### APHIS Risk Evaluation of the Importation of Highly Pathogenic Avian Influenza (HPAI) and Virulent Newcastle Disease (END) Virus from a European Union Region of Twenty

- five Member States

Animal and Plant Health Inspection Service Veterinary Services

March 2011

_Page 2 of 58 TABLE OF CONTENTS

A BBREVIATIONS 3

E XECUTIVE S UMMARY 4

I NTRODUCTION 6

O BJECTIVE 8

B ACKGROUND 8

H AZARD I DENTIFICATION 12

R ELEASE A SSESSMENT 1 2

E XPOSURE A SSESSMENT 24

R ISK MITIGATION MEASU RES 30

C ONSEQUENCE A SSESSMENT 3 2

R ISK E STIMATION 36

C ONCLUSION AND S UMMARY OF P ROPOSED A CTION 37

R EFERENCES 4 0

A PPENDIX A

. E PIDEMIOLOGIC CHARACT ERISTICS OF N EWCASTLE D ISEASE 4 5

A PPENDIX B

. E PIDEMIOLOGIC CHARACTERISTICS OF A VIAN I NFLUENZA 49

A PPENDIX C

. T ABLE OF R ELEVANT EU L EGISLATION 5 4

A PPENDIX D. A DMINISTRATIVE U NITS OF THE EU

- 25 5 8

_______________________________________________________________________________________________Page 3 of 58 A BBREVIATIONS :

ADNS Animal Disease Notification System

AI Avian Influenza

AIV Avian Influenza Virus

APHIS Animal and Plant Health Inspection Service

APMV -1 Avian Paramyxovirus Subtype 1

AU Administrative Units

AVIC Area Veterinarian in Charge

BIP Border Inspec tion Post

CFR Code of Federal Regulations

CSF Classical Swine Fever

CVO Chief Veterinary Officer

DVFA Danish Veterinary and Food Administration

EC European Commission

END Exotic Newcastle Disease (virulent Newcastle disease)

END V Exotic Newcastle Disease virus

EU European Union

EU -15 Fifteen EU Member States prior to 1 May 2004 accession

EU -25 Twenty

- five EU Member States in the year 2006

EU

- PTR European Union Poultry Trade Region

FR Federal Register

FVO Food and Veterinary Office of the European Commission

HPAI Highly Pathogenic Avian Influenza

HPAI H5N1 Highly Pathogenic Avian Influenza subtype H5N1

ICPI Intracerebral Pathogenicity Index

LBM Live bird market

LPAI Low Pathogenicity Avian Influenza

MS Member States

NAI Notifiable Avian Influenza

ND Newcastle disease

NDV Newcastle disease virus

NPIP National Poultry Improvement Plan

OIE World Organization for Animal Health

PPMV -1 Pigeon Paramyxovirus Variant Subtype 1

SVD Swine Vesicular Disease

TRACES Trade Control and Expert System

UK United Kingdom

USDA United States Department of Agriculture

WHO World Health OrganizationPage 4 of 58 E XECUTIVE S UMMARY The Animal and Plant Health Inspection Service ( APHIS ) Veterinary Services (VS)

evaluated the risk of virulent Newcastle disease and Highly Pathogenic Avian Influenza (HPAI) from the European Union (EU) Member States (MS) which constitut ed the EU in the year 2006, collectively referred to as the European Union-25 1

APHIS based this evaluation of the Newcastle disease and HPAI status of the EU -25 on the performance measures found in T itle 9 of the Code of Federa l Regulations part 92.2 (9 CFR 92.2) using the documentation submitted by the European Commission (EU -25) . B ased on our evaluation of representative MS, APHIS is proposing to recognize the EU- 25 as free of

both Newcastle disease and HPAI. APHIS is now proposing to recognize the EU

- 25 as a single region for which import requirements will be uniformly applied . This region wil l

be referred to as the “APHIS -defined EU Poultry Trade Region” (poultry trade region).

2

**•** The region has an effective veterinary infrastructure capable of identifying and applying control measures to eradicate incursions of Newcastle disease or HPAI in domestic poultry. ( EC ), Food and Veterinary Office (FVO) reports, EC legislation, reports to World Organization for Animal Health ( OIE ) and a site visit

. The April 2008 VS site visit to the EC in Brussels and five representative EU -MS (Cyprus, Denmark, Germany, the Netherlands, and Poland) was conducted to evaluate their avian disease statu s and how uniformly EC legislation i s implemented and enforced throughout the EU-25.

The result s of the evaluation indicate the following :

**•** The region has a comprehensive legislative framework in place to ensure consistent implementation of EC legislation by all EU -MS. E C services provide resources to review and inspect for compliance

.

**•** Newcastle disease and HPAI are notifiable (reportable) diseases

.

**•** Appropri ate surveillance , both active and passive, using serological and agent

detection is in place with the capacity to effectively and quickly detect the presence of Newcastle disease or HPAI , even in the absence of clinical signs.

**•** Laboratory confirmation capabilities are effective and laboratory testing procedures are well documented and standardized.

**•** Newcastle disease and HPAI eradication program s include implementation of appropriate quarantine and surveillance zones, with monitoring of those zones and movement restrictions. Procedures for establishing and lifting quarantines are sufficient to prevent further spread of disease.

1 European Union -2 5 (EU

- 25) wa s defined as including the Member States: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom

. 2 The European Commission (EC) is the EU institution responsible for representing the EU as a whole. It proposes legislation, policies and programs of action and implements decisions of the EU Parliament and

Council.Page 5 of 58 **•** Contingency plans, s tandard operating procedures

, biosecurity measures

, and

emergency response are well d ocumented and relevant personnel well resourced

and trained

. APHIS concluded that the overall risk of introducing either Newcastle disease or HPAI into the United States through the import of live birds, poultry carcasses, parts or products of poultry carcasses, and eggs of poultry, game birds, or other birds from the EU

to be extremely low . However, APHIS recognizes that limited Newcastle disease and

HPAI outbreaks are likely to continue to occur in the EU-25. Therefore, APHIS intends to apply the conditions found in 9 CFR 92.3 in the event of future outbreaks of either disease in poultry to recognize the EC quarantine decisions. These restriction a reas will include all protection, surveillance, and buffer zones established around Newcastle

disease or HPAI outbreaks in domestic poultry and the affected zones established around

outbreaks of Newcastle disease or HPAI in wild birds and pigeons held in captivity (including pigeons held for racing, exhibition, breeding, and fattening).

Summary of requirements (restrictions) for export to the U nited S tates In summary, APHIS will address the Newcastle disease and HPAI risk from the EU -25 using the following approach:

1. It will expand the scope of the restrictions currently defined in § 94.6 to apply to all

EU

- 25 Member States

.

2. I n the event of an outbreak of Newcastle disease or HPAI , i t will apply the movement restrictions defined in § 92.3 to the EU-25 for avian diseases and recognize the quarantine or restriction areas established by the EC.

3. It will require the competent veterinary authority of the individual EU -25 MS to certif y that the poultry, including hatching eggs, exported to the United States or the poultry from which exported poultry meat and poultry products, including eggs and egg products (other than hatching eggs), were derived originated in the EU-25 and had never resided in a region under rest rictions for the presence of Newcastle disease or HPAI in domestic poultry for the last 90 days. In the case of movement restrictions put in place following

the detection of Newcastle disease or H PAI in wild birds or in racing pigeon s, APHIS will recognize the duration of restrictions as imposed by the EC upon the affected zone.

4. It will require the competent veterinary authority of the individual EU -25 MS to certif y that the farms of origin for the poultry, poultry meat, or poultry products did not receive birds from outside the poultry t rade region or from areas under restrictions for Newcastle

disease or HPAI within the poultry t rade r egion

. 5. It will require the competent veterinary authority of the individual EU -25 MS to certif y that the birds, or the birds from which hatching eggs derived, were not vaccinated for subtypes H5 or H7 avian influenza ( AI ).

6. The products must not have commingled with poultry meat or poultry products derived from other poultry that w ere not from the EU-25 or were in any restriction zones

established because of the presence of Newcastle disease or HPAI.

7. Equipment or transport used for the live poultry from which the poultry meat or poultry products were derived from the farm of origin to the slaughtering establishmentPage 6 of 58 must not have been used previously for transporting live poultry that do not meet the above requirements, unless th e equipment and materials have first been adequately

cleaned and disinfected.

I NTRODUCTION The U.S. Department of Agriculture’s APHIS regulates the importation of live birds, poultry, meat, other animal products and byproducts into the United States in order to prevent the introduction of various animal diseases, including virulent Newcastle disease

and HPAI s ubtypes H5 and H7. APHIS previously recognized nine MS 3

In this document APHIS evaluates the EU-25 as a single region using the performance

standards found in 9 CFR 92.2 for which import restrictions could be uniformly applied based on the legal requirements for all individual MS of the EU to uniformly apply all EC legislation. The region evaluated contains the 25 EU-M S which constitut ed the EU in the year 2006; collectively referred to as the EU -25 of the EU as region s in which Newcastle disease is not known to exist by individually evaluating each

of these MS.

4

In April 2008, VS conducted a site visit to the EC Brussels and five representative EU

MS (Cyprus, Denmark, Germany, the Netherlands, and Poland) to evaluate the avian

disease status and incorporation and implementation of EC regulations by these

representat ive MS [37]. APHIS evaluated documentation submitted by the EC, FVO reports, EC legislation, site visit observations , and reports to OIE. In addition to the information provided by the EC and gathered during the site visit, APHIS used a variety

of earlier evaluations to inform this assessment, including an evaluation of Denmark following an extensive Newcastle disease outbreak in 2002 [22, 25, 31] and several more recent evaluations of the HPAI status of several regions in the EU affected by HPAI subtype H5N1 [5-10, 12-16 ]. It was determined that the EU -25 would be evaluated as a . APHIS evaluated the EU

- 25 as a single region with the intention to standardize regulations for all of the EU-25 as the “ APHIS

defined EU Poultry Trade Region ” (EU

- PTR).

The evaluation reviewed the EC legislation and the measures established in this legislation for detecting, controllin g, and eradicating animal diseases, in this case

Newcastle disease and HPAI. Based on the free movement of animals and animal products within the EU and legal requirement s for the uniform application of EU regulations to all MS, APHIS evaluated whether the risk would be similar for all EU

- MS

. In addition, APHIS proposes to apply existing regulations found in 9 CFR 92.3 regarding movement restrictions established by the EC to the “ APHIS -defined EU Poultry Trade Region ” (poultry trade region).

3 The regions recognized as END

- free in 9 CFR 94.6 ar e Denmark, Finland, France, Great Britain (England, Scotland, Wales and the Isle of Man), Greece, Luxembourg, Republic of Ireland, Spain and

Sweden

. 4 European Union -2 5 (EU

- 25) is defined as including the Member States: Austria, Belgium, Cyprus, Czech
Repu blic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United KingdomPage 7 of 58 single region under the harmonized regulation and oversight of the EC and the application of a single set of requirements for the importation of live birds and poultry products from the region.

Communication from the EC regarding detection and control of outbreaks has been timely and comprehensive. The EC circulates freque nt reports on the status of designating control zones, application of surveillance, results of the epidemiolog ic investigation , and progress of the control efforts . These reports provide accurate appraisal

of the animal health situation and date the restri ctions are lifted

. APHIS anticipates that the EC will continue to provide reports on the surveillance results, epidemiological findings, and progress of the control effort in a similar manner to current practices and plans to continue to use these reports to monitor the animal health status of the EU -25.

APHIS based its conclusions on the following factors:

**•** The region has an effective veterinary infrastructure capable of identifying and applying control measures to eradicate incursions of Newcastle disease or HPAI in domestic poultry.

**•** The region has a comprehensive legislative framework in place to ensure consistent implementation of EC legislation to assure that all EU -MS correctly

transpose EC legislation into their domestic legislati ve frameworks. The E C also actively monitors MS compliance with animal health legislation implementation by review and inspection in the individual EU –MS.

**•** Newcastle disease and HPAI are notifiable (reportable) diseases; there was an ongoing awareness program in place for veterinary officials and the public.

**•** An appropriate surveillance program exists supporting the detection and investigation of the outbreaks with clinical inspection, active and passive surveillance (serological and agent detection), an d serological and virological testing in high -risk areas and of high-risk flocks. The program is capabl e of rapidly and effectively detecting the presence of Newcastle disease or HPAI , even in the absence of clinical signs.

**•** The system for recording, managing, and analyzing diagnostic and surveillance

data is sufficient to demonstrate effectiveness of disease control measures.

**•** Laboratory confirmation capabilities are effective and laboratory testing procedures are well documented and standardized.

**•** Newcastle disease and HPAI eradication program s include appropriate quarantine and surveillance zones, monitoring of those zones, and implementation of movement restrictions. Procedures for establishing and lifting quarantines are sufficient to prevent further spread of disease.

**•** Standard operating procedures for biosecurity measures implemented during the outbreak, depopulation, cleaning and disinfection, and other applicable measures (such as carcass disposal) are well documented an d relevant personnel well

resourced and trained.Page 8 of 58 APHIS concluded that the risk of introducing Newcastle disease or HPAI from the poultry trade region into the United States through the legal importation of live birds, poultry meat, or poultry products is very low.

O BJECTIVE
APHIS evaluated the Newcastle disease and HPAI risk associated with the importation of live birds, poultry, hatching eggs, poultry meat, and poultry products from the EU -25 into

the United States . The evaluation was based on the following characteristics of the poultry trade region.

**•** The EU -25 would be recognized as a single region for Newcastle disease and

HPAI and be referred to as the “APHIS

- defined EU Poultry Trade Region” (or poultry trade reg ion).

**•** Re quirements that are currently imposed on exports of live birds, poultry carcasses, parts or products of poultry carcasses, and eggs of poultry, game birds,

or other birds in existing regulation and applicable to the nine MS listed in

9 CFR 94.6 previously evaluated individually will be applied generally to the EU25.

**•** Consistent with the 9 CFR 92.3, EC quarantine decisions and movement

restrictions with respect to areas affected by Newcastle disease or HPAI would provide the basis for U.S. import restrictions imposed and removed with respect

to that disease

.

**•** The competent veterinary authority of the individual EU -25 MS would certify that the appropriate control measures, including both EU and U.S. requirements, had been applied.

APHIS considers the risk to be similar for all counties within the EU -25 because of the

open trade practices and unrestricted movement of poultry and poultry products in the

EU -25 and the fact that the E C regulations apply uniformly to all MS. Therefore, APHIS

assessed recogni tion of the EU -25 as a single region , referring to the region as the

“ APHIS defined EU Poultry Trade Region,” for which import restrictions could be uniformly applied.

B ACKGROUND

Current APHIS regulation for Newcastle disease and HPAI

Currently , APHIS regulation ( 9 CFR 94.6 ) restricts the importation of poultry carcasses,

meat, parts or products of poultry carcasses, and eggs (other than hatching eggs) into the United States from regions where Newcastle diseas e or any subtype of HPAI is

considered to exist , allowing only cooked products or consign ment directly to an approved establishment in the United States.

APHIS regulations for the importation into the United States from regions where

Newcastle disease or HPAI is considered to exist allow importing poultry carcasses and parts and products of poultry carcasses only if they have been cooked throughout to reach a minimum internal temperature of 74 o C . I n regions where HPAI is considered to exist,Page 9 of 58 APHIS requir es that carcasses and parts or products of carcasses, including meat, poultry, game birds, or other birds, may be imported if they are accompanied by a certificate that is signed by a full-time, salaried veterinarian of the government agency responsible fo r animal health in the region and that specifies that the articles were cooked to this specification

.

Carcasses of game birds may not be imported from regions where any subtype of HPAI is considered to exist, except for those consigned to a museum, educational institution

, or other establishment which has provided evidence that it has the equipment, facilities, and capabilities to store, handle, process, or disinfect such articles so as to prevent the

introduction or dissemination of HP AI into the United States, as approved by the

Administrator.

Eggs and egg products (other than hatching eggs) of poultry, game birds, or other birds from regions where Newcastle disease exists may be imported into the United States only if: (1) They are accompanied by a health certificate regarding the flock of origin and meet certain other conditions; (2) they are consigned directly to an approved establishment for breaking and pasteurization; (3) they are imported under permit for scientific,

education al, or research purposes; or (4) they are imported under permit and have been cooked or processed and will be handled in a manner that prevents the introduction of

Newcastle disease into the United States . Table eggs from Newcastle disease affected regions may only enter if accompanied by official certification that the flock was visited within the last 90 days; the eggs were packed and sealed; testing of cull birds; and there

was no indication of the presence of the disease within 50 km for the last 90 day s [ 11, 17,

21 ].

