United States Department of Agriculture

Marketing and Regulatory Programs

Animal and
Plant Health Inspection
Service 

# Proposed Rulemaking
for the Status of the European Union Regarding Virulent (Exotic) Newcastl e Disease (END) and Highly Pathogenic Avian Influenza (HPAI)

Environmental Assessment, July 2010

# Proposed Rulemaking for the Status of the European Union Regarding Virulent (Exotic) Newcastle Disease (END) and Highly Pathogenic Avian Influenza (HPAI)

Environmental Assessment, July 2010

Agency Contact for the Proposed Rulemaking Mr. Javier Vargas Case Manager

Nat ional Center for Import and Export Veterinary Services Animal and Plant Health Inspection Service U.S. Department of Agriculture 4700 River Road, Unit 38 Riverdale, MD 20737

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– 5964 (voice and TDD). USDA is an equal opportunity provider and employer.

## Table of Contents

I. Need for the Proposed Action

............................................... 1

II. Alternatives

............................................................................. 2

III. Potential Environmenta l Impacts

.......................................... 5

IV. Agencies Contacted

............................................................ 19

V. References

............................................................................ 20

Appendix A . Threatened and Endangered Birds Federally
Listed in the United States and Its Territories1 

## I. Need for the Proposed Action

The United States Department of Agriculture (USDA) , Animal and Plant Health Inspection Service (APHIS) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases. APHIS’ regulations allow for the importation of live birds and poult ry (including hatching eggs), poultry

meat and poultry products from regions considered as free of or low risk

for virulent (Exotic) Newcastle Disease ( END ) and Highly Pathogenic

Avian Influenza ( HPAI ) under specified conditions. APHIS evaluated the

END a nd HPAI risk associated with importation into the United States of

live birds and poultry (including hatching eggs ), poultry meat and poultry products from the 25 Member States of the European Union (EU) which constituted the EU in the year 2006, collectiv ely referred to as the European Union-25 1 (EU -25).

APHIS’ evaluation of the EU -25 found that this region meets the requirements for being recognized as a region free of END and HPAI. The proposed action is needed to allow the importation of live birds and poultry (including hatching eggs), poultry meat and poultry products from

the EU -25 because there is no scientific basis for trade restriction. Allowing the trade of these commodities would be consistent with internationally recognized standards as found in the 2009 World Organization for Animal Health (commonly referred to as the Office of International des Epizooties (OIE)) Terrestrial Animal Health Code for

END (10.13 ) and HPAI (10.4) (OIE , 2009 a; OIE, 2009b).

In response to this proposed rule ame ndment, APHIS analyzed the potential disease risks (in “APHIS Risk Considerations on Importation of Highly Pathogenic Avian Influenza (HPAI) and Virulent (Exotic) Newcastle Disease (END) Virus from a European Union Region of Twenty

- five Member States” (USD A– APHI S, 2009)) and environmental effects associated with this action. This environmental assessment (EA) addresses potential environmental impacts related to the amendment of APHIS’ regulations to include the EU -25 as a region free of END and

HPAI with r egard to the importation of live birds and poultry (including hatching eggs ), poultry meat and poultry products from that region to the

United States.

This EA has been prepared to comply with the provisions of the National Environmental Policy Act of 1969 (NEPA) (42 United States Code (U.S.C.) 4321, et. seq.) as prescribed in implementing regulations adopted

1 European Union

- 25 (EU

- 25) was defined as including the Member States: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.2 by the Council on Environmental Quality ( Title 40 Code of Federal Regulations (CFR) §§ 1500–1508), USDA’s NEPA regulations (7 CFR part 1b), and APHI S’ NEPA implementing procedures (7 CFR part 372). The Council on Environmental Quality NEPA implementing regulations require s that environmental documents are made available to agencies and persons who may be interested or affected.



## II. Alternatives

The two alternatives considered in this EA include: (1) the no action alternative in which the current regulations would remain unchanged, continuing to omit the EU -25 from the list of regions considered as free of

END and HPAI , and, therefore, would not allow the importation of live birds and poultry (including hatching eggs ), poultry meat, and poultry products from that region to the United States ; and (2) the rule amendment of 9 CFR part 94, which would designate the EU -25 as free of END and

HPAI and would, therefore, allow the importation of live birds and poultry (including hatching eggs ), poultry meat, and poultry products from the

EU -25 under certain conditions.



### A. No Action

Currently , APHIS regulation (9 CFR § 94.6) restricts the importation of poultry carcasses, meat, parts or products of poultry carcasses, and eggs (other than hatching eggs) into the United States from regions where END or any subtype of HPAI is considered to exist, allowing only cooked products or consignment directly to an approved esta blishment in the

United States. Th ese conditions were considered to present a low disease

risk with negligible environmental effects (USDA –APHIS, 2009).

APHIS regulations for the importation into the United States

, from regions

where END or H PAI is considered to exist, allow importing poultry carcasses and parts and products of poultry carcasses only if they have been cooked throughout to reach a minimum int ernal temperature of

74 o C. In regions where HPAI is considered to exist, APHIS requi res that carcasses and parts or products of carcasses, including meat, of 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 we re cooked to this specification (USDA– APHIS, 2009).

Carcasses of game birds may not be imported from regions where any subtype of HPAI is considered to exist, except for those consig ned to a museum, educational institution or other establishment which has3 provided evidence that it has the equipment, facilities, and capabilities to store, handle, process, or disinfect such articles so as to prevent the

introduction or dissemination of HPAI into the United States, as approved by the Administrator (USDA –APHIS, 2009).

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) the eggs are acco mpanied by a health certificate regarding the flock of origin , and meet certain other conditions; (2) the eggs are consigned directly to an approved establishment for breaking and pasteurization; (3) the eggs are imported under permit for scientific, educational, or research purposes; or (4) the eggs are imported under permit and have been cooked or processed and will be handled in a manner that prevents the

introduction of END into the United States.

Table eggs from END- affected regions may only enter the United States if accompanied by official certification verifying that—

**•** the flock was visited within the last 90 days,

**•** the eggs were packed and sealed

,

**•** the cull birds were tested , and

**•** there is no indication of the presence of the disease within

50 kilometer (km) for the last 90 days (USDA –APHIS, 2009).

