Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Finding of No Significant Impact and Affirmation of Final Rule, 18252-18262 [05-7141]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Rules and Regulations]
[Pages 18252-18262]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7141]



[[Page 18251]]

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Part VII





Department of Agriculture





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Animal and Plant Health Inspection Service



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9 CFR Part 93, et al.



Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation 
of Commodities; Finding of No Significant Impact and Affirmation of 
Final Rule; Final Rule

Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Rules 
and Regulations

[[Page 18252]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, 95, and 98

[Docket No. 03-080-7]
RIN 0579-AB73


Bovine Spongiform Encephalopathy; Minimal-Risk Regions and 
Importation of Commodities; Finding of No Significant Impact and 
Affirmation of Final Rule

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Affirmation of final rule.

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SUMMARY: We are publishing a finding of no significant impact for a 
final rule concerning bovine spongiform encephalopathy minimal risk 
regions published January 4, 2005, and, based on that finding, we are 
affirming the provisions of the final rule. The finding of no 
significant impact is based on an environmental assessment that 
documented our review and analysis of potential environmental impacts 
associated with the final rule and our review of issues raised by the 
public regarding the environmental assessment. Together, the 
environmental assessment and our review of the issues raised provide a 
basis for our conclusion that the provisions of the final rule will not 
have a significant impact on the quality of the human environment and 
support our affirmation of the final rule.

DATES: The final rule published January 4, 2005 (70 FR 460), with a 
partial delay of applicability published March 11, 2005 (70 FR 12112), 
was effective March 7, 2005. This affirmation of the final rule is 
effective April 8, 2005.

ADDRESSES: The environmental assessment on which this finding of no 
significant impact is based may be accessed by any of the following 
methods:
     On the EDOCKET Web site at https://docket.epa.gov/edkfed/
do/ EDKStaff CollectionDetailView?objectId = 0b0007d48055a20d.
     On the APHIS Web site at https://www.aphis.usda.gov/lpa/
issues/bse/bse.html.
     In the APHIS Reading Room 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.
     You may request paper copies of the environmental 
assessment and the finding of no significant impact by calling or 
writing to the person listed under FOR FURTHER INFORMATION CONTACT. 
Please refer to the titles of these documents when requesting copies.

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 and requested comment on a 
proposed rule (68 FR 62386-62405, Docket No. 03-080-1) 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 to add Canada to 
this category. The proposed rule also included provisions for the 
importation of certain live ruminants and ruminant products and 
byproducts from Canada under certain conditions. Also on November 4, 
2003, we made available for public comment an environmental assessment 
(EA) regarding the potential impact on the quality of the human 
environment due to the importation of ruminants and ruminant products 
and byproducts under the conditions of the proposed rule. We carefully 
considered all comments that addressed the EA, along with those that 
addressed the proposed rule itself.
    On January 4, 2005, we published in the Federal Register (70 FR 
460-553, Docket No. 03-080-3) a final rule to the proposed rule, to 
become effective March 7, 2005.\1\
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    \1\ On March 11, 2005, the Department published a document in 
the Federal Register (70 FR 12112-12113, Docket No. 03-080-6), 
effective March 7, 2005, that delayed until further notice the 
applicability of certain provisions of the final rule. On March 2, 
2005, Judge Richard F. Cebull of the U.S. District Court for the 
District of Montana ordered that the implementation of the final 
rule is preliminarily enjoined.
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    Also in the January 4, 2005, issue of the Federal Register, we 
published a notice (70 FR 554, Docket No. 03-080-4) announcing the 
availability of, and requesting comments on, a final EA regarding the 
potential impact on the quality of the human environment due to the 
importation of ruminants and ruminant products and byproducts from 
Canada under the conditions specified in the final rule. APHIS' review 
and analysis of the potential environmental impacts associated with 
those importations were documented in the final EA, titled ``Rulemaking 
to Establish Criteria for the Importation of Designated Ruminants and 
Ruminant Products from Canada into the United States, Final 
Environmental Assessment (December 2004).'' We announced that the EA 
would be available to the public for review and comment until February 
3, 2005.
    We became aware, however, that the version of the EA that was made 
available on January 4, 2005, contained some transcription errors that 
resulted in the omission of several references to an updated APHIS risk 
analysis regarding the final rule, as well as the incorrect formatting 
of several source citations. We corrected those errors and, on January 
21, 2005, published a notice in the Federal Register (70 FR 3183-3184, 
Docket No. 03-080-5) announcing the availability to the public of the 
corrected EA and extending the comment period on the EA until February 
17, 2005.
    We reviewed and considered all issues raised by commenters on the 
final EA. Of the issues raised by the commenters, some addressed the 
potential effects of the rule on the environment, while others 
addressed issues unrelated to such potential effects. Most of these 
issues had been raised by commenters on the proposed rule and had been 
previously considered and addressed in our final rule and supporting 
analyses.
    Additionally, shortly after issuance of the final rule, the 
Ranchers-Cattlemen Action Legal Fund, United Stockgrowers of America 
(R-CALF), filed a complaint challenging the rule in the United States 
District Court for the District of Montana. In that complaint, R-CALF 
raised several issues regarding the EA that it had not included in 
either its comments on the proposed rule or in any comment on the final 
EA. In addition, no other commenter on the EA raised those potential 
environmental impact issues. Nonetheless, we addressed those issues in 
our finding of no significant impact (FONSI), discussed below.
    We carefully considered environmental issues throughout the 
rulemaking. Based on the EA and on our review of the comments received 
on the original and final EAs, on the proposed rule, and in litigation, 
we have determined that the provisions of our January 4, 2005, final 
rule will not