Generally when a r egion recognized by APHIS to be free of Newcastle disease sustain s an outbreak of Newcastle disease in commercial poultry it is removed by interim rule

from the list of Newcastle disease free regions . Regions are returned to the list of

Newcastle disease free regions in accordance with the procedures for reestablishment of a region's disease

- free status found in 9 CFR 92.4 . Briefly, APHIS promulgates interim regulation s to immediately prohibit or restrict imports from the affected region followed by reassessment of the disease status of that affected region. The evaluation is made available for public comment and if no substantive comments are made the region is

re turned to the APHIS list of Newcastle disease free regions t hrough the publication of a

final rule . This is generally a lengthy process. For example, in the case of Denmark, an

extensive outbreak of Newcastle disease occurred from July until August of 2002. APHIS responded with the publication of an interim rule on September 20, 2002, effective retroactively to July 16, 2002. Although the outbreak was rapidly controlled, APHIS did

not return Denmark to the list of Newcastle disease free regions until July of 2006 [22, 27, 31 ].

In the case of HPAI, APHIS maintains a list of affected regions on the agency W eb site

as “ USDA -R ecognized A nimal Health Status of Countries /R egions Regarding S pecific Livestock or Poultry D iseases , or A cceptable C ommodities .” 5

5 available at: http://www.aphis.usda.gov /import_export/animals/animal_disease_status.shtml Rulemaking is not neededPage 10 of 58 to remove a region from the APHIS HPAI affected list , although a region will be removed only after APHIS completes an evaluation

, makes it available for public comment through a notice published in the Federal Register (FR) , followed by response

to comments , and publication of a notice of determination announcing APHIS’ decision [4 ].

Eggs and egg products (other than hatching eggs) of poultry, game birds, or other birds from regions where Newcastle disease exists may be imported into the United States only if: (1) They are accompanied by a heal th certificate regarding the flock of origin and meet certain other conditions; (2) they are consigned directly to an approved establishment for breaking and pasteurization; (3) they are imported under permit for scientific, educational, or research purpos es; or (4) they are imported under permit and have been cooked or processed and will be handled in a manner that prevents the introduction of

Newcastle disease or HPAI into the United States [11, 21].

Recently APHIS added an alternative pathway for the importation of table eggs from regions where Newcastle disease is considered to exist based on testing a nd certification by the competent national veterinary authority. The certification must state that within the last 90 days the flock of origin was inspected and no evidence of communicable diseases of poultry was found and that the eggs were packed and seale d with a seal of the competent veterinary authority. Certification must also be made that the flock of origin of the eggs was free of Newcastle disease based on a testing regimen using virus isolation from cull birds, and verification that the weekly cull rate did not exceed 0.1 percent. Egg drop syndrome must be a notifiable disease in the region of origin and certification must

indicate that in the past 90 days there were no reports of egg drop syndrome in the

flock (s) of origin or within a 50 kilometer r adius of the flock of origin [11, 21 ].

Legal entry of live birds into the United States is done under permit and controlled through existing quarantine and testing measures in quarantine facilities operated or approved by APHIS (9 CFR 93.205). In addition, live birds or poultry, including hatching

eggs, must be accompanied by official certification that, as far as it has been possible to determine, during the 90 days prior to movement, the poultry were not exposed to communicable diseases of poultry, inclu ding Newcastle disease and HPAI and the premises were not in any area under quarantine. The birds must not be vaccinated for the H5 or H7 subtype of AI or transit regions where HPAI of any subtype is considered to

exist or where birds were vaccinated for H5 or H7 subtypes of AI as part of disease

control . It is important to note that current trade restrictions did not prohibit importation of live birds from regions considered by APHIS to have Newcastle disease . No live birds, poultry, or hatching eggs from poultry can enter from areas where HPAI exists or where

Newcastle disease has occurred in the last 90 days [4]. All birds are subject to appropriate testing for Newcastle disease and HPAI prior their release from quarantine.

Hatching egg s imported from any part of the world must be accompanied by a veterinary health certificate issued by a national government veterinarian of the exporting country

and a USDA import permit . Conditions for certification include that the flock of origin

was f ree of communicable disease and the premises was not in an area under quarantine.Page 11 of 58 It must also be certified that the hatching eggs were not derived from birds vaccinated for either H5 or H7 subtypes of AI. Hatching eggs from regions not designated in § 94. 6 as

free of Newcastle disease and HPAI must be quarantined upon arrival. These hatching eggs are required to be transported from the port of entry to the hatchery in a vehicle sealed by the USDA and hatched and brooded under the supervision of the Area

Ve terinarian in Charge (AVIC) in the State of destination . The poultry hatched from

these eggs must remain in quarantine for at least 30 days following hatching. The hatchery must meet specific biosecurity standards and be inspected and approved by the

AVIC prior to issuance of the import permit. During quarantine, the hatching eggs and poultry from such eggs are subject to inspection, disinfection, and diagnostic testing to determine that they are free of Newcastle disease and HPAI. Hatching eggs from region s APHIS considers free of Newcastle disease and HPAI must be accompanied by official

certification but do not undergo quarantine [4].

Previous actions taken by APHIS relative to Newcastle disease and HPAI in the EU Previously, APHIS recognize d nine EU

- MS individually as regions in which Newcastle

disease was not known to exist. Th is recognition was made prior to the establishment of

the EU and the original evaluations conducted did not consider risks that might arise from the opening of borders within the EU with the free movement of trade between MS

, including MS that APHIS had not previously evaluated for avian disease status.

Restrictions on EU- MS that were evaluated previously by APHIS are less stringent than

those on MS that have not been evaluated for Newcastle disease status. However,

because of the unrestricted movement of animals and animal products in the EU, and the fact that the same regulations apply to all EU

- MS, APHIS considers the risk to be similar for both groups.

As a result of the incursion of HPAI H5N1 into Europe, several regions of the EU-25

were added to the APHIS list of affected regions. All of these affected regions have since

been removed from the affected list as a result of i ndividual assessments conduc ted by

APHIS [5-10, 12-16, 18-19] . These assessments were based on internationally established criteria for the evaluation of the HPAI H5N1 status of a region all of which are satisfied by EU regulation.

Specifically, APHIS used the following criteria in these evaluations:

**•** The region has been HPAI-free for 3 months (90 days) as a result of control measures undertaken by an effective veterinary infrastructure.

**•** HPAI (as defined in 9 CFR) was notifiable (reportable) , and there was an ongoing

awareness program in place for veterinary officials and the public.

**•** A surveillance program existed which addressed the specific needs in the region. This program supported detection and investigation of the outbreaks and included clinical inspection, active and pass ive surveillance (serological and agentdetection), and serological and virological testing in high-risk areas and of highrisk flocks. The program detected disease effectively and quickly, even in the absence of clinical signs.Page 12 of 58 **•** Under the surveillance program, all notified and/or suspect AI cases were investigated and appropriate actions taken

, samples were collected and transported in a manner that ensured integrity of the sample for testing purposes, and laboratory results were documented.

**•** The system fo r recording, managing, and analyzing diagnostic and surveillance

data was sufficient to demonstrate effectiveness of disease control measures.

**•** Laboratory confirmation capabilities were effective ; and l aboratory testing procedures were documented and standardized.

**•** The eradication program included the definition of appropriate quarantine and surveillance zones, monitoring of those zones, and implementation of movement restrictions. Measures were capable of containing and controlling disease spread

from thes e zones. Procedures for lifting quarantines were followed and were sufficient to prevent further spread of disease.

**•** Standard operating procedures for biosecurity measures implemented during the outbreak, depopulation, cleaning and disinfection, and other a pplicable measures (such as carcass disposal) were documented, familiar to relevant personnel, and followed during the outbreak. These measures were effective in controlling the

disease.

**•** Premises were repopulated (if applicable) according to documented pro cedures and there was no disease recurrence. Monitoring conducted after repopulation

demonstrated that the disease has been eradicated.

H AZARD I DENTIFICATION The Terrestrial Animal Health Code recommends identifying the pathogenic agents which could potentially produce adverse consequences associated with the importation of a commodity [44 ]. In this case the pathogenic agents are Newcastle disease and HPAI and the commodities are live birds, poultry meat, and poultry products [Appendix I and II].

R IS K A NALYSIS This analysis is composed of four components: the release assessment, the exposure assessment, the consequence assessment, and the risk estimation. These components are defined in OIE guidelines and represent the internationally recommended components for animal health import risk analysis [ 44]. Although the primary focus for this analysis is the evaluation of risks associated with poultry products import ed from the EU -25, the exposure and consequence assessments include discussion of live bird f actors because of their historical significance to Newcastle disease and HPAI outbreaks in the United

States.

R ELEASE A SSESSMENT The Terrestrial Animal Health Code recommends describing the biological pathways necessary for an importation activity to 'rel ease' or introduce the identified pathogenic

agent (s) into a particular environment and estimate the probability of that occurring underPage 13 of 58 the proposed conditions of importation. If the release assessment demonstrates no significant risk, the risk assessment does not need to continue. However, for the sake of thoroughness, APHIS conduct ed a further assessment.

EU animal health controls for Newcastle disease and HPAI

The EC is the EU institution responsible for representing the EU as a whole. The EC

proposes legislation, policies , and programs of action and implements decisions of the

EU Parliament and Council with the responsibility to ensure that Community legislation on food safety, animal health, plant health, and animal welfare are properly implemented

and enforced. Within this framework

, Newcastle disease and HPAI control measures are completely harmonized through specific EU legislation, and binding upon all EU

- MS [Appendix 4]. These harmonized a nimal health regulations include compulsory

notification of Newcastle disease and HPAI

.

Live birds move freely between EU

- MS and within the individual EU- MS . Poultry born

in one EU

- MS are routinely raised or slaughtered in another. Poultry moving between the

EU

- MS are required to be accompanied by an official health certificate, issued by the official veterinarian appointed by the competent authority of the EU

- MS , and prior notification of the movement is reported electronically through an electronic network

linkin g veterinary authorities of the EC and MS.

The EU recognizes that the risk for Newcastle disease and HPAI outbreaks can never be

reduced to zero due to the occurrence of the se disease s in wild birds. In the case of the

detection o f the disease in wild birds, EU-MS have the obligation to inform the Commission of the measures that they are taking and they may apply more stringent hygienic measures in nearby poultry farms to prevent the introduction of the disease. Additional biosecurity and surveillance m easures may also be applied to backyard and hobby flocks. The implementation of basic Community rules laid down in Council

Directive s 92/66/EEC (Newcastle disease) and 2005/94/EC (avian influenza ) have served

to rapidly and effective ly control any Newcastle disease and HPAI outbreaks that have occurred in the Community in the last decade.

EU animal movement controlsThe general provisions for veterinary and zootechnical checks applicable to intraCommunity trade of live poultry and poultry produc ts as found in Council Directive 90/425/EEC, establish official veterinary controls at the holding of origin before

intra -Community movement with certification validated by an official veterinarian . This

Directive also provides the legal basis to establish movement controls during disease outbreaks as part of the disease specific control measures to prevent the spread of disease

and safeguard the trade in live animals

.

The EU Trade Control and Expert System ( TRACES ), established under Commission

Decision 2003/623, maintains an internet

- based service for the traceability of live animals that provides information on the intra- Community trade of live animals and certain types

of animal products. TRACES, in place since 2004, replaced earlier databases with a single central database t o track the movement of animals , including the importation ofPage 14 of 58 animals and products into the EU. The system enables the immediate review of animal movements preceding the detection of an animal disease outbreak to allow for rapid

emergency response and traceability

. Th e system also allows the receiving M S to verify that the consignment arriving at the destination corresponds to that specified in the original accompanying veterinary certificate from the country of origin. The consignments of live poultry and hatching eggs must be appropriately identified ensuri ng that when they are shipped to another MS, they are accounted for on arrival at the ir

destination.

The animal health conditions governing intra-community trade in poultry and hatching

eggs are closely regulated under Council Directive 90/539/EEC. The EU has standardized

a nimal health certificates for use with different poultry categories , such as breeding, production, day-old hatching eggs, slaughter poultry, and poultry for r estocking game supplies . The certificate is signed by the official veterinarian, confirming compliance with the Directive's requirements. T he certificates must indicate if the poultry have been vaccinated against Newcastle disease and if the poultry ha ve been vaccinated, the certificate must specify the age at vaccination and the characteristics of the Newcastle

disease vaccine used . The regulation also specifies conditions for the production of live poultry and hatching eggs as well as movement of live po ultry ; all poultry for breeding and production must come from establishments officially approved by the EU , and have undergone an animal health inspection.

The import ation of poultry and hatching eggs from countries or regions into the EU is also regulated. T he general animal health requirements governing imports from non- EU countries of poultry and hatching eggs are also harmoniz ed and require that the non- EU exporting country supply certification signed by an official veterinarian of the co mpetent authority of the exporting third country guaranteeing that the conditions for import into

the EU have been me t and that the exporting country has been evaluated and found to have adequate animal health controls in place. Upon arrival in the EU, the animals and the accompanying certificates must be verified and checked by EU official veterinarians at a designated Border Inspection Post (BIP). Council Directive 91/496/EEC lays down the principles governing the organization of veterinary checks on anim als entering the Community from third countries. The conditions under which poultry, hatching eggs, day-old chicks, poultry products, eggs and egg products, specified pathogen- free eggs

, ratites , and wild game-birds may be imported into and transit through the EU is regularly updated with conform ing changes to the model health certificates

.

Measures to detect, control , and eradicate Newcastle disease and HPAI in domestic poultry

EC regulations designate both Newcastle disease and HPAI as notifiable animal disease s in the EU and require the establishment of mandatory restriction zones as part of the emergency procedures

. The Animal Disease Notification System (ADNS) is used by the

EC to regist er and document important infectious animal diseases and ma nage the availability of detailed information about outbreaks of reportable animal disease . ADNS participants include all of the EU countries as well as non -EU countries, such as Andorra, the Faroe Islands, Iceland, Switzerland, and Turkey [1]. Newcastle disease and a ll formsPage 15 of 58 of AI in all avian species are report ed and tracked. The authority for ADNS is longstanding under Council Directive s 82/894/EC and Commission Decision 2005/176/EC and ensures the rapid exchange of information between the competent

na tional animal health authorities and the EC. The system allows co -ordination and monitoring of outbreaks of contagious animal diseases and enables MS and E C services to take immediate measures to prevent the spread of reportable diseases.

Initial reports of a primary outbreak of reportable animal disease must be submitted

within 24 hours of confirmation of the outbreak . I mmediate communication options are available in the case of highly contagious animal diseases . Reports of primary outbreaks

are inserted directly into the ADNS system and all the countries in the system are immediately notified electronically

. Primary outbreak s are defined as an outbreak of a contagious animal disease not epizootiologically linked with a previous outbreak in a region or the first outbreak in a previously unaffected region of a MS. Secondary

outbreak s are defined as an outbreak following a primary outbreak in an already affected region ; and notification of secondary outbreaks must be updated weekly.

All identifications of AI, both HPAI and LPAI, in domestic poultry and wild birds are immediately reported to ADNS. Confirmation of the presence of Newcastle virus in poultry or other captive birds with an intracerebral pathogenicity index (ICPI) greater

than 0.7 must be immediate ly reported to the EC

. EU regulations describing control

measures in place in the EU require the investigation of all suspected cases and the killing of birds upon confirmation of the disease. All products capable of spreading the disease ( live birds, eggs, meat present on the holding, litter, manure , etc. ) must also be destroyed and the holding cleansed and disinfected using approved disinfectants in

accordance with the instructions of the official veterinarian

.

A 3 km protection zone and a 10 km surveillance zone are established around the affected holding with enforcement of movement restrictions for live poultry and poultry products. Epidemiological investigations must be performed to trace back and trace out all movements that could have led to the introduction or spread of infection.

Council Directive 2005/94 also requires establish ing control measures following the detection of LPAI based on the risk that low pathogenic viruses may mutate into HPAI

viruses. H owever, the control measures for LAPI may differ from those applied following the detection of HPAI. Surveillance measures for the early detection of infection in poultry aimed with appropriate and proportionate control and eradication measures for LPAI are applied an d an epidemiologic inquiry is made so that control measures are based on an assessment of the risk posed.

The competent authority is required to ensure that all poultry on the LPAI holding, including contact holdings, are depopulated under official supervision to prevent the spread of AI . Movement controls are put in place and, if assessed as appropriate, the poultry may be sent directly from the holding to a designated slaughterhouse under official control. Each consignment must be sealed before transpor t by the official

veterinarian.Page 16 of 58 The official veterinarian responsible for the holding ensures compliance with any additional biosecurity measures prescribed by the competent authority and oversees the cleaning and disinfection of vehicles and equipment used for transporting the live poultry to the designated slaughterhouse. The competent authority also must ensure that disposition is performed under official supervision for any carcasses, hatching eggs, or other affected materials . Restriction zones with a radius of at least one kilometer around

the affected holding must be established following the detection of LPAI and includes the implementation of the following measures: a census of all commercial holdings in the

zone is made as soon as possible; labora tory tests are carried out on these commercial poultry holdings; and all movements of poultry within the zone must be authorized by the competent authority.

Newcastle disease Vaccination policy

All M S except Sweden, Finland , and Estonia routinely use prophylactic Newcastle

disease vaccination . All Newcastle disease vaccines must be approved and made only

from lentogenic Newcastle disease strains . Individual MS determine appropriate vaccination programs to meet their specific needs. For example, in Denmark, after a long period under a no-vaccination policy, the approach for Newcastle disease was revised following the 2002 outbreaks, and since October 2004, systematic prophylactic

vaccination has been used. By EC regulation, r acing pigeon s in a ll MS must be

vaccinated to participate in races and shows.

