### APHIS Risk **Evaluation o**  **f the**  **Importation of Highly Pathogenic Avian**

**Influenza (HPAI) and Virulent**  **New castle 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** 

_**Page 2**  **of 59**  **TABLE OF CONTENTS**
**A BBREVIATIONS**  **3 E**  **XECUTIVE S**  **UMMARY 4**  **I NTRODUCTION**  **6 O**  **BJECTIVE 7**  **B ACKGROUND**  **8 H**  **AZ ARD**  **I DENTIFICATION**  **12 R** **ELEASE A**  **SSESSMENT 13**  **E XPOSURE**  **A SSESSMENT**  **24 R** **ISK MITIGATION MEASU RES**  **30 C**  **ONSEQUENCE A**  **SSESSMENT 3**  **2 R** **ISK E**  **STIMATION 36**  **C ONCLUSION AND**  **S UMMARY OF**  **P ROPOSED**  **A CTION**  **37 R** **EFERENCES 4**  **0 A**  **PPENDIX A**  **. E**  **PIDEMIOLOGIC CHARACT ERISTICS OF**  **N EWCASTLE**  **D ISEASE**  **4 4**  **A PPENDIX**  **B .**  **E PIDEMIOLOGIC**  **CHARACTERISTICS OF A** **VIAN I**  **NFLUENZA 49**  **A PPENDIX**  **C .**  **T ABLE OF**  **R ELEVANT**  **EU L**  **EGISLATION 5**  **3 A**  **PPENDIX D.**  **A DMINISTRATIVE**  **U NITS OF THE**  **EU -**  **25 5**  **7**

_______________________________________________________________________________________________**Page 3**  **of 59** 

**A BBREVIATIONS**  **:** ADNS Animal Disease Notification System AI Avian Influenza AIV Avian Influenza Virus APHI S Animal and Plant Health Inspection Service APMV
- 1 Avian Param yx ovirus Subty pe 1 AU Administrative Units AVI C 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) END V Exotic Newcastle Disease virus EU European Union EU
- 15 Fifteen EU Member States prior to 1 May 2004 accession EU
- 25 Twenty
- five EU Member States in the year 2006 FR Federal Register FVO Food and Veterinary Office of the European Commission HPAI Highl y Pathogenic Avian Influenza HPAIH5N1 Highl y Pathogenic Avian Influenza subty pe 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 OI E World Organization for Animal Health PPMV
- 1 Pigeon Paramy xovirus Variant Subty

pe 1 SVD Swine Vesicular Disease TRACES T rade Control and Expert System UK United Kingdom USDA United States Department of Agriculture WHO World Health Organization**Page 4**  **of 59** 

**E XECUTIVE**  **S UMMARY**  The Animal and Plant Health In spection Service ( APHI S ) Veterinary Services (VS ) evaluated the risk of virulent Newcastle disease ( END ) and Highl y Pathogenic Avian In fluenza (HPAI) from the European Union (EU) Member States (M S ) which constitut ed the EU in the year 2006 , collectively referred to as the European Union

- 2 5 1 (EU

- 25)
. B ased on our evaluation of representative MS, APHI S is proposing to recognize the EU

25 as free of both END and HPAI
. APHI S is now propos ing 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 “APHI S
- defined EU Poultry Trade Region” (poul try

trade region). APHI S based this evaluation of the END and HPAI status of the EU
- 25 on the performance measures found in T itle 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 ( OI E ) and a site visit
. The April 2008 VS site visit to the EC in Brussels and five representative EU

- MS (Cy prus, Denmark, Germany , the Netherlands , and Poland) was conducted to evaluate their avian disease statu s and how uniformly EC legislation i s implemented and enforced throughout the EU

- 25. The result s of the evaluation indicate the follow ing :
 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
- M S
. E C services provide resources to review and inspect for compliance
.  END and HPAI are notifiable (reportable) diseases
.  Appropriate surveillance , both a ctive 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 l aboratory testing procedures are well documented and standardized.
 END and HPAI eradication program s include implementation of appropriate quarantine and surveillance zones, with monitoring of those zones and movement restrictions. Procedures for establishing and lifting quarantines are sufficient to prevent further spread of disease.

1 European Union

- 2 5 (EU

- 25) wa s defined as including the Member States: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom
. 2 The European Commission (EC) is the EU institution responsible for representing the EU as a whole. It proposes legislation, policies and programs of action and implements decisions of the EU Parliament and Council.**Page 5**  **of 59** 

 Contingency

plans, s tandard operating procedures , biosecurity measures , and emergency

response are well documented and relevant personnel well

- resourced and trained
. APHI S concluded that the overall risk of introducing either END or HPAI into the United States through the import of l ive 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 i n 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 z ones 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 U nited**  **S tates**  In summary , APHI S 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 , i t will apply the movement restrictions defined in § 92.3 to the EU

- 25 for avian diseases and recognize the quarantine or restriction areas established by the EC. 3. It will require the competent veterinary authority of the individual EU

- 25 MS to 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 HPAIin domestic poultry for the last 90 day s. In the case of movement restrictions put in place following the detection of END or HPAI in wild birds or in racing pigeon s , APHI S will recognize the duration of restrictions as imposed by the EC upon the affected zone. 4. Itwill require the competent veterinary authority of the individual EU

- 25 MS to certify that the shipment of hatching eggs that have transited HPAI affecte d regions travels under seal issued b y 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. Seal s should not be broken until the shipment reaches its U
. S
. port of entry
. Hatching egg shipment s with seals that are not intact will be rejected at the U
. S
. p ort of e ntry by the VS port official. 5
. Itwill require the competent veterinary authority of the individual EU
- 2 5 MS to certif y that the farms of origin for the poultry , poultry meat , or poultry

products did not receive birds within the last 30 day s from outside the p oultry trade r egion or from areas under restrictions for END or HPAIwithin the p oultry trade region
.**Page 6**  **of 59** 

6
. Itwill require the competent veterinary authority of the individual EU
- 2 5 MS to certif y that the birds , or the birds from which hatching eggs derived , were not vaccinated for subty pes H5 or H7 avian influenza (AI )
. 7 . The products must not have commingled with poultry meat or poultry

products derived from other poultry

that w ere not from the EU

- 25 or were in any restriction zones established because of the presence of 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 mate rials have first been adequately cleaned and disinfected. **I NTRODUCTION**  The U.S. Department of Agriculture’s APHI S regulates the importation of live birds, poultry , meat, other animal products and by products into the United States in order to prevent the introduction of various animal diseases, including virulent END and HPAI s ubty pes H5 and H7
. APHI S previously recognized nine MS 3 of the EU as region s in which END is not known to exist b y individually evaluating each of these MS. In this document APHI S e valuates 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 b ased on the legal requirements for all individual MS of the EU to uniformly appl y all EC legislation. The region evaluated contains the 25 EU

- M S which constitut ed the EU in the ye ar 2006 ; collectively

referred to as the EU
- 2 5 4

. APHI S evaluated the EU

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

- 25 as the “ APHIS
defined EU Poultry

Trade Region.” The evaluation reviewed the EC legislation and the measures established in this legislation for detecting, controllin g, 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 requirement s for the unifor m application of EU regulations to all MS, APHI S evaluat ed whether the risk would be similar for all EU
- MS
. Inaddition, APHI S 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 EU

MS (Cy prus, Denmark, Germany, the Netherlands , and Poland) to evaluate the avian disease status and incorporation and implementation of EC regulation s by these

3 The regions recognized as END

- free in 9 CF R 94.6 are Denmark, Finland, France, Great Britain (England, Scotland, Wales and the Isle of Man), Greece, Luxembourg, Republ ic of Ireland, Spain and Sweden
. 4 European Union

- 2 5 (EU

- 25) is defined as including the Member States: Austria, Belgium, Cyprus, C zech 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**Page 7**  **of 59** 

representative MS [ 3 6 ]
. APHI S evaluat ed documentation submitted by the EC , FVO reports , EC legislation, site visit observations , and reports to OIE. In addition to the information provided b y the EC and gathered during the site visit, APHI S used a variety of earlier evaluations to inform this assessment, including an evaluation of Denmark following an extensive END outbreak in 2002 [ 21 , 2 6 , 30] and several more recent evaluations of the HPAI status of several regions in the EU affected b y HPAI subty pe H5N1 [ 5
- 8, 10
- 14 ]. It was determined that the EU

- 25 w ould be evaluated as a si ngle 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. C ommunication from the EC regarding detection and control of outbreaks has been timely and comprehensive. The EC circulates f requent reports on the status of designating control zones, application of surveillance, results of the epidemiolog ic investigation , and progress of the control efforts . These reports provide accurate appraisal of the animal health situation and date the 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. APHI S based its conclusions on the following factors:
 The region has an ef

fective 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 as sure that all EU
- M S correctly transpose EC legislation into their domestic legislative frameworks. The E C also activel y monitors MS compliance with animal health legislation implementation by review and inspection in the individual EU