Recently , APHIS added an alternative pathway for the importation of table eggs from regions where END is considered to exist based on testing and certification by the competent national veterinary authority. The certification must state that within the last 90 days the flock -of-origin was inspected and no evidence of communicable diseases of poultry was found, and that the eggs were packed and sealed with a seal of the competent veterinary authorit y. Certification must also be made that the

flock of origin of the eggs was free of END based on a testing regimen using virus isolation from cull birds, and verification that the weekly cull rate did not exceed 0.1 percent. Egg drop syndrome must be a n otifiable disease in the region of origin

, and certification must indicate that in the past 90 days there were no reports of egg drop syndrome in the flock(s) of origin or within a 50-km radius of the flock of origin (USDA– APHIS, 2009).

Legal entry of live birds into the United States is allowable under permit and controlled through existing quarantine and testing measures in quarantine facilities operated or approved by APHIS (9 CFR 93.205). In addition, live birds or poultry, including hatching eggs, mu st be4 accompanied by official certification that, as far as it has been possible to determine, during the 90 days prior to movement, the poultry were not exposed to communicable diseases of poultry, including END and HPAI, and the premises were not within a quarantine area for such disease. The birds must not be vaccinated with a vaccine for the H5 or H7 subtype of avian influenza or transit regions where END or HPAI of any subtype is

considered to exist or where vaccination for H5 or H7 subtypes of AI is

used for disease control. All birds are subject to appropriate testing for END and HPAI prior to their release from quarantine (USDA

– APHIS, 2009).

It must also be certified that the hatching eggs were not derived from birds

vaccinated for either H5 or H7 subtypes of AI. Hatching eggs from regions not designated in 9 CFR 94.6 as free of END and HPAI must be quarantined upon arrival. Imported hatching eggs are required to be transported from the port of entry to the hatchery in a vehicle sealed by USDA, and hatched and brooded under the supervision of the Area Veterinarian in Charge (AVIC) in the State of destination. The poultry hatched from these eggs must remain in quarantine for at least 30 days following hatching. The hatchery must meet specific biosecurity standards, and be inspected and approved by the AVIC prior to issuance of the import permit. During quarantine, the hatching eggs and poultry from such eggs are subject to inspection and diagnostic testing to verify that they are free of END and HPAI. Hatching eggs from regions APHIS considers free of END and HPAI must be accompanied by official

certification , but do not undergo quarantine (USDA

– APHIS, 2009).

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.

C ertification includes statements that the flock of origin was free of

communicable disease , and the premises w ere not in an area under

quaran tine (USDA –APHIS, 2009).

The no action alternative would leave the current importation regulations unchanged. Under this alternative, the EU -25 would continue not to be listed as a region free of END and HPAI and, therefore, would not be allowed to expor t live birds and poultry (including hatching eggs ), poultry

meat , and poultry products to the United States. The status in the EU -25

as free of END and HPAI is not reflected in the current import regulations. The continuance of such unsupported trade restrictions would be contrary to U.S. obligations under international trade agreements.



### B. Proposed Rule Amendment

APHIS –V eterinary S ervices (VS) evaluated the risk of END and HPAI5 from the EU - 25. Based on our evaluation of representative Member

States and the European Commission regulation and implementation

, APHIS is proposing to recognize the EU-25 as free of both END and

HPAI. APHIS is now proposing to recognize the EU-25 as a single region for which import requirements will be uniformly applied in the EU Poultry Trade Region (USDA –APHIS, 2009). The region contains all of the European Union (EU) Member States (MS) which constituted the EU in the year 2006 that we collectively refer to as the European Union-25 (EU

25).

APHIS based th e evaluation of the END and HPAI status of the EU-25 on the performance measures found in Title 9 CFR 92.2 using the documentation submitted by the European Commission (EC), Food and Veterinary Office reports, EC legislation, reports to World Organization for Animal Health (OIE) and the site visit. The April 2008 VS site visit to the EC in Brussels and five representative EU Member States (Cyprus, Denmark, Germany, the Netherlands and Poland) was conducted to evaluate their avian disease status and how uniformly EC legis lation is implemented an d enforced throughout the EU- 25 (USDA –APHIS, 2009).

The rule amendment alternative would amend the current regulations to

add the EU -25 to the list of region s APHIS considers as free of END and

HPAI . In doing so, this alternative would allow the importation of live birds and poultry (including hatching eggs ), poultry meat, and poultry products under specified conditions from the EU -25. The rule amendment

would add the EU -25 to the list of E ND - and HPAI- free regions in

9 CFR 9 4.6 and apply the movement restrictions found in 9 CFR 92.3.

Title 9 CFR 92.3 recognizes the quarantine measures and movement restrictions implemented by the EC for certain diseases , and bans the importation into the United States of animals and animal produ cts that are prohibited movement in the EU as a result of the quarantine (USDA

– APHIS, 2009).



## III. Potential Environmental Impacts

The diseases of concern , with regard to allowing the importation of live birds and poultry (including hatching eggs ), po ultry meat and poultry products from 25 Member States of the EU, are END and HPAI. APHIS prepared a risk assessment, “APHIS Risk Considerations on Importation of Highly Pathogenic Avian Influenza (HPAI) and Virulent (Exotic) Newcastle Disease (END) Virus from a European Union Region of Twenty

- five Member States ,” to evaluate the risk of both END and HPAI

introduction to the United S tates as a result of allowing importation of

these commodities from the EU

- 25 (USDA –APHIS, 2009). APHIS

evaluated the status of the EU -25 with regard to its infrastructure and6 control measures in place for these diseases, including an assessment of disease surveillance measures, import practices, laboratory capacity, emergency response procedures, and other factors that could in fluence the

risk of disease introduction into the United States.