HPAI Vaccination policy Vaccination against AI is generally prohibited in the EU by Council Directive

2005/94/ EC . However, emergency or preventative vaccination for HPAI H5N1 in poultry or other captive birds as a short term measure to contain an outbreak, or more likely the protection of zoo birds, may be used but only after development of a risk assessment and approval by the EC. The vaccination proposal must include a risk assessment to indicate that there is a significant and immediate threat of AI spreading within or into the MS. All vaccinated birds are subject to additional requirements for movement and b y EU regulation, any vaccination plan must include a strategy to differentiate infected from

vaccinated animals.

Contingency plans for Newcastle disease or HPAI control

All MS are required to maintain a current contingency plan that defines proactive approaches to Newcastle disease and HPAI control. These plans are regularly reviewed and approved by the EC as specified in Commission Decision s 2004/402/ EC

, 2006/563/EC and 2007/24/EC. In each MS , veterinary officials must have in place sufficient legal powers, a detailed chain

- of command, and appropriate resources, including emergency funds, laboratory staff, equipment, and infrastructure necessary to carry out a rapid and effective eradication campaign prior to a Newcastle disease or HPAI

outbreak. Each contingency plan must include a manual detailing all procedures, instructions, and measures, including emergency vaccination plans, if deemed necessary, to be implemented in the event of a Newcastle disease or HPAI outbreak. Appropriate staff must regularly receive training and conduct drills for Newcastle disease and HPAI diagnosis, con trol measures, and communication techniques. The EC performs onsitePage 17 of 58 reviews of the MS for compliance with the directives and r epresentatives of the EC and

MS regularly design, conduct, and attend exercises to test emergency preparedness.

The EC requires that all Individual MS guarantee the swift deployment of financial resources for control measures and the rapid compensation of owners for the killed

animals . To comply with EC requirements e ach MS must establish national and local

disease control centers with a defined chain -of- command and expert groups. To comply with EC requirements each MS must maintain sufficient manpower and equipment to deal with emergencies and have in place adequate planning for the specific roles of the various involved sectors such as farmers, industry, veterinarians, slaughter house workers, and the public. To comply with EC requirements each MS must also develop

and maintain the expertise of staff in the field and at the diagnostic laboratories

. To comply with EC requirements all contingency plans must also support provisions for emergency vaccination and campaign planning for publicity campaigns to raise animal

disease awareness and enhance compliance.

EU controls and recent Newcastle disease outbreaks

APHIS ’ review of the Newcastle disease outbreaks in the EU-25 as reported to OIE or through ADNS indicates that the pigeon variant is predominant and the infection of commercial poultry is minimal [1, 36, 43, 45] . The most recent

, large Newcastle disease

outbreaks to occur in commercial birds in the EU date back to 2002 in Denmark, and 2000 in Italy.

In 2002, the Danish Veterinary and Food Administration (DVFA) reported a suspected

outbreak of Newcastle disease to the OIE. Over the next 7 weeks, a total of 135

Newcastle disease outbreaks were confirmed in 8 counties although a relatively small number of birds were involved in these outbreaks (a total of 175,455 birds were destroyed as a result of the 135 outbreaks). The infection was dispe rsed by placement of infected pullets to commercial flocks (2 breeder, 5 layer, and 5 dealer flocks) and 126 backyard flocks. Epidemiological investigations concluded that the pullets were infected at the time of delivery and subsequently spread the infection to the receiving farms. Movement of infected birds by two poultry dealers spread Newcastle disease to five commercial flocks and 126 backyard flocks.

In October 2005, Denmark diagnosed Newcastle disease in a single flock of breeder hens. In this case, wild birds were considered to be the most likely source of the disease ; however, the results of the epidemiological investigations were inconclusive. Vaccination against the disease is now fully implemented in Denmark , and no additional outbreaks have been reported

. APHIS extensively reviewed the 2002 outbreak in Denmark and

found that the ND V was the same strain implicated in Denmark’s 1995, 1996, and 1998 outbreaks, as well as the same strain isolated in 2000, 2001, and 2002 from wild birds in Denmark. The appearance over time of the same Newcastle disease viral strain suggests that a viral reservoir may exist and observed that all four primary infected flocks were located within 2 km of the coastline [3, 22, 27 ].Page 18 of 58 In 2000, Italy diagnosed Newcastle disease in the Piemonte Region , and over a 6 -month period 257 small flocks in several regions of northern and central Italy were identified as

in fected [37, 43, 45] with the virus. The epidemiological investigation indicated that the

disease s pread from a single hatchery that supplied backyard flocks. Birds of a number of species and categories, including layers, turkeys, guinea fowl, and pheasants in these

small mixed species flocks were infected. More recently

, Italy reported a total of five

small outbreaks of Newcastle disease in pigeons in 2006, 2007, and 2008 [1, 43, 45].

Newcastle disease in pigeons in the EU

In the late 1970’s a Newcastle panzootic was attributed to pigeons. It is thought that the

contact between birds at races and shows and the large international trade in these type s of bird s spread the virus, eventually causing infection in 24 countries, remaining primarily in pigeons. Feed contaminated with droppings from infected pigeons was implicated in an outbreak in commercial poultry in the United Kingdom (UK) in 1984.

The disease is now enzootic in racing pigeons in many countries and regularly spreads to

wi ld pigeons, proving a continuing threat to poultry [1, 2, 40, 47].

The variant pigeon paramyxovirus variant subtype 1 is referred to as PPMV -1 to distinguish it from the avian paramyxo virus (APMV-1) that causes most of the virulent

Newcastle disease in po ultry . Isolates of the pigeon

- adapted NDV (PPMV -1) have been genetically

- sequenced and results show a pattern of amino acids at the cleavage site which is compatible with the pattern of virulent Newcastle disease viruses butcharacterized by unique monoclonal antibody binding profiles [40, 47]. The pigeonadapted or pigeon variant strain of the virus has caused numerous outbreaks in pigeons in

various EU- MS . NDV has frequently been recovered from pigeons in the United States ; however, to date , there have been no reports of the strain in commercial poultry in the

U nited States [40, 47]

Pigeon rearing and sports are very popular and widespread activities in the EU with lofts located in areas ranging from the most rural to the most urban. The pigeon sports include racing over long distances. Wild pigeons, too, are scattered throughout the area providing ample opportunities for contact with domestic birds. The EU has long recognized the risk

associated with the movements of racing pigeons and other birds kept in captivity and specifically included this population in the Community measures for Newcastle disease

control found in Council Directive 92/66/EC. V accination for Newcastle disease of all pigeons at registered racing meets and exhibitions is o ne of the specific control measures in place

. Ho wever, while immunity derived from vaccination may provide some resistance to infection it does not prevent infection and does not eliminate the risk of infection in pigeons. Vaccination can decrease the severity of infection, but infected birds

may shed virus and serve as a source of infection to other avian populations. Biosecurity measures in place at commercial poultry operations serve to prevent contact between wild birds and commercial poultry.

In 2008, the EU -25 reported limited detections of the pigeon variant of NDV in Finland, Germany

, and Italy [1, 45] . In Germany , the pigeon variant Newcastle disease was found on a holding with a mixed bird population; however; however, only pigeons werePage 19 of 58 infected a nd were considered to be the source. Italy reported the pigeon variant

N ewcastle disease on two pigeon holdings; one of these holdings also had a small number of other poultry (33 total birds). Fin land detected PPMV -1 in six interrelated pigeon holdings that occurred in areas with very little commercial poultry ; an e pidemiologic investigation was done on all holdings within 10 km. In 2007, pigeons were the source of outbreaks in Belgium ( eight isolations), Italy (two isolations ) and the one in the Czech Republic which was transferred to Slovakia. In 2006, the pigeon variant was responsible for outbreaks in Italy (homing pigeons), the UK ( contact with wild pigeons), and France in fattening pigeons in contact with wild pigeons.

M ovement restrictions are p ut in place for all detection s or suspicions of pigeon variant

N ewcastle disease in racing pigeons. Confirmation of the presence of NDV results in epidemiological investigation with tracing of animal movements and surveillance of birds and poultry in the surrounding area. Laboratory confirmation with virus characterization

is attempted for all incidents

.

EU controls and recent HPAI outbreaks

Council Directive 2005/94 /EEC defines AI for th e purposes of regulation as an infection of poultry or other captive birds caused by any influenza A virus which has an intravenous pathogenicity index in six

- week -old chickens greater than 1.2 or any infection with influenza A viruses of H5 or H7 subtype for which nucleotide sequencing

has demonstrated th e presence of multiple basic amino acids at the cleavage site of the hemagglutinin.

HPAI is a notifiable disease in the EU

. Immediate notification of the competent authority of the MS and EC is compulsory for any suspected or confirmed presence of AI as required by Council Directive s 82/894/EEC and 92/40/EC. All detection s of the virus confirmed in poultry or other captive birds are immediately reported to ADNS , making

the information available to all MS.

EU regulations specify the notification requirements, preventive biosecurity, surveillance programs, and epidemiological investigation of all suspected cases and the killing of birds upon confirmation of the disease. All items able to spread the disease (live birds,

eggs, meat present on the holding, litter, manure, etc.) must be destroyed and the holding cleaned and disinfected using approved disinfectants in compliance with the instructions of the official veterinarian. A 3 km protection zone and a 10 km surveillance zone are established around the affected holding where movement restrictions for live poultry and poultry products are enforced. Epidemiological investigations must be performed to trace back and trace out all movements that could have led to the introduction and spread of

infection.

EU controls and recent HPAI outbreaks After the recognition of the spread of HPAI H5N1 from Asia to Europe in 2005, the EU intensified surveillance for the virus in wild and migratory birds, enhanced systems to detect and report AI

, an d required MS to adopt measures to prevent contact between wild and domestic birds. In October 2005, HPAI H5N1 was found in a captive bird at aPage 20 of 58 quarantine station in the UK prompting the restrictions on the importation of captive

birds fr om third countries found in Commission Decision 2005/760/EC. By the end of 2005, HPAI H5N1 had been reported to OIE in several countries very near the EU-25, including Croatia, Romania, Russia, Turkey, and Ukraine [24, 35-36, 38, 43, 45].

In 2006, HPAI H5N1 was reported in wild birds in 14 of the EU-25 MS. Wild bird

isolations of HPAI H5N1 were made in the following regions: wild swans in Austria, Bulgaria, Czech Republic, Germany, Greece, Hungary, Italy, Poland, Slovakia, Slovenia,

and the UK ; wild ducks in France, Spain, and Sweden; and a ( wild ) buzzard in Denmark [36, 38]. The presence of HPAI H5N1 was made in domestic poultry in France, Germany

, and Sweden.

The first detection of HPAI H5N1 in domestic poultry in the EU- 25 was i n February 2006, in a flock of breeding turkeys in France. The outbreak was located within the 3 km protection zone established following the detection of HPAI H5N1 in a wild duck. In

March , Sweden confirmed HPAI H5N1 on a game bird (duck) breeding farm within a 10 km zone set up for the detection in wild birds. I n April , German authorities confirm ed the presence of HPAI H5N1 in domestic poultry in a large mixed commercial flock of approximately 10,000 birds (chickens, geese, and turkeys). On May, Denmark detected

HPAI H5N1 in a backyard poultry f arm , and in June, Hungar y detected HPAI H5N1 on a holding of g ee se. [5, 19, 35-36, 43]

In 2006, e xtensive AI surveillance a lso found the presence of several LPAI strain s in the following MS : LPAI H5N2 in Denmark ( farmed game birds ) and Portugal ( free range ducks); LPAI H7N3 in the UK ( broiler breed er farm ); and LPAI H7N7 in the Netherlands and Hungary (farmed geese) . [36-37, 43]

In 2007 and 2008, HPAI H5N1 was reported in Czech Republic, France (wild swans only), Germany, Hungary, Poland, Slovenia, a nd the UK . Germany confirmed the presence of HPAI H5N1 in wild swans and numerous wild birds followed by detections in backyard poultry and a duck farm with 170,000 ducks. The Czech Republic confirmed HPAI H5N1 in a wild swan, as well as a commercial turke y holding, two broiler farms, and two breeding hen farm s. Hungary reported HPAI H5N1 in several flocks of domestic geese. The UK reported an outbreak of HPAI H5N1 on a commercial turkey farm. In 2007, LPAI was reported in the following MS : LPAI H7N3 in Ita ly (a holding with 2,000

ornamental birds with ducks, geese, pheasants, peacocks, ostriches, etc.); and LPAI

H7N2 in the UK in backyard poultry flock. [5-10, 12, 19, 35-36].

In 2008, Germany was the only EU-25 MS to report the presence of HPAI H5N1 in

dom estic poultry (mixed poultry holding). The UK was the only MS to report H5N1 in

wild swans , but the UK also detected HPAI H7N7 in poultry. Several MS reported the presence of several subtypes of LPAI in 2008 : Germany reported a number of LPAI H5N3 positive flocks; Belgium reported LPAI H5 in two holdings of geese ; and Italy

found LPAI H7N1 in a flock of laying hens. In the first 4 months of 2009, the only report of HPAI H5N1 was a wild duck in Germany. During this time, Germany confirmed the presence of several subtypes of LPAI , including a single detection of LPAI H7H7 on aPage 21 of 58 turkey holding and more than 30 detections of LPAI H5N3 ; France reported LPAI H5 subtype on a holding with 5,000 breeding ducks ; t he Czech Republic reported LPAI H7 ; and Italy reported LPAI H5 on poultry a fattening turkey holding.

Worldwide, the presence of wild birds infected with the AI virus continues to pose a risk for the introduction of the AI virus into domestic poultry. In reviewing the H PAI H5N1

situation in the EU during the 2006 – 2009 outbreaks, it was found that swans, especially mute swans ( Cygnus olor ), were most frequently involved [3 5] . The exception occurred

in Germany during 2007; grebes were the most frequently affected species

, wh ile swans in the same area were not affected. In 2006, HPAI H5N1 was also isolated from grebes in Spain, Denmark, and Sweden [36-37 ].

EU quarantine decisions with respect to areas affected by Newcastle disease or HPAI would provide the basis for U.S. import restrictions

E xisting APHIS regulation s (9 CFR 93.205) require that a ll poultry, except eggs for hatching, offered for importation from any region of the world , regardless of N ewcastle

disease or HPAI status, b e accompanied by a certificate signed by a salaried veterinary officer of the national government verifying that the poultry and flocks of origin were inspected on the premises of origin immediately before the date of movement. The

certification must also state that the region of origination w as free of evidence of communicable diseases of poultry, including N ewcastle disease or HPAI , for the 90 days prior to movement. APHIS requires import certificate s only be issued for birds not exposed to N ewcastle disease or HPAI and not originati ng from a premise located in any area under quarantine during the preceding 90 days.

Th e 90- day period is consistent with international standards for regaining notifiable avian influenza ( NAI ) free status in a previously free country or zone after a stamping -out policy with depopulation, cleaning and disinfection of all affected establishments , and supported by appropriate additional surveillance [44]. However, EU regulations allow

N ewcastle disease and HPAI restriction and protection zones to be removed as early as 21 days after completion of cleaning and disinfection measures on the affected holding if approved by the veterinary authorities. The Terrestrial Animal Health Code considers an

area to be affected with N ewcastle disease until at least 21 days after the confirmation of the last case and the completion of a stamping -out policy and disinfection procedure s have been completed . The Code also considers 21 days to be the incubation period for both END and AI [44]. APHIS will continue to apply the 90-day standard under this proposal and prohibit the importation of poultry or poultry products originating from any

restriction area established following the detection of either N ewcastle disease or HPAI in commercial poultry until 90 days after the cleaning and disinfection of the last affected

establishments

.

Current APHIS regulation s require that imported live birds or poultry undergo 30- day quarantine at a USDA Animal Import Center (§§ 93.106 and 93.209), and be tested for

both N ewcastle disease and AI before being released. Hatching eggs imported from regions recognized to free of N ewcastle disease and HPAI are not required to be quarantined; however, they must be accompanied by a veterinary health certificate issuedPage 22 of 58 by a nati onal government veterinarian of the exporting country as well as by a USDA import permit . Hatching egg s may not enter from HPAI-affected regions and must also originate from birds that were not vaccinated for H5 or H7 subtypes of AI. Hatching eggs

from regions not considered to be f ree of N ewcastle disease must be hatched and brooded under the supervision of the AVIC in the State of destination. The hatchery must meet certain biosecurity standards and be inspected and approved by the AVIC prior to

issuan ce of the import permit . A fter hatching , t he derived poultry must be in quarantine for not less than 30 days

. During quarantine, the hatching eggs and derived poultry are subject to appropriate inspections, disinfections, and diagnostic testing to determin e that they are free from communicable disease.

N ewcastle disease and HPAI remain endemic in many countries o f Asia, the Middle East, Africa, and Central and South America [ 43]. The potential for N ewcastle disease or HPAI introduction into the EU-25 via the migration of infected wild birds from endemic

areas deserves consideration . Howev er, t his potential exists world -wide and is not unique

to the EU. APHIS is not aware that it is a particular concern in the EU -25 ; therefore

, APHIS does not consider this as a critical issue for this evaluation.