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significantly impact human health or the environment, and that there is 
no basis in the comments we received and the issues that have been 
raised to alter the rule. Therefore, we are affirming the final rule as 
published.
    Our FONSI is included in this document under the heading ``Bovine 
Spongiform Encephalopathy: Minimal-Risk Regions and Importation of 
Commodities (Final Rule; APHIS Docket No. 03-080-3), Finding of No 
Significant Impact.'' The FONSI includes a discussion of the comments 
received on the final EA. The EA and FONSI may also be accessed by any 
of the means listed above under the heading ADDRESSES.
    The EA and FONSI have been prepared in accordance with: (1) The 
National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 
4321 et seq.), (2) regulations of the Council on Environmental Quality 
for implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).

Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation 
of Commodities (Final Rule; APHIS Docket No. 03-080-3)

Finding of No Significant Impact

United States Department of Agriculture, Animal and Plant Health 
Inspection Service, Veterinary Services, National Center for Import and 
Export, Technical Trade Services, 4700 River Road, Unit 38, Riverdale, 
MD 20737
    This finding concludes the environmental assessment process 
undertaken for the rulemaking, Bovine Spongiform Encephalopathy; 
Minimal-Risk Regions and Importation of Commodities (``MRR rule''). An 
environmental assessment (``EA''), dated October 2003, was prepared for 
this rulemaking and it was made available to the public for comment on 
November 4, 2003. Comments on the EA were received and carefully 
considered. A final EA was completed and it was made available to the 
public on January 4, 2005, for a 30-day comment period. On January 21, 
2005, a corrected final EA was made available to the public and the 
comment period was extended for an additional 14 days until February 
17, 2005. The corrected final EA had no changes or additions to the 
version issued on January 4, 2005, other than some specific references 
to the latest risk analysis for the MRR rule that had been 
inadvertently omitted from the final EA. This finding summarizes and 
incorporates by reference the final EA.
    Thirteen comments were received in response to our request for 
comments on the final EA. One was submitted by a state farm bureau 
federation with certain specific suggestions. This comment counseled 
caution in implementing the rule for the following reasons. It pointed 
to the four confirmed cases of bovine spongiform encephalopathy (BSE) 
in cows of Canadian origin'particularly the most recent diagnosis in a 
cow that was determined to have been born after implementation of a 
feed ban in Canada--and recommended that USDA confirm that the Canadian 
feed ban is being effectively enforced before resuming imports of 
Canadian cattle under 30 months of age and beef from such younger 
cattle. Additionally, the comment requested that an effective feed ban 
have been in place in Canada for a full 8 years before cattle over 30 
months of age, and meat from such cattle, are allowed to be imported 
into the United States. It recommended further review of Canada's 
surveillance program and asked whether the current level of 
surveillance in Canada is adequate. The comment supported the animal 
identification provisions in the rule and recommended that appropriate 
steps be taken to ensure that all imported cattle were slaughtered 
before 30 months of age. Finally, the comment noted concerns, which we 
believe are outside the scope of the environmental assessment, about 
consumer confidence, our ability to regain access to export markets, 
and potential impacts on producer returns.
    One comment, filed by an individual consumer of beef products who 
asserted he was not associated with any cattle production or processing 
business, raised five concerns or issues. These included that there was 
no quantitative risk assessment in the EA, concern about the duration 
and effectiveness of Canada's feed ban, concern about the tissues 
defined as specified risk materials (SRMs) under international 
standards, concern that public health risk was not adequately analyzed 
in light of recent diagnoses of BSE in Canada and the levels of feed 
ban compliance and surveillance in that country, and, finally, a 
recommendation that an environmental impact statement be completed to 
study the effect of BSE and TSE disease agents in soil, water, air, and 
the food chain.
    Eight comments--one from a South Dakota organization, one from an 
Oregon organization, and six from individuals, including an assistant 
state veterinarian--raised a generally similar array of concerns. The 
thrust of these eight comments is that the commenters believe the risk 
of introducing BSE into the United States weighs against implementation 
of the rule. The comments noted support for maintaining the current 
prohibitions on imports of live animals and beef products from Canada, 
concerns about the effect of importation into the United States of 
Canadian cattle and cattle products on U.S. export markets, concern 
about the effectiveness of the Canadian feed ban and the adequacy of 
Canada's surveillance program, concerns about feeding animal protein of 
any kind to cows or sheep, a recommendation for country-of-origin 
labeling, and support for testing for BSE all cattle of Canadian origin 
that are in the United States. Again, certain of these issues are 
outside the scope of the EA. Several of the comments also raised 
questions about the implications of the most recently confirmed BSE-
positive animals in Canada on January 2 and January 11, 2005, including 
the fact that one of these animals was born shortly after 
implementation of the Canadian feed ban in 1997.
    A comment from a pharmaceutical association noted the importance of 
animal-derived materials in numerous products. This comment was 
received on February 24, 2005, 7 days after the close of the extended 
comment period for the final EA. Nevertheless, because, as the 
commenter pointed out, it had commented in a timely fashion on the 
proposed rule and its EA comment was intended to update its 
recommendations based on recent developments, we will respond to this 
comment. The comment supported the need to revise what it termed the 
``binary system'' of BSE classification of countries and the adoption 
of what it termed a science-based approach to identifying minimal-risk 
regions for BSE as outlined in the rule. The comment, therefore, 
supported implementation of the rule. It recommended permanently 
identifying cattle from Canada and distinguishing Canadian and U.S.-
origin cattle for the sourcing of bovine raw materials, which would 
allow companies to make sourcing decisions to satisfy BSE regulatory 
requirements in the countries to which these companies would ship their 
products. The association supported the implementation of a national 
animal identification system.
    One comment took issue with the notation in the final EA that 
alkaline hydrolysis tissue digesters were a preferred method of 
disposal for BSE-contaminated carcasses. It took issue with that 
conclusion and suggested the commenter's validated protocol and

