Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Notices 56027

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 94–106–8]

RIN 0579–AA71

APHIS Policy Regarding Importation of

Animals and Animal Products

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: The Animal and Plant Health

Inspection Service is adopting a policy

that recognizes regions, and levels of

risk among those regions, with regard to

the importation of animals and animal

products. We are applying this policy to

all species of animals regulated under

the Code of Federal Regulations, title 9,

chapter I, subchapter D, including, but

not limited to, ruminants, swine, birds,

poultry, and horses. We consider this

policy to be consistent with and to meet

the requirements of international trade

agreements entered into by the United

States.

ADDRESSES: You may submit comments

on this statement of policy by sending

an original and three copies of your

comments to Docket No. 94–106–8,

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. 94–106–8.

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 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 20237–1231, (301) 734–

8590.

SUPPLEMENTARY INFORMATION:

Purpose

In this document, the Animal and

Plant Health Inspection Service (APHIS)

sets forth our policy regarding the

manner in which we will apply the

concepts of regionalization and risk

analysis to regulating the importation of

animals and animal products into the

United States. We are applying this

policy to all species of animals

regulated under the Code of Federal

Regulations, title 9 (9 CFR), chapter I,

subchapter D, including, but not limited

to, ruminants, swine, birds, poultry, and

equines.

We have traditionally viewed animal

disease distribution on a country-bycountry basis, with the presence or

absence of a particular disease

anywhere within a country’s borders

serving to establish, for regulatory

purposes, the status of the entire

country with regard to that disease. That

approach has had the effect of

establishing an all-or-nothing standard

of risk avoidance that precludes our

consideration of factors such as diseasefree zones or low disease prevalence

within a country when establishing

restrictions on the importation into the

United States of animals and animal

products. Consistent with our

obligations under international trade

agreements, APHIS is altering its

traditional country-based import

restrictions by recognizing that there are

identifiable and measurable gradations

in the degree of disease risk presented

by imported animals and animal

products, and that these gradations are

often tied more to climatological,

geographical, and biological factors than

to national political boundaries.

To help ensure that our standards for

regulating imports on a regional basis

and for assessing disease risk within

defined regions are transparent and

applied on a consistent basis, we have

decided to issue this policy statement

setting forth the factors we will take into

account when considering future

requests to export animals or animal

products to the United States from

distinct or definable regions that may

not be national entities.

The Concept of Regionalization

Regionalization (division of areas into

regions) is rooted in the concept that

restrictions on the movement of animals

and animal products for the purpose of

disease control are biologically and

ecologically most logical when applied

to areas that are geographically

homogenous with respect to disease

distribution and livestock health

infrastructures. Under this concept of

regionalization, regions may be

countries, parts of countries, or groups

of countries.

Regionalization is used for:

• Localization and containment of

existing, exotic, or newly emerging

diseases.

• Recognition of distinct, definable

areas of reduced risk within areas of

greater risk.

• Providing a geographic basis for

sanitary (animal) measures to reduce the

risk of disease introduction through the

movement of animals and animal

products.

Contemporary international

regionalization expectations are

outlined in the World Trade

Organization (WTO) Sanitary and

Phytosanitary (SPS) Agreement that was

authorized by the General Agreement on

Tariffs and Trade (GATT). The WTOSPS Agreement obliges member

countries to develop transparent SPS

measures based on sound scientific

principles, risk assessment, and relevant

international standards, and to apply

them without discrimination, using the

principles of equivalence and

regionalization.

The United States has applied these

concepts for decades in domestic

programs for controlling brucellosis,

tuberculosis, and pseudorabies, and for

containing and eradicating outbreaks of

exotic diseases such as highly

pathogenic avian influenza. These

concepts have also been used to

facilitate exports by regionalizing the

United States for bluetongue and other

agents.

Recent APHIS Rulemaking

We have already applied the concept

of regionalization of a region of low risk

to the importation of beef from

Argentina. On June 26, 1997, we

published a final rule in the Federal

Register (62 FR 34385–34394, Docket

No. 94–106–5) allowing the importation

of fresh, chilled or frozen beef from

Argentina under certain import

conditions, based on our determination

that the unrestricted importation of such

beef would present a low risk of

introducing FMD into the United States.

We have also applied the concept of

regionalization in several other recent

rulemaking actions. For example, on

May 9, 1997, we published in the

Federal Register a final rule (62 FR

25439–25443, Docket No. 94–106–6) to

allow, under certain conditions, the

importation of fresh, chilled or frozen

pork from the State of Sonora, Mexico.

On June 12, 1997, we published in the

Federal Register a proposal (62 FR

32051–32053, Docket No. 97–002–1) to

recognize all of Italy, except Sardinia, as

an area in which African swine fever

does not exist. Each of these actions was

taken after we thoroughly investigated,

through site visits and other data

collection, the disease history,

surveillance systems, animal health

policies, and infrastructure of the areas

in question. This document gives notice

of our intent to apply such approaches

to regionalization and risk analysis in

future rulemaking actions.

