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, Updated April 2012

_
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TABLE OF CONTENTS

ABBREVIATIONS 3

EXECUTIVE SUMMARY 4

INTRODUCTION 6

OBJECTIVE 7

BACKGROUND 8

HAZARD IDENTIFICATION 12

RELEASE ASSESSMENT 13

EXPOSURE ASSESSMENT 24

RISK MITIGATION MEASURES 30

CONSEQUENCE ASSESSMENT 32

RISK ESTIMATION 36

CONCLUSION AND SUMMARY OF PROPOSED ACTION 37

REFERENCES 40

APPENDIX A. EPIDEMIOLOGIC CHARACTERISTICS OF NEWCASTLE DISEASE 44

APPENDIX B. EPIDEMIOLOGIC CHARACTERISTICS OF AVIAN INFLUENZA 49

APPENDIX C. TABLE OF RELEVANT EU LEGISLATION 53

APPENDIX D. ADMINISTRATIVE UNITS OF THE EU- 25 57

_______________________________________________________________________________________________
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ABBREVIATIONS:

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 Inspection 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)

ENDV 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

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 Organization
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EXECUTIVE SUMMARY

The Animal and Plant Health Inspection Service (APHIS) Veterinary Services (VS)

evaluated the risk of virulent Newcastle disease (END) and Highly Pathogenic Avian 

Influenza (HPAI) from the European Union (EU) Member States (MS) which constituted

the EU in the year 2006, collectively referred to as the European Union-25

1

(EU-25). 

Based on our evaluation of representative MS, APHIS is proposing to recognize the EU25 as free of both END 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 will 

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

APHIS based this evaluation of the END and HPAI status of the EU-25 on the 

performance measures found in Title 9 of the Code of Federal Regulations part 92.2

(9 CFR 92.2) using the documentation submitted by the European Commission2(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 status and how uniformly EC 

legislation is implemented and enforced throughout the EU-25.

The results of the evaluation indicate the following: 

 The region has an effective veterinary infrastructure capable of identifying and 

applying control measures to eradicate incursions of END or HPAI in domestic 

poultry.

 The region has a comprehensive legislative framework in place to ensure 

consistent implementation of EC legislation by all EU-MS. EC services provide 

resources to review and inspect for compliance.

 END and HPAI are notifiable (reportable) diseases.

 Appropriate surveillance, both active and passive, using serological and agent 

detection is in place with the capacity to effectively and quickly detect the 

presence of END or HPAI, even in the absence of clinical signs. 

 Laboratory confirmation capabilities are effective and laboratory testing 

procedures are well documented and standardized.

 END and HPAI eradication programs 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-25 (EU-25) was 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.
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 Contingency plans, standard operating procedures, biosecurity measures, and 

emergency response are well documented and relevant personnel well-resourced

and trained.

APHIS concluded that the overall risk of introducing either END 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 END 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 areas will include all protection, surveillance,

and buffer zones established around END or HPAI outbreaks in domestic poultry and the 

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). 

Summary of requirements (restrictions) for export to the United States

In summary, APHIS will address the END 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. In the event of an outbreak of END or HPAI, it 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 certify

that the poultry, including hatching eggs, exported to the United States or the poultry

from which exported poultry meat and poultry products were derived originated in the 

EU-25 and had never resided in a region under restrictions for the presence of END or 

HPAI in domestic poultry for the last 90 days. In the case of movement restrictions put 

in place following the detection of END or HPAI in wild birds or in racing pigeons,

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 certify

that the shipment of hatching eggs that have transited HPAI affected regions travels 

under seal issued by the veterinary competent authority. The seal number must be listed 

on the health certificate that accompanies the shipment. The veterinarian who placed the 

seal must sign his or her name under the seal number. Seals should not be broken until 

the shipment reaches its U.S. port of entry. Hatching egg shipments with seals that are 

not intact will be rejected at the U.S. port of entry by the VS port official.

5. It will require the competent veterinary authority of the individual EU-25 MS to certify 

that the farms of origin for the poultry, poultry meat, or poultry products did not receive 

birds within the last 30 days from outside the poultry trade region or from areas under 

restrictions for END or HPAI within the poultry trade region.
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6. It will require the competent veterinary authority of the individual EU-25 MS to certify

that the birds, or the birds from which hatching eggs derived, were not vaccinated for 

subtypes H5 or H7 avian influenza (AI). 

7. The products must not have commingled with poultry meat or poultry products derived 

from other poultry that were not from the EU-25 or were in any restriction zones 

established because of the presence of END or HPAI.

8. 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 establishment 

must not have been used previously for transporting live poultry that do not meet the 

above requirements, unless the equipment and materials have first been adequately

cleaned and disinfected.

INTRODUCTION

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 END and HPAI 

subtypes H5 and H7. APHIS previously recognized nine MS3of the EU as regions in 

which END is not known to exist by individually evaluating each of these MS.

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-MS which constituted the EU in the 

year 2006; collectively referred to as the EU-25

4

. APHIS evaluated the EU-25 as a single 

region with the intention to standardize regulations for all of the EU-25 as the “APHISdefined EU Poultry Trade Region.”

The evaluation reviewed the EC legislation and the measures established in this 

legislation for detecting, controlling, and eradicating animal diseases, in this case END 

and HPAI. Based on the free movement of animals and animal products within the EU

and legal requirements 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).

In April 2008, VS conducted a site visit to the EC Brussels and five representative EUMS (Cyprus, Denmark, Germany, the Netherlands, and Poland) to evaluate the avian 

disease status and incorporation and implementation of EC regulations by these 

 

3 The regions recognized as END-free in 9 CFR 94.6 are Denmark, Finland, France, Great Britain 

(England, Scotland, Wales and the Isle of Man), Greece, Luxembourg, Republic of Ireland, Spain and 

Sweden.

4

European Union-25 (EU-25) is 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
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representative MS [36]. 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 END outbreak in 2002 [21, 26, 30] and several more recent 

evaluations of the HPAI status of several regions in the EU affected by HPAI subtype 

H5N1 [5-8, 10-14]. It was determined that the EU-25 would be evaluated as a 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 frequent reports on the status of 

designating control zones, application of surveillance, results of the epidemiologic 

investigation, and progress of the control efforts. These reports provide accurate appraisal 

of the animal health situation and date the restrictions 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 END 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 legislative frameworks. The EC also 

actively monitors MS compliance with animal health legislation implementation 

by review and inspection in the individual EU–MS...

