### APHIS Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in the Czech Republic and Sweden

Animal and Plant Health Inspection Service

Veterinary Services

July 2009APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

2 A BBREVIATIONS

ADNS Animal Disease Notification System
AI avian influenza APHIS Animal and Plant Health Inspection Service
AU Administrative Units CFR Code of Federal Regulations CRL Community Reference Laboratory
CSF Classical Swine Fever EC European Commission
END Exotic Newcastle Disease EU European Union FAO Food and Agriculture Or ganization of the United Nations FVO Food and Veterinary Office of the European Commission H5N1 hemagluttin 5 neuraminidase 1 HPAI highly pathogenic avian influenza LPAI low pathogenicity avian influenza
MS Member State OIE World Organization for Animal Health PCR polymerase chain reaction TRACES Trade Control and Expert System SCFCAH Standing Committee on the Food Chain and Animal Health USDA United States Department of AgricultureAPHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

E XECUTIVE S UMMARY On March 17, 2006, the Swedish Board of Agricu lture reported their first case of Highly Pathogenic Avian Influenza subtype H5N1 (H PAI H5N1) in domestic poultry to the World Organization for Animal Health (O IE).The outbreak was confirmed on a game bird breeding farm of mallard ducks in the village of Gässhult, Os karshamn in Kalmar Län (County). No further reports of HPAI H5 N1 in wild or domestic birds have been reported in Sweden since that time.

On June 22, 2007, the State Veterinary Admi nistration of the Cz ech Republic reported
the first occurrence of HPAI H5N1 in dome stic poultry to the OIE. The outbreak was confirmed in a flock of 6,000 turkeys near the town of Tisova, Usti na d Orlici district, in the Pardubicky Region (kraj). Several ot her nearby commercial poultry farms were
affected over the next several weeks. No furt her reports of HPAI H5N1 in domestic birds have been reported in the Czech Republic since that time.

In this document, APHIS presen ts the results of its evaluati on of the HPAI H5N1 status of the Czech Republic and Sweden based on information supplied to European Commission (EC), EC legisla tion, and reports to OIE. APHIS has maintained contact with EC veterinary authoritie s who kept APHIS apprised of animal disease conditions in the European Union (EU) and concludes that a document review is sufficient to meet the
needs of this evaluation. In addition, because of the long hi story of trade between the United States and the EU, APHIS did not require a site visit to comple te this evaluation.

The documentation reviewed was consistent with the OIE Terrestrial Animal Health
Code recommendation for reinstatement of trad e with a region that has experienced an
HPAI H5N1 outbrea k. In brief, APHIS based this ev aluation on the following critical factors: the Czech Republic and Sweden have been free of HPAI H5N1 for at least 3
months as the result of effective control m easures undertaken by the competent veterinary infrastructure; HPAI H5N1 was a notifiabl e disease in the EU; an ongoing awareness disease program was in place; all notified or susp ect occurrences were investigated; an effective surveillance program for HPAI H5N1 existed that supporte d the detection and investigation of outbreaks; di agnostic and laborato ry capabilities were adequate and effective; eradication and control measures and movement restrictions were appropriate to prevent further spread of disease; and procedures used for repopulation of affected premises included monitoring to demonstrate that HPAI H5N1 had been eradicated.

AHPIS considers that the presence of HPAI H5N1 in wild birds presents the highest risk
for the reintroduction of HPAI H5N1 into th e Czech Republic and Sweden. Eradication of disease should mitigate the immediate risk from the outbreak that occurred but the
reintroduction of disease into domestic poultry remains a concern whenever HPAI H5N1 is present in wild or migratory bird p opulations. However, the ongoing surveillance programs for wild birds and domestic poultry in the Czech Republic and Sweden and the surrounding EU region have not indicated th e reoccurrence or re introduction of HPAI H5N1 in the Czech Republic or Sweden. Th e EC recognizes wild birds as the major pathway of introduction of HPAI and had in place an adequate and appropriate surveillance system for HPAI in wild birds. Extensive surveillan ce in wild birds and

3APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

domestic poultry for HPAI H5N1 in the Czech Republic and Sweden since eradication of
the outbreak indicates that it ha s not been reintroduced. APHIS considers that if there is
a reintroduction of HPAI H5N1 into the Czech Republic or Sweden it would be rapidly detected and appropriate c ontrol and eradication measur es would be applied.

As a result of this evaluation, APHIS conc ludes that the Czech Republic and Sweden were able to effectively control and erad icate HPAI H5N1 in their domestic poultry population and that authorities in both countires have adequate control measures in place to rapidly identify, control and eradicate the disease should it be reintroduced in either wild birds or domestic poultry. The eff ectiveness of the eradication program was attributed to prompt actions taken by the vete rinary authorities in the Czech Republic and Sweden with cooperation from backyard a nd commercial flock owners. Based on the results of the assessment, APHIS could iden tify no additional risk factors that would indicate that domestic poultr y in the Czech Republic and Swed en continue to be affected with HPAI H5N1. Therefore, APHIS concl udes that the likelihood of introducing HPAI H5N1 into the United States through the impor t of live birds, poultr y carcasses, parts or products of poultry carcasses, and eggs of pou ltry, game birds or other birds from the Czech Republic and Sweden to be low.

I NTRODUCTION On March 17, 2006, the Swedish Board of Agricu lture reported their first case of Highly Pathogenic Avian Influenza subtype H5N1 (H PAI H5N1) in domestic poultry to the World Organization for Animal Health (OIE ) [20, 23]. The outbreak was confirmed in a mallard duck on a mixed species game bird breeding farm in the village of Gässhult, Oskarshamn, in Kalmar Län (County). The proba ble source of the infection was contact
with infected wild birds. The affected fa rm was located in an area which was already under restriction since the end of February 2006 due to the detection of HPAI H5N1 in wild birds. Between February and April, 2006, 508 samples from wild birds and 3 minks were tested, of which 64 wild birds from 16 different places were positive for HPAI H5N1. No further reports of HPAI H5N1 in do mestic or wild birds have been reported in Sweden since that time [1, 15-17, 20].

On June 22, 2007, the Director of the Depart ment of Animal Health and Welfare in Ministry of Agriculture of the Czech Repub lic reported the first occurrence of HPAI H5N1 in domestic poultry to the OIE [20]. The outbreak was confirmed in a flock of 6,000 turkeys near the town of Tisova, Usti nad Orlici distri ct, in the Pardubicky Region (kraj). Over the next several weeks othe r nearby commercial poultry farms were also affected. Restrictions were removed on August 14, 2007, following depopulation of affected premises and extensive additional surveillance. No further detections of HPAI H5N1 in domestic birds have been reported in the Czech Republic since that time [1, 15- 17, 20]

In this document, APHIS presen ts the results of its re-evalu ation of the HPAI H5N1status of the Czech Republic and Sweden. APHIS is basing this review on the evaluation of

4APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

documentation of the European Commission (EC) [15-17, 22], Food and Veterinary Office report [18, 19]], EC legislation [A ppendix A], and reports to OIE [20].

Previously, APHIS has conducted reviews of the animal health control system of the European Union (EU) and has concluded that the Czech Republic and Sweden have in place an effective system to identify, contro l and eradicate animal disease [9, 11-14]. Several previous evaluations of the HPAI H5N1 status of regions within the EU concluded that the veterinary infrastructure was adequate to rapidly identify, control and
eradicate the disease should it be reintroduced into their count ry in either wild birds or domestic poultry [2-8]. In the 2004 risk a ssessment for Classical Swine Fever (CSF), APHIS evaluated the veterinary infrastructure of 15 Member States (M S) of the EU with regard to the ability to apply the harmoni zed and binding animal health regulations imposed by the EC on all MS [13]. This re gion included Sweden and in 2007 the Czech Republic was added [9]. Important animal health requirements include compulsory notification of specific animal diseases to both the EC and OIE. CSF and HPAI are
notifiable diseases in the EU.