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process for enzymatic prion degradation was perhaps equally effective. 
We acknowledge this comment and would welcome more information and data 
regarding this technology. It is our view, however, that it does not 
raise an issue that requires discussion in this document. One comment 
urged the lifting of the prohibitions on camelids because camelids have 
no demonstrated history of being susceptible to any type of TSE and 
because these animals are not used for human consumption. We agree with 
this comment and note that the MRR rule so provided.
    Of the issues raised by the commenters, many concerned topics other 
than the potential effects of the rule on the environment (for example, 
comments regarding country-of-origin labeling, market access, and 
consumer confidence). These issues had been raised by commenters on the 
proposed rule and were considered and addressed by APHIS in its final 
rule and supporting analyses. Likewise, most of the commenters who did 
address the potential effects of the rule on the environment raised 
issues that had already been raised and addressed at considerable 
length in the final rule and supporting analyses. This fact illustrates 
the substantial identity of the central animal and public health issues 
of the rule and the issues evaluated in the environmental assessments.
    It is important to note that issues raised in relation to the two 
most recent BSE-positive cows in Canada on January 2 and January 11, 
2005, will be discussed below. Certain commenters observed that these 
incidents would call into question the effectiveness and adequate 
duration of the Canadian feed ban. Because these incidents occurred 
either after or immediately before the publication of the final EA, we 
welcome the opportunity to respond in this document.
    On January 4, 2005, APHIS issued a final rule to amend regulations 
regarding the importation of animals and animal products to establish a 
category of regions that present a minimal-risk of introducing BSE into 
the United States by way of live ruminants and ruminant products and 
byproducts, and to add Canada to that category. (70 FR 460-553.) The 
final rule also established conditions for the importation of certain 
live ruminants and ruminant products and byproducts from minimal-risk 
regions. Under the Animal Health Protection Act (7 U.S.C. 8301 et 
seq.), the Secretary of Agriculture may prohibit or restrict the 
importation or entry of any animal, article, or means of conveyance, or 
use of any means of conveyance or facility, if the Secretary determines 
that the prohibition or restriction is necessary to prevent the 
introduction into or dissemination within the United States of any pest 
or disease of livestock. (7 U.S.C. 8303.) The MRR rule will regulate 
the importation of ruminants and ruminant products and byproducts from 
Canada in a manner that prevents the introduction of BSE into the 
United States.
    The rule defines a BSE minimal-risk region as one that:
    1. Maintains, and, in the case of regions where BSE was detected, 
had in place prior to the detection of BSE in an indigenous ruminant, 
risk mitigation measures adequate to prevent widespread exposure and/or 
establishment of the disease. Such measures include the following:
     Restrictions on the importation of animals sufficient to 
minimize the possibility of infected ruminants being imported into the 
region, and on the importation of animal products and animal feed 
containing ruminant protein sufficient to minimize the possibility of 
ruminants in the region being exposed to BSE;
     Surveillance for BSE at levels that meet or exceed 
recommendations of the World Organization for Animal Health (Office 
International des Epizooties or OIE) for surveillance for BSE; and
     A ruminant-to-ruminant feed ban that is in place and is 
