Importation of Animals and Animal Products

SUMMARY: We are proposing to amend the regulations concerning

importation of animals and animal products. The proposed changes

include a complete rewrite of 9 CFR part 92, subparts D (ruminants) and

E (swine), a transfer of current part 92 to 9 CFR part 93, and the

establishment of a new part 92. We are proposing to establish criteria

for foreign ``regions'' based on risk class levels. The criteria would

be used to establish importation requirements for particular animals

and animal products from different regions outside of the United

States. We believe this change is in accordance with international

trade agreements entered into by the United States. We are also

proposing to allow, under certain conditions, the unloading and

reloading at the port of arrival of meat and other animal products

otherwise prohibited entry into the United States. We believe this

change is warranted because it would remove unnecessary restrictions on

the importation of meat and other animal products into the United

States.

DATES: Consideration will be given only to comments received on or

before July 17, 1996.

ADDRESSES: Comments may be submitted as paper copies or by electronic

mail. If you submit paper copies, please send an original and three

copies of your comments to Docket No. 94-106-1, Regulatory Analysis and

Development, PPD, APHIS, suite 3C03, 4700 River Road Unit 118,

Riverdale, MD 20737-1238. Please state that your comments refer to

Docket No. 94-106-1. We encourage the submission of copies by

electronic mail, since this both facilitates our analysis of the

comments and allows us to make the text of comments available to the

public via the Internet. The e-mail address for comments on this

proposed rule is [email protected]. Please be sure to include

your full name and organization in any comments you submit by e-mail.

If your e-mail comment is a duplicate of a paper copy you have

submitted, please state this in the first line of your e-mail message.

Comments submitted by e-mail will be posted to the APHIS

Regionalization Proposal Web Page within a few days after receipt. This

Web page also contains copies of the proposed rule in several formats

and related information. The Web page URL is http://www.aphis.usda.gov/

PPD/region. Both paper and e-mail comments received may be inspected at

USDA, room 1141, South Building, 14th Street and Independence Avenue

SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through

Friday, except holidays. Persons wishing to inspect comments are

requested to call ahead on (202) 690-2817 to facilitate entry into the

comment reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, Chief Staff

Veterinarian, National Center for Import and Export, VS, APHIS, 4700

River Road Unit 38, Riverdale, MD 20737-1231, (301) 734-8590.

SUPPLEMENTARY INFORMATION:

Background

The Animal and Plant Health Inspection Service (APHIS), United

States Department of Agriculture (USDA), has promulgated regulations

regarding the importation of animals and animal products in order to

guard against the introduction into the United States of animal

diseases not currently present or prevalent in this country. These

regulations are set forth in the Code of Federal Regulations (CFR),

title 9, chapter 1.

Under the current regulations, with several exceptions,

restrictions on the importation of animals and animal products are

based on whether a particular disease exists in any part of the foreign

country from which the animals or animal products originate or transit

before importation into the United States. (In a few cases,

restrictions are placed on the importation of animal products from

countries where a certain disease is not known to exist, because of

risk factors such as those countries' importation policies or proximity

to countries where the disease exists.)

The current USDA policy of prohibiting or restricting importations

based solely on whether a disease exists anywhere within a national

entity does not take into account whether regions within a country, or

regions made up of several countries, have in place adequate natural

and man-made defenses against the introduction or spread of animal

diseases in those regions. Nor, we believe, do the current regulations

adequately address variations in the risk of disease transmission both

between regions where a disease exists and between those where the

disease is not present. We believe that these policies unnecessarily

prohibit or restrict the importation of animals and animal products in

many situations where such importation can be carried out with

insignificant risk of introducing disease agents into the United

States.

Therefore, in this document, we are proposing to revise the

regulations in six different parts of 9 CFR to establish importation

criteria for certain animals and animal products based on the level of

disease risk in specified geographical regions. We believe that these

regulatory changes are consistent with and meet the requirements of

international trade agreements that have recently been entered into by

the United States, as discussed below under the heading ``International

Trade Agreements.''

Limits of This Proposed Rule

It is important to note that the changes we are proposing at this

time apply only to the importation of ruminants and swine, and their

products. The importation of all other types of animals would continue

to be governed by the current regulations, rather than by a

regionalized, risk class approach. It is our intent, however, to

extend, in future rulemaking, the regionalized, risk class approach to

the importation of all animals and animal products that are subject to

the regulations.

International Trade Agreements

Both the North American Free Trade Agreement (NAFTA) and the

General Agreement on Tariffs and Trade (GATT) Uruguay Round agreements

contain provisions establishing the rights and obligations of signatory

countries concerning sanitary and phytosanitary (SPS) regulation. SPS

measures are generally defined as governmental measures intended to

protect human, animal, or plant life or health. The applicable

provisions are, respectively: Articles 709 through 724 of the NAFTA

(``NAFTA-SPS''); and the World Trade Organization (WTO) Agreement on

the Application of Sanitary and Phytosanitary Measures (``WTO-SPS'').

Although the two agreements differ in a few respects, both NAFTA-

SPS and WTO-SPS provide that:

A Member Country shall recognize the concepts of regions of low

pest or disease prevalence, and shall ensure that its sanitary and

phytosanitary measures are adapted to take into account the

characteristics of regions from which products originate and to

which products are destined. In doing so, the

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Member should take into account relevant geography, ecology, methods

of surveillance and effectiveness of control systems. [NAFTA-SPS,

Article 716; WTO-SPS, Articles 6.1-6.2]

The changes being proposed in this regulation are intended to

comply with U.S. obligations under NAFTA-SPS and WTO-SPS with respect

to the importation of live animals and animal products.

Format Changes to 9 CFR

Because we are proposing to make significant substantive changes to

the current regulations in order to incorporate provisions regarding

both regionalization and the risk classification of exporting regions,

we believe it is necessary, to aid readers of the regulations, to make

several major formatting changes to 9 CFR. Although we are proposing to

amend in some way parts 92, 93, 94, 95, 96, and 98, only two of those

parts--parts 92 and 93--would require extensive structural

reformatting. We would make a number of substantive changes to part 94,

but that part would largely retain its current format. Parts 95, 96,

and 98 would require fewer substantive changes and no format changes.

Parts 92 and 93

The regulations in current parts 92 and 93 govern the importation

into the United States of certain live animals, in order to prevent

animals infected with certain diseases from transmitting those diseases

to livestock and poultry in the United States. The animals regulated by

current part 92 include birds, poultry, horses, ruminants, swine, dogs,

hedgehogs and possums. Current part 93 regulates the importation of

elephants, hippopotami, rhinoceroses, and tapirs.

As part of the format changes we are proposing, we would move the

regulations in current part 92 to part 93. Along with this relocation

of the current part 92 regulations, we would make extensive changes to

two of the subparts in current part 92--subpart D (ruminants) and

subpart E (swine). These changes are discussed in detail below in this

supplementary information.

The movement of current part 92 to part 93 would leave no

regulations at part 92. We are proposing to fill the vacated part 92

with an entirely new set of regulations, which would include criteria

for establishing geographical regions for the purpose of importing

animals and animal products, and criteria for classifying regions

according to the disease risk (risk assessment and classification) that

animals and animal products from those regions would pose to U.S.

livestock if no import restrictions were in place. New part 92 would

also include a list of restricted diseases for the purposes of the

import regulations. Each of these provisions is discussed in detail

below.

Additionally, new Sec. 92.4 would include a listing of the risk

classification APHIS has assigned to each region of the world for each

restricted disease agent. The listing in this proposed rule consists,

for the most part, of countries, because, under the existing

regulations, disease status is determined on a country-by-country

basis. However, this proposed rule would allow for application for

regional status for areas smaller or larger than individual countries.

The application process is discussed in this Supplementary Information

under the heading ``Application for Risk Class Recognition.''

Proposed Part 92

As noted above, we are proposing to set forth in part 92 the

criteria for classification of regions according to risk assessment as

required by NAFTA and GATT. These criteria would be incorporated into

the amended regulations in parts 93, 94, 95, 96 and 98, which contain

restrictions on the importation of certain animals and animal products.

As revised, Sec. 92.2 would list those disease agents and vectors

of agents that would be restricted entry into the United States, either

because they are not known to exist in the United States or because

they are subject to Federal or cooperative Federal/State control or

eradication programs in the United States. Some of the diseases that we

are proposing to list in revised Sec. 92.2 are already addressed in the

current import regulations. In addition, we are proposing to add other

specified diseases.

The diseases we would add to those already addressed in the

regulations have, in many cases, been of concern even under the current

regulations, but have not posed a significant practical risk because

the countries in which they exist have also been countries in which

rinderpest or foot-and-mouth disease (FMD) exists. The current

regulations ban the importation into the United States of most animals

and animal products from countries in which rinderpest or foot-and-

mouth disease exists. In those cases where animals and animal products

are allowed to be imported from these countries, they must meet

stringent quarantine or processing requirements. These prohibitions and

safeguards effectively ban many animals and products affected with

other diseases.

However, we believe that several factors now make it necessary to

provide specific regulatory restrictions for certain diseases not

currently addressed in the regulations. The first factor is this

proposed revision of the import regulations, which would provide for

regionalization and for various classification levels of disease risk.

Under this proposal, for example, and unlike under the current

regulations, the fact that FMD exists in one region of a country may

not significantly restrict the importation of animals and animal

products from another region of the same country, if the two regions

are so separated and monitored that the risk of the disease being

transferred from one region to the other is negligible. This is a

departure from the current regulations, in which FMD in any part of

country determines the FMD status of the entire country.

The second factor is the progress many countries have made in

eradicating, or moving toward eradication of, rinderpest and FMD in

specific regions. In countries where FMD exists, an increasing number

of regions have eradicated or come close to eradicating the disease.

Therefore, under this proposal, import restrictions due to FMD in one

part of a country could no longer be relied upon to guard against the

importation of diseases not specifically addressed in the regulations.

In addition to FMD and rinderpest viruses, other disease agents

that are specifically addressed in current parts 92 and 94 are: In part

94, African swine fever virus, hog cholera (also known as classical

swine fever virus), swine vesicular disease virus, velogenic Newcastle

disease virus (also known as avian pneumoencephalitis or VVND virus),

fowl pest (also known as fowl plague or highly pathogenic avian

influenza), bovine spongiform encephalopathy, and Salmonella

enteritidis phage type 4; in part 92, Akabane virus, bluetongue virus,

epizootic hemorrhagic disease virus, contagious pleuropneumonia, surra

caused by Trypanosoma evansi, fever ticks and other ticks, vesicular

stomatitis, Trypanosoma vivax, dourine caused by Trypanosoma

equigenitalium, glanders caused by Pseudomonas mallei, equine

piroplasmosis caused by Babesia equi or B. caballi, equine infectious

anemia, contagious equine metritis caused by Taylorella equigenitalis,

African horse sickness virus, Venezuelan equine encephalitis virus,

epizootic lymphangitis caused by Histoplasma farciminosum, and Taenia

[[Page 16980]]

multiceps (also known as Taenia coenurus).

Additions of Exotic Diseases

In this document, we are proposing to add the following exotic

diseases to the list of restricted diseases mentioned above. A

description of the disease that would be added is included with each

entry.

African or wildebeest or alcephalene malignant catarrhal fever

(MCF) is caused by a herpesvirus found in Africa, and is primarily

transmitted from carrier wildebeest to cattle when the wildebeest

calve. Wildebeest are the primary reservoir of this virus. The ``sheep-

associated form'' of MCF is present in most of the world, including the

United States. Neither the wildebeest-transmitted form nor the sheep-

associated form of MCF are known to spread directly from cattle to

cattle, so the principal concern would be importation of wildebeest or

other host species from Africa that could increase the spread and

seriousness of the disease in cattle or native wildlife species, some

of which have been shown to be susceptible. (Heuschele, W. P., 1992,

Foreign Animal Diseases, U. S. Animal Health Assoc., Richmond, VA, 273-

284.) Because it cannot be concluded with certainty that other

ruminants cannot spread the disease, the restrictions of this proposal

with regard to MCF would apply to all ruminants.

Aino virus is a Bunyavirus of the Simbu group that produces fatal

deformities in cattle similarly to Akabane virus. It has been found in

Australia and Asia, particularly in Japan and Taiwan. It is transmitted

by various species of Culicoides and, because of the distribution of

potential vectors in the southern United States, could potentially

become endemic in that area if it were to become established.

(Moriwaki, M. et al. 1977. Natl. Inst. Anim. Heal. Qtrly, Jap.

17(3):95-106.; St. George, T. D. et al. 1989, in The Arboviruses:

Epidemiology and Ecology. Vol IV. Ed. Monath, T.P. CRC Press, Boca

Raton, FL, 145-166.; Fukutomi, T. 1991. J. Jap. Vet. Med. Assoc.

44(1):17-19.)

Bovine ephemeral fever, also known as Kotonkan, Obadhiang, Puchong,

or bovine epizootic fever virus, is an arthropod-borne viral disease of

cattle and water buffalo in Africa, Australia and Asia. Affected cattle

suffer severe loss of weight and condition, decreased milk production,

and infertility in males. The reservoir hosts are not known, but water

buffalo have been shown to have a prolonged viremia (Young, P.L., 1979,

Austl Vet J. 55(7):349-350). It could be a potentially serious problem

in the southern States of the United States because of the distribution

of potential vectors. If it were to become established, there would be

little likelihood that it could be eradicated. (St. George, T. D.,

1992, Foreign Animal Diseases, U. S. Animal Health Assoc., Richmond,

VA, 125-133.)

Bovine infectious petechial fever, also known as Ondiri disease, is

caused by the rickettsia Erlichia (Cytocetes) ondiri in cattle and

results in high mortality, abortion, and reduced lactation. It is found

primarily in east Africa, and a tick vector is suspected. Infected

cattle can remain infected for many months. There may be potential

ticks or other vectors in the United States that can transmit the

rickettsial cause of this disease. (Davies, G. 1993. Vet. Microbiol.

34(2):103-121.)

Brucella melitensis has been eradicated from the United States, but

is found in Mexico, Central and South America, southern Europe, Asia,

and Africa. It is a serious disease, causing abortion in sheep and

goats, and can also infect cattle. It is also a serious human health

risk. (Alton, G.G., 1990, in Animal Brucellosis., Ed. Neilson, K. and

J. R. Duncan, CRC Press, Boca Raton, FL, 383-410.)

Congo or Crimean hemorrhagic disease virus is caused by tick-

transmitted virus and causes fever, anorexia and depression in cattle

and goats in Africa and Asia. It may cause a sporadic, severe, and

often fatal disease in people. A tick-rodent-cattle cycle maintains the

virus in nature. Birds are responsible for distributing infected ticks,

but most birds are resistant. Infection has been reported in ratites.

Transmission to humans has been reported to occur with direct contact

with blood of infected cattle and ostriches. This group of viruses is

not found in the Western hemisphere but could possibly become

established, and would be virtually impossible to eradicate. (Lvov,

D.K., 1994, in Handbook of Zoonoses, 2nd Ed. Section B., ed. Beran, G.

W., CRC Press, Boca Raton, FL, 251-252.)