 END 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 virological 

testing in high-risk areas and of high-risk flocks. The program is capable of 

rapidly and effectively detecting the presence of END 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.

 END and HPAI eradication programs include appropriate quarantine and 

surveillance zones, monitoring of those zones, and implementation of movement 
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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 and relevant personnel wellresourced and trained.

APHIS concluded that the risk of introducing END 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.

OBJECTIVE

APHIS evaluated the END 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 END and HPAI and be 

referred to as the “APHIS-defined EU Poultry Trade Region” (or poultry trade 

region).

 Requirements 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 END 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 EC regulations apply uniformly to all MS. Therefore, APHIS 

assessed recognition 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.

BACKGROUND

Current APHIS regulation for END 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 END or any subtype of HPAI is considered to exist, 
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allowing only cooked products or consignment directly to an approved establishment in 

the United States. 

APHIS regulations for the importation into the United States from regions where END 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 oC. In regions where HPAI is considered to exist, APHIS requires 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 fulltime, salaried veterinarian of the government agency responsible for 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 HPAI into the United States, as approved by the 

Administrator. 

Eggs (other than hatching eggs) of poultry, game birds, or other birds from regions where 

END 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, educational, 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 END into the United States. Table eggs from 

END 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 days [9, 15, 18].

Generally when a region recognized by APHIS to be free of END sustains an outbreak of 

END in commercial poultry it is removed by interim rule from the list of END free 

regions. Regions are returned to the list of END 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 regulations 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 returned to the APHIS list of END free 

regions through the publication of a final rule. This is generally a lengthy process. For 

example, in the case of Denmark, an extensive outbreak of END 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 END free regions until July of 

2006 [21, 26, 30].
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In the case of HPAI, APHIS maintains a list of affected regions on the agency Web site 

as “USDA-Recognized Animal Health Status of Countries/Regions Regarding Specific

Livestock or Poultry Diseases, or Acceptable Commodities.”

5 Rulemaking is not needed 

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 (other than hatching eggs) of poultry, game birds, or other birds from regions where 

END 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, educational, 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 END or HPAI into the United States [9, 18]. 

Recently APHIS added an alternative pathway for the importation of table eggs from 

regions where END is considered to exist based on testing and 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 sealed with a seal of the competent 

veterinary authority. Certification must also be made that the flock of origin of the eggs 

was free of END 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 radius of the flock of origin [9, 18].

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, including END 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 END. No live birds, poultry, or hatching eggs from poultry

can enter from areas where HPAI exists or where Newcastle disease (ND) has occurred in 

the last 90 days [4]. All birds are subject to appropriate testing for END and HPAI prior 

their release from quarantine. 

 

5

available at: http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml
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Hatching eggs 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 free of communicable disease and the premises was not in an area under quarantine. 

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 END 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 Veterinarian 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 END and HPAI. Hatching eggs from regions APHIS considers free of 

END and HPAI must be accompanied by official certification but do not undergo

quarantine [4].

Previous actions taken by APHIS relative to END and HPAI in the EU

Previously, APHIS recognized nine EU-MS individually as regions in which END was 

not known to exist. This 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 END 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 individual assessments conducted by 

APHIS [5-8, 10-14, 16, 17]. 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 passive surveillance (serological and agent 

detection), and serological and virological testing in high-risk areas and of high-
Page 12 of 59

risk flocks. The program detected disease effectively and quickly, even in the 

absence of clinical signs. 

 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 for recording, managing, and analyzing diagnostic and surveillance 

data was sufficient to demonstrate effectiveness of disease control measures. 

 Laboratory confirmation capabilities were effective; and laboratory 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 these 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 applicable 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 procedures 

and there was no disease recurrence. Monitoring conducted after repopulation 

demonstrated that the disease has been eradicated.

HAZARD IDENTIFICATION

The Terrestrial Animal Health Code recommends identifying the pathogenic agents 

which could potentially produce adverse consequences associated with the importation of 

a commodity [43]. In this case the pathogenic agents are END and HPAI and the 

commodities are live birds, poultry meat, and poultry products [Appendix I and II].

RISK ANALYSIS

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 [43]. Although the primary focus for this analysis is 

the evaluation of risks associated with poultry products imported from the EU-25, the 

exposure and consequence assessments include discussion of live bird factors because of 

their historical significance to END and HPAI outbreaks in the United States.

RELEASE ASSESSMENT

The Terrestrial Animal Health Code recommends describing the biological pathways

necessary for an importation activity to 'release' or introduce the identified pathogenic 

agent(s) into a particular environment and estimate the probability of that occurring under 
Page 13 of 59

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 conducted a further assessment.

EU animal health controls for END 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, END and HPAI control measures are completely

harmonized through specific EU legislation, and binding upon all EU-MS [Appendix 4]. 

These harmonized animal health regulations include compulsory notification of END 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 

linking veterinary authorities of the EC and MS. 

The EU recognizes that the risk for END and HPAI outbreaks can never be reduced to 

zero due to the occurrence of these diseases in wild birds. In the case of the detection of 

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 measures may also be applied to backyard and hobby flocks. The 

implementation of basic Community rules laid down in Council Directives 92/66/EEC 

(Newcastle disease) and 2005/94/EC (avian influenza) have served to rapidly and

effectively control any END and HPAI outbreaks that have occurred in the Community in 

the last decade. 

EU animal movement controls

The general provisions for veterinary and zootechnical checks applicable to intraCommunity trade of live poultry and poultry products 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 to track the movement of animals, including the importation of 
Page 14 of 59

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. The system also allows the receiving MS 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 ensuring

that when they are shipped to another MS, they are accounted for on arrival at their 

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 

animal health certificates for use with different poultry categories, such as breeding, 

production, day-old hatching eggs, slaughter poultry, and poultry for restocking game 

supplies. The certificate is signed by the official veterinarian, confirming compliance 

with the Directive's requirements. The certificates must indicate if the poultry have been 

vaccinated against END and if the poultry have been vaccinated, the certificate must 

specify the age at vaccination and the characteristics of the END vaccine used. The 

regulation also specifies conditions for the production of live poultry and hatching eggs 

as well as movement of live poultry; all poultry for breeding and production must come 

from establishments officially approved by the EU, and have undergone an animal health 

inspection.