In 2005 APHIS identified and presented for public comment what it would consider to be the smallest sub-national jurisdictions or Administrative Units (AUs) in the 15 EU MS [12]. The AU was considered to have “eff ective oversight of normal animal movements into, out of, and within that jurisdiction, and that, in associ ation with national authorities, if necessary, has effective control over anim al movements and animal diseases locally.” APHIS recognized that local aut horities in the individual MS have effective oversight and control of animal diseases locally within their respective AUs and in the event of future animal disease outbreaks in the EU, APHIS wo uld regionalize Member States to the level
of one or more of the iden tified AUs. Although the document sp ecifically addressed CSF, the concept of regionalization to the AU le vel was considered to be more broadly applicable and not be disease- specific [2-8]. In the case of the Czech Republic the AU is
the kraj or county [11]. For Sweden th e AU is the Län or County [12].

APHIS’s evaluations of the veterinary infras tructure including laboratory capability and its ability to implement appropriate control measures, movement controls, and emergency measures apply equally to HPAI H5N1. Th e information available regarding HPAI H5N1, in addition to the information from pr evious evaluations of poultry, swine, and ruminant diseases provide a b ackground that is consistent w ith the 11 factor approach in
9 CFR 92.2. APHIS has maintained contact w ith EC veterinary au thorities who kept
APHIS advised of animal disease conditions in their country a nd concludes that a
document review is sufficient to meet the need s of this risk analys is. In addition, because of the long history of trade between the Unite d States and the EU, APHIS did not require a site visit to complete this evaluation.

The information available to APHIS supporti ng the removal of these two regions from the APHIS list of H5N1 affected regions was consistent with recommendations outlined
in Article 2.7.12.2 of the OIE Terrestrial Animal Health Code for information
recommended for reinstatement of trade HPAI H5N1 free status from a region that has

5APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

experienced an HPAI H5N1 outbreak [21]. APHIS conducted a risk analysis that is
consistent with these re commendations, specifically:

• The Czech Republic and Sweden have been HPAI H5N1 free for 3 months because of control measures undertaken by an e ffective veterinary infrastructure

.

• HPAI (as defined in 9 CFR) was a notif iable disease in the Czech Republic and Sweden. An ongoing awareness program was in place for veterinary officials and the public, and all notified or susp ect occurrences of HPAI H5N1 were subjected to field and laboratory investigations.

• A surveillance program for HPAI H5N1 alr eady existed that addressed needs of the Czech Republic and Sweden. This program supported the detection and investigation of outbreaks, including clinical inspec tion, active and passive surveillance (both serological and agent detection), and serolo gical and virological testing in high-risk areas and of high-risk flocks. These acti ons were sufficient to detect disease effectively and quickly, even in the absence of clinical signs.

• Under the surveillance program , all notified and/or suspected avian influenza cases were investigated, and offici als took appropriate actions in cluding collecting samples, transporting these samples in a manner th at ensured their integrity for testing purposes, and documenting subse quent laboratory results.

• The system for recording, managing, and an alyzing diagnostic and surveillance data
was sufficient to demonstrate the effectiveness of the disease control measures in the Czech Republic and Sweden.

• Laboratory confirmation capabilities were e ffective, and testing procedures were
documented and standardized.

• The eradication program included the de finition of appropriate quarantine and surveillance zones, monitori ng of those zones, and implementation of movement restrictions. Measures taken by officials were able to contai n and control the spread of
disease from these zones due to effectiv e program measures. Procedures for lifting quarantines were followed and were sufficien t to prevent further spread of disease.

• Documented standard operating procedures described procedures for depopulation, cleaning, disinfecting, and other applicable measures, such as carcass disposal. All relevant personnel were familiar with these standard procedures and followed them during the outbreak. These measures were effective in controlling the disease.

• Premises repopulation, if applicable, was carried out according to documented procedures, including evidence that the di sease did not recur and monitoring after repopulation to demonstrate that the disease was eradicated.

As a result of this evaluation, APHIS conc ludes that the Czech Republic and Sweden were able to effectively c ontrol and to eradicate HPAI H5N1in their domestic poultry populations. The effectiveness of the eradi cation program was attributed to prompt actions taken by veterinary authorities in the Czech Republic and Sweden and the cooperation of backyard and commercial floc k owners. Since these outbreaks, the Czech Republic and Sweden have conducted extensiv e surveillance for HPAI H5N1 and have not identified any new HPAI H5N1ou tbreaks in domestic poultry.

O BJECTIVE

6APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

The objective of this review is to evaluate the HPAI H5N1 status of the Czech Republic and Sweden following the outbreak in domes tic poultry in Sweden (2006) and in the Czech Republic (2007) to serve as the basis to characterize the risk associated with the import of live birds (including hatching eggs), poultry carcasses, parts or products of poultry carcasses, and eggs (other than hatc hing eggs) of poultry, game birds, or other birds from the Czech Republic or Sweden.

B ACKGROUND The Czech Republic and Sweden, as members of the EU, are obligated to comply with EC regulations. Council Directiv e 2005/94/EC describes the m easures for the control of avian influenza (AI) and Commission Deci sion 2004/402/EC requires all EU-MS have AI contingency plans to ensure that the most appropriate measures are immediately implemented. These measures are harmonized and binding throughout the EU serving as an important means to prevent the spread of HPAI H5N1 within the EU as well as other countries through its export market. The EC has the authority to conduct periodic evaluations to verify i ndividual MS compliance.

The United States had a long hi story of trade of poultry a nd poultry products with the EU. The veterinary infrastructure of the Czech Republic [11] and Sweden [12, 13] were previously evaluated for other animal diseases as individual countries and as part of the EU. The EU system for animal disease cont rol has been extensively evaluated by APHIS and provides a basis for understanding the EU system for control of HPAI in the Czech Republic and Sweden [2-14]. APHIS has ma intained contact with EC veterinary authorities who kept APHIS advised of an imal disease conditi ons in their region. Therefore, APHIS concludes that a document re view is sufficient to meet the needs of this risk analysis.

APHIS has concluded that the veterinary authorities in the Czech Republic and Sweden were able to effectively c ontrol and to eradicate disease in their domestic poultry population and that the EU system for anim al disease control provides a basis for understanding the EC regulations and system for control of HPAI. Based on the results of the assessment, APHIS could identify no addition al risk factors currently applicable to the Czech Republic or Sweden that would indicate that the Czech Republic or Sweden are currently affected with HPAI H5N1.

H ISTORY OF HPAI H5N1 IN S WEDEN AND THE C ZECH R EPUBLIC In 2005 the presence of HPAI H5N1 in wild birds and domestic pou ltry was detected in Europe, first in Russia, Croatia and then Romania (not yet an EU MS) [17]. In 2006, HPAI H5N1was widely reported in Europe in wild birds; Austria, Bulgaria (not yet an EU-MS), Greece, Italy, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom and in both wild birds a nd domestic poultry in the Czech Republic Denmark [7], France [8], Germany [2, 4], and Hungary [5]. In 2007, HPAI H5N1 was again reported in wild birds in Austria, the Czech Republic, France [8] and Slovenia, and domestic poultry in the Germany [2,4] Hunga ry [5], Poland [6] and the United Kingdom [3], [16].

7APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

In reviewing the HPAI H5N1situation in the EU during the 2006 – 2007 it was found that swans, especially mute swans ( Cygnus olor ) were most frequently involved. The exception was Germany in 2007, where grebes were the most frequently affected species and there was an incident with high mortality in which swans in the same area were not affected. In 2006, HPAI H5N1 was also isol ated from grebes in Spain, Denmark and Sweden [22].

After the recognition of the spread of HPAI H5N1from Asia into Western Europe, the
EU increased surveillance in wild and migratory birds. In mid-February 2006, HPAI H5N1 was found in wild birds in Rügen Germany, in early March in Sweden and
Denmark. Increased surveill ance of wild birds thr oughout the region was also undertaken, with special emphasis on costal regions and migratory waterfowl.

Sweden [1, 15-17, 20, 23] Between February and April, 2006, HPAI H5N1 was de tected in 64 wild birds and 3 wild minks from a total of 508 samples tested from an area primarily along the south east coast
of Sweden. HPAI H5N1 was first isolated on February 24, 2006, from two tufted ducks ( Aythya fuligula ) of 76 wild birds tested in Kalmar Län (County) [see Figures 1 and 2].
Positive isolations of HPAI H5N1 were also made in five other south eastern Län (Bleknge, Gotland, Skäne, Stockholm and Sädermanland). The isolations were primarily in tufted ducks ( Aythya fuligula ) (36 of 64); other waterfow l including greater scaups ( Aythya marila ), mute swans ( Cygnus olor ), goosanders ( Mergus merganser ), smews ( Mergus albellus ); as well as eagle owls ( Bubu bubo ), common buzzards ( Buteo buteo ), and gulls ( Larus argentatus ). One of three mink (small carnivous mammal of the

Mustelidae family) tested in Blekinge Län was also positive.

In compliance with Commission Decisions pr otections zones (3 km) and surveillance zoned (10 km) were established around these findings and additional surveillance was
conducted. Passive surveillance was c onducted throughout Sweden and active surveillance was conducted in regions on the flight lines of migratory species.

On March 17, 2006, the Swedish Board of Agri culture (Jordbruksverket) reported their first case of HPAI H5N1 in domestic pou ltry to the OIE [20]. The outbreak was confirmed in a mallard ducks on mixed species game bird breeding farm in the village of Gässhult in Kalmar Län (County). The affected farm was within the restriction zone area already established under Commission Deci sion 2006/115/EC following the detection in wild birds [22]. Under Commission Decision 2006/293, in addition to the required 3 km protection and, 10 km surveilla nce zones, an extended 20 km surveillance zone was established. The probable source of the infection was contact with infected wild birds. No further outbreaks in domestic poultry have si nce been reported in Sweden, despite
extensive surveillance in both the wild and domestic bird populations.

8APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

Figure 1. Map of Sweden; source http://www.map-of-sweden.com/sweden-map-800.gif

The Gässhult holding had approximately 500 mallard ducks, 150 pheasants, 25 pigeons, 15 laying hens and 2 peacocks and all very in apparent good clinical condition. On March 10 and 13, as part of the rou tine surveillance measures follo wing the wild bird detection, cloacal swab samples were taken from 30 of the pheasants and 50 of the mallards. Two mallard samples were positive; one for HPAI and on for LPAI. The HPAI positive sample was further characteri zed by amino acid sequencing.

On March 18, additional testing was done on this farm; 249 cloacal swab samples were collected (149 from mallards, 58 pheasants, 15 hens, 25 pigeons and 2 peacocks). Matrix PCR found 17 of the mallard samples to be positive but negative by conventional PCR.
An additional 9 wild mallards found dead near the holding were tested; one of these was positive on Matrix PCR by negative to the H5 conventional PCR. Blood samples (156

9APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

total; 96 mallards, 36 pheasants, 14 hens, and 2 peacocks) were also taken on March 18; 84 samples were positive to H5 by hemagglu tination inhibition test (82 mallards and 2 hens).

Figure 1. Restriction areas established on March 18, 2006 surrounding the Gässhult outbreak

The Gässhult holding was depopulated on Marc h 18 and preliminary disinfection was
done. New restrictions zones were establishe d including the 3 km pr otection zone, 10 km surveillance zone; “A” zone of 20 km and “B” zone encompassing all of Kalmar Lan [see figure 1]. Movement controls were put in place with registration and inspection of all poultry holdings in the survei llance zone. No commercial pou ltry holdings were located
within 30 km of the affected holding and there were no cont acts with other farms. The
restrictions of zone “A” a nd “B” were lifted on April 25, 2006. The veterinary authorities approved the final cleaning and disinfecti on of the affected holding on May 23, 2006; however, the Gässhult premises remained empty until July 24, 2006 and restrictions on the premises were lifted on July 24, 2006. Sweden declared itself free of HPAI H5N1 in compliance with OIE guidelines on August 23, 2006 [20-23].

Czech Republic On March 29, 2006, the Czech Republic reported the first identification of HPAI H5N1 in wild birds following the detecti on of the virus in a wild swan ( Cygnus olor ) on the
river Moldau in the Southern Bohemian region. Protection and surveillance zones
established in accordance with EU Commi ssion Decision 2006/115/EC. On March 30, in the same region a second HPAI H5N1 positive wild bird was detected in the city of Ceske Budejovice and additional protection and surveillance zones were established. Between January 1 and April 22, 2006, the Czech Republic tested 2,038 samples from wild birds of which several samples from wild swans ( Cygnus olor ) were positive. By April 8, 2006, 12 cases of HPAI H5N1 in wild birds were detected and a total of 5 protection and surveillance z ones had been established. On May 11, the Czech Republic imposed additional biosecurity measures to poultry farms [20, 22].

On June 22, 2007, the veterinary authorities in the Czech Republic reported the first occurrence of HPAI H5N1 in domestic poultr y to the OIE. The outbreak was confirmed in a flock of production turkeys near the town of Tisova, Usti nad Orlici district, in the

10APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

Pardubicky Region (kraj). Of the 6,000 turkey s on the farm, 1,800 died and 3,000 were affected. The farm was promptly depopulated and additional protect ion and surveillance zones were established around the farm. Sample s were sent to the European Community Reference Laboratory (CRL) in Weybridge, England, for typing and further
characterization. The results indicated a new independent introduction of HPAI of H5N1 subtype unlike those detected previously with in the EU. This was followed by additional testing in the restriction zones [CD 2007/434/EC] and surv eillance of wild birds.

On June 27, 2007, a second outbreak of the new HPAI H5N1 strain was detected in a flock of 27,800 30-day old broile r chickens. The flock presen ted no clinical signs. This
farm was located in No ř ín, 4 km north of the first outbr eak within the restriction zone
established around the first domestic outbreak. Additional testing of the flock on June 22, 1,069 blood samples for antibody detection and 8 63 swabs for virological testing were negative; 168 wild bird samples were also ne gative. On June 25, the flocks were retested prior to moving to slaughter and several pos itive samples were found (9 positives of the 60 samples tested). The flock was depopulat ed and preventive depopulation of local backyard poultry was completed.