Reintroduction of N ewcastle disease or HPAI into the EU -25 may also occur through legal trade of poultry or poultry products if imported commodities are infected with

N ewcastle disease or AI . This is a potenti al risk because the EU trades with countries or regions that the United States does not recognize as free of N ewcastle disease or HPAI

. In keeping with APHIS policy regarding the risk presented by the commingling of animal products when a country recognized as disease

- free supplements its supply with animals or products from regions not recognized by APHIS as disease

- free , a s a safeguard APHIS will require certain certifications by the exporting country which will be incorporated into

the requirements for importation from the EU-25.

APHIS will require certification to ensure that poultry and poultry products from the

EU -25 originate in the EU-25, or in any other region recognized by APHIS as free of

N ewcastle disease and HPAI, and that prior to export to the United States, such poultry and poultry products are not commingled with poultry and poultry products from regions

where N ewcastle disease or HPAI exists.

Previously, based on risk analysis and implemented in rulemaking, APHIS recognized effective Administrative Units (AU) at the sub

- national level within the EU with effective control over classical swine fever (CSF) and applied the concept of regionalization to the

AU level for other animal disease s [25 ]. The approach is consistent with APHIS’ obligation under the World Trade Organization Agreement on Sanitary and Phytosanitary Measures to recognize disease

- free areas as well as areas of low disease prevalence for which mitigations can be established to reduce risk [29]. The AU for the remaining MS were identified during site visits, as listed in Appendix D.Page 23 of 58 C ONCLUSIONS APHIS considers the risk of N ewcastle disease or HPAI from live poultry, hatching eggs

, and poultry products to be low under the conditions described in this document. APHIS

considers the EU control measures to be effective , and that the conditions with regard to

N ewcastle disease and HPAI in the EU-25 have either remained constant or improved, despite the potential viral reservoir in wild birds and the infrequent, but continuing, outbreaks in domestic pigeons or poultry. Acknowledging that the EU N ewcastle disease and HPAI control measures are harmonized and binding on all EU -25 MS, APHIS recognizes the EU -2 5 as a single region for N ewcastle disease and HPAI for which restrictions can be placed on exports that are appropriate for a region in which APHIS expects that N ewcastle disease or HPAI outbreaks will continue to occur.

Since many of the appropriate restrictions reflect EC quarantine decisions, APH IS is willing to recognize the EC quarantine decisions to define restriction and affected zone boundaries. However, APHIS does not consider the 21-day duration of quarantine found in EC regulation to be sufficient for restriction zones. Rather, it consider s it necessary to require there be no exportation from the quarantine areas imposed when N ewcastle

disease or HPAI has been detected in a domestic poultry flock for 90 days.

In summary, APHIS will address N ewcastle disease and HPAI risk from the EU-25 using the following approach:

**•** It will expand the scope of the restrictions currently defined in 9 CFR 94.6 that apply to Denmark, France, Great Britain (England, Scotland, Wales and the Isle of Man), Greece, Luxembourg, Republic of Ireland, Spain, and Sweden to all EU

25 Member States

.

**•** It will require the competent veterinary authority of the individual EU -25 MS to provide certification that the poultry, including hatching eggs, exported to the

United States or the poultry from which exported products were derived had never lived in a region of the EU-25 under restrictions for N ewcastle disease or HPAI

. T his certification will apply the EC definition of the borders of the relevant region as a restricted zone and recognize EC authority to maintain adequate co ntrols as described previously in this document. Specifically, the restriction zone will

encompass all protection, surveillance , and buffer zones established around

N ewcastle disease or HPAI outbreaks in domestic poultry and affected zones established arou nd N ewcastle disease or HPAI outbreaks in wild birds.

**•** Certification will require that the birds , or the birds from which hatching eggs

were derived

, were not vaccinated for subtypes H5 or H7 AI viruses.

**•** For the purposes of export to the United States, it will require the competent veterinary authorit ies of the EU -25 MS to certify that no commodities originated

from

, or were comingled with

, commodities from a restriction zone established

because of N ewcastle disease or HPAI in domestic poultry for a period of 90

da ys

.Page 24 of 58 E XPOSURE A SSESSMENT The Terrestrial Animal Health Code states that the Exposure Assessment is a description

of the biological pathway(s) necessary for exposure of animals and humans in the importing country to the hazards (in this case the pathogenic agents N ewcastle disease and HPAI) released from a given risk source, and estimating the probability of the exposure(s) occurring [44]. If the release assessment demonstrates no significant risk, the risk assessment does not need to continue; however, for the sake of thoroughness, APHIS continued the risk assessment process and conducted an exposure assessment.

This exposure assessment is based in large part on an analysis of historical information regarding N ewcastle disease and HPAI outbreaks in the United States. Of particular note

were the N ewcastle disease outbreaks that occurred in 2002 and 2003 in several western

States. Earlier N ewcastle disease outbreaks were also examined to the extent that relevant

information was available. N ewcastle disease and HPAI have similar epidemiological characteristics and review of the possible pathways of introduction of N ewcastle disease

is relevan t to risk [2 7, 32].

In this regard, we consider data reflecting real events occurring during outbreaks in the United States to be the most legitimate model for this exposure assessment. Historical information provides valuable insight into the past and potential pathways of entry, exposure, and mechanisms of disease spread in the United States. This exposure assessment therefore uses such historical information to prioritize potential risk pathways

for N ewcastle disease and HPAI introduction and spread.

Pathways of introduction and spread in the United States

Historical information from N ewcastle disease and HPAI outbreaks in the United States is presented here in order to identify the most likely pathways of disease introduction, as well as risk factors influencing the spread of N ewcastle disease and HPAI once introduced. Possibilities for mitigation of identified risk factors are also considered. The historical information is further used to provide a basis for the economic section of the consequence analysis which is derived from actual costs incurred during at least some of

these outbreaks.

The United States has experienced multiple N ewcastle disease outbreaks over the last 50 years ( see table 1 ) [ 27, 29, 32-33 ]. Of note is the fact that the disease was most likely introduced through live birds in all cases except for one incident in 1973, involving hatching eg gs from Hungary. Live birds implicated in N ewcastle disease outbreaks entered the United States through either legal or illegal channels. In the case of HPAI,

recent outbreaks have been the result of contact with infected wild birds and not the result

of i ntroduction of the viral agent through importation of the live birds or products.

Review of Newcastle disease outbreaks An extensive, multistate N ewcastle disease outbreak occurred in commercial poultry in 1971, which lead to the development of regulations to control the importation of live poultry. Introductions through legal pathways declined substantially after regulations to require quarantine of imported live birds in facilities operated or approved by APHISPage 25 of 58 were implemented in 1972. The approval of private quarantine facilities in 1979

e ssentially eliminated this risk pathway. The dramatic decrease in N ewcastle disease introductions is apparent in the table below. The quarantine process also mitigates the

ri sk of importing HPAI through legal importation of live birds and poultry.

The most extensive N ewcastle disease outbreaks in the United States involving commercial poultry occurred in 1971-1973 and 2002-2003. In November 1971,

N ewcastle disease was introduced into the United States via a shipment of Mexican double yellow -headed parrots from South America to a pet bird importer located in the city of Fontana, California. At that time there were no quarantine requirements for imported birds and some of the infected birds escaped and exposed the dense population of backyard flocks and commercial poultry flocks in the area to the N ewcastle disease virus. The outbreaks subsequently spread to involve much of southern California before

containment in 1973.

In 2002, N ewcastle disease was introduced into a California backyard flock and later appeared in Arizona and Nevada, most likely seeded from the California outbreaks. Although overlapping chronologically, the 2003 outbreak in Texas is thought to have resulted from a separate introduction of N ewcastle disease , possibly through unauthorized movement of game fowl. This hypothesis is based on the observation that the type of virus isolated in Texas differed from that found in the other affected States.

Table 1. History of Newcastle disease introductions into the United States [2 7]

Date Place of Outbreaks Exposure Pathway

1950 (Apr) Contra Cost a County, CA Chukars and pheasants imported from Hong Kong 1970 (Aug) Bronx, NY Quaker parrots from Paraguay
1970 (Aug) Clint, TX Domestic chickens
1970 (Sept) Blackstone, MA Domestic chickens
1971 (Apr) Las Cruces, NM; El Paso, TX Domestic chickens
1971 (Apr) Largo, FL Mynah bird from Thailand
1971 (Sept) Dade County, FL; Sonoma County, CA Domestic game chickens
1971 (Oct) Miami, FL Commercial and game birds
1971 (Nov) Manchester, CT Parrot from Paraguay
1971 (Nov) Fontana, CA Parrots imported from South America
1971 (Dec) Puerto Rico Commercial and game chickens
1972 (Feb) Chicago, IL Parrot of unknown origin
1972 (Apr) Parker, AZ Game chickens
1972 (Apr) Atlanta, GA Parrot from Mexico
1972 (May) Kingman, AZ Fancy chickens
1972 (May) Dade and Broward Counties, FL Commercial and game chickens
1972 (June) Los Angeles, CA Exotic birds from Thailand
1972 (July) Los Angeles, CA Exotic birds from Thailand and Columbia
1972 (July) Denver, CO Parrot from Mexico
1973 (Jan) Los Ebanos, TX Game chickens
1973 (Sept) Somerset, KY Hatching eggs from Hungary
1974 (Feb) El Paso, TX Domestic and game chickensPage 26 of 58 1974 (May) Hidalgo, TX Domestic chickens
1974 (May) Bulverde, TX Parrots from Mexico
1975 (Mar) Long Island, NY Pet bird dealer
1975 (June) Pharr, TX Domestic chickens

1977 (Feb) Charlotte Courthouse, VA; San Diego,

CA Pet birds

1977 (July) Kaneohe, HI Pet birds

1980 Florida and 22 other States Pet birds
1991 (Apr) MI

, IN

, IL

, TX Double yellow

- headed Amazon parrots
1992 (Aug) ND Migratory cormorants
1998 (May) Fresno, CA Game fowl (never established)
2002 (Oct) CA

, AZ, NV Game fowl (never established)
2003 (Apr) El Paso C ounty

, TX Game fowl

In summary, the majority of introductions of N ewcastle disease into the United States are thought to have been associated with live birds, although one was apparently associated with hatching eggs. None of the introductions have been known to be associated with other poultry products, such as meat. Historical experien ce in the United States therefore suggests that importation of live birds represents a far more likely initial exposure pathway than poultry meat or products.

Review of HPAI outbreaks

In contrast to N ewcastle disease

, AIV s of all known subtypes can be fo und in wild ( feral ) birds, especially migratory waterfowl such as ducks and geese. The outbreaks of both HPAI and LPAI in domestic poultry appear to be the result of introduction initially from

wild birds. Although in fl uenza viruses are isolated from domestic poultry in some countries, it is not considered that these viruses are enzootic in turkeys or chickens. However, once introduced to domestic poultry the influenza virus can be spread from flock to flock under poor biosecurity conditions [ 2, 4].

The fi rst HPAI outbreak (H7) in the United States was identified in 1924 in several ea st

c oast live bird markets (LBMs) and was rapidly eradicated. In 1983-1984, an extensive

outbreak of HPAI H5N2 occurred in Pennsylvania, Maryland, New Jersey, and Virginia

and resulted in destruction of 17 million chickens, turkeys, and guinea fowl . The cost to
contain and eradicate the disease was more that $60 million. The virus involved was

isolated from 24 flocks . Initially classified as LPAI , the virus changed to HPAI duri ng th e

cours e of the outbreak. Additionally, some flocks exhibited mixed infections with both

HPAI and LP AI forms of the virus [46 ].

In 2004, USDA confirmed an HPAI H5N2 outbreak in a flock (6,600) of chickens in Gonzales County, Texas. Although the clini cal manifestations in the infected flock were

consistent with AI caused by a LPAI, the virus (A/chicken/Texas/298313/04) was classified as a HPAI virus by genetic sequencing [41, 46]. Extensive epidemiologic investigation identified infected birds in two live -bird markets in the area of Houston,

Texas

, which were depopulated , and cleaned and disinfected. Extensive follow up testing found no other positive flocks with no indication that the virus continued to circulat e.Page 27 of 58 Other notable outbreaks of HPAI hav e occurred in the following Western Hemisphere

locations: Canada during 1966 ( H5N9 ), 2004, and 2007 ( H7N3 ); Mexico during 1994- 1995 ( H5N2 ); and Chile in 2002 ( H7N3) (See Table 2) [4 6].

Table 2. Occurrences of HPAI in the Western Hemisphere since 1960 : [41, 46, 47]

Year Location Species Subtype

1966 Canada (Ontario) Turkey H5N9

1983–1984 United States (Pennsylvania, Maryland, New Jersey

, and Virginia) Chicken H5N2

1994 Mexico Chicken H 5 N2

2002 Chile Chicken H7N3

2004 Canada (British Columbia) Chicken H7N3

2005 United States (Texas) Chicken H5N2

2007 Canada ( Saskatchewan) Chicken H7N3

Canada - The 1966 H5N9 outbreak in Canada was limited to two flocks of turkeys with low mortality but the virus was found to be highly pathogenic to chickens. In 2004, in the H7N3 outbreak in the Frasier Valley of British Columbia, over one million infected birds

were identified on 42 affected commercial poultry fa rms and 11 backyard flock over a 4

- month period. An additional 16 million birds were depopulated to control the outbreak, and a 51-day downtime was enforced before restocking. In 2007, H7N3 was found in a single broiler breeder flock in southern Saskatchewan Province about 150 miles from the border with Montana [47-48].

Mexico

- In Mexico during 1994-1995, H5N2 LPAI was diagnosed in 11 Mexican S tates. In late 1994, the pathogenicity index of virus changed to HPAI. Control of the HPAI was complicated by the widespread concurrent infection with LPAI virus and measures including use of an inactivated H5N2 vaccine were put in place [46]. In 2002, outbreaks

of the H7N3 virus w ere initially determined to be LPAI but one month later the same

farm was determined to have HPAI H7N3 . The mutation from LP AI to HP AI was presumed to have occurred on the index farm and further characterization of the virus found that it was not closely related to previous North American H7 AI viruses.

In summary, in the United States HPAI introduction s are thought to be associated with live birds, primarily wild birds. None of the introductions have been known to be associated with other poultry products, such as meat. Historical experience in the United

States with both N ewcastle disease and AI suggests that importation of live birds represents a far more likely initial exposure pathway than poultry meat or products.

Commodity factors for Newcastle disease and HPAI Commodity factors that are relevant to an exposure assessment include the type and quantity of the commodity to be imported, the intended commodity use, disposition of the products in the region, and waste disposal procedures. The potential amount of poultry meat imported from the EU is expected to be relativ ely low.Page 28 of 58 Although the precise disposition of the imported poultry product is as yet unknown, it is

reasonable to assume that it will enter common wholesale channels for distribution to restaurants, retail markets, and other institutions. Usage patterns a nd waste disposal procedures would be expected to follow common practices in the United States. In this regard, exposure of domestic poultry populations through waste feeding to backyard flocks or other channels cannot be precluded. However, based on histo rical data, APHIS considers this to be a far less likely exposure pathway than introduction via live birds.

Pathways of spread of Newcastle disease

Historical accounts of N ewcastle disease outbreaks in the United States also provide significant informatio n regarding likely pathways and extent of disease spread after introduction. In this regard, the 1971-1973 and 2002-2003 outbreaks are examined here in greater detail.

As mentioned above, N ewcastle disease was introduced into the United States in November 1971 via a shipment of Mexican double yellow-headed parrots from South America, some of which subsequently escaped and exposed domestic flocks. Once the disease was introduced into commercial poultry, it spread rapidly throughout southern California. The disease threatened not only the California poultry industry but the entire

United S tates poultry and egg supply.

The 2002 introduction of N ewcastle disease into California initially caused outbreaks primar ily in backyard flocks (flocks with small numbers of birds on private premises for hobby, exhibition, and personal consumption) in a predominantly immigrant communit y. The types of birds involved included game fowl, pet birds, ostriches, and waterfowl.

How ever, the N ewcastle disease virus ultimately spread from backyard flocks to commercial facilities for laying hens as well.

The disease also spread from California to Arizona and Nevada, most likely through unauthorized movement of infected game fowl. In Arizona and Nevada, the primary facilities involved were backyard flocks of game fowl or poultry. No commercial poultry

were infected in either Arizona or Nevada, possibly due to a lack of interaction between

infected backyard flocks and the small number o f commercial facilities in the area. Similarly, there was no significant spread as a result of the 2003 outbreak in a backyard flock of game fowl in Texas, and no commercial facilities were affected.

