[Federal Register Volume 62, Number 208 (Tuesday, October 28, 1997)]
[Notices]
[Pages 56027-56033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28472]



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

[[Page 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-by-country 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 disease-free 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:
    <bullet> Localization and containment of existing, exotic, or newly 
emerging diseases.
    <bullet> Recognition of distinct, definable areas of reduced risk 
within areas of greater risk.
    <bullet> 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 WTO-SPS 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

[[Page 56028]]

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 ``not-
disease-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:
    <bullet> A national entity (country);
    <bullet> Part of a national entity (zone, county, department, 
municipality, parish, Province, State, etc.);
    <bullet> Parts of several national entities combined into an area; 
or
    <bullet> 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 Secs. 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 Secs. 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, Sec. 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 pre-embarkation 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:
    <bullet> The authority, organization, and infrastructure of the 
veterinary services organization in the region.
    <bullet> 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?
    <bullet> Diagnostic laboratory capabilities.

[[Page 56029]]

    <bullet> 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?
    <bullet> The extent of an active disease control program, if any, 
if the agent is known to exist in the region.
    <bullet> 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?
    <bullet> Disease status of adjacent regions.
    <bullet> The degree to which the region is separated from regions 
of higher risk through physical or other barriers.
    <bullet> 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.
    <bullet> Livestock demographics and marketing practices in the 
region.
    <bullet> 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:
    <bullet> Negligible risk;
    <bullet> Slight risk;
    <bullet> Low risk;
    <bullet> Moderate risk;
    <bullet> 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:
    <bullet> 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.
    <bullet> The restricted agent is not known to exist within any 
adjacent defined region.
    <bullet> 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 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 the restricted agent into the United 
States).
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> The region maintains an adequate passive surveillance 
system with the demonstrated capability of detecting restricted agents 
in a timely fashion.
    <bullet> 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:

[[Page 56030]]

    <bullet> The restricted agent has not been known to exist in the 
region for a period of time appropriate for that agent.
    <bullet> Vaccination for the restricted agent is prohibited within 
the region (exceptions may be made for certain restricted agents 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).
    <bullet> 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 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).
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> The region maintains adequate passive and/or active 
surveillance systems with the demonstrated capability of detecting 
restricted agents in a timely fashion.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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).
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> The region maintains adequate passive and active 
surveillance systems with the demonstrated capability of detecting 
restricted agents in a timely fashion.
    <bullet> 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.
    <bullet> 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.
    <bullet> An active control program with a goal of eradication for 
the restricted agent is in operation in the region.
    <bullet> 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).
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> The region maintains adequate passive and active 
surveillance systems with the demonstrated capability of detecting 
restricted agents in a timely fashion.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.

[[Page 56031]]

    <bullet> Vaccination for the restricted agent may vary from herd to 
herd.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

[[Page 56032]]

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:
    <bullet> Certificate of origin of animals and animal products.
    <bullet> Tests and inspection of imported animals or products.
    <bullet> Tests and inspections of herds or premises of origin.
    <bullet> Treatment of animals or products.
    <bullet> Quarantine of imported animals.
    <bullet> 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:
    <bullet> The incubation period.
    <bullet> The duration of carrier status in animals.
    <bullet> The number of potential host species that may be affected.
    <bullet> The survivability of the disease agent outside the host 
animal.
    <bullet> The effectiveness of available test procedures to detect 
the disease agent.
    <bullet> The effectiveness of available treatment procedures to 
eliminate the disease agent or its vector.
    <bullet> The availability of technology to eradicate the disease 
agent if it were introduced.
    <bullet> 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  deg.F (4 to 10  deg.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  deg.F (4 
deg.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

[[Page 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