice 3282-RNU............ Reckitt Benckiser Brodifacoum........ Consumer product containing a SGAR.
Inc.
D-Con Bait Station XVI Kills 3282-RNL............ Reckitt Benckiser Brodifacoum........ Consumer product containing a SGAR.
Mice. Inc.
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In addition, this Notice summarizes EPA's basis for these actions
(see Unit III.), and explains how eligible persons may request a
hearing and the consequences of requesting or failing to request such a
hearing (see Unit VI.).
B. What is the Agency's authority for taking these actions?
The Agency's authority is contained in FIFRA sections 3(c)(6) and
6(b), 7 U.S.C. 136a(c)(6) and 136d(b).
C. Who is affected by this action?
This announcement will directly affect the pesticide registrant
listed in Tables 1 and 2, and others who may sell, distribute, or use
the products listed in Table 1. This announcement may also be of
particular interest to a wide range of stakeholders including
environmental and human health 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 other
specific entities that may be affected by this action.
D. How can I get copies of this document and other related information?
To facilitate public access to this document and additional
information supporting this action, EPA has established a docket for
this action, identified by docket identification (ID) number EPA-HQ-
OPP-2013-0049. Please note that this docket provides access to related
information, but cannot be used for requesting a hearing. Please see
Unit VI. for instructions on submitting a request for a hearing.
The docket is available at http://www.regulations.gov and at the
OPP Docket in the Environmental Protection Agency Docket Center (EPA/
DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington,
DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPP Docket is (703) 305-5805. Please review the visitor
instructions and additional information about the docket that is
available at http://www.epa.gov/dockets.
II. Legal Authority
With minor exceptions not at issue here, as provided in FIFRA
section 3(a), a pesticide product may not be lawfully sold or
distributed in the United States unless and until the product is
registered by EPA. 7 U.S.C. 136a(a). A pesticide registration is a
license allowing a pesticide product to be sold, distributed, and used
for specified uses in accordance with use instructions, precautions,
and other terms and conditions established by EPA when it grants the
registration.
As a general matter, in order to obtain or maintain a registration
for a pesticide under FIFRA, an applicant or registrant must
demonstrate that the pesticide satisfies the statutory standard for
registration, section 3(c)(5) of FIFRA. 7 U.S.C. 136a(c)(5). That
standard requires, among other things, that the pesticide performs its
intended function without causing ``unreasonable adverse effects on the
environment.'' The term ``unreasonable adverse effects on the
environment'' is defined under FIFRA section 2(bb) as ``any
unreasonable risk to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
any pesticide.'' 7 U.S.C. 136(bb). This standard requires a finding
that the risks associated with the use of a pesticide are justified by
the benefits of such use, when the pesticide is used in compliance with
the terms and conditions of registration or in accordance with commonly
recognized practices. See Defenders of Wildlife v. Administrator, EPA,
882 F.2d 1294, 1298-99 (8th Cir. 1989) (describing FIFRA's required
balancing of risks and benefits). The burden of demonstrating that a
pesticide product satisfies the statutory criteria for registration is
at all times on the proponents of the initial or continued
registration, and continues as long as the registration is in effect.
40 CFR 164.80(b). See also, Industrial Union Dept. v. American
Petroleum Institute, 448 U.S. 607, 653 n.61 (1980); Stearns Electric
Paste v. EPA 461 F.2d 293 (7th Cir. 1972); Environmental Defense Fund
v. EPA, 510 F.2d 1292, 1297 (D.C. Cir. 1975)).
Under FIFRA section 6(b), the Agency may issue a Notice of Intent
to Cancel the registration of a pesticide product whenever it appears
either that:
1. A pesticide or its labeling or other material required to be
submitted does not comply with FIFRA, or
2. When used in accordance with widespread and commonly recognized
practice, the pesticide generally causes unreasonable adverse effects
on the environment. 7 U.S.C. 136d (b).
If a hearing is requested by an adversely affected person, the
final order concerning cancellation of the product is not issued until
after an administrative hearing.
In the cancellation hearing, the Agency has the burden of going
forward to present an affirmative case for cancellation. 40 CFR
164.80(a). However, the ultimate burden of proof is on the proponent of
the registration. 40 CFR 164.80(b); Industrial Union Dept., 448 U.S. at
653 n. 61; Stearns Electric Paste v. EPA 461 F.2d 293, (7th Cir. 1972).
