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38259

Rules and Regulations Federal Register


Vol. 71, No. 129

Thursday, July 6, 2006

This section of the FEDERAL REGISTER other things, the importation of ending July 5, 2005. We received two
contains regulatory documents having general carcasses, parts or products of carcasses, comments in that time; one from the
applicability and legal effect, most of which and eggs (other than hatching eggs) of European Commission (EC) and the
are keyed to and codified in the Code of poultry, game birds, or other birds from other from a group of private
Federal Regulations, which is published under regions where exotic Newcastle disease individuals. Both commenters raised
50 titles pursuant to 44 U.S.C. 1510.
(END) is considered to exist. END is concerns regarding APHIS procedures
The Code of Federal Regulations is sold by considered to exist in all regions not for recognizing the disease status of
the Superintendent of Documents. Prices of listed in § 94.6(a)(2). other countries. These concerns are
new books are listed in the first FEDERAL In an interim rule effective July 16, discussed below.
REGISTER issue of each week. 2002, and published in the Federal Issue: Both the EC and the private
Register on September 20, 2002 (67 FR citizens expressed concern about the
59136–59137, Docket No. 02–089–1), we procedures used by APHIS in first
DEPARTMENT OF AGRICULTURE amended the regulations by removing removing and then reinstating Denmark
Denmark from the list of regions from the list of END free regions. The
Animal and Plant Health Inspection considered to be free of END. The private citizens expressed concern that
Service interim rule was necessary because END there was a 2-month difference between
had been confirmed in Denmark. The the detection of the outbreak and the
9 CFR Part 94 effect of the interim rule was to restrict publication of the interim rule in 2002.
[Docket No. 02–089–3] the importation of carcasses, parts or The EC stated that the United States has
products of carcasses, and eggs (other been unacceptably slow in returning
Add Denmark to the List of Regions than hatching eggs) of poultry, game Denmark to the list of END free regions,
Free of Exotic Newcastle Disease birds, and other birds into the United as the EC considered Denmark to be
States from Denmark. END free as of March 1, 2003.
AGENCY: Animal and Plant Health Although we removed Denmark from Furthermore, the EC stated that the
Inspection Service, USDA. the list of regions considered free of present APHIS rulemaking process is
ACTION: Final rule. END, we recognized that Denmark not in compliance with the OIE
immediately responded to the outbreak Terrestrial Animal Health Code Article
SUMMARY: We are amending the
of END by imposing restrictions on the 2.7.13.2 or with agreements between the
regulations to add Denmark to the list of
movement of poultry and poultry United States and the EC regarding
regions considered free of exotic
products within its borders and regionalization of the European Union
Newcastle disease. This final rule
initiating measures to eradicate the (EU).
follows an interim rule that removed
disease. We stated that we intended to Response: We are required to adhere
Denmark from that list due to an
reassess the situation in the region at a to certain procedures in establishing or
outbreak of exotic Newcastle disease in
future date, and that as part of that amending regulations, including actions
that region. A recent risk analysis
reassessment process, we would regarding the animal health status of a
indicated that Denmark now meets our
consider all comments received region. Our policy in situations in
requirements for recognition as a region
regarding the interim rule. We received which a region experiences a disease
free of exotic Newcastle disease. This
no comments on the interim rule. outbreak is to issue an immediate
rule relieves certain restrictions on the
Additionally, we stated that our administrative ban on imports from an
importation of carcasses, parts or
future assessment would enable us to affected region and then follow with the
products of carcasses, and eggs (other
determine whether it would be rulemaking process required by the
than hatching eggs) of poultry, game
necessary to continue to restrict the Administrative Procedure Act; the
birds, and other birds from Denmark
importation of poultry and poultry interim rule may be given an effective
into the United States.
products from Denmark, whether we date earlier than the date of the rule’s
DATES: Effective Date: July 6, 2006. could restore Denmark to the list of signature or publication to affirm our
FOR FURTHER INFORMATION CONTACT: Dr. regions in which END is not known to authority for issuing previous
Chip Wells, Senior Staff Veterinarian, exist, or whether we could restore administrative orders. In this case, a
Regionalization Evaluation Services— portions of Denmark as free of END. port alert instructing APHIS port offices
Import, National Center for Import and On May 5, 2005, we published in the to refuse any shipment of poultry or
Export, VS, APHIS, 4700 River Road Federal Register (70 FR 23809–23810, poultry products from Denmark that did
Unit 38, Riverdale, MD 20737–1231; Docket No. 02–089–2) a notice not meet the requirements for poultry or
(301) 734–4356. announcing the availability of a risk poultry products from regions affected
SUPPLEMENTARY INFORMATION: analysis we had prepared concerning with END was issued on July 31, 2002.
the END status of Denmark and the This action applied retroactively to
Background related disease risks associated with shipments received on or after July 16,
The regulations in 9 CFR part 94 importing carcasses, parts or products of 2002, the day suspicion of the outbreak
(referred to below as the regulations) carcasses, and eggs (other than hatching was initially reported. The interim rule
govern the importation of specified eggs) of poultry, game birds, and other removing Denmark from the list of END-
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animals and animal products into the birds from Denmark into the United free regions was also made effective
United States in order to prevent the States. retroactively to July 16, 2002.
introduction of various animal diseases. We solicited public comments We received the request to return
The regulations in § 94.6 govern, among concerning the evaluation for 60 days Denmark to the list of END-free regions