On July 9, 2007, within the 3 km protecti on zone established around the flock in No ř ín a
third flock in Choce ň was determined to be positive for HPAI H5N1. This flock of 54,000 breeding hens did not show clinical signs and was negative on surveillance testing
done on both June 22 and 27. The flock was de populated by July 13 and additional local backyard poultry were preventively depopulat ed. A fourth flock was confirmed to be positive for HPAI H5N1 in the municipality of Č eské He ř manice on July 9. This flock was located within the 3 km protect ion zone established around the No ř ín. Again the flock of 17,000 breeding hens did not show any clinical signs and had 2 sets of negative test results before testing confirmed the pr esence of the virus on July 11. The flock and nearby backyard poultry were depopulated on July 12.

Within the 3 km protection zones established for the third and fourth outbreaks there were two additional commercial poultry holdings; one with 3,000 fattening turkeys and another with 10,000 fattening turkeys and 55,000 br oilers (see Figure 1). These flocks were depopulated as a preventative measure. Within the 10 km surveillance zone there were 7 holdings with a total of 350,000 bird s, including 3 flocks of breeding poultry, 2 flocks of laying hens, 1 broile r flock and a flock of pheasants . All flocks were tested at least once and all were found to be negative. The flocks of breedi ng poultry were tested three times and remained negativ e. Wild bird surveillance wa s done in the region as well. By July 14 a total of 271 birds were test ed in the surrounding regions of Pardubický, Královéhradecký, and Jihomoravský. The restrict ions zones were lifted in mid-August of

2007.

During this time HPAI H5N1 was isolated fr om a dead wild swan in the District of

B ř eclav in the Jihomoravský Region. Emergenc y veterinary measures and surveillance were implemented throughout the Czech Republic . On July 10, modifications were made
to the restriction zoned in the Czech Republic to incl ude the areas in Germany.

11APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

Figure 1. map of the aff ected flocks in the Czech Republic [source: 16]

H AZARD I DENTIFICATION APHIS has identified several animal diseases listed by OIE that pose primary hazards associated with initiating tr ade in animals and animal products from foreign regions. The listed foreign animal diseases of primary concern are addressed specifically in APHIS regulations. One of these diseases, High Pa thogenicity Avian Influenza H5N1 (HPAI H5N1) is recognized by APHIS as a hazard of primary concern. In this regard, before resuming trade in poultry and poultry products with a region or country considered by
APHIS to have been affected with HPAI H5N1, APHIS must conduct an import risk analysis to support this action.

Avian influenza (AI) is caused by an orthomyxov irus virus that inf ects wild birds (such as ducks, gulls, and shorebirds) and domestic poultry (such as chickens, turkeys, ducks, and geese). AI viruses are classified by a combination of two groups of proteins: the hemagglutinin or H proteins, of which ther e are 16 (H1-H16), and neuraminidase or N proteins, of which there are 9 (N1-N9). AI st rains also are divided into two groups based upon the ability of the virus to produce diseas e (pathogenicity): low pathogenic (LP) and highly pathogenic (HP).

HPAI H5N1, often referred to as the "Asian" H5N1, is th e subtype causing worldwide concern. HPAI H5N1 ("Asian" H5N1) spreads ra pidly and is often fa tal to chickens and turkeys. Millions of birds have died in c ountries where HPAI H5N1 has been detected. This virus has also infected pe ople, most of whom have had direct contact with infected
birds. “Asian” HPAI H5N1 has not been detected in the United States.

12APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

Low pathogenicity (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, specifica lly H5N2, of HPAI have been detected and eradicated
three times in the United States: in 1 924, 1983 and 2004. The 2004 H5N2 isolate did not
cause clinical disease and i noculation studies sh owed it to be a low pathogenic strain, however, genetic sequencing was consistent with one of the OIE definitions for HPAI. No significant human illness resulted from these outbreaks.

A NALYSIS OF THE S TATUS OF HPAI H5N1 IN THE C ZECH R EPUBLIC AND S WEDEN

APHIS conducted this evaluation based on the information outlined in the OIE

Terrestrial Animal Health Code Article 2.7.12.2, information recommended for reinstatement of trade HPAI free status from a region that has experienced an HPAI outbreak. For the purpose of this report, risk refers to the like lihood that HPAI H5N1 exists in the Czech Republic or Sweden, and, if so, how likely it would be for the disease
to be introduced into the United States thr ough imports of live bird s, poultry carcasses, parts or products of poultry carcasses, and eggs of poultry, game birds, or other birds from the Czech Republic or Sweden. The likelihood will depend on th e effectiveness of
the eradication and control measures undert aken by the Czech Republic or Sweden in response to the 2006 and 2007 outbreaks of HPAI H5N1 and the ability to identify the presence of HPAI H5N1 if it were to be re-introduced.

Evidence that the Czech Republic or Sweden have been HPAI-free for 3 months because of control measures undertaken by an effective veterinary infrastructure.

The Czech Republic and Sweden have the le gal authority to respond to HPAI through a comprehensive set of regulations, directiv es and decisions that are harmonized and regularly updated for all EU MS [Appendi x A]. In addition to the fixed body of legislation laid down for avian influenza, the EC has adopted a dditional or emergency measures under the AI Directive, with other pieces of primary animal health legislation as their legal basis. The Commission, with back ing of the individual MS, puts forward legislative measures through the Standi ng Committee on the Food Chain and Animal Health (SCFCAH). Measures implemented in clude import bans, prevention and control measures, domestic and wild bird surveill ance programs and defini ng risk areas around protection and surveillance zone s. APHIS found the contingenc y plans, as required by EC regulations, adequately provided emergenc y funds, laboratory staff, equipment and
infrastructure for animal disease outbreak control and eradication.

Comprehensive avian influenza specific meas ures are provided in Council Directive 2005/94/EC, replacing Council Directive 92/ 40/EEC, and are frequently updated by
Commission Decisions. Council Directive 2005/94/EC established comprehensive provisions for the early detecti on of infection in poultry aime d at a quick reaction and the adoption of appropriate and proportionate control and eradication measures. This includes a system of active surveillance to be carried out by MS, control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds. Compulsory notification of suspected cases of HPAI, de population of poultry on holdings

13APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

where HPAI is confirmed, cleaning and disinf ection of affected premises, repopulation, establishment of protection (3 kilometer radius) and survei llance (10 kilometer radius) zones around affected holdings to enfor ce movement controls, epidemiological investigations of all cases, the presence of a national labo ratory in each MS and EC reference laboratory for HPAI diagnosis ar e also detailed in the Directive.

Immediate notification of the competent auth ority is compulsory under Council Directive 82/894/EEC for the suspected or confirmed pres ence of avian influenza. Notification of
outbreaks of animal diseases to the EC is required by Council Directive 92/40/EC.
Commission Decision 2004/402/EC requires that each MS have approved AI contingency plans and Commission Decision 2006/563/EC requi res that all Member States establish the legal powers necessary for the implementation of the contingency plans.
Commissions Decision 2004/450/EC establishe d standard requirements for Community financing for programs for the eradication, m onitoring and control of animal disease.

AI surveillance in both domestic poultry and wild birds has been in place for many years in the EU and the programs have been re gularly updated. Following the recognition of risks associated with the pres ence of HPAI H5N1 in wild birds, a number of specific
measures related to surveillance and control measures following detection of HPAI H5N1 in wild birds were implemented and ar e updated frequently (Appendix A). These measures establish control and monitoring ar eas for wild and domestic bird population
where HPAI H5N1 is detected in wild bi rds to help prevent virus introduction into commercial and non-commercial poultry flocks. For example, Commission Decision 2006/563/EC specifies the characteristics of the surveillance programs, required
notification and describes the necessary epidemiological inve stigation to be done in all cases where the presence of HPAI H5N1 in wild birds is confirmed. This decision requires the establishment of protection, surveillance and rest ricted zones for domestic
birds around the areas HPAI H5N1 was identified in wild birds.

