Add Denmark to the List of Regions Free of Exotic Newcastle Disease, 38259-38261 [E6-10555]

Download as PDF 38259 Rules and Regulations Federal Register Vol. 71, No. 129 Thursday, July 6, 2006 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 94 [Docket No. 02–089–3] Add Denmark to the List of Regions Free of Exotic Newcastle Disease Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. AGENCY: SUMMARY: We are amending the regulations to add Denmark to the list of regions considered free of exotic Newcastle disease. This final rule follows an interim rule that removed Denmark from that list due to an outbreak of exotic Newcastle disease in that region. A recent risk analysis indicated that Denmark now meets our requirements for recognition as a region free of exotic Newcastle disease. This rule relieves certain restrictions on the importation of carcasses, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds, and other birds from Denmark into the United States. DATES: Effective Date: July 6, 2006. FOR FURTHER INFORMATION CONTACT: Dr. Chip Wells, Senior Staff Veterinarian, Regionalization Evaluation Services— Import, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737–1231; (301) 734–4356. SUPPLEMENTARY INFORMATION: wwhite on PROD1PC61 with RULES Background The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of specified animals and animal products into the United States in order to prevent the introduction of various animal diseases. The regulations in § 94.6 govern, among VerDate Aug<31>2005 16:26 Jul 05, 2006 Jkt 208001 other things, the importation of carcasses, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds from regions where exotic Newcastle disease (END) is considered to exist. END is considered to exist in all regions not listed in § 94.6(a)(2). In an interim rule effective July 16, 2002, and published in the Federal Register on September 20, 2002 (67 FR 59136–59137, Docket No. 02–089–1), we amended the regulations by removing Denmark from the list of regions considered to be free of END. The interim rule was necessary because END had been confirmed in Denmark. The effect of the interim rule was to restrict the importation of carcasses, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds, and other birds into the United States from Denmark. Although we removed Denmark from the list of regions considered free of END, we recognized that Denmark immediately responded to the outbreak of END by imposing restrictions on the movement of poultry and poultry products within its borders and initiating measures to eradicate the disease. We stated that we intended to reassess the situation in the region at a future date, and that as part of that reassessment process, we would consider all comments received regarding the interim rule. We received no comments on the interim rule. Additionally, we stated that our future assessment would enable us to determine whether it would be necessary to continue to restrict the importation of poultry and poultry products from Denmark, whether we could restore Denmark to the list of regions in which END is not known to exist, or whether we could restore portions of Denmark as free of END. On May 5, 2005, we published in the Federal Register (70 FR 23809–23810, Docket No. 02–089–2) a notice announcing the availability of a risk analysis we had prepared concerning the END status of Denmark and the related disease risks associated with importing carcasses, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds, and other birds from Denmark into the United States. We solicited public comments concerning the evaluation for 60 days PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 ending July 5, 2005. We received two comments in that time; one from the European Commission (EC) and the other from a group of private individuals. Both commenters raised concerns regarding APHIS procedures for recognizing the disease status of other countries. These concerns are discussed below. Issue: Both the EC and the private citizens expressed concern about the procedures used by APHIS in first removing and then reinstating Denmark from the list of END free regions. The private citizens expressed concern that there was a 2-month difference between the detection of the outbreak and the publication of the interim rule in 2002. The EC stated that the United States has been unacceptably slow in returning Denmark to the list of END free regions, as the EC considered Denmark to be END free as of March 1, 2003. Furthermore, the EC stated that the present APHIS rulemaking process is not in compliance with the OIE Terrestrial Animal Health Code Article 2.7.13.2 or with agreements between the United States and the EC regarding regionalization of the European Union (EU). Response: We are required to adhere to certain procedures in establishing or amending regulations, including actions regarding the animal health status of a region. Our policy in situations in which a region experiences a disease outbreak is to issue an immediate administrative ban on imports from an affected region and then follow with the rulemaking process required by the Administrative Procedure Act; the interim rule may be given an effective date earlier than the date of the rule’s signature or publication to affirm our authority for issuing previous administrative orders. In this case, a port alert instructing APHIS port offices to refuse any shipment of poultry or poultry products from Denmark that did not meet the requirements for poultry or poultry products from regions affected with END was issued on July 31, 2002. This action applied retroactively to shipments received on