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38260 Federal Register / Vol. 71, No. 129 / Thursday, July 6, 2006 / Rules and Regulations

in April 2004. Once the request was Rulemaking,’’ which describes the We are amending the regulations by
received, we responded by initiating the process APHIS follows when adding Denmark to the list of regions
risk analysis. Some aspects of the conducting foreign animal disease status considered free of END. We are taking
information submitted required evaluation, regionalization, risk this action because Denmark has met
clarification, and during the review analysis, and related rulemaking, is our requirements for recognition as a
period (after receipt of the original available to the public through that Web region free of END. This action relieves
submission) Denmark made a significant site by clicking on the document title at restrictions on the importation of
change to its END control policy with the bottom of the page. carcasses, parts or products of carcasses,
the implementation of a mandatory Issue: The private citizens stated that and eggs (other than hatching eggs) of
vaccination policy. We considered it APHIS should have made a site visit to poultry, game birds, or other birds from
necessary to acquire additional Denmark to evaluate the END status of Denmark which are no longer
information to evaluate the effect of this the region. warranted.
change. We exchanged correspondence Response: We disagree. As we Denmark produced 412 million
on several occasions with the EC and explained in the risk analysis, prior to pounds (equivalent to about 1.2 percent
received the requested information on the outbreaks in 2002, the United States of U.S. production) and exported 250
November 26, 2004. On May 5, 2005, we had a long history of trade of poultry million pounds (equivalent to about 0.7
published the notice of availability cited and poultry products with Denmark. percent of U.S. production) of poultry
above and invited public review and Denmark, as a country and as a Member meat in 2005. The United States is the
comment of the risk analysis cited above State of the EU, has previously been world’s largest producer and exporter of
until July 5, 2005. While we were evaluated for END and other animal poultry meat. In 2005, U.S. poultry meat
considering the public comments diseases. We have maintained contact production totaled 35.3 billion pounds,
received, Denmark experienced a single with Danish veterinary authorities who of which 84.3 percent was broiler meat,
new END outbreak, which was reported keep us advised of animal disease 12.4 percent was turkey meat, and 3.3
on October 21, 2005. We have conditions in their country. percent was other chicken meat. During
considered the impact of this situation Furthermore, the EU system for animal the same period, the United States
on the previously published risk disease control for classical swine fever exported 6 billion pounds of poultry
analysis, and this final rule reflects that has been extensively evaluated by meat valued at $2.5 billion.
consideration. APHIS and provides additional In theory, if poultry available for
Issue: The group of private citizens confidence in the EU veterinary consumption in U.S. markets increases,
stated that the focus on live poultry in infrastructure. The document referenced poultry prices would decrease, U.S.
the risk analysis was misplaced, and the above, ‘‘Process for Foreign Animal consumers of poultry would benefit,
focus should have been on the risk of Disease Status Evaluations, and U.S. producers would be harmed.
introducing END through poultry Regionalization, Risk Analysis, and U.S. freight forwarding, trucking, and
products. Rulemaking,’’ describes circumstances transport firms that transport poultry
Response: As we explained in the when a site visit may not be deemed from U.S. ports could benefit from
exposure assessment portion of the risk necessary for an evaluation. increased economic activity. However
analysis, it was necessary for us to focus Accordingly, we concluded that a these impacts are expected to be
on exposure pathways involving live document review was sufficient for the negligible because the amounts of
poultry because historically END needs of the risk analysis. poultry products produced in Denmark
introductions into the United States As noted previously, while we were are a small fraction of U.S. production.
have been associated with the reviewing these comments and Denmark has a well established world-
importation of live birds. Live birds preparing its response, Denmark wide market and is unlikely to divert its
were, therefore, considered a higher risk experienced a new outbreak of END in exports from these markets to the more
pathway than the importation of poultry a single flock. We monitored the distant U.S. market.
products. Since the risk from live birds situation and evaluated the information The Small Business Administration
was low, the risk from poultry products provided by Danish veterinary (SBA) has established guidelines for
should also be low. authorities and have concluded that the determining which types of firms are to
Issue: The group of private citizens outbreak was limited to a single flock, be considered small under the
asked for clarification of the process which was depopulated, and that the Regulatory Flexibility Act. This rule
APHIS uses in adding and removing outbreak has successfully been would mainly affect poultry farms
countries on the list in § 94.6(a)(2) of the contained and eradicated. Denmark has (North American Industry Classification
regulations. They also asked for more lifted all protective measures as of System [NAICS] code 112320).
information on the procedures that December 4, 2005. We consider this According to the 2002 Census of
APHIS uses to rank risk. isolated outbreak to be consistent with Agriculture, there are 83,381 poultry
Response: The regulatory process we the conclusions stated in the previously farms that produce broilers and other
use to recognize the animal health status released risk analysis. meat type chickens. These facilities are
of a region or to reestablish a region’s Therefore, for the reasons given in considered to be small if their annual
disease-free status after an outbreak is this document and based on our risk receipts are not more than $750,000.
detailed in 9 CFR part 92. General analysis, we are amending § 94.6 in this Over 93 percent of these operations are
information on determining animal final rule to add Denmark to the list of considered to be small. Any effects of
disease status and risk assessment can regions considered free of END. the rule for U.S. producers will be
be found online at the Veterinary negligible. Other entities that could
Services Regionalization Evaluation Executive Order 12866 and Regulatory theoretically be affected include U.S.
Services Staff Web site, http:// Flexibility Act trucking firms (NAICS code 4842302),
www.aphis.usda.gov/vs/ncie/reg- This rule has been reviewed under U.S. freight forwarders (NAICS code
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request.html. The informational Executive Order 12866. For this action, 4885101), and deep sea freight transport
document ‘‘Process for Foreign Animal the Office of Management and Budget companies (NAICS code 483111). The
Disease Status Evaluations, has waived its review under Executive SBA classifies trucking firms as small if
Regionalization, Risk Analysis, and Order 12866. their annual receipts are less than $21.5