Once the Agency makes its prima facie case that the risks of the
product's continued use fail to meet the FIFRA standard for
registration, the responsibility to demonstrate that the product meets
the FIFRA standard is upon the proponents of continued registration. 40
CFR 164.80(b); Dow v Ruckelshaus, 477 F.2d 1317, 1324 (8th Cir. 1973).
FIFRA Section 3(c)(6) provides that where EPA determines that an
application for registration does not meet the registration criteria of
section 3(c)(5) for registration, the Agency must publish a notice of
denial and the reasons therefore. Section 3(c)(6) further provides that
upon such notification of the denial, the applicant for registration,
or other interested person with the concurrence of the applicant, shall
have
[[Page 8125]]
the same remedies as provided for in section 6.
III. Basis for Issuance of Notice of Intent To Cancel
EPA has determined that the rodenticide registrations listed in
Table 1 should be cancelled because they cause unreasonable adverse
effects on the environment. EPA has further determined that the
applications for registration listed in Table 2 should be denied
because they do not meet the standard for registration under FIFRA. The
Agency's rationale for cancellation and denial is set forth more fully
in the document ``Statement of Reasons and Factual Basis for Notice of
Intent to Cancel and Notice of Denial of Certain Rodenticide Bait
Product Registrations and Applications'' dated January 29, 2013. That
document can be found in docket EPA-HQ-OPP-2013-0049 at
www.regulations.gov. While interested parties should consult that
document for a more detailed rationale of the bases for cancellation
and denial, a short summary of the rationale follows.
The purpose of this action is to protect children, pets, and non-
target wildlife from unnecessary, unreasonable exposures to certain
consumer-use rodenticides. EPA has determined that all consumer-use
rodenticide bait products must be used in, and sold with, protective
bait stations reasonably anticipated not to release the rodenticide
bait; and has further determined that consumer-use rodenticides must
not contain second-generation anti-coagulants as active ingredients.
The products subject to this Notice all fail to meet at least one of
these criteria, and many fail to meet both.
The rodenticides subject to this Notice are designed to kill
commensal mice and rats. As mammalian poisons, they are also highly
toxic to other mammals and birds. EPA has been concerned about the
risks of consumer-use rodenticides to children, pets, and non-target
wildlife for many years. This action is an important step in the
Agency's continuing efforts to mitigate unnecessary risks associated
with rodenticides, while still assuring that people have multiple
effective tools for controlling mice and rats in homes.
A. Bait Stations
For many years, EPA has required rodenticide products used to
control commensal mice and rats in and around homes to have label
language requiring that the products must be applied in tamper-
resistant bait stations if children, pets, domestic animals, or non-
target wildlife may be exposed to the product. Unfortunately, that
requirement has not proved effective in preventing exposures to
children, pets, and wildlife. Separate tamper-resistant bait stations
are rarely found in the stores that sell the products subject to this
Notice, and thousands of children each year are exposed to rodenticides
in the home. Each exposure incident has the potential to cause adverse
effects owing to the amount of active ingredient in a single placement
of any of the products subject to this Notice. While it is fortunate
that children rarely have serious health consequences from exposures to
rodenticides used in and around homes, one percent of exposed children
(an average of 128 per year from 1999-2005) were reported to have
experienced symptoms from the exposure. While EPA is unaware of any
fatal or untreatable incidents involving children, pets are not so
fortunate, and on average more than 100 pet deaths are reported each
year from exposure to rodenticides. And even though children do not
routinely suffer significant adverse health consequences, EPA does not
believe the great bulk of children's exposures to rodenticides are
risk-free or should be taken lightly. To the contrary, the incidence of
young children being exposed to rodenticides in the home is unnecessary
and poses real risks that should no longer be tolerated.
The risks to young children posed by rodenticide exposure are
clearly worthy of regulatory action when compared to other risks
Congress has directed EPA to address. In 1996, Congress unanimously
adopted the Food Quality Protection Act (FQPA), amending both FIFRA and
the Federal Food, Drug, and Cosmetic Act (FFDCA) to assure that
children receive special protection from pesticide residues in food,
and that such residues not be allowed in food unless EPA can find a
reasonable certainty of no harm from exposure to those residues. Under
this risk-only standard, no level of economic benefits can justify
pesticide residues in food that do not meet the reasonable certainty of
no harm standard.
The exposures children can get from eating small amounts of
rodenticide bait well exceed the safety standard promulgated in the
FQPA. EPA fully appreciates that rodenticides are governed by the FIFRA
risk-benefit standard rather than the FFDCA reasonable certainty of no
harm standard, and that any hearing on this Notice must consider the
benefits of rodenticide use against the risks of such use.
