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Release No. 0372.03

Alisa Harrison (202) 720-4623

##  Jerry Redding (202) 720-6959

**USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL IMPORTS FROM CANADA**

# Releases Risk Assessment by Harvard Center for Risk Analysis 

WASHINGTON, Oct. 31, 2003\--The United States Department of Agriculture
today issued a proposed rule to amend its bovine spongiform
encephalopathy (BSE) regulations to establish a new category of regions
that recognizes those that present a minimal risk of introducing BSE
into the United States via the importation of certain low-risk live
ruminants and ruminant products.

USDA\'s Animal and Plant Health Inspection Service is seeking public
comment on the proposal to allow the importation of certain live
ruminants and ruminant products and byproducts from minimal risk regions
under specified conditions. This proposed rule would place Canada on a
list of countries considered a minimal risk for BSE, thus making Canada
eligible to export certain live ruminant and ruminant products.

"The United States has a long history of having safeguards in place to
prevent the introduction of BSE," said Agriculture Secretary Ann M.
Veneman. "The continued protection of the U.S. food supply is our top
priority. This proposal reflects a thorough review of the scientific
evidence, which shows the risk to public health to be extremely low."

The proposed minimal risk region would include regions in which an
animal has been diagnosed with BSE but in which specific preventive
measures have been in place for an appropriate period of time that
reduce the risk of BSE being introduced to the United States. Based on a
comprehensive risk analysis and review, USDA believes that the
surveillance, prevention and control measures implemented by Canada are
sufficient to be included in the minimal risk category.

The proposed rule has a 60-day comment period. Once this period closes,
USDA will consider the comments as it makes any final decisions on the
importation of certain live ruminants and ruminant products from Canada
and other minimal risk regions for BSE.

-more-

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Under this proposal, ruminant and ruminant products eligible for entry
into the United States from a BSE minimal risk region would include: 1)
bovine animals less than 30 months of age for immediate slaughter; 2)
bovine animals for feeding to be moved to a designated feedlot and then
to slaughter at less than 30 months of age; 3) sheep and goats less than
12 months of age for immediate slaughter; 4) sheep and goats for feeding
to be moved to a designated feedlot and then to slaughter at less than
12 months of age; 5) cervids for immediate slaughter; 6) fresh (chilled
or frozen) meat from bovines less than 30 months of age; 7) fresh
(chilled or frozen) whole or half carcasses of bovines less than 30
months of age; 8) fresh (chilled or frozen) bovine liver; 9) fresh
(chilled or frozen) bovine tongues; 10) fresh (chilled or frozen) meat
of sheep or goats less than 12 months of age; 11) fresh (chilled or
frozen) carcasses of sheep or goats less than 12 months of age; 12)
hunter-harvested wild ruminant products; 13) fresh (chilled or frozen)
meat of cervids either farm-raised or harvested on a game farm or
similar facility; 14) fresh (chilled or frozen) meat from wild-
harvested caribou, musk ox, or other cervids; and 15) certain types of
gelatin, tallow and offal. A full listing of the risk mitigation
measures required to be eligible for entry into the United States can be
found at [http://www.aphis.usda.gov/.]{.underline}

The proposed rule is consistent with the approach taken by the World
Organization for Animal Health (OIE) -- the standard setting
organization for animal health for 164 member nations. In recent
correspondence, the Director General of the OIE acknowledged that there
has been an "increase in unjustified restrictions in international
trade, particularly as it relates to cattle and cattle products." The
letter was in response to a request from Secretary Veneman, Agricultural
Minister Lyle Vanclief, Canada, and Agriculture Secretary Javier
Usabiaga, Mexico, to the OIE to provide more practical guidance
regarding the resumption of trade with countries that have reported
cases of BSE. The United States continues to work with the OIE to ensure
that countries establish import policy decisions based on standards that
are commensurate with the BSE risks identified for each situation.

**HARVARD RISK REASSESSMENT**

USDA also released the findings of a second assessment conducted by the
Harvard Center for Risk Analysis (HCRA) that confirms the findings of
the initial study released in 2001. The study found that even if
infected animals or ruminant feed material entered the U.S. animal
agriculture system from Canada, the risk of it spreading extensively
within the U.S. herd was low, that any possible spread would now have
been reversed by controls put in place in the late 1990's, and that
eventually, the disease would be eliminated from the United States.