The epidemiological investigations of both the 1971-1973 and the 2002-2003 N ewcastle

disease outbreaks identified four primary pathways of disease spread: (1) movement of infected birds, (2) movement of infected products (eggs), (3) movement of contaminated equipment, and (4) movement of people. In the 1971-1973 outbreaks, there was strong epidemiological evidence that an organized effort to vaccinate all birds in southern California contributed as much to disease spread as any other factor. This occurred as personnel untrained in disease prevention methods tr aveled rapidly between premises with poor biosecurity, often carrying the virus with them and exposing other premises in

the area.Page 29 of 58 In the 2002-2003 outbreaks, appropriate biosecurity measures were implemented to prevent the task force personnel from act i ng as vectors for disease spread. In this outbreak, vaccination was not used as a component of the control and eradication plan. Despite extensive outreach and public education efforts, movement of birds and eggs, equipment sharing among farms, and employee contact with off- farm poultry were subsequently identified as significant factors in disease spread. The extent of disease spread was further influenced by proximity of neighboring infected backyard flocks and the presence of a commercial poultry industry in the area. A risk factor influencing the likelihood of exposure in a backyard flock was the presence of game fowl on a premise with a large flock size. Presence of feral chicken on the premises may also have contributed to disease spread.

Pathways of spread of HPAI Historical accounts of HPAI outbreaks in the United States also provide significant information regarding likely pathways and extent of disease spread after introduction (see table 2). Of particular interest are the 1983 –1984 and 2004 outb reaks in the United States

. In the 1983-1984 HPAI outbreak , the epidemiological investigation identified four primary pathways of disease spread: (1) movement of contaminated transportation and equipment; (2) movement of infected birds (live and dead); (3) movement of contaminated feed, eggs, and water ; and (4) movement of people [2, 46 ].

Following the introduction of the HPAI virus into domestic poultry the potential pathways of spread are similar to associated with N ewcastle disease . Biosecurity

meas ures and routine surveillance in current practice are directed to rapidly identifying and preventing the spread of viral agents and work well for HPAI. Nearly 100 percent of

the comm ercial poultry industry participates in the National Poultry Improvement P lan ( NPIP ) AI programs , including primary breeding operations and commercial production

flocks. NPIP is a cooperative Federal/State/industry program supporting the AI Clean Program for AI surveillance in poultry breeder flocks; the H5/H7 LPAI Program in

Co mmercial Poultry; and the LPAI Prevention and Control Program for LBMs.

In September 2006, in response to recent changes to the Terrestrial Animal Health Code regarding notification for H5 and H7 LPAI, NPIP implemented a new H5/H7 LPAI control program for commercial table -egg layers, broilers, and turkeys. Th is program is

for commercial birds a s an active surveillance program conducted at table

- egg layer houses, broiler and turkey flocks, and poultry slaughter plants. H5/H7 LPAI is a reportable disease and all d iagnostic laboratories are required to test all submitted cases of unexplained respiratory disease, egg production drop, and mortality for AI.

APHIS has a Memoranda of Understanding in place with 49 Official State Agencies to carry out commerci al flock surveillance through the NPIP. In addition, NPIP has 135 authorized laboratories to conduct diagnostic surveillance. Essentially 100 percent of the commercial poultry industry participates in the NPIP, including both primary breeding operations and commercial production flocks. The NPIP conducts AI surveillance in 250

egg -type chicken breeding flocks, 5,000 meat-type breeding flocks, and 700 turkey breeding flocks.Page 30 of 58 In summary, historical experience in the United States indicates that, once N ewcastle

disease or HPAI are introduced into a live bird population, the most significant pathways of disease spread involve movement of equipment, birds, products, and people. The extent of disease spread depends in large part on biosecurity practices and the de nsity of susceptible populations. In addition, backyard flocks and non- commercial birds may play an important role in disease introduction and spread.

R ISK MITIGATION MEASU RES

Mitigation measures affecting Newcastle disease and HPAI introduction As previously discussed, the most likely pathway of N ewcastle disease introduction into the United States is through legal or illegal importation of live birds. Several N ewcastle

disease outbreaks prior to 1972 resulted from legal entry of imported pet and game birds. These introductions occurred at a time when the United States had no quarantine requirements in place for birds from N ewcastle disease

- affected regions ; therefore, infected birds were released without a period of observation for clinical signs.

In March 1972, APHIS published regulations (9 CFR 93.106) to enhance its import control measures by requiring live birds to be imported under permit through designated ports and subjected to a 30-day quarantine in facilities operated or approved by AP HIS

. The quarantine requirement was further strengthened in 1979 with the addition of

approv ed private quarantine facilities. The legal introduction of infected birds declined significantly after 1972, and has not been documented since the 1979 quarantine requirement was instituted. Although not confirmed, the 1998 exposure was hypothesized to have resulted from illegal entry of an infected bird or birds.

Except for special provisions for birds from Canada or birds returning after being gone for less than 60 days, all live birds must go through a quarantine period when they enter

the United States. Birds originating from the United States that have been out of the country for more than 60 days are kept for a minimum of 30 days in a USDA quarantine facility or a private USDA -approved quarantine facility or home quarantine.

Poultry imported under quarantine are brought directly to the quarantine facility in a sealed truck. USDA personnel perform inspections and testing of birds in both the APHIS

and private quarantine facilities. Cloacal swabs are taken from the birds to test for

N ewcastle disease and HPAI via virus isolation. If the tests are positive, a re- test is performed. The quarantine period may be extended at the discretion of the USDA management. If the birds test negative, they can be released after the end of the quarantine period. If positive, they may be destroyed. The birds are held for a sufficient period of time that exceeds the incubation period of N ewcastle disease or HPAI , so that

t he likel ihood that infected birds could remain undetected throughout the quarantine process is very low.

APHIS considers the risk of N ewcastle disease or HPAI introduction through legal importation of live birds to be effectively mitigated by the quarantine meas ures currently in place in the United States. The risk of illegal importation of live birds would logically be highest where land borders are shared. Illegal importation of live birds from the EU-25Page 31 of 58 would be technically difficult because of the travel dist ance between the two countries and inspection procedures at airports and seaports. APHIS therefore considers the likelihood of illegal introduction of live poultry from the EU-25 to be very low.

While the N ewcastle disease and HPAI viruses can be transmitted in poultry meat, APHIS considers the likelihood that disease would be detected clinically in the EU-25 prior to arrival of the product in the United States to be relatively high. While most commercial poultry in the EU -2 5 are routinely vaccinated for N ewcastle disease , most backyard birds are not such that these backyard flocks serve as sentinel animals for detecting N ewcastle disease outbreaks in the broader poultry population. Extensive

surveillance for AI is conducted in the EU-25 and has been very effective in identifying the presence of all forms of AI, as discussed previously.

Mitigation measures affecting the spread of Newcastle disease or HPAI after

introduction Epidemiological investigations of the outbreaks in the United States have identified several potential and confirmed pathways of avian disease spread, most notably movement of people, live birds, products, and equipment [2, 27, 29, 33 ]. Epidemiological investigations done in the U nited States and internationally have suggested that the likelihood of spread after N ewcastle disease or HPAI are introduced is increased when the following factors are present:

**•** A large commercial poultry industry exists in the region.

**•** Backyard flock sizes are relatively large.

**•** Backyard flocks are commonly present.

**•** Feral chickens (or other wildlife that could serve as vectors) exist in the region.

**•** Areas of concentration are common and interrelated.

**•** Cockfighting is practiced in the region.

**•** Reporting of clinical or suspect case s is slow or delayed.

**•** Poultry and poultry products can be introduced illegally from affected regions.

**•** Biosecurity measures are ineffective.

**•** Movement control measures are insufficient.

**•** Surveillance is inadequate.

Specific mitigations have been developed in the United States that address some, but not all, of these risk factors. Mitigation measures have included implementation of biosecurity measures by producers to reduce the probability of contact with infected birds, public awareness campaigns to faci litate biosecurity and disease reporting, and cleaning and disinfection of vehicles, equipment, and people moving among facilities. Such procedures, which are routine for commercial poultry facilities, can be readily enhanced significantly under outbreak conditions. Cockfighting is now banned in the entire United States. The Animal Welfare Act as modified by the Farm and Security

Rural Investment Act of 2002 prohibits sponsorship or exhibition of animal in an animalPage 32 of 58 fighting venture, if the animal was moved in interstate or foreign commerce. APHIS highlighted this law by publication of a FR notice in 2003 [30]. However, although this may have some risk mitigating effect, it is likely that cockfighting and the associated movement of game birds continues illegally at an unknown level.

APHIS has standard practices and requirements in place for reporting suspect cases of

disease at the F ederal level. APHIS has also taken actions to increase the awareness of the need to report suspicions of animal disease among the general public. Under outbreak conditions, APHIS cooperates in outreach programs in affected areas to educate the public in order to facilitate disease recognition and reporting, as well as to emphasize appropriate biosecurity measures.

APHIS a lso increases its routine surveillance activities during outbreak periods and includes small poultry holdings that are not part of other surveillance programs as well as

increased wild bird surveillance. APHIS has in place contingency plans for outbreak

si tuations to mitigate the risk of disease spread and most effectively facilitate the rapid

allocation of appropriate resources to identified risk areas during outbreak periods.

While the events in the 1983-1984 HPAI outbreaks and 2002 and 2003 N ewcastle disease outbreaks demonstrate that these risk mitigation activities do not eliminate disease spread once introduction has occurred, it is highly likely that they mitigate the extent of spread.

E XPOSURE S UMMARY Given the results of the release assessment, APHIS considers the likelihood of

introduction of N ewcastle disease or HPAI -infected birds and products from the EU-25 to be extremely low. Historical experience indicates that the likelihood of N ewcastle disease or HPAI introduction is substantially higher for live birds than for other commodities, including poultry meat. APHIS considers that the quarantine requirements currently in place are sufficient to mitigate the risk posed by legal importation of live birds. The likelihood of illegal importation of live birds from the EU-25 is quite low based on travel distance and current inspection practices. Furthermore, a change in the N ewcastle disease

status within the EU

- 25 is unlikely to substantially impact the risk of illegal importation

of live birds.

S ignificant direct and indirect mitigation measures are currently in place in the United

States to address the risk of N ewcastle disease or HPAI spread should introduction occur. Major pathways of disease spread include movement of people, birds, products, and equipment; however, the extent of spread is influenced by a number of other factors. Based on current conditions, and depending on the local circumstances, substantial disease spread could occur if either N ewcastle disease or HPAI were introduced to a concentrated susceptible population.

C ONSEQUENCE A SSESSMENT The Terrestrial Animal Health Code recommends that a consequence assessment include an evaluation of the consequences of importing a foreign animal disease with regard to animal and public health, and also consider relevant environmental and economic factors.Page 33 of 58 Animal health consequences

Ne wcastle disease and HPAI are some of the most severe diseases of poultry throughout the world and its consequences in terms of animal health are significan t [2, 4, 39 ]. Morbidity and mortality rates vary according to the strain of virus, but morbidity may approach 100 percent and mortality may approach 90 percent in susceptible chickens.

Public health consequences In contrast to the severe animal health consequences, direct human health consequences

of N ewcastle disease are minor as N ewcastle disease is not considered to be a significant human pathogen [Appendix A, 33, 39 ]. Disease manifestation of N ewcastle disease in

humans is generally lim ited to conjunctivitis and recovery is usually rapid.

“Human influenza virus” usually refers to those subtypes that spread widely among humans. There are only three known A subtypes of influenza viruses (H1N1, H1N2, and H3N2) currently circulating among humans. It is likely that some genetic parts of current human influenza A viruses came from birds originally. Influenza A viruses are constantly changing, and they might adapt over time to infect and spread among humans [34]. The

risk from AI is generally low to most people, because the viruses do not usually i nfect humans. However, confirmed cases of human infection from several subtypes of AI infection have been reported since 1997 [Appendix B].

Most cases of AI infection in humans have resulted from direct contact with infected poultry (e.g., domesticated chicken, ducks, and turkeys) or surfaces contaminated with secretion/excretions from infected birds. The spread of AI viruses from one ill person to another has been reported very rarely, and has been limited and unsustained. During an outbreak of avian influenza among poultry, there is a possible risk to people who have

co ntact with infected birds or surfaces that have been contaminated with secretions or excretions from infected birds [34].

Symptoms of AI in humans have ranged from typical human influenza- like symptoms (e.g., fever, cough, sore throat, and muscle aches) to eye infections, pneumonia, severe respiratory diseases (such as acute respiratory distress), and other severe and life

threatening compl ications. The symptoms of AI may depend on which virus caused the

infection [34].

The World Health Organization ( WHO ) has reported cases of H5N1 AI in humans in Asia, Africa, the Pacific, Europe, and the Near East. Indonesia and Vietnam have reported the highest number of human H5N1 cases to date with mortalities of up to 60 percent, especially in cases hospitalized late in the course of the illness . Despite the high mortality, human cases of H5N1 remain rare to date. T he most significant risk factor for

human H5N1 infection is direct contact with sick or dead poultry or wild birds [49].

Environmental consequences Environmental consequences resulting from N ewcastle disease or HPAI introduction occur primarily when there is a need to dispose of large numbers of carcasses due to death from disease or depopulation of flocks. Disposal of large amounts of litter andPage 34 of 58 manure can also be problematic. The environmental consequences in relation to poultry and poultry product imports from the EU-25 were considered negligible as the proposed action would not result in significant adverse impacts, including no extraordinary circumstances which might affect the significance of any potentia l impacts and no cumulative impacts with other related projects that might result in significant adverse impacts. [42]

Economic consequences This assessment of economic consequences is largely based on historical experience in

the United States relative to N ewcastle disease or HPAI outbreaks. The economic data from previous outbreaks in the United States provides the most legitimate approximation of consequences of future outbreaks. Although estimates of the costs of foreign animal

disease eradication fr om other countries are available, information from other countries may not be a good model for the United States. This is because other countries have different production practices and approaches to disease eradication and co ntrol [29, 33 ].

The outbreaks that have occurred in the United States for which economic information is available can be categorized as relatively limited or relatively extensive. This section

examines in more detail the N ewcastle disease outbreaks in 1950 in California and 2002- 2003 in Arizona, Nevada, and Texas as examples of relatively limited disease spread, and

the 1971-1973 and 2002-2003 N ewcastle disease outbreaks in California as examples of relatively extensive disease spread. The distinction was made to provide comparative information on economic consequences under conditions of extensive and more limited disease incidence. The discussion of economic consequences of relatively limited outbreaks is restricted to control and eradication costs, whereas the discussion of

relative ly extensive outbreaks is expanded to include effects on trade and indirect effects on the poultry industry in affected areas.

Relatively limited disease incidence (1950 in California and 2002-2003 in Arizona, Nevada, Texas)

The 1950 N ewcastle disease o utbreaks were limited to five poultry farms in Contra Costa County, California. The infection was quickly eliminated through depopulation of the infected chickens. The control and eradication efforts cost approximately $30,000 in 1950, which is equivalent to approximately $229,000 in 2003 [27, 29, 33].

The outbreaks in 2002-2003 in Arizona, Nevada, and Texas could each be considered representative of a limited incidence with N ewcastle disease infection detected only on a single premise in each of the States of Arizona and Texas, and 10 premises in Nevada. Approximately $3.5 million dollars were spent on eradication efforts in Arizona; $6.2 million in Nevada; and $4.2 million in Texas [46].

Relatively extensive disease incidence (1971 -1973, 2002-2003)

Control and eradication costs

The introduction of N ewcastle disease into southern California between 1971 and 1973

resulted in a major occurrence of the disease [ 33 ]. A total of 1,341 infected flocks were

identified and 12 million infected and exposed birds were destroyed , most ly laying hens.Page 35 of 58 Eradication activities severely disrupted the operations of many producers and increased the prices of poultry and poultry products to consumers.

The eradication effort was coordinated throug h a State

- Federal Newcastle Disease Task Force. Eradication efforts, which continued throughout 1972 and into 1973, cost approximately $56 million

, the equivalent of approximately $232 million in 2003 [29] . A total of 3,102 personnel directly participated in the task force between March 14, 1972, and June 30, 1974.

Eradication efforts for the 2002-2003 N ewcastle disease outbreaks in California, Arizona, Nevada and Texas were also labor intensive and expensive. Spread within the S tate of

California was the most extensive among the four S tates affected. Ultimately, birds from 920 premises in California tested positive for the disease, and nearly 4 million birds were depopulated in California alone. Approximately $168 million had been spent on the

eradication efforts in the four S tates [ 29]. The costs includes expenses for long- term goals and measures such as surveillance and diagnosis; euthanasia, carcass disposal, and cleaning and disinfection; administrative and logistical costs; compensation or indemnification; and personnel costs. Personnel were recruited from various F ederal, State, county, and metropolitan agencies to participate; the effort included approximately 2,780 personnel from the F ederal sector alone.

Effects of the 2002-2003 N ewcastle disease outbreaks on trade

The effects of an extensive N ewcastle disease incidence on U.S. trade can be characterized using information from the 2002-2003 outbreaks ; e cono mic impacts of an extensive HPAI outbreak would be similar. Immediately following the confirmation of

N ewcastle disease in the United States in 2002, trading partners imposed trade restrictions on poultry products that were perceived as posing a risk of exporting

N ewcastle disease from the United States. Live birds; fresh, frozen , or chilled poultry

meat ; and hatching eggs from the United States were commonly banned. At the peak of the incident, 46 countries had imposed restrictions [29, 46].

