[Federal Register Volume 69, Number 45 (Monday, March 8, 2004)]
[Proposed Rules]
[Pages 10633-10636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5265]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, and 95

[Docket No. 03-080-2]
RIN 0579-AB73


Bovine Spongiform Encephalopathy; Minimal Risk Regions and 
Importation of Commodities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: We are reopening the comment period for our proposed rule that 
would amend the regulations regarding the importation of animals and 
animal products to recognize, and add Canada to, a category of regions 
that present a minimal risk of introducing bovine spongiform 
encephalopathy into the United States via live ruminants and ruminant 
products. The proposed rule also set out conditions under which we 
would allow the importation of certain live ruminants and ruminant 
products and byproducts from such regions. This action will allow 
interested persons additional time to prepare and submit comments.

DATES: We will consider all comments that we receive on or before April 
7, 2004.

ADDRESSES: You may submit comments by any of the following methods:

[[Page 10634]]

     Postal Mail/Commercial Delivery: Please send 
four copies of your comment (an original and three copies) to Docket 
No. 03-0801, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 03-080-1.
     E-mail: Address your comment to 
[email protected]. Your comment must be contained in the body 
of your message; do not send attached files. Please include your name 
and address in your message and ``Docket No. 03-080-1'' on the subject 
line.
     Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to 
submit an e-mail comment through the APHIS Web site.
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this 
docket and submitting comments.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: You may view APHIS documents published in the 
Federal Register and related information, including the names of groups 
and individuals who have commented on APHIS dockets, on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Karen James-Preston, Director, 
Technical Trade Services, National Center for Import and Export, VS, 
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.

SUPPLEMENTARY INFORMATION:

Background

    On November 4, 2003, the Animal and Plant Health Inspection Service 
(APHIS) published in the Federal Register (68 FR 62386-62405, Docket 
No. 03-080-1) a proposal to amend the regulations regarding the 
importation of animals and animal products to recognize a category of 
regions that present a minimal risk of introducing bovine spongiform 
encephalopathy (BSE) into the United States via live ruminants and 
ruminant products, and proposed to add Canada to this category. We also 
proposed to allow the importation of certain live ruminants and 
ruminant products and byproducts from such regions under certain 
conditions. Comments on the proposed rule were required to be received 
on or before January 5, 2004. In addition to inviting comments on the 
proposed rule itself, APHIS invited comments on an analysis the Agency 
had conducted of the risk of importing the animals and animal products 
in question from Canada under the conditions of the proposed rule. At 
the time the proposed rule was published, BSE had never been detected 
in the United States and only a single case had been reported in Canada 
(in Alberta in May 2003).
    On December 23, 2003, the U.S. Department of Agriculture (USDA) 
announced a presumptive positive case of BSE in a Holstein cow in 
Washington State. The diagnosis was verified on December 25, 2003, by 
an international reference laboratory. The investigation that was 
conducted following detection of the disease revealed the animal was 
born in Canada and had most likely been exposed to the BSE agent in 
that country.
    Since the date of detection of BSE in the cow in Washington State, 
the USDA and other Federal and State agencies have worked together 
closely to perform an epidemiological investigation, trace any 
potentially infected cattle, trace potentially contaminated rendered 
product, increase BSE surveillance, and take additional measures to 
address human and animal health. Additionally, an international panel 
of scientific experts appointed by the Secretary of Agriculture has 
provided a review of U.S. BSE response actions and has made 
recommendations for enhancements of the national BSE response program 
in the United States.\1\
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    \1\ You may view the international panel's report on the 
Internet by accessing the APHIS Web site at http://www.aphis.usda.gov/lpa/issues/bse/bse.html. At the BSE page, click 
on the listing for ``The Secretary's Foreign Animal and Poultry 
Disease Advisory Committee's Report on Measures Relating to Bovine 
Spongiform Encephalopathy (BSE) in the United States.''
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    Detection of BSE in the imported cow in Washington State occurred 
after APHIS conducted its analysis of the risk of importing ruminants 
and ruminant products and byproducts from Canada under the conditions 
of the proposed rule. Therefore, it is important for us to explain the 
extent to which we believe that detection may affect the conclusions of 
the risk analysis, and, consequently, the validity of the proposed 
rule. Therefore, we have prepared an explanatory document, discussed 
below, that addresses the effect of the detection of the imported cow 
on the analysis of risk that we conducted for the November 2003 
proposed rule.