Nevertheless, the FFDCA criteria for unsafe exposures to pesticides in
food provide a meaningful benchmark. If Congress would not allow these
levels of pesticide exposure in food--no matter how beneficial the
pesticide use might be to agricultural producers--it is reasonable to
infer that children should not suffer the same levels of exposures
through other routes absent important countervailing benefits.
EPA has looked at the benefits of allowing continued use of
consumer-use rodenticide products not in appropriately protective bait
stations reasonably anticipated not to release the rodenticide bait,
and has concluded that the benefits of such products are generally
minimal, and are insufficient to justify the increased risks to
children, pets, and non-target wildlife. It is worth noting at the
outset that existing labels of the products subject to this Notice do
not allow the use of the products in or around homes if children, pets,
or non-target wildlife can get access to the product; in such
situations the labels direct users to apply the product only in tamper-
resistant bait stations. Unfortunately, in the past this label language
has failed to prevent many thousands of unlawful exposures of children,
pets, and non-target wildlife to rodenticides. Now, however, consumer-
use rodenticide products are commercially available with tamper-
resistant bait stations, and in block form that prevents bait from
easily escaping the stations. These bait-station products are effective
for use against commensal rodents; products similar to these have been
widely and successfully used by professional applicators for many
years. The great majority of the use of consumer-use rodenticide
products is targeted against house mice; bait-station products
targeting mice are commercially available at essentially the same price
as the products subject to this Notice. There is simply no reason today
to allow the continued exposure of children, pets, and non-target
wildlife to the rodenticide products subject to this Notice when safer,
effective, and economically comparable products are available. These
unnecessary, and in most cases unlawful, exposures of children, pets,
and non-target wildlife meet the unreasonable risk standard for
cancellation and denial.
While there is some increased cost associated with bait station
products targeting commensal rats, EPA believes that the increased cost
to those consumers who now use unprotected rodenticide baits to control
commensal rats in residences where children and pets are never present
is acceptable under FIFRA taking into account: The small amount of
consumer-use products currently used to target commensal rats; the
availability of a number of pesticidal
[[Page 8126]]
and non-pesticidal alternatives for effectively controlling commensal
rats; the lack of success of existing labels to prevent exposures to
children, pets, and non-target wildlife; the risks associated with
those exposures; and the difficulties in preventing unprotected ``rat''
products sold in the general consumer market from being diverted to the
much more common use against mice. EPA does not believe it appropriate,
in making these cancellation and denial decisions, to consider price
increases for consumers who are currently using products subject to
this Notice inappropriately, in circumstances where children, pets,
and/or non-target wildlife can get access to the placed product.
B. Second-Generation Anti-Coagulants
As noted earlier, all rodenticides are highly toxic to non-target
mammals and birds. The risks associated with ``primary'' exposure
(exposure where non-target wildlife consumes the bait intended for
rodents) to consumer-use rodenticides are similar across the various
rodenticide active ingredients, and can be significantly reduced for
most species by requiring that such rodenticides be placed in tamper-
resistant bait stations. Bait stations will not, however, protect non-
target wildlife from a significant portion of ``secondary'' exposure to
rodenticides; secondary exposures are those where non-target wildlife
gets exposed to rodenticides by preying upon or scavenging poisoned
rodents or non-target wildlife.
EPA has assessed the secondary risks of rodenticides, and has
determined that the class of rodenticides known as second generation
anti-coagulants (SGARs) pose significantly greater risks to predators,
particularly raptors, than do the other active ingredients contained in
consumer-use rodenticide products--bromethalin and first generation
anti-coagulants. SGARs pose greater risks of secondary poisoning
primarily because of their greater toxicity; their persistence in
tissue; and the potential for poisoned rodents to carry ``super-
lethal'' doses (although rodents feeding upon SGARs can consume a
lethal dose in a single night's feeding, the effects are delayed for a
number of days during which time the rodents can continue to consume
more poison, resulting in many times the lethal dose being found in
poisoned rodents). Incident reports provide further support for the
conclusion that consumer-use SGAR products pose significant risks to
non-target mammals and raptors, and that these risks are greater than
those posed by the other rodenticide active ingredients.
The greater risks of secondary poisoning of non-target mammalian
predators and raptors associated with residential consumer use of SGARs
are not supported by commensurate benefits. Other rodenticides
registered and available for residential consumer use can provide
equally effective control of rodents, at similar costs. Non-chemical
control methods will remain available, and the use of rodenticides by
professional applicators (and agricultural users) is unaffected by this
Notice. There are no benefits associated with the residential consumer
use of SGARs that justify the significant risks those products pose to
non-target wildlife from secondary-poisoning.