Regionalization and Risk Assessment

The principles of the WTO–SPS

Agreement are consistent with the
56028 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Notices

regulatory strategies adopted by many

national veterinary services, as they

have adapted to advances in animal

health technology, progress in the

control and eradication of major animal

plagues, worldwide privatization of

regulatory responsibilities, changing

national boundaries, formation of

trading blocks, and movement toward

more transparent governmental

decisionmaking.

In response to these changes, APHIS

is adopting a policy of evaluating

hazards presented by proposed animal

and animal product importations based

on the disease risk associated with the

region from which they are exported,

rather than on ‘‘disease-free’’ or ‘‘notdisease-free’’ statuses determined on a

country-by-country basis. APHIS will

analyze the disease risk involved and

fashion appropriate import

requirements over a wide range of

variables. Thus, this policy approach

will encompass the concepts of

regionalization and risk assessment.

Risk assessment consists of

identifying risk factors and evaluating

their seriousness. The concept of

assessing risk has underpinned

regulatory decision-making in numerous

sectors for some time. There are many

risk assessment techniques. Some are

very simple and others are extremely

complex. APHIS has developed

guidelines it has used and will use in

the future in assessing the risk of

disease introduction from the

unrestricted importation of animals and

animal products from specified regions,

and in determining which conditions of

importation will reduce any disease risk

to a negligible level. These guidelines

are discussed below.

Definition of ‘‘Region’’

With only minor exceptions, the

regulations in 9 CFR, chapter I,

subchapter D, are currently based on the

disease status of entire countries. This

document gives notice of APHIS’s

policy to consider, for purposes of the

importation of animals and animal

products, the disease status of regions.

APHIS considers a region to be any

defined geographic land area

identifiable by geological, political, or

surveyed boundaries. A region may

consist of any of the following:

• A national entity (country);

• Part of a national entity (zone,

county, department, municipality,

parish, Province, State, etc.);

• Parts of several national entities

combined into an area; or

• A group of national entities

(countries) combined into a single area.

It is important to note that a region

can be a national entity. Consistent with

this concept, we are continuing to apply

on a country-by-country basis the

importation requirements currently set

forth in 9 CFR, chapter I, subchapter D,

for countries listed as being affected or

not affected with specific diseases. We

will continue to apply the current

importation requirements to these

countries until we receive a request to

‘‘regionalize’’ a country into regions, or

to ‘‘regionalize’’ a group of countries

into a region, or both. Once a request is

made, we will evaluate the request and

its supporting documentation to

determine if the requested action is

scientifically supportable, and solicit

public comment on the request and its

supporting data.

New Paradigms to Describe Risk

In reality, ‘‘free’’ is not the same as

‘‘risk-free,’’ and a ‘‘not-free’’ designation

does not ensure that all regions so

considered pose an identical risk. Under

the current regulations in 9 CFR,

chapter I, subchapter D, unrestricted

imports (i.e., importations subject to no

import conditions) from countries

classified as ‘‘free’’ of a certain disease

can present different levels of risk.

Current §§ 94.11 and 94.13 address this

risk by imposing restrictions on the

importation of meat from countries that

are ‘‘free’’ of certain diseases, but that

present a higher disease risk due to

importation practices of these countries

or the geographical proximity to

countries with a higher disease risk. We

consider the countries listed in §§ 94.11

and 94.13 to be ‘‘modified-free’’

countries.

Levels of risk exist upon a continuum.

The extremes of this continuum can be

exemplified by the risk statuses of

countries set forth in the current

regulations. For instance, § 94.1 of the

current regulations lists countries

considered to be free of rinderpest and

foot-and-mouth disease (FMD). The two

diseases are considered to exist in all

countries not included on the ‘‘free’’

list. Under APHIS policy, conditions for

‘‘freedom’’ from disease under the

current regulations include the

requirement that vaccination for the

disease not be carried out in the country

in question. Thus, certain countries

might not be included on the ‘‘free’’ list,

even though they have reported no case

of the disease for several years, because

they continue to vaccinate for the

disease. At the other end of the

spectrum are countries where rinderpest

or FMD is known to exist. Under the

current regulations, all countries listed

as those in which the diseases are

considered to exist are treated as if the

diseases exist throughout those

countries at a uniformly high

prevalence.

The import conditions applied under

the current regulations for animals and

their products reflect the extremes of

‘‘free’’ as currently understood and ‘‘not

free.’’ On the one hand, countries

considered free of FMD and rinderpest

may in most cases export animals to the

United States with only a certificate of

the animal’s origin and health (subject

to general inspection and quarantine at

the U.S. port of arrival). At the other

extreme, animals from countries where

the diseases are considered to exist may

not be imported into the United States,

unless they have undergone preembarkation quarantine and testing in

the country of origin and are imported

through the high-security Harry S

Truman Animal Import Center.