or after July 16, 2002, the day suspicion of the outbreak was initially reported. The interim rule removing Denmark from the list of ENDfree regions was also made effective retroactively to July 16, 2002. We received the request to return Denmark to the list of END-free regions E:\FR\FM\06JYR1.SGM 06JYR1 wwhite on PROD1PC61 with RULES 38260 Federal Register / Vol. 71, No. 129 / Thursday, July 6, 2006 / Rules and Regulations in April 2004. Once the request was received, we responded by initiating the risk analysis. Some aspects of the information submitted required clarification, and during the review period (after receipt of the original submission) Denmark made a significant change to its END control policy with the implementation of a mandatory vaccination policy. We considered it necessary to acquire additional information to evaluate the effect of this change. We exchanged correspondence on several occasions with the EC and received the requested information on November 26, 2004. On May 5, 2005, we published the notice of availability cited above and invited public review and comment of the risk analysis cited above until July 5, 2005. While we were considering the public comments received, Denmark experienced a single new END outbreak, which was reported on October 21, 2005. We have considered the impact of this situation on the previously published risk analysis, and this final rule reflects that consideration. Issue: The group of private citizens stated that the focus on live poultry in the risk analysis was misplaced, and the focus should have been on the risk of introducing END through poultry products. Response: As we explained in the exposure assessment portion of the risk analysis, it was necessary for us to focus on exposure pathways involving live poultry because historically END introductions into the United States have been associated with the importation of live birds. Live birds were, therefore, considered a higher risk pathway than the importation of poultry products. Since the risk from live birds was low, the risk from poultry products should also be low. Issue: The group of private citizens asked for clarification of the process APHIS uses in adding and removing countries on the list in § 94.6(a)(2) of the regulations. They also asked for more information on the procedures that APHIS uses to rank risk. Response: The regulatory process we use to recognize the animal health status of a region or to reestablish a region’s disease-free status after an outbreak is detailed in 9 CFR part 92. General information on determining animal disease status and risk assessment can be found online at the Veterinary Services Regionalization Evaluation Services Staff Web site, https:// www.aphis.usda.gov/vs/ncie/regrequest.html. The informational document ‘‘Process for Foreign Animal Disease Status Evaluations, Regionalization, Risk Analysis, and VerDate Aug<31>2005 16:26 Jul 05, 2006 Jkt 208001 Rulemaking,’’ which describes the process APHIS follows when conducting foreign animal disease status evaluation, regionalization, risk analysis, and related rulemaking, is available to the public through that Web site by clicking on the document title at the bottom of the page. Issue: The private citizens stated that APHIS should have made a site visit to Denmark to evaluate the END status of the region. Response: We disagree. As we explained in the risk analysis, prior to the outbreaks in 2002, the United States had a long history of trade of poultry and poultry products with Denmark. Denmark, as a country and as a Member State of the EU, has previously been evaluated for END and other animal diseases. We have maintained contact with Danish veterinary authorities who keep us advised of animal disease conditions in their country. Furthermore, the EU system for animal disease control for classical swine fever has been extensively evaluated by APHIS and provides additional confidence in the EU veterinary infrastructure. The document referenced above, ‘‘Process for Foreign Animal Disease Status Evaluations, Regionalization, Risk Analysis, and Rulemaking,’’ describes circumstances when a site visit may not be deemed necessary for an evaluation. Accordingly, we concluded that a document review was sufficient for the needs of the risk analysis. As noted previously, while we were reviewing these comments and preparing its response, Denmark experienced a new outbreak of END in a single flock. We monitored the situation and evaluated the information provided by Danish veterinary authorities and have concluded that the outbreak was limited to a single flock, which was depopulated, and that the outbreak has successfully been contained and eradicated. Denmark has lifted all protective measures as of December 4, 2005. We consider this isolated outbreak to be consistent with the conclusions stated in the previously released risk analysis. Therefore, for the reasons given in this document and based on our risk analysis, we are amending § 94.6 in this final rule to add Denmark to the list of regions considered free of END. Executive Order 12866 and Regulatory Flexibility Act This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866. PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 We are amending the regulations by adding Denmark to the list of regions considered free of END. We are taking this action because Denmark has met our requirements for recognition as a region free of END. This action relieves restrictions on the importation of carcasses, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds from Denmark which are no longer warranted. Denmark produced 412 million pounds (equivalent to about 1.2 percent of U.S. production) and exported 250 million pounds (equivalent to about 0.7 percent of U.S. production) of poultry meat in 2005. The United States is the world’s largest producer and exporter of poultry meat. In 2005, U.S. poultry meat production totaled 35.3 billion pounds, of which 84.3 percent was broiler meat, 12.4 percent was turkey meat, and 3.3 percent was other chicken meat. During the same period, the United States exported 6 billion pounds of poultry meat valued at $2.5 billion. In theory, if poultry available for consumption in U.S. markets increases, poultry prices would decrease, U.S. consumers of poultry would benefit, and U.S. producers would be harmed. U.S. freight forwarding, trucking, and transport firms that transport poultry from U.S. ports could benefit from increased economic activity. However these impacts are expected to be negligible because the amounts of poultry products produced in Denmark are a small fraction of U.S. production. Denmark has a well established worldwide market and is unlikely to divert its exports from these markets to the more distant U.S. market. The Small Business Administration (SBA) has established guidelines for determining which types of firms are to be considered small under the Regulatory Flexibility Act. This rule would mainly affect poultry farms (North American Industry Classification System [NAICS] code 112320). According to the 2002 Census of Agriculture, there are 83,381 poultry farms that produce broilers and other meat type chickens. These facilities are considered to be small if their annual receipts are not more than $750,000. Over 93 percent of these operations are considered to be small. Any effects of the rule for U.S. producers will be negligible. Other entities that could theoretically be affected include U.S. trucking firms (NAICS code 4842302), U.S. freight forwarders (NAICS code 4885101), and deep sea freight transport companies (NAICS code 483111). The SBA classifies trucking firms as small if their annual receipts are less than $21.5 E:\FR\FM\06JYR1.SGM 06JYR1 Federal Register / Vol. 71, No. 129 / Thursday, July 6, 2006 / Rules and Regulations million; freight forwarding firms are small if their annual receipts are less than $6 million, and deep sea freight transport firms are small if they have not more than 500 workers. According to the 2002 Economic Census, there were 9,177 trucking firms, 5,840 freight forwarders, and 383 deep sea freight transport companies. Over 99 percent of trucking firms, 90 percent freight forwarders, and 70 percent of deep sea freight transport firms are considered to be small. Although the majority of these establishments are small entities, the effect of this rule will be negligible. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. Done in Washington, DC, this 29th day of June 2006. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E6–10555 Filed 7–5–06; 8:45 am] Executive Order 12988 HHS. This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. Paperwork Reduction Act This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). List of Subjects in 9 CFR Part 94 Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements. I Accordingly, we are amending 9 CFR part 94 as follows: PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, FOWL PEST (FOWL PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS 1. The authority citation for part 94 continues to read as follows: I wwhite on PROD1PC61 with RULES Authority: 7 U.S.C. 450, 7701–7772, 7781– 7786, and 8301–8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4. § 94.6 [Amended] 2. In § 94.6, paragraph (a)(2) is amended by adding the word ‘‘Denmark,’’ before the word ‘‘Fiji.’’ I VerDate Aug<31>2005 19:48 Jul 05, 2006 Jkt 208001 BILLING CODE 3410–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment AGENCY: ACTION: Food and Drug Administration, Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Altana Inc. The ANADA provides for veterinary prescription use of gentamicin sulfate, betamethasone valerate, clotrimazole ointment for the treatment of canine otitis externa. DATES: This rule is effective July 6, 2006. data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. List of Subjects in 21 CFR Part 524 Animal drugs. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 524 is amended as follows: PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 524 continues to read as follows: I FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Altana Inc., 60 Baylis Rd., Melville, NY 11747, filed ANADA 200–283 that provides for veterinary prescription use of VETRO– MAX (gentamicin sulfate, USP; betamethasone valerate, USP; and clotrimazole, USP, ointment) for the treatment of canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin. Altana Inc.’s VETRO–MAX Otic Ointment is approved as a generic copy of Schering-Plough Animal Health Corp.’s OTOMAX Ointment approved under NADA 140–896. The ANADA is approved as of June 1, 2006, and the regulations are amended in 21 CFR 524.1044g to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 38261 Authority: 21 U.S.C. 360b. 2. In § 524.1044g, add paragraph (b)(4) to read as follows: I § 524.1044g Gentamicin sulfate, betamethasone valerate, clotrimazole ointment. * * * * * (b) * * * (4) No. 025463 for use of 7.5- or 15g tubes, or 215-g bottles. * * * * * Dated: June 22, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6–10496 Filed 7–5–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 Corporate Distributions and Adjustments CFR Correction In Title 26 of the Code of Federal Regulations, part 1 (§§ 1.301 to 1.400), E:\FR\FM\06JYR1.SGM 06JYR1