APHIS concluded that the overall risk of introducing either END or HPAI into the United States through the import of live birds, poultry carcasses, parts or products of poultry carcasses, and eggs of poultry, game birds, or other birds from the EU-25 to be extremely low. However, APHIS recognizes that limited END and HPAI outbreaks are likely to continue to

occur in the region

. Therefore, APHIS intends to apply the conditions

found in 9 CFR 92.3 in the event of future outbreaks of either END or

HPAI in the “APHIS -defined poultry trade area.” The restriction areas will include all protection, surveillance , and buffer zones established around END or HPAI outbreaks in domestic poultry, and the infected

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). APHIS will require the competent veterinary authority of the individual EU-25 Member State to certify that the live birds or poultry, including hatching eggs, exported to the United States, or the poultry from which exported poultry meat and poultry products originated in the EU-25 and had never resided in a region under

restrictio ns for the presence of END or HPAI in domestic poultry for the last 90 days. In the case of movement restrictions put in place following the detection of END or HPAI in wild birds or domestic (racing) pigeons, APHIS will recognize the duration of restrict ions as imposed by the EC upon the infected zone (USDA –APHIS, 2009).



### A. Background

E ND is caused by an avian paramyxovirus. Paramyxoviruses isolated from avian species have been classified by serological testing into nine serotypes designated APMV -1 through APMV -9; N ewcastle disease virus (NDV) has been designated APMV -1. Since its recognition in 1926, E ND is regarded as being endemic in many countries. Prophylactic vaccination is practiced in all but a few of the countries that produce poultry on a

commercial scale ( OIE , 2002a; OIE , 2009b; OIE , 2009d).

NDV can be a human pathogen causing transient, usually localized infections. Reported infections have been non- life threatening and usually not debilitating for more than a day or two. The most freq uently reported and best substantiated clinical signs in human infections have been eye infections, usually consisting of unilateral or bilateral r eddening, excessive tear production, edema (abnormal accumulation of fluid beneath the skin) of the eyelids, conjunctivitis (swelling, inflammation, or infection of the membrane lining the eyelids) , and sub-conjunctival hemorrhage (bleeding7 underneath the eye). Although the effect on the eye may be quite severe, infections are usually transient and the cornea is not affected. Reports of other clinical symptoms in humans infected with NDV are less well substantiated, but suggest a more generalized infection may sometimes occur resulting in chills, headaches, and fever, with or without conjunctivitis. There is ev idence 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 (OIE, 2009d).

Avian influenza (AI) is caused by infection with viruses of the family Orthomyxoviridae, placed in the genus influenzavirus A. Influenza A viruses are the only orthomyxoviruses known to affect birds and m any species of birds have been shown to be susceptible to infection with influenza A viruses. Aquatic birds are a major natural reservoir of these viruses, but the overwhelming majority of isolates have been of low pathogenicity for chickens and turkeys. Influenza A viruses are classified into subtypes on the basis of their haemagglutinin (H) and neuraminidase (N) antigens. At pre sent, 16 H subtypes (H1–H16) and 9 N subtypes (N1– N9) are recognized . To date, the highly virulent influenza A viruses that produce acute clinical disease in chickens, turkeys, and other birds of economic importance have been associated only with the H5 and H7 subtypes ; h owever, m ost viruses of H5 and H7 subtype isolated from birds have been of low virulence for poultry. Due to the risk of a H5 or H7 virus of low virulence becoming virulent by mutation, all H5 and H7

viruses have been identified as notifiable avian influenza ( NAI ) viruses (OIE, 2009a).

Depending on the species, age, specific characteristics of the viral strain involved, environmental factors and co

- infection , the highly pathogenic disease, in fully susceptible birds, may vary from one of sudden death with little or no overt clinical signs to a more characteristic disease with variable clinical presentations including respiratory signs, such as eye and nasal discharges, coughing, and dyspnea (difficult breathing) , swelling of

the sinuses an d/or head, apathy, reduced vocalization , marked reduction in feed and water intake, cyanosis (discoloration of skin) of the unfeathered skin, wattles , and comb, incoordination and nervous signs and diarrhea. In laying birds

, additional clinical features i nclude a marked drop in egg production usually accompanied by an increase in numbers of poor quality

eggs . Typically, high morbidity is accompanied by high and rapidly escalating unexplained mortality. However, none of these signs can be

considered disti nctively characteristic of a particular disease . In addition, low pathogenicity avian influenza (LPAI) viruses, which may cause mild or no clinical disease, or may produce a spectrum of clinical signs the severity of which may approach that of highly pathogenic avian influenza, particularly if exacerbating conditions or co-infections are present (OIE, 2002b; OIE , 2009a; OIE , 2009c).8 Avian influenza viruses are subject to official control and the virus has a high risk of spread from the laboratory; consequ ently, a risk assessment should be carried out to determine the level of biosecurity needed for laboratory diagnosis and chicken inoculation; characterization of the virus

should be conducted at biocontainment level 3 2

, at least. Countries lacking access to such a specialized national or regional laboratory should send specimens to an OIE Reference Laboratory (OIE, 2009c).

The potential for impacts on the human environment from the importation

of live birds and poultry (including hatching eggs ), poultry m eat and poultry products from the EU -25 are dependent upon the ability of mitigation measures or mitigative factors to prevent the introduction of

END or HPAI via the biological pathways of transmission of the diseases. This section addresses the potential environmental impacts that could

occur under the alternatives considered.



### B . No Action

The no action alternative would not allow live birds and poultry (including hatching eggs ), poultry meat , and poultry products to be imported from the

EU -25; that is, it would maintain the current rules governing the importation of these commodities. This alternative would have no potential effect on human health or the environment. This alternative, however, is inconsistent with our commitments under internationa l trade

agreements.