–M S
. . .  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 support ing the detection and investigation of the outbreaks with clinic al 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 capabl e of rapidly and effectivel y detecting the presence of END or HPAI , e ven in the absence of clinical signs.
 The sy stem for recording, managing, and analyzing diagnostic and surveillance data is sufficient to demonstrate effectiveness of disease control measures.
 Laboratory

confirmation capabilities are effective and l abo ratory testing procedures are well documented and standardized.
 END and HPAI eradication program s include appropriate quarantine and surveillance zones, monitoring of those zones, and implementation of movement**Page 8**  **of 59**  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 well

resourced and trained
. APHI S conclude d 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
. **O BJECTIVE**  APHI S 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 Pou ltry Trade R egion” (or poultry trade region).
 Re quirements that are currentl y 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 applicabl e to the nine MS listed in 9 CFR 9 4 .6 previously

evaluated individually

will be applied generall y to the EU

25
.  Consistent with the 9 CFR 92.3, E C quarantine decisions and movement restrictions with respect to areas affected b y 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
- 2 5 MS would certify that the appropriate control measures, including both EU and U.S. requirements, had been applied. APHI S considers the risk to be similar for all counties within the EU

- 25 because of the open trade practices and unrestricted movement of poultry and poultry

products in the EU
- 25 and the fact that the E C regulations appl y uniformly to all MS. Therefore, APHIS assessed recogni tion of the EU

- 25 as a single region , referring to the region as the “ APHI S defined EU Poultry Trade Region , ” for which import restrictions could be uniformly applied
. **B ACKGROUND**  **Current APHIS regulati**

**on for END and HPAI** Currently , APHI S 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 subty pe of HPAI is considered to exist ,**Page 9**  **of 59** 

allowing onl y cooked products or consignment directl y to an approved establishment in the United States. APHI S regulations for the importation into the United States from regions where END or HPAIis consid ered to exist allow importing poultry carcasses and parts and products of poultry carcasses onl y if they have been cooked throughout to reach a minimum internal temperature of 74 o C . In regions where HPAI is considered to exist, APHI S requires that carcass es and parts or products of carcasses, including meat, poultry , game birds, or other birds, may

be imported if they

are accompanied by a certificate that is signed by a full

time, salaried veterinarian of the government agency responsible 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 subty pe of HPAI is considered to exist, except for those consigne d to a museum, educational instituti on , 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 HPAIinto the United States, as appro ved 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 an d 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 onl y enter if accompanied by official certification that the flock was visited within the last 90 day s; the eggs were packed and sealed; testing of cull birds; and there was no indication of the presence of the disease within 50 km for the last 90 day s [ 9, 15, 18 ]. Generally when a region recognized b y APHIS to be free of END sustain s an outb reak 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
. Briefl y, APHI S promulgate s interim regulation s to immediately prohibit or restrict imports from the affected region followed b y reassessment of the disease status of th at affected region. The evaluation is made available for public comment and if no substantive comments are made the region is re turned to the APHI S list of END free regions through the publication of a final rule . This is generall y a length y process. For example, in the case of Denmark, an extensive outbreak of END occurred from July until August of 2002. APHI S responded wi th the publication of an interim rule on September 20, 2002 , effective retroactively to July 16, 2002. Although the outbreak was rapidl y controlled , APHI S did not return Denmark to the list of END free regions until July of 2006 [ 21, 26, 30 ].**Page 10**  **of 59** 

In the case of HPAI, APHI S maintains a list of affected regions on the agency W eb site as “USDA
- R ecognized Animal Health S tatus of C ountries /R egions Regarding S pecific L ivestock or P oultry D iseases , or A cceptable C ommodities
. ” 5 Rulemaking is not needed to remove a region from the APHI S HPAI affected list , although a region will be removed onl y after APHIS completes an evaluation , makes it available for public comment through a notice published in the Federal Register (FR) , follow ed by response to comments , and publication of a notice of determination announcing APHI S’ 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) the y 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 APHI S added an alternativ e 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 day s the flock of origin was i nspected 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 sy ndrome 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 s yn drome 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 b y APHIS (9 CFR 93.205 )
. In addition, l ive 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 day s 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 subty pe of AI or transit regions where HPAI of any subtyp e is considered to exist or where birds were vaccinated for H5 or H7 subty pes 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 b y APH IS to have END. N o 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 day s [4] . All birds are subject to appropriate testing for END and HPAIprior thei r release from quarantine.

5 available at: http://www.aphis .usda.gov/import_export/animals/animal_disease_status.shtml**Page 11**  **of 59** 

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 subtyp es 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 th e supervision of the Area Veterinarian in Charge (AVIC) in the State of destination . T he poultry hatched from these eggs must remain in quarantine for at least 30 day s following hatching. The hatchery must meet specific biosecurity

standards and be inspect ed and approved b y 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 eg gs from regions APHI S 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 recognize d nine EU
- MS individually as regions in which END was not known to exist. Th is recognition was made prior to the establishment of the EU and the original evaluations conducted did not consider risk s that might arise from the opening of borders within the EU with the free movement o f 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, becau se of the unrestricted movement of animals and animal products in the EU , and the fact that the same regulations appl y t o all EU

- MS, APHI S considers the risk to be similar for both groups. As a result of the incursion of HPAI H5N1 into Europe, several re gions of the EU

- 25 were added to the APHIS list of affected regions. All of these affected regions have since been removed from the affected list as a result of i ndividual assessments conducted b y APHI S [ 5
- 8, 10
- 14, 16, 17] . These assessments were based o n internationally established criteria for the evaluation of the HPAI H5N1 status of a region all of which are satisfied by EU regulation. Specificall y, APHIS used the following criteria in these evaluations:
 The region has been HPAI

- free for 3 months (90 day s) as a result of control measures undertaken b y 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 quickl y, even in the absence of clinical signs.
 Under the surveillance program, all notified and/or suspect AI cases were investigated and app ropriate 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 sy stem for recording, managing, and analyzing diagnostic and surveillance data was sufficient to demonstrate effectiveness of disease control measures.
 Laboratory

confirmation capabilities were effective ; and l aboratory testing procedures were documented and standardized.
 The eradication program included the definition of appropri ate 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 su fficient 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, famili ar 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 aft er repopulation demonstrated that the disease has been eradicated. **H AZ** **ARD I**  **DENTIFICATION** The Terrestrial Animal Health Code recommends identifying the pathogenic agents which could potentially

produce adverse consequences associated with the importation o f 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 ]. **R ISK**  **A NALYSIS**  This analy sis 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 anal ys is [ 43] . Although the primary focus for th is anal ys is is the evaluation of risks associated with poultry products import ed from the EU

- 25, the exposure and consequence assessments include discussion of live bird factors because of their historical significance to END and HPAI outbreaks in the United States. **R ELEASE**  **A SSESSMENT**  The Terrestrial Animal Health Code recommends describing the biological pathway s necessary for an importation activity to 'release' or introduce the identified pathogenic agent ( s ) into a particular environment and estimat e 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 , APHI S conduct ed a further as sessment. **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 properl y 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 freel y 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 b y an official health certificate, issued by the official veterinarian appointed by the competent authority

of the EU
- MS , and prior notificatio n of the movement is reported electronically through an electronic network linking veterinary

authorities of the E C and MS. The EU recognizes that the risk for END and HPAI outbreaks can never be reduced to zero due to the occurrence of the se disease s i n wild birds. Inthe case of the detection o f the disease in wild birds, EU

- MS have the obligation to inform the Commission of the measures that they

are taking and they

may appl y more stringent hygienic measures in nearb y poultry

farms to prevent the introduction of the disease. Additional biosecurity and surveillance measures may also be applied to backyard and hobb y flocks
. The implementation of basic Community rules laid down in Council Directive s 92/66/EEC (Newcastle disease) and 2005/94/EC ( avian influenza) have served to rapidly and effective ly contro l 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 intra

Community

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

- Co mmunity

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 disea se specific control measures to prevent the spread of disease and safeguard the trade in live animals
. The EU T r ade Control and Expert System ( TRACES ) , established under Commission Decision 2003/623, maintains an internet

- based service for the traceability of live animals that provides information on the intra - Community trade of live animals and certain types of animal products
. TRACES, in place since 2004, replaced earlier databases with a single central database t o track the movement of animals , including the importation of**Page 14**  **of 59** 

animals and products into the EU. The s ys tem enables the immediate review of animal movements preceding the detection of an animal disease outbreak to allow for rapid emergency response and traceability
. Th e sy stem also allows the receiving M S to verify th at the consignment arriving at the destination corresponds to that specified in the original accompanyi ng veterinary certificate from the country of origin. The consignments of live poultry and hatching eggs must be appropriatel y identified ensuri ng that when they

are ship ped to another MS, they are accounted for on arrival at the ir destination. T he animal health conditions governing intra