Direct trade impacts of N ewcastle disease were calculated for the period between October 2002 and September 2003 for five categories of product: live poultry, ducks and geese, poultry meat and offal, hatching eggs, and table eggs [27, 29 ]. The total estimated cost of

the poultry restrictions for the roughly 12 month period of the N ewcastle disease eradication was $121 million, approximately 7 percent of the trade recorded during that period.

This relatively low percent reduction in trade probably reflects the effects of a regionalization approach taken by most countries for imposing restrictions in which live birds and products were only banned from areas adjacent to affected areas and/or affected areas alone. The effect of regionalization was most likely to reduce the trade consequences at the national level. However, the economic impact at the local level was significant in terms of trade dollars. The costs of trade restrictions on the individual

States involved were estimated from February 7, 2003, through September 17, 2003, asPage 36 of 58 $34 million in California, $2 million in Arizona, $690,000.00 in Colorado (unaffected but adjacent to an affected State), $20,000.00 in New Mexico and $57 million in Texas.

These estim ates do not account for trade shifting or the movement of production within the United States to avoid export restrictions. In this regard, companies operating in multiple States could have shifted production or processing to States on which there were no restrictions. Products that were restricted from one export country could also have been shifted to alternate export markets or sold at new outlets within the United States. It is possible that the true impact of the trade restrictions is significantly les s than the calculated values presented [ 29].

C ONSEQUENCE S UMMARY This consequence assessment provides general information regarding the type and magnitude of the effects of N ewcastle disease or HPAI introduction into the United

States from an historical perspective. The major consequences of the N ewcastle disease or HPAI outbreaks concerned animal health and economic costs of control, indemnity, and lost trade. The consequences of a poultry disease outbreak in a State with a small commercial poultry indu stry are likely to be relatively minor. However, the economic and animal health consequences of a disease outbreak in a State with a large concentration of poultry are likely to be substantial [29, 46].

R ISK E STIMATION According to OIE guidelines, if th e release assessment indicates that there is no significant risk of introduction, the risk assessment may conclude. However, APHIS continued its analysis in the interest of completeness and conducted exposure and consequence assessments based on information available on the history and economic effects of past N ewcastle disease introductions and HPAI events in the United States.

Regarding the likelihood of exposure, historical experience indicates that the risk of introducing N ewcastle disease or HPAI via importation of live birds is considerably higher than via poultry products. Legal entry of live birds is satisfactorily controlled through existing quarantine and testing measures in the United States. Likewise, recognition of the EU-25 as a low risk regio n for N ewcastle disease or HPAI would not likely impact illegal bird movement from the EU -25. Poultry product imports historically have not been implicated in N ewcastle disease or HPAI introductions into the United States. Therefore, taken together with the low risk assessed by the release assessment, APHIS considers the likelihood of exposure from poultry imports from the EU-25 to be

low.

APHIS continued its assessment further and conducted a consequence assessment that addressed the potential effects of a N ewcastle disease or HPAI outbreak on animal and public health, as well as associated environmental and economic considerations. Consequences of human exposure from N ewcastle disease are low. Consequences of human exposure from HPAI depend on the strain but historically have not been a major human health threat, with the exception of the “Asian” strain of H5N1, although noPage 37 of 58 human cases have been reported in the EU-25. While consequences on poultry health are high, effective disease surveillance and control measures should reduce the consequences by reducing the extent of spread. Consequences to the environment should be within the scope of APHIS resources and authority to manage adequately.

The economic portion of the consequence assessment was based on av ailable information regarding the economic consequences of N ewcastle disease introductions into the United States since 1950. This assessment, while demonstrating that the consequences can be significant under certain conditions, also demonstrated that a N ewcastle disease introduction does not necessarily result in extensive consequences. If the disease is diagnosed prior to extensive spread, appropriate biosecurity measures are implemented, and the public is educated to look for clinical signs, the consequ ences can be minimized. Furthermore, in response to the outbreak in the western United States in 2002-2003,

APHIS enhanced its N ewcastle disease surveillance program to increase the likelihood of future detection prior to spread. A comparable economic impa ct would be expected for an

extensive outbreak of HPAI.

C ONCLUSION AND S UMMARY OF P ROPOSED A CTION APHIS considers that the evidence it has collected to date and the results of several analyses support the concept that the MS constituting the EU in the year 2006, collectively referred to as the EU -25, is a region from which the risk of exporting

N ewcastle disease or HPAI virus in live poultry, hatching eggs, poultry semen, and fresh poultry meat and products to the United States is very low. The estimates of risk suggest

that the E C control mechanisms are fully implemented by the individual MS and are sufficiently effective to mitigate the risk of exporting N ewcastle disease or HPAI virus in live poultry, hatching eggs, poultry semen, and fresh poultry meat and products to the United States. This risk is low, despite the continued presence of infected wild birds and pigeons in the EU and the expectation that outbreaks of N ewcastle disease or HPAI will continue to occur infrequently in the EU.

Our conclusions are as follows:

**•** The region has an effective veterinary infrastructure capable of identifying and applying control measures to eradicate incursions of N ewcastle disease or HPAI in domestic poultry.

**•** The region has a comprehensive le gislative framework in place to ensure consistent implementation of EC legislation to ensure that all EU -MS correctly

transpose EC legislation into their domestic legislative frameworks. The EC also

pursues MS compliance with animal health legislation impl ementation by review and inspection in the EU-MS by the Commission services.

**•** N ewcastle disease and HPAI are notifiable (reportable) diseases; there was an ongoing awareness program in place for veterinary officials and the public.

**•** An appropriate surveillance program exists supporting the detection and investigation of the outbreaks with clinical inspection, active and passive surveillance (serological and agent detection), and serological and virologicalPage 38 of 58 testing in high -risk areas and of high- risk flocks. The program is capab le of effectively and quickly detecting the presence of N ewcastle disease and HPAI, even in the absence of clinical signs.

**•** The system for recording, managing, and analyzing diagnostic and surveillance

data is sufficient to de monstrate effectiveness of disease control measures.

**•** Laboratory confirmation capabilities are effective and laboratory testing procedures are well documented and standardized.

**•** N ewcastle disease and HPAI eradication program s include appropriate quarantine and surveillance zones, monitoring of those zones, and implementation of movement restrictions. Procedures for lifting quarantines are sufficient to prevent further spread of disease.

**•** Standard operating procedures for biosecurity measures implemented duri ng the outbreak, depopulation, cleaning and disinfection, and other applicable measures (such as carcass disposal) are well documented and relevant personnel well

resourced and trained.

APHIS is proposing to recognize the “APHIS -defined EU Poultry Trade Region” as a single region for N ewcastle disease and HPAI and apply the conditions found in 9 CFR 92.3 to recognize the movement restrictions established by the EC. This is a regulatory

process similar to that used for CSF in the EU [20, 23, 26, 28, 31]. APHIS considers the

risk to be similar for all counties within the EU

- 25 because of the patterns of animal movement in the EU and the fact that the EC regulations apply uniformly to all MS. Therefore, APHIS is proposing that areas within the EU -25 that have an outbreak of

N ewcastle disease in domestic poultry will not be removed from the list of N ewcastle

disease -free regions in 9 CFR 94.6 by interim rule, unless APHIS suspects that EU control measures are not effectively controlling an N ewcastle disease outbreak. In the case of HPAI, the affected regions would not be added to the HPAI affected list, unless APHIS suspects that EU control measures are not effectively controlling the HPAI

outbreak. Instead APHIS will rely on the EC to define and maintain rest ricted zones using the regions defined in the EC quarantine restrictions established and published for

an y N ewcastle disease or HPAI outbreak.

Although EU legislation allows for lifting restrictions as early as 21 days, APHIS will not accept commodities from a restriction zone implemented by the EC because of an

outbreak of N ewcastle disease or HPAI in domestic poultry until 90 days have elapsed following the depopulation, and cleaning and disinfection of the last af fected premises

. This timeframe is compatible with current APHIS regulation (9 CFR 93.205) . OIE also recognizes 90 days as the time period to regain NAI free status in a previously free country, zone or compartment, following and eradication campaign including disinfection

of all affected establishments with additional disease surveillance [44]. When N ewcastle

disease or HPAI are detected in a wild bird population, APHIS will recognize the duration of restrictions as imposed by the EC. The shorter restriction period for wild birds

or racing pigeons as determined by the EC can be applied with relatively lower risk because all commercial poultry in the restriction zone would be evaluated to be sure thePage 39 of 58 infection had not been introduced into commercial poultry befor e the release of zone

restrictions

.

APHIS defines the restriction zone to encompass all protection, surveillance, and buffer

zones established around END or HPAI outbreaks in domestic poultry and to encompass

affected zones established around outbreaks of END or HPAI in wild birds and pigeons held in captivity (including pigeons held for racing, exhibition, breeding, and fattening) as prescribed in Council Directive s 96/66/EC and 2005/94/EC. Definition and maintenance of the integrity of those zones will b e the purview of the EC.

To ensure that the commodities are not exported from regions that the EC has designated as affected (restriction and infection zones and all other restriction zones established for the control of the animal health emergency, including surveillance and buffer zones ),

APHIS will require certification by the competent veterinary authority of the individual

EU

- MS that exported commodities did not originate from such regions. In addition, the certification by the competent veterinary a uthority of the MS will certify that all certification requirements in current APHIS regulation have been met ( 9 CFR 93.205).

APHIS considers the N ewcastle disease or HPAI risk presented by the poultry trade region to be sufficiently low to justify this approach and will add the poultry trade region

to the list of N ewcastle disease

- free regions listed in 9 CFR 94.6. However, APHIS anticipates that limited N ewcastle disease and HPAI outbreaks will continue to occur infrequently but be rapidly recognized and controlled in the EU- 25 with implementation of quarantine restrictions and movement controls. Therefore, APHIS proposes to recognize restriction zone boundaries for N ewcastle disease or HPAI that are established

under EC legislation by applying the existing regulations found in 9 CFR 92.3 regarding

movement restrictions to the poultry trade region. The criteria used to determine the scope of the restriction zones and when to release movement restrictions are detai led in

the EC -approved eradication plans for N ewcastle disease or HPAI in domestic and wild

birds.

In summary, APHIS concludes that the risk of introducing N ewcastle disease or HPAI into the United States as a result of trade in poultry carcasses, parts o r products of poultry carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds from

the EU -25 is low. APHIS also appropriately mitigates the risk of introducing N ewcastle

disease or HPAI by the legal importation of live birds a nd hatching eggs under the established quarantine and testing requirements. Although consequences of an N ewcastle

disease or HPAI outbreak are potentially substantial, the likelihood of an outbreak occurring from exposure of the domestic poultry population to poultry products imported

from the EU -25 is extremely low.Page 40 of 58 R EFERENCES 1. ADNS (2009). Animal Disease Notification System of the European Commission

Available at: http://ec.europa.eu/food/animal/diseases/adns/index_en.htm or http://ec.europa.eu/food/animal/diseases/adns/adns_en.htm

2. Alexander, D.J., (2007). An overview of the epidemiology of avian influenza. Vaccine. (25) 5637-5644.

3. Alexander, D.J., (2003). Newcastle Disease, in Diseases of Poultry, 11 th ed., 64-87.

4. APHIS (20 11) Interim rule and request for comments Highly Pathogenic Avian Influenza. 76 FR 4046, published January 24, 2011.

5. APHIS (2010). Notice of Determination of the High Pathogenicity Avian Influenza Subtype H5N1 Status of the Czech Republic and Sweden. 75 FR 69046, published November 10, 2009. Preceded by Notice of Availability of Evaluations of the Highly Pathogenic Avian Influenza Subtype H5N1 Status of the Czech Republic and Sweden. 75 FR 17368, published April 6, 2010.

6. APHIS (2009). AP HIS’ Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in the Czech Republic and Sweden. July 2009

7. APHIS (2009). Notice of Determination of the High Pathogenicity Avian Influenza Subtype H5N1 Status of Hungary. 74 FR 48711, published September 24, 2009. Preceded by Notice of Availability of Evaluations of the Highly Pathogenic Avian Influenza Subtype H5N1 Status of Hungary. 74 FR 28217, published June 15,

2009.

8. APHIS (2009). Notice of Determination of the High Pathogenicity Avian Influenza Subtype H5N1 Status of Saxony (Gorlitz and Bautzen) Germany. 74 FR 48519, published September 23, 2009. Preceded by Notice of Availability of Evaluations of the Highly Pathogenic Avian Influenza Subtype H5N1 Status of

Sax ony (Gorlitz and Bautzen) Germany. 74 FR 28008, published June 12, 2009. Notice of Availability of the High Pathogenicity Avian Influenza Subtype H5N1 Status of Saxony (Gorlitz and Bautzen) Germany. 74FR 28008, published June 12,

2009.

9. APHIS (2009). Notice of Determination of the High Pathogenicity Avian Influenza Subtype H5N1 Status of Suffolk and Norfolk Counties in England. 74 FR 48519, published September 23, 2009. Preceded by Notice of Availability of the High Pathogenicity Avian Influenza Subtype H5N1 Status of Suffolk and Norfolk Counties in England. 74 FR 21312, published May 7, 2009.

10. APHIS (2009). Notice of Determination of the High Pathogenicity Avian Influenza Subtype H5N1 Status of Germany and Poland. 74 FR 274, published JunePage 41 of 58 5, 2009. Preceded by Notice of Availability of Evaluations of the Highly Pathogenic Avian Influenza Subtype H5N1 Status of Germany and Poland. 74 FR 69, published January 2, 2009.

11. APHIS (2009). Final Rule for Importation of Table Eggs from Regions Where

Exotic Newcastle Disease Exists. 74 FR 18285, published April 22, 2009.

12. APHIS (2009). Evaluation of the Highly Pathogenic Avian Influenza H5N1 Status of Suffolk and Norfolk Counties, England. January 2009

13. APHIS (2008). APHIS’ Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Hungary. November 2008.

14. APHIS (2009). APHIS’ Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Germany. October 2008.

15. APHIS (2008). APHIS’ Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Poland. October 2008.

16. APHIS (2008). Notice of Determination of the High Pathogenicity Avian Influenza Subtype H5N1 Status of Denmark and France. 73FR 42313, published July 21, 2008. Preceded by Notice of Availability of the High Pathogenicity Avian Influenza Subtype H5N1 Status of Denmark and France; 73 FR 16245, published March 27, 2008.

17. APHIS (2008). Justification for the changes to the reg ulations governing the importation of table eggs from regions where Exotic Newcastle disease exists into the United States. Revised April 2008.

18. APHIS (2007). APHIS Analysis of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Denmark. December 2007.

19. APHIS (2007). APHIS Analysis of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in France. December 2007.

20. APHIS (2007). Importation of Live Swine, Swine Semen, Pork and Pork Products from the Czech Republic, Latvia, Lithuania and Poland. Final Rule. Published November 28, 2007: 72 FR 67227. Proposed rule. Published February 12, 2007: 71

FR 6490.

21. APHIS (2007). Proposed Rule for Importation of Table Eggs from Regions

Where Exotic Newcastle Disease Exists. 72 FR 45177, published August 13, 2007.

22. APHIS (2006). Final Rule to Add Denmark to the List of Regions Free of Exotic Newcastle Disease. 71 FR 38259, published July 6, 2006.Page 42 of 58 23. APHIS (2006). Final rule: Importation of swine and swine product from th e European Union Docket 02-046-2]. Published May 10, 2006: 71 FR 29061.

24. APHIS (2006). Add Kazakhstan, Romania, Russia, Turkey, and Ukraine to List of Regions in Which Highly Pathogenic Avian Influenza Subtype H5N1 Is Considered

To Exist. Interim rule and request for comments. Published February 13, 2006: 71 FR 7401; affirmed on May 18, 2006 in 71 FR 28763.

25. APHIS (2005). APHIS Considerations on the Identification of Administrative Units for (AU) Certain Member States of the European Union. June 2005

26. APHIS (2005) Importation of Swine and Swine Products from the European Union Proposed rule. Published Friday, April 8, 2005: 70 FR 17928

27. APHIS (2005) APHIS Risk Analysis on Importation of Exotic Newcastle Disease (END) Virus from Denmark. Mar ch 2005. Notice of Availability published May 5, 2005; 70 FR 23809.

28. APHIS (2004). APHIS risk considerations on the importation of classical swine fever (CSF) virus in breeding swine, swine semen, and fresh pork from a European Union region of fifteen Member States. September 2004.

29. APHIS (2003). Summary of Exotic Newcastle Disease Direct and Indirect Impacts, Centers for Epidemiology and Animal Health, APHIS, Veterinary Services, October 2002 - September 2003

30. APHIS (2003). Animal Welfare; Animal Fighting Venture Prohibition; Notice. Published May 12, 2003: 68 FR 25315

31. APHIS (2003). Recognition of Animal Disease Status of Regions in the European

Union for classical swine fever (CSF) ; Final Rule. Published April 7, 2003: 68 FR

16922

32. APHIS (2002). Interim rule and request for comments Change in Disease Status of Denmark Because of Exotic Newcastle Disease. 67 FR 59136, published September 20, 2002.