As noted above, until otherwise

requested by foreign regions and

approved by APHIS, we will continue to

operate under the system of ‘‘free,’’

‘‘not-free,’’ and ‘‘modified-free’’ on a

country-by-country basis for those

countries currently so listed in 9 CFR,

chapter I, subchapter D. However, we

will, in the future, evaluate the risk of

importations and seek to determine the

degree of risk involved to ascertain

where the proposed importation would

fall on the risk continuum. This will

allow APHIS to address the degree of

risk involved in a particular type of

importation, rather than trying to fit it

into one of the three categories

contained in the current regulations.

Factors Considered in Assessing Risk

Factors affecting the risk levels of

‘‘free’’ regions are many and can include

geographical proximity to areas where

the disease exists, and importation

practices that increase the risk that the

disease might be introduced into the

‘‘free’’ region. Similarly, significant

differences in risk can exist among

regions in which a particular disease is

known to exist, depending on the

prevalence of the disease (the number of

cases at a given time) or the

infrastructure in place for identifying,

containing or eradicating the disease.

In this policy statement, we are

setting forth the factors we will consider

in determining the risk of unrestricted

importations from a region. Broadly,

these factors are the following:

• The authority, organization, and

infrastructure of the veterinary services

organization in the region.

• The type and extent of disease

surveillance in the region—e.g., is it

passive and/or active; what is the

quantity and quality of sampling and

testing?

• Diagnostic laboratory capabilities.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Notices 56029

• Disease status—is the disease agent

known to exist in the region? If ‘‘yes,’’

at what prevalence? If ‘‘no,’’ when was

the most recent diagnosis?

• The extent of an active disease

control program, if any, if the agent is

known to exist in the region.

• The vaccination status of the region.

When was the last vaccination? What is

the extent of vaccination if it is

currently used, and what vaccine is

being used?

• Disease status of adjacent regions.

• The degree to which the region is

separated from regions of higher risk

through physical or other barriers.

• The extent to which movement of

animals and animal products is

controlled from regions of higher risk,

and the level of biosecurity regarding

such movements.

• Livestock demographics and

marketing practices in the region.

• Policies and infrastructure for

animal disease control in the region—

i.e., emergency response capacity.

Characterization of Levels of Risk

In practice, regions could have

numerous possible combinations of the

above factors. For instance, one region

might have a low prevalence of a

disease (the number of cases at a given

time), but have loosely restricted

borders with adjacent regions where the

disease is present. Another region might

have tighter border controls but a higher

incidence of the disease (the number of

new cases over a given period of time).

Two regions with identical histories of

disease incidence and disease

prevalence might differ in that

vaccination continues in one region, but

not in the other. Two regions might

theoretically share all risk

characteristics, including adjacency to a

region where a disease of concern is

known to exist. However, in one case,

the disease in the affected neighboring

region might exist close to the border. In

the other, it might exist two time zones

away, if the neighbor is a large country

that has not yet requested to be

subdivided into regions. This one

variable could affect the actual risk level

between the two regions, and could

potentially support two different sets of

conditions necessary to reduce the risk

of the importation of animals and

animal products to a negligible level.

Therefore, although each of the factors

we will consider are accepted on an

international level as potentially

affecting the disease risk in a region, the

weight each of the factors will be given

will depend on the individual

circumstances of the region.

Because of the number of potential

variables and the vast number of

possible combinations of those variables

in assessing the risk of unrestricted

importation of animals and animal

products from a region, the precise

combination of measures necessary to

reduce the risk of disease introduction

to a negligible level may vary from

region to region depending on the

commodities to be imported and the

diseases of concern.

Recognizing these potential variables,

we nonetheless consider it useful to

provide benchmarks or ‘‘targets’’ of

general risk characterization, by

dividing the continuum of risk into five

general categories, based on the risk

factors described above. These

benchmark risk categories are:

• Negligible risk;

• Slight risk;

• Low risk;

• Moderate risk;

• High risk.

In order to determine the risk category

of a region, we must have or be supplied

with sufficient information to evaluate

the region’s level of risk. Any region for

which sufficient data is not available to

make such an evaluation would be

considered to be high risk until

information became available to support

an alternative determination.

As noted above, there are factors that

we always look at in determining the

level of risk that unrestricted

importations from a region would

present (veterinary infrastructure,

disease status, disease status of adjacent

regions, vaccination status, etc.). We

have weighed these factors in our

determination of a country’s disease

status under the current regulations, and

will continue to do so in the future. The

difference between the current

regulations and the policy we are

adopting is that, in the future, our

consideration of these factors will not

always result in one of the three current

classifications of ‘‘free’’ ‘‘not free,’’ or

‘‘modified free.’’ In theory, and likely in

practice, regions where an animal

disease is not known to exist may

present different levels of risk, and

regions where an animal disease is

known to exist may likewise present

different levels of risk. We will establish

import conditions appropriate to each of

the regions in a transparent, scientific

manner, subject to public review and

comment, as discussed below. A region

will be able, however, to determine how

we will generally view its animal

disease risk, according to the following

factors and scenarios.