The EU Trade Control and Expert System (TRACES), established under Commission Decision 2003/623, maintains an internet-based service for the traceability of live animals that provides information on the intra-Commun ity trade of live animals and certain types of animal products. TRACES, in place sin ce 2004, replaced earlier databases with a single central database to track the moveme nt of animals, incl uding the importation of animals and products into the EU. The system also enables the immediate review of animal movements preceding the detection of an animal disease outbreak to allow for rapid emergency response and traceability. The system also allows the receiving MS to verify that the consignment arriving at the de stination corresponds to that specified in the original accompanying veteri nary certificate from th e country of origin. The consignments of live poultry and hatching eggs must be appropriat ely identified ensuring that when they are shipped to another MS, they are accounted for on arrival at their
destination.

APHIS has previously evaluated the EC vete rinary infrastructure and found it effective and able to implement adequate and timely an imal health control a nd disease eradication

14APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

measures. [9, 12-14]. APHIS has recently eval uated the HPAI H5N1 status of several regions in the EU and rem oved them from the list of affected regions [2-8].

Conclusion : The Czech Republic and Sweden have not reported the identification of HPAI H5N1 in domestic poultry since making th eir final reports to OIE; Sweden’s final report was on August 9, 2006 and the Czech Republic was on August 16, 2007. APHIS concludes that the Czech Republic and Sweden ha ve an effective veterinary infrastructure able to carry out the appropriate control measures to keep the Czech Republic and Sweden free of HPAI H5N1 in domestic poul try for much longer than the established
international standard of three months.

Documentation that HPAI (as defined in 9 CFR) was a notifiable disease in the Czech Republic and Sweden and an ongoing awaren ess program was in place for veterinary officials and the public, and all notified or suspect occurrences of HPAI were subjected to field and laboratory investigations

.

HPAI H5N1 is a notifiable disease in the Czech Republic and Sweden. Council Directive 2005/94/EC requires that all EU MS notify the EC within 24 hours of the confirmation of any primary outbreak or detection of avian in fluenza and of all suspected or confirmed
incidents. All forms of avian influen za confirmed by the competent authority in slaughterhouses, means of transport, bor der inspection posts and other places at Community borders and quarantine facilities or centers operating in accordance with Community legislation on imports of poultry or other captive birds ar e considered to be
notifiable under Council Di rective 92/40/EC. Commission Decision 2004/402/EC requires that all Member States have AI c ontingency plans, reviewed and approved by EC, in place to ensure that the most appropriate measures are immediately implemented.

Specific regulations in the Czech Republic and Sweden were also put into force following the identification of the HPAI H5N1 outbreaks. Outreach to the public and bird owners was made through announcements and information campaigns in the national and local press related to all findi ngs of infected wild birds.

In the Czech Republic and Sweden, a variety of disease awareness and outreach programs were used to ensure the awareness and cooperation by poultry owner and the general public. Posters in several languages were publishe d and set up in all international airports
and borders. Simulation exercises for avian in fluenza outbreaks have been conducted at the national and local level with the coope ration of veterinary and human health
authorities. Avian influenza ha s been the topic of several courses arranged by the EC for emergency management training for personnel from the veterinary authorities and other personnel handling infectious animal disease outbreaks.

Conclusion: In the Czech Republic and Sweden, HPAI H5N1 was and continues to be a notifiable disease and all notified or suspect occurrences of HPAI H5N1 are subject to immediate field and laboratory investig ation. Awareness and educational outreach programs were in place and efforts were incr eased following the identification of the presence of HPAI H5N1 in wild birds.

15APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

A surveillance program for HPAI already exis ted that addressed the needs of the Czech Republic and Sweden. This program supported the detection and investigation of outbreaks, including clinical inspection, active and passive surveillance (both serological and agent detection), and serol ogical and virological testing in high-risk areas and of high-risk flocks. These actions were sufficient to detect disease effectively and quickly, even in the absen ce of clinical signs.

The EU has long standing surveillance measures in place for H5 and H7 AI viruses and
annual surveillance is co nducted by all EU-MS. In 2002 the EU implemented surveillance for avian influenza in poultry and wild birds requiring the MS to pay 50% and the EC to pay 50%. For example, Sweden initiated a national screening program for AI in 2003 primarily to detect LPAI by using a combination of an early warning system (passive surveillance) and serologic screen ing of various poultry production types. The sampling strategy is based on a risk assessment using demographic data and biosecurity
factors.

The surveillance measures are updated annua lly and since 2005 incl ude requirements for
the surveillance of avian influenza in wild birds. The individual MS are required to
submit their annual surveillan ce program plans to the EC annually and complete and report their findings by the target dates sp ecified in the annual program. Commission Decision 2006/111 further expanded requirement s for active and passi ve surveillance in wild birds and provided a list of higher risk wild bird spec ies to focus sampling. The EC continues to enhance and target HPAI survei llance by expanding the list of the wild bird species that have been shown to present the highest risk and include s lists of birds living in proximity to domestic poultry, share farmland associated with poultry production or may share wetlands with domestic poultry; the species are also ranked by probability of contact with poultry (Commi ssion Decision 2007/268/EC).

HPAI H5N1 infection in wild birds spread from Asia to the European continent by the middle of January 2006. The potential for spr ead to the Czech Republic and Sweden was foreseen due to prior findi ngs in neighboring regions and surveillance was intensified. During 2006 there were 748 positive identifications of HPAI H5 N1 in wild birds in the entire EU; 200 in February, 362 in Ma rch, 162 in April and 18 in May [1].

In 2006 the Czech Republic surveillance meas ures, as reported in Animal Disease Notification System (ADNS) (see below), repor ted 14 incidents of HPAI H5N1 in wild birds, with the last one reported on May 22. In 2007, HPAI H5N1 was reported in wild
birds as well as the four incidents in domestic poultry. In 2008 the Czech Republic reported no incidents of HPAI in eith er wild birds or domestic poultry.

In 2006, Sweden reported the si ngle occurrence of HPAI H5N1 in domestic poultry on a mixed species holding in Gässhult during Ma rch. Between February and April, 2006,
HPAI H5N1 was detected in 64 wild birds a nd 3 wild minks in 16 locations from a total of 508 samples tested. Although surveillan ce was conducted throughout the country the positive isolations were primarily along the south east coast of Sweden. In 2007 and 2008

16APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

there were no positive identifications of HPAI H5N1 in Sweden in either wild birds or domestic poultry.

Conclusion: APHIS concludes that the existing su rveillance program for HPAI H5N1 was appropriate for the detection the presence of HPAI effectively and quickly, even in the absence of clinical signs. The surveillance was adequate to indica te that no additional outbreaks of HPAI H5N1 had occurred in domestic poultry in either the Czech Republic
or Sweden.

Under the surveillance program, all notified and/or suspected avian influenza cases were investigated, and officials took appropria te actions including collecting samples, transporting these samples in a manner that ensured their in tegrity for testing purposes, and documenting subsequent laboratory results.

Council Directive 2005/94/EC requi res the establishment of a protection zone following the identification of HPAI (H5 or H7) in domestic poultry. A census of all the poultry holdings in zone made as soon as possible and visits by the official veterinarian to all commercial holdings for clinical examination of the poultry and othe r captive birds with collection of samples for laboratory tests, as necessary. Non-commerci al holdings in the protection zone are also visi ted by an official veterinari an before the lifting of the protection zone. Surveillance in the restriction zones is immediately implemented to identify any further spread to the ho ldings located in the protection zone.