effectively enforced.
    2. In regions where BSE was detected, conducted an epidemiological 
investigation following detection of BSE sufficient to confirm the 
adequacy of measures to prevent the further introduction or spread of 
BSE, and continues to take such measures.
    3. In regions where BSE was detected, took additional risk 
mitigation measures, as necessary, following the BSE outbreak based on 
risk analysis of the outbreak, and continues to take such measures.
    These standards are based upon, and are consistent with, 
international guidelines issued by OIE. For a full analysis and 
discussion of these standards, see APHIS' November 4, 2003, proposed 
rule (68 FR 62388-62389) (please note that some revisions were made to 
the wording of the proposed standards in the final rule) and the update 
to our risk analysis.\2\
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    \2\ See ``Analysis of Risk-Update for the Final Rule: Bovine 
Spongiform Encephalopathy; Minimal Risk Regions and Importation of 
Commodities, December 2004.'' pp. 2-5. This update can be viewed on 
the Internet at https://www.aphis.usda.gov/lpa/issues/bse/bse.html.
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    APHIS conducted a comprehensive examination and evaluation of all 
the relevant risk factors in determining whether Canada qualified as a 
BSE minimal-risk region. A complete discussion of this evaluation can 
be found in the risk analysis.\3\ In summary, APHIS determined that 
Canada met the standards for a BSE minimal-risk region because:
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    \3\ Ibid, pp. 5-18.
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    1. Canada has implemented comprehensive, effective measures for 
preventing BSE introduction and the potential for spread within Canada 
in order to minimize the possibility that infected ruminants, ruminant 
products, byproducts, or contaminated feedstuffs enter the country. The 
potential for introduction of the BSE agent into Canada has been 
limited by import restrictions on meat-and-bone meal (MBM) and live 
animals. Canada's Animal Disease and Protection Regulations (1978) and 
Health of Animals Regulations (1991) prohibited importation of MBM from 
countries other than the United States and, later, from Australia and 
New Zealand. These rules were first initiated in response to foot-and-
mouth disease and later extended to address BSE issues. Canada has not 
imported live cattle from the United Kingdom (UK) since 1990. In 1994, 
an import ban was imposed on all countries where BSE had been detected 
in native cattle, and from 1996 live cattle could only be imported from 
countries that Canada designated as free from BSE following a 
comprehensive risk assessment. After detection of BSE in an imported 
animal in 1993, Canada traced and destroyed and incinerated or 
repatriated all surviving cattle imported from the UK.
    2. Canada has an adult cattle population of approximately 5.5 
million cattle older than 24 months of age. The 2004 OIE Code, Appendix 
3.8.4, references adult cattle populations as those greater than 30 
months and recommends examining at least 300 samples per year from 
high-risk animals in a country with an adult cattle population of 5 
million, or 336 samples per year in a country with an adult cattle 
population of 7 million. Even though the adult cattle population in 
Canada is defined as greater than 24 months of age and OIE defines it 
as greater than 30 months, Canada has met or exceeded this level of 
surveillance for the past 7 years, thus exceeding the OIE guidelines. 
Since 1992, the surveillance has been targeted surveillance, with 
samples obtained from adult animals exhibiting some type of clinical 
signs or considered high risk for other reasons that could be 
considered consistent with BSE. From January 2004 through March