1. Negligible Risk. A region in which

all of the following factors are present

would generally be considered a region

of negligible risk for a restricted disease

agent:

• The restricted agent has not been

diagnosed within the region for a period

of time appropriate for that agent. This

period of time will depend on the

disease in question, but can range from

1 year for a disease such as FMD, to a

longer period of time for diseases with

long incubation times, such as

spongiform encephalopathies and

mycobacterial diseases.

• The restricted agent is not known to

exist within any adjacent defined

region.

• Vaccination for the restricted agent

has been prohibited within the region

for a period of time appropriate to the

disease in question (exceptions may be

made for certain diseases such as vectortransmitted diseases, or for animals

specifically vaccinated to meet import

requirements of other regions, and such

vaccination would not increase the risk

of importing the restricted agent into the

United States).

• Any adjacent regions of slight risk

or low risk for the restricted agent are

separated by natural or man-made

physical barriers or protected borders,

or other movement controls and other

measures and restrictions that are

equivalent to those imposed in the

United States for similar diseases

subject to domestic control programs.

• All border access points from

adjacent regions of slight risk or low risk

for the restricted agent are controlled to

prevent movement of susceptible

animals or animal products from the

adjacent regions except under

conditions that achieve the same level

of biosecurity as required for

importations from such regions of

greater risk into the United States.

• Movement of animals and animal

products into the region from regions of

greater than negligible risk for the

restricted agent is done only under

conditions that achieve the same level

of biosecurity as required for

importations from such regions of

greater risk into the United States.

• The region maintains an adequate

passive surveillance system with the

demonstrated capability of detecting

restricted agents in a timely fashion.

• The region maintains policies and

infrastructure to respond to any

occurrences of a restricted agent.

2. Slight Risk. In general, a particular

disease agent would not be known to

exist in a region of slight risk, but

adjacency to or extensive trade with

regions of higher risk levels would

create a greater risk of disease exposure

than exists in a region of negligible risk.

A region in which all of the following

factors are present would be considered

a region of slight risk for a restricted

disease agent:
56030 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Notices

• The restricted agent has not been

known to exist in the region for a period

of time appropriate for that agent.

• Vaccination for the restricted agent

is prohibited within the region

(exceptions may be made for certain

restricted agents such as vectortransmitted diseases, or for animals

specifically vaccinated to meet import

requirements of other regions, and such

vaccination would not increase the risk

of importing restricted agents into the

United States).

• Any animals previously vaccinated

against the disease have been

slaughtered or moved out of the region,

or are under provisional quarantine

(exceptions may be made for certain

restricted agents such as vectortransmitted diseases, or for animals

specifically vaccinated to meet import

requirements of other regions, and such

vaccination would not increase the risk

of importing restricted agents into the

United States).

• Any adjacent regions of greater than

slight risk for the restricted agent are

separated by natural or man-made

physical barriers or protected borders,

or other movement controls and other

measures that are equivalent to those

employed in the United States for

similar diseases subject to domestic

control programs.

• All border access points from

regions of greater than slight risk for the

restricted agent are strictly controlled to

prevent movement of susceptible

animals or animal products from the

adjacent regions, except under

conditions that achieve the same level

of biosecurity as required for

importations from such regions of

greater risk into the United States.

• Movement of animals and animal

products into the region from regions of

greater than slight risk for the restricted

agent is done only under conditions that

achieve the same level of biosecurity as

required for importation from such

regions of greater risk into the United

States.

• The region maintains adequate

passive and/or active surveillance

systems with the demonstrated

capability of detecting restricted agents

in a timely fashion.

• The region maintains policies and

infrastructure to respond to any

occurrences of a restricted agent.

3. Low Risk. A particular disease agent

would not be known to exist in a region

of low risk, but continued vaccination

would create concerns about residual

infection and/or masking of the agent. A

region in which all of the following

factors are present would be considered

a region of low risk for a restricted

disease agent.

• The restricted agent has not been

diagnosed within the region during the

past year, except for diseases with long

incubation periods such as spongiform

encephalopathies and mycobacterial

diseases, and the prevalence of the

restricted agent has been low over a

period of time appropriate to the disease

in question.

• Vaccination for the restricted agent

is prohibited within the region or is

limited to those herds that are at greatest

risk of exposure from animals from

regions of higher risk levels (exceptions

may be made for certain diseases such

as vector-transmitted diseases, or for

animals specifically vaccinated to meet

import requirements of other regions,

and such vaccination would not

increase the risk of importing restricted

agents into the United States).