Contagious agalactia of sheep and goats caused by Mycoplasma

agalactiae results in fever, malaise, arthritis, eye lesions, and, in

females, mastitis and reduced milk production. Losses are due to high

morbidity and loss of milk and meat production. It is found in parts of

Europe, Asia, and North Africa and has been reported from Australia,

South Africa, and South America. Low virulence strains are found in

North America, but do not cause classical disease. Infected animals are

the primary reservoir. This is potentially a costly disease for the

milk goat industry in the United States. (Mare, J., 1992, Foreign

Animal Diseases, U. S. Animal Health Assoc., Richmond, VA, 140-145.)

Globidiosis is due to the protozoan parasites Besnoitia besnoiti

that affect ruminants, causing damage to skin, subcutis, blood vessels,

mucous membranes and other tissues. They cause large, thick-walled

cysts and severe debilitation of the animal. Convalescence is slow, and

permanent sterility can occur in male animals. Affected animals are

lifelong carriers, but cats and other felines are the definitive

carrier host. It is found in southern Europe, Africa, Asia, and South

America, and is transmitted by several biting flies, many species of

which exist in the United States. A related species, Besnoitia bennetti

is rare, but has been found in the southern States of the United

States, and can cause a chronic disease in horses. This species would

not be considered a restricted agent. (Levine, N.D., 1985, Veterinary

Protozology, Iowa St. U. Press, Ames, IA, 256-259.)

Goat pox and sheep pox viruses cause acute to chronic generalized

pox lesions, fever, and pneumonia with a long recovery and occasionally

high mortality in sheep and goats. They are found in Africa, Asia, and

parts of Europe. Besides loss of animal productivity, these viruses

cause damage to hides and wool. The viruses are very resistant and can

be carried on hides or wool. (House, J. A, 1992, Foreign Animal

Diseases, U. S. Animal Health Assoc., Richmond, VA, 343-350.)

Heartwater, also known as Cowdriosis, is caused by a rickettsia

Cowdria ruminantium and produces an acute disease of ruminants

transmitted by ticks. It is primarily transmitted by ticks of the genus

Amblyomma. It is one of the three most serious livestock diseases in

Africa, and has been found on some of the islands of the Caribbean. Two

native North American species of Amblyomma have been found capable of

transmitting the disease. Some wild ruminant species in Africa are

known to be carriers of the infection. This is potentially one of the

most serious exotic disease threats to the U. S. livestock industry.

(Mare, J., 1992, Foreign Animal Diseases, U. S. Animal Health Assoc.,

Richmond, VA, 218-228.)

Japanese encephalitis virus causes encephalitis in people and

horses. Its primary reservoir is in birds and in swine, in which it

causes stillbirths. It is transmitted by various species of

[[Page 16981]]

mosquitoes. It is primarily found in temperate and tropical eastern

Asia. (Shope, R. E., 1992. Foreign Animal Diseases, U. S. Animal Health

Assoc., Richmond, VA, 246-253.)

Jembrana disease, also known as Tabanan disease, is caused by a

retrovirus related to Bovine Immunodeficiency-like Virus (Chadwick, B.

J., 1995, J. Gen. Virol. 76(1):189-192). It causes a rinderpest-like

disease of cattle and buffalo, and has caused heavy losses in

Indonesia. Recovered cattle may be lifetime carriers. Ticks are thought

to be a vector. (Hartaningih, N., et al., 1993. Vet. Microbiol. 38(1-

2):15-23; ibid. 38(1-2):23-29; Darma, D.M.N, et al., 1994. Vet.

Immunol. & Immunopath. 44(1):31-44.) This virus could be a serious

disease problem in much of the world. Until the epidemiology is better

known, great care should be taken to avoid importing animals that may

carry this virus into the United States.

Lumpy skin disease virus, also known as Neethling virus, causes an

acute or chronic disease in cattle characterized by skin nodules and

lymphadenitis. The virus is similar to sheep pox and goat pox viruses.

It is found throughout Africa and the Middle East. It is transmitted

primarily by biting flies. Losses are primarily due to a prolonged

recovery, with emaciation, lowered milk production, hide damage, and

other secondary infections. The virus may persist for long periods on

contaminated premises. The disease is very difficult to eradicate once

it becomes established. (House, J. A., 1992, Foreign Animal Diseases,

U. S. Animal Health Assoc., Richmond, VA, 264-272.)

Melioidosis, caused by the saprophytic soil bacteria Pseudomonas

pseudomallei, affects people and a wide variety of animals and

resembles glanders. It occurs widely throughout southeastern Asia and

parts of the tropical Americas, including Puerto Rico. It is a serious

public health problem in southeastern Asia and also causes serious loss

of production in animals. Animals may be latently infected for many

months. Once the soil becomes contaminated, it is virtually impossible

to eliminate the organism. The soil of the southeastern States in the

United States could readily become endemically contaminated with the

organism. Care must be taken to be certain that imported animals are

not the source of introduced contamination with the organism, as they

would more likely result in soil contamination than infected humans.

(Grove, M. G., Harrington, K. S., 1994, Handbook of Zoonoses, Section

A. 2nd Ed., CRC Press, Boca Raton, FL, 155-165.)

Near east encephalomyelitis affects horses and domestic ruminants,

causing a low-grade fever, nervous signs and death. The causative agent

is uncertain, but a tick-borne virus is suspected. The disease is

similar to Borna disease, which is found in Europe. The disease is

found in the Middle East and Asia. (Robertson, 1976, Handbook on Animal

Diseases in the Tropics, British Vet. Assoc., London, Eng, UK. 67-68.)

Nairobi sheep disease virus, also known as Dugbe or Ganjam virus,

is transmitted by ticks to sheep and goats and is characterized by

acute hemorrhagic gastroenteritis and high mortality. The disease is

found in Africa and Asia (Ganjam virus). The primary reservoir is the

tick Rhipicephalus appendiculatus, in which transovarial transmission

of the virus occurs. Other ticks have been found able to transmit the

virus, but cannot maintain the virus because they do not transmit it

through their eggs. (Groocock, C. M., 1992, Foreign Animal Diseases, U.

S. Animal Health Assoc., Richmond, VA, 285-292.)

Parafilaria bovicola is a filarial worm that causes hemorrhagic

nodules on the skin, with bruise-like lesions under the skin and in

muscle tissues. Several licking flies have been shown to be capable of

transmitting the parasite, including some present in the United States.

Although the parasite has been found in imported cattle in Canada, it

does not appear to have become established. All regions of the world

except Australia, New Zealand, North America, and South America appear

to be affected with this parasite. Losses include damage to hides, and

condemnation of meat from slaughtered animals. (Steen Bech-Nielsen,

1992, Foreign Animal Diseases, U. S. Animal Health Assoc., Richmond,

VA, 293-302.)

Peste des petits ruminants, also known as goat plague, is a

contagious disease due to a virus similar to rinderpest virus in sheep

and goats. Rare cases have been described in cattle and swine, but

these animals appear unable to transmit the disease to other animals.

It occurs in Africa, the Middle East and southern Asia. Wild ungulates

such as the white-tailed deer in the United States are susceptible. The

virus could become established in sheep or goats in the United States

and cause severe losses if it became established in white-tailed deer

herds or other native North American wild ruminants. (Saliki, J. T.,

1992, Foreign Animal Diseases, U.S. Anim. Health Assoc., Richmond, VA,

303-310.)

Rift Valley fever virus affects ruminants, dogs, cats and people.

It causes abortions and a fatal illness in young animals, and is

transmitted by various species of mosquitoes, including native North

American species. Its distribution has been limited to Africa. Animals

do not remain carriers of the virus for long periods of time. (Peters,

C. J. and K. J. Linthicum, 1994, in Handbook of Zoonoses, 2nd Ed.,

Section B., Ed. Beran, G. W., CRC Press, Boca Raton, FL, 125-138.)

Teschen disease, also known as polioencephalomalacia of swine,

Talfan disease, or benign enzootic paresis, is an infectious nervous

disease of pigs caused by an enterovirus similar to human

poliomyelitis. It has been found only in Europe and parts of Africa.

Control programs in Europe have virtually eliminated the virulent form

of the virus in Europe. Similar enteroviruses of swine with low

pathogenicity are found throughout the world, including North America.

Infected swine may shed the virus for several weeks even though they

may be asymptomatic. (Derbyshire, J. B., 1989, in Virus Infections of

Porcines, Ed. M. B. Pensaert, Elsevier Science Publishers, B.V., New

York, NY, 225-239.)

Theileriosis, also known as east coast fever, corridor disease, or

Mediterranean fever, are a group of diseases that affect cattle and

that occur primarily in Africa and the Mediterranean area. The

causative agent of east coast fever, Theileria parva, and the causative

agent of corridor disease, T. lawrenci, are limited in their

distribution to Africa by the distribution of Rhipicephalus spp. ticks,

which are the intermediate host. However, the existence of potential

vectors in the United States could make introduction of this agent an

animal health problem in this country. Mediterranean fever is caused by

T. annulata, which is found in the Mediterranean area and eastern

Europe and for which the intermediate host are ticks of the Hyalomma

genus. Malignant theileriosis of sheep and goats is caused by T. hirci,

and the intermediate host has been shown to be ticks of the genus

Rhipicephalus and Hyalomma. It is similar to T. annulata in its

distribution. (Young, A. S. and C. M. Groocock, 1992, Foreign Animal

Diseases, U.S. Anim. Heal. Assoc., Richmond, VA, 177-187; 1976,

Handbook on Animal Diseases in the Tropics, Ed. Robertson, A., British

Vet. Assoc., London, Eng., 178-189.)

Tick-borne encephalitis, also known as louping ill or Central

European encephalitis, is caused by a tick-transmitted group of viruses

found in Asia and Europe. Louping ill primarily affects sheep with an

acute, often fatal, encephalitis. Swine, cattle, horses, and humans may

also be affected. There may

[[Page 16982]]

be ticks in the United States that could transmit these agents, but

they have not been sufficiently researched. (Timoney, P. J., 1992,

Foreign Animal Diseases, U.S. Animal Health Assoc. Richmond, VA, 254-

263.)

Tick-borne fever (TBF), due to the rickettsia Erlichia (Cytocetes)

phagocytophilia, affects domestic and wild ruminants, causing high

fever, reduced lactation and abortion. It is transmitted by various

ticks. It is found in Africa, Asia and Europe. The carrier state in

cattle lasts for several months. The disease is seldom fatal but causes

a severe immunosuppression that exacerbates other latent infections,

such as Johne's disease. (Larsen, H. J. S. et al., 1994, Res. Vet. Sci.

56(2):216-224.) It may be able to be transmitted by some native North

American ticks, so care should be taken to prevent introduction.

(Robertson, A., 1976, Handbook on Animal Diseases in the Tropics, Brit.

Vet. Assoc. London, Eng. U.K. 88-90.)

Wesselsbron virus causes abortions, neonatal death and congenital

abnormalities primarily in sheep, but also has caused mild disease in

cattle, goats, pigs, equines, camels, rodents, dogs, and humans in sub-

Saharan Africa. It is carried by many species of African wildlife and

is transmitted by mosquitoes. This disease, if introduced into the

United States, could probably become established. It is likely that

mosquito vectors in the United States could easily transmit the virus.

(Barnard, B.J.H., 1990, in Virus Infections of Ruminants, Ed. Dinter,

Z. and B. Morein, Elsevier Sci. Publishers, New York, NY, 291-294.)

Additions of Domestic Diseases

In addition to import restrictions to guard against the importation

into the United States of animal diseases from other countries, the

regulations in 9 CFR contain requirements regarding livestock disease

agents that exist in the United States but that are subject to Federal

or cooperative Federal/State control or eradication programs. For

ruminants and swine, these diseases include Brucella abortus, B. suis

(9 CFR part 78), Mycobacterium bovis (9 CFR part 77), pseudorabies

virus (9 CFR part 85), scabies (9 CFR part 73), and scrapie (9 CFR

parts 54 and 79). With our proposed shift to a regionalized approach,

we believe it is now necessary to specifically address these diseases

in the import regulations.

Definition of Region

In Secs. 92.1, 93.401, 93,501, 94.1, 95.1, and 96.1 of this

proposed rule, we would define the term region to mean ``any defined

geographic land region identifiable by geological, political, or

surveyed boundaries.'' Under this definition, a region may be a

national entity, part of a national entity, combined parts of several

national entities, or a group of several national entities combined

into a single trading block. Section 92.5 of this proposed rule

contains procedures, discussed below under the heading ``Application

for Risk Class Recognition,'' for requesting establishment of a

specific region.

Criteria for Risk Classification

As discussed above, this proposed rule is a departure from the

current regulations in that a region would not be classified simply as

one in which a specific disease is or is not known to exist. Rather, a

region in which we have determined that a certain disease does not

exist would be classified as one of three different risk class levels,

depending on the risk that the disease might be introduced into the

region. Likewise, under this approach, two separate risk

classifications for regions in which a disease is known to exist would

be established, as well as one additional risk class category for

countries or regions that do not yet have specific classification as

another risk class level. Therefore, under this proposed rule, regions

would fall into one of six risk class levels or categories.

The six risk class levels would be titled ``RN'' or ``negligible

risk class regions,'' ``R1'' or ``slight risk class region,'' ``R2'' or

``low risk class region,'' ``R3'' or ``moderate risk class region,''

``R4'' or ``high risk class region,'' and ``RU'' or ``unknown or

unclassified risk class region.'' The criteria for each risk class are

set forth in Sec. 92.3 of this proposal. A region classified as RN

would present the least risk of disease transmission, with R1, R2, R3,

and R4 presenting increasing risk of disease transmission. An RU region

would be one that has not yet been classified.

It is important to note that each of the risk classifications would

be based on unrestricted importation of animals and animal products--

i.e., the risk of a disease being imported into the United States if no

mitigating biosecurity measures were in place. Under this proposal, the

actual biosecurity measures for the importation of animals and animal

products become increasingly stringent as the risk class number

increases. With these biosecurity measures in place, we believe that

the disease risk from the importation of animals and animal products

from each of the regions would be negligible, or equivalent to that of

a Risk Class RN. In some cases, however, because of the virulent nature

of the disease in question, no importations of susceptible animals or

animal products would be allowed from regions classified as Risk Class

R3, R4, or RU.

Under this proposal, it is possible that a region would have two or

more different classifications for different diseases that affect the

same type of animal. For example, with regard to diseases that affect

swine, a region could theoretically be classified as RN for African

swine fever and R3 for hog cholera. In such a case, the risk

classification with the more stringent restrictions (in this case R3

for hog cholera) would govern the importation of any swine from the

region, in order to assure that the most protective restrictions are

applied.

Criteria for Risk Classification

A region could seek a particular risk classification in one of two

ways. The first option would be to demonstrate to APHIS that it meets a

series of conditions, discussed below under the heading ``Risk Class

Criteria,'' regarding such factors as disease history, surveillance,

geography, and infrastructure. Assessing disease risk based solely on

such conditions is consistent with APHIS's current method of

determining the risk that a particular disease exists in a country. It

differs from our current approach in that it would be applicable to

regions, rather than just to countries, and that it takes into account

different levels of risk.

We recognize, however, that qualitative conditions can be used in

developing a quantitative risk assessment (QRA) that estimates the

probability of the existence of disease in numerical terms. We view

such a QRA, conducted according to accepted scientific standards, as an

alternative to assessing disease risk based solely on qualitative

criteria, and have included such an option in Sec. 92.3 of this

proposed rule. Therefore, under this proposed rule, a region seeking a

particular disease classification could do so either by meeting the

qualitative criteria for that classification, or by conducting and

submitting to APHIS a scientifically valid QRA determined by the

Administrator to demonstrate that the probability of the existence in

that region of a live animal infected with a particular disease does

not exceed the risk limit we propose for that disease classification.