The importation of poultry and hatching eggs from countries or regions into the EU is

also regulated. The general animal health requirements governing imports from non-EU 

countries of poultry and hatching eggs are also harmonized and require that the non-EU 

exporting country supply certification signed by an official veterinarian of the competent 

authority of the exporting third country guaranteeing that the conditions for import into 

the EU have been met 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 animals 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 conforming changes to the model health certificates.

Measures to detect, control, and eradicate END and HPAI in domestic poultry

EC regulations designate both END and HPAI as notifiable animal diseases 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 

register and document important infectious animal diseases and manage 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 all forms of AI in 

all avian species are reported and tracked. The authority for ADNS is longstanding under
Page 15 of 59

Council Directives 82/894/EC and Commission Decision 2005/176/EC and ensures the

rapid exchange of information between the competent national animal health authorities 

and the EC. The system allows co-ordination and monitoring of outbreaks of contagious 

animal diseases and enables MS and EC 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. Immediate 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 outbreaks 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

outbreaks 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 immediately 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 establishing control measures following the 

detection of LPAI based on the risk that low pathogenic viruses may mutate into HPAI

viruses. However, 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 and 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 transport by the official 

veterinarian. 
Page 16 of 59

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; laboratory tests are carried out on these commercial 

poultry holdings; and all movements of poultry within the zone must be authorized by the 

competent authority.

END Vaccination policy

All MS except Sweden, Finland, and Estonia routinely use prophylactic ND vaccination. 

All ND vaccines must be approved and made only from lentogenic ND 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 

END was revised following the 2002 outbreaks, and since October 2004, systematic 

prophylactic vaccination has been used. By EC regulation, racing pigeons in all 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 by EU 

regulation, any vaccination plan must include a strategy to differentiate infected from 

vaccinated animals.

Contingency plans for END or HPAI control

All MS are required to maintain a current contingency plan that defines proactive 

approaches to END and HPAI control. These plans are regularly reviewed and approved 

by the EC as specified in Commission Decisions 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 an END 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 an 

END or HPAI outbreak. Appropriate staff must regularly receive training and conduct 

drills in END and HPAI diagnosis, control measures, and communication techniques. The 

EC performs onsite reviews of the MS for compliance with the directives and 
Page 17 of 59

representatives 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 each 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 END outbreaks

APHIS’ review of the ND 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, 42]. The most recent, large END 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 END to the OIE. Over the next 7 weeks, a total of 135 END 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 dispersed 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 END to five commercial flocks and 126 backyard flocks. 

In October 2005, Denmark diagnosed END 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 

ENDV 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 END 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 [2, 26].

In 2000, Italy diagnosed END in the Piedmonte Region, and over a 6-month period 257 

small flocks in several regions of northern and central Italy were identified as infected

[42] with the virus. The epidemiological investigation indicated that the disease spread 
Page 18 of 59

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 ND in pigeons in 2006, 2007, and 2008 [42].

END 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 types

of birds 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 

wild pigeons, proving a continuing threat to poultry [1, 2, 39, 46].

The variant pigeon paramyxovirus variant subtype 1 is referred to as PPMV-1 to 

distinguish it from the avian paramyxovirus (APMV-1) that causes most of the virulent 

ND in poultry. Isolates of the pigeon-adapted NDV (PPMV-1) have been geneticallysequenced and results show a pattern of amino acids at the cleavage site which is 

compatible with the pattern of virulent ND viruses but characterized by unique 

monoclonal antibody binding profiles [39, 46]. 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; however, to date, there 

have been no reports of the strain in commercial poultry in the United States [39, 46]

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 END control found 

in Council Directive 92/66/EC. Vaccination for END of all pigeons at registered racing 

meets and exhibitions is one of the specific control measures in place. However, 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 ENDV in Finland, 

Germany, and Italy [42]. In Germany, ND was found on a holding with a mixed bird 

population; however, only pigeons were infected and were considered to be the source.

Italy reported ND on two pigeon holdings; one of these holdings also had a small number 

of other poultry (33 total birds). Finland detected PPMV-1 in six interrelated pigeon 

holdings that occurred in areas with very little commercial poultry; an epidemiologic 

investigation was done on all holdings within 10 km. In 2007, pigeons were the source of 
Page 19 of 59

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.

Movement restrictions are put in place for all detections or suspicions of END 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 the 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 the 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 Directives 82/894/EEC and 92/40/EC. All detections 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, and 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 a 

quarantine station in the UK prompting the restrictions on the importation of captive 

birds from 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 [37, 42]. 
Page 20 of 59

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 

[37]. 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 in 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 [17]. 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 [37]. In April, German authorities 

confirmed 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 farm, and in June, Hungary detected HPAI 

H5N1 on a holding of geese.

In 2006, extensive AI surveillance also found the presence of several LPAI strains in the 

following MS: LPAI H5N2 in Denmark (farmed game birds) and Portugal (free range 

ducks); LPAI H7N3 in the UK (broiler breeder farm); and LPAI H7N7 in the Netherlands 

and Hungary (farmed geese). 

In 2007 and 2008, HPAI H5N1 was reported in Czech Republic, France (wild swans 

only), Germany, Hungary, Poland, Slovenia, and the UK [42]. 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 turkey holding, two broiler farms,

and two breeding hen farms. 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 Italy (a holding with 2,000 

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

H7N2 in the UK in backyard poultry flock [35].

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

domestic 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 a 

turkey holding and more than 30 detections of LPAI H5N3; France reported LPAI H5 

subtype on a holding with 5,000 breeding ducks; the Czech Republic reported LPAI H7; 

and Italy reported LPAI H5 on poultry a fattening turkey holding.
Page 21 of 59

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 HPAI H5N1 

situation in the EU during the 2006 – 2009 outbreaks, it was found that swans, especially

mute swans (Cygnus olor), were most frequently involved [34]. The exception occurred 

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

in the same area were not affected. In 2006, HPAI H5N1 was also isolated from grebes in 

Spain, Denmark, and Sweden [37].