• Any adjacent regions of greater risk

for the restricted agent are separated by

natural or man-made physical barriers,

or protected borders, or other movement

controls and other measures that are

equivalent to those employed in the

United States for similar diseases

subject to domestic control programs.

• All border access points from

adjacent regions of greater risk for the

restricted agent are controlled to prevent

movement of susceptible animals or

animal products from the adjacent

regions except under conditions that

achieve the same level of biosecurity as

required for importations from such

regions of greater risk into the United

States.

• Movement of animals and animal

products into the region from regions of

greater risk for the restricted agent is

done only under conditions that achieve

the same level of biosecurity as required

for importation from regions of greater

risk into the United States.

• The region maintains adequate

passive and active surveillance systems

with the demonstrated capability of

detecting restricted agents in a timely

fashion.

• The region maintains policies and

infrastructure to respond to any

occurrences of the restricted agent.

4. Moderate Risk. A particular disease

agent would be known to exist in a

region of moderate risk, but at a low

level. A region in which all of the

following factors are present would be

considered a region of moderate risk for

a restricted disease agent.

• The restricted agent has been

diagnosed within the region during the

past year, or within a longer period of

time for diseases with long incubation

periods such as spongiform

encephalopathies and mycobacterial

disease, but the prevalence of the

restricted agent has been low for a

period of time appropriate for the

disease agent.

• An active control program with a

goal of eradication for the restricted

agent is in operation in the region.

• Vaccination for the restricted agent

is currently limited to those herds at

greatest risk of infection (exceptions

may be made for certain diseases, such

as vector-transmitted diseases, or for

animals specifically vaccinated to meet

import requirements of other regions,

and such vaccination would not

increase the risk of importing restricted

agents into the United States).

• Any adjacent regions of greater risk

are separated by natural or man-made

physical barriers or protected borders,

or other movement controls and

measures equivalent to those employed

in the United States for similar diseases

subject to domestic control programs.

• All border access points from

adjacent regions of greater risk for the

restricted agent are strictly controlled to

prevent movement of susceptible

animals or animal products from the

adjacent regions except under

conditions that achieve the same level

of biosecurity as required for

importation from such regions of greater

risk into the United States.

• Movement of animals and animal

products into the region from regions of

greater risk is done only under

conditions that achieve the same level

of biosecurity as required for

importation from regions of greater risk

into the United States.

• The region maintains adequate

passive and active surveillance systems

with the demonstrated capability of

detecting restricted agents in a timely

fashion.

• The region maintains policies and

infrastructure to eliminate any

outbreaks of the restricted agent that

may occur.

5. High Risk. A disease agent would

be known to exist in a region of high

risk, possibly at a high level. A region

in which the following factors are

present would be considered a region of

high risk for a restricted disease agent.

• The restricted agent has been

diagnosed within the region within the

past year, or within a longer period of

time for diseases with long incubation

periods such as spongiform

encephalopathies and mycobacterial

disease, and the prevalence of the

disease agent in the time period

appropriate to the disease agent exceeds

that of a moderate-risk region.

• A control program for restricted

agents may be in operation in the region

but does not meet the minimum

standards for a region of moderate risk.
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Notices 56031

• Vaccination for the restricted agent

may vary from herd to herd.

• Movement of animals and animal

products into the region may not be

adequately controlled from regions of

moderate risk or high risk for the

restricted agent.

• The region does not maintain a

passive and active surveillance system

for the restricted agent at a level that

meets standards for a region of moderate

risk.

• The region may or may not

maintain policies and infrastructure to

effectively control and restrict spread of

any outbreaks of the restricted agent that

may occur.

It should be noted that of the five

general categories of risk set forth above,

the categories referred to as ‘‘negligible

risk,’’ ‘‘slight risk,’’ and ‘‘high risk’’

correspond to risk classifications as set

forth in the current regulations.

‘‘Negligible risk’’ is comparable to our

current free-without-restrictions status.

‘‘Slight risk’’ is comparable to our

current modified-free status, applied to

those countries where a disease is not

known to exist but which, because of

their proximity to countries where the

disease exists or because of their

importation practices, are considered to

present more than a negligible risk of

unrestricted importation of meat

products. ‘‘High risk’’ is comparable to

those countries where a disease is

known to exist. To these three current

classifications, the factors described

above add the categories of ‘‘low risk’’

(to address regions that have reported

no cases of disease over a specified

period of time but that still vaccinate for

the disease) and ‘‘moderate risk’’ (to

address those regions where a disease

may exist on a limited basis, but where

it is adequately controlled and

contained). Examples of regions that

would fall under one of these two

additional characterizations, along with

an example of a high risk region, are as

follows.

Example 1: A Region Considered To

Present a Low Risk of FMD Introduction

Through Unrestricted Importation

The example of a region characterized

as presenting a low risk for FMD is one

that we recently applied with regard to

the importation of beef from Argentina.