- community trade in poultry

and hatching eggs are closel y 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 b y the official veterinarian, confirming compliance with the Directive's requirements. T he certificates must indicate if the poultry have been vaccinated against END and i f 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 app roved by

the EU , and have undergone an animal health inspection
. The i mport ation of poultry and hatching eggs from countries or regions into the EU is also regulated. T he general animal health requirements governing imports from non - EU countries of poultry

and hatching eggs are also harmoniz ed and require that the non

- EU exporting country supply certification signed b y an official veterinarian of the competent authority of the exporting third country guaranteeing that the conditions for import into the EU have been me t and that the exporting country has been evaluated and found to have adequate animal health controls in place. Upon arrival in the EU, the animals and the accompanyi ng certificates must be verified and checked by EU official veterinarians at a designated Border Inspection Post (BIP). Council Directive 91/496/EEC lay s down the principles governing the organization of veterinary checks on animals entering the Community

from third countries. T he conditions under which poultry , h atching 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 regularl y updated with conform ing changes to the model health certificates
. **Measures to detect, control ,**  **and eradicate END and HPAI**  **in domestic poultry** E C regulations designate both END and HPAI as notifiable animal disease s in the EU and require the establishment of mandatory restriction zones as part of the emergency procedur es . The Animal Disease Notification Sy stem (ADNS) is used b y the EC t o regist e r and document important infectious animal diseases and manage the availability of d etailed 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 report ed and tracked. The a uthority for ADNS is longstanding under**Page 15**  **of 59** 

Council Directive s 82/894/EC and Commission Decision 2005/176/EC and e nsure s the rapid exchange of information between the competent national animal health authorities and the E C
. The s ys tem allows co

- ordination and monitoring of outbreaks of contagious animal diseases and enables MS and E C services to take immediate measures to prevent the spread of reportable diseases. Initial reports of a primary outbreak of reportable animal disease must be submitted within 24 hours of confirmation of the outbreak . Immediate communication options are available in the case of highl y contagious animal diseases
. Reports of primary outbreaks are inserted directly

into the ADNS sy stem and all the countries in the s ys tem are immediately notified electronically
. Primary outbreak s are defined as an outbreak of a contagious animal disease not epizootiologically linked with a previous outbreak in a region or the first outbreak in a previously unaffected region of a M S
. Secondary outbreak s are defined as an outbreak following a primary outbreak in an already affected region ; and notification of secondary outbreaks must be updated weekly
. All identifications of AI, both HPAIand LPAI , in domestic poultry and wild birds are immediately

reported to ADNS. C onfirmation of the pre sence of Newcastle virus in poultry or other captive birds with an intracerebral pathogenicity index (I CPI) greater than 0.7 must be immediate ly reported to the EC
. EU regulations describing control measures in place in the EU require the investigation of all suspected cases and the killing of birds upon confirmation of the disease. All products capable of spreading the disease ( live birds, eggs, meat present on the holding, litter, manure , etc. ) must also be destroyed and the holding cleansed and disinfected using approved disinfectants in accordance with the instructions of the official veterinarian
. A 3 km protection zone and a 10 km surveillance zone are established around the affected holding with enforcement of movement restrictions for live poultry and poultry

products. Epidemiological investigations must be performed to trace back and trace out all movements that could have led to the introduction or spread of infection. Council Directive 2005/94 also requires establish ing control measures following the detection of LPAI based on the risk that low pathogenic viruses may mutate into HPAI viruses . H owever, the control measures for LAPI may differ from those appl ied following the detection of HPAI. Surveillance measures for th e earl y 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 pose d
. The compe tent 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 m ay be sent directly from the holding to a designated slaughterhouse under official control. Each consignment must be sealed before transport b y the official veterinarian.**Page 16**  **of 59** 

The official veterinarian responsible for the holding ensures compliance with any a dditional biosecurity

measures prescribed b y 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 an d 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 M S except Sweden, Finland , and Estonia routinely use prophylactic ND vaccination
. All ND vaccines must be approve d and made onl y from lentogenic ND strains
. Individual MS determine appropriate vaccination program s 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 , sy stematic prophylactic vaccination has been used. By EC regulation, racing pigeon s in all MS must be vaccinated to participate in races and shows. **HPAI Vaccination policy** Vaccination against AI is generall y 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 app roval b y the E C. The vaccination proposal must include a risk assessment to indicate that there is a significant and immediate threat of AI spreading within or into the MS. All vaccinated birds are subject to additional requirements for movement and b y EU regulation, any

vaccination plan must include a strategy to differentiate infected from vaccinated animals. **Contingency plans for END or HPAI**  **control** All MS are required to maintain a current contingency plan that defin es proactive approaches to END and HPAI control . These plans are regularl y reviewed and approved by the E C as specified in Commission Decision s 2004/402/EC , 2006/563/EC and 2007/24/EC . In each M S , veterinary officials must have in place sufficient legal powers, a detailed chain

- of comm and, 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 regularl y receive training and conduct drills in END and HPA I diagnosis, control measures, and communication techniques. The EC performs onsite reviews of the MS for compliance with the directive s and**Page 17**  **of 59** 

representatives of the EC and MS regularl y design, conduct , and attend exercises to test emergency

preparedness. The EC requires that all Individual MS guarantee the swift deplo ym ent of financial resources for control measures and the rapid compensation of owners for the killed animals
. To comply

with EC requirements e ach MS must establish national and local disease control centers with a defined chain

- of

- command and expert group s . 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 inv olved 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 rais e animal disease awareness and enhance compliance. **EU controls and recent**  **END outbreak**  **s** APHI S ’ 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 outbreak s to occur in commercial birds in the EU date back to 2002 in Denmark , and 2000 in Ital y. In 2002, the Danish Veterinary and Food Administration (DVFA) reported a suspected outbreak of END to the OIE . O ver the next 7 weeks, a total of 135 END outbreaks were confirmed in 8 counties although a relativel y 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 b y 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
. Inthis case , w ild birds were considered to be the most like ly source of the disease ; however, the results of the epidemiological investigations were inconclusive. Vaccination against the disease is now full y implemented in Denmark , and no additional outbreaks have been reported
. APHI S extensively reviewed the 2002 outbreak in Denmark and found that the END V was the same strain implicated in Denmark’s 1995, 1996 , and 1998 outbreaks, as well as the same strain isolated in 2000, 2001, and 2002 from wild birds in Denmark. The appearance over time of the same 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, It al y diagnosed END in the Pie dmonte Region , and over a 6
- month period 257 small flocks in several regions of northern and central Italy were identified as in fected [ 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, turkey s, guinea fowl, and pheasants in these small mixed species flocks were infected . More recentl y , Ital y 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 ty pe s of bird s spread the virus, eventuall y causing infection in 24 countries, remaining prim arily 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 p igeons , proving a continuing threat to poultry [ 1, 2, 39, 46 ]
. The variant pigeon paramy xovirus variant subty

pe 1 is referred to as PPMV

- 1 to distinguish it from the avian param yx o virus (APMV

- 1) that causes most of the virulent ND in poultry . Isolates of the pigeon

- adapted NDV (PPMV

- 1) have been geneticall ysequenced and results show a pattern of amino acids at the cleavage site which is compatible with the pattern of virulent ND viruses but characterized b y 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 specificall y included this population in the Community measures fo r END control found in Council Directive 92/66/EC. V accination for END of all pigeons at registered racing meets and exhibitions is one of the specific control measures in place
. Ho wever, while immunity derived from vaccination may provide some resistance to infection it does not prevent infection and does not eliminate the risk of infection in pigeons. Vaccination can decrease the severity of infection, but infected birds may shed v irus 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 pi geon variant of ENDV in Finland, Germany , and Ital y [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
. Ital y reported ND on two pigeon holdings; one of these h oldings also had a small number of other poultry

(33 total birds)
. Fin land detected PPMV
- 1 in six interrelated pigeon holdings that occurred in areas with very little commercial poultry ; an epidemiologic investigation was done on all holdings within 10 km. In2007, pigeons were the source of**Page 19**  **of 59** 

outbreaks in Belgium ( eight isolations), Ital y (two isolations ) and the one in the Czech Republic which was transferred to Slovakia. In 2006, the pigeon variant was responsible for outbreaks in It aly