The risk limit for each of the risk level classifications is discussed

below.

Because determination of disease risk through a scientifically

valid QRA would constitute a substantial departure from our current

method of assessing the disease risk of an area, we encourage

[[Page 16983]]

comments from the public on whether such QRA's constitute a reasonable

alternative to assessing risk solely based on qualitative criteria,

and, if so, what methodologies would be acceptable in determining

disease risk. We are proposing that a risk classification would be

assigned by the Administrator based on a QRA only after the

Administrator has reviewed the assessment and has determined that it

was developed according to scientifically acceptable methods.

For each of the proposed risk classifications we discuss below, we

set forth a risk limit we believe would be acceptable for that

classification if a valid QRA were conducted. For instance, for a

region to be classified as Risk Class RN (Negligible Risk), we propose

that a QRA must conclude that fewer than 1 per 1 million (10-6)

live animals in that region would be expected to be infected with a

restricted agent. We have proposed these numerical limits based on the

level of risk we believe should reasonably be expected in a region

considered to be of ``negligible,'' ``slight,'' ``low,'' ``moderate,''

``high,'' or ``unknown'' risk, respectively. We recognize, however,

that research and other data may be available from the public that will

suggest that the numerical limits we are proposing be adjusted before

this rule is made final. We encourage the submission of such

information from the public.

A discussion of each of the risk class levels follows.

Risk Class RN Regions

Animals or animal products imported from a region classified as

Risk Class RN would present a negligible risk of introducing or

spreading a disease in the United States. The dictionary definition of

``negligible'' would apply,i.e., ``so small or unimportant or of so

little consequence as to warrant little or no attention'' (Webster's

3rd New International Dictionary, 1966, Rand McNally and Co. Chicago,

Ill.).

To achieve Risk Class RN classification, the region would have to

be one in which the restricted agent has not been diagnosed within the

region during the lifetime of any currently living susceptible animals.

The mere fact that the restricted agent has not been reported in a

region would not be considered adequate evidence of absence of the

disease, if it cannot be shown that surveillance in the region is in

place to report, diagnose, and control any occurrences of the disease

(passive surveillance). Occasional or periodic surveys for the

restricted agent in the region (active surveillance) would be

beneficial but not necessarily required in all cases. The requirement

for surveys could depend upon the disease and type of infrastructure in

the region. For instance, although it may be necessary, in order to

determine the initial classification of a region, to have a survey

conducted to establish that a disease does not appear to be present,

there may be no need for subsequent surveys as long as passive

surveillance exists. This determination would be made by the APHIS

evaluation team that evaluates the application for recognition of a

region. Not requiring active surveillance in all cases in an RN region

would be parallel to the situation in the United States, where as a

rule routine surveillance testing is not done for exotic diseases but

passive surveillance is maintained.

Additionally, for a region to be classified as RN, the restricted

agent could not be known to exist within any defined region adjacent to

the RN region, and any adjacent R1 or R2 regions (described below) for

the disease would need to be separated from the RN region by natural or

man-made physical barriers or protected borders. All border access

points from adjacent R1 or R2 regions for the disease would need to be

controlled to prevent movement of susceptible animals or animal

products from the adjacent regions, except under conditions that have

been reviewed and approved by the Administrator of APHIS. Movement of

animals and animal products into the RN region from R1, R2, R3, R4 or

RU regions for the disease would need to be done only under conditions

that have been determined by the Administrator to achieve the same

level of biosecurity as required for importation from R1, R2, R3, R4,

or RU regions into the United States.

Also, in general, vaccination of any potential carrier animals for

restricted disease agents must have been prohibited within the RN

region during the lifetime of any currently living susceptible animals.

However, vaccinations could be allowed for certain diseases such as

vector-transmitted diseases, or for animals specifically vaccinated to

meet import requirements of other regions, when the Administrator

determines that such vaccination would not increase the risk of

importing restricted agents into the United States. Whether such

vaccination would be allowed would depend on the disease in question,

the type of vaccine used, and factors such as whether the vaccinated

animals are immediately exported from the region.

In a region classified as Risk Class RN, there would need to be

resources and commitment on the part of the animal health authorities

governing the region and of the animal industry in question to respond

to any occurrences of a restricted agent. We would interpret

``respond'' to mean taking action to rapidly control and eradicate any

occurrences of the restricted agent that might occur.

If a QRA using scientifically accepted methods is done, the results

for an RN region would need to show that fewer than 1 out of 1 million

(1 x 10-6) live animals would be expected to be affected with the

restricted agent. Based on the standards of negligible risk employed by

other Federal agencies, we believe that a region in which 10-6

live animals would be expected to be infected could reasonably be

classified as a region of negligible risk.

A region previously classified as Risk Class RN in which a

restricted agent is determined to exist could be reclassified as Risk

Class RN 3 years after all known infected and exposed reservoirs of

disease in the region have been eliminated.

Risk Class R1 Regions

Animals or animal products imported without restriction from a

region classified as Risk Class R1 would present a slight risk of

introducing or spreading a disease in the United States. Again, the

dictionary definition of the term would apply. ``Slight'' is defined as

``small of its kind or in amount'' (Webster's 3rd New International

Dictionary, 1966, Rand McNally and Co. Chicago, Ill.). We would

consider a region that presents a slight risk (Risk Class R1) to be

essentially the same as one that presents a negligible risk (Risk Class

RN), except that regions classified as R1 that have been previously

affected with a particular disease may not have been without the

presence of the disease for as long a period of time as an RN region,

and R1 regions may be regions that share borders with, or trade

extensively with, regions where the disease is known to exist. The

likelihood of residual infection in the R1 region would be considered

to be negligible.

Vaccination requirements would be the same as for Risk Class RN

regions, except that there could be animals within the region that were

vaccinated prior to the region being classified as Risk Class R1,

provided they are under provisional quarantine. In Sec. 92.1 of the

proposed regulations, a provisional quarantine would be defined as

restrictions placed on movements of vaccinated livestock where the

restricted agent in question is not known to exist in livestock, but

where

[[Page 16984]]

the possibility of exposure exists. Under a provisional quarantine,

vaccinated livestock not known to be affected with the disease could be

moved to affected regions, i.e., to regions having animals affected

with the disease, or to regions that do permit vaccination.

Under the proposed regulations, a region classified as R1 could be

adjacent to regions that are affected with the disease in question, but

would need to be separated from those regions by natural or man-made

physical barriers, or by protected borders. If border controls were not

in place, affected animals, animal products, or vectors could move or

be moved readily across the border. However, to guard against such

movement, all border access points from adjacent R2, R3, R4 or RU

regions would need to be controlled to prevent movement of susceptible

animals or animal products from the adjacent regions, except under

conditions that have been reviewed and approved by the Administrator.

In an R1 region, there must be active surveillance for the

restricted agent in the region. However, as a matter of policy, we

would not require that the surveillance be continuous, because, in a

region classified as Risk Class R1, the concern would not be primarily

with residual infection in the region or with vaccine masking of

infection. Any infection that might be found in the region should be an

introduced infection. Because the population in an R1 region would be

susceptible and the disease would be one not familiar to the region,

passive surveillance would be effective in detecting any occurrence of

the disease. The requirement regarding adequate response to disease

introduction that is discussed above under RN criteria would also apply

to R1 regions.

If a QRA is done using scientifically accepted methods, the results

for an R1 region would need to show that fewer than 1 per 100,000

(1x10-5) live animals would be expected to be infected with the

restricted agent.

A region previously classified as Risk Class RN or R1 in which a

restricted agent is determined to exist could be reclassified as Risk

Class R1 2 years after all known infected and exposed reservoirs of

disease in the region have been eliminated.

Risk Class R2 Regions

Animals or animal products imported without restriction from a Risk

Class R2 region would present a low risk of introducing or spreading a

disease in the United States. A Risk Class R2 region would be one that

has been affected with a particular restricted agent in the past, but

in which a sufficient period of time has passed (5 years for bovine

spongiform encephalopathy and scrapie, 1 year for all other restricted

diseases) with no reported cases of the disease to make it likely that

active disease no longer exists in the region. In a Risk Class R2

region, the maximum annual herd incidence of the restricted agent over

the past 5 years would need to be less than 0.1 percent, the likelihood

of residual infection would be low and there would be a low risk of

importation of affected animals, animal products or vectors from

adjacent areas or trading partners.

Any adjacent R3, R4, or RU regions for the disease would need to be

separated by natural or man-made physical barriers, or protected

borders, and there would need to be suitable control of border access

points from adjacent R3, R4, or RU regions for the disease to prevent

movement of susceptible animals or animal products from the adjacent

regions, except under conditions that have been reviewed and approved

by the Administrator. Movement of animals and animal products into the

R2 region from R3, R4, or RU regions for the disease could be done only

under conditions that have been reviewed by the Administrator and that

have been determined to achieve the same level of biosecurity as

required for importation from R3, R4, or RU regions into the United

States.

There would need to be a continuous active surveillance program in

the region, as well as a passive surveillance system, and, as for an R1

region, there would need to be resources and commitment on the part of

the animal health authorities governing the region and of the animal

industry in question to respond to (i.e., rapidly control and

eradicate) any occurrences of the restricted agent.

Vaccination may be allowed in the R2 region, under the same

conditions as for an RN or R1 region, with additional vaccination

allowed for those herds that are at greatest risk of exposure from

animals from affected regions. Generally, however, as a matter of

policy, vaccinated animals will not be allowed into the United States.

Under our current regulations in parts 92 and 94, a country that

permits vaccination would not normally be considered free of the

disease in question.

If a QRA is done using scientifically accepted methods, the results

for an R2 region would need to show that fewer than 1 per 10,000

(1x10-4) live animals would be expected to be infected with the

restricted agent.

Risk Class R3 Regions

Animals or animal products imported without restriction from a Risk

Class R3 region would present a moderate risk of introducing or

spreading a disease in the United States. Such a region would meet the

definition of a ``low prevalence region'' under the GATT agreement.

(GATT, Side Agreement on the Application of Sanitary and Phytosanitary

Measures, Annex A, Item 7; also GATT Implementing Act, Dec. 1994,

Sanitary and Phytosanitary Measures, Section 1, Paragraph f). In an R3

region, a restricted agent may have been diagnosed within the previous

year, but the annual herd incidence of the disease over the previous 5

years may not have exceeded 0.1 percent.

Any adjacent R4 and RU regions for the disease would need to be

separated by natural or man-made physical barriers or protected

borders, and all border access points from adjacent R3, R4, or RU

regions for the disease would have to be strictly controlled to prevent

movement of susceptible animals or animal products from the adjacent

regions, except under conditions that have been reviewed and approved

by the Administrator. Movement of animals and animal products into the

region would need to be carried out only under conditions that have

been reviewed by the Administrator and that have been determined to

achieve the same level of biosecurity as required for importation from

R4 or RU regions into the United States.

Vaccination would be allowed under the same conditions as for an R2

region. Such a region would need to have an active control and

surveillance program, with the goal of eradicating the disease in

question.

The results of a QRA for an R3 region, if done, would need to show

that fewer than 1 per 1,000 (1x10-3) live animals would be

expected to be infected with the restricted agent.

Risk Class R4 Regions

Animals or animal products imported without restriction from a Risk

Class R4 region would present a high risk of introducing or spreading a

disease in the United States. A ``high risk'' region would be one in

which a control and surveillance program exists, but in which the

prevalence of the restricted agent is excessively high or where the

program does not have the goal of eradication. In an R4 region, a

restricted agent has been diagnosed during the previous year, and the

annual herd incidence of the disease over the past 5 years may have

exceeded 0.1 percent in 1 or more years or may be unknown.

[[Page 16985]]

The R4 region would need to maintain a passive and active surveillance

system for restricted disease agents, but the level of surveillance may

not fully meet standards for an R3 region.

In an R4 region, vaccination for any restricted agent may vary from

herd to herd within the region. If vaccination is used as the primary

control procedure, at least 80 percent of the livestock in 80 percent

of the herds must be vaccinated as often as recommended by the

manufacturers of the vaccine. In an R4 region, movement of animals and

animal products from R3, R4 and RU regions for the restricted agent may

not be adequately controlled.

The results of a QRA for an R4 region, if done, would need to show

that less than 1 per 100 (1x10-2) live animals would be expected

to be infected with the restricted agent.

Risk Class RU Regions

An additional risk category, Risk Class RU, will be defined as an

unclassified or unknown risk. Such a region may not have any

surveillance or control program. A region classified as RU may report

no known occurrence of a restricted agent, but, because of lack of

surveillance, cannot be expected to provide reliable data about the

occurrence of the disease in the region. A region classified as RU may

have the necessary data to qualify as a classified region, but if the

officials in the region have not furnished the data, requested

classification of the region, or allowed reasonable access as required

in NAFTA, vol. I, part 2, chap. 7, section B, article 716 or GATT-

AASPM, article 6, the region shall remain unclassified. The results of

a QRA may not be possible from an RU region due to lack of information;

or, if information is available, the results may exceed 1 per 100

(1x10-2) live animals in the region expected to be infected.

In cases where a QRA is not done, the qualitative criteria for

classification of an area, as set forth in proposed Sec. 92.3,

``Criteria for risk classification,'' will be used to classify a region

as a Risk Class RN (Negligible Risk), R1 (Slight Risk), R2 (Low Risk),

R3 (Moderate Risk), or R4 (High Risk). Any region that does not meet

the qualitative requirements of these risk classifications, or does not

meet the minimally acceptable risk level expected of a QRA, will be

classified as Risk Class RU (Unclassified or Unknown). When the results

of a QRA are not available for calculating the risk of introduction of

a restricted agent through a specific commodity, then the upper limits

of the QRA for the risk class region will be used as the source or

country factor (explained below) in calculating the final risk.

Calculating Risk

In determining whether a particular commodity (animal or animal

product) should be imported into the United States, the ultimate

concern is how much of a risk of disease introduction does that

commodity present. For the purposes of this discussion, we refer to the

ultimate risk of disease introduction as ``final risk.'' Before a

commodity would be allowed to be imported under this proposed rule, the

final risk would have to be negligible.

In arriving at final risk, several different types of risk need to

be considered. These risks can be identified according to the source

(country or region), to the commodity (live animals or animal

products), and to the destination (importing country or region). All of

these risks contribute to calculating the final risk of disease

introduction into the importing country or region. Even commodities

from regions with a relatively high source risk can present a

negligible final risk if adequate mitigating measures are taken to

reduce the commodity risk. Measures can also be taken at the

destination (e.g., post-entry quarantine) to reduce the destination

risk.

The risk classifications described in Sec. 92.3 of this proposed

rule establish the risk only for the source, with no consideration of

what kind of product or commodity is being exported. These risk

classifications are then used as a starting point from which to

determine the necessary mitigating measures for each commodity, as set

forth in Secs. 93.415 and 93.515 of this proposed rule, for live

ruminants and swine respectively, and as set forth in parts 94, 95, 96,

and 98 for meat, germplasm, and other animal products.