Because the last outbreak of FMD

occurred in Argentina in 1994, we

considered the disease risk in Argentina

to be low, although higher than in other

countries in which the disease has not

occurred, due to the following factors:

(1) Vaccinations for FMD still

continue in Argentina;

(2) Argentina supplements its national

meat supply by importing fresh, chilled

and frozen meat of ruminants and swine

from countries where some prevalence

of FMD occurs; and

(3) Argentina shares land borders with

Brazil and Bolivia, for which we do not

have enough information to establish a

disease risk characterization for FMD.

For these reasons, we established

import conditions on the importation of

beef from Argentina that do not apply to

other countries in which FMD is not

known to occur. These conditions are

discussed below under the heading

‘‘Examples of Import Conditions.’’

Example 2: A Region Considered to

Present a Moderate Risk of FMD

Introduction Through Unrestricted

Importation

In this example, Region X has had an

outbreak of FMD in the past year, but

the prevalence of the disease in recent

years has been low. Region X borders a

region where FMD is known to exist.

However, Region X has in place

adequate passive and active surveillance

systems for detection and reporting of

the disease. Further, Region X has in

place an active control program with the

goal of eradication of FMD. Vaccination

for FMD is currently limited to those

herds at greatest risk of infection.

Region X maintains policies and

infrastructure to eliminate any

outbreaks of the restricted agent that

may occur.

Compare Region X to Region Y, which

is:

Example 3: A Region Considered To

Present a High Risk of FMD Introduction

Through Unrestricted Importation

Region Y is identical to Region X in

every way except two. First, it does not

have an active control program with the

goal of eradication of FMD. Second, it

has in place policies only to restrict,

rather than eliminate, outbreaks of FMD.

We would consider Region X to

present a moderate risk of the

introduction of FMD through

unrestricted importation. We would

consider Region Y to present a high risk.

Import Conditions Based on Risk

The risk characterizations described

above are guidelines for the use of

regions seeking to export animals or

their products to the United States, and

to provide guidance as to the factors we

consider in deciding where a particular

region falls on the disease risk

continuum. The risk characterizations

themselves do not determine whether

an animal or its products may be safely

imported into the United States, nor do

they dictate the precise import

conditions that would be appropriate to

the importation of a particular

commodity. But they do provide an

indication as to the severity of the

disease risk and the necessary

restrictions that we would apply to

importations to reduce the disease risk

to a negligible level.

The actual decision whether to allow

importations, and under what

conditions, would be based on the

outcome of a risk analysis conducted on

a particular commodity from a

particular region. In accordance with

the WTO–SPS Agreement, we recognize

that different import conditions might

achieve equivalent results in reducing

disease risk. However, the final

determination of which import

conditions to impose, and whether

different sets of conditions are

equivalent, will rest with APHIS. The

WTO–SPS Agreement principles require

that SPS measures be equitably applied,

scientifically sound, guided by

international standards, and

‘‘transparent.’’ Signatory countries must

also recognize that equal levels of risk

mitigation can be achieved by applying

differing sanitary measures

(equivalence), based on risk-assessments

applied on a regional basis.

In accordance with the WTO–SPS

Agreement principles, it will be our

policy to establish appropriate

conditions for the importation of

animals and animal products based

either on international standards or as

the result of an individual assessment of

risk of the importation of a particular

type of commodity from a particular

region. A document describing the

Agency’s internal guidelines for risk

assessment is currently under

development. It will be made available

electronically upon completion. In

general, we will process applications for

regionalization according to the

following procedure:

The potential exporting region must

submit a request to the APHIS

Administrator for approval to export a

particular type of animal or animal

product to the United States. Along with

the request, the region must provide

information addressing the areas

described above in this notice, under

the heading ‘‘Factors Considered in

Assessing Risk.’’ This information will

be made available to the public prior to

our initiating any rulemaking action on

the request. Additional information may

be requested from the exporting region

depending upon the specific commodity

and the risk being evaluated.

Once we have received from a

potential exporting region the

information necessary to conduct a risk

assessment, and have evaluated the risk,

we will make a determination whether

an import can be safely allowed and
56032 Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Notices

under what conditions. If we believe the

importation can be safely allowed, we

will propose in the Federal Register to

allow such importations, and under

what conditions, along with a

discussion of how we reached that

decision. We will then provide a period

of time during which the public may

comment on our proposal. We will find

most useful those comments that

support their position with verifiable

data or scientific information. During

the comment period, the public will

have access, both in hard copy and

electronically, to the information upon

which we based our risk analysis, as

well as to our methodology in

conducting the analysis. Once we have

reviewed all comments received, we

will make a final decision on what

conditions will be necessary to allow

the importation in question, and will

publish that decision in the Federal

Register.