Commission Decisions 2006/115/ EC and 2006/135/EC established EU-wide measures following the finding of HPAI H5NI in wild birds. This measure replaced the interim protection measures applied shortly after HPAI H5NI first entered the EU to apply the necessary protection measures appropriate to the epidemiological situation and to prevent that disease from spreading from w ild birds to poultry. Commission Decision 2006/115/EC requires the establishment of prot ection (3 km) and surveillance zones (10 km) around the place where the disease was detected in wild birds to prevent virus
introduction into commercial and noncomme rcial poultry flocks. These zones are based on geographical, administrative, ecological a nd epidemiological factors and may include the territory of adj acent MS. Housing or confinement of the poultry in these zones is required to prevent direct and indirect cont act between wild birds and poultry or captive
birds.

Conclusion: APHIS concludes that the surveillan ce program implemented by the Czech Republic and Sweden following the identification of HPAI H5N1 in their domestic poultry were comprehensive and able to dete ct the presence of HPAI H5N1in domestic poultry. The system in place was able to inve stigate all notified and/or suspected avian influenza cases and provide the necessary diagnostic support to verify the eradication of HPAI H5NI in domestic poultry in both of these regions. The effectiveness of the eradication program was mainly due to th e prompt actions taken by the veterinary authorities in the Czech Republic and Sweden with the cooperation of backyard and
commercial flock owners.

17APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

The system for recording, managing, and an alyzing diagnostic and surveillance data was sufficient to demonstrate the effectiven ess of the disease co ntrol measures in t he Czech Republic and Sweden.

The Czech Republic, Sweden and other EU MS have several mechanisms to record and manage surveillance data, including the An imal Disease Notification System (ADNS) and the Trade Control and Expert System (TRACES). ADNS was established by Council
Directive 82/894/EC and updated by Commission Decisi on 2005/176/EC, records and reports outbreaks of notifiable animal diseas es in the EU-MS and other participating countries including Turkey, Iceland, the Fa roe Islands, Andorra, and Switzerland. ADNS provides a reporting system for documenting i ndividual outbreaks of notifiable animal diseases which automatically forwards information on primary outbreaks to the EC
within 24 hours of identificati on and weekly for secondary outbreaks. The information is posted on the internet with maps updated w eekly showing the location of the outbreaks and summary data. In 2006, ADNS registered a total of 3787 notif ications, 1005 in 2005, and 1850 notifications in 2004, covering all repo rtable animal diseases and species.

TRACES is a centralized database to ensure the control and traceability of animals and animal products moving within the EU. The syst em provides electronic certification, data
retrieval and central statistical information for imports of animals and animal products
and allows for the issuance of central risk assessments and warnings. TRACES provides a platform for updated information on disease alerts to be instantly available. EC measures in place for the control of avian influenza in Council Directive 2005/94/EC requires maintaining records of all visits by th e official veterinarian s in protection zones which are specifically supporte d by Commission Decisions.

Conclusion: APHIS concludes that the system in place in the Czech Republic, Sweden and the EU for recording, managing, and anal yzing diagnostic and surveillance data was
sufficient to demonstrate the effectiveness of the Czech Republic’s and Sweden’s HPAI
H5NI disease control measures.

Laboratory confirmation capabili ties were effective, and testing procedures were documented and standardized.

The EU has in place comprehensive requi rements for the laboratory confirmation procedures for HPAI H5NI, put in place in Council Directive 92/40/EEC and updated in great detail in Council Direc tive 2005/94/EC. The National Re ference Laboratory in the Czech Republic is the National Reference Labo ratory for Newcastle Disease and Highly Pathogenic Avian Influenza (Statni veterina rni ustav, Praha) in Prague. The National Reference Laboratory in Sweden is Na tional Veterinary Institue (Statens Veterinärmedicinska Anstalt (SVA)) in Uppsal a. The laboratories perform the virological diagnostic analyses for AI, including HPAI H5NI in compliance with Council Directive 2005/94/EC. The EU reference laboratory is the Weybridge laboratory in the United Kingdom, which also serves as an OIE reference laboratory for HPAI.

18APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

Conclusion: APHIS concludes that the Czech Republic and Sweden have the laboratory capabilities to diagnose avian influenza as part of an effective local, national and EC laboratory system with appropriately standard ized testing and documentation procedure.

Emergency control, biosecurity procedures and eradication progr am: The eradication program included the definition of appropriate quarantine and surveillance zones, monitoring of those zones, and implementation of movement restrictions. Measures taken by officials were able to contain an d control the spread of disease from these zones due to effective progr am measures. Procedures for lifting quarantines were followed and were sufficient to pr event further spread of disease.

Commission Decision 2004/402/EC requires all MS to maintain approved contingency plans for the control of avian influenza a nd Newcastle disease. Under Council Directive 2005/94/EC each Member State is required to develop and maintain a contingency plan which is periodically reviewed and updated at least every five years. The plan must specify the national measures to be implemented in the event of an outbreak including the
establishment of a crisis centre at the national level to coordinate all control measures in
the individual MS.

Additional components of the contingency plan must include: establishment of local disease control centers with adequate staff, facilities and resource to coordinate local disease control measures; make available equi pment and materials to effectively carry out the disease control measures; training progr ams for field and administrative personnel; ensuring that diagnostic laboratories have the necessary testing capacity and sample handling to ensure rapid diagnosis; maintain registration of commerci al poultry holdings with identification of areas with a high dens ity of poultry. The plan must also provide for diagnostic laboratory support and cooperati on with the OIE and Food and Agriculture Organization of the United Nations (FAO) refe rence laboratories for avian influenza. The EC reviews and approves all contingency plans to determine that they are adequate and has the authority to suggest a ny necessary amendments required to ensure that they are compatible with those of the other MS.

Protection and surveillance zones are esta blished around areas where HPAI H5N1 is detected in wild birds in complian ce with Commission Decision 2006/115/EC. The protection zone established due to findings of HPAI H5N1 in wild birds can be lifted no earlier than 21 days after the bird was received at the labo ratory for analysis. Under EC regulation the earliest that pr otection zones can be lifted is 21 days after completing the cleaning and disinfection of the infected fl ock of domestic poultry. All poultry flocks within the zone, including b ackyard and hobby flocks, must be visited before lifting the protection zone. A surveillance zone can be lifted 30 days af ter the cleaning and
disinfection of the infected flocks has been completed.

No further outbreaks in domestic poultry have since been reported in the Czech Republic or Sweden, despite extensive surveillance in both the wild and domestic bird populations.

Conclusion : APHIS concludes that the emergency controls, biosecurity procedures, and eradication procedures were ad equate to contain and control the spread of disease. The Czech Republic and Sweden put in place appr opriate quarantine and surveillance zones,

19APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

with monitoring adequate to detect the presence of HPAI H5N1 if it were present. The measures taken by veterinary officials befo re lifting quarantines were sufficient to prevent further spread of disease.

Documented standard operating procedures described procedures for depopulation, cleaning, disinfecting, and other applicable me asures, such as carcass disposal. All relevant personnel were familiar with these standard procedures and followed them during the outbreak. These measures were effective in cont rolling the disease. Premises repopulation, if applicable, wa s carried out according to documented procedures, including evidence that the disease did not recur and monitoring after repopulation to demonstrate that the disease was eradicated.