The ``commodity risk'' is distinct from the source or destination

risk. In calculating the commodity risk, the assumption is that the

commodity begins as infected or contaminated. The commodity risk would

be the likelihood that the commodity would still be infected after the

storage, handling, processing, etc., it must undergo in reaching the

final user. The commodity risk would be the same for like commodities,

regardless of the source or destination risk. Theoretically, the final

risk, i.e., the risk after mitigating measures are applied, would be

the source risk times the commodity risk times the destination risk.

However, in calculating the ``final risk'' for importations into the

United States, we would multiply only the commodity risk times the

source risk, and not factor in the destination risk. We are using this

cautious approach to determine risk based on the premise that any

importation of a restricted agent is undesirable.

However, we invite comments on whether ``destination risk'' should

also be factored into ``final risk.'' We recognize that, in some cases,

the restricted transportation in the United States and ultimate

restricted use of a regulated product can reduce the risk that the

product will endanger the livestock of the United States. For instance,

Sec. 94.12(b)(4) of the current regulations allows, in specific cases,

for the importation of small amounts of pork or pork products whose

importation is otherwise restricted due to the existence of swine

vesicular disease in the country of origin, provided the pork or

product is imported for examination, testing, or analysis, and provided

the importation is approved by the Administrator.

We invite comment on whether factors such as destination or use

should be generally considered in establishing ``final risk'' under the

revised regulations. We particularly invite comment regarding the

mitigating effects of the use of products and the destination of

animals. For example, with regard to a vector-borne disease, should

restrictions on the importation of an animal take into account whether

the vector is not known to exist in the area of the animal's

destination, or is not active at the time of year the animal is to be

imported?

Proposed Risk Model

The formulae for calculating the risk of importing a restricted

agent can be illustrated with the following model: Assuming that a

commodity with a risk factor calculated to be 1 per million (1/

1,000,000) is imported from a source region classified as R3 (risk

factor 1 per thousand (1/1,000)) where a specific QRA has not been

done, then the final risk per unit of the commodity would be 1/

1,000,000 times 1/1,000 or 1/1,000,000,000 (1 per billion or

.000,000,001). If 1 million animal units were going to be represented

in the total commodity imported per year, then the likelihood of

importing one or more infected units of the commodity would be as

follows:

Given:

P{I=0} = Probability of zero infected units in the shipment.

P{I>0} = Probability of one or more infected units in the

shipment.

p = Risk probability factor = 1 per billion or .000,000,001.

N = Number of animal units represented in the shipment.

[[Page 16986]]

Then: From the Binomial distribution function, the following

formula is derived.

P{I=0} = (1-p)N

Therefore:

P{I>0} = 1-P{I=0} = 1-(1-p)N

= 1-[1-(.000,000,001)]1,000,000 = .001 (1 per 1,000)

or, to calculate the frequency that such an event would be expected to

occur:

1.001 = 1,000

Therefore, we could expect importation of 1 or more infected units

of the commodity every 1,000 years, provided the same commodity from 1

million animal units were imported each year into perpetuity.

APHIS requests comments on whether, or to what extent, the binomial

model proposed above is appropriate for estimating in the context of

animal populations. Comments should suggest and describe alternative

statistical models.

Listing of Risk Classifications for Individual Regions

Section 92.4 of this proposed rule contains listings of risk

classifications for individual regions. This information is presented

in two formats. Proposed Sec. 92.4(a) is formatted so that each region

listed is followed immediately by the risk classification assigned to

that region for each restricted agent. For instance, a listing for all

the regions in Africa is followed by the information that those regions

are classified as Risk Class RN for Japanese encephalitis virus.

Proposed Sec. 92.4(b) is formatted in such a way that all regions

that fall under a particular risk classification for a particular

disease are listed together. For instance, the listing for RN regions

for Japanese encephalitis virus would include all regions in Africa and

all other regions that are classified RN for Japanese encephalitis

virus.

In the following paragraphs, we list the proposed classifications

of the regions of the world, and set forth the rationale for such

classifications. Because this initial proposed listing is based on

disease statuses as set forth in the current regulations or, in cases

where the disease is not specifically listed in the current

regulations, on the published epidemiologic information about the

disease distribution, it consists of national entities (countries).

However, under this proposed rule, requests may be submitted to APHIS

for recognition and classification of regions smaller or larger than

individual countries. In all cases where neither regulatory precedent

nor adequate published epidemiologic data existed to classify a country

as either Risk Class RN, R1, R2, R3 or R4, we have proposed to classify

the country as Risk Class RU for unknown risk or unclassified risk.

Where a disease agent has not been reported from a country, and there

is no evidence that the disease agent now exists or has ever existed in

the country, we have proposed to classify the country as Risk Class RN.

(Because this rationale for Risk Class RN classification is the same

for most but not all countries, we have used a footnote to refer to

this rationale where applicable.) The proposed classifications are

based on the epidemiological, geographical, and infrastructure data

currently available to us. We welcome information from the public,

supported by specific scientific evidence or other data, concurring

with or recommending changes to the classifications.

In many cases, the risk classification for a particular disease is

the same for all the countries in a geographically or politically

linked group of countries. Therefore, to avoid unnecessary repetition

of individual countries, for the purposes of these regulations we have

combined countries of the world into groupings. The following groupings

are set forth in Sec. 92.1, ``Definitions,'' of the proposed

regulations.

Africa: Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi,

Cameroon, Central African Republic, Chad, Comoros, Congo, Djibouti,

Egypt, Equatorial Guinea, Gabon, Ghana, Guinea, Guinea-Bissau, Ivory

Coast, Kenya, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali,

Mauritania, Morocco, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao

Tome and Princip, Senegal, Sierra Leone, Somalia, South Africa, Sudan,

Swaziland, Tanzania, The Gambia, Togo, Tunisia, Uganda, Western Sahara,

Zaire, Zambia, Zimbabwe.

Asia: Afghanistan, Armenia, Azerbaijan, Bangladesh, Bhutan, Burma,

Cambodia, China, Georgia, Hong Kong, India, Iran, Japan, Kazakhstan,

Kygyzstan, Laos, Macau, Malaysia, Mongolia, Nepal, North Korea,

Pakistan, Russia, Singapore, South Korea, Sri Lanka, Taiwan,

Tajikistak, Thailand, Turkistan, Uzbekistan, Vietnam.

Atlantic: Bermuda, Cape Verde, Falkland Islands, South Georgia.

Australia: Australia.

Caribbean: Anguilla, Aruba, Barbados, British Virgin Islands,

Cayman Islands, Cuba, Dominica, Dominican Republic, Grenada,

Guadeloupe, Haiti, Jamaica, Martinique, Montserrat, Netherlands

Antilles, Puerto Rico, Saint Lucia, Saint Vincent, The Bahamas,

Trinidad and Tobago, Turks and Caicos, U.S. Virgin Islands.

Europe: Albania, Andorra, Austria, Belgium, Bosnia-Herzogovania,

Bulgaria, Bylorus, Croatia, Czech Republic, Denmark, Estonia, Finland,

France, Germany, Gibraltar, Greece, Greenland, Hungary, Iceland,

Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg,

Macedonia, Moldavia, Monaco, Netherlands, Norway, Poland, Portugal,

Romania, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Ukraine, United Kingdom (England, Scotland, Wales, Northern Ireland,

Channel Islands, Isle of Man), Vatican City, Yugoslavia.

Middle America: Belize, Costa Rica, El Salvador, Guatemala,

Honduras, Nicaragua, Panama.

Middle East: Bahrain, Cyprus, Iraq, Israel, Jordan, Kuwait,

Lebanon, Malta, North Yemen, Oman, Palestine, Qatar, Saudi Arabia,

South Yemen, Syria, Turkey, United Arab Emirates.

New Zealand: New Zealand.

North America: Canada, Mexico, United States.

Oceania: Brunei, Fiji, French Polynesia, Indonesia, Kiribati,

Maldives, Mauritius, Nauru, New Caledonia, Papua New Guinea,

Philippines, Seychelles, Solomon Islands, Tonga, Vanuatu, Western

Samoa.

South America: Argentina, Bolivia, Brazil, Chile, Colombia,

Ecuador, French Guiana, Guyana, Paraguay, Peru, Suriname, Uruguay,

Venezuela.

Note: We use the term ``Middle America'' for the area sometimes

referred to as ``Central America,'' in order to make clear that Panama

is a part of the grouping in question. Historically, in some usages,

Panama was not considered to be part of Central America.

Risk Classification by Region

African swine fever virus.

Risk Class RN. All regions of Asia, Atlantic, Australia, Middle

America, Middle East, New Zealand, North America, and Oceania.1

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\1\ The restricted agent in question has not been reported from

these countries, nor is there any evidence that it now or has ever

existed in these countries.

---------------------------------------------------------------------------

Risk Class R1. All regions of Europe except Italy, Spain and

Portugal; all regions of the Caribbean except Cuba and Haiti; and all

regions of South America except Brazil.

African swine fever has been reported in parts of Italy, Spain and

Portugal. The rest of Europe is tentatively classified as R1 because

the regions there are adjacent to affected regions or conduct extensive

trade with these regions. African swine fever has been reported in

Cuba, Haiti, and Brazil, and the current

[[Page 16987]]

status of the disease in these countries is uncertain.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Aino virus.

Risk Class RN. All regions of Atlantic, Caribbean, Europe, Middle

America, New Zealand, North America, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Akabane virus.

Risk Class RN. All regions of Atlantic, Caribbean, Europe, Middle

America, New Zealand, North America, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Bluetongue virus (except serotypes 10, 11, 13 and 17).

Risk Class RN. Canada, New Zealand, Mexico, and all regions of

Europe except Greece.

Bluetongue virus has not been reported in Europe, except recently

in Greece. Bluetongue type 10 occurred in Spain and Portugal in the

1950's but never became established. New Zealand has never had

Bluetongue of any type. Canada and Mexico are known only to be affected

with the same types as the United States (10, 11, 13 and 17).

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Besnoitia besnoiti (globidiosis).

Risk Class RN. All regions of Atlantic, Australia, Caribbean,

Middle America, New Zealand, North America, and Oceania.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Bovine ephemeral fever virus group (Kotonkan, Obodhiang).

Risk Class RN. All regions of Atlantic, Caribbean, Europe, Middle

America, Middle East, New Zealand, North America, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Bovine spongiform encephalopathy.

Risk Class RN. All regions of Africa, Asia, Atlantic, Australia,

Caribbean, Middle America, New Zealand, Oceania, and South America; all

regions of North America except Canada.\1\

Risk Class R1. All regions of the Middle East except Oman; All

regions of Europe except Denmark, France, Great Britain, Northern

Ireland, Republic of Ireland, and Switzerland.

Bovine spongiform encephalopathy has never been reported from the

Middle East except for Oman. No country of Europe except those listed

as exceptions to Risk Class R1 have ever reported the disease. They are

listed as Risk Class R1 because of adjacency to affected countries and/

or extensive trade with those countries.

Risk Class R2. Canada.

Canada had a single case of bovine spongiform encephalopathy in a

bovine imported from the United Kingdom. The animal was destroyed and

the United States has been kept well informed of the status of all

contact animals.

There is no evidence of further cases in Canada.

Risk Class R3. None.

Risk Class R4. Denmark, France, United Kingdom, Republic of

Ireland, Oman, and Switzerland.

These are all countries that have reported one or more cases of

bovine spongiform encephalopathy. All of these countries have programs

to control the disease. Some of these countries or regions within them

may qualify as Risk Class R1, R2 or R3 regions but we do not have

sufficient information at present to consider them for a higher class.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Bovine infectious petechial fever.

Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,

Europe, Middle America, Middle East, New Zealand, North America,

Oceania, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Brucella abortus.

Risk Class RN. Belize, Bulgaria, Channel Island (U.K), Cyprus,

Denmark, Finland, French Polynesia, Hungary, Israel, Norway, Papua New

Guinea, Romania, Sweden, and Switzerland.

All of these regions have reported eradication of Brucella abortus

from their livestock populations over 15 years ago. (Crawford RP, Huber

JD, Adams BS. Epidemiology and Surveillance. in Animal Brucellosis

edited by Nielsen K, and Duncan JR. CRC Press, Boca Raton, Florida,

33431, 131-151, 1990.)

Risk Class R1. Australia, Canada, Czech Republic, Germany,

Slovakia, United Kingdom except Channel Islands.

All of these regions have reported eradication of Brucella abortus

from their livestock population more than 5 years ago. (Crawford RP,

Huber JD, Adams BS. Epidemiology and Surveillance. in Animal

Brucellosis edited by Nielsen K, and Duncan JR. CRC Press, Boca Raton,

Florida, 33431, 131-151, 1990.)

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Brucella melitensis.

Risk Class RN. All regions of Oceania, Australia, Canada, Czech

Republic, Denmark, Estonia, Finland, Greenland, Iceland, Ireland,

Latvia, Lithuania, Luxembourg, Netherlands, New Zealand, Norway,

Poland, Slovakia, Sweden, United Kingdom, and Taiwan.

None of these regions has ever reported Brucella melitensis (Alton

GG. Brucella melitensis. in Animal Brucellosis edited by Nielsen K, and

Duncan JR. CRC Press, Boca Raton, Florida, 33431, 393-409, 1990.)

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Brucellosis due to Brucella suis except biovar 4.

Risk Class RN. Canada, Ireland, United Kingdom.

None of these regions has ever reported Brucella suis (Alton GG.

Brucella suis. in Animal Brucellosis edited by Nielsen K, and Duncan

JR. CRC Press, Boca Raton, Florida, 33431, 411-422, 1990.)

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Brucellosis due to Brucella suis biovar 4.

[[Page 16988]]

Risk Class RN. Africa, Asia except Russia, Atlantic, Australia,

Caribbean, Europe, Mexico, Middle America, Middle East, New Zealand,

Oceania, South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3, or R4.

Congo virus (Crimean Hemorrhagic Disease).

Risk Class RN. All regions of Atlantic, Caribbean, Middle America,

New Zealand, North America, Oceania, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Contagious agalactia of sheep and goats due to Mycoplasma

agalactiae.

Risk Class RN. All regions of Australia, Caribbean, Middle America,

New Zealand, North America, South America.\1\

Risk Class R1. None

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Contagious bovine pleuropneumonia due to Mycoplasma mycoides var

mycoides (CBPP).

Risk Class RN. All regions of Atlantic, Caribbean, Middle America,

New Zealand, North America, and South America.

These regions have never reported the presence of this agent, or

the agent has been eradicated for more than 15 years. (Brown C.

Contagious Bovine Pleuropneumonia, in Foreign Animal Diseases, edited

by Buisch WW, Hyde JL, Mebus CA. United States Animal Health

Association, Richmond VA. 146-151, 1992.)

Risk Class R1. Australia, all regions of Europe except Portugal

and Spain. Europe has been free of CBPP for over 15 years, except for

recent outbreaks in Portugal and Spain. Australia eradicated the

disease in 1975, but the status of neighboring areas in Oceania is more

uncertain. Therefore, we have proposed to classify Australia and all

regions of Europe as Risk Class R1 until further data can be reviewed.

(Clay AL, Lloyd LC. The Eradication of Contagious Bovine

Pleuropneumonia from Australia. Bull. Off. Inter. Epiz., 81(7/8):533-

546, 1975.)