(homing pigeons), the UK ( contact with wild pigeons) , and France in fattening pigeons in contact with wild pigeons. M ovement restrictions are put in place for all d etection s or suspicion s of END in racing pigeons . Confirmation of the presence of NDV results in epidemiologi cal investigation with tracing of animal movements and surveillance of birds and poultry in the surrounding area. L aboratory confirmation with virus characterization is attempted for all incidents
. **EU controls and recent HPAI outbreaks** Council Directi ve 2005/94 /EEC defines AI for th e purposes of regulation as an infection of poultry or other captive birds caused b y 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 subty pe for which nucleotide sequencing has demonstrated the presence of multiple basic amino acids at the cleavage site of the hemagglutinin. HPAIis 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 b y Council Directive s 82/894/EEC and 92/40/EC. All detection s of the virus confirmed in poultry

or other captive birds are immediately reported to ADNS , making the information available to all MS. EU regulations specify the notification requirements, preventive biosecurity, surveillance programs , and epidemiological investigation of all suspected cas es 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
. Epidemiologic al 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 sy stems 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 c aptive bird at a quarantine station in the UK prompting the restrictions on the importation of captive birds fro m third countries found in Commission Decision 2005/760/EC. By the end of 2005 , HPAIH5N1 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 HPAIH5N1 were made in the following regions: wild swans in Austria, Bulgaria, Cze ch Republic, Germany, Greece, Hungary , Ital y, 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 i n February 2006, in a flock of breeding turkey s 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 HPAIH5N1 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 confirm ed the presence of HPAI H5N1 in domestic poultry in a large mixed commercial flock o f approximately

10,000 birds (chickens, geese , and turkey s). On May , Denmark detected HPAI H5N1 in a backyard poultry farm , and i n June , Hungary detected HPAI H5N1 on a holding of g ee se. In 2006, e xtensive AI surveillance also found the presence of several LPAI strain s in the following MS : LP AIH5N2 in Denmark ( farmed game birds ) and Portugal ( free range ducks ) ; LPAIH7N3 in the UK (broiler breed er farm) ; and LPAIH7N7 in the Netherlands and Hungary (farmed geese)
. In 2007 and 2008, HPAI H5N1 was report ed 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 d ucks. The Czech Republic confirmed HPAIH5N1 in a wild swan, as well as a commercial turkey holding , two broiler farms, and two breeding hen farm s. Hungary reported HPAIH5N1 in several flocks of domestic geese. The UK reported an outbreak of HPAI H5N1 on a commercial turkey farm. In 2007 , LP AIwas reported in the following MS : LP AIH7N3 in Ital y ( a holding with 2,000 ornamental birds with ducks, geese, pheasants, peacocks, ostriches, etc.) ; and LPAI H 7N2 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 onl y MS to report H5N1 in wild swans , but the UK also detected HPAI H7N7 in poultry . Several MS reported the presence of sev eral subtypes of LPAI in 2 00 8 : Germany reported a number of LPAI H5N3 positive flocks ; Belgium reported LPAIH5 in two holdings of geese ; and Italy found LP AI 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 LP AI H7H7 on a turkey holding and more than 30 detections of LP AI H5N3 ; France reported LPAI H5 subty pe on a holding with 5 , 000 breeding duck s ; the Czech Republic reported LPAIH7 ; and It al y reported LPAI H5 on poultry a fattening turkey holding
.**Page 21**  **of 59** 

W orldwide , 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 e xception occurred in Germany during 2007 ; grebes were the most frequently affected species , wh ile swans in the same area were not affected. In 2006, HPAI H5N1 was also isolated from grebes in Spain, Denmark , and Sweden [ 37 ]. **EU quarantine decisions with r espect to areas affected by**  **END or HPAI**  **would provide the basis**  **for U.S. import restrictions** E xisting APHI S regulation s ( 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, b e accompanied by a certificate signed by a salaried veterinary officer of the national government verifying that the poultry and flocks of origin were inspected on the premises of origin immediately before the date of m ovement . 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 day s prior to movement
. APHIS requires import certificate s onl y be issued for birds not exposed to END or HPAI and not originati ng from a premise located in any area under quarantine during the preceding 90 day s. Th e 90
- day period is consistent with international standards for regaining notifiable avian influenza (NAI ) free status in a previously free country or zone after a stamping

- out policy with depopulation, cleaning and disinfection of all affected establishments , and supported by appropriate additional surveillance [ 4 3 ]
. However, EU regulations allow END and HPAI restriction and protection zones to be removed as early as 21 day s after completion of cleaning and disinfection measures on the affected holding if approved b y the veterinary

authorities
. The Terrestrial Animal Health Code considers an area to be affected with END until at least 21 day s after the confirmation of the last case and the completion of a stamping

- out policy and disinfection procedure s have been completed
. The Code also considers 21 day s to be the incubation period for both END and AI [ 43 ]
. APHI S 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 day s after the cleaning and disinfection of the last affected establishments
. Current APHI S regulation s require that imported live birds or poultry undergo 30

- day quarantine at a USDA Animal Import Center ( §§ 93.106 and 93.209), and be tested for both END and AI befo re 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 b y a veterinary health certificate issued by a national government veterinarian of the exporting country as well as by

a USDA import permit . Hatching egg s may not enter from HPAI

- affected regions and must also originate from birds that were not vaccinated for H5 or H7 subty pes of AI . Hatching eggs from regions not considered to be f ree 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 t o issuance of the import permit . A fter 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 o f Asia, the Middle East, Africa, and Central and South America [ 38, 42 ]. T he potential for END or HPAI introduction into the EU
- 25 via the migration of infected wild birds from endemic areas deserves consideration . Howev e r, this potential exists world

- wide and is not unique to the EU
. APHI S is not aware that it is a particular concern in the EU
- 25 ; therefore , APHI S 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 HPA I
. In keeping with APHIS policy regarding the risk presented b y the commingling of animal products when a country recognized as disease

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

- free , a s a safeguard APHIS will require certain certifications by the exporting country which will be incorporated into the requirements for importation from the EU

- 25
. APHI S 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 b y 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 anal ys is and implemented in rulemaking [ 24 ] , APHI S 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 regionali zation to the AU level for other animal disease s [ 24 ]. The approach is consistent with APHI S’ obligation under the World Trade Organization Agreement on Sanitary and Phy tosanitary Measures to recognize disease

- free areas as well as areas of low disease pre valence for which mitigations can be established to reduce risk [ 2 8]. The AU for the remaining MS were identified during site visits, as listed in Appendix D
. **C ONCLUSIONS**  APHI S 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. APHI S considers the EU control measures to be effective , and that the conditions with regard to END and HPAI in the EU

- 2 5 have either remained constant or improved, despite th e 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, APHI S recognizes the EU

- 2 5 as a sing le region for END and HPAI for which restrictions can be placed on exports that are appropriate for a region in which APHI S expects that END or HPAI outbreaks will continue to occur. Since many

of the appropriate restrictions reflect EC quarantine decisio ns, APHI S is willing to recognize the EC quarantine decisions to define restriction and affected zone boundaries. However, APHI S 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 th ere be no exportation from the quarantine areas imposed when END or HPAI has been detected in a domestic poultry flock for 90 day s . In summary , APHI S will address END and HPA I 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 I sle of Man) , Greece, Luxembourg, Republic of Ir eland, Spain , and Sweden to all EU

25 Member States.
 It will require the competent veterinary authority of the individual EU

- 25 MS to provide certification that the poultry , including hatching eggs, exported to the United States or the poultry from which e xported 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 ade quate 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
- 2 5 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 mu st be listed on the health certificate that accompanies the s hipment. 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 shipment s with seals that are not intact will be rejected at the U
. S
. p ort of e ntry 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 day s.**Page 24**  **of 59** 

**E XPOSURE**  **A SSESSMENT**  The Terrestrial Animal Health Code states that the Exposure Assessment is a description of the biological pathway(s) necessary for exposure of animals and humans in the importing country

to the hazards (in this case the pathogenic agents 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 thorou ghness , APHI S continued the risk assessment process and conducted an exposure assessment. This exposure assessment is based in large part on an anal ys is of historical information regarding END and HPAI outbreaks in the United States. Of particular note w ere 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 poss ible pathway s 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 informati on provides valuable insight into the past and potential pathway s of entry , exposure, and mechanisms of disease spread in the United States. This exposure assessment therefore uses such historical information to prioritize potential risk pathway s 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

pathway s 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 histo rical information is further used to provide a basis for the economic section of the consequence anal ys is 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 t able 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 pathway s declined substantially after regulations to require quarantine of imported live birds in facilities operated or approved b y APHIS were implemented in 1972 . The approval of private quarantine facilities in 1979 e ssentially 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 Uni ted 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 ye llow