EU quarantine decisions with respect to areas affected by END or HPAI would provide 

the basis for U.S. import restrictions

Existing APHIS regulations (9 CFR 93.205) require that all poultry, except eggs for 

hatching, offered for importation from any region of the world, regardless of END or 

HPAI status, be 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 was free of evidence of communicable diseases of 

poultry, including END or HPAI, for the 90 days prior to movement. APHIS requires 

import certificates only be issued for birds not exposed to END or HPAI and not 

originating from a premise located in any area under quarantine during the preceding 90 

days.

The 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 [43]. However, EU regulations allow 

END 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 END until at least 21 days after the confirmation of the last case and the 

completion of a stamping-out policy and disinfection procedures have been completed. 

The Code also considers 21 days to be the incubation period for both END and AI [43].

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 END or HPAI in commercial poultry until 

90 days after the cleaning and disinfection of the last affected establishments.

Current APHIS regulations 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 END and AI before being released. Hatching eggs imported from regions

recognized to free of END and HPAI are not required to be quarantined; however, they

must be accompanied by a veterinary health certificate issued by a national government 

veterinarian of the exporting country as well as by a USDA import permit. Hatching eggs 

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 free of END 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 
Page 22 of 59

inspected and approved by the AVIC prior to issuance of the import permit. After 

hatching, the 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 determine that they are free from communicable 

disease. 

END and HPAI remain endemic in many countries of Asia, the Middle East, Africa, and 

Central and South America [38, 42]. The potential for END or HPAI introduction into the 

EU-25 via the migration of infected wild birds from endemic areas deserves 

consideration. However, this 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 END or HPAI into the EU-25 may also occur through legal trade of 

poultry or poultry products if imported commodities are infected with END or AI. This is 

a potential risk because the EU trades with countries or regions that the United States 

does not recognize as free of END of 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, as 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 

END 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 END 

or HPAI exists.

Previously, based on risk analysis and implemented in rulemaking [24], 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 diseases [24]. 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 [28]. The AU for the

remaining MS were identified during site visits, as listed in Appendix D.

CONCLUSIONS

APHIS considers the risk of END 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 END 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 END and HPAI control measures are harmonized 
Page 23 of 59

and binding on all EU-25 MS, APHIS recognizes the EU-25 as a single region for END

and HPAI for which restrictions can be placed on exports that are appropriate for a region 

in which APHIS expects that END or HPAI outbreaks will continue to occur.

Since many of the appropriate restrictions reflect EC quarantine decisions, APHIS 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 considers it necessary to 

require there be no exportation from the quarantine areas imposed when END or HPAI 

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

In summary, APHIS will address END 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 EU25 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 END or HPAI. This 

certification will apply the EC definition of the borders of the relevant region as a 

restricted zone and recognize EC authority to maintain adequate controls as 

described previously in this document. Specifically, the restriction zone will 

encompass all protection, surveillance, and buffer zones established around END 

or HPAI outbreaks in domestic poultry and affected zones established around 

END 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 authorities of the EU-25 MS to certify that no commodities originated

from, or were comingled with, commodities from a restriction zone established 

because of END or HPAI in domestic poultry for a period of 90 days.

 It will require the competent veterinary authority of the individual EU-25 MS to 

certify that the shipment of hatching eggs that have transited HPAI-affected 

regions travels under seal issued by the veterinary competent authority. The seal 

number must be listed on the health certificate that accompanies the

shipment. The veterinarian who placed the seal must sign his or her name under 

the seal number. Seals should not be broken until the shipment reaches its first 

U.S. port of entry. Hatching egg shipments with seals that are not intact will be 

rejected at the U.S. port of entry by the VS port official.

 It will require that the premises of origin did not receive live poultry or hatching 

eggs from outside of the EU-25 in the last 30 days.
Page 24 of 59

EXPOSURE ASSESSMENT 

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 END and HPAI) 

released from a given risk source, and estimating the probability of the exposure(s) 

occurring [43]. 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 END and HPAI outbreaks in the United States. Of particular note were the 

END outbreaks that occurred in 2002 and 2003 in several western States. Earlier END 

outbreaks were also examined to the extent that relevant information was available. END 

and HPAI have similar epidemiological characteristics and review of the possible 

pathways of introduction of END is relevant to risk [26, 31].

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 END and HPAI introduction and spread. 

Pathways of introduction and spread in the United States

Historical information from END 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 END 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 END outbreaks over the last 50 years (see 

table 1) [26]. 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 eggs from Hungary. 

Live birds implicated in END 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 introduction of the viral agent through 

importation of the live birds or products.

Review of END outbreaks

An extensive, multistate END 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 APHIS were 

implemented in 1972. The approval of private quarantine facilities in 1979 essentially

eliminated this risk pathway. The dramatic decrease in END introductions is apparent in 
Page 25 of 59

the table below. The quarantine process also mitigates the risk of importing HPAI

through legal importation of live birds and poultry.

The most extensive END outbreaks in the United States involving commercial poultry

occurred in 1971-1973 and 2002-2003. In November 1971, END 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 END virus. The outbreaks subsequently spread to involve much

of southern California before containment in 1973. 

In 2002, END 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 END, 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 END introductions into the United States [26]

Date Place of Outbreaks Exposure Pathway 

1950 (Apr) Contra Costa 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 chickens 

1974 (May) Hidalgo, TX Domestic chickens 

1974 (May) Bulverde, TX Parrots from Mexico 

1975 (Mar) Long Island, NY Pet bird dealer 
Page 26 of 59

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 County, TX Game fowl 

In summary, the majority of introductions of END 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 experience 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 END, the AIV of all known subtypes can be found 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 influenza 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 due 

to poor biosecurity [2, 3]. 

The first HPAI outbreak (H7) in the United States was identified in 1924 in several east 

coast 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 during the 

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

HPAI and LPAI forms of the virus [45].