### C. Proposed Rule Amendment Alternative

The proposed rule amendment alternative would allow the importation of

live birds and poultry (including hatching eggs ), poultry meat, and products from the EU-25 under specific conditions desig ned to prevent the introduction of END and HPAI into the United States. Any potential for impacts to the human environment would be the result of exposure to the

END and /or HPAI virus via a breakdown in the se requirements designed to mitigate the risk of exposure to the virus by United States poultry. Animal health, the physical environment, and public health are addressed as components of the human environment in the United States that have the potential to be impacted in the event that the END or HPAI v irus were

to be introduced to United S tates poultry as a result of the rule amendment

2 A biosafety level is the level of the biocontainment (or laboratory biosafety) precautions required to isolate dangerous biological agents in an enclosed facility. The levels of containment range from the lowest biosafety level 1 to the highest at level 4. In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels. In the European Union, the same biosafety levels are defined in a directive. Biocontainment level 3 is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents (including bacteria and viruses) which may cause serious or potentially lethal disease after inhalation.9 to list the EU -25 as free of END and HPAI and, therefore

, allowing importation of live birds and poultry (including hatching eggs), poultry

meat and poultry products. Al so, other environmental review considerations for the protection of the human environment are addressed

in this section of the EA.

a. Virulent ( Exotic ) Newcastle Disease (END)

END is a disease caused by avian paramyxovirus type 1 viruses. END is known to affect more than 250 bird species, with varying levels of mortality. In general, the END viruses are separated into five pathotypes

base d on the clinical signs seen in chickens , ranked from asymptomatic to highly pathogenic types. In some bird species, the less virulent END

viruses do not cause clinical signs or mortality ( OIE , 2002b; OIE , 2009b ; OIE , 2009d).

Chickens are known to be particularly susceptible to the strains of the virus causing virulent END. In chickens, mortality rates resulting f rom virulent END infection can be as high as 100 percent

. In the field definitive diagnosis of END in chickens is difficult because the clinical signs exhibited by infected chickens can vary widely and a combination of clinical signs and laboratory tests must be used to confirm the presence of

the disease (OIE , 2002b; OIE , 2009b; OIE , 2009d).

Infected birds shed the END virus in respiratory secretions and in feces so

that END viruses are spread between birds by either the ingestion or inhalation routes. Depending on the pathotype of the END virus in question, the average incubation period ranges from 2 to 15 days ( USDA

– APHIS, 2009 ).

In general, live birds are thought to be a higher risk for introduction of END than hatching eggs or poultry meat or poultry products (USDA– APHIS, 2009). Biosecurity measures are generally effective in preventing END introduction and spread. If END is not present in poultry flocks, biosecurity measures that significantly lower the potential for introduction

of the disease include:

**•** preventing contact between existing flocks and any live birds or poultry with unknown health status, pet birds, and wild or feral birds, such as gulls, pigeons or cormorants;

**•** quarantine for at least 30 days of all newly acquired birds of species wi th the potential to transmit END;

**•** vaccination of chickens, aviary birds, birds in breeding farms, and birds in zoos; 1. Animal

Health10 **•** routine surveillance measures, including the use of sentinel 3

**•** maintaining good biosecurity. birds

to monitor vaccinated flocks ; and

Vacc ination of poultry may prevent development of clinical signs, but does not completely prevent the END virus from replicating or being shed by infected birds ( Alexander 2003).

If an outbreak of END were to be discovered, implementation of appropriate biosecurity and quarantine measures could prevent the further spread of the infection (USDA– APHIS , 2009). These measures, in addition to those discussed above, include:

**•** establishing a protective zone around the area that includes the infected flock(s)

, and a larger surveillance zone around the protective zone, with appropriate surveillance and restrictions on the movement of poultry and poultry products;

**•** depopulation of all infected and potentially exposed birds;

**•** identification of any animals moved into the flock and monitoring of their source;

**•** identification and monitoring of any flock or individual birds in contact with birds recently moved from the infected flock;

**•** appropriate disposal of carcasses and associated animal products; and

**•** extensive cleaning and d isinfection of premises following depopulation of infected flock(s) with appropriate disinfectant products.

Because of the potentially high mortality in infected birds and the need to depopulate infected animals, the animal health consequences of the

intr oduction of END resulting in an outbreak of the disease in the United States are significant. The primary environmental impacts from the mitigation and control measures described above result from the disposal of large numbers of contaminated carcasses and associated animal products, such as feces or animal litter , from an outbreak of END.

The impact of such disposal activities would be proportionate to the size of the outbreak. However, the likelihood of introduction of END into the

United States as a result of the legal importation of live birds or poultry and poultry products for the EU-25 was found to be negligible. Further, APHIS has in place broad and effective disease control measures that would be undertaken to minimize the potentially high ani mal health impacts from an END introduction and a subsequent outbreak.

3 Sentinels are unvaccinated fully susceptible animals used to monitor for the presence of a disease agent.11 For the proposed rule amendment alternative being considered for the

EU -25 in this document, all of the above preventive and disease

containment measures are followed. All of the measures described above are required by the 25 EU countries with respect to the surveillance for, prevention of, and control of outbreaks of END through the harmonized measures established by the EC

. These measures are compatible with OIE

Terrestrial Animal Code in terms of biosecurity, monitoring, and other

restrictions , and the periods of time for which the conditions must be

maintained in order for a region to be classified as END free (OIE

, 2009b).

USDA –APHIS prepared a risk considerations document that accompanies

this environmental a ssessment (USDA –APHIS, 2009). The conclusion in this document is that, assuming all relevant guidelines and requirements from the regulations are followed, while the impacts of an outbreak of END would be potentially substantial, the risk of introduction of END into

the United States , or the risk of an outbreak as a result of the proposed rule amendment for 25 EU countries importing live birds and poultry (including hatching eggs ), poultry meat and poultry products is low.

b. Highly Pathogenic Avian Influenza (HPAI)

HPAI is a disease caused by influenzavirus A genus viruses. Influenza A virus types also include viruses that cause influenza in humans, horses, pigs , and dogs. While it is typical for an influenza virus to infect only a host-specific species (i.e., equine influenza in horses or canine influenza in dogs), occasionally the se viruses will infect other species. Influenza viruses can also change often through mutation, shift, or drift, causing the emergence of new types of viruses with differing pathogenicity ( Swayne 2003).