IV. Status of Products That Become Cancelled
A. Timing of Cancellation or Denial of Registration
The cancellation or denial of registration for the specific
products identified in Table 1 of Unit I.A. of this document will be
final and effective on March 7, 2013 unless a valid hearing request is
received regarding that specific rodenticide product.
In the event a hearing is held concerning a particular product, the
cancellation or denial 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).
B. Existing Stocks Issues
Existing stocks of cancelled pesticides are those products that
were ``released for shipment'' under FIFRA before the effective date of
cancellation. This provision addresses two issues: Whether questions
concerning the treatment of existing stocks can be raised at any
cancellation hearing; and how the Agency intends to treat existing
stocks when and if products are cancelled pursuant to this Notice.
1. Whether questions concerning the treatment of existing stocks
can be raised at the hearing. It is settled law that existing stocks
issues are not required to be a part of a cancellation proceeding, and
that the treatment of existing stocks issues is only included as an
issue in a cancellation proceeding when the Notice giving rise to the
right to a hearing voluntarily identifies and includes existing stocks
as an issue for examination. In the Matter of Cedar Chemical Co., et
al., 2 E.A.D. 584, nn. 7,9, 1988 WL 525242 (June 9, 1988) (Decision of
the Administrator). The Administrator's decision in Cedar Chemical on
whether existing stocks had to be included as an issue in the hearing
was affirmed by the United States Court of Appeals for the Ninth
Circuit in Northwest Food Processors Association v. Reilly, 886 F. 2d
1075, 1078 (9th Cir. 1989). In the case of this rodenticide
cancellation Notice, EPA has determined not to include existing stocks
as an issue in this hearing. Instead, the only issues for hearing under
this Notice are whether the subject products should be cancelled, or
the applications should be denied.
2. Treatment of existing stocks in the event of cancellation. FIFRA
section 6(a)(1) allows the Agency to permit the continued sale and use
of existing stocks of pesticides whose use has been cancelled, to the
extent 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). The
Agency does not believe that it would be appropriate under FIFRA to
allow any further sale or distribution by any person of the products
identified in this Notice if this Notice results in the cancellation of
such products, and it does not intend to allow any such sale or
distribution if this Notice results in the cancellation of such
products. First and most importantly, the continued sale and
distribution of products cancelled in a proceeding pursuant to this
Notice would continue to cause unreasonable adverse effects on health
and the environment. Second, the regulated community has been on notice
since May 28, 2008 that the Agency intended that the sale and
distribution of these products by registrants cease by June 4, 2011.
During that period, most registrants have amended existing rodenticide
products, or registered new rodenticide products, that conform to EPA's
May 28, 2008 regulatory decision and consequently pose significantly
less risk to health and the environment, and such rodenticide products
are widely available. EPA does not believe it to be consistent with the
purposes of FIFRA to continue to put registrants who timely complied
with the Agency's 2008 decision, and brought safer products to the
market, at a competitive disadvantage relative to registrants who
declined to improve their products. Accordingly, EPA has determined
that the continued sale and distribution of existing stocks of
pesticide products cancelled pursuant to this Notice should
[[Page 8127]]
not be permitted, except that EPA intends to allow the limited shipment
of existing stocks for the sole purposes of lawful export, proper
disposal, or return to the person from whom the holder of the existing
stock purchased the product.
V. Mandated FIFRA Reviews
When EPA intends to issue a Notice of Intent to Cancel, it must
furnish a draft of that Notice and an analysis of the impact of the
proposed action on the agricultural economy to the Secretary of the
Department of Agriculture (USDA) for comment at least 60 days prior to
issuing the Notice (FIFRA section 6(b), 7 U.S.C. 136d(b)). When a
public health use is involved, section 6(b) directs EPA to solicit
information from the Department of Health and Human Services (HHS) on
the impact of the cancellation on public health control efforts. In
addition, the Agency must within the same time period submit the
proposed cancellation action to the FIFRA Scientific Advisory Panel
(SAP) for comment concerning the impact of the proposed action on
health and the environment (FIFRA section 25(d), 7 U.S.C. 136w(d)).
In the event that written comments are received from the USDA, HHS
or the SAP within 30 days of such referral, the Agency must publish
those comments and the Agency's response to the comments.