In 2004, USDA confirmed an HPAI H5N2 outbreak in a flock (6,600) of chickens in 

Gonzales County, Texas. Although the clinical 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 [40]. 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 circulate.

Other notable outbreaks of HPAI have 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) [45].
Page 27 of 59

Table 2. Occurrences of HPAI in the Western Hemisphere since 1960: [42, 45]

Year Location Species Subtype

1966 Canada (Ontario) Turkey H5N9

1983–1984

United States (Pennsylvania, Maryland, 

New Jersey, and Virginia) Chicken H5N2

1994 Mexico Chicken H5N2

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 farms 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].

Mexico - In Mexico during 1994-1995, H5N2 LPAI was diagnosed in 11 Mexican States. 

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 [45]. In 2002, outbreaks 

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

farm was determined to have HPAI H7N3. The mutation from LPAI to HPAI 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 introductions 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 END and AI suggests that importation of live birds represents a far more 

likely initial exposure pathway than poultry meat or products. 

Commodity factors for END 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 relatively low. 

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 and waste disposal 

procedures would be expected to follow common practices in the United States. In this 
Page 28 of 59

regard, exposure of domestic poultry populations through waste feeding to backyard 

flocks or other channels cannot be precluded. However, based on historical data, APHIS 

considers this to be a far less likely exposure pathway than introduction via live birds.

Pathways of spread of END 

Historical accounts of END outbreaks in the United States also provide significant 

information 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, END 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 States poultry

and egg supply. 

The 2002 introduction of END into California initially caused outbreaks primarily in 

backyard flocks (flocks with small numbers of birds on private premises for hobby, 

exhibition, and personal consumption) in a predominantly immigrant community. The

types of birds involved included game fowl, pet birds, ostriches, and waterfowl. 

However, the END 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 of 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 END 

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 traveled rapidly between premises

with poor biosecurity, often carrying the virus with them and exposing other premises in 

the area. 

In the 2002-2003 outbreaks, appropriate biosecurity measures were implemented to 

prevent the task force personnel from acting 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 
Page 29 of 59

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 outbreaks 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 [45].

Following the introduction of the HPAI virus into domestic poultry the potential 

pathways of spread are similar to associated with END. Biosecurity measures 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 commercial 

poultry industry participates in the National Poultry Improvement Plan (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 Commercial 

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. This program is

for commercial birds as 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 diagnostic 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 commercial 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.

In summary, historical experience in the United States indicates that, once END 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 density of susceptible 
Page 30 of 59

populations. In addition, backyard flocks and non-commercial birds may play an 

important role in disease introduction and spread.

RISK MITIGATION MEASURES 

Mitigation measures affecting END and HPAI introduction 

As previously discussed, the most likely pathway of END introduction into the United 

States is through legal or illegal importation of live birds. Several END 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 END-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 APHIS. 

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

approved 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 END 

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 END or HPAI, so that the likelihood that infected birds could remain 

undetected throughout the quarantine process is very low. 

APHIS considers the risk of END or HPAI introduction through legal importation of live 

birds to be effectively mitigated by the quarantine measures 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-25 would be 

technically difficult because of the travel distance 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. 
Page 31 of 59

While the END 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-25 are routinely vaccinated for END, most backyard birds are not such that these 

backyard flocks serve as sentinel animals for detecting END outbreaks in the 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 END 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 [26, 33]. Epidemiological 

investigations done in the United States and internationally have suggested that the 

likelihood of spread after END 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 cases 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 facilitate 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 animal 

fighting venture, if the animal was moved in interstate or foreign commerce. APHIS 

highlighted this law by publication of a FR notice in 2003 [29]. 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. 
Page 32 of 59

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

disease at the Federal 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 also 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 

situations 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 END 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. 

EXPOSURE SUMMARY 

Given the results of the release assessment, APHIS considers the likelihood of 

introduction of END or HPAI-infected birds and products from the EU-25 to be 

extremely low. Historical experience indicates that the likelihood of END 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 END status within the EU-25 is 

unlikely to substantially impact the risk of illegal importation of live birds. 

Significant direct and indirect mitigation measures are currently in place in the United 

States to address the risk of END 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 END or HPAI were introduced to a concentrated susceptible 

population.

CONSEQUENCE ASSESSMENT 

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. 

Animal health consequences 

END and HPAI are some of the most severe diseases of poultry throughout the world and 

its consequences in terms of animal health are significant [38]. 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. 
Page 33 of 59

Public health consequences 

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

of END are minor as END is not considered to be a significant human pathogen 

[Appendix A, 32, 38]. Disease manifestation of END in humans is generally limited 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 [32]. 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 [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 

contact with infected birds or surfaces that have been contaminated with secretions or 

excretions from infected birds [32].

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

infection [32].

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. The most significant risk factor for 

human H5N1 infection is direct contact with sick or dead poultry or wild birds [48]. 

Environmental consequences 

Environmental consequences resulting from END 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 and 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 potential impacts and no cumulative impacts with 

other related projects that might result in significant adverse impacts. 
Page 34 of 59

Economic consequences 

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

the United States relative to END 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 from 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 control [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 END 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 END 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 relatively 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 END outbreaks 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 [26, 31]. 

The outbreaks in 2002-2003 in Arizona, Nevada, and Texas could each be considered 

representative of a limited incidence with 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 [36].

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

Control and eradication costs 

The introduction of END into southern California between 1971 and 1973 resulted in a 

major occurrence of the disease [31]. A total of 1,341 infected flocks were identified and 

12 million infected and exposed birds were destroyed, mostly laying hens. 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 through 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 [26]. A 
Page 35 of 59

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 END outbreaks in California, Arizona, Nevada and 

Texas were also labor intensive and expensive. Spread within the State of California was 

the most extensive among the four States 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 States [26]. 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 Federal, State, county, and metropolitan agencies 

to participate; the effort included approximately 2,780 personnel from the Federal sector 

alone. 

Effects of the 2002-2003 END outbreaks on trade 

The effects of an extensive END incidence on U.S. trade can be characterized using 

information from the 2002-2003 outbreaks; economic impacts of an extensive HPAI 

outbreak would be similar. Immediately following the confirmation of END in the 

United States in 2002, trading partners imposed trade restrictions on poultry products that 

were perceived as posing a risk of exporting END 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 

[33]. 