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Contagious caprine pleuropneumonia (Mycoplasma mycoides subsp.

capri)

Risk Class RN. All regions of Atlantic, Caribbean, Middle America,

New Zealand, North America, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Epizootic hemorrhagic disease virus of deer (Ibaraki) (except

serotypes 1 and 2).

Risk Class RN. Canada, Europe, Mexico, New Zealand. Europe and New

Zealand have never reported the presence of this agent and there is no

evidence that it now exists or has ever existed in these regions.

Canada and Mexico have been affected only by serotypes 1 and/or 2,

which are endemic in the United States.

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Foot-and-mouth disease virus.

Risk Class RN. Australia; Barbados; Bermuda; all regions of North

and Middle America except Panama; all regions of the Caribbean except

The Bahamas; Greenland, Iceland, Territory of St. Pierre and Miquelon,

Trust territory of the Pacific Islands.

These regions are listed in Sec. 94.1(a)(2) of the current

regulations as countries free of both rinderpest and foot-and-mouth

disease. They are not listed in current Sec. 94.11(a) as countries

that, because of importations of meat from or proximity to rinderpest

or FMD-affected countries, are subject to restrictions on importations

of meat or meat products into the United States.

Risk Class R1. Austria, The Bahamas, Belgium, Chile, Denmark, Fiji,

Finland, France, Germany, United Kingdom, Hungary, Japan, New

Caledonia, The Netherlands, Norway, Papua New Guinea, Panama, Poland,

Portugal, Republic of Ireland, Republic of Korea, Sweden, Spain,

Switzerland, and Uruguay.

These regions are listed in Sec. 94.11(a) as countries free of

rinderpest and FMD that supplement their meat supply with imports from

countries affected with rinderpest or FMD, or that have a contiguous

border with countries affected with rinderpest or FMD. Because the

current regulations do not distinguish between countries affected with

rinderpest and those affected with FMD, at this time we cannot separate

those that import from countries that are infected with rinderpest but

not with FMD. We are proposing to include Fiji, New Caledonia and

Panama as Risk Class R1 regions because they are adjacent to regions

that are considered to be affected with FMD.

Risk Class R2. Argentina.

The effect of this classification would be to allow the importation

into the United States from Argentina of ruminants and fresh, chilled,

and frozen meat of ruminants. However, those importations would be

subject to certain restrictions, as set forth in Sec. 93.415 of this

proposal. This classification would also relieve certain prohibitions

and restrictions on the importation from Argentina of milk and milk

products of ruminants.

We believe classifying Argentina as a Risk Class R2 region for FMD

is appropriate. The last outbreak of FMD in Argentina occurred in 1994.

However, vaccinations for FMD in Argentina still continue.

Additionally, Argentina supplements its national meat supply by

importing fresh, chilled and frozen meat of ruminants and swine from

countries listed in this proposed rule as Risk Class R3, R4 or RU.

Argentina also shares land borders with Brazil and Bolivia, which are

both designated in this proposed rule as Risk Class RU regions.

In determining the proposed classification for Argentina, APHIS

reviewed the documentation submitted by the government of Argentina in

support of its request to be considered free of FMD, and a team of

APHIS officials traveled to that country in 1994 to conduct an on-site

evaluation of the country's animal health program. The evaluation

consisted of a review of Argentina's veterinary services, diagnostic

procedures, vaccination practices, and administration of laws and

regulations intended to prevent the introduction of FMD into Argentina

through the importation of animals, meat, or animal products. The APHIS

officials conducting the on-site evaluation concluded that Argentina is

a low risk region for FMD. (Details concerning the on-site evaluation

are available from the person listed under FOR FURTHER INFORMATION

CONTACT.'')

Based on our proposed risk classification of Argentina, meat and

other animal products of ruminants or

[[Page 16989]]

swine, as well as the ship's stores, airplane meals, or baggage

containing such meat or other animal products originating in Argentina

would be subject to the restrictions specified in Sec. 94.11 of these

proposed regulations.

Risk Class R3. Greece and Italy.

Greece and Italy recently have had localized outbreaks of FMD,

which have been controlled. Until more information is available, we are

proposing to classify these countries as Risk Class R3 regions.

However, it is possible this classifications could be limited to

smaller areas of these countries when the situation is further reviewed

under the procedures provided in Sec. 92.5 of this proposal.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Getah virus.

Risk Class RN. All regions of Africa, Atlantic, Caribbean, Europe,

Middle America, Middle East, New Zealand, North America, and South

America.1

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Heartwater due to rickettsia Cowdria ruminantium.

Risk Class RN. All regions of Asia, Atlantic, Australia, Europe,

Middle America, Middle East, New Zealand, North America, Oceania, and

South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Hog cholera (classical swine fever).

Risk Class RN. Australia, Canada, Dominican Republic, Fiji, United

Kingdom, Iceland, New Zealand, Norway, the Republic of Ireland, Sweden,

and Trust Territory of the Pacific Islands.

These regions are listed in Secs. 94.9 and 94.10 of the current

regulations as countries where hog cholera does not exist, and they

neither are adjacent to nor trade extensively with regions where hog

cholera is known to exist.

Risk Class R1. Denmark, Finland, Spain, and the State of Sonora in

Mexico.

Denmark, Finland, and Spain are listed in Secs. 94.9 and 94.10 of

the current regulations as countries where hog cholera does not exist.

However, because they are adjacent to or trade extensively with regions

where hog cholera is known to exist, we propose that these regions be

classified as Risk Class R1.

In June, 1994, the Department received a request from the Chief

Animal Health Officials in the country of Mexico for recognition of the

State of Sonora as a region free of hog cholera under the sanitary and

phytosanitary provisions of the North American Free Trade Agreement

(NAFTA) and the General Agreement on Tariffs and Trade (GATT).

Under the current regulations, there is no provision for

recognition of regions of a country as free of a disease if the entire

country is not free of that disease. However, such recognition would be

possible under this proposed rule. Therefore, as a result of the

request from Mexico, a team of APHIS personnel reviewed the request in

accordance with Sec. 92.3 of this proposed rule. A site visit by

personnel from APHIS was conducted on October 24-28, 1994, which

confirmed the facts of the request from the Mexican government.\2\

---------------------------------------------------------------------------

\2\ Copies of the State of Sonora site visit report may be

obtained from USDA, APHIS, National Center for Import and Export,

4700 River Road Unit 39, Riverdale, MD 20837-1231. Requests may be

made by telephone to (301) 734-7511 or by FAX to (301) 734-6402.

---------------------------------------------------------------------------

Therefore, in this proposed rule, we are proposing that the State

of Sonora in the country of Mexico be included as a Risk Class R1

region for hog cholera, because we believe the region meets some of the

criteria for a Risk Class RN region for hog cholera, and some of the

criteria for an R1 region according to Sec. 92.3 of this proposed rule.

We believe this classification would be warranted due to the

following facts:

1. Hog cholera virus has not been diagnosed in Sonora, Mexico for

10 years (since 1985). This would meet the requirements for a Risk

Class RN (negligible risk) region for hog cholera according to

Sec. 92.3(a)(1) of this proposed rule.

2. Hog cholera virus is currently not known to exist in any of the

States of Mexico or the United States that adjoin the State of Sonora,

Mexico. This would meet the requirements of a Risk Class RN region for

hog cholera according to Sec. 92.3(a)(2) of this proposed rule.

3. Vaccination for hog cholera has been prohibited since 1989. This

would meet the requirements for a Risk Class R1 (slight risk) region

for hog cholera according to Sec. 92.3(b)(4) of this proposed rule.

4. Adjacent States of Mexico are separated by natural physical

barriers or manmade fences. The State of Sonora, Mexico is bordered by

the United States on the north; the State of Baja California Norte,

Mexico and the Gulf of California on the west; The State of Chihuahua,

Mexico on the east; and the State of Sinaloa, Mexico on the south. The

border between Sonora and Chihuahua is separated by the Sierra Madre

mountains. There are few mountain passes crossing from Chihuahua to

Sonora along this entire border, from the United States to Sinaloa,

with only minor road crossings at Puerto San Luis and Maycoba. The

southern border of the State of Sonora is separated for most of the

eastern part of the border by the same mountains that separate it from

Chihuahua. Major highway and rail crossings near Estacion Don are on

the coastal plain within a few miles of the Gulf of California. This

would meet the requirements for a Risk Class R1 region for hog cholera

according to Sec. 92.3(b)(5) of this proposed part.

5. All border access points from adjacent States of Mexico are

controlled to prevent movement of swine or swine products into the

State of Sonora. The only major ports with other States of Mexico are

to Sinaloa on Mexico Federal Highway 15 near Estacion Don, Sonora,

Mexico, and a rail crossing near the same town. Estacion Don has

washing and disinfection facilities for livestock trucks entering

Sonora, cattle corrals and dipping facilities for tick control, and an

incinerator for confiscated meats. Swine are not allowed to enter

through this port from other areas of Mexico. The disinfection of

trucks that have carried swine is funded by the pork producers

associations of Sonora. Other road and/or rail crossings are near San

Luis, Sonora, Mexico, and Riito, Sonora, Mexico, where bridges cross

the Colorado river from Sonora to Baja California Norte, Mexico, and to

Puerto San Luis and Maycoba where minor roads cross from the State of

Chihuahua, Mexico. Inspection procedures for trucks moving from

Chihuahua are similar to those for trucks moving from Sinoloa at

Estacion Don. Airports with commercial connections to other areas of

Mexico include numerous local airports and 3 international airports

located at Obregon, Hermosillo, and Guaymas. The principle seaport is

located at Guaymas on the Gulf of California. This would meet the

requirements for a Risk Class R1 region for hog cholera according to

Sec. 92.3(b)(6) of this proposed rule.

6. Movement of swine and swine products into the State of Sonora

from other States of Mexico has been reviewed by the Administrator and

appears to meet the same level of biosecurity as required in proposed

[[Page 16990]]

Sec. 93.515(e)(1) of this chapter. This would meet the requirements for

a Risk Class R1 region for hog cholera according to Sec. 92.3(b)(7) of

this proposed part.

7. The State of Sonora maintains a passive surveillance system that

includes reporting all suspect cases in back yard herds and commercial

herds. The state of Sonora also has active surveillance that consists

of periodic surveys of swine on farms and at slaughter plants. In a

serological survey, 50 percent of the commercial operations were

sampled in 1991, and 25 percent of the commercial operations were

sampled in 1993. No evidence of hog cholera was found in these surveys.

These surveys did not include small backyard operations. Continuous

monitoring of swine at slaughter plants is planned until the State of

Sonora achieves recognition as a Risk Class RN region for hog cholera

according to Sec. 92.3(a) of this proposed part. Passive and active

surveillance in the State of Sonora would meet the requirements for a

Risk Class R1 region for hog cholera according to Sec. 92.3(b)(8) of

this proposed rule.

8. The laws, regulations, policies, and infrastructure in the State

of Sonora and the country of Mexico have been reviewed by the

Administrator and are believed to be adequate to maintain surveillance

and control and to eradicate hog cholera rapidly in the event of any

outbreaks in the State of Sonora, and to curtail and restrict movements

of swine or swine products from any other regions of Mexico where hog

cholera exists. This would appear to meet the requirements for a Risk

Class R1 region for hog cholera according to Sec. 92.3(b)(9) of this

proposed rule.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Japanese encephalitis virus.

Risk Class RN. All regions of Africa, Atlantic, Caribbean, Europe,

Middle America, Middle East, New Zealand, North America, and South

America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Jembrana (Tabanan) virus.

Risk Class RN. All regions of Africa, Atlantic, Caribbean, Europe,

Middle America, Middle East, New Zealand, North America, and South

America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Lumpy skin disease (Neethling virus).

Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,

Europe, Middle America, New Zealand, North America, Oceania, and South

America.

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Malignant catarrhal fever virus (wildebeest form).

Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,

Europe, Middle America, Middle East, New Zealand, North America,

Oceania, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Mycobacterium bovis.

Risk Class RN. Bermuda, The Bahamas, Falkland Islands, Luxembourg,

Norway, Isle of Jersey (United Kingdom), Cyprus.

These regions have reported complete absence of bovine tuberculosis

for over 15 years. (Regional and Country Status Reports, in

``Mycobacterium bovis Infection in Animals and Humans,'' Edited by

Thoen, C.D. and Steele, J.H., pp. 169-345, Iowa State University Press,

Ames Iowa, 1995).

Risk Class R1. None.

Risk Class R2. Canada.

All Provinces of Canada are either accredited-free or modified-

accredited for bovine tuberculosis. Accredited-free provinces could be

classified as Risk Class R1 regions, and modified-accredited as Risk

Class R2 if at least 1 year has elapsed without the discovery of any

infected herds. Canada follows a tuberculosis eradication program

equivalent to that conducted in the United States. Other countries may

be equivalent to Canada, but we currently cannot evaluate their status.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Near east encephalomyelitis virus.

Risk Class RN. All regions of Atlantic, Australia, Caribbean,

Europe, Middle America, New Zealand, North America, Oceania, and South

America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Nairobi sheep disease (Ganjam, Dugbe) virus.

Risk Class RN. All regions of Atlantic, Australia, Caribbean,

Europe, Middle America, Middle East, New Zealand, North America,

Oceania, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Parafilariosis due to Parafilaria bovicola.

Risk Class RN. All regions of North America, Middle America, South

America and Caribbean.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Peste des petits ruminants (Kata) virus.

Risk Class RN. All regions of Atlantic, Europe, North America,

South America, Australia, and Oceania.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Pseudomonas pseudomallei (melioidosis).

Risk Class RN. All regions of Europe, Canada, and Atlantic.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Pseudorabies (Aujesky's) virus.

Risk Class RN. None.

Risk Class R1. Canada.

Canada eradicated pseudorabies over 15 years ago. However, because

it is adjacent to the United States, which is affected with

pseudorabies, we are proposing to classify Canada as a Risk Class R1

region for this disease, which would be equivalent in status to

pseudorabies-free States in the United States.

Risk Class R2. None.

[[Page 16991]]

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Restricted ectoparasites.

Risk Class RN. Canada.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Rift Valley fever virus.

Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,

Europe, Middle America, New Zealand, North America, Oceania, and South

America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Rinderpest virus.

Risk Class RN. Australia; Bermuda; all regions of North America,

Middle America, South America except Chile, and the Caribbean except

The Bahamas; Greenland; Iceland; New Zealand; Territory of St. Pierre

and Miquelon; and Trust Territory of the Pacific Islands.

These regions are currently listed in Sec. 94.1(a)(2) as countries

free of both rinderpest and FMD. They are not listed in current

Sec. 94.11(a) as countries that, because of importations of meat from

or proximity to rinderpest or FMD-affected countries, are subject to

restrictions on importations of meat or meat products into the United

States. We are proposing to include South America and the Caribbean as

Risk Class RN regions for rinderpest because they have never reported

rinderpest and there is no reason to believe these regions are now or

have ever been infected with rinderpest.

Risk Class R1. Austria, The Bahamas, Belgium, Channel Islands,

Chile, Denmark, Finland, France, Germany, United Kingdom, Hungary,

Japan, The Netherlands, Norway, Papua New Guinea, Poland, Republic of

Ireland, Republic of Korea, Spain, Sweden, Fiji, New Caledonia.