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2005, over 37,000 samples were obtained. Canadian Food Inspection 
Agency (CFIA) officials have stated that this surveillance program is 
designed to detect one case of BSE in one million adult cattle.
    3. Since August 4, 1997, Canada has implemented a ruminant-to-
ruminant feed ban that is comparable to that existing in the United 
States and prohibits the feeding of proteins from ruminant species to 
ruminant animals. Based on CFIA inspections since 2003, virtually 100 
percent of Canadian rendering facilities are in compliance with the 
ruminant-to-ruminant feed ban requirements applicable to this industry. 
With regard to inspections of feed mills, CFIA reported that, for an 
annual inspection period of April to March, the fraction of mills 
reportedly in compliance was 92 percent, 99 percent, and 95 percent for 
2002, 2003, and 2004, respectively.\4\ CFIA has identified 
noncompliance of ``immediate concern'' in fewer than 2 percent of feed 
mills inspected during 2003-2004. Those instances of noncompliance of 
``immediate concern'' are dealt with rapidly when identified. 
Noncompliance of ``immediate concern'' includes situations where direct 
contamination of ruminant feed with prohibited materials has occurred, 
as identified through inspections of production documents or visual 
observation, and where a lack of appropriate written procedures, 
records, or product labeling by feed manufacturers may expose ruminants 
to prohibited animal proteins. Accordingly, it is clear that Canada's 
feed ban is effective.
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    \4\ Canadian Food Inspection Agency (CFIA). Memorandum from Dr. 
Brian Evans, Chief Veterinary Officer, to Dr. John Clifford, Deputy 
Administrator, VS, APHIS. July 30, 2004.
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    4. Canada conducted rigorous epidemiological investigations after 
the BSE cases were detected in May 2003 and December 2003 and after the 
detections in January 2005.\5\ In all but the most recent detection, 
the cases were animals that were born before the implementation of the 
feed ban in 1997, with exposure assumed to occur prior to or near the 
time of the imposition of the feed regulations. The cow in the last 
detected case was born within a year after implementation of the 
Canadian feed ban. Although a specific source of infection was not 
identified, the most likely possibility was the introduction of a low 
level of infectivity into the animal feed supply originating from an 
infected animal imported from the UK in the period between 1982 and 
1989. These investigations have resulted in the destruction and 
sampling of a large number of potentially exposed cattle, and results 
from all testing have yielded no further evidence of infection. CFIA 
has traced and destroyed the majority of surviving cattle that were 
birth cohorts of each of the cases of Canadian origin.
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    \5\ Canadian reports of the investigations can be accessed at 
https://www. inspection. gc. ca/ english/ anima/ heasan/ disemala/ 
bseesb/ bseesbindexe. shtml.
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    5. CFIA imposed new regulations to further strengthen its 
safeguards against BSE. Measures taken included requiring the removal 
of bovine SRMs; enhancing enforcement activities associated with the 
existing cattle identification system; and increasing the level of BSE 
testing.
    Canada has provided comprehensive information throughout this 
rulemaking regarding its BSE status and the actions it has taken to 
protect animal and public health and food safety. The most recent 
Canadian status update can be accessed through the CFIA 2 Web site at 
https://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/
200503canadae.shtml.
    In summary, the essential factors that led us to conclude that 
Canada qualified as a BSE minimal-risk region include longstanding 
Canadian import restrictions, an effective ban on the feeding of 