- 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 s ome 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 hy pothesis is based on the observation that the ty pe 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 Cost a County, CA Chukars and pheasants imported from Hong Kong 1970 (Aug) Bronx, NY Quaker parrots from Paraguay 1970 (Aug) Clint, TX Domestic chickens 1970 (Sept) Blackstone, MA Domestic chickens 1971 (Apr) Las Cruces, NM; El Paso, TX Domestic chickens 1971 (Apr) Largo, FL My nah 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 C ounty , 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 apparentl y associated with hatching eggs. None of the introductions have been known to be associated with other po ultry products, such as meat. Historical experience in the United States therefore suggests that importation of live birds represents a far more likel y initial exposure pathway than poultry

meat or products. **Review of HPAI outbreaks** In contrast to END, the AIV of all known subtyp es can be found in wild ( feral ) birds, especiall y migratory

waterfowl such as ducks and geese. The outbreaks of both HPAIand LPAI in domestic poultry appear to be the result of introduction initially from wild birds. Although in fluenza 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 poo r biosecurity

[ 2, 3 ]
. The first HPAI outbreak (H7) i n the United States was identified in 1924 in several ea st c oast live bird markets (LBMs) and was rapidly eradicated. In 1983

- 19 84 , an extensive outbreak of HPAI H5N2 occurred in Penns yl vania, Maryland, New Jersey , and Virginia and resulted in destruction of 17 million chickens, turkey s , 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 HPAIduring th e cours e of the outbreak. Additionally , some flocks exhibited mixed infections with both HPAIand LP AI 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 LPA I, 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 n o other positive flocks with no indication that the virus continued to circulat e . Other no table 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) [4 5 ]
.**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**

**– 198**  **4** United States (Pennsylvania, Maryland,

New Jersey , and Virginia) Chicken H5N2 **1994** Mexico Chicken H 5 N2 **2002** Chile Chicken H7N3 **2004** Canada (British Columbia) Chicken H7N3 **2005** United States (Texas) Chicken H5N2 **2007** Canada ( Saskatchewan) Chicken H7N3 Canada

- The 19 6 6 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 Saskatchew an Province about 150 miles from the border with Montana [ 47 ]
. Mexico

- In Mexico during 1994

- 1995 , H5N2 LPAI was diagnosed in 11 Mexican S tates. In late 1994 , the pathogenicity index of virus changed to HPAI. Control of the HPAI was complicated b y the widespread concurrent infection with LPAI virus and measures including use of an inactivated H5N2 vaccine were put in place [ 4 5]. In 2002, outbreaks of the H7N3 virus w ere initially determined to be LPAI but one month later the same farm was determined to have HPAI H7N3
. The mutation from LP AI to HP AI was presumed to have occurred on the index farm and further characterization of the virus found that it was not closely related to previous North Am erican H7 AI viruses. In summary , in the United States HPAIintroduction s are thought to be associated with live birds, primarily

wild birds. None of the introductions have been known to be associated with other poultry products, such as meat. Historical experience in the United States with both 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 ty pe 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 di sposal 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, APHI S 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 pathway s 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 Uni ted 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 onl y the California poultry industry but the entire United S tates poultry and egg suppl y. 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 ty pes of birds involved included game fowl, pet birds, ostriches, and waterfowl. However, the END virus ultimately spread fro m 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 wer e 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 w as 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 prim ary 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 n ot 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 emplo ye e contact with off

- farm poultry

were subsequently

identified as signi ficant factors in disease spread. The extent of disease**Page 29**  **of 59** 

spread was further influenced b y 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 i n 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 HPAIoutbreaks in the United States also provide significant information regarding likely pathway s 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

- 198 4 HPAI outbreak , the epide miological investigation identified four primary pathway s 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 pathway s of spread are similar to associated with END. Biosecurity measures and routine surveillance in current practice are directed to rap idly identifying and preventing the spread of viral agents and work well for HPAI. Nearl y 100 percent of the comm ercial 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 LBM s . 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 turkey s. Th is program i s for commercial birds a s an active surveillance program conducted at table

- egg layer houses, broiler and turkey flocks, and poultry

slaughter plants. H5/H7 LPAIis a reportable disease and all diagnostic laboratories are required to test all submitted cas es of unexplained respiratory disease, egg production drop, and mortality for AI. APHI S 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 - ty pe chicken breeding flocks, 5,000 meat

- ty pe 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 signific ant pathway s 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

- commerci al birds may play an important role in disease introduction and spread. **R ISK MITIGATION MEASU**  **RES 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, APHI S published regulation s (9 CFR 93.106) to enhance its import control measures b y 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
. T he quarantine requirement was further strengthened in 1979 with the addition of approv ed private quarantine facilities. The legal introduction of infected birds declined significantl y after 1972 , and has not been documented since the 1979 quarantine requirement was instituted. Although not confirmed, the 1998 exposure was hy pothesized to have resulted from illegal entry of an infec ted bird or birds
. Except for special provisions for birds from Canada or birds returning after being gone for less than 60 day s, all live birds must go through a quarantine period when they enter the United States. Birds originating from the United Stat es that have been out of the country for more than 60 day s are kept for a minimum of 30 day s 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 APHI S and private quarantine facilities. Cloacal swabs are taken from the birds to test for END and HPAI via virus isolat ion. I f 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 destro ye d. 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. APHI S considers the risk of END o r HPAI introduction through legal importation of live birds to be effectivel y mitigated b y the quarantine measures currentl y 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 technicall y difficult because of the travel distance between the two countries and inspection procedures at airports and seaports. APHI S therefore considers the likelihood of illegal introductio n 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 relativel y high. While most commercial poultry in the EU
- 25 are routinel y 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 surv eillance 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 th e outbreaks in the United States have identified several potential and confirmed pathway s of avian disease spread, most notably movement of people, live birds, products, and equipment [ 26, 33 ]. Epidemiological investigations done in the United States and i nternationally 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 relativel y 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 s low 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 bi rds, 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 readil y enhanced significantl y 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 fi ghting venture, if the animal was moved in interstate or foreign commerce. APHI S 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 illegall y at an unknown level.**Page 32**  **of 59** 

APHI S has standard practices and requirements in place for reporting suspect cases of disease at the F ederal level . APHI S has also taken actions to increase the awareness of the need to rep ort suspicions of animal disease among the general public. Under outbreak conditions, APHI S cooperates in outreach programs in affected areas to educate the public in order to facilitate disease recognition and reporting, as well as to emphasize appropriat e biosecurity measures. APHI S 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 effectivel y 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 likel y that they mitigate the extent of spread. **E XPOSURE**  **S UMMARY**  Give n 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. APHI S considers that the quarantine requirements currentl y i n 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 currentl y in place in the United States to address the risk of END or HPAI spread should introduction occur. Major pathway s of disease spread include movement of people, birds, products, and equipment; h owever, the extent of spread is influenced b y 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 popul ation. **C ONSEQUENCE**  **A SSESSMENT**  The Terrestrial Animal Health Code recommends that a consequence assessment include an evaluation of the consequences of importing a foreign animal disease with regard to animal and public health, and also consider relevant environmental and economic factors. **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 acc ording 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 lim ited to conjunc tivitis and recovery is usuall y rapid. “Human influenza virus” usually refers to those subty

pes that spread widel y among humans. There are onl y three known A subty pes of influenza viruses (H1N1, H1N2, and H3N2) currentl y circulating among humans. Itis l ikely that some genetic parts of current human influenza A viruses came from birds originally . Influenza A viruses are constantl y changing, and they

might adapt over time to infect and spread among humans [ 32 ]
. The risk from AI is generall y low to most peo ple, because the viruses do not usually infect humans. However, confirmed cases of human infection from several subty pes of AI infection have been reported since 1997 [Appendix B]
. Most cases of AI infection in humans have resulted from direct contact wi th infected poultry (e.g., domesticated chicken, ducks, and turkey s) or surfaces contaminated with secretion/excretions from infected birds. The spread of AI viruses from one ill person to another has been reported very rarel y, and has been limited and uns ustained. During an outbreak of avian influenza among poultry , there is a possible risk to people who have co ntact with infected birds or surfaces that have been contaminated with secretions or excretions from infected birds [ 32 ]
. Sy mptoms of AI in humans have ranged from typi cal human influenza

- like sy mptoms (e.g., fever, cough, sore throat, and muscle aches) to eye infections, pneumonia, severe respiratory

diseases (such as acute respiratory distress), and other severe and life

threatening compl ications. The sy mptoms 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. T he 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 primaril y 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 co ntro l [ 33 ]. The outbreaks that have occurred in the United States for which economic information is available can be categorized as relativel y limited or relativel y extensive. This section examines in more detail the END outbreaks in 1950 in California and 2 002
- 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 relativel y limited outbreaks is restricted to control and eradication costs, whereas the discussion of relatively ext ensive 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 limite d to five poultry farms in Contra Costa County , California. The infection was quickl y eliminated through depopulation of the infected chickens. The control and eradication efforts cost approximately $30,000 in 1950, which is equivalent to approximately $22 9,000 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 onl y 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 1 973 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 , m ost ly laying hens. Eradicati on activities severel y 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 S tate of California was the most extensive among the four S tates affected. Ultimately , birds from 920 premises in California tested positive for the disease, and nearly 4 million birds were depopulated in California alone. Approximately $168 million had been spent on the eradication efforts in the four S tates [ 26 ]. The cost s include s expenses for long