33. APHIS (1978) . Eradication of Exotic Newcastle Disease in Southern California,

1971-1974. APHIS-91- 34 , February 1978.

34. Center for Disease Control (2006). Past avian influenza outbreaks. Available at: http://www.cdc.gov/flu/avian/

35. European Commission (2009). Avian I nfluenza Chronology Situation as of 18 May 2009 and List of D ecis ions Adopted by the European Commission 2008. DG Health and Consumer Protection, Unit D1: Animal Health and Standing Committees

.Page 43 of 58 Response to outbreaks in Member States and third countries

36. European Commission (2007). Avian I nfluenza E xtensive C hronology and List of Decisions Adopted by the European Commission 2007. DG Health and Consumer

Protection

, Unit D1: Animal Health and Standing Committees

.

37. European Commission (2007). Information on the Newcastle Disease Legislation

and Disease Situa tion in the European Union. September 2007.

38. European Commission (2006). Avian I nfluenza E xtensive C hronology and List of

Decisions Adopted by the European Commission in 2006; P art II - Including overview of events in 2004-2005 with Response to Outbreaks in Member States and third countries. DG Health and Consumer Protection, Unit D1: Animal Health and Standing Committees

.

39. Foreign Animal Diseases, the Gray Book, 7 th ed

. United States Animal Health Association. Revised, 2008 . http://www.vet. uga.edu/vpp/gray_book/

40. Kommers, G. D., King, D. L. et. al. (2002). “Pathogenesis of six pigeon-origin

isolates of Newcastle disease virus for domestic chickens”. Vet Path 39: 353 -362.

41. Lee, C -W, Swayne, D. E., et.al. (2005) H5N2 Avian Influenza Outbreak in Texas in 2004: the First Highly Pathogenic Strain in the United States in 20 Years? J. Virology 79 (17), p. 11412–11421.

42. National Environmental Policy Act Implementing Procedures. Classification of actions. Categorically excluded actions. Routine measures. In Title 7, Code of Federal Regulations, Part 372.5 (c)(1). Animal and Plant Health Inspection Service.

43. OIE (2009). W eekly disease information update archive; available at: http://www.oie.int/eng/info/hebdo/a_csum.htm

44. OIE (2008). Terrestrial Animal Health Code, World Organization for Animal

Health. Available at: http://www.oie.int/eng/normes/mcode/en_sommaire.htm

45. SCOFCAH Animal Health and Animal Welfare meeting pres entations, available

at: http://ec.europa.eu/food/committees/regulatory/scfcah/animal_health/index_en.htm

46. Swayne, D.E., (2008). “High Pathogenicity Avian Influenza in the America” in Avian Influenza, ed. D. E. Swayne, Blackwell Publishing, p 191 -211.

47. Toro, H., Hoerr, A. B., et. (2005). Al. Pigeon Paramyxovirus: Association with Common Avian Pathogens in Chickens and Serologic Survey in Wild Birds. A vian

D is. 49:92–98, 2005.Page 44 of 58 48. USDA Foreign Agricultural Service Gain Report (2007). Canada; Poultry and Products, Minimal Economic & Trade Impact of HPAI H7N3, Detection on Saskatchewan Farm. Report CA7046, dated October 2, 2007. Available at: http://www.fas.usda.gov/gainfiles/200710/146292626.doc

49. World Health Organization “Epidemic and Pand emic Alert and Response (EPR)

- Avian influenza”. Available at: http://www.who.int/csr/disease/avian_influenza/en/Page 45 of 58 A

PPENDIX A

. E PIDEMIOLOGIC C HARACTERISTICS OF N EWCASTLE D ISEASE

Disease Virulent (exotic) Newcastle disease is a contagious and fatal viral disease affecting all species of birds caused by an enveloped RNA virus, paramyxovirus serotype 1 (APMV -1), of the Paramixoviridae family, Paramyxovirinae subfamily and Rubulavirus genus [2]. Newcastle disease viruses occur as three pathotypes: lentogenic, mesogenic, and velogenic, reflecting increasing levels of virulence. The most virulent (velogenic) isolates are further subdivided into neurotropic and viscerotropic types. The velogenic isolates (the subject of the analysis presented here) are considered exotic to the United

States.

Newcastle disease is an acute, rapidly spreading, and usually fatal viral infection of poultry caused by an avian paramyxovirus serotype 1 that meets one of the followingcriteria for virulence: The virus has an intracerebral pathogenicity index (ICPI) in dayold chicks ( Gallus gallus ) of 0.7 or greater; or multiple basic amino acids have been

demons trated in the virus (either directly or by deduction) at the C -terminus of the F2 protein and phenylalanine at residue 117, which is the N-terminus of the F1 protein. The term “multiple basic amino acids” refers to at least three arginine or lysine residu es between residues 113 and 116. In this definition, amino acid residues are numbered from

the N -terminus of the amino acid sequence deduced from the nucleotide sequence of the F0 gene; 113-116 corresponds to residues -4 to - 1 from the cleavage site. Fai lure to demonstrate the characteristic pattern of amino acid residues as described above may require characterization of the isolated virus by an ICPI test. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.[4]

Previously known as velogenic viscerotropic Newcastle disease (VVND) and currently referred to as Newcastle disease (ND) in the OIE Terrestrial Code [ 7].

Clinical Signs

Newcastle disease is one of the most infectious diseases of poultry in the world and may be so virulent that many birds die without showing any clinical signs. A death rate of almost 100 percent can occur in unvaccinated poultry flocks. Newcastle disease can infect and cause death even in vaccinated poultry [1].

Clinical symptoms of Newcastle disease vary depending on viral strain, host, age, and

environment. Newcastle disease is a systemic disease most notably involving the respiratory, digestive, or nervous systems. The incubation period for the disease ranges from 2 to 15 days. An infected bird may exhibit the following signs:

• Respiratory: sneezing, gasping for air, nasal discharge, coughing;

• Digestive: greenish, watery diarrhea;

• Nervous: depression, muscular tremors, drooping wings, twisting of head and

neck, circling, complete paralysis;

• Partial to complete drop in egg production or production of thin- shelled eggs;Page 46 of 58 • Swelling of the tissues around the eyes and in the neck; and

• Sudden death and increased death loss in a flock.

Susceptibility of different types of birds may be variable; n atural or experimental infection with NDV has been demonstrated in at least 236 species from 27 of the 50

orders of bi rds [1, 2, 3]. Chickens, turkeys, pigeons, guinea fowl, peafowl, pheasants, quail, and partridges are susceptible while geese and ducks are usually regarded as resistant even to NDV strains most virulent for chickens [2]. Wild birds represent a potentially important but unknown reservoir.

A persistent carrier state has been demonstrated in psittacine and other wild birds lasting for more than a year and virus may be recovered from most other species for a period of 2-4 weeks or less or until antibody is developed [3]. Experimentally turkey shed the virus from the intestinal tract of unvaccinated poults for up to 46 days and NDV was recovered up to 53 days postchallenge from turkey poults that were vaccinated once at 4 days of age and challenged at 1 month of age.

Newcastle disease Spread

Newcastle disease is spread primarily through direct contact between healthy birds and the bodily discharges of infected birds. The disease is transmitted through infected birds’ droppings and secretions from the nose, mouth, and eyes. Ne wcastle disease spreads rapidly among birds kept in confinement, such as commercially raised chickens. High

concentrations of the Newcastle disease virus are in birds’ bodily discharges. Therefore, the disease can be spread easily by mechanical means. Viru s- bearing material can be picked up on shoes and clothing and carried from an infected flock to a healthy one. The disease is often spread by vaccination and debeaking crews, manure haulers, rendering truck drivers, feed delivery personnel, poultry buyers, egg service people, and poultry farm owners and employees.

The Newcastle disease virus can survive for several weeks in a warm and humid environment on birds’ feathers, manure, and other materials ; i t can survive indefinitely in frozen material. However, the virus is destroyed rapidly by dehydration and by the ultraviolet rays in sunlight. Smuggled pet birds, especially Amazon parrots from Latin America, pose a great risk of introducing Newcastle disease into U.S. poultry flocks. Amazon parrots that are carriers of the disease but do not show symptoms are capable of shedding Newcastle disease virus for more than 400 days [3].

Newcastle disease Control in Commercial poultry The only way to eradicate Newcastle disease from commercial poultry is by rapidly destroying all infected flocks and imposing strict quarantine and in-depth diagnostic and surveillance programs. Poultry producers should strengthen biosecurity practices to prevent the introduction of the disease to their flocks. Biosecurity is also important to protect backyard and hobby flocks. The following are appropriate biosecurity practices: • Permit only essential workers and vehicles on the premises. • Provide clean clothing and disinfection facilities for employees.Page 47 of 58 • Clean and disinfect all vehicles (including tires and undercarriages) entering and

leaving the premises. • Avoid visiting other poultry operations.

• Maintain an “all -in, all-out” philosophy of flock management with a single age

flock; do not “skim” (thin) mature birds from a flock for sale to a live-poultry market and clean and disinfect poultry houses between each lot of birds. • Do not keep pet birds on the farm or hire employees who own pet birds. • Exclude vaccination crews, catching crews, and other service personnel who

may have been in contact with other poultry operations within 24 hours. • Protect flocks from wild birds that may try to nest in poultry houses or feed with

domesticated birds. • Control movements associated with the disposal of bird carcasses, litter, and

manure.

Newcastle disease Control in Pet Birds , Pigeons and Backyard Poultry Newcastle disease is also a threat to the caged -birds and poultry- hobby birds. Birds illegally smuggled into the United States that have not been quarantined and tested by APHIS may carry the Newcastle disease virus. Some psittacines and other birds may be persistent shedders of the virus. Owners of pet birds should request certification from

their suppliers that birds are legally imported or are of U.S. stock and were healthy prior to shipment. All newly purchased birds should be isolated for at least 30 days and movement of personnel between new and old birds restricted.

In the late 1970’s, a Newcastle disease panzootic em erged that was attributed to pigeons. It is thought that the contact between birds at races and shows and the large international trade in such birds spread the virus, eventually causing infection in 24 countries, primarily in pi geons. Feed contaminated with droppings from infected pigeons was implicated in an outbreak in the UK in 1984. The disease is enzootic in racing pigeons in

many countries and regularly spreads to wild pigeons providing a continuing threat to poultry [1, 6, 8].

To distinguish the pigeon variant from the avian paramyxovirus serotype 1 (APMV-1), the pigeon variant is referred to as pigeon paramyxovirus 1 (PPMV-1); however, not all paramyxovirus isolated from pigeons are of the PPMV-1. The isolation of highly virulent

Newcastle disease viruses from pigeon, whether the strain is AMPV-1 or PPMV-1, represents a potential source of Newcastle disease infection for commercial poultry [ 6]. Isolates of the pigeon adapted NDV have been genetically

- sequenced and results show a pattern of amino acids at the cleavage site which is compatible with the pattern of

virulent Newcastle disease viruses but characterized by unique monoclonal antibody - binding profiles [6, 8]. The pigeon-adapted or pigeon variant strain of the virus has caused numerous outbreaks in pigeons in various EU- MS . NDV has frequently been recovered from pigeons in the United States but to date there have been no reports in commercial poultry in the United States [6].Page 48 of 58 OIE Definition of Newcastle disease Most species of birds are susceptible to infection with Newcastle disease viruses of both high and low virulence for chickens. Although the clinical signs seen in birds infected

with Newcastle disease virus vary widely and none are regarded as pathognomoni c. The

Newcastle disease viruses show a considerable range of virulence in the intracerebral pathogenicity index (ICPI) in day-old chicks.

The OIE definition for reporting an outbreak of Newcastle disease is that the virus has an intracerebral pathogenic ity index (ICPI) in day-old chicks ( Gallus gallus ) greater than 0.7 or the demonstration of the presence of specific characteristic multiple basic amino acids in the virus [7].

Newcastle D isease in H umans NDV is a potential human pathogen. Reported infections have been non- life threatening and usually not debilitating for more than a day or two [5]. The most frequently reported and best substantiated clinical signs in human infections have been eye infections; usually consisting of unilateral or bilatera l reddening, excessive lachrymation, edema of the eyelids, conjunctivitis , and sub-conjunctival hemorrhage. Although the effect on the eye may be quite severe, infections are usually transient and the cornea is not affected. Reports of other clinical symptoms in humans infecte d with NDV are less well substantiated, but suggest a more generalized infection may sometimes occur resulting in chills, headaches , and fever, with or without conjunctivitis. There is evidence that both vaccinal and virulent (for poul try) strains of NDV may infect and cause clinical signs in

humans. There is no evidence of human- to -human spread. [6]

References

1. Alexander, D. J. (2003). “Newcastle Disease.” In Diseases of Poultry, 11 th ed. Saif, Y. M., H. J . Barnes, A. M. Fadly, et al (Eds). Iowa, Blackwell Publishing:

64 -87.

2. Alexander, D. J., R. J. Manvell, J. P. Lowing, et al (1997). “ Antigenic diversity and similarities detected in avian paramyxovir u ses type 1 (Newcastle disease virus) isolates using monoclonal antibodies.” Avian Pathology 26: 399-418.

3. Alexander, D. J. (1995). “The epidemiology and control of avian influenza and Newcastle disease.” J. Comp. Path. 112: 105-126.

4. APHIS (2011), Title 9, Code of Federal Regulation - Parts 1 to 199, Animals and animals products.

5. Chang, P.W. (1981). Newcastle disease. In: CRC Handbook Series in Zoonoses. Section B: Viral Zoonoses, Volume II, Beran G.W., ed. CRC Press, Boca Raton, Florida, USA, 261–274.

6. Kommers, G. D., King, D. L. et. al. (2002). “Pathogenesis of six pigeon-origin

isolat es of Newcastle disease virus for domestic chickens”. Vet Path 39: 353 -362.

7. OIE (2008). Newcastle Disease. In Terrestrial Animal Health Code, Paris, World Organization for Animal Health: Section 10.13Page 49 of 58 8. Toro, H., Hoerr, A. B., et. (2005). Al. Pigeon Paramyxovirus: Association with Common Avian Pathogens in Chickens and Serologic Survey in Wild Birds. Avian Dis. 49:92–98, 2005Page 50 of 58 A

PPENDIX B

. E PIDEMIOLOGIC C HARACTERISTICS OF A VIAN I NFLUENZA

Disease Avian influenza (AI) is caused by an orthomyxovirus. AI viruses are divided into 5 genera; of which Influenza A is the most important and widespread with the capacity to infect many different avian and mammalian species [ 1, 2, 8 ]. AI viruses infect chickens, turkeys, pheasants, quail, ducks, geese, and gui nea fowl, as well as a wide variety of wild birds (such as ducks, gulls, and shorebirds). Migratory waterfowl have proved to be a natural reservoir for the less virulent strains of the disease known as low-pathogenicity

avian influenza (LPAI) [1, 2, 5].

AI viruses are classified by a combination of two groups of proteins: the hemagglutinin or H proteins, of which there are 16 (H1-H16), and neuraminidase or N proteins, of which there are 9 (N1 -N9). AI viruses are also classified into LPAI and highpathogenicity (HPAI) based on the severity of the illness they cause. The ability to cause clinical signs may depend on the species of bird infected and may change over time, becoming more or less pathogenic [5, 6 ]. HPAI is an extremely infectious and fatal for m of the disease that, once established, can spread rapidly from flock to flock. Some LPAI

virus strains have mutated under field conditions into HPAI viruses.

All virulent strains of AI isolated to date have been either of the H5 or H7 subtype. Although most H5 or H7 isolates have been of low virulence, a low virulent H5 or H7 may become virulent by mutation in poultry hosts. For this reason OIE considers all H5 and H7 viruses to be classified as Notifiable Avian Influenza (NAI) viruses [5].

HPAI subtype H5N1 (HPAI H5N1), often referred to as "Asian” H5N1, is the type causing worldwide concer n an d has caused outbreaks in birds and poultry in Asia, Africa, Europe, and other foreign regions. HPAI H5N1 spreads rapidly and is often fatal to

chickens and turkeys. Millio ns of birds have died in countries where HPAI H5N1 has been detected. This virus has also infected people, most of whom have had direct contact

with infected birds. “Asian ” H5N1 has not been detected in the United States.

LPAI H5N1, often referred to as the "North American" H5N1, is of less concern. LPAI

H5N1 has been detected in wild birds in the United States , as recently as 2007. Other strains, specifically HPAI H5N2

, have been detected and eradicated three times in the

United States: 1924, 1983, and 2004. The 2004 H5N2 isolate did not result in clinical disease and inoculation studies showed it to be a low pathogenic strain; however, genetic sequencing was consistent with one of the OIE definitions for HPAI. No significant human illness resulted from these outbreaks [6, 7].

APHIS defines H PAI as an influenza virus that kills at least 75 percent of eight 4- to 6-

week -old susceptible chickens within 10 days following intravenous inoculation with 0.2

ml of a 1:10 dilution of a bacteria- free, infectious allantoic fluid; or a n H5 or H7 virus

that does no t meet the first criteria but has an amino acid sequence at the hemagglutinin cleavage site that is compatible with highly pathogenic avian influenza viruses; orPage 51 of 58 an influenza virus that is not an H5 or H7 subtype and that kills one to five chickens and grows in cell culture in the absence of trypsin [3].