ruminant protein to ruminants, the quality of Canada's surveillance and 
monitoring program, and other measures, such as the required removal of 
SRMs from cattle at the time of slaughter and enhanced enforcement of 
Canada's existing mandatory cattle identification system.
    APHIS has concluded that the animal and public health measures that 
Canada has in place to prevent BSE, combined with existing U.S. 
domestic safeguards and additional safeguards provided in the final 
rule, provide the utmost protection to U.S. consumers and livestock. 
With respect to Canadian cattle, the MRR rule will allow the 
importation of:
     Bovines, for immediate slaughter, or for feeding, as long 
as they are slaughtered at less than 30 months of age;
     Meat from bovines; and
     Certain other products and byproducts, including bovine 
livers and tongues, gelatin, and tallow.
    The final rule provides the following additional requirements for 
live Canadian feeder cattle that will ensure they are slaughtered 
before they reach 30 months of age:
     Feeder cattle must be permanently marked with a brand to 
identify the BSE minimal-risk region of origin before entering the 
United States. Feeder cattle exported from Canada will be branded with 
``C/[Lambda]N'';
     Cattle must be individually identified with an ear tag 
before entering the United States. This ear tag allows the animal to be 
traced back to the premises of origin (birth herd);
     Information must be included on the cattle's animal health 
certification, relating to animal identification, origin, destination, 
and responsible parties;
     Cattle must be moved to feedlots in sealed containers and 
cannot go to more than one feedlot; and
     SRMs will be removed from Canadian cattle slaughtered in 
the United States in accordance with FSIS regulations.
    Based on our risk analyses, APHIS concluded that the cumulative 
effect of all of the measures in place in Canada and the United States, 
and the additional measures imposed by the final rule, is an extremely 
effective set of interlocking, overlapping and sequential barriers to 
the introduction and establishment of BSE in the United States.\6\ The 
preceding discussion and conclusions provide the foundation for the 
finding of no significant impact described below.
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    \6\ See ``Analysis of Risk-Update for the Final Rule: Bovine 
Spongiform Encephalopathy; Minimal Risk Regions and Importation of 
Commodities, December 2004.'' pp. 25-27.
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    The final rule was scheduled to become effective on March 7, 2005. 
On February 9, 2005, the Secretary of Agriculture announced that the 
provisions of the final rule allowing the importation of beef products 
from cattle over 30 months of age would be delayed.\7\ On March 2, 
2005, the United States District Court for the District of Montana 
issued a preliminary injunction that enjoined implementation of the MRR 
rule.
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    \7\ On March 11, 2005, APHIS published a notice in the Federal 
Register delaying the applicability of the provisions of the rule 
relating to beef products and byproducts from bovines 30 months of 
age or older (70 FR 12112).
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    Pursuant to the National Environmental Policy Act (NEPA) (42 U.S.C. 
4321 et seq.), the purpose of an environmental assessment is to provide 
sufficient information and analysis to agency decision makers to allow 
them to determine whether the proposed agency action will have a 
significant effect on the human environment. If a determination is made 
that the action would have a significant effect on the human 
environment, the agency is obligated to prepare an environmental impact 
statement. If a determination is made that the action will not have a 
significant effect on the human environment, a finding of no 
significant impact is issued.
    The two EAs issued for the MRR rule considered two alternatives: 
(1) The ``No