- term g oals and measures such as surveillance and diagnosis; euthanasia, carcass disposal, and cleaning and disinfection; administrative and logistical costs; compensation or indemnification; and personnel costs. Personnel were recruited from various F ederal, S tate, county , and metropolitan agencies to participate ; the effort included a pproximately

2,780 personnel from the F ederal sector alone. Effects of the 2002

- 2003 END outbreaks on trade The effects of an extensive END incidence on U.S. trade can be charact erized using information from the 2002

- 2003 outbreaks ; e conomic impacts of an extensive HPAI outbreak would be similar. Immediatel y following the confirmation of END in the United States in 2002, trading partners imposed trade restrictions on poultry prod ucts 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 estimat ed 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 b y 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 signif icantly less than the calculated values presented [ 33 ]. **C ONSEQUENCE**  **S UMMARY**  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 t o be relativel y minor. However, the economic and animal health consequences of a disease outbreak in a State with a large concentration of poultry are likel y to be substantial [ 45 ]
. **R ISK**  **E STIMATION**  According to OIE guidelines, if the release assessment i ndicates that there is no significant risk of introduction, the risk assessment may conclude. However, APHI S continued its analy sis in the interest of completeness and conducted exposure and consequence assessments based on information available on the his tory 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 considerabl y higher than via poultry products. Legal entry

of live birds is satisfactorily controlled through existing quarantine and testing measures in the United States. L ikewise, 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 b y the release assessment, APHI S considers the likelihood of exposure from poultry imports from the EU

- 25 to be low. APHI S 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 env ironmental 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 H 5N1, 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 APHI S 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, APHI S enhanced its END s urveillance program to increase the likelihood of future detection prior to spread. A comparable economic impact would be expected for an extensive outbreak of HPAI. **C ONCLUSION AND**  **S UMMARY OF**  **P ROPOSED**  **A CTION**  APHI S considers that the evidence it has collected to date and the results of several anal ys es support the concept that the MS constituting the EU in the ye ar 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 E C control mechanisms are fully implemented b y the individual MS and are sufficientl y 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
- M S 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

- M S 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 support ing 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 capab le of effectivel y and quickl y detecting the presence of END and HPAI , even in the absence of clinical signs.
 The sy stem for recording, managing, and analyzing diagnostic and surveillance data is sufficient to demo nstrate effectiveness of disease control measures.
 Laboratory

confirmation capabilities are effective and l aboratory testing procedures are well documented and standardized.
 END and HPAI eradication program s include appropriate quarantine and surveillanc e 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 sy stem also allows the effective verification of hatching eggs that have transited HPAI affected regions have traveled under seal issued b y the veterinary competent authority
. APHI S is proposing to recognize the “APHIS
- defined EU Poultry Trade Region” as a single region for END and HPAIand appl y 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]. APHI S 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 uniforml y t o all MS. Therefore, APHI S is proposing that areas within the EU
- 25 that hav e 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 APHI S suspects that EU control measures are not effectivel y controlling an END outbreak. In the case of HPAI, the affected regions would not be added to the HPAI affected list, unless APHI S suspects that EU control measures are not effectivel y controlling the HPAI outbreak. Instead APHI S will rel y 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 earl y as 21 day s , APHI S 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 day s have elapsed following the depopulation, and cleaning and disinfection of the last af fected premises . This timeframe is compatible with current APHI S regulation ( 9 CFR 93.205 ) . OIE also recognize s 90 day s as the time period to regain NAI free status in a previousl y free country, zone or compartment, following and eradication campaign including disinfection of all affected establishments with additional disease surveillance [ 4 3 ]. When END or HPAI are detected in a wild bird population , APHI S will recognize the duration of restrictions as imposed by

the EC. The shorter restriction period for wild birds or racing pigeon s as determined b y 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
. APHI S defines the restriction zone to encompass all protection , surveillance , and buffer zones established around END or HPAI outbreaks in domestic poultry and to encompass affected zones established around outbreaks of END or HPAI in wild birds and pigeons held in captivity

(including pigeons held for racing, exhibition, breeding , and fattening) as prescribed in Council Directive s 96/66/EC and 2005/94/EC . Definition and maintenance of the integrity of those zones will be the purv iew of the EC.**Page 39**  **of 59** 

T o 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 ), APHI S 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 b y 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
. Hatc hing egg shipment s with seals that are not intact will be rejected at the first U
. S
. p ort of e ntry by the VS port official
. APHI S 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, APHI S 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 HPAIthat 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 , APH IS 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 . APHI S 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** 

**R EFERENCES**  1. ADNS (2009). Animal Disease Notification Sy stem 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

- 5 644. 3. Alexander, D.J., (2003). Newcastle Disease, in Diseases of Poultry , 11 th ed., 64

- 87. 4. APHI S (2009) Interim rule and request for comments Highl y Pathogenic Avian In fluenza AS YET 2b Published ** 5. Notice of Determination of the High Pathogenicity Avian Influenza Subty

pe H5N1 Status of Hungary . 74 FR 48711, published September 24, 2009. Preceded by Notice of Availability

of Evaluations of the Highl y Pathogenic Avian Influenza Subty pe H5N1 Status of Hungary . 74 FR 28217, published June 15, 2009. 6. APHI S (2009)
. Notice of Determination of the High Pathogenicity Avian In fluenza Subty

pe H5N1 Status of Saxony (Gorlitz and Bautzen) Germany . 74 FR 48519, published September 23, 2009. Preceded by Notice o f Availability of Evaluations of the Highly Pathogenic Avian Influenza Subty pe H5N1 Status of Saxony (Gorlitz and Bautzen) Germany . 74 FR 28008 , published June 1 2, 2009. Notice of Availability of the High Pathogenicity Avian Influenza Subty pe H5N1 Status o f Saxony

(Gorlitz and Bautzen) Germany. 74FR 28008, published June 12, 2009. 7. APHI S (200 9 )
. Notice of Determination of the High Pathogenicity Avian Influenza Subty pe H5N1 Status of Germany and Poland. 74 FR 274, published June 5 , 200 9
. Preceded b y Noti ce of Availability of Evaluations of the Highly Pathogenic Avian In fluenza Subty

pe H5N1 Status of Germany and Poland. 74 FR 69, published January 2, 2009. 8. APHI S (2009). Notice of Determination of the High Pathogenicity Avian Influenza Subty pe 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 Subty pe H5N1 Status of Suffolk and Norfolk Counties in England. 74 FR 21312, published May 7, 2009. 9. APHI S (200 9 )
. Final Rule for Importation of Table Eggs from Regions Where Exotic Newcastle Disease Exists. 74 FR 18285 , published April 22 , 200 9
. 10. APHI S (2009)
. Evaluation of the Highl y Pathogenic Avian In fluenza H5N1 Status of Suffolk and Norfolk Counties, England . January 2009**Page 41**  **of 59** 

11. APHI S (2009)
. APHIS’ Evaluation of the Status of High Pathogenicity Avian In fluenza H5N1 (HPAI H5N1) in Germany . October 2008. 12. APHI S (2008)
. APHIS’ Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Hungary . November 2008. 13
. APHI S (200 8 )
. APHIS’ Evaluation of the Status of High Pathogenicity Avian In fluenza H5N1 (HPAI H5N1) in Poland. October 2008. 1 4
. APHI S (2008)
. Notice of Determination of the High Pathogenicity Avian In fluenza Subty

pe H5N1 Status of Denmark and France. 73FR 42313, published July 21, 2008. Preceded by Notice of Availability of the High Pathogenicity Avian In fluenza Subty

pe H5N1 Status of Denmark and France. 73 FR 16245 , published March 27, 2008. 1 5
. APHI S (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. 1 6
. APHI S (2007)
. APHIS Analy sis of the Status of High Pathogenicity Avian In fluenza H5N1 (HPAI H5N1) in Denmark. December 2007. 1 7
. APHI S (2007)
. APHIS Analy sis of the Status of High Pathogenicity Avian In fluenza H5N1 (HPAI H5N1) in France. December 2007. 1 8
. APHI S (200 7)
. Proposed Rule for Importation of Table Eggs from Regions Where Exotic Newcastle Disease Exists. 72 FR 45177, published August 13, 2007. 1 9
. APHI S (2007)
. Importation of L ive Swine, Swine Semen, Pork and Pork Products from the Czech Republic, L atvia, Li thuania and Poland. Final Rule. Published November 28, 2007: 72 FR 67227. 20
. APHI S (2007)
. Importation of L ive Swine, Swine Semen, Pork and Pork Products from the Czech Republic, L atvia, Li thuania and Poland. Published APHI S (2007) Importation of L ive Swine, Swine Semen, Pork and Pork Products From the Czech Republic, Latvia, Lithuania and Poland. Proposed rule. Published February 12, 2007 : 71 FR 6490. 2 1
. APHI S (2006)
. Final Rule to Add Denmark to the L ist of Regions Free of Exotic Newcastle Disease. 71 FR 38259, published July 6, 2006. 2 2
. APHI S (2006). Final rule: Importation of swine and swine product from the European Union [Docket 02