Although the import conditions

applied in each situation may vary

according to the region, the disease, and

the commodity involved, we anticipate,

based on our experience enforcing the

current regulations, that similar levels of

risk will require similar conditions of

importation. We have adopted, and have

been applying for decades, a body of

risk mitigation measures that will likely

be used in some combination for each

importation. These can include

measures ranging from something as

simple as a certificate of origin, to the

requirement that animals intended for

importation from regions of high risk be

quarantined at APHIS’s high-security

Harry S Truman Animal Import Center,

to outright prohibition of an

importation.

The broad risk management options

available for application, either

individually or in combination, to

animals or their products are:

• Certificate of origin of animals and

animal products.

• Tests and inspection of imported

animals or products.

• Tests and inspections of herds or

premises of origin.

• Treatment of animals or products.

• Quarantine of imported animals.

• Restricted use or movement of

imported animals or products.

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:

• The incubation period.

• The duration of carrier status in

animals.

• The number of potential host

species that may be affected.

• The survivability of the disease

agent outside the host animal.

• The effectiveness of available test

procedures to detect the disease agent.

• The effectiveness of available

treatment procedures to eliminate the

disease agent or its vector.

• The availability of technology to

eradicate the disease agent if it were

introduced.

• If the disease agent were

introduced, the potential costs (both

economic and environmental) to

eradicate it, or potential costs into

perpetuity if the agent cannot be

eradicated.

Application of Import Conditions

The three examples we presented

earlier in this document of regions

characterized as either ‘‘low risk,’’

‘‘moderate risk,’’ or ‘‘high risk’’ for FMD

can also be used to illustrate the types

of mitigation measures we would

consider appropriate for a disease such

as FMD, which is a serious disease with

significant potential costs in the event of

introduction and establishment.

Examples of the types of import

conditions that would be appropriate

are set out as follows. Please note,

however, that the precise import

conditions in any specific case will

depend on all of the factors affecting a

particular region.

Example 1: Importation of Beef From a

Region Characterized as Low-Risk for

FMD

As noted above, we recently made

final a rule allowing the importation of

beef from Argentina, which we

determined to be a country that would

present a low risk of FMD introduction

if unrestricted imports were allowed

into the United States. Because of the

potentially severe consequences of FMD

introduction, we considered it necessary

to apply the following import

conditions to any fresh, chilled or

frozen beef imported from Argentina,

and to cured or cooked beef from

Argentina that does not meet the

requirements of 9 CFR 94.4. An

authorized official of Argentina must

certify on a meat inspection certificate

that each of the following conditions

was met.

(1) The meat is beef that originated in

Argentina;

(2) The beef came from bovines that

were moved directly from the premises

of origin to the slaughterhouse without

any contact with other animals;

(3) The beef has not been in contact

with beef from regions in which FMD is

considered to exist;

(4) The beef came from bovines that

originated from premises where FMD

and rinderpest have not been present

during the lifetime of any of the bovines

slaughtered for export of beef;

(5) The beef is from bovines that

originated from premises on which

ruminants or swine have not been

vaccinated with modified or attenuated

live viruses for FMD at any time during

the lifetime of any of the bovines

slaughtered for export of beef;

(6) The beef originated from premises

where no bovines have been vaccinated

for rinderpest at any time during the

lifetime of any of the bovines

slaughtered for export of beef;

(7) All bone, blood clots, and

lymphoid tissue have been removed

from the beef; and

(8) The beef comes from carcasses that

have been allowed to maturate at 40 to

50 °F (4 to 10 °C) for a minimum of 36

hours after slaughter, and have reached

a pH of 5.8 or less in the loin muscle

at the end of the maturation period. Any

carcass in which the pH does not reach

5.8 or less may be allowed to maturate

an additional 24 hours and be retested,

and, if the carcass still does not reach

a pH of 5.8 or less after 60 hours, the

beef from the carcass may not be

imported into the United States.

Example 2. Importation of Beef From a

Region Characterized as Moderate Risk

for FMD

In the examples or risk

characterization we provided earlier in

this document, we considered Region X

to be a region of moderate risk for FMD.

Although the actual conditions for the

importation of beef from Region X might

be established by means of a risk

analysis, based on our experience

enforcing the regulations, it is likely that

the conditions would be similar to those

for a low risk region, with the following

differences due to the existence of FMD

in the region and the resulting higher

risk:

1. The beef would have to come from

bovines that originated from premises

where FMD or rinderpest has not been

diagnosed within 15 statute miles (25

kilometers) within the previous 12

months; and

2. The beef would have to be held at

no more than 40 °F (4 °C) for a

minimum of 14 days before export,

during which time the premises of

origin of all animals from which the

beef in the shipment came would have

to remain free of FMD and rinderpest.

Example 3: Importation of Beef From a

Region Characterized as High Risk for

FMD.