Effect of the Detection of BSE on APHIS's Analysis of Risk

    The epidemiological investigation that was conducted following 
detection of BSE in an imported cow in Washington State \2\ revealed 
several points that are relevant to whether and how that detection 
affects our analysis of the risk of importing ruminants and ruminant 
products from Canada under the conditions of the November 2003 proposed 
rule.
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    \2\ A summary of the epidemiological investigation is included 
in our explanatory note document. Instructions for accessing the 
explanatory note document are included in this notice under the 
heading ``How to View APHIS Risk Documents Related to this Notice.''
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     The infected heifer was approximately 6 years 
and 8 months old at the time the disease was diagnosed. Its age 
indicated that it was born before implementation of a ban in Canada on 
feeding mammalian protein to ruminants and was most likely to have 
become infected before that feed ban was implemented.
     The animal was imported into the United States 
in 2001 at approximately 4 years of age.
    Among the conditions for importing cattle from Canada under the 
proposed rule was the requirement that the animals be no more than 30 
months old. This restriction was based on research indicating the most 
likely cattle to have infectious levels of the BSE agent are those 
older than 30 months. Additionally, the proposed rule required that the 
animals not have been fed ruminant protein.
    Although the BSE-infected cow identified in Washington State was 
more than 30 months of age when it was diagnosed, it was obviously not 
imported under the conditions of the yet-to-be-implemented proposed 
rule, and would not have been allowed to be imported under the proposed 
rule. Further, as discussed in the risk analysis, a ban on feeding 
mammalian protein to ruminants was implemented in Canada in 1997 and 
compliance with that feed ban appears to have been, and to continue to 
be, good. The cow identified with BSE in the United States was born in 
Canada before the feed ban was implemented. Therefore, we continue to 
believe that the import controls of the proposed rule would be 
effective.
    The analysis of risk we conducted addressed the issue of the 
prevalence of BSE in Canada. The risk analysis

[[Page 10635]]

presented evidence that the prevalence was very low and that Canada had 
strong BSE controls in place. Although the detection of an imported 
BSE-infected cow in Washington State means an additional animal of 
Canadian origin has been diagnosed with BSE since completion of the 
risk analysis and publication of the proposed rule, the total number of 
diagnosed cases attributed to that country remains low. Further, Canada 
has implemented strong measures to prevent the establishment, 
propagation, and spread of BSE among cattle in that country, to detect 
infected animals through surveillance, and to protect the Canadian 
animal and human food supplies.
    Given the conditions APHIS is proposing for the importation of 
ruminants and ruminant products from Canada, we believe it is highly 
unlikely that BSE would be introduced from Canada under the proposed 
rule. Based on the factors discussed in the original risk analysis, 
along with risk mitigation measures currently in place and those that 
would be added by the proposed rule, we have concluded that a BSE case 
in a second cow of Canadian origin does not alter our risk estimate.

Canadian Investigation Following Detection of a BSE-Infected Cow in 
Washington State

    The Canadian Food Inspection Agency (CFIA) initiated an 
epidemiological investigation specifically in response to the 
confirmation of a BSE-infected cow of Canadian origin in Washington 
State. This investigation was conducted concurrently and cooperatively 
with the U.S. investigation of animals from the same Canadian herd of 
origin. CFIA is continuing its epidemiological investigation.
    The Government of Canada has also announced plans to enhance 
existing measures being taken in that country regarding BSE 
surveillance and animal tracking by increasing the number of animals 
tested for BSE annually and by strengthening Canada's animal 
identification program.\3\
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    \3\ These measures are discussed in greater detail in our 
explanatory note to the risk analysis we conducted for our November 
2003 proposed rule, and may also be viewed on the Internet by 
accessing the CFIA Web site at http:\\www.inspection.gc.ca.
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Actions Taken in the United States After Detection of the Imported BSE-
Infected Cow

    Although the detection of an imported BSE-infected cow does not, in 
our view, alter the conclusions of our original risk analysis, it did 
raise consciousness of BSE challenges that might exist for the United 
States. As noted above, the United States is redirecting resources 
toward planning, implementation, and enforcement of measures to enhance 
BSE surveillance and to protect human and animal health.
    Both the USDA and the U.S. Department of Health and Human Services' 
Food and Drug Administration (FDA) have either put in place or have 
announced additional safety measures in response to the detection of 
the case of BSE.\4\ USDA requested a review of the U.S. BSE program by 
an international scientific panel and has received its recommendations. 
Although the U.S. Government has already taken significant actions that 
directly address many of the expert panel's recommendations, and is 
considering policy options to further address the recommendations, we 
believe the recent detection and investigation of the BSE case in a cow 
of Canadian origin demonstrate the effective nature of the surveillance 
and response measures currently in place.
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    \4\ A listing of each of the measures taken or announced is 
included in our explanatory note document. Instructions for 
accessing the explanatory note document are included in this notice 
under the heading ``How to View APHIS Risk Documents Related to this 
Notice.''
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    The risk analysis we conducted for our November 2003 proposal was 
developed after, and took into consideration, the diagnosis of BSE in a 
cow in Canada in May 2003. In that analysis, we considered the sum 
total of the control mechanisms (e.g., effectiveness of surveillance, 
import controls, and feed ban) in place in Canada at the time of the 
diagnosis and the actions taken by Canada following that diagnosis. The 
conclusion of our analysis was that those control mechanisms and 
actions were adequate to mitigate the risk of BSE being brought into 
the United States from Canada through the importation of ruminants and 
ruminant products, provided the conditions of the proposed rule were 
met. Enhancements the United States has made to its own BSE control 
program since the December 2003 detection--such as elimination of 
nonambulatory disabled cattle from the food chain, the removal of 
``specified risk materials'' from human food, and increased 
surveillance--and the adoption of equivalent measures by Canada, 
continue to support our basic conclusions that ruminants and ruminant 
products can be safely imported.