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Federal Register / Vol. 71, No. 129 / Thursday, July 6, 2006 / Rules and Regulations 38261

million; freight forwarding firms are Done in Washington, DC, this 29th day of data and information submitted to
small if their annual receipts are less June 2006. support approval of this application
than $6 million, and deep sea freight Kevin Shea, may be seen in the Division of Dockets
transport firms are small if they have Acting Administrator, Animal and Plant Management (HFA–305), Food and Drug
not more than 500 workers. According Health Inspection Service. Administration, 5630 Fishers Lane, rm.
to the 2002 Economic Census, there [FR Doc. E6–10555 Filed 7–5–06; 8:45 am] 1061, Rockville, MD 20852, between 9
were 9,177 trucking firms, 5,840 freight BILLING CODE 3410–34–P a.m. and 4 p.m., Monday through
forwarders, and 383 deep sea freight Friday.
transport companies. Over 99 percent of The agency has determined under 21
trucking firms, 90 percent freight DEPARTMENT OF HEALTH AND CFR 25.33(a)(1) that this action is of a
forwarders, and 70 percent of deep sea HUMAN SERVICES type that does not individually or
freight transport firms are considered to cumulatively have a significant effect on
be small. Although the majority of these Food and Drug Administration the human environment. Therefore,
establishments are small entities, the neither an environmental assessment
effect of this rule will be negligible. 21 CFR Part 524 nor an environmental impact statement
Under these circumstances, the is required.
Administrator of the Animal and Plant Ophthalmic and Topical Dosage Form This rule does not meet the definition
Health Inspection Service has New Animal Drugs; Gentamicin of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
Sulfate, Betamethasone Valerate, it is a rule of ‘‘particular applicability.’’
determined that this action will not
Clotrimazole Ointment Therefore, it is not subject to the
have a significant economic impact on
congressional review requirements in 5
a substantial number of small entities. AGENCY: Food and Drug Administration, U.S.C. 801–808.
Executive Order 12988 HHS.
List of Subjects in 21 CFR Part 524
ACTION: Final rule.
This final rule has been reviewed Animal drugs.
under Executive Order 12988, Civil SUMMARY: The Food and Drug ■ Therefore, under the Federal Food,
Justice Reform. This rule: (1) Preempts Administration (FDA) is amending the Drug, and Cosmetic Act and under
all State and local laws and regulations animal drug regulations to reflect authority delegated to the Commissioner
that are inconsistent with this rule; (2) approval of an abbreviated new animal of Food and Drugs and redelegated to
has no retroactive effect; and (3) does drug application (ANADA) filed by the Center for Veterinary Medicine, 21
not require administrative proceedings Altana Inc. The ANADA provides for CFR part 524 is amended as follows:
before parties may file suit in court veterinary prescription use of