Direct trade impacts of END 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 [33]. The total estimated cost of the poultry

restrictions for the roughly 12 month period of the END 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, as 

$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 estimates 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 
Page 36 of 59

is possible that the true impact of the trade restrictions is significantly less than the 

calculated values presented [33]. 

CONSEQUENCE SUMMARY 

This consequence assessment provides general information regarding the type and 

magnitude of the effects of END or HPAI introduction into the United States from an 

historical perspective. The major consequences of the END 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 industry 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 [45]. 

RISK ESTIMATION

According to OIE guidelines, if the 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 END introductions and HPAI events in the United States.

Regarding the likelihood of exposure, historical experience indicates that the risk of 

introducing END 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 region for END or HPAI would not likely impact illegal bird movement 

from the EU-25. Poultry product imports historically have not been implicated in END 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 an END or HPAI outbreak on animal and public health, 

as well as associated environmental and economic considerations. Consequences of 

human exposure from END 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 no 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 available information 

regarding the economic consequences of END introductions into the United States since

1950. This assessment, while demonstrating that the consequences can be significant 

under certain conditions, also demonstrated that an END introduction does not 

necessarily result in extensive consequences. If the disease is diagnosed prior to extensive 
Page 37 of 59

spread, appropriate biosecurity measures are implemented, and the public is educated to 

look for clinical signs, the consequences can be minimized. Furthermore, in response to

the outbreak in the western United States in 2002-2003, APHIS enhanced its END 

surveillance program to increase the likelihood of future detection prior to spread. A 

comparable economic impact would be expected for an extensive outbreak of HPAI.

CONCLUSION AND SUMMARY OF PROPOSED ACTION

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 END 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 EC

control mechanisms are fully implemented by the individual MS and are sufficiently 

effective to mitigate the risk of exporting END 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 END 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 END or HPAI in domestic 

poultry.

 The region has a comprehensive legislative 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 implementation by review 

and inspection in the EU-MS by the Commission services.

 END 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 virological 

testing in high-risk areas and of high-risk flocks. The program is capable of 

effectively and quickly detecting the presence of END and 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.

 END and HPAI eradication programs include appropriate quarantine and 

surveillance zones, monitoring of those zones, and implementation of movement 
Page 38 of 59

restrictions. Procedures for 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 and relevant personnel well-resourced and trained.

In addition, an effective system for traceability of hatching eggs enables the immediate 

review of movements and allows the effective verification that shipments arriving at the 

destination are appropriately identified ensuring that when they are shipped to another 

Member State, they are accounted for on arrival at their destination. This system also 

allows the effective verification of hatching eggs that have transited HPAI affected 

regions have traveled under seal issued by the veterinary competent authority. 

APHIS is proposing to recognize the “APHIS-defined EU Poultry Trade Region” as a 

single region for END 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-15 [19-20, 22, 25, 27, 28]. 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 END 

in domestic poultry will not be removed from the list of END-free regions in 9 CFR 94.6 

by interim rule, unless APHIS suspects that EU control measures are not effectively 

controlling an END 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 restricted zones using the regions defined in the EC quarantine restrictions 

established and published for any END 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 END or HPAI in domestic poultry until 90 days have elapsed following the 

depopulation, and cleaning and disinfection of the last affected 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 [43]. When END 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 the infection had not been 

introduced into commercial poultry before 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 Directives 96/66/EC and 2005/94/EC. Definition and 

maintenance of the integrity of those zones will be the purview of the EC. 
Page 39 of 59

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 authority of the MS will certify that all 

certification requirements in current APHIS regulation have been met (9 CFR 93.205). 

It will require the competent veterinary authority of the individual EU-25 MS to certify

that the shipment of hatching eggs that have transited HPAI affected regions travels 

under seal issued by the veterinary competent authority. The seal number must be listed 

on the health certificate that accompanies the shipment. The veterinarian who placed the 

seal must sign his or her name under the seal number. Seals should not be broken until 

the shipment reaches its first U.S. port of entry. Hatching egg shipments with seals that 

are not intact will be rejected at the first U.S. port of entry by the VS port official.

APHIS considers the END 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 

END-free regions listed in 9 CFR 94.6. However, APHIS anticipates that limited END 

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 END 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 detailed in the EC-approved eradication plans for END or HPAI in 

domestic and wild birds.

In summary, APHIS concludes that the risk of introducing END or HPAI into the United 

States as a result of trade in poultry carcasses, parts or 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 END or HPAI by the 

legal importation of live birds and hatching eggs under the established quarantine and 

testing requirements. Although consequences of an END 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 59

REFERENCES1. 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, 11th ed., 64-87.

4. APHIS (2009) Interim rule and request for comments Highly Pathogenic Avian 

Influenza AS YET 2b Published **

5. 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.

6. 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 

Saxony (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.

7. APHIS (2009). Notice of Determination of the High Pathogenicity Avian Influenza 

Subtype H5N1 Status of Germany and Poland. 74 FR 274, published June 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.

8. 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.

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

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

10. APHIS (2009). Evaluation of the Highly Pathogenic Avian Influenza H5N1 

Status of Suffolk and Norfolk Counties, England. January 2009
Page 41 of 59

11. APHIS (2009). APHIS’ Evaluation of the Status of High Pathogenicity Avian 

Influenza H5N1 (HPAI H5N1) in Germany. October 2008.

12. APHIS (2008). APHIS’ Evaluation of the Status of High Pathogenicity Avian 

Influenza H5N1 (HPAI H5N1) in Hungary. November 2008. 

13. APHIS (2008). APHIS’ Evaluation of the Status of High Pathogenicity Avian 

Influenza H5N1 (HPAI H5N1) in Poland. October 2008. 

14. 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.

15. APHIS (2008). Justification for the changes to the regulations governing the 

importation of table eggs from regions where Exotic Newcastle disease exists into the 

United States. Revised April 2008. 

16. APHIS (2007). APHIS Analysis of the Status of High Pathogenicity Avian 

Influenza H5N1 (HPAI H5N1) in Denmark. December 2007.