Agencies

[Federal Register Volume 71, Number 129 (Thursday, July 6, 2006)]
[Rules and Regulations]
[Pages 38259-38261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10555]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


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

[[Page 38259]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 02-089-3]


Add Denmark to the List of Regions Free of Exotic Newcastle 
Disease

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending the regulations to add Denmark to the list of 
regions considered free of exotic Newcastle disease. This final rule 
follows an interim rule that removed Denmark from that list due to an 
outbreak of exotic Newcastle disease in that region. A recent risk 
analysis indicated that Denmark now meets our requirements for 
recognition as a region free of exotic Newcastle disease. This rule 
relieves certain restrictions on the importation of carcasses, parts or 
products of carcasses, and eggs (other than hatching eggs) of poultry, 
game birds, and other birds from Denmark into the United States.

DATES: Effective Date: July 6, 2006.

FOR FURTHER INFORMATION CONTACT: Dr. Chip Wells, Senior Staff 
Veterinarian, Regionalization Evaluation Services--Import, National 
Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, 
Riverdale, MD 20737-1231; (301) 734-4356.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 94 (referred to below as the 
regulations) govern the importation of specified animals and animal 
products into the United States in order to prevent the introduction of 
various animal diseases. The regulations in Sec.  94.6 govern, among 
other things, the importation of carcasses, parts or products of 
carcasses, and eggs (other than hatching eggs) of poultry, game birds, 
or other birds from regions where exotic Newcastle disease (END) is 
considered to exist. END is considered to exist in all regions not 
listed in Sec.  94.6(a)(2).
    In an interim rule effective July 16, 2002, and published in the 
Federal Register on September 20, 2002 (67 FR 59136-59137, Docket No. 
02-089-1), we amended the regulations by removing Denmark from the list 
of regions considered to be free of END. The interim rule was necessary 
because END had been confirmed in Denmark. The effect of the interim 
rule was to restrict the importation of carcasses, parts or products of 
carcasses, and eggs (other than hatching eggs) of poultry, game birds, 
and other birds into the United States from Denmark.
    Although we removed Denmark from the list of regions considered 
free of END, we recognized that Denmark immediately responded to the 
outbreak of END by imposing restrictions on the movement of poultry and 
poultry products within its borders and initiating measures to 
eradicate the disease. We stated that we intended to reassess the 
situation in the region at a future date, and that as part of that 
reassessment process, we would consider all comments received regarding 
the interim rule. We received no comments on the interim rule.
    Additionally, we stated that our future assessment would enable us 
to determine whether it would be necessary to continue to restrict the 
importation of poultry and poultry products from Denmark, whether we 
could restore Denmark to the list of regions in which END is not known 
to exist, or whether we could restore portions of Denmark as free of 
END.
    On May 5, 2005, we published in the Federal Register (70 FR 23809-
23810, Docket No. 02-089-2) a notice announcing the availability of a 
risk analysis we had prepared concerning the END status of Denmark and 
the related disease risks associated with importing carcasses, parts or 
products of carcasses, and eggs (other than hatching eggs) of poultry, 
game birds, and other birds from Denmark into the United States.
    We solicited public comments concerning the evaluation for 60 days 
ending July 5, 2005. We received two comments in that time; one from 
the European Commission (EC) and the other from a group of private 
individuals. Both commenters raised concerns regarding APHIS procedures 
for recognizing the disease status of other countries. These concerns 
are discussed below.
    Issue: Both the EC and the private citizens expressed concern about 
the procedures used by APHIS in first removing and then reinstating 
Denmark from the list of END free regions. The private citizens 
expressed concern that there was a 2-month difference between the 
detection of the outbreak and the publication of the interim rule in 
2002. The EC stated that the United States has been unacceptably slow 
in returning Denmark to the list of END free regions, as the EC 
considered Denmark to be END free as of March 1, 2003. Furthermore, the 
EC stated that the present APHIS rulemaking process is not in 
compliance with the OIE Terrestrial Animal Health Code Article 2.7.13.2 
or with agreements between the United States and the EC regarding 
regionalization of the European Union (EU).
    Response: We are required to adhere to certain procedures in 
establishing or amending regulations, including actions regarding the 
animal health status of a region. Our policy in situations in which a 
region experiences a disease outbreak is to issue an immediate 
administrative ban on imports from an affected region and then follow 
with the rulemaking process required by the Administrative Procedure 
Act; the interim rule may be given an effective date earlier than the 
date of the rule's signature or publication to affirm our authority for 
issuing previous administrative orders. In this case, a port alert 
instructing APHIS port offices to refuse any shipment of poultry or 
poultry products from Denmark that did not meet the requirements for 
poultry or poultry products from regions affected with END was issued 
on July 31, 2002. This action applied retroactively to shipments 
received on or after July 16, 2002, the day suspicion of the outbreak 
was initially reported. The interim rule removing Denmark from the list 
of END-free regions was also made effective retroactively to July 16, 
2002.
    We received the request to return Denmark to the list of END-free 
regions