Measures for cleaning and disinfection of the HPAI H5N1 infected holdings are carried out under official supervision in complia nce with Council Dir ectives 92/40/EC and 2006/563/EC. Council Directive 2005/94/EC provi des a comprehensive set of criteria under which repopulation of holdings can occu r. Repopulation can not take place for a period of 21 days following the date of comp letion of the final cl eaning and disinfection. Poultry on the repopulated premises undergo at least one clinical examination by an official veterinarian with routine laboratory testing and mandatory testing of all poultry that die during the repopulation phase. The owner is required to keep records of production data, including morbidity and mo rtality data, immediately reporting any significant change or abnormalities to the competent authority. The newly repopulated facility is monitored for compliance with appropriate biosecurity measures. No commercial poultry can leave th e holding without the author ization of the competent authority.

Conclusion: Standard operating procedures for depopulation, cleaning, disinfecting, carcass disposal and repopulation were in place and would have been conducted under official supervision during the outbreak. AP HIS concludes that these measures were effective in controlling the disease.

R ISK FACTORS APPLICABLE TO THE C ZECH R EPUBLIC AND S WEDEN The occurrence of the HPAI H5N1 outbr eaks the Czech Republic (2007) and Sweden (2006), posed a risk to the United States fr om export of live birds, poultry, parts or products of poultry carcasses, and eggs of pou ltry, game birds or other birds exported to
the United States. While eradication of dis ease should mitigate immediate risk from the outbreaks that occurred, rein troduction of disease into domestic poultry remains a concern when HPAI H5N1 is present in wild or migratory bird populations. However, the response to these HPAI H5N1 outbreaks demonstr ates that veterinary authorities in the Czech Republic and Sweden have adequate cont rol measures in place to rapidly identify,
control and eradicate the disease should it be reintroduced into the Czech Republic or Sweden in either wild birds or domestic poultry.

APHIS cites the following factors as relevant to the situation in the Czech Republic and
Sweden:

20APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

• The presence of HPAI H5N1 in wild birds represents a high risk for the
reoccurrence of the disease in domestic poultry. Ongoing surveillance programs n the EU for wild birds are in place to de tect the present of the disease should it reoccur. The veterinary authorities in the Czech Republic and Sweden recognized wild birds as the major pathway of in troduction of HPAI and had in place an adequate and appropriate surveillance syst em for the detection of the presence of
HPAI in wild birds.

• The veterinary authorities in the Czec h Republic and Sweden were able to effectively control and eradicate the HP AI H5N1 outbreaks in domestic poultry as a result of an effective eradication pr ogram and prompt actions taken with the cooperation of backyard and co mmercial flock owners. .

• From the time the presence of HPAI H5N1 was first confirmed in wild birds, the Czech Republic and Sweden authorities have conducted an extensive surveillance program in w ild birds and domestic pou ltry. No other flocks of poultry were found to be infected with HP AI H5N1 and no restriction zones have been put in place for the presence of HPAI H5N1 since the last zones were lifted in the Czech Republic in 2007 and Sweden in 2006.

With the successful eradication of HPAI H5 N1 following the HPAI H5N1 outbreaks in Sweden and the Czech Republic, and the subsequent measures implemented in response to those outbreaks, APHIS could identify no addi tional risk factors curr ently applicable to the Czech Republic and Sweden that would justify not removing the regions in the Czech Republic and Sweden from the APHIS of Countries/Regions Af fected with Highly Pathogenic Avian Influenza subtype H5N1.

R ISK E STIMATION AND C ONCLUSION With the successful eradication of HPAI H5 N1 following the HPAI H5N1 outbreaks in Sweden and the Czech Republic, and the subsequent measures implemented in response to those outbreaks, APHIS could identify no addi tional risk factors curr ently applicable to the Czech Republic and Sweden that would justify not removing the regions in the Czech Republic and Sweden from the APHIS of Countries/Regions Af fected with Highly Pathogenic Avian Influenza subtype H5N1. Fo r the Czech Republic the specific regions (kraj) are Kralovehradecky and Pardubicky, a nd for Sweden the specified region is the Län (County) of Kalmar.

The Czech Republic and Sweden were able to rapidly identify, control and successfully eradicate HPAI H5N1 following the outbreaks in domestic poultry. The Czech Republic and Sweden have in place adequate surveillanc e measures to indicate that the disease has
not reoccurred in either w ild or domestic bird populati on. In addition, APHIS considers
that if there is a reintroduc tion, the Czech Republic and Sweden would be able to rapidly identify, control and eradicate the disease.

APHIS concludes that there ex ists a likelihood of reintroducti on of HPAI H5N1 into the Czech Republic’s or Sweden’s poultry populatio n when HPAI H5N1 is present in the wild or migratory bird populations. However, in consideration of the quick and decisive action undertaken by the veterinary author ities of the Czech Republic and Sweden

21APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

following the identification of HPAI H5N1 in wild birds in the Czech Republic and Sweden and its neighboring countries, the m easures implemented, and the high level of awareness and cooperation from poultry keep ers in the Czech Republic and Sweden, APHIS concludes that, if reintroduced, spread of HPAI in the Czech Republic or Sweden
would be limited.

APHIS considers the risk of introducing HPAI H5N1 into the United States from the import of live birds, poultry carcasses, part s or products of poultry carcasses, and eggs (other than hatching eggs) of poultry, game bi rds or other birds from the Czech Republic
and Sweden to be low.

R EFERENCES

1. ADNS (2009). Animal Disease Notification System of the European Commission Available at: http://ec.eu ropa.eu/food/animal/disea ses/adns/index_en.htm or http://ec.europa.eu/food/animal/diseases/adns/adns_en.htm

2. APHIS (2009) APHIS’ Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Saxony, Germany. February 2009 Notice of Availability, published June 12, 2009; 74FR 28008,

3. APHIS (2009) Evaluation of the Highly Pa thogenic Avian Influenza H5N1 Status of Suffolk and Norfolk Counties, Engl and. January 2009. Notice of Availability published May 7, 2009; 74 FR 21312.

4. APHIS (2008) APHIS’ Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Germany. October 2008. Notice of Availability published January 2, 2009; 74 FR 69. Notice of Determination published June 5, 2009; 74 FR 274.

5. APHIS (2008) APHIS’ Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Hungary. November 2008. Notice of Availability published June 15, 2009; 74 FR 28217.

6. APHIS (2009) APHIS’ Evaluation of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Pola nd. October 2008. Notice of Availability published January 2, 2009; 74 FR 69. Notice of Determination published June 5,

2009: 74 FR 274.

7. APHIS (2007) APHIS Analysis of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in Denmark. December 2007. Notice of Determination published July 21, 2008; 73FR 42313. Preceded by Notice of Availability published March 27, 2008; 73 FR 16245.

22APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

8. APHIS (2007) APHIS Analysis of the Status of High Pathogenicity Avian Influenza H5N1 (HPAI H5N1) in France. December 2007. Notice of Determination published July 21, 2008; 73FR 42313. Preceded by Notice of Availability published March 27, 2008; 73 FR 16245.

9. APHIS (2007) Importation of Live Swine, Swine Semen, Pork and Pork Products from the Czech Republic, Latvia, Lithua nia and Poland. Final Rule. Published November 28, 2007: 72 FR 67227.

10. APHIS (2006) Add Kazakhstan, Romania, Russi a, Turkey, and Ukraine to List of Regions in Which Highly Pathogenic Avian Influenza Subtype H5N1 Is
Considered To Exist. Interim rule an d request for comments published February 13, 2006: 71 FR 7401; affirmed on May 18, 2006 in 71 FR 28763.