These regions are listed in current Sec. 94.11(a) as countries that

are free of both rinderpest and FMD, but that supplement their meat

supply with imports from areas affected with rinderpest or FMD, or that

share borders with countries affected with rinderpest or FMD. Because

the current regulations in Sec. 94.11 do not distinguish whether a

country's meat supply is being supplemented from a rinderpest or from

an FMD-affected country, we cannot separate those that import from

countries infected with foot-and-mouth disease but not rinderpest. Fiji

and New Caledonia would be classified as Risk Class R1 for rinderpest

because they are adjacent to regions that are considered to be infected

with rinderpest.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Scrapie disease agent.

Risk Class RN. All regions of Australia and New Zealand.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. Canada.

Scrapie exists at a low prevalence in Canada, which has a program

to eradicate this disease that is equivalent to the scrapie eradication

program in the United States.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Sheep pox and/or goat pox virus.

Risk Class RN. All regions of Atlantic, Australia, Caribbean,

Middle America, New Zealand, and North America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Swine vesicular disease.

Risk Class RN. Australia, all regions of North America, Middle

America, Dominican Republic, Fiji, Finland, Greenland, Haiti, Iceland,

New Zealand, Norway, Rumania, Sweden, and Trust Territory of the

Pacific Islands.

These regions are listed in Sec. 94.12 of the current regulations

as countries where swine vesicular disease does not exist, and are not

listed in current Sec. 94.13 as countries that supplement their pork

supply from countries affected with swine vesicular disease.

Risk Class R1. Austria, The Bahamas, Bosnia-Herzogovania, Bulgaria,

Chile, Croatia, Denmark, Finland, Hungary, Luxembourg, Macedonia,

Republic of Ireland, Slovenia, Switzerland, United Kingdom, and

Yugoslavia.

These regions are listed in Sec. 94.12 as countries free of swine

vesicular disease, but are listed in Sec. 94.13 as countries that

supplement their national pork supply from countries that are affected

with swine vesicular disease.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Taenia (Multiceps) multiceps (dog tapeworm) in livestock handling

dogs.

Risk Class RN. All regions of North America, Middle America, and

Caribbean.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Teschen disease virus.

Risk Class RN. All regions of Africa, Asia, Atlantic, Australia,

Caribbean, Middle America, Middle East, New Zealand, North America,

Oceania, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Theileriosis (east coast fever, corridor disease, Mediterranean

fever).

Risk Class RN. All regions of Atlantic, Asia, Australia, Caribbean,

Europe, Middle America, Middle East, New Zealand, North America,

Oceania, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Tick-borne encephalitis (louping ill, Central European

encephalitis) virus.

Risk Class RN. All regions of Africa, Atlantic, Australia,

Caribbean, Middle America, Middle East, New Zealand, North America,

Oceania, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Tick-borne fever due to Erlichia (Cytoecetes) phagocytophilia.

Risk Class RN. All regions of Atlantic, Australia, Caribbean,

Middle America, Middle East, New Zealand, North America, Oceania, and

South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

[[Page 16992]]

African (salivarian- or tsetse-transmitted) Trypanosoma spp. (T.

brucei, T. congolense, T. evansi, T. suis, T. simiae, T. uniforme, T.

vivax).

Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,

Europe, Middle America, Middle East, New Zealand, North America,

Oceania, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Trypanosoma spp. transmitted by vectors other than tsetse flies

(NTT- Trypanosomas).

Risk Class RN. All regions of Asia, Atlantic, Australia, Europe,

Middle America, Middle East, New Zealand, and North America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Vesicular stomatitis virus.

Risk Class RN. All regions of Africa, Asia, Atlantic, Australia,

Caribbean, Europe, Middle East, New Zealand, North America except

Mexico, and Oceania.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Wesselsbron virus.

Risk Class RN. All regions of Asia, Atlantic, Australia, Caribbean,

Europe, Middle America, Middle East, New Zealand, North America,

Oceania, and South America.\1\

Risk Class R1. None.

Risk Class R2. None.

Risk Class R3. None.

Risk Class R4. None.

Risk Class RU. All regions of the world except those specifically

listed as Risk Class RN, R1, R2, R3 or R4.

Application for Risk Class Recognition

Section 92.5 of this proposed rule contains procedures for applying

for recognition of a risk class for a region, procedures that would be

followed by APHIS in making a determination of a region's risk class,

and provisions for the removal or change of status of a region due to a

failure of the region to meet the criteria of its current risk class,

or due to the discovery of a restricted agent in a Risk Class RN, R1,

or R2 region.

Proposed Part 93

Current 9 CFR part 93 contains provisions governing the importation

of elephants, hippopotami, rhinoceroses, and tapirs into the United

States. As discussed above in this ``Supplementary Information'' under

the heading ``Parts 92 and 93,'' we are proposing to keep these

provisions in part 93, and are also proposing to add to part 93 the

provisions regarding the importation of birds, poultry, horses,

ruminants, swine, dogs, and hedgehogs and possums that are currently

set forth in part 92. These provisions would be grouped according to

the same subpart designations as in current part 92 (e.g., provisions

regarding the importation of birds would continue to be subpart A,

provisions for poultry would continue to be subpart B, etc.), and the

current part 93 provisions for elephants, hippopotami, rhinoceroses,

and tapirs would be designated as subpart H.

The only changes to the provisions for elephants, hippopotami,

rhinoceroses, and tapirs would be to correct cross references and to

amend the definitions and the introductory text to the definitions

section to bring the language in line with that in the other subparts.

Aside from being moved to part 93, the regulations regarding birds

(subpart A), poultry (subpart B), horses (subpart C), dogs (subpart F),

and hedgehogs and possums (subpart G) would be changed only to correct

cross references. The only changes to those subparts would be to

correct cross references.

However, in this proposal, we are proposing significant substantive

changes to the provisions of subpart D (ruminants) and subpart E

(swine) in current part 92. These changes would be in accordance with

NAFTA and GATT provisions regarding the assessment of the risk of

importing animals and animal products from foreign regions.

In subparts D and E of proposed part 93, we would set forth

specific criteria for the importation of ruminants and swine from

foreign regions, based on the risk classification of a region for a

particular restricted agent, and on the type of animal intended for

importation. (Unlike current part 92, no criteria for the importation

of animal products would be included in proposed part 93. Those

provisions that currently appear in part 92 regarding products would be

incorporated into part 94, and would be revised as necessary to

accommodate our proposed changes to regionalization and risk

assessment. These revised criteria for the importation of animal

products are discussed in this Supplementary Information in the

discussion of changes to part 94.)

In setting forth specific importation criteria in proposed part 93,

we would refer to the various risk classification levels set forth in

proposed part 92, discussed above under the heading ``Criteria for Risk

Classification.'' The discussion that follows in this Supplementary

Information explains what would be required to import specific types of

animals from each region based on the region's risk classification for

the disease in question.

Removal of Country-By-Country Exemptions

Subparts D and E of part 92 of the current regulations restrict the

importation of ruminants and swine from various countries, due to the

existence of certain animal diseases in those countries. For the most

part, the regulations are structured so that the restrictions are

applied to a list of countries in which the diseases in question exist.

However, because of individual circumstances particular to several

individual countries, some of the provisions of the regulations refer

only to those countries. These include provisions for the importation

of ruminants and swine from Canada in current Secs. 92.417, 92.418,

92.419, 92.420, 92.421, 92.516, 92.517, 92.518, and 92.519; from the

Caribbean countries in Secs. 92.422, 92.423, and 92.520; and from

Mexico in Secs. 92.424, 92.425, 92.426, 92.427, 92.428, 92.429, and

92.521. They also include provisions for the importation of cattle from

the Republic of Ireland in Sec. 92.432, and for sheep from New Zealand

in Secs. 92.433.

In this proposed rule, we do not include special provisions for

specific countries, but rather we set forth requirements for

importation that would apply to all countries or regions that meet the

criteria for a particular risk classification for a specific restricted

agent. In some cases, these criteria may, practically speaking, apply

to only one or two countries--for instance, countries that import into

the United States through land border ports (discussed below under the

heading ``Exemption from Import Permit Requirements''). However, we

believe it is appropriate not to refer to individual countries in this

proposal, in light of the requirement in GATT that sanitary and

phytosanitary measures must not arbitrarily or unjustifiably

discriminate between members where identical or similar conditions

prevail (Agreement on the Application of Sanitary and Phytosanitary

Measures, GATT, article 2, paragraph 3). In future rulemaking, we would

adapt the regulations to recognize regions that do not meet any

[[Page 16993]]

of the risk categories we are proposing to establish in this document.

In such future rulemaking, we would establish classifications

appropriate to that risk posed by those regions. Any other region that

meets the criteria established for a new risk classification would be

assigned that same classification.

General Prohibitions; Inspection; Importation Ports

In the current regulations, Secs. 92.401, 92.402, and 92.403

(ruminants), and Secs. 92.501, 92.502, and 92.503 (swine) include,

respectively, provisions regarding general import prohibitions, the

inspection, unloading, and cleaning of means of conveyance; and ports

for importation. In this proposal, these sections would be redesignated

as being in part 93, but would remain substantively unchanged.

Import Permit Requirements

Under the current regulations, with certain exceptions, before

ruminants and swine may be imported into the United States, the

importer must first apply for and obtain from APHIS an import permit.

The requirements for an application for the import permit are set forth

in the current regulations in Secs. 92.404 and 92.504 for ruminants and

swine, respectively. On the application, the importer must include

information regarding the type, number, and identification of the

animals to be imported, and information on the origin, intended

arrival, route, and destination of the animals. These requirements are

the same in this proposal.

Under the current regulations, however, an import permit is not

required, under certain conditions, for ruminants or swine from certain

specified countries or areas of the world (e.g., Canada, Mexico, the

West Indies, and Central America). In this proposed rule, we are not

setting forth permit exemptions for specifically named countries or

regions, because of the need for general applicability of requirements

as discussed above. However, we continue to believe that certain

importations from countries with land border ports to the United States

can be carried out without the need for import permits, for the reasons

discussed below.

In Secs. 93.404 and 93.504 of this proposal, we are setting forth

provisions that would exempt certain ruminants or swine presented at a

land border port from the import permit requirements. To be eligible

for this exemption, the animals would have to originate in regions that

are not known to be affected with foot-and-mouth disease and

rinderpest, and for swine, hog cholera, African swine fever, or swine

vesicular disease. These provisions would apply only to animals being

imported by land from either Canada or Mexico. We believe these

exemptions are warranted, because, if the animals are found upon

inspection at the port of entry to be affected with any communicable

disease, the animals are not accepted into the United States, whereas

animals transported to the United States by air or ship are difficult

and costly to return to their origin, and holding them at the

quarantine facility may create a space problem.

Import permits are used primarily as reservations for space in the

quarantine stations. The need for permits for importation at facilities

other than land border ports is to assure that the port facilities have

sufficient space to handle animals as they are imported. At land border

ports there may be a limited amount of space, but the animals can be

unloaded on the Canadian or Mexican side of the border until space

becomes available. It is not possible to hold animals for any length of

time on planes or ships at other ports.

In the current regulations, Sec. 92.404(a)(2) includes the

statement that ``An application for permit to import will be denied for

domestic ruminants from any country where it has been declared, under

section 306 of the Act of June 17, 1930, that foot-and-mouth disease

(FMD) or rinderpest has been determined to exist, except as provided in

Sec. 92.430.'' Section 92.504(a)(2) includes a like statement for

swine. In Secs. 93.404 and 93.504 of this proposal, we are not

including this statement. While it is true that ruminants and swine may

not be imported, without stringent restrictions, from countries at high

risk for such animals being affected with FMD or rinderpest, we believe

it is misleading to imply that such importations are prohibited except

in rare cases. Under Secs. 93.415 and 93.515 of this proposed rule,

ruminants and swine imported from regions classified as R3, R4, or RU

for FMD and rinderpest would be required to be quarantined at the Harry

S Truman Animal Import Center (HSTAIC), just as is required under the

current regulations for ruminants and swine from countries where FMD or

rinderpest exists.

Certificate Requirements

In the current regulations, Secs. 92.405 (ruminants) and 92.505

(swine) require that, with certain exceptions based on whether the

animals come from specifically named countries of origin, ruminants and

swine imported into the United States be accompanied by a certificate

issued in the country of origin. This document must certify that the

ruminants and swine have been in the country of origin for at least 60

days immediately preceding the date of intended exportation from that

country, and must also certify that the country or district of origin

has been free of certain specified diseases during that 60-day period.

In addition, the certificate for sheep and goats must contain certain

statements related to scrapie.

In this proposed rule, in Secs. 93.405 (ruminants) and 93.505

(swine), we would require that all ruminants and swine imported, except

for ruminants and swine imported for immediate slaughter from regions

classified as RN for all restricted disease agents of ruminants and

swine, respectively, must be accompanied by a certificate of export.

This certificate of export, which would have to be issued and signed by

an authorized veterinarian and endorsed by an official of the National

Veterinary Services of the country of export, would need to certify

that the ruminants or swine originate from premises that are not known

to have been affected with any communicable disease or restricted

ectoparasites of the type of animal in question for the previous 60

days. The certificate would also need to state that during

transportation to the port of embarkation, there was no direct or

indirect exposure to potential carrier animals from any region affected

with restricted disease agents; that while en route to the port of

entry, the animals were not trailed or driven through any Risk Class

R3, R4, or RU region for (i.e., region affected by) any tick-borne

restricted diseases; and that while en route to the port of entry, the

animals were not trailed, driven, transported, or otherwise moved

through any Risk Class R3, R4, or RU region for any restricted insect-

transmitted diseases during a time of year when insect vectors are

active. Finally, the certificate would need to certify that the animals

either were inspected on the day of embarkation and were found to be

free of restricted ectoparasites, or were treated for ectoparasites

within 10 to 14 days of embarkation.

As noted above, only ruminants or swine that are from Risk Class RN

(negligible risk) regions for all restricted disease agents of

ruminants or swine, respectively, and that are imported for immediate

slaughter would be exempted from the requirements for a certificate of

export. Most ruminants or swine would still be required to have a

certificate of export even though they may not be required to have an

import permit under proposed Secs. 92.404 and 92.504.

[[Page 16994]]

The value of the required certification would be dependent on the

integrity and quality of inspections in the exporting country. The

animal health infrastructure of a country is a factor in assigning a

risk classification to a region. For regions with higher risk,

quarantine or testing requirements validate the export certification.

Current Secs. 92.407/92.506

In the current regulations, Secs. 92.407 (ruminants) and 92.506

(swine) set forth provisions regarding the presentation of

certificates, declarations, and affidavits required by the regulations.

These provisions are set forth in Secs. 93.406 and 93.506 of this

proposal, and except for the addition of clarification as to which

documents are being referred to, would remain unchanged.

Current Secs. 92.408/92.507

The current regulations in Secs. 92.408 (ruminants) and 92.507

(swine) contain requirements for the inspection, at the port of entry,

of imported ruminants and swine. These requirements are set forth in

Secs. 93.407 and 93.507 of this proposed rule, and would be amended in

one respect. The inspection requirements in current Secs. 92.408 and

92.507 refer to certain exceptions for animals from specific

countries--i.e., Canada, Mexico, and the British Virgin Islands when

importing into the United States Virgin Islands. In accordance with

GATT, these exceptions for specific countries would be removed.