Of the three general categories of influenza viruses (A, B, and C), only type A is known to infect avian species. Avian influenza viruses are classified as either high or low pathogenicit y. In general, all avian influenza viruses are highly contagious and cause different effects in infected avian species depending on the strain with which the bird is

infected and the species of bird infected . Additional f actors such as the

immune status of the infected animal , environmental conditions and secondary infections can also influence effects on infected birds. Low pathogenicity viruses generally cause mild disease in poultry, while high pathogenicity viruses can result in 90 to 100 percent mor tality in infected flocks. Isolation and identification of the virus and its pathotype in the laboratory are required for definitive diagnosis of HPAI ( OIE , 2002b;

OIE , 2009a).12 HPAI viruses are primarily spread within infected flocks through contact

wi th feces, saliva , and nasal secretions. HPAI viruses have been detected in large quantities in fecal matter. HPAI can also be transmitted through contaminated feed, water, clothing, broken eggs, or other fomites 4 . The average incubation period of HPAI is reported to be 3 to 5 days ( OIE

, 2002b). For purposes of establishing the guidelines for monitoring and control of HPAI, OIE considers the incubation period to be 21 days (OIE, 2009a).

All avian species should be considered to be susceptible to infection by

avian influenza viruses (OIE , 2002b; Perkins and Swayne, 2001). The measures for controlling the introduction of HPAI into uninfected flocks are similar to the measures described above for END. In general, these

methods include:

**•** preventing contact between healthy birds and birds of unknown health status that could potentially transmit HPAI;

**•** quarantine of newly acquired birds for at least 30 days before introduction into an existing flock;

**•** practicing good biosecurity; and

**•** routine disease surveillance.

If an HPAI outbreak were to be detected, measures for controlling the spread of the outbreak are also similar to the measures used for controlling END outbreaks. In general, these measures include:

**•** immediate quarantine of suspect flocks;

**•** epidemio logic investigation;

**•** establishing protective and surveillance zones around infected flock(s);

**•** depopulation of infected and potentially exposed birds;

**•** appropriate disposal of carcasses and associated animal products;

and

,

**•** extensive cleaning and disinfectio n of affected premises.

Because of the potentially high mortality in infected birds and the need to depopulate infected animals, the animal health consequences of the

introduction of HPAI resulting in an outbreak of the disease in the United

States are si gnificant. The primary environmental impacts from any of the mitigation and control measures described above would result from the disposal of large numbers of contaminated carcasses and associated animal products, such as feces or animal litter

, from an outbreak of HPAI.

4 A fomite is an object that may be contaminated with infectious organisms and serve in their

transmission.13 The impact of such disposal activities would be proportionate to the size and duration of the outbreak. However, the likelihood of introduction of

HPA I into the United States as a result of the lega l importation of live birds or poult ry and poultry products from the EU-25 was found to be extremely low

. Further, APHIS has in place broad and effective disease

control measures that would be undertaken to minimize the potentially high animal health impacts from HPAI introduction and a ny subsequent

outbreak that would be no different than that of an outbreak of domestic origin

.

All of the animal health control measures described above are required by the 25 EU countries with respect to the surveillance for, prevention of, and

control of outbreaks of HPAI through the harmonized measures established by the EC. These measures are compatible with the OIE

Terrestrial Animal Code including the appropriate standards that must be

met for biosecurity, monitoring, quarantine and movement restrictio ns, and other conditions that must be met in order for a country to be

classified as HPAI free (OIE , 2009a).

USDA –APHIS prepared a risk considerations document that accompanies

this environmental a ssessment (USDA –APHIS, 2009). The conclusion in

this docu ment is that, assuming all relevant guidelines and requirements from the regulations are followed, although the impacts of an outbreak of HPAI would be potentially substantial, the risk of introduction of HPAI

into the United States , or the risk of an outbreak as a result of the proposed rule amendment for 25 EU countries importing live birds and poultry (including hatching eggs ), poultry meat and poultry products is extremely

low.

The H5 and H7 influenza viruses have the potential to change from a low pathogenic virus into a highly pathogenic virus capable of causing death in

most infected poultry. The “Asian” strain of H5N1 avian influenza virus

has been transmitted from infected birds to mammals. In addition to wild birds and domestic poultry, infecti on with this H5N1 virus has been found

in domestic cats, tigers, leopards, dogs, swine, and humans. Th is H5N1 virus has the potential to kill the infected subjects.

Avian influenza virus can survive in physical environments (such as water and manure) for many days depending on the environmental conditions. Humans are the primary spreaders of avian influenza virus between flocks through clothing, footw ear , hands, and equipment (Trampel, 2006).

END is transmitted through direct contact between healthy b irds and the bodily discharges of infected birds, specifically feces and secretions from the nose, mouth, and eyes. It spreads rapidly among birds in confinement, 2. Physical

Environment14 such as commercially raised chickens. Like HPAI, END can be spread by feed, water, tools, premises, human clothing and shoes, from an infected flock to a healthy flock . Often it is spread by vaccination and debeaking crews, manure haulers, rendering

- truck drivers, feed -delivery personnel, poultry buyers, egg-service workers, and poultry farm ow ners and employees ( Seal et al, 2000 ; USDA –APHIS, 2003).

If an introduction of HPAI or END in to United S tates poultry were to occur, potential impacts to the physical environment could result from disposal of carcasses due to death from disease and depopu lation of poultry herds or disposal of contaminated bedding and manure. USDA’s authority, under the Animal Health Protection Act, provides for the control and eradication of serious foreign animal disease agents; typically, these efforts include depopulation and disposal of affected or exposed livestock,

and of domestic commercial birds. Because of its statutory authorities for protection of human health and the environment, the U.S. Environmental Protection Agency ( EPA ) (both S tate and local authorities) could be consulted by USDA– APHIS for technical assistance regarding poultry carcass disposal.

Similar to EPA’s support role to USDA in providing technical assistance and guidance on carcass disposal options, the U.S. Department of the Interior (DOI) wou ld coordinate the Federal government’s surveillance of wild migratory birds for the presence of highly pathogenic avian influenza

and coordinate Federal surveillance with related surveillance activities of

S tate fish and wildlife agencies . The U.S. DOI is also the primary Federal department responsible for addressing avian influenza matters in wild,

free

- ranging bird species.

Disposal methods for poultry carcasses include rendering, landfill, incineration, and on- farm burial or burning. If not handled properly, disposal of infected animals and materials could impact air, water, and soil quality, and potentially release the live END or HPAI virus into the environment. Factors influencing proper disposal methods include the

volume of infected animals and contaminated materials, geographic features of the area (e.g. water resources and soil type), other physical environment considerations (such as weather and temperature), and available funds, equipment, and personnel.