Requirements of the November 2003 Proposed Rule in Light of Recent U.S. 
Measures

    As noted above, the USDA has responded to the detection of the case 
of BSE in an imported BSE-infected cow with significant BSE risk 
mitigation measures in this country. Perhaps most importantly, parts of 
slaughtered animals that are considered at particular risk of 
containing the BSE agent in an infected animal (referred to as 
``specified risk materials'' or ``SRM's'') have been banned from the 
human food supply. The USDA's Food Safety and Inspection Service (FSIS) 
has established as SRM's the skull, brain, trigeminal ganglia, eyes, 
vertebral column, spinal cord, and dorsal root ganglia of cattle over 
30 months of age, as well as the tonsils and small intestine of cattle 
of all ages, and prohibits such SRM's from the human food supply. In 
addition, FSIS has, among other measures, required that nonambulatory, 
disabled cattle be excluded from the food supply. The Canadian 
Government has established similar safeguards in Canada.
    The measures taken by FSIS do not restrict the slaughter of cattle 
in the United States based on the age of the animals--i.e., meat from 
cattle 30 months of age or older will continue to be allowed into the 
human food supply. However, measures are in place to ensure that SRM's 
from such cattle do not enter the food supply. We now believe it would 
not be necessary to require that beef imported from BSE minimal-risk 
regions be derived only from cattle less than 30 months of age, 
provided equivalent measures are in place to ensure that SRM's are 
removed when the animals are slaughtered, and that such other measures 
as are necessary are in place. We believe such measures are already 
being taken in Canada. We invite comment from the public regarding this 
change to the provisions we proposed in November 2003 regarding the 
importation of beef.
    With regard to the importation of live animals from BSE minimal-
risk regions, APHIS is currently evaluating the appropriate approach 
regarding such animals and intends to address that issue in a 
supplemental rulemaking proposal in the Federal Register.

Extension of Comment Period

    In order to give interested persons an opportunity to comment on 
our November 2003 proposed rule in light of recent developments 
described above, we are reopening the comment period on Docket No. 03-
080-1 for an additional 30 days. We will also

[[Page 10636]]

consider all comments received between January 6, 2004 (the day after 
the close of the original comment period), and the date of this notice.

How To View APHIS Risk Documents Related to This Notice

    You may view the original analysis we conducted for our November 
2003 proposed rule and the explanatory note to that analysis in our 
reading room (information on the location and hours of the reading room 
is provided under the heading ADDRESSES at the beginning of this 
proposed rule). You may also request a copy of each document by calling 
or writing to the person listed under FOR FURTHER INFORMATION CONTACT. 
Please refer to the title of the analysis and the explanatory note when 
requesting copies. You may also view the analysis and the explanatory 
note \5\ on the Internet by accessing the APHIS Web site at http://www.aphis.usda.gov. At the APHIS website, click on the ``Hot Issues'' 
button. On the next screen, click on the listing for ``Bovine 
Spongiform Encephalopathy (BSE).'' On the next screen, click on the 
listing for ``BSE Canada.'' On the next screen, click on the listing 
for either ``Risk Analysis'' or ``Explanatory Note: Risk Analysis.''
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    \5\ The analysis is titled ``Risk Analysis: BSE Risk from 
Importation of Designated Ruminants and Ruminant Products from 
Canada into the United States.'' The explanatory note is titled 
``Explanatory Note-Risk Analysis: BSE Risk from Importation of 
Designated Ruminants and Ruminant Products from Canada into the 
United States.''

    Authority: 7 U.S.C. 450, 1622, and 8301-8317; 21 U.S.C. 136 and 
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136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 4th day of March, 2004.
Bobby R. Acord,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-5265 Filed 3-5-04; 8:45 am]
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