Clinical Signs The clinical signs of AI virus infection of domestic poultry are highly variable and depend on the pathogenicity of the infecting viral strain. Infected poultry may exhibit syndromes rangi ng from asymptomatic infection, mild respiratory disease with drops in egg production, or severe systemic disease with near 100 percent mortality [8]. Typically HPAI in domestic poultry is characterized by high morbidity accompanied by high and rapidly esc alating unexplained mortality. However, none of these signs can be considered pathognomonic. Lesions may be absent in cases of sudden death [1-2, 4-9 ]. Disease is not usually apparent with AI virus infection in most wild bird species [2, 9].

AI Transmission [1-2, 4-6] The incubation period for AI is 3 to 5 days, although OIE uses 21 days for the NAI.

AI viruses may be transmitted by direct contact with secretions from infected birds, especially feces , or by exposure to c ontaminated feed, water, equipment, and clothing.

C ontact with clinically normal waterfowl and sea birds may introduce the virus into flocks of domestic poultry.

HPAI viruses may remain viable for long periods of time in infected feces as well as

infected tissues and water

. AI spreads rapidly among birds kept in confinement, such as commercially raised chickens.

AI Control in Commercial P oultry The only way to eradicate AI from commercial poultry is by rapidly destroying all infected flocks and imposing strict quarantine and in

- depth diagnostic and surveillance programs. Poultry producers should strengthen biosecurity practices to prevent the introduction of the disease to their flocks. Biosecurity is also important to protect backyard and hobby flocks. The same biosecurity pr actices discussed for Newcastle disease (see Appendix I) are appropriate for AI.

AI Control in Pet Birds , Pigeons and Backyard Poultry AI is also a threat to the caged -birds and poultry hobbyists. Birds illegally smuggled into

the United States that hav e not been quarantined and tested by APHIS may carry the AI virus. Owners of pet birds should request certification from their suppliers that birds are legally imported or are of U.S. stock and were healthy prior to shipment. All newly purchased birds should be isolated for at least 30 days and movement of personnel

between new and old birds restricted.

AI in H umans The risk from AI is generally low to most people, because the viruses do not usually infect humans. However, confirmed cases of human infection from several subtypes of

AI infection have been reported since 1997. Most cases of AI infection in humans havePage 52 of 58 resulted from contact with infected poultry (e.g., domesticated chicken, ducks, and turkeys) or surfaces contaminated with secretion s or excretions from infected birds. The spread of AI viruses from one ill person to another has been reported very rarely, and has been limited, inefficient and unsustained. During an outbreak of AI among poultry, there is a possible risk to people who have co ntact with infected birds or surfaces that have been contaminated with secretions or excretions from infected birds [4, 10].

Symptoms of AI in humans have ranged from typical human influenza- like symptoms (e.g., fever, cough, sore throat, and muscle aches) to eye infections, pneumonia, severe respiratory diseases (such as acute respiratory distress), and other severe and life

threatening complications. The symptoms of AI may depend on which virus caused the

infection [4].

The WHO has reported cases of H5N1 AI in humans in Asia, Africa, the Pacific, Europe, and the Near East. Indonesia and Vietnam have reported the highest number of H5N1

cases to date with mortalities of up to 60 percent , especially in cases hospitalized late in

the illness

. Despite the high mortality, human cases of H5N1 remain rare to date. T he most significant risk factor for human H5N1 infection is direct contact with sick or dead poultry or wild birds [10].

Past AI Outbreaks [1-2, 4, 8, 9] Most recently, outbreaks of HPAI H5N1 among poultry have been associated with illness and death in humans in Asia, Europe, and the Near East (http://www.cdc.gov/flu/avian/outbreaks/current.htm). In North American there have

been two AI outbreaks with transmission to humans, in Canada (2004, N7N3) and New

York (2003, H7N2). During the February 2004 outbreak of HPAI H5N2 in Texas, there

were no cases of transmission to humans.

In February 2004, the Canadian Food Inspection Agency announced an outbreak of AI (H7N3) in poultry in the Fraser Valley region of British Columbia. Health Canada reported two cases of laboratory confirmed influenza A (H7): one in a person involved in culling operations on March 1314, and the other in a poultry worker who had close contact with poultry. Both patients developed conjunctivitis (eye infection) and other flulike symptoms. Their illnesses resolved after treatment with the antiviral medication oseltamivir. Another group of approximately 10 other poultry workers exhibited conjunctival and/or upper respiratory symptoms after having contact with poultry but infection was not confirmed by laboratory methods.

In November 2003, a patient with serious underlying medical conditions was admitted to a hospital in New York with respiratory symptoms. One of the initial laborator y tests identified influenza A virus that was thought to be H1N1. The patient recovered and went home after a few weeks. Subsequent confirmatory tests conducted in March showed that the patient had been infected with an H7N2 avian influenza A virus but dir ect contact with infected birds or poultry was not documented.Page 53 of 58 References

1. Alexander, D. J. (2007). An overview of the epidemiology of avian influenza.

Vaccine 25:5637-5644.

2. Alexander, D. J. (2000). A review of avian influenza in different bird species. Veterinary Microbiology 74: 3-13.

3. APHIS, Title 9, Code of Federal Regulation - Parts 1 to 199, Animals and animals products

.

4. Center for Disease Control (2006). Past avian influenza outbreaks. Available at: http://www.cdc.gov/flu/avian/

5. OIE (2008). Chapter 10.4 Avian Influenza. In Terrestrial Animal Health Code, World Organization for Animal Health.

6. OIE (2008). Technical Disease Card Highly pathogenic a vian influenza and low pathogenic avian influenza (poultry). World Organization for Animal Health,

available at: http://www.oie.int/eng/maladies/fiches/a_A150.htm

7. OIE (2008). Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Chapter 2.3.4 Avian Influenza. World Organization for Animal Health. Available at: http://www.oie.int/eng/normes/mmanual/A_summry.htm

8. Suarez, D. L., (2008) . ‘Influenza A virus.” In Avian Influenza, Swayne, D. E., (Ed.) Iowa, Blackwell Publishing: 3-22.

9. Swayne, D. E., D. A. Halvorson. (2003).“Influenza.” In Diseases of Poultry, 11 th

ed. Saif, Y. M., H. J . Barnes, A. M. Fadly, et al (Eds). Iowa, Blackwell Publishing: 135-106.

10. World Health Organization “Epidemic and Pandemic Alert and Response (EPR )

- Avian influenza”. Available at: http://www.who.int/csr/disease/avian_influenza/en/Page 54 of 58 Appendix C.

Relevant EU Legislation

Council Directive Full Title

Council Directive

2005/94/EC Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC

Council Directive

92/66/EEC Council Directive 92/66/EEC of 14 July 1992 introducing Community measures for the control of Newcastle disease

Council Directive

92/40/EEC Council Directive 92/40/EEC of 19 May 1992 introducing Community measures for the control of avian influenza, as

amended.

Council Directive

91/496/EEC Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC,

90/425/EEC and 90/675/EEC

Council Directive

90/425/EEC Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intraCommunity trade in certain live animals and products with a view to the completion of the internal market

Council Directive

90/539/EEC C ouncil D irective of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs

Council Directive

82/894/EEC Council Directive of 21 December 1982 on the notification of animal diseases within the Community

Commission Decision Full Title

Commission Decision

2007/878/EC Commission Decision of 21 December 2007 amending Decision 2006/415/EC concerning certain protection measures in relation to highly pathogenic avian influenza of the subtype H5N1 in poultry in Germany, Poland and the

United Kingdom

Commission D ecision

2007/598/EC Commission Decision of 28 August 2007 concerning measures to prevent the spread of highly pathogenic avian influenza to other captive birds kept in zoos and approved bodies, institutes or centres in the Member States

Commission Decisio n 2007/556/EC Commission Decision of 1 August 2007 amending Decision 2006/415/EC concerning certain protection measures in relation to highly pathogenic avian influenza of the subtype H5N1 in poultry in the Community

Commission Decision

2007/268/EC Commission Decision of 13 April 2007 on the implementation of surveillance programs for avian influenza in poultry and wild birds to be carried out in the Member States and amending Decision 2004/450/ECPage 55 of 58 Council Directive Full Title

Commission Decision

2007/105/EC Commission Decisio n 2007/105/EC of 15 February 2007 amending Decisions 2005/731/EC and 2005/734/EC as regards the extension of their period of application 2005/734/EC as last amended by decisions 2006/574/EC

and 2007/105/EC.

Commission Decision

2007/24/EC Commission Decis ion 2007/24/EC of 22 December 2006 approving contingency plans for the control of avian

influenza and Newcastle disease

Commission Decision

2006/696 /EC Commission Decision 2006/696 /EC of 28 August 2006 laying down a list of third countries from which poultry, hatching eggs, day-old chicks, meat of poultry, ratites and wild game -birds, eggs and egg products and specified pathogen- free eggs may be imported into and transit through the Community and the applicable veterinary

certification conditions, and amending Decisions 93/342/EEC, 2000/585/EC and 2003/812/EC

Commission Decision

2006/574/EC Commission Decision of 18 August 2006 amending Decision 2005/734/EC as regards certain additional risk mitigating measures against the spread of avian influenza

Commission Decision

2006/563/EC Commission Decision of 11 August 2006 concerning certain protection measures in relation to highly pathogenic avian influenza of subtype H5N1 in wild birds in the Community and repealing Decision 2006/115/EC

Commission Decision

2006/474/EC Commission Decision of 6 July 2006 concerning measures to prevent the spread of highly pathogenic avian influenza caused by influenza A virus of subtype H5N1 to birds kept in zoos and approved bodies,

institutes and centres in the Member States and repealing

Decision 2005/744/EC

Commission Decision

2006/415/EC Commission Decision of 14 June 2006 concerning certain protection measures in relation to highly pathogenic avian influenza of the subtype H5N1 in poultry in the Community

an d repealing Decision 2006/135/EC

Commission Decision

2006/314/EC Commission Decision 2006/314/EC of 16 March 2006 approving the Member States' survey programs for avian influenza in poultry and wild birds during 2006.

Commission Decision

2006/135/EC Commission Decision of 22 February 2006 concerning certain protection measures in relation to highly pathogenic avian influenza in poultry in the Community

Commission Decision

2006/115/EC Commission Decision of 17 February 2006 concerning

certain protection measures in relation to highly pathogenic avian influenza in wild birds in the Community and repealing Decisions 2006/86/EC, 2006/90/EC, 2006/91/EC, 2006/94/EC,2006/104/EC and 2006/105/ECPage 56 of 58 Council Directive Full Title

Commission Decision

2006/101/EC Commission Decision of 6 February 2006 on the implementation of survey programs for avian influenza in poultry and wild birds to be carried out in the Member

States in 2006

Commission Decision

2005/855/EC Commission Decision of 30 November 2005 amending Decision 2005/734/EC laying down biosecurity measures to reduce the risk of transmission of highly pathogenic avian influenza caused by Influenza virus A subtype H5N1 from birds living in the wild to poultry and other captive birds and providing for an early detection system in areas at particular risk

Commission Decision

2005/760/EC Commission Decision of 27 October 2005 concerning certain protection measures in relation to highly pathogenic avian influenza in certain third countries for the import of captive birds

Commission Decision

2005/745/EC Commission Decision of 21 October 2005 amending Decision 2005/734/EC laying down biosecurity measures to reduce the risk of transmission of highly pathogenic avian influenza caused by influenza A virus of subtype H5N1 from birds living in the wild to poultry and other captive birds and providing for an early detection system in areas at particular risk

Commission Decision

2005/734/EC Commission Decision of 19 October 2005 laying down biosecurity measures to reduce the risk of transmission of highly pathogenic avian influenza caused by Influenza virus A subtype H5N1 from birds living in the wild to poultry and other captive birds and providing for an early detection system in areas at particular risk

Commission Decision

2005/732/EC Commission Decision 2005/732/EC of 17 October 2005 approving the programs for the implementation of Member States' surveys for avian influenza in poultry and wild birds during 2005 and laying down reporting and eligibility rules for the Community financial contribution to the implementation costs of those programs

Commission Decision

2005/731/EC Commission Decision 2005/731/EC of 17 October 2005 laying down additional requirements for the surveillance of

avian influenza in wild birds

Commi ssion Decision

2005/726/EC Commission Decision of 17 October 2005 amending Decision 2005/464/EC on the implementation of survey programmes for avian influenza in poultry and wild birds to

be carried out in the Member StatesPage 57 of 58 Council Directive Full Title

Commission Decision

2005/464/EC Commission Decision 2005/464/EC of 21 June 2005 on the implementation of survey programs for avian influenza in poultry and wild birds to be carried out in the Member

States

Commission Decision of

2004/630/EC Commiss ion Decision of 2004/630/EC of 27 July 2004 approving the programs for the implementation of Member States' surveys for avian influenza in poultry and wild birds during 2004 and laying down reporting and eligibility rules

for the financial contribution fro m the Community to the implementation costs of those programs, as amended.

Commission Decision

2004/615/EC Commission Decision of 23 July 2004 amending Decision 2004/111/EC on the implementation of surveys for avian influenza in poultry and wild birds i n the Member States to be carried out during 2004

Commission Decision

2004/464/EC Commission Decision of 21 June 2005 on the implementation of survey programmes for avian influenza in poultry and wild birds to be carried out in the Member

States

Commissions Decision

2004/450/EC Commissions Decision of 29 April 2004 laying down standard requirements for the content of applications for Community financing for programs for the eradication, monitoring and control of animal disease

Commission Decisi on 2004/402/EC Commission Decision of 26 April 2004 approving contingency plans for the control of avian influenza and

Newcastle disease

Commission Decision

2004/111/EC Commission Decision 2004/111/EC of 29 January 2004 on the implementation of surveys for avian influenza in poultry and wild birds in Member States, to be carried out during 2004

Commission Decision

2003/623/EC Commission Decision 2003/623/EC of 19 Augu st 2003 concerning the development of an integrated computerized veterinary system known as Traces.

Commission Decision

2002/673/EC Decision 2002/673/EC of 22 August 2002 approving the programs for the implementation of Member States' surveys for avian influenza in poultry and wild birds

Commission Decision

2002/649/EC Commission Decision 2002/649/EC of 5 August 2002 on the implementation of surveys for avian influenza in poultry and wild birds in the Member States

Commission Decision

94/327/EC Commission Decision of 19 May 1994 fixing the criteria for annual testing of breeding poultry for Newcastle disease, in application of Article 12 (2) of Council

Directive 90/539/EECPage 5 8 of 58 Appendix D.

Administrative Units of the EU - 25

Member State Administrative Unit Austria (AT) Bezirk (district veterinary service) 1

Belgium (BE) Province Cyprus (CY) Entire territory (no sub

- national AU identified 2

Czech Republic (CZ) Kraj (region) 3

Denmark (DK) Amt (county) Estonia (EE) County 4

Finland (FI) Provincial veterinary office France (FR) Commune 5 Germany (DE) Kreis Greece (EL) Nomos (prefecture) Hungary (HU) County Ireland, Republic of (IE) District Veterinary Office Italy (IT) Region 6

Latvia (LV) Rajon ( district) 7

Lithuania (LT) Apskrity ( county) 8

Luxembourg (LU) Entire territory (no sub

- national AU identified) Malta (MT) Entire territory (no sub

- national AU identified) 9

Netherlands (NL) Compartment Poland (PL) Powiat ( district) 10

Portugal PT) Divisao de Intervencao Veterinaria (DIV) Slovakia (SK) District Slovenia (SI) County Spain (ES) Comarca Sweden (SE) Län United Kingdom (UK) County or district

1 APHIS Considerations on the Identification of Administrative Units for Certain Member States of the European Union, included Austria, Belgium, Denmark, Finland, Greece, Republic of Ireland, Italy, Luxembourg , The Netherlands, Portugal, Sweden

, and the United Kingdom , dated June 2005.

2 As identified during 2008 CSF site visit.

3 APHIS Evaluation of the Status of the Czech Republic Regarding Classical Swine Fever and Swine Vesicular Disease, dated A pril 2006.

4 APHIS (2011) Proposed rule for the Importation of Live Swine, Swine Semen, Pork, and Pork Products; Estonia, Hungary, Slovakia, and Slovenia; February 11, 2011, 76 FR 7721.

5 APHIS Risk Analysis for Importation of the Classical Swine Fever V irus in Swine and Swine Products from France and Spain. Dated November 2003

. 6 Change p roposed in 76 FR 7721, published February 11, 2011.

7 APHIS Evaluation of the Status of Latvia Regarding Classical Swine Fever, Swine Vesicular Disease, and Foot and Mouth Disease, dated April 2006

. 8 A PHIS Evaluation of the Status of Lithuania Regarding Classical Swine Fever, Swine, Vesicular Disease,

and Foot and Mouth Disease. Dated January 2006.

9 As identified during APHIS site visit in 2007.

10 APHIS Evaluation of t he Status of Poland Regarding Classical Swine Fever and Swine Vesicular Disease, dated January 2006.