The use of disinfectants to prevent the transfer of the END or HPAI virus

from surfaces could impact the physical environment. If not used properly, disinfectants could end up in sewage systems and potentially impact aquatic systems, impact air quality or terrestrial ecosystems during

use, and cause health problems, such as dermal or respiratory impacts to workers using them. As part of an animal disease eradication program, disinfection of equipment, transport vehicles, and/or premises where15 infected poultry were maintained would be necessary to prevent
mechanical transfer of the HAPI or END virus. Disinfectants used for such purposes would have to be registered for specific use with EPA and used according to label requirements. Label instructions for a disinfectant would be provided for its proper application to prevent potential environmental impacts associated with the use of the registered product (EPA , 2008 ; Pollard et al., 2008).

END can be considered a human pathogen, producing transient, usually localized, infection

. Reported infections have been non- life threatening and usually not debilitating for more than a day or two. The most frequently reported and best substantiated clinical signs in human

infections have been the result of accidental exposure to the agent in a

labora tory setting resulting in eye infections usually consisting of unilateral or bilateral reddening, excessive tear production, edema (abnormal accumulation of fluid beneath the skin) of the eyelids, conjunctivitis (swelling, inflammation, or infection of the membrane lining the eyelids) and sub-conjunctival hemorrhage (bleeding underneath the eye) . Although the effect on the eye may be quite severe, infections are usually transient and the cornea is not affected. Reports of other clinical symptoms in humans infected with the virus that causes END 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 the virus that cause END may infect and cause clinical signs in humans. There is no evidence of human- to -human spread (USDA –APHIS, 2009).

The risk from avian influenza is generally low to most people, because the viruses do not usually infect humans. However, confirmed cases of human infection from several subtypes of avian influenza infection have been reported since 1997. Most cases of avian influenza infection in

humans have resulted from direct contact with infected poultry (e.g., domesticated chicken, ducks, and turkeys) or surfaces contaminated with secretions or excretions from infected birds. The spread of avian influenza viruses from one ill person to another has been reported very rarely, and has been limited, ineffi cient , and unsustained. During an outbreak of avian influenza among poultry, there is a possible risk to people who have contact with infected birds, birds that died from the disease or surfaces

that have been contaminated with secretions or excretions fr om infected

birds (USDA –APHIS, 2009).

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

acute respiratory distress), and other severe and life- threatening 3. Public

Health16 complications. The symptoms of avian influenza depend on the strain of

the virus that caused the infection (USDA –APHIS, 2009).

The World Health Organization (WHO) has reported cases of the “Asian”

strain of H5N1 avian influenza in humans in Asia, Africa, the Pacific, Europe, and the Near East. Indonesia, Egypt and Vietnam have reported the highest number of human H5N1 cases , to date, with mortalities of up

to 60 percent, especially in cases wh ere patients were hospitalized late in

the illness. Despite the high mortality, human cases of H5N1 remain rare

to date. The most significant risk factor for human H5N1 infection is direct contact with sick or dead poultry or wild birds (USDA

– APHIS, 2009).

In North America, there have been two reports of AI tr ansmission to humans, in Canada and New York. However, in the most extensive outbreak of avian influenza (HPAI H5N2) to occur in the United States 5

the re were no cases of transmission to humans. In November 2003, a patient with serious underlying medical conditions was admitted to a hospital in New York with respiratory symptoms but recovered after a few

weeks. I nitial ly laboratory tests identified the influenza A virus as H1N1 ; however, subsequent confirmatory tests showed that the patient had been infected with an H7N2 avian influenza A virus. However, no contact with infected birds or poultry could be documented in this case

.

In February 2004, the Canadian Food Inspection Agency announced an outbreak of avian influenza A (H7N3) in poultry in the Fraser Valley region of British Columbia. Health Canada reported two human cases of laboratory confirmed influenza A (H7), one in a person involved in culling operations and one in a poultry worker wi th close contact with infected poultry. Both patients developed conjunctivitis (eye infection) and other

flu

- like symptoms and t heir illnesses resolved after treatment with

antiviral medication. Another group of approximately 10 other poultry

workers exh ibited conjunctival and/or upper respiratory symptoms after having contact with poultry; however laboratory testing did not confirm

infection

.

Should a substantial foreign animal disease outbreak occur in the United

States , f armers and their families cou ld suffer psychologically from the loss of animals, including blood lines maintained over many generations,

the loss of control over their business due to animal movement

restrictions , disruptions in community life, and from stress over their

financial fut ure. Further, these losses would affect the farming community

as a whole.

5 This outbreak occurred in February 2004 in Texas

.17 a. Environmental Executive Orders

Some executive orders such as Executive Order 13045 (Protection of Children From Environmental Health Risks and Safety Risks), and Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations), and departmental or agency directives require special environmental reviews in certain circumstances. In considering these additional environmental review requirements, no circumstance that would trigger the need for special environmental reviews is involved in implementing the proposed action considered in this document. The proposed rul e amendment alternative presents no risk to the health or safety of children, and will not result in disproportionately high and adverse human health and/or environmental effects on any minority populations and/or low-income populations in the

United State s.

b. Endangered Species Act

Section 7 of the Endangered Species Act and its implementing regulations require Federal agencies to ensure that their actions are not likely to jeopardize the continued existence of threatened or endangered species or

res ult in the destruction or adverse modification of critical habitat. APHIS considered the potential effects of the proposed action on threatened and endangered species and designated critical habitat. All federally listed bird species in the United States and its Territories (appendix A) may be susceptible to END and HPAI, although susceptibility of different types of birds may be variable.