[[Page 38260]]

in April 2004. Once the request was received, we responded by 
initiating the risk analysis. Some aspects of the information submitted 
required clarification, and during the review period (after receipt of 
the original submission) Denmark made a significant change to its END 
control policy with the implementation of a mandatory vaccination 
policy. We considered it necessary to acquire additional information to 
evaluate the effect of this change. We exchanged correspondence on 
several occasions with the EC and received the requested information on 
November 26, 2004. On May 5, 2005, we published the notice of 
availability cited above and invited public review and comment of the 
risk analysis cited above until July 5, 2005. While we were considering 
the public comments received, Denmark experienced a single new END 
outbreak, which was reported on October 21, 2005. We have considered 
the impact of this situation on the previously published risk analysis, 
and this final rule reflects that consideration.
    Issue: The group of private citizens stated that the focus on live 
poultry in the risk analysis was misplaced, and the focus should have 
been on the risk of introducing END through poultry products.
    Response: As we explained in the exposure assessment portion of the 
risk analysis, it was necessary for us to focus on exposure pathways 
involving live poultry because historically END introductions into the 
United States have been associated with the importation of live birds. 
Live birds were, therefore, considered a higher risk pathway than the 
importation of poultry products. Since the risk from live birds was 
low, the risk from poultry products should also be low.
    Issue: The group of private citizens asked for clarification of the 
process APHIS uses in adding and removing countries on the list in 
Sec.  94.6(a)(2) of the regulations. They also asked for more 
information on the procedures that APHIS uses to rank risk.
    Response: The regulatory process we use to recognize the animal 
health status of a region or to reestablish a region's disease-free 
status after an outbreak is detailed in 9 CFR part 92. General 
information on determining animal disease status and risk assessment 
can be found online at the Veterinary Services Regionalization 
Evaluation Services Staff Web site, https://www.aphis.usda.gov/vs/ncie/
reg-request.html. The informational document ``Process for Foreign 
Animal Disease Status Evaluations, Regionalization, Risk Analysis, and 
Rulemaking,'' which describes the process APHIS follows when conducting 
foreign animal disease status evaluation, regionalization, risk 
analysis, and related rulemaking, is available to the public through 
that Web site by clicking on the document title at the bottom of the 
page.
    Issue: The private citizens stated that APHIS should have made a 
site visit to Denmark to evaluate the END status of the region.
    Response: We disagree. As we explained in the risk analysis, prior 
to the outbreaks in 2002, the United States had a long history of trade 
of poultry and poultry products with Denmark. Denmark, as a country and 
as a Member State of the EU, has previously been evaluated for END and 
other animal diseases. We have maintained contact with Danish 
veterinary authorities who keep us advised of animal disease conditions 
in their country. Furthermore, the EU system for animal disease control 
for classical swine fever has been extensively evaluated by APHIS and 
provides additional confidence in the EU veterinary infrastructure. The 
document referenced above, ``Process for Foreign Animal Disease Status 
Evaluations, Regionalization, Risk Analysis, and Rulemaking,'' 
describes circumstances when a site visit may not be deemed necessary 
for an evaluation. Accordingly, we concluded that a document review was 
sufficient for the needs of the risk analysis.
    As noted previously, while we were reviewing these comments and 
preparing its response, Denmark experienced a new outbreak of END in a 
single flock. We monitored the situation and evaluated the information 
provided by Danish veterinary authorities and have concluded that the 
outbreak was limited to a single flock, which was depopulated, and that 
the outbreak has successfully been contained and eradicated. Denmark 
has lifted all protective measures as of December 4, 2005. We consider 
this isolated outbreak to be consistent with the conclusions stated in 
the previously released risk analysis.
    Therefore, for the reasons given in this document and based on our 
risk analysis, we are amending Sec.  94.6 in this final rule to add 