The importation of fresh, chilled or

frozen beef would be prohibited from a
Federal Register / Vol. 62, No. 208 / Tuesday, October 28, 1997 / Notices 56033

region characterized as presenting a

high risk for FMD.

Diseases of Concern

The current regulations specifically

address a number of diseases subject to

import regulations, 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. We will continue to

regulate the importation of animals and

their products with regard to these

diseases. Additionally, it will be our

policy to consider the risk presented by

certain diseases not currently

specifically listed in 9 CFR when

determining whether to allow an

importation and under what conditions.

With regard to ruminants and swine,

the diseases we are specifically naming

here 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

FMD exists. Accordingly, such

importations were prohibited. The

current regulations ban the importation

into the United States of most animals

and animal products from countries in

which rinderpest or FMD exists. In

those cases where animals or 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, several factors now make it

necessary to consider specific regulatory

restrictions for certain diseases not

currently addressed in the regulations.

The first factor is the policy we are

adopting of providing for

regionalization and for various levels of

characterization of disease risk. For

example, 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 a 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 our policy of regionalization,

import restrictions due to FMD in one

part of a country can no longer be relied

upon to guard against the importation of

other animal diseases of concern.

In addition to FMD and rinderpest,

other disease agents that are specifically

addressed in current 9 CFR 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, exotic

Newcastle disease (END) virus (also

known as velogenic Newcastle disease

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,

contagious pleuropneumonia, scrapie,

surra caused by Trypanosoma evansi,

fever ticks and other ticks, vesicular

stomatitis, 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 multiceps

(also known as Taenia coenurus).

In addition to the diseases listed

above, we will consider the following

diseases when determining conditions

for the importation of animals and

animal products: Akabane virus,

bluetongue virus, epizootic hemorrhagic

disease virus, malignant catarrhal fever

virus (African or wildebeest form), blue

eye disease of swine (paramyxovirus),

Brucella abortus, Brucella melitensis,

Brucella suis, Trypanosoma vivax,

contagious agalactiae of sheep and goats

due to Mycoplasma agalactiae,

Mycobacterium bovis, pseudorabies,

sheep pox and goat pox, heartwater due

to Cowdria ruminantium, Japanese

encephalitis virus, lumpy skin disease

(Neethling virus), Nairobi sheep disease

(Ganjam, Dugbe) virus, peste des petits

ruminants, Rift Valley fever, and

theileriosis (east coast fever, corridor

disease, Mediterranean fever), turkey

rhinotracheitis (swollen head), goose

parvovirus (Derzsy’s disease),

adenovirus 127 (egg drop syndrome),

salmonella pullorum, and salmonella

gallinarium.

In determining conditions for the

importation of animals, we will also

consider the presence in the region of

ectoparasites of animals if the

ectoparasites are not known to exist in

the United States or are subject to

cooperative Federal/State control

programs in the United States. These

ectoparasites include the following:

Ticks: Amblyomma astrion, A.

cohaerens, A. gemma, A. hebraeum, A.

javenese, A. lepidum, A. marmoreum,

A. pomposum, A. sparsum, A.

testudinarium, A. tholloni, A.

variegatum, Boophilus annulatus, B.

decoloratus, B. florae, B. geigyi, B.

kohisi, B. microplus, Dermacentor

daghestanicus, D. marginatus, D.

nuttalli, D. pictus, D. reticulatus, D.

silvarium, Haemaphysalis bispanosa, H.

leachii, H. longicornis, H. otophila, H.

punctata, H. sulcata, Hyalomma

anatolicum anatolicum, H. anatolicum

excavatum, H. detritum, H. dromedarii,

H. marginatum marginatum, H.

marginatum rufipes, H. marginatum

turanicum, H. scupense, H. truncatum,

Ixodes persulcatus, I. pilosus, I. ricinus,

Ornithodoros erraticus, O. moubata, O.

moubata porcinus, Rhipicephalus

appendiculatus, R. bursa, R. capensis,

R. compositus, R. evertsi evertsi, R.

evertsi, mimeticus, R. glabroscutatum,

R. kochi, R. lunulatus, R. pulchellus, R.

simus, R. turanicus, and R.

zambeziensis.

Mites: Chorioptes bovis, various

subspecies of which cause mange in

horses, cattle, and sheep; Psorergates

ovis, the causative agent of sheep

scabies; Psoroptes cuniculi, the

causative agent of ear mange in goats

and rabbits; and P. ovis, various

subspecies of which cause scabies and

mange in horses, cattle, sheep, and

swine.

Insects: Chrysomyia bezziana (Old

World screwworm), Cochliomyia

hominivorax (Callitrogra americana)

(New World screwworm), and

Hippobosca spp. and Lipoptema spp.

(louse flies).

Done in Washington, DC, this 22nd day of

October 1997.

Terry L. Medley,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 97–28472 Filed 10–23–97; 12:52

pm]

BILLING CODE 3410–34–P