17. APHIS (2007). APHIS Analysis of the Status of High Pathogenicity Avian 

Influenza H5N1 (HPAI H5N1) in France. December 2007.

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

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

19. 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.

20. APHIS (2007). Importation of Live Swine, Swine Semen, Pork and Pork Products 

from the Czech Republic, Latvia, Lithuania and Poland. Published APHIS (2007) 

Importation of Live Swine, Swine Semen, Pork and Pork Products From the Czech 

Republic, Latvia, Lithuania and Poland. Proposed rule. Published February 12, 2007: 

71 FR 6490.

21. APHIS (2006). Final Rule to Add Denmark to the List of Regions Free of Exotic 

Newcastle Disease. 71 FR 38259, published July 6, 2006.

22. APHIS (2006). Final rule: Importation of swine and swine product from the 

European Union [Docket 02-046-2]. Published May 10, 2006: 71 FR 29061. 

23. APHIS (2006). Add Kazakhstan, Romania, Russia, Turkey, and Ukraine to List of 

Regions in Which Highly Pathogenic Avian Influenza Subtype H5N1 Is Considered 
Page 42 of 59

To Exist. Interim rule and request for comments. Published February 13, 2006: 71 FR 

7401; affirmed on May 18, 2006 in 71 FR 28763.

24. APHIS (2005). APHIS Considerations on the Identification of Administrative 

Units for (AU) Certain Member States of the European Union. June 2005

25. APHIS (2005) Importation of Swine and Swine Products from the European 

Union Proposed rule. Published Friday, April 8, 2005: 70 FR 17928

26. APHIS (2005) APHIS Risk Analysis on Importation of Exotic Newcastle Disease 

(END) Virus from Denmark. March 2005. Notice of Availability published May 5, 

2005; 70 FR 23809.

27. 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. 

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

Union; Final Rule. Published April 7, 2003: 68 FR 16922

29. APHIS (2003). Animal Welfare; Animal Fighting Venture Prohibition; Notice. 

Published May 12, 2003: 68 FR 25315

30. 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.

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

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

32. Center for Disease Control (2006). Past avian influenza outbreaks. Available at: 

http://www.cdc.gov/flu/avian/

33. CEAH (2003). Summary of Exotic Newcastle Disease Direct and Indirect 

Impacts, Centers for Epidemiology and Animal Health United States Department of 

Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, 

October 2002 - September 2003. 

34. European Commission (2009). Avian Influenza Chronology Situation as of 18 

May 2009 and List of Decisions Adopted by the European Commission 2008. DG 

Health and Consumer Protection, Unit D1: Animal Health and Standing Committees. 

Response to outbreaks in Member States and third countries

35. European Commission (2007). Avian Influenza Extensive Chronology and List of 

Decisions Adopted by the European Commission 2007. DG Health and Consumer 

Protection, Unit D1: Animal Health and Standing Committees. 
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36. European Commission (2007). Information on the Newcastle Disease Legislation 

and Disease Situation in the European Union. September 2007.

37. European Commission (2006). Avian Influenza Extensive Chronology and List of 

Decisions Adopted by the European Commission in 2006; Part 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. 

38. Foreign Animal Diseases, the Gray Book, 7th ed. United States Animal Health 

Association. Revised, 2008. http://www.vet.uga.edu/vpp/gray_book/

39. 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.

40. 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.

41. 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.

42. OIE (2009). Weekly disease information update archive; available at: 

http://www.oie.int/eng/info/hebdo/a_csum.htm

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

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

44. SCOFCAH Animal Health and Animal Welfare meeting presentations, available 

at: 

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

45. Swayne, D.E., (2008). “High Pathogenicity Avian Influenza in the America” in 

Avian Influenza, ed. D. E. Swayne, Blackwell Publishing, p 191 -211.

46. 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, 2005.

47. 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
Page 44 of 59

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

Avian influenza”. Available at: http://www.who.int/csr/disease/avian_influenza/en/

 
Page 45 of 59

APPENDIX A. EPIDEMIOLOGIC CHARACTERISTICS OF NEWCASTLE DISEASE

Disease

Virulent (exotic) Newcastle disease (END) 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.

APHIS regulation defines the Newcastle disease as any virulent Newcastle disease and 

routinely uses the abbreviation END. Previously, velogenic Newcastle disease was used 

to describe virulent Newcastle disease in APHIS regulation. Regulations in 9 CFR 121 

further defines virulent Newcastle disease virus as avian paramyxovirus serotype 1 with 

an intracerebral pathogenicity index in day-old chicks (Gallus gallus) of 0.7 or greater or 

has an amino acid sequence at the fusion (F) protean cleavage site that is consistent with 

virulent strains of Newcastle disease virus. A failure to detect a cleavage site that is 

consistent with virulent strains does not confirm the absence of a virulent virus. 

Previously known as velogenic viscerotropic Newcastle disease (VVND) and currently

referred to as Newcastle disease (ND) in the OIE Terrestrial Code [6], ND is a commonly

used alternative designation.

Clinical Signs

END 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. END can infect and cause death even in 

vaccinated poultry [1].

Clinical symptoms of END vary depending on viral strain, host, age, and environment. 

END 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; 

• 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; natural or experimental 

infection with NDV has been demonstrated in at least 236 species from 27 of the 50 
Page 46 of 59

orders of birds [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. 

END Spread 

END 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. END spreads rapidly among birds kept in 

confinement, such as commercially raised chickens. High concentrations of the END 

virus are in birds’ bodily discharges. Therefore, the disease can be spread easily by

mechanical means. Virus-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 END virus can survive for several weeks in a warm and humid environment on 

birds’ feathers, manure, and other materials; it 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 END into U.S. poultry flocks. Amazon parrots that are carriers 

of the disease but do not show symptoms are capable of shedding END virus for more 

than 400 days [3]. 

END Control in Commercial poultry

The only way to eradicate END 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. 

• 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. 
Page 47 of 59

• 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. 

END Control in Pet Birds, Pigeons and Backyard Poultry 

END 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 

END 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 ND panzootic emerged 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 pigeons. 

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, 5, 7].