EPA provided the draft Notice of Intent to Cancel and Notice of
Denial of Registration for Certain Rodenticide Bait Products and
documents supporting that Notice to the SAP on November 3, 2011, and to
USDA and HHS on November 17, 2011. EPA convened a meeting of the SAP on
November 28 through December 1, 2011, to review science issues related
to the proposed cancellations. EPA received the SAP's comments on
December 29, 2011; EPA received minutes from the SAP meeting (SAP
Minutes No. 2011-06: A Set of Scientific Issues Being Considered by the
Environmental Protection Agency Regarding: Scientific Conclusions
Supporting EPA's FIFRA Section 6(b) Notice of Intent to Cancel Twenty
Homeowner Rodenticide Bait Products) on January 4, 2012. These
documents are available in docket EPA-HQ-OPP-2011-0718 at
www.regulations.gov.
USDA advised EPA on April 11, 2012 that it had no comments on the
proposed cancellation. On April 20, 2012, the Centers for Disease
Control and Prevention (CDC) of the Public Health Service submitted
comments on behalf of HHS stating they are supportive of requiring bait
stations for products used in buildings and of requirements that end
residential consumer use of second generation anticoagulants. On April
20, 2012, EPA posted the letters from USDA and CDC in docket EPA-HQ-
OPP-2006-0955 at www.regulations.gov.
The letters from USDA and CDC require no response from EPA. The
Agency has prepared a response to the comments from the SAP; that
response, dated January 29, 2013, can be found in docket EPA-HQ-OPP-
2013-0049 at www.regulations.gov.
VI. 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 or denial of registration as
described in this Notice may request a hearing.
2. When must a hearing be requested? A request for a hearing by a
registrant or applicant for registration must be submitted in writing
within 30 days after the date of receipt of the Notice of Intent to
Cancel, or within 30 days after publication of this announcement in the
Federal Register, whichever occurs later. A request for a hearing by
any other person adversely affected by the Agency's proposed action
must be submitted within 30 days of the date of publication of this
Notice in the Federal Register. See the DATES section of this document.
3. How must a hearing be requested? All persons who request a
hearing must comply with the Agency's Rules of Practice Governing
Hearings, 40 CFR Part 164. Among other requirements, these rules
include the following:
i. 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);
ii. 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 Notice and/or the related
``Statement of Reasons and Factual Basis for Notice of Intent to Cancel
and Notice of Denial of Certain Rodenticide Bait Product Registrations
and Applications'' dated January 29, 2013, in docket Id number EPA-HQ-
OPP-2013-0049, and state the factual basis for each such objection, 40
CFR 164.22(a); and
iii. 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 or denial of registration for the
product in question by operation of law.
iv. 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, 1200 Pennsylvania Avenue NW., Mail Code 1900L, Washington,
DC 20460-2001.
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,
1099 14th Street NW., Franklin Court Building, Suite 350, Washington,
DC 20005.
B. The Hearing
If a hearing concerning any product affected by this Notice is
requested in a timely and effective manner, the hearing will be
governed by the Agency's Rules of Practice Governing Hearings, 40 CFR
Part 164, and the procedures set forth in Unit VI. Any interested
person may participate in the hearing, in accordance with 40 CFR
164.31.
Documents and transcripts will be available in the public docket
for the hearing, located at U.S. Environmental Protection Agency,
Office of Administrative Law Judges, Franklin Court, Suite 350, 1099
14th St. NW., Washington, DC 20005. The references can be viewed from
8:30 a.m. to 4:30 p.m., Monday through Friday, except Federal holidays.
C. Separation of Functions
EPA's Rules of Practice forbid anyone who may take part in deciding
this case, at any stage of the proceeding, from discussing the merits
of the proceeding ex parte with any party or with any person who has
been connected with the preparation or presentation of the proceeding
as an advocate or in any investigative or expert capacity, or with any
of their representatives (40 CFR 164.7). To facilitate compliance with
the
[[Page 8128]]
ex parte rule, the following are designated as adjudicatory personnel
for purposes of this proceeding: The Administrative Law Judges and
their staff, the Environmental Appeals Board and its staff, the
Administrator and certain members of her immediate office, and the
General Counsel and certain members of his immediate office. None of
the persons identified as adjudicatory personnel may discuss the merits
of the proceeding with any person with an interest in the proceeding,
or representative of such person, except in compliance with 40 CFR
164.7.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: January 29, 2013.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2013-02500 Filed 2-4-13; 8:45 am]
BILLING CODE 6560-50-P