Denmark to the list of regions considered free of END.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. For this 
action, the Office of Management and Budget has waived its review under 
Executive Order 12866.
    We are amending the regulations by adding Denmark to the list of 
regions considered free of END. We are taking this action because 
Denmark has met our requirements for recognition as a region free of 
END. This action relieves restrictions on the importation of carcasses, 
parts or products of carcasses, and eggs (other than hatching eggs) of 
poultry, game birds, or other birds from Denmark which are no longer 
warranted.
    Denmark produced 412 million pounds (equivalent to about 1.2 
percent of U.S. production) and exported 250 million pounds (equivalent 
to about 0.7 percent of U.S. production) of poultry meat in 2005. The 
United States is the world's largest producer and exporter of poultry 
meat. In 2005, U.S. poultry meat production totaled 35.3 billion 
pounds, of which 84.3 percent was broiler meat, 12.4 percent was turkey 
meat, and 3.3 percent was other chicken meat. During the same period, 
the United States exported 6 billion pounds of poultry meat valued at 
$2.5 billion.
    In theory, if poultry available for consumption in U.S. markets 
increases, poultry prices would decrease, U.S. consumers of poultry 
would benefit, and U.S. producers would be harmed. U.S. freight 
forwarding, trucking, and transport firms that transport poultry from 
U.S. ports could benefit from increased economic activity. However 
these impacts are expected to be negligible because the amounts of 
poultry products produced in Denmark are a small fraction of U.S. 
production. Denmark has a well established world-wide market and is 
unlikely to divert its exports from these markets to the more distant 
U.S. market.
    The Small Business Administration (SBA) has established guidelines 
for determining which types of firms are to be considered small under 
the Regulatory Flexibility Act. This rule would mainly affect poultry 
farms (North American Industry Classification System [NAICS] code 
112320). According to the 2002 Census of Agriculture, there are 83,381 
poultry farms that produce broilers and other meat type chickens. These 
facilities are considered to be small if their annual receipts are not 
more than $750,000. Over 93 percent of these operations are considered 
to be small. Any effects of the rule for U.S. producers will be 
negligible. Other entities that could theoretically be affected include 
U.S. trucking firms (NAICS code 4842302), U.S. freight forwarders 
(NAICS code 4885101), and deep sea freight transport companies (NAICS 
code 483111). The SBA classifies trucking firms as small if their 
annual receipts are less than $21.5

[[Page 38261]]

million; freight forwarding firms are small if their annual receipts 
are less than $6 million, and deep sea freight transport firms are 
small if they have not more than 500 workers. According to the 2002 
Economic Census, there were 9,177 trucking firms, 5,840 freight 
forwarders, and 383 deep sea freight transport companies. Over 99 
percent of trucking firms, 90 percent freight forwarders, and 70 
percent of deep sea freight transport firms are considered to be small. 
Although the majority of these establishments are small entities, the 
effect of this rule will be negligible.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This rule contains no information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

List of Subjects in 9 CFR Part 94

    Animal diseases, Imports, Livestock, Meat and meat products, Milk, 
Poultry and poultry products, Reporting and recordkeeping requirements.

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Accordingly, we are amending 9 CFR part 94 as follows:

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL 
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL 
SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND 
RESTRICTED IMPORTATIONS

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1. The authority citation for part 94 continues to read as follows:

    Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 
U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.


Sec.  94.6  [Amended]

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2. In Sec.  94.6, paragraph (a)(2) is amended by adding the word 
``Denmark,'' before the word ``Fiji.''

    Done in Washington, DC, this 29th day of June 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-10555 Filed 7-5-06; 8:45 am]
BILLING CODE 3410-34-P

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