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 

END viruses from pigeon, whether the strain is AMPV-1 or PPMV-1, represents a 

potential source of END infection for commercial poultry [5]. 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 ND viruses but 

characterized by unique monoclonal antibody -binding profiles [5, 7]. 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 

but to date there have been no reports in commercial poultry in the United States [5].

OIE Definition of Newcastle disease

Most species of birds are susceptible to infection with ND viruses of both high and low 

virulence for chickens. Although the clinical signs seen in birds infected with NDV vary

widely and none are regarded as pathognomonic. The ND 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 ND is that the virus has an intracerebral 

pathogenicity 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 [6]. 
Page 48 of 59

Newcastle Disease in Humans

NDV is a human pathogen. Reported infections have been non-life threatening and 

usually not debilitating for more than a day or two [4]. The most frequently reported and 

best substantiated clinical signs in human infections have been eye infections; usually

consisting of unilateral or bilateral 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 infected 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 poultry) 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, 11th 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 paramyxoviruses 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. 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.

5. 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.

6. OIE (2008). Newcastle Disease. In Terrestrial Animal Health Code, Paris, World 

Organization for Animal Health: Section 10.13

7. 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, 2005
Page 49 of 59

APPENDIX B.

EPIDEMIOLOGIC CHARACTERISTICS OF AVIAN INFLUENZA

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, 7]. AI viruses infect chickens, 

turkeys, pheasants, quail, ducks, geese, and guinea 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, 4]. 

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 [4, 5]. HPAI is an extremely infectious and fatal form 

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 [4].

HPAI subtype H5N1 (HPAI H5N1), often referred to as "Asian” H5N1, is the type 

causing worldwide concern and 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. Millions 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 [5, 6]. 

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 ranging from asymptomatic infection, mild respiratory disease with drops in 

egg production, or severe systemic disease with near 100 percent mortality [8]. Typically 
Page 50 of 59

HPAI in domestic poultry is characterized by high morbidity accompanied by high and 

rapidly escalating unexplained mortality. However, none of these signs can be considered 

pathognomonic. Lesions may be absent in cases of sudden death [1-8]. Disease is not 

usually apparent with AI virus infection in most wild bird species [2, 8]. 

AI Transmission [1-5]

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 contaminated feed, water, equipment, and clothing.

Contact 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 Poultry

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 practices 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 have 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 Humans

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 have 

resulted from contact with infected poultry (e.g., domesticated chicken, ducks, and 

turkeys) or surfaces contaminated with secretions 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 contact with infected birds or surfaces that have 

been contaminated with secretions or excretions from infected birds [3, 9].

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 
Page 51 of 59

respiratory diseases (such as acute respiratory distress), and other severe and lifethreatening complications. The symptoms of AI may depend on which virus caused the 

infection [3].

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. The 

most significant risk factor for human H5N1 infection is direct contact with sick or dead 

poultry or wild birds [9].

Past AI Outbreaks [1-3, 7, 8]

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 laboratory 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 direct contact 

with infected birds or poultry was not documented.

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. Center for Disease Control (2006). Past avian influenza outbreaks. Available at: 

http://www.cdc.gov/flu/avian/
Page 52 of 59

4. OIE (2008). Chapter 10.4 Avian Influenza. In Terrestrial Animal Health Code, 

World Organization for Animal Health.

5. OIE (2008). Technical Disease Card Highly pathogenic avian influenza and low 

pathogenic avian influenza (poultry). World Organization for Animal Health, 

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

6. 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 

7. Suarez, D. L., (2008). ‘Influenza A virus.” In Avian Influenza, Swayne, D. E., 

(Ed.) Iowa, Blackwell Publishing: 3-22.

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

ed. Saif, Y. M., H. J . Barnes, A. M. Fadly, et al (Eds). Iowa, Blackwell 

Publishing: 135-106.

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

Avian influenza”. Available at: 

http://www.who.int/csr/disease/avian_influenza/en/
Page 53 of 59

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

Council Directive 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 Decision 

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 Decision 

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/EC 
Page 54 of 59

Council Directive Full Title 

Commission Decision

2007/105/EC

Commission Decision 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 Decision 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

and 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/EC
Page 55 of 59

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 

Commission 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 States
Page 56 of 59

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 

Commission 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 from 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 in 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 Decision 

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 August 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/EEC
Page 57 of 59

Council Directive Full Title 

Commission Decision 

93/342/EC

Commission Decision of 12 May 1993 laying down the 

criteria for classifying third countries with regard to avian 

influenza and Newcastle disease

Council Decision 

90/424/EEC 

Council Decision of 26 June 1990 on expenditure in the 

veterinary field
Page 58 of 59

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 identified2

Czech Republic (CZ) Kraj (region)3

Denmark (DK) Amt (county)

Estonia (EE) County4

Finland (FI) Provincial veterinary office

France (FR) Commune 5

Germany (DE) Kreis 

Greece (EL) Nomos (prefecture)

Hungary (HU) County6

Ireland, Republic of (IE) District Veterinary Office

Italy (IT) Province

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) District11

Slovenia (SI) County12 (10)

Spain (ES) Comarca 13

 

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 April 2006.

4 As identified during 2005 CSF site visit.

5 APHIS Risk Analysis for Importation of the Classical Swine Fever Virus in Swine and Swine Products 

from France and Spain. Dated November 2003.

6 As identified during 2004 CSF site visit.

7 APHIS Evaluation of the Status of Latvia Regarding Classical Swine Fever, Swine Vesicular Disease, and 

Foot and Mouth Disease, dated April 2006.

8 APHIS Evaluation of the Status of Lithuania Regarding Classical Swine Fever, Swine, Vesicular Disease, 

and Foot and Mouth Disease. Dated January 2006.

9 Unpublished but identified during APHIS site visit in 2007.

10 APHIS Evaluation of the Status of Poland Regarding Classical Swine Fever and Swine Vesicular 

Disease, dated January 2006.

11 As identified during 2004 CSF site visit.

12 As identified during 2005 CSF site visit.

13 APHIS Risk Analysis for Importation of the Classical Swine Fever Virus in Swine and Swine Products 

from France and Spain. Dated November 2003.
Page 59 of 59

Member State Administrative Unit

Sweden (SE) Län

United Kingdom (UK) County or district