APHIS conducted a risk analysis that concluded the overall risk of introducing either END or HPAI into the United States through the import of live birds or poultry, poultry carcasses, parts or products of poultry carcasses, and eggs of poultry, game birds, or other birds from the EU-25 to be extremely low (USDA –APHIS, 2009). This determination is based on the following for the EU

- 25 (USDA

– APHIS, 2009) :

• t he region has an effective veterinary infrastructure capable of identifying and applying control measures to eradicate incursions of END or HPAI in domestic poultry;

• t he region has a comprehensive legislative fram ework in place to ensure consistent implementation of EC legislation by all EU -25

M ember S tates . EC services provide resources to review and inspect for compliance;

• END and HPAI are notifiable (reportable) diseases in the region; • appropriate surveilla nce is in place with the capacity to effectively and quickly detect the presence of END or HPAI, even in the 4. Additional
Environ

m ental
Review
Consider a tions18 absence of clinical signs ; • l aboratory confirmation capabilities are effective , and laboratory testing procedures are well documented and standa rdized ; • END and HPAI eradication programs include implementation of appropriate quarantine and surveillance zones, with monitoring of

those zones and movement restrictions. Procedures for establishing and lifting quarantines are sufficient to prevent fu rther spread of disease; and, • contingency plans, standard operating procedures, and biosecurity

measures for emergency response are well documented , and relevant personnel are well resourced and trained.

Based upon the low likelihood that END or HPAI wo uld become

establish ed in the United States as a result of poultry imports from the

EU -25, and the effectiveness of the movement restrictions included in

9 CFR 92.3 , the effect of an END or HPAI outbreak on federally listed endangered or threatened birds, birds proposed for listing as threatened or endangered, or designated critical habitat would be no different than a

domestic outbreak of either disease such that the implementation of the proposed rulemaking is expected to have no effect.19 

## IV. Agencies Co ntacted

U.S. Department of Agriculture Animal and Plant Health Inspection Service Policy and Program Development Environmental and Risk Analysis Services 4700 River Road, Unit 149 Riverdale, MD 20737–123820 

## V. References

Alexander, D. J., 2003. “Newcas tle Disease.” In Diseases of Poultry, 11th ed. Saif, Y. M., H. J. Barnes, A. M. Fadly, et al (E ds). Iowa, Blackwell Publishing: 64 -87.

EPA

— See U.S. Environmental Protection Agency.

FWS

— See U.S. Fish and Wildlife Service

OIE —See World Organization for A nimal Health.

Perkins, L.E.L ., and Swayne, D.E., 2001. Pathobiology of A/Chicken/Hong Kong/220/97 (H5N1) Avian influenza virus in s even

g allinaceous species. Vet Pathol 38: 149–164.

Pollard, S.J.T., Gordon, A.W. , Hickman, P.I., Rupert

, L. , Hough,
D.M., Gauntlett, S

. F. , Howson, A.H., Gayford, P., and Gent, N., 2008. Exposure a ssessment of c arcass disposal options in the event of a

n otifiable e xotic a nimal d isease: Application to avian influenza v irus Environ. Sci. Tech., 42, 3145–3154.

Seal B. S., K ing, D.J., and Sellers , H.S., 2000. The avian response to Newcastle disease virus. Developmental and Comparative Immunology 24 (2000) 257-268.

Swayne, D. E., and Halvorson, D. A. , 2003. “Influenza” in Diseases of Poultry, 11th ed. Saif, Y. M., H. J . Barnes, A. M. Fadly, et al (Eds). Iowa, Blackwell Publishing: 135-106.

Trampel, D.W., 2006. Manure disposal following an outbreak of avian influenza on a commercial poultry farm. Odor and Nutrient Management, Summer 2006 EDC-129-32, Vol. 9, Issue 2.

U SDA

– APHIS

— See U.S. Department of Agriculture, Animal and Plant Health Inspection Service.

U.S. Department of Agriculture, Animal and Plant Health Inspection Service (USDA –APHIS), 2009. APHIS Risk Considerations on Importation of Highly Pathogenic Avian Influenza (HPAI) and Exotic Newcastle Disease (END) Virus from a European Union Region of Twenty

- five Member States (May, 2009).21 U.S. Department of Agriculture, Animal and Plant Health Inspection

Service

, 2003. Exotic Newcastle Disease: A deadly disease that affects poultry and pet birds. Program Aid No. 1739, Issued March 2003. [Online.] Availab le: http://www.aphis.usda.gov/lpa/pubs/pub_ahend.html [2009, Aug. 26.]

U.S. Environmental Protection Agency, 2008. Frequently asked questions: Pandemic flu. [Online.] Available: http://www.epa.gov/pandemicflu/faq.htm [2009, Aug. 26.]

U.S. Fish and Wildlife Service, Threatened and End angered Species System. [Online.] Available: http://ecos.fws.gov/tess_public/pub/SpeciesReport.do

World Organization for Animal Health (OIE), 2002a. Newcastle Disease

, Animal Di seases Data; Technical Disease Card . [Online.] Available: http://www.oie.int/eng/maladies/fiches/a_A160.htm [2009, July 27.]

World Organization for Animal Health (OIE), 2002b. Highly Pathogenic Avian Influenza

, Animal Diseases Data; Technical Disease Card

. [Online.] Available: http://www.oie.int/eng/maladies/fiches/a_A150.htm [2009, July 27.]

World Organization for A nimal Health (OIE), 200 9a. Terrestrial Animal

Health Code , Chapter 2.7.12: Avian Influenza. [2009, July 27.]

World Organization for Animal Health ( OIE), 2009b. Terrestrial Animal

Health Code , Chapter 10.13: Newcastle Disease. [Online.] Available: http://www.oie.int/eng/normes/mcode/en_chapitre_1.10.13.htm [2009, July 29.]

World Organization for Animal Health (OIE), 2009c. Chapter 2.3.4: Avian Influenza. [Online.] Available: http://www.oie.int/eng/Normes/mmanual/2008/pdf/2.03.04_AI.pdf [2009, Aug. 26.]

World Organization for Animal Health (OIE), 2009d. Terrestrial Diagnostic Manual , Chap ter 2.3.14: Newcastle Disease. Available: http://www.oie.int/eng/normes/mmanual/A_summry.htm [2009, July 29.]1 

## Appendix A

. Threatened and E ndangered B irds

F ederally L isted in the Unite d States and

I ts T erritories (USFWS

– TESS, 2009).2 Threatened and Endangered Birds Federally Listed in the United States and Its Territories (USFWS

– TESS, 2009).