Current Secs. 92.409/92.508 and 92.410/92.509

The current regulations in Secs. 92.409 (ruminants)/92.508 (swine)

and Secs. 92.410/92.509 set forth requirements regarding articles

accompanying imported animals and regarding movement from conveyances

to quarantine stations. These provisions are set forth in Secs. 93.408

and 93.509 (ruminants) and Secs. 93.508 and 93.509 of this proposal,

and would remain unchanged.

Current Secs. 92.411/92.510

The current regulations in Secs. 92.411 (ruminants) and 92.410

(swine) include quarantine requirements for ruminants and swine,

respectively, imported into the United States. The length of required

quarantine for swine as set forth in current Sec. 92.410 is the same

(15 days) no matter what the origin of the swine. However, the length

of required quarantine for ruminants varies according to which country

the ruminants originated in.

Under this proposed rule, these provisions would be removed.

Because Secs. 93.415 and 93.515 of this proposed rule include

quarantine requirements specific to the risk class of the region of

origin and the disease in question, it would no longer be adequate or

appropriate to have a uniform length of quarantine, as currently is the

case with swine, or, alternatively, to refer to specific countries, as

currently is the case with ruminants. The quarantine requirements for

animals from any particular country or region would be governed by the

risk class of the region of origin.

Current Secs. 92.412/92.511 and 92.413/92.512

Under the current regulations, Secs. 92.412 and 92.413 (ruminants)

and Secs. 92.511 and 92.512 (swine) include requirements regarding

importation quarantine facilities. These provisions are set forth in

Secs. 93.411 and 93.412 (ruminants) and Secs. 93.511 and 93.512 (swine)

of this proposed rule and would remain unchanged.

Current Secs. 92.414/92.513 and 92.415/92.514

Under the current regulations, Secs. 92.414 and 92.415 (ruminants)

and Secs. 92.513 and 92.514 (swine) set forth, respectively, provisions

regarding milk and manure from quarantined animals. These provisions

are set forth in Secs. 93.413 and 92.414 (ruminants) and Secs. 92.513

and 92.514 (swine) of this proposed rule and would remain unchanged.

Appearance of Disease Among Ruminants in Quarantine

In the current regulations, Secs. 92.416 (ruminants) and 92.515

(swine) provide that if any contagious disease appears among the

animals in quarantine, special precautions must be taken to prevent the

spread of the infection to other animals in the quarantine station or

those outside the grounds. Under this provision, the Administrator may

take action to deal with outbreaks of clinical disease while the

animals are in quarantine. These provisions are in proposed

Secs. 93.414 (ruminants) and 93.514 (swine).

Additionally, the proposed rule would provide that, if there are

test-positive animals during quarantine (in the absence of clinical

signs of disease), the Administrator may require additional testing of

both the test-positive and the test-negative animal(s). We believe that

this provision is necessary because many diseases are not immediately

manifested in a clinical form and depend upon serological or other

tests for diagnosis in live animals.

Requirements for Importation Based on Disease Risk

As discussed above in this ``Supplementary Information'' under the

heading ``Parts 92 and 93,'' the current regulations in part 92 include

restrictions on the importation of certain ruminants and swine due to

their risk of transmitting diseases to animals in the United States.

Current part 92, in general, bases restrictions on importation on

whether a disease in question is considered to exist or not exist in a

particular country.

In this proposed rule, we are proposing to move from a country-by-

country approach to one based on individual regions, and are also

proposing to substitute a gradation of risk levels for an ``exist/does

not exist'' consideration of disease risk.

Restrictions on the importation of ruminants and swine from

regions, based on risk level, are set forth in this proposed rule in

Secs. 93.415 (ruminants) and 93.515 (swine). The requirements for a

particular importation would depend on three factors: (1) The type of

animal to be imported; (2) the disease in question; and (3) the risk

classification level of the region from which the animals are to be

imported. As the risk increases that unrestricted importations from a

region will result in disease transmission, the need for greater import

restrictions also increases. To mitigate disease risk, several broad

risk management options, applied individually or in combination, are

available. These options can be applied to either animals or their

products. The risk management options available are:

1. Certification of origin of animals and animal products.

2. Tests and inspection of imported animals or products.

3. Tests and inspection of herds or premises of origin.

4. Treatment of animals or products.

5. Quarantine of imported animals.

6. Restricted use or movement of imported animals or products to

reduce costs of failure.

In this proposed rule each of these management options is used for

various disease agents. Not all of the options are appropriate for

every disease agent, so different strategies will be necessary for

different agents. Some of the variabilities of the disease agents

include:

1. Incubation period.

2. Duration of carrier status in animals.

3. Number of potential host species that may be affected.

4. Survivability of agent outside the host animal.

[[Page 16995]]

5. Effectiveness of available test procedures to detect the disease

agent.

6. Effectiveness of available treatment procedures to eliminate the

disease agent.

7. Availability of technology to eradicate agent if it were

introduced.

8. If agent were introduced, potential cost to eradicate, or

potential costs into perpetuity if agent cannot be eradicated.

Rationale for Import Requirements for Ruminants and Swine from

Differing Risk Class Levels

Although the import requirements in this proposal differ for

different animals and diseases, a broad model of requirements based on

risk class levels can be drawn, and we believe that certain

generalizations can be made about the type of mitigation measures

necessary for each risk class level. In general, the measures

established for each level of risk are built upon the protections

proposed for levels of lesser risk. For example, the requirements for

importation from a region classified as R4 for foot-and-mouth disease

would incorporate and add to the requirements for an R3 region. The

requirements for an R3 region would incorporate and add to the

requirements for an R2 region, and so on. The rationale for the broad

requirements for each Risk Class level are as follows (specific

requirements for specific diseases are discussed later in this

Supplementary Information under the heading ``Risk Level

Classifications other than Risk Level RN''):

Risk Class R1 Regions: From a Risk Class R1 region, there should be

no concern about possible residual infection in the region. The

principal concern is the possible deliberate introduction of animals

into this region from regions with higher risk classifications in order

to qualify them as animals from a Risk Class R1 region. Requiring a

negative serological test for any animals imported from R1 regions

would ensure that animals offered for importation are not vaccinated,

and that animals from regions of higher risk are not being presented as

being from the Risk Class R1 region. Requiring such tests would also

provide some additional active surveillance for the exporting region.

Risk Class R2 Regions: There could possibly be residual infection

in Risk Class R2 regions. Requiring a pre-embarkation quarantine for

animals from such regions for importation into the United States would

ensure that any imported animals are not incubating the disease when

they are presented for export. As for Risk Class R1 regions, a negative

serological test during the quarantine period for any animals from such

regions would ensure that the animals intended for export are not

vaccinated, and would ensure that animals from other higher risk

regions are not presented as being from the Risk Class R2 regions.

Again, such testing would provide some additional active surveillance

for the exporting region.

Requiring a serological test at the U.S. post-importation

quarantine facility would ensure that animals have not been exposed to

a restricted disease agent during pre-embarkation quarantine, and that

any incubating animals during the pre-embarkation quarantine period

have had ample opportunity to develop antibodies to the disease.

Risk Class R3 Regions: Risk Class R3 regions would be low

prevalence regions with a good history of disease surveillance and

control. Herds would be identified that are free of the contagious

disease of concern. Although the risk of importing a restricted disease

agent from an established herd is small, the risk of disease exposure

to such a herd while in transit or while being assembled is much

higher. Due to the incubation period for many of the diseases of

concern, the proposed requirements for Risk Class R3 regions would

generally require a 30- to 60-day pre-embarkation quarantine period for

animals assembled. We believe this would be necessary to detect any

incubating animals, depending upon the disease. Although vaccination is

often an important method of control of some contagious diseases, we

would be concerned that vaccinated animals may mask a low prevalence of

disease in the herd. Therefore, we would expect that animals being

prepared for export would not be vaccinated and would serve as

sentinels for possible residual infection in the source herd.

Unvaccinated animals would therefore be more likely to develop disease

during the pre-embarkation quarantine, but this would also serve to

monitor the presence of any agent that may be introduced into the

quarantine center. If there are any incubating animals in the group of

animals intended for export, the exposed susceptible animals should

develop clinical illness either during the pre-embarkation or, when

required, during the post-importation quarantine. For this reason we do

not believe that additional sentinel animals are necessary for the

importation of animals from this Risk Class level where sentinel

animals are generally specified.

Risk Class R4 and RU Regions: Risk Class R4 or RU regions would be

higher prevalence regions, or regions that may have less than adequate

control and surveillance programs. The health status of animals in

source herds would be considered to be more uncertain, and more

difficult for the veterinarians in the region of origin to certify. The

likelihood of incubating animals, innately resistant animals, or

animals that have been vaccinated and not identified as such would be

greater than for Risk Class R3 regions. The pre-embarkation quarantine

and testing would be generally the same as for R3 regions, but the

post-importation quarantine may require using U.S.-source sentinel

animals that would be highly susceptible to any foot-and-mouth disease,

hog cholera, African swine fever, or swine vesicular disease virus that

may be shed by infected animals in the shipment. A 30- to 60-day pre-

embarkation and post-importation quarantine period would be necessary

to detect these agents.

Solicitation of Information

The following proposed import requirements have been formulated

based on current import requirements and the most recent

epidemiological data available to us. We welcome information from the

public, supported by scientific evidence or other data, regarding the

proposed requirements.

Requirements for Importation From Risk Class RN Regions

Although, for the most part, the importation restrictions in

proposed Secs. 93.415 and 93.515 vary according to the restricted agent

in question, the requirement for one risk class level, that of RN for

negligible risk, would be the same for all diseases. This requirement,

set forth in Secs. 93.415(a) (ruminants) and 93.515(a) (swine), would

be a certification that the animal in question have only been on

premises in RN regions. A region that is classified as RN for all

restricted disease agents would be able to import animals into the

United States without any quarantine or testing requirements. Such

animals would still need to be inspected at the U.S. port of entry for

the general freedom from communicable diseases and, if found to be

affected with a disease agent, would be quarantined either until they

recovered from the disease, were destroyed, reexported or were returned

to the region of origin. Animals imported through land border ports

could be returned directly to the region of origin. At this time, based

on the information available to us, there are no countries in the world

that would qualify as Risk Class RN for all restricted disease agents

of ruminants or swine, although individual regions in some countries

may be able to meet such requirements.

[[Page 16996]]

At this time, there are many countries that may be classified as

Risk Class RN for certain restricted disease agents. Therefore,

specific testing and quarantine would not be required for those disease

agents, even though testing or quarantine would be required for other

agents. For example, Canada and Mexico would both be considered as Risk

Class RN for foot-and-mouth disease virus and rinderpest virus in

ruminants and swine. Canada would also be considered as Risk Class RN

for hog cholera in swine, but because hog cholera does exist in parts

of Mexico, those Mexican regions would be required to meet specific

test and quarantine requirements to import swine into the United

States. However, we would not have any greater requirements for Mexico

for foot-and-mouth disease or rinderpest virus than we would have for

Canada.

The criteria for a Risk Class RN region include the requirement

that all susceptible animals present in the region were not living when

the region was last infected. Arriving at an estimate for the specific

time interval this requires will vary with the species involved. In the

case of cattle, although the lifespan of a few cattle can exceed 20

years, for practical purposes most cattle in a domestic herd would be

culled before 15 years. In swine, occasionally a sow or boar may live

15 years, but in practice, nearly all sows and boars in domestic farm

operations are culled before 5 years of age, although there may be some

marginal farm operations that keep a boar for up to 10 years. In

determining the birthdates of ruminants and swine in a region for the

purpose of classifying the region RN, we would use 15 years as the

estimated life expectancy for cattle and 10 years for swine. These time

spans reflect the pragmatic management of domestic livestock. Although

other susceptible ruminants such as elk, camels, llamas, or bison may

theoretically be kept longer than the 15 years we are considering as

the maximum life span, we do not believe that in these species survival

after 15 years would occur at a high frequency.

Risk Level Classifications Other Than Risk Class RN

Except for Risk Class RN, the requirements for the importation of

animals from regions of each risk class level would be dependent on the

disease in question, as well as the animal. As discussed above in this

Supplementary Information under the heading ``Proposed Part 92,'' there

are certain restricted diseases that are not specifically mentioned in

the current regulations, because, practically speaking, animals that

may have been affected with these diseases were prohibited or

restricted importation due to the existence of other diseases in the

country of origin. With the proposed establishment of risk class levels

for regions, however, a region may be of low risk for a disease that is

addressed in the current regulations, but of high risk for a disease

not specifically addressed in the current regulation. Therefore, we

believe it is necessary to establish distinct restrictions regarding

all disease agents of concern, even those not addressed in the current

regulations.

One broad category of diseases not addressed consistently in the

current importation regulations is that of disease agents that are

present in the United States, but that are subject to control or

eradication programs. The requirements that do exist are specific to

particular importing countries. For example, current Sec. 92.418

includes testing requirements for tuberculosis and brucellosis for

cattle from Canada. Current Sec. 92.419 includes requirements for

scrapie certification for sheep and goats from Canada. Current

Sec. 92.427 includes requirements for fever ticks, tuberculosis, and

brucellosis for cattle from Mexico. Each of these requirements is

particular to the country specified. In this proposal, we are setting

forth requirements regarding the importation of ruminants and swine

from countries affected with restricted disease agents subject to

control or eradication programs in the United States, and we apply

these requirements according to the Risk Class levels of foreign

regions, rather than to specifically named countries.

Restricted Diseases That are Present in the United States But Are

Subject to Control or Eradication Programs.

Mycobacterium Bovis

Proposed Secs. 93.415(b) and 93.515(g) include requirements for the

importation of ruminants and swine, respectively, from Risk Classes R1

through RU with regard to Mycobacterium bovis (M. bovis), the causative

agent of bovine tuberculosis. M. bovis can affect a wide variety of

animals, including most species of ruminants, swine and rodents. The

United States has been working since 1917 to eradicate this disease

agent. At present, there are a few cases of bovine tuberculosis in some

States of the United States.

Bovine tuberculosis has a long incubation period, often measured in

months or years. Affected animals may not show any external clinical

evidence of the disease until the final terminal stages, but most will

remain carriers for life. There is no cost effective treatment for

bovine tuberculosis, even though treatments with various antibacterial

chemicals are routinely done for humans affected with tuberculosis. The

use of similar treatments in animals is not desirable because of the

risk of developing resistant strains of the organism, and the

prohibitive cost.

The only effective method of detecting infected carrier animals is

by use of various tests. Intradermal tests have generally been applied.

These tests require injection of tuberculin into the skin of the

animal, and then observation of the reaction at a later time, usually

72 hours. Animals generally cannot be retested again for at least 60

days, because the test usually results in desensitization of the skin

at the test site. The skin test is relatively insensitive and may miss

many infected animals. It is generally more sensitive in detecting

infected herds when applied to the entire herd of origin. Quarantine

beyond the period of time necessary to conduct an intradermal test is

not effective for bovine tuberculosis, except to prevent the

quarantined animals from contacting infected animals.

The domestic regulations for bovine tuberculosis are set forth in 9

CFR part 77. Essentially, the program in the United States is based on

domestic ``regionalization,'' through the classification of States

based on their risk status. Each of the States in the United States

qualifies as either Accredited free or Modified accredited, as defined

in Sec. 77.1. In order for a State to become accredited free, 5 years

must pass without any known infection in the State.