challenging this rule. gentamicin sulfate, betamethasone PART 524—OPHTHALMIC AND
Paperwork Reduction Act valerate, clotrimazole ointment for the TOPICAL DOSAGE FORM NEW
treatment of canine otitis externa. ANIMAL DRUGS
This rule contains no information DATES: This rule is effective July 6,
collection or recordkeeping ■ 1. The authority citation for 21 CFR
2006.
requirements under the Paperwork part 524 continues to read as follows:
Reduction Act of 1995 (44 U.S.C. 3501 FOR FURTHER INFORMATION CONTACT: Authority: 21 U.S.C. 360b.
et seq.). Daniel A. Benz, Center for Veterinary
■ 2. In § 524.1044g, add paragraph (b)(4)
Medicine (HFV–104), Food and Drug
List of Subjects in 9 CFR Part 94 to read as follows:
Administration, 7500 Standish Pl.,
Animal diseases, Imports, Livestock, Rockville, MD 20855, 301–827–0223, e- § 524.1044g Gentamicin sulfate,
Meat and meat products, Milk, Poultry mail: daniel.benz@fda.hhs.gov. betamethasone valerate, clotrimazole
and poultry products, Reporting and SUPPLEMENTARY INFORMATION: Altana ointment.
recordkeeping requirements. Inc., 60 Baylis Rd., Melville, NY 11747, * * * * *
filed ANADA 200–283 that provides for (b) * * *
■ Accordingly, we are amending 9 CFR (4) No. 025463 for use of 7.5- or 15-
part 94 as follows: veterinary prescription use of VETRO–
MAX (gentamicin sulfate, USP; g tubes, or 215-g bottles.
PART 94—RINDERPEST, FOOT-AND- betamethasone valerate, USP; and * * * * *
MOUTH DISEASE, FOWL PEST (FOWL clotrimazole, USP, ointment) for the Dated: June 22, 2006.
PLAGUE), EXOTIC NEWCASTLE treatment of canine otitis externa Stephen F. Sundlof,
DISEASE, AFRICAN SWINE FEVER, associated with yeast (Malassezia Director, Center for Veterinary Medicine.
CLASSICAL SWINE FEVER, AND pachydermatis, formerly Pityrosporum [FR Doc. E6–10496 Filed 7–5–06; 8:45 am]
BOVINE SPONGIFORM canis) and/or bacteria susceptible to
BILLING CODE 4160–01–S
ENCEPHALOPATHY: PROHIBITED gentamicin. Altana Inc.’s VETRO–MAX
AND RESTRICTED IMPORTATIONS Otic Ointment is approved as a generic
copy of Schering-Plough Animal Health
■ 1. The authority citation for part 94 Corp.’s OTOMAX Ointment approved DEPARTMENT OF THE TREASURY
continues to read as follows: under NADA 140–896. The ANADA is Internal Revenue Service
Authority: 7 U.S.C. 450, 7701–7772, 7781– approved as of June 1, 2006, and the
7786, and 8301–8317; 21 U.S.C. 136 and regulations are amended in 21 CFR 26 CFR Part 1
136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 524.1044g to reflect the approval. The
371.4. basis of approval is discussed in the Corporate Distributions and
freedom of information summary.
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§ 94.6 [Amended] Adjustments


In accordance with the freedom of
■ 2. In § 94.6, paragraph (a)(2) is information provisions of 21 CFR part CFR Correction
amended by adding the word 20 and 21 CFR 514.11(e)(2)(ii), a In Title 26 of the Code of Federal
‘‘Denmark,’’ before the word ‘‘Fiji.’’ summary of safety and effectiveness Regulations, part 1 (§§ 1.301 to 1.400),

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