Document ID: EPA-HQ-OPP-2013-0049-0011
Agency: epa
Document Type: Notice
Title: Intents To Cancel Registrations and Denials of Applications: Certain Rodenticide Bait Products
Posted Date: 2013-02-05T05:00Z

[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8123-8128]
From the Federal Register Online via the Government Printing 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: anderson.neil@epa.gov.

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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

[[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
             Product               EPA Application No.       Registrant       Active ingredient                         Deficiency
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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