If each State classified under the domestic bovine tuberculosis

program were a foreign region, the State classifications would fall

into regional risk classifications as follows:

------------------------------------------------------------------------

Comparable risk

Domestic classification Conditions class

------------------------------------------------------------------------

``Modified Accredited''....... Infected herds in R4

State; more than 0.1%

of herds infected. No

States in the United

States currently in

this category.

[[Page 16997]]

``Modified Accredited''....... Infected herds in R3

State; fewer than

0.1% of herds

infected.

``Modified Accredited''....... No known infected R2

herds in State for at

least 1 year.

``Accredited Free''........... No known infected R1

herds in State for at

least 5 years.

``Accredited Free''........... No known infected RN

herds in State for at

least 15 years

``Accredited Free''

at least 10 years.

------------------------------------------------------------------------

Currently, there are no States in the United States that are not

at least ``Modified Accredited.'' If there were such areas, they would

be equivalent to proposed Risk Class R4 if testing were being done to

achieve a ``Modified Accredited'' status or as proposed Risk Class RU

if such testing were not being done.

As indicated above, the risk classes we are proposing for foreign

regions with regard to M. bovis are comparable to the domestic

classifications of accredited free and modified accredited. The

proposed requirements for importations from Risk Class R1 regions would

be similar to interstate movement requirements in the United States

from ``Accredited Free'' States. A certification of origin would be

required for importation from both Risk Class RN and R1 regions to

prevent presentation of ruminants or swine from higher risk regions as

originating from Risk Class RN or R1 regions. Because of the prolonged

incubation period for bovine tuberculosis, this requirement would be

applicable during the lifetime of any ruminant or swine intended for

importation from these regions. If animals that originated in a Risk

Class R2, R3, R4 or RU region were presented for export from Risk Class

RN or R1 regions, they would be required to meet the requirements for

importation from the region of greater risk.

The proposed requirements for importation of ruminants or swine

from regions classified as R2 and R3 for bovine tuberculosis would be

similar to the requirements for interstate movement requirements in the

United States from modified accredited States. Although the Federal

regulations do not require a test for breeding cattle or swine moving

interstate from modified accredited States, most States do have such a

requirement for cattle and other ruminants entering their State from

modified accredited States.

In the case of ruminants or swine intended for importation from

regions classified as Risk Class R2 for M. bovis, only non-neutered

ruminants or swine would be required to be tested, 60 to 90 days prior

to export, with a retest at the port of entry. We believe these tests

would be necessary, because these are the animals most likely to move

into established breeding herds in the United States. Because neutered

animals usually remain separate from other animals, and are slaughtered

soon after reaching the United States, combined with the low risk of

the source region and the low risk of transmission once in the United

States, we believe neutered animals do not need to be tested.

For importation from a region classified as Risk Class R3 for M.

bovis, the ruminants and swine must either originate from a herd that

meets the criteria for ``accredited-free'' as defined in Sec. 77.1, or

the herd of origin must have had a negative test for bovine

tuberculosis 4 to 12 months prior to export to the United States. We

believe the minimum 4-month requirement is necessary to allow at least

60 days before the individual exported animals must be retested,

because the intradermal tests for M. bovis must be at least 60 days

apart.

For importation from a Risk Class R3 region, the certificate of

export for swine must certify that the swine have never been on any

premises while animals affected with M. bovis have been present on

those premises. Both neutered and non-neutered ruminants and swine

would need to be tested 60 to 90 days before export, and non-neutered

animals would be required to be tested again at the port of entry.

Because of the increased risk that neutered animals from Risk Class R3

regions might be infected, such animals would need to be identified

with a permanent mark on the left hip, consisting of the letter ``M''

for males and ``Mx'' for neutered females. Traditionally most animals

imported into the United States that would fit into this class have

been from Mexico, so, currently, such an ``M'' has been interpreted to

mean ``Mexican origin,'' but we propose the ``M'' be used to indicate

high risk for ``Mycobacterium'' from any origin.

The proposed requirements for the importation of ruminants and

swine from regions classified as R4 and RU regions for M. bovis would

be similar to those for R3 regions. However, because the equivalent of

accredited herds are not recognized in R4 or RU regions, all ruminants

or swine would be required to originate from a herd that has had a

negative test for bovine tuberculosis 4 to 12 months prior to export.

The animals to be exported would be required to be quarantined for at

least 60 days prior to export to prevent exposure to infection to other

untested animals before export.

Brucella Abortus, B. Suis, and B. Melitensis

In Sec. 93.415(c) of this proposal, we set forth the requirements

for the importation of ruminants imported from Risk Class R1 through

Risk Class RU for Brucella abortus, B. suis biovar 4, and B.

melitensis. The United States currently has an eradication program for

B. abortus, which exists at a low prevalence in a few States. Brucella

suis biovar 4 does not occur in the United States except in caribou in

the State of Alaska. Brucella melitensis has been eradicated from the

United States.

The bovine brucellosis eradication program in the United States in

effect regionalizes the United States according to the prevalence of

brucellosis infected herds in the individual States. The regulations

regarding brucellosis in the United States are set forth in 9 CFR part

78. In Sec. 78.1, definitions for the disease risk status of individual

States are set forth for Class Free, Class A, Class B, or Class C for

bovine brucellosis.

It is possible to gauge where each of these classes would fall if

the States to which they apply were foreign regions classified by Risk

Class level. The following comparison could be made:

------------------------------------------------------------------------

Comparable risk

Domestic classification Conditions class

------------------------------------------------------------------------

Class Free.................... Class Free for more RN

than 15 years and

vaccination not

permitted except for

export

Class Free.................... Class Free for more R1

than 4 years and

vaccination not

permitted except for

export

Class Free.................... No known infected R2

herds for more than 1

year and/or

vaccination permitted

[[Page 16998]]

Class A....................... Less than 0.1% herd R3

incidence rate.

Class A....................... More than 0.1% herd R4

incidence rate.

Class B

Class C

Quarantined area.............. Does not meet minimum RU

standards of

eradication program.

------------------------------------------------------------------------

Currently, all States in the United States are either Class Free or

Class A. If the individual States were in a foreign country, all of the

Class A States would be classified as Risk Class R3, because the herd

infection rate is less than 0.1% (1 per 1000). Class A status allows

for herd infection rates up to 0.25% (2.5 per 1000) so in theory it

would be possible for a Class A State to be Risk Class R4. All of the

Class Free States in the United States would be Risk Class R2 because

they all permit, and some even encourage, calfhood vaccination. Some of

these States could easily qualify as Risk Class RN or R1 if they were

to prohibit calfhood vaccination except for animals that were to be

exported to other States.

Because the only clinical evidence of brucellosis in animals is

abortion, inspection of animals is not a reliable indicator of

infection. Brucella affects only breeding animals, so there is no need

to test neutered animals for brucellosis. The approved testing

procedures for brucellosis are very sensitive, and most infected

animals that have had a sufficient incubation period will be positive

to the test. The incubation period for brucella infections can be quite

variable, depending primarily on the stage of pregnancy in the infected

animal. For this reason, under the restrictions for importation from

Risk Class R3, R4, and RU regions, we would not allow animals to be

imported from infected herds, even if the individual animals test

negative.

There is no cost-effective treatment for brucella infections in

animals. Since most animals will show some serological signs of

brucellosis after 30 days, quarantines of 30 to 60 days are an

effective method of preventing introduction of exposed animals.

To qualify for importation from a region classified as either Risk

Class RN or R1 for brucellosis, non-neutered ruminants over 6 months of

age would need to be accompanied to the United States with a

certification of origin and certification that the ruminants were not

vaccinated with any live brucella vaccine. However, if ruminants to be

imported originate from a Risk Class R1 region and had been vaccinated

with Brucella abortus Strain 19 vaccine before the region became a Risk

Class R1 region, they would be subject to the requirements for

importation from Risk Class R2 regions.

To qualify for importation from a region classified as either Risk

Class R2 or (if a certified brucellosis-free herd) as Risk Class R3,

these proposed rules would require a certification of origin for the

ruminants to be imported from either a Class RN, R1, R2, or (if a

certified brucellosis-free herd) R3 region, negative results to a

brucellosis test of the animals to be imported conducted 30 to 60 days

before being presented for export, and a retest with negative results

at the port of entry. The ruminants may have been vaccinated only with

B. abortus Strain 19 in accordance with the procedures in 9 CFR part

78.

For non-neutered ruminants from herds not certified as brucellosis-

free in Risk Class R3 regions, or for non-neutered ruminants from Risk

Class R4 and Risk Class RU regions, the herd of origin must have been

tested and found negative for brucellosis within 6 to 12 months prior

to export of the ruminants. If any test-positive animals were found

during the test, they must have been removed from the herd and all

remaining animals must be retested with negative results not less than

6 months after any test-positive animals were removed. Additionally,

individual ruminants to be imported must have undergone a minimum of 30

days pre-embarkation quarantine prior to export, must have had a

negative result to an approved test for B. abortus, B. suis biovar 4,

and/or B. melitensis within the 30 days prior to export, must be

quarantined for at least 15 days at a post-importation quarantine

designated and approved by the Administrator, and must have a negative

result to approved tests for B. abortus, B. suis biovar 4, and/or B.

melitensis during the post-importation quarantine period.

Brucella Suis

Proposed Sec. 93.515(b) specifies requirements for swine intended

for export from regions classified from Risk Class R1 through RU for

Brucella suis. Just as comparisons can be made between domestic State

Risk Class status and foreign Risk Class status for bovine brucellosis,

similar comparisons can be made with regard to swine brucellosis, as

follows:

------------------------------------------------------------------------

Comparable risk

Swine brucellosis classification Conditions class

------------------------------------------------------------------------

Validated Brucellosis-Free...... Validated Free for RN

more than 10

years. No

adjacent States

risk class R3, R4

or RU.

Validated Brucellosis-Free Stage No known infected R1

II. domesticated

herds for more

than 5 years,

Validated Free

for more than 3

years.

Validated Brucellosis-Free Stage No known infected R2

III. domestic herds

for more than 1

year and/or

infected feral

swine in region.

May include some

Stage II areas

qualifying for

Stage III.

Non-validated Stage II.......... Less than 0.1% R3

herd incidence

rate.

Non-validated Stage I........... More than 0.1% R4

herd incidence

rate.

Non-validated................... Does not meet RU

minimum standards

of eradication

program.

------------------------------------------------------------------------

Currently all States in the United States are either validated

brucellosis-free or, if non-validated, have less than 0.1% herd

incidence rates. If the States in this country were foreign regions,

all of the validated brucellosis-free States would be Risk Class RN,

R1, or R2, and the non-validated States would be Risk Class R3.

[[Page 16999]]

Vaccination is not permitted or recommended in swine herds. Some

States have known infection in feral swine located in the State. These

States, if foreign regions, would fall into the Risk Class R2

classification, provided there has been no transmission of B. suis to

domesticated swine herds within the previous year. States in which

transmission to domestic swine herds has occurred would, if foreign

regions, be Risk Class R3.

Under proposed Sec. 93.515(b) regarding B. suis, swine from any

regions classified as Risk Class R1 or R2 for the disease, or from an

R3 region if from a validated brucellosis-free herd, would be allowed

to move for slaughter to any approved slaughter plant in the United

States, provided they move in vehicles closed with official seals of

the United States government applied and removed by an APHIS

representative, or an individual authorized for this purpose by an

APHIS representative.

For swine to be otherwise imported from regions classified as Risk

Class R1, these proposed rules would require that the swine be

accompanied by a certification that they originated in a Risk Class RN

or R1 region, and that the animals were not vaccinated with any live

brucella vaccine.

For swine to be imported from regions classified as Risk Class R2,

or for swine from validated brucellosis-free herds in Risk Class R3

regions, a certification of origin in a Risk Class RN, R1, or R2

region, or from a validated brucellosis-free herd would be required,

along with a negative test of the imported animals for B. suis 30 to 60

days before being presented for export. A negative retest at the port

of entry would also be required.

For the importation of non-neutered swine over 6 months of age from

herds not validated brucellosis-free in Risk Class R3 regions, and for

non-neutered swine over 6 months of age from Risk Class R4 or RU

regions, all swine over 6 months of age in the herd of origin would

need to have had negative results to a test for B. suis within 6 months

prior to the date the swine to be imported are removed from the herd.

If any swine were found to be positive on a herd test, the herd would

need to have undergone a herd cleanup plan equivalent to the plan

required in 9 CFR part 78. The complete herd test, and clean-up of each

infected herd, would essentially qualify the herd as a validated

brucellosis-free herd. Therefore, individual swine subsequently

intended for importation from R3 regions would be subject to the same

requirements as swine from R3 regions intended for importation from

validated brucellosis-free herds.

No swine from any risk category would be eligible for importation

if they have been vaccinated with a live Brucella vaccine. Vaccination

of swine for brucellosis has not been found to be efficacious in the

United States. Some areas of the world use a live attenuated B. suis

biovar 2 vaccine. Brucella suis biovar 2 is not known to exist in the

United States, so this vaccine, even though attenuated, would be

considered an exotic disease agent in the United States.

Pseudorabies

In this proposed rule, Sec. 93.515(c) sets forth import

requirements for swine intended for importation from regions classified

from Risk Class R1 through RU for pseudorabies virus (PRV).

Pseudorabies affects all classes of swine and can occasionally affect

other animals, such as sheep or cattle, which are dead-end hosts. The

primary reservoir is in swine. On breeding swine farms, reproductive

disorders and nervous disorders in baby pigs are the most frequently

seen clinical signs of PRV. The incubation period of PRV in susceptible

swine is usually variable, ranging from 36 to 48 hours in newborn pigs,

and 3 to 5 days in older swine.

Most infected swine excrete virus only for 14 to 28 days following

infection, but some do become persistent carriers of the virus for long

periods of time. Recrudescence with virus excretion can occur following

stress or other stimuli, such as parturition. Any seropositive animal

should be considered a potential virus carrier. Carrier swine would not

be expected to have any clinical signs of the infection.

Current tests for PRV are very sensitive, and infected swine will

be expected to have detectable antibody as early as 6-7 days after

exposure, with peak antibody titers about 5 weeks after exposure.

Antibodies in recovered or carrier swine may persist for years.

Vaccinated swine may be protected from clinical disease, but the

virulent virus may still replicate and become established in a carrier

state.

Pseudorabies virus is relatively stable at mild acidic or alkaline

conditions, although strong acids and strong alkalis readily kill the

virus. The virus can survive for long periods in the environment if the

pH and humidity remain within an optimal range of ph 6-8, and the

temperature remains between -8 deg. C to 25 deg. C. The virus generally

dies out rapidly when frozen at -13 deg. C to -20 deg. C. However,

although freezing in most cases rapidly kills the virus, it can be

preserved for years frozen at -90 deg. C. Direct sunlight rapidly

destroys the virus. Although the virus can survive for relatively long

periods of time in meat, usually little virus is found in the muscle of

naturally infected swine. The virus exists primarily in the lymphoid

and nerve tissue. There are no known treatment procedures that will

clear infected carrier swine of the infection.

Currently, a cooperative Federal/State eradication program for PRV

is conducted in all States of the United States. The PRV eradication

program in the United States in effect regionalizes the country by

State, according to the prevalence of PRV infected herds and the

progress in the eradication program in each State. The State

class

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