Scientific Name Common Name Critical Habitat (Y/ N) Listing Status*

Accipiter striatis venator Puerto Rican sharp

- shinned

hawk N E

Acrocephalus familiaris kingi Nihoa millerbird N E

Acrocephalus luscinia Nightingale reed warbler N E

Aerodramus vanikorensis

bartschi Mariana gray swiftlet N E

Agelaiu s xanthomus Yellow

- shouldered blackbird Y E

Amazona vittata Puerto Rican parrot N E

Ammodramus maritimus

mirabilis Cape Sable seaside sparrow Y E

Ammodramus savannarum
floridanus Florida grasshopper sparrow N E

Amphispiza belli clementeae San Clemente sage sparrow N T

Anas laysanensis Laysan duck N E

Anas wyvilliana Hawaiian (=koloa) duck N E

Aphelcoma coerulescens Florida scrub

- jay N T

Brachyramphus marmoratus Marbled murrelet Y T

Branta (=Nesochen)

sandvicensis Hawaiian goose N E

Buteo platypter us brunnescens Puerto Riacn broad

- winged hawk N E

Buteo solitarius Hawaiian (=’Io) hawk N E

Campephilus principalis Ivory

- billed woodpecker N E

Caprimulgus noctitherus Puerto Rican nightjar N E

Charadrius alexandrinus

nivosus Western snowy plover Y T

Charadrius melodus Piping plover Y E; T

Chasiempis sandwichensis

ibidis Oahu elepaio Y E

Colinus virginianus ridgwayi Masked bobwhite (quail) N E

Columba inornata wetmorei Puerto Rican plain pigeon N E

Corvus hawaiiensis Hawaiian (=’alala) crow N E

Co rvus kubaryi Mariana (=aga) crow Y E

Corvus leucognaphalus White

- necked crow N E

Crax alberti Blue

- billed curassow N PE

Dendroica chrysoparla Colden

- cheeked warbler N E

Dendroica kirtlandii Kirtland’s warbler N E

Empidonax traillii extimus Southweste rn willow flycatcher Y E

Falco femoralis septentrionalis Northern aplomado falcon N E; XN

Fulica americana alai Hawaiian coot N E

Gallinula chloropus guami Mariana common moorhen N E

Gallinula chloropus

sandvicensis Hawaiian common moorhen N E

Grallar ia milleri Brown

- banded antpitta N PE

Grus americana Whooping crane Y E; XN3 Grus canadensis pulla Mississippi sandhill crane Y E

Gymnogyps californianus California condor Y E; XN

Halcyon cinnamomina

cinnamomina Guam Micronesia kingfisher Y E

Haliaeetu s leucocephalus Bald eagle (Sonoran Desert Distinct Population Segment) N T

Hemignathus lucidus Nukupu’u (honeycreeper) N E

Hemignathus munroi Akiapola’au (honeycreeper) N E

Hemignathus procerus Kauai akailoa (honeycreeper) N E

Himantopus mexicanus

knu dseni Hawaiian stilt N E

Lanius ludovicianus mearnsi San Clemente loggerhead shrike N E

Loxioides bailleui Palila (honeycreeper) Y E

Loxops caeruleirostris Akekee N PE

Loxops coccineus ochraceus Maui akepa (honeycreeper) N E

Loxops coccineus coccineus Hawaii akepa (honeycreeper) N E

Megapodius laperouse Micronesian megapode N E

Melamprosops phaeosoma Po’ouli (honeycreeper) N E

Moho braccatus Kauai ‘o’o (honeyeater) N E

Myadestes lanaiensis rutha Molokai thrush N E

Myadestes myadestinus Large Kauai (=kamao) thrush N E

Myadestes palmeri Small Kauai (=puaioho) thrush N E

Mycteria americana Wood stork N E

Numenius borealis Eskimo curlew N E

Oreomystis bairdi Kauai creeper N PE

Oreomystis mana Hawaiian creeper N E

Palmeria dolei Crested honeycreep er N E

Paroreomyza flammea Molokai creeper N E

Paroreomyza maculata Oahu creeper N E

Pelecanus occidentalis Brown pelican N E

Phoebastria (=Diomedea)

albatrus Short

- tailed albatross N E

Phoenicoparrus andinus Andean flamingo N PE

Picoides borealis Re d

- cockaded woodpecker N E

Pipilo crissalis eremophilus Inyo California towhee Y T

Polioptila californica californica Coastal California gnatcatcher Y T

Polyborus plancus audubonii Audobon’s crested caracara N T

Polysticta stelleri Steller’s eider Y T

Pseudonestor xanthophrys Maui parrotbill (honeycreeper) N E

Psittirostra psittacea ‘O’u (honeycreeper) N E

Pterodroma phaeopygia

sandwichensis Hawaiian dark

- rumped petrel N E

Puffinus auricularis newelli Newell’s Townsend’s shearwater N T

Puffinus hein rothi Heinroth’s shearwater N PT

Rallus longirostris levipes Light

- footed clapper rail N E

Rallus longirostris obsoletus California clapper rail N E

Rallus longirostris yumanensis Yuma clapper rail N E4 Rallus owstoni Guam rail N E; XN

Rostrhamus socia bilis plumbeus Everglade snail kite Y E

Somateria fischeri Spectacled eider Y T

Sterna antillarum Least tern N E

Sterna antillarum browni California least tern N E

Sterna dougallii dougallii Roseate tern N E; T

Strix occidentalis caurina Northern spot ted owl Y T

Strix occidentalis lucida Mexican spotted owl Y T

Telespyza cantans Laysan finch (honeycreeper) N E

Telespyza ultima Nihoa finch (honeycreeperP N E

Tympanuchus cupido attwateri Attwater’s greater prairie

- chicken N E

Vermivora bachmanii Bac hman’s warbler N E

Vireo atricapilla Black

- capped vireo N E

Vireo bellii pusillus least Bell’s vireo Y E

Zosterops conspicillatus conspicillatus Bridled white

- eye N E

Zosterops rotensis Rota bridled white

- eye Y E

* E = E ndangered ; T = T hreatened ; PE = Proposed for listing as E ndangered ; PT = Proposed for listing as T hreatened

XN = E xperimental population