11. APHIS (2006) APHIS Evaluation of the St atus of the Czech Republic Regarding
Classical Swine Fever and Swin e Vesicular Disease. April 2006.

12. APHIS (2005). APHIS Considerations on th e Identification of Administrative Units for (AU) Certain Member Stat es of the European Union. June 2005

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

14. APHIS (2003). Recognition of Animal Diseas e Status of Regions in the European Union; Final Rule. Published April 7, 2003: 68 FR 16922

15. European Commission (2009) Avian Infl uenza Chronology Situation as of 18 May 2009 and List of Decisions Adopt ed by the European Commission 2008. DG Health and Consumer Protection, Unit D1: Animal Health and Standing
Committees.

16. European Commission (2007). Avian Influe nza Extensive Chronology and List of Decisions Adopted by the European Co mmission 2007. DG Health and Consumer Protection, Unit D1: Animal Hea lth and Standing Committees.

17. European Commission (2006) Avian Influe nza Extensive Chronology and List of Decisions Adopted by the European Comm ission in 2006; Part II - Including
overview of events in 2004-2005 with Res ponse to Outbreaks in Member States
and third countries. DG Health and Consum er Protection, Unit D1: Animal Health and Standing Committees.

18. FVO Report (2008). DG/SANCO/7705/2008. C ountry Profile of Sweden on food and feed safety, animal health, animal welfare and plant health. Available at: http://ec.europa.eu/f ood/fvo/ir_search_en.cfm.

23APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

19. FVO Report (2006). DG/SANCO/8207/2006. Country Profile of the Czech Republic on food and feed safety, animal h ealth, animal welfare and plant health. Available at: http://ec.europa .eu/food/fvo/ir _search_en.cfm.

20. OIE (2009) weekly disease informa tion update archive; available at: http://www.oie.int/eng /info/hebdo/a_csum.htm

21. OIE (2008). Terrestrial An imal Health Code, 14th edition. Paris, World Organization for Animal Health. Available at: http://www.oie.int/eng/norme s/mcode/en_sommaire.htm

22. SCOFCAH Animal Health and Animal We lfare meeting presentations, available

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

m

23. Swedish Board of Agriculture (2009). Highly pathogenic avian influenza (HAPI) H5N1 status of Sweden; clar ification of freedom regard ing avian influenza (AI) in Sweden. Correspondence, dated July 13, 2009, from Dr. Leif Denneberg, Sweden’s Chief Veterinary Officer To Dr. John Clifford.

24APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

Appendix A: Summary of selected EU Co uncil Directives and Council Decisions applicable to avian influenza control.

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
92/40/EEC Council Directive 92/40/EEC of 19 May 1992 introducing Community measures for the cont rol of avian influenza, as amended for the accession of Norway, Austria, Finland and Sweden, Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia

Council Directive
91/496/EEC Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organiza tion 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
90/539/EEC Council Directive of 15 October 199 0 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs

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

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

Commission

Decision Full Title

Commission

Decision
2007/598/EC Commission Decision of 28 August 2007 concerning measures to prevent the spread of highly pa thogenic 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 prot ection measures in relation to highly pathogenic avian influenza of the subtype H5N1 in poultry in the Community

Commission

Decision
2007/434/EC Commission Decision of 21 June 2007 amending Decision 2006/415/EC concerning certain prot ection measures in relation to highly pathogenic avian influenza of the subtype H5 in poultry in the Czech Republic

Commission

Decision
2007/268/EC Commission Decision of 13 April 2007 on the implementation of surveillance programs for avian infl uenza in poultry and wild birds
to be carried out in the Member States and amending Decision
2004/450/EC

Commission

Decision
2007/24/EC Commission Decision 2007/24/EC of 22 December 2006 approving contingency plans for the control of avian influenza and
Newcastle disease

25APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

Commission

Decision
2006/293/EC Commission Decision of 12 Apr il 2006 amending Commission Decision 2006/135/EC as regarding the establishment of areas A
and B in certain Member Stat es due to outbreaks of highly pathogenic avian influenza (Germany and Sweden).

Commission

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

Commission

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

Commission

Decision
2006/474/EC Commission Decision of 6 July 2006 concerning measures to prevent the spread of highly pa thogenic avian influenza caused by influenza A virus of subtype H5N1 to birds kept in zoos and approved bodies, institutes and cen tres in the Member States and repealing Decision 2005/744/EC

Commission

Decision
2006/405/EC Commission Decision of 7 J une 2006 amending Decisions 2005/710/EC, 2005/734/EC, 2005/758/EC, 2005/759/EC, 2005/760/EC, 2006/247/EC and 2006/265/EC as regards certain protection measures in relati on to highly pathogenic avian
influenza

Commission

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

Commission

Decision
2006/293/EC Commission Decision of 12 Apr il 2006 amending Commission Decision 2006/135/EC as regarding the establishment of areas A
and B in certain Member Stat es due to outbreaks of highly pathogenic avian influenza

Commission

Decision
2006/135/EC Commission Decision of 22 February 2006 concerning certain protection measures in relati on to highly pathogenic avian influenza in poultry in the Co mmunity; repealed by 2006/415/EC

Commission

Decision
2006/115/EC Commission Decision of 17 Febr uary 2006 concerning certain protection measures in relati on to highly pathogenic avian
influenza in wild birds in the Community and repealing Decisions 2006/86/EC, 2006/90/EC, 2006/91/EC, 2006/94/EC, 2006/104/EC
and 2006/105/EC

Commission

Decision
2006/101/EC Commission Decision of 6 Febr uary 2006 on the implementation of survey programs for avian influe nza in poultry and wild birds to
be carried out in the Member States in 2006.

Commission

Decision 2005/855/EC; Commission Decision of 30 N ovember 2005 amending Decision 2005/734/EC laying down biosecurity measures to reduce the risk of transmission of highly pathoge nic avian influenza caused by Influenza virus A subtype H5N1 fr om birds living in the wild to poultry and other captive bird s and providing for an early detection system in area s at particular risk.

26APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

Commission

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

Commission

Decision
2005/734/EC Commission Decision 2005/ 734/EC of 19 October 2005 laying down biosecurity measur es to reduce the risk of transmission of highly pat hogenic avian influenza caused by influenza virus A subtype H5N1 from birds living in the wild to poultry and othe r captive birds and providing for an early detection system in ar eas at particular risk (valid until December 31, 2009).

Commission

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

programs. Commission

Decision
2005/731/EC Commission Decision 2005/731/EC of 17 October 2005 laying down additional requirements fo r the surveillance of avian
influenza in wild birds

Commission

Decision
2005/464/EC Commission Decision 2005/464/EC of 21 June 2005 on the implementation of survey program s 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 implementati on of Member States' surveys for avian influenza in poultr y and wild birds during 2004 and laying down reporting and eligibil ity rules for the financial contribution from the Community to the implementation costs of those programs. [amended by 2004/679/EC on 5 October 2004]

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

Commission

Decision
2004/402/EC Commission Decision of 26 April 2004 approving contingency plans for the control of avian influenza and Newcastle disease.

Commission

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

Commission

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

27APHIS Analysis of the Status of High Pathogenicity Av ian Influenza H5N1 (HPAI H5N1) in the Czech Republic
and Sweden

28 Commission

Decision
2002/673/EC Decision 2002/673/EC of 22 Augus t 2002 approving the programs for the implementation of Member States' surveys for avian influenza in poultry and wild birds.

Commission

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