- 046
- 2]. Publis hed May 10, 2006: 71 FR 29061. 2 3
. APHI S (2006)
. Add Kazakhstan, Romania, Russia, Turkey , and Ukraine to L ist of Regions in Which Highly Pathogenic Avian Influenza Subty pe H5N1 Is Considered**Page 42**  **of 59** 

To Exist. Interim rule and request for comments. Published Febr uary 13, 2006: 71 FR 7401; affirmed on May

18, 2006 in 71 FR 28763. 2 4
. APHI S (2005) . APHIS Considerations on the Identification of Administrative Units for (AU) Certain Member States of the European Union. June 2005 2 5
. APHI S (2005) Importation of Swine and Swine Products from the European Union Proposed rule. Published Friday , April 8, 2005: 70 FR 17928 2 6
. APHI S (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. 2 7
. APHI S (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. 2 8
. APH IS (2003). Recognition of Animal Disease Status of Regions in the European Union; Final Rule. Published April 7, 2003: 68 FR 16922 2 9
. APHI S (2003). Animal Welfare; Animal Fighting Venture Prohibition; Notice. Published May

12, 2003: 68 FR 25315 30
. APHI S (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. 3 1
. APHI S (1978) . Eradication of Exotic Newcastle Disease in Southern California, 1971
- 1974. APHI S
- 91
- 34 , February 1978. 3 2
. Center for Disease Control (2006). Past avian influenza outbreaks. Available at: http://www.cdc.gov/flu/avian/ 3 3
. CEAH (2003). Summary of Exotic Newcastle Disease Direct and Indirect Impacts, Centers for Epidem iology and Animal Health United States Department of A griculture, Animal and Plant Health Inspection Service, Veterinary Services, October 2002

- September 2003. 3 4 . European Commission (2009)
. Avian Influenza C hronology Situation as of 18 May 2009 and List of D ecisions 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 3 5
. European Commission (2007)
. Avian Influenza E xtensive C hronology and L ist of D ecisions Adopted b y the European Commission 2007. DG Health and Consumer Protection , Unit D1: Animal Health and Standing Committees
.**Page 43**  **of 59** 

3 6
. European Commission (2007)
. Information on the Newcastle Disease Legislation and Dis ease Situation in the European Union. September 2007
. 3 7 . European Commission (2006)
. Avian Influenza E xtensive C hronology and L ist of Decisions Adopted b y the European Commission in 2006; P art II
- Including overview of events in 2004

- 2005 with Response to Outbreaks in Member States and third countries
. DG Health and Consumer Protection , Unit D1: Animal Health and Standing Committees
. 3 8
. Foreign Animal Diseases, the Gray Book , 7 th ed
. United States Animal Health Association. Revised, 2008 . http://www.v et.uga.edu/vpp/gray _book/ 3 9
. 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
. Le e, C
- W, Sway

ne, D. E., et.al. (2005) H5N2 Avian Influenza Outbreak in Texas in 2004: the First Highl y Pathogenic Strain in the United States in 20 Years? J
. Virology 79 (17) , p. 11412

– 11421
. 4 1
. National Environmental Policy Act Implementing Procedures. Classification of actions. Categoricall y excluded actions. Routine measures. In Title 7, Code of Federal Regulations, Part 372.5 (c)(1). Animal and Plant Health Inspection Service. 4 2
. OI E (2009)
. W eekl y disease information update archive; available at: http://www.oie.int/eng/info/hebdo/a_csum.htm 4 3
. OI E (2008). Terrestrial Animal Health Code, World Organization for Animal Health. Available at: http://www.oie.int/eng/normes/mcode/en_sommaire.htm 4 4
. SCOFCAH Animal Health and Animal Welfare meeting pres entations, available at: http://ec.europa.eu/food/committees/regulatory /scfcah/animal_health/index_en.htm 4 5
. Sway ne, D.E., (2008)
. “High Pathogenicity Avian Influenza in the America” in Avian Influenza, ed. D. E. Sway ne, Blackwell Publishing, p 191

- 211. 4 6
. Toro, H., Hoerr, A. B., et. (2005). Al. Pigeon Param yx ovirus: Association with Common Avian Pathogens in Chickens and Serologic Survey in Wild Birds. Avian D is. 49:92

– 98, 2005
. 4 7
. USDA Foreign Agricultural Service Gain Report (2007). Canada; Poultry and Products, Minimal Economic & Trade Impact of HPAIH7N3, Detection on Saskatchewan Farm. Report CA7046, dated October 2, 2007. Available at: http://www.fas.usda.gov/gainfiles/200710/1 46292626.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**  **A PPENDIX**  **A .**  **E PIDEMIOLOGIC**  **C HARACTERISTICS OF**  **N EWCASTLE**  **D ISEASE**  **Disease** Virulent (exotic) Newcastle disease (END) is a contagious and fatal viral disease affecting all species of birds caused b y an enveloped RNA virus, paramy xovirus seroty

pe 1 (APMV

- 1), of the Paramixoviridae family , Paramy xovirinae subfamily

and Rubulavirus genus [2]
. Newcastle disease viruses occur as three pathoty pes: lentogenic, mesogenic, and velogenic, reflecting increasing levels of virulence. The most virulent (velogenic) isolates are further subdivided into neurotropic and viscerotropic ty pes. The velogenic isolates (the subject of the analy sis presented here) are considered exotic to the United States. APHI S regulation defines the Newcastle disease as any virulent Newcastle disease and routinely uses the abbreviation END . Previously , velogenic Newcastle disease was used to desc ribe virulent Newcastle disease in APHI S regulation. Regulation s in 9 CFR 121 further defines virulent Newcastle disease virus as avian paramy xovirus seroty

pe 1 with an intracerebral pathogenicity index in day

- old chicks ( Gallus gallus ) of 0.7 or greater o r 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 infec tious 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 sy

mptoms of END vary

depending on viral strain, host, age , and environment. END is a s ys temic disease most notably involving the respiratory , digestive , or nervous sy stems. The incubation period for the disease ranges from 2 to 15 day s. An infe cted 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 paral ys is; • Partial to complete drop in egg production or production of thin

- shelled eggs; • Swelling of the tissues around the eyes and in the nec k; and • Sudden death and increased death loss in a flock. Susceptibility

of different ty

pes of birds may

be variable; n atural or experimental infection with NDV has been demonstrated in at least 236 species from 27 of the 50**Page 46**  **of 59** 

orders of bi rds [ 1, 2, 3 ] . Ch ickens, turkey s, 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 day s and NDV was recovered up to 53 day s postchallenge from turkey poults that were vaccinated once at 4 day s of age and challenged at 1 month of age. **END Spre ad**  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 bird s kept in confinement, such as commercially raised chickens. High concentrations of the END virus are in birds’ bodil y discharges. Therefore, the disease can be spread easily by mechanical means. Virus

- bearing material can be picked up on shoes and clothin g 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 employe es. The END virus can survive for several weeks in a warm and humid environment on birds ’ feathers, manure, and other materials ; i t can survive indefinitely in frozen material. However, the virus is destroyed rapidl y b y deh ydration and by the ultraviole t ray s in sunlight. Smuggled pet birds, especiall y 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 sy mptoms are capable of shedding END virus for more than 400 day s [3]
. **END Control in Commercial poultry** The only way to eradicate END from commercial poultry is by rapidl y 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 hobb y flocks. The following are appropriate biosecurity practices: • Permit only

essential wor

kers 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 b irds 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 b y 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 s hould be isolated for at least 30 day s and movement of personnel between new and old birds restricted. In the late 1970’s , a ND panzootic em erged that was attributed to pigeons. It is thought that the contact between birds at races and shows and the larg e 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 rac ing pigeons in many countries and regularl y spreads to wild pigeons providing a continuing threat to poultry [ 1, 5, 7 ]
. To distinguish the pigeon variant from the avian paramyx ovirus seroty pe 1 (APMV

- 1), the pigeon variant is referred to as pigeon paramyx ovirus 1 (PPMV

- 1); however, not all param yx ovirus isolated from pigeons are of the PPMV

- 1. The isolation of highl y 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 ]. I solates of the pigeon adapted NDV have been geneticall y- 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 b y unique monoclonal antibody

- binding p rofiles [ 5, 7 ]. The pigeon

adapted or pigeon variant strain of the virus has caused numerous outbreaks in pigeons in various EU