"This study shows that the measures taken in the United States over the
years greatly reduce the chance of BSE spreading and help ensure that
the disease will not become a major animal or public health problem in
America," said Dr. George Gray, executive director of HCRA.

The risk reassessment was commissioned by USDA shortly after the
discovery of a single case of BSE in Canada on May 20, 2003. The study
evaluates the potential for BSE to spread if it were introduced from
Canada prior to May 20, when USDA banned all ruminant and ruminant
products from Canada because of the discovery of the single case of BSE.
The reassessment specifically examined scenarios for the likely
introduction of BSE from Canada into the United States.

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The scenarios used for this assessment included hypothetical
introductions at various times of both infected animals and contaminated
animal feed. These scenarios were entered into the HCRA computer model
that simulates conditions in the U.S. cattle herd given the actions that
have already been taken to minimize the risk of spreading the disease.
In the worst case scenario, where infection was introduced as early as
1990, the results demonstrated that the disease could have spread with a
peak infection rate occurring in 1997 and peak numbers of clinical cases
occurring in 2000. When infection was introduced later in 1996 or 1998,
there was minimal or no spread of the disease.

As with the initial study, which hypothetically introduced as many as
500 infected animals into the U.S. herd, the Food and Drug
Administration's 1997 ban on feeding most mammalian protein back to
other ruminants essentially stops the possible spread of the disease.

Even allowing for incomplete compliance with that feed ban, the HCRA
analysis finds that, had infected animals or feed come in from Canada or
elsewhere, by now the spread of BSE in the U.S. herd would have been
reversed and that human exposure to contaminated animal tissue would
have been very low.

A complete copy of the second Harvard Report can be obtained from USDA's
official website at <http://www.usda.gov/.>

**USDA PREVENTIVE ACTION**

BSE is a progressive neurological disease among cattle that is always
fatal. It belongs to a family of diseases known as transmissible
spongiform encephalopathies. Also included in that family of illnesses
is variant Creutzfeldt-Jakob Disease (vCJD), which is believed to be
caused by eating neural tissue, such as brain and spinal cord, from BSE
affected cattle.

BSE has never been detected in U.S. cattle. The USDA and other agencies
have had preventive measures in place since recognition of BSE as a
serious disease. Since 1989, USDA has banned the import of live
ruminants, such as cattle, sheep and goats, and most ruminant products
from the United Kingdom and other countries having BSE. The ban was
extended to Europe in 1997. And, as more evidence was accumulated about
how the disease spread, the Food and Drug Administration prohibited the
use in 1997 of most mammalian protein in the manufacture of animal feed
intended for cows and other ruminants.

Since 1990, USDA has had an aggressive BSE surveillance program in place
to ensure detection and swift response in the event that an introduction
of BSE were to occur. Last year, USDA tripled testing levels and this
year testing reached an all-time high of 20,526 head, or 47 times the
level recommended by the OIE. Because of the May 20, 2003 occurrence of
a single case of BSE in Canada, APHIS is reviewing its current level of
surveillance to continue to ensure a high confidence level.

USDA's Food Safety and Inspection Service is evaluating a proposal to
further address specified risk material such as brain and spinal cord to
continue to reduce any potential risk. These tissues are considered to
be the most infectious in animals with BSE. Therefore, this measure
could further reduce the already very low risk of BSE in the United
States, thus providing additional protection for consumers.

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**TO COMMENT ON THE PROPOSAL**

The notice of proposed rulemaking to permit entry of low-risk live
animals from certain minimal risk regions is scheduled for publication
in the Nov. 4 *Federal Register*. APHIS documents published in the
*Federal Register* and related information, including the names of
organizations and individuals who have commented on APHIS dockets, are
available on the Internet at [http://www.aphis.usda.gov/.]{.underline}

Consideration will be given to comments received on or before Jan. 5,
2004. Comments may be submitted by postal mail, commercial delivery or
by e-mail. Send an original and three copies of postal or commercial
delivery comments to Docket No. 03-080-1, Regulatory Analysis and
Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118,
Riverdale, Md. 20737-1238. If you use e-mail, address your comments to
regulations@aphis.usda.gov. Comments must be contained in the body of
the message; do not send attached files. Please include your name and
address in the message and use "Docket No. 03-080-1\" on the subject
line.

Comments received may be reviewed at USDA, Room 1141, South Building,
14th Street and Independence Avenue, S.W., Washington, D.C., between 8
a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons
wishing to review comments are requested to call ahead on (202) 690-2817
to facilitate entry into the comment reading room.

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