- MS . NDV has frequentl y 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 (I CPI ) in day

- old chicks. The OIE definition for reporting an outbreak of ND is that the virus has an intracerebral pathogenicity

index (I CPI) 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 D**  **isease in H**  **umans** 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 lachry mation, edema of the eyelids, conjunctivitis , and sub

- conjunctival hemorrhage . Although the effect on the eye may be quite severe, infections are usuall y transient and the cornea is not affected. Reports of other clinical sy mptoms in humans infecte d with NDV are less well substantiated, but suggest a more generalized infection may sometimes occur resulting in chills, headaches , and fever, with or without conjunctivitis. There is evidence that both vaccinal and virulent (for 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 , 11 th ed. Saif, Y. M., H. J. Barnes, A. M. Fadl y, et al (Eds). Io wa, Blackwell Publishing: 64

- 8 7. 2. Alexander, D. J., R. J. Manvell, J. P. L owing, et al (1997). “ Antigenic diversity and similarities detected in avian param yx ovir u ses ty pe 1 (Newcastle disease virus) isolates using monoclonal antibodies.” Avian Patholo gy 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. OI E (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 Paramy xovirus: Association with Common Avian Pathogens in Chickens and Serologic Survey in Wild Birds. Avian Dis. 49:92

– 98, 2005**Page 49**  **of 59**  **A PPENDIX**  **B .**  **E PIDEMIOLOGIC**  **C HARACTERISTICS OF**  **A VIAN**  **I NFLUENZA**  **Disease** Avian influenza (AI) is caused b y an orthom yx ovirus. AI viruses are divided into 5 genera; of which Influenza A is the most important and widespread with the c apacity to infect many different avian and mammalian species [ 1, 2, 7 ]. AIviruses infect chickens, turkey s, pheasants, quail, ducks, geese , and guinea fowl, as well as a wide variety of wild birds (such as ducks, gulls, and shorebirds). Migratory waterfow l 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 ]
. AIviruses 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 high

pathogenicity

(HPAI) based on the severity of the illness the y cause. The ability to cause clinical signs may

dep end on the species of bird infected and may change over time, becoming more or less pathogenic [ 4 , 5 ]. HPAIis an extremely infectiou s and fatal form of the disease that, once established, can spread rapidly from flock to flock. Some LPAI virus strains hav e mutated under field conditions into HPAIviruses. All virulent strains of AI isolated to date have been either of the H5 or H7 subty pe. Although most H5 or H7 isolates have been of low virulence, a low virulent H5 or H7 may become virulent by

mutation i n poultry

hosts. For this reason OIE considers all H5 and H7 viruses to be classified as Notifiable Avian Influenza (NAI) viruses [ 4 ]
. HPAIsubtype H5N1 (HPAIH5N1), often referred to as "Asian ” H5N1, is the ty pe causing worldwide concer n an d has caused outbreaks in birds and poultry in Asia, Africa, Europe, and other foreign regions. HPAI H5N1 spreads rapidly and is often fatal to chickens and turkey s. Millio ns of bi rds have died in countries where HPAI H5N1 has been detected. This virus has also infecte d 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, specificall y 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 i t 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 highl y variable and depend on the pathogenicity of the infecting viral strain. Infected poultry may exhibit sy ndromes ranging from asy mptomatic infection, mild respiratory disease with drops in egg production, or severe sy stemic disease with ne ar 100 percent mortality [ 8 ]
. Ty picall y**Page 50**  **of 59** 

HPAIin 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 cas es 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 day s, although OIE uses 21 day s for the NAI. AIviruses may

be transmitted by

direct contact with secretions from infected birds, especiall y feces , or by

exposure to c ontaminated feed, water, equipment , and clothing
. C ontact with c linically

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
. AIspreads rapidl y among birds kept in confinement, such as commerciall y raised chickens. **AI Control in Commercial P**  **o ultry**  The only way to eradicate AI from commercial poultry is by rapidl y 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 hobb y flocks. The same biosecurity practices discussed for Newcastle disease (see Appendix I) are appropriate for AI. **AI Control in Pet Birds**  **, Pigeons a**  **nd Backyard Poultry** AIis also a threat to the caged

- birds and poultry hobbyists. Birds illegall y 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 f rom 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 day s and movement of personnel between new and old birds restricted. **AI in**  **H umans**  Th e 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 subty pes of AI infection have been reported since 1997. Most cases of AI infection in humans have res ulted from contact with infected poultry (e.g., domesticated chicken, ducks, and turkey s) or surfaces contaminated with secretion s or excretions from infected birds. The spread of AI viruses from one ill person to another has been reported very rarel y, and has been limited, inefficient and unsustained. During an outbreak of AI among poultry , there is a possible risk to people who have co ntact with infected birds or surfaces that have been contaminated with secretions or excretions from infected birds [ 3, 9 ]
. Sy mptoms of AI in humans have ranged from typi cal human influenza

- like sy mptoms (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 life

threatening complications. The sy mptoms 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 Pac ific, Europe , and the Near East. Indonesia and Vietnam have reported the highest number of H5N1 cases to date with mortalities of up to 60 percent , especially in cases hospitalized late in the illness
. Despite the high mortality, human cases of H5N1 remain rare to date. T he most significant risk factor for human H5N1 infection is direct contact with sick or dead poultry or wild birds [ 9 ]
. **Past AI**  **Outbreaks** [ 1
- 3, 7, 8 ] Most recentl y, 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). InNorth American there have been two AIoutbreaks with transmission to humans , in Canada (2004, N7N3) and New York ( 200 3, 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 Cana da 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 o ther flulike sy mptoms. Their illnesses resolved after treatment with the antiviral medication oseltamivir. Another group of approximately 10 other poultry

workers exhibited conjunctival and/or upper respiratory s ymptoms after having contact with poultry but infection was not confirmed by laboratory

methods. In November 2003, a patient with serious underl yi ng medical conditions was admitted to a hospital in New York with respiratory s ymptoms. 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 p oultry 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. OI E (2008). Chapter 10.4 Avian Influenza. In Terrestrial Animal Health Code, World Organization for Animal Health. 5. OI E (2008). Technical Diseas e Card Highl y pathogenic avian i nfluenza and low pathogenic avian influenza (poultry). World Organization for Animal Health , available at: http://www.oie.int/eng/maladies/fiches/a_A150.htm 6. OI E (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, Sway ne, D. E., (Ed.) Iowa, Blackwell Publishing: 3
- 22. 8. Sway ne, D. E., D. A. Halvorson
. (2003 )
. “Influenza.” In Diseases of Poultry , 11 th ed. Saif, Y. M., H. J . Barnes, A. M. Fadl y, 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 g overning 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 veteri nary

and zootechnical checks applicable in intra

Community

trade in certain live animals and products with a view to the completion of the internal market Council Directive 90/539/EEC C ouncil D irective of 15 October 1990 on animal health conditions governing intra

- Community trade in, and imports from third countries of, poultry and hatching eggs Council Directive 82/894/EEC Council Directive of 21 December 1982 on the notification of animal diseases within the Community **Commission Decision Full**  **Title** Commission Decision 2007/878/EC Commission Decision of 21 December 2007 amending Decision 2006/415/EC concerning certain protection measures in relation to highl y pathogenic avian influenza of the subty pe 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 highl y 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 highl y pathogenic avian influenza of the subty pe 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 Decisio n 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 p rotection measures in relation to highl y pathogenic avian influenza of subtyp e 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 sp read of highly pathogenic avian influenza caused b y influenza A virus of subty pe 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 subty

pe H5N1 in poultry

in the Community and repealing Decision 2006/135/EC Commission Decision 2006/314/EC Commission Dec ision 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 highl y 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 highl y 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 an d 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 earl y 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 highl y 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 av ian influenza caused by influenza A virus of subty pe H5N1 from birds living in the wild to poultry and other captive birds and providing for an earl y 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 highl y pathogenic avian influenza caused b y Influenza virus A subty

pe H5N1 from birds living in the wild to poultry and other captive birds and providing for an earl y detec tion sy stem 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 requirement s 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 eligibi lity 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 survey s fo r 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 survey s for avian influenza in poultry and wild birds in Member States, to be carried out during 2004 Commission Decision 2003/623/EC Commission Decision 2003/623/EC of 19 Augu st 2003 concerning the development of an integrated computerized veterinary

s ys tem 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 i nfluenza in poultry and wild birds Commission Decision 2002/649/EC Commission Decision 2002/649/EC of 5 August 2002 on the implementation of survey s 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 d own 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 Cy prus (CY) Entire territory (no sub

- national AU identified 2 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 (E L) Nomos (prefecture) Hungary (HU) County 6 Ireland, Republic of (IE) District Veterinary Office Ital y (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) District 11 Slovenia (SI) County 12 (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, Ital y, 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, date d 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 200 5 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