[[Page 18256]]

Action'' alternative, which would maintain the continued regulatory 
prohibition of the importation of ruminants, ruminant products, 
ruminant by-products from Canada and from any other country or region 
that could eventually be classified as a BSE minimal-risk region 
pursuant to the rulemaking and (2) the preferred alternative, which 
will allow for the importation of certain ruminant products and by-
products and certain ruminants, providing the country or region seeking 
recognition as a BSE minimal-risk region demonstrates that it meets the 
relevant factors consistent with standards recommended by the OIE.
    The environmental issues involved in this rulemaking, including 
those raised in comments on the two EAs as well as in litigation, are 
discussed below.

A. The Degree to Which the Action May Affect Public Health or Safety

    The introduction of BSE into the United States has the potential to 
affect both human and animal health. BSE, commonly known as ``mad cow 
disease,'' is a disease that belongs to a family of mostly very rare 
diseases known as TSEs. Cases of BSE in cattle were first reported in 
the UK in 1986. To date, over 95 percent of all known BSE cases 
worldwide have occurred in the UK. Within cattle herds, BSE is not 
contagious and does not spread from animal to animal. It is spread to 
cattle primarily through the consumption of animal feed containing 
protein from ruminants infected with BSE. In 1996, a new disease, 
variant Creutzfeldt-Jakob disease or vCJD, was detected in humans and 
linked to the BSE epidemic in cattle. Consumption of cattle products 
contaminated with the BSE agent is reported to be the cause of vCJD. 
Approximately 153 cases of vCJD have been identified worldwide and 95 
percent of these cases have been linked to exposure in the UK. When 
compared with the significant number of cattle exposed to BSE, the 
relatively small number of cases of vCJD indicates a substantial 
species barrier that protects humans from widespread illness due to BSE 
exposure.
    As previously discussed, the MRR rule amends APHIS' regulations to 
allow the importation of certain ruminants, ruminant products and by-
products from regions that pose a minimal risk for BSE. The rule will 
preclude introduction of BSE into the United States and will ensure the 
protection of domestic livestock and the food supply. The MRR rule is 
fully consistent with the guidelines and recommendations of the OIE for 
trade in animals and animal products from BSE-affected countries.
    In determining whether it was necessary to continue the 
prohibitions and restrictions on imports from Canada pursuant to the 
Animal Health Protection Act, APHIS analyzed the risks associated with 
such imports. The analysis is consistent with OIE guidelines and the 
internationally recommended components for animal health import risk 
analysis. The risk analysis drew on a number of sources of information, 
including: Previous analyses of risk conducted by APHIS; scientific 
literature; results of epidemiological investigations; data provided by 
the Canadian Government; a quantitative analysis of the risk of BSE in 
Canada; quantitative analyses of the consequences of BSE being 
introduced into the United States; measures implemented by USDA's Food 
Safety and Inspection Service (FSIS) and the U.S. Department of Health 
and Human Services' Food and Drug Administration (FDA) to protect 
against human exposure to the BSE agent in the United States; reports 
by international review teams; and the BSE guidelines adopted by the 
OIE. The determination to allow imports of certain Canadian ruminants 
and ruminant products was based on a thorough evaluation of the BSE 
risk in Canada, the potential for BSE infectivity to be introduced into 
the United States, the potential spread of BSE in cattle and possible 
human exposure if BSE infectivity were introduced into the United 
States, and the likelihood that BSE could become established in the 
United States.
    A great deal is now known about BSE. There is a strong scientific 
consensus about the BSE agent, the mechanisms for its spread, and the 
tissues that are most likely to harbor the infective agent. Scientific 
research, backed by practical experience, has resulted in a defined 
series of measures that countries can use to keep the BSE agent out of 
the food and feed chain and thus ensure the safety of animal and public 
health. APHIS has concluded that such measures are in place in Canada 
and the United States. The risk analysis contains a comprehensive 
discussion of the facts and circumstances relevant to Canada's BSE 
status and of the mitigation measures in place in both Canada and the 
United States that will ensure that BSE is not introduced into the 
United States. The critical country-of-origin factors leading to APHIS' 
conclusion and this finding of no significant impact are:
    1. Import Restrictions--Canada has implemented effective methods 
for preventing the introduction of BSE into its herd by restricting the 
importation of live ruminants and meat-and-bone meal from any country 
that had not been recognized as BSE-free following a comprehensive risk 
assessment.
    2. Surveillance--Canada has been actively monitoring for BSE in its 
herd since 1992 and has met or exceeded the OIE recommended level of 
BSE surveillance for the past 7 years. The number of cattle tested 
annually has steadily increased over the years, and in 2003, 
approximately 5,700 cattle were tested. In 2004, more than 23,500 
animals were tested. In 2005, more than 14,000 samples were tested as 
of March 23.
    3. Feed Ban--Canada and the United States implemented substantially 
identical feed bans simultaneously in 1997 that prohibit the feeding of 
mammalian protein to ruminants. Canada's feed ban is more stringent 
than the feed ban in the United States, as it prohibits the use of 
plate waste and poultry litter in ruminant feed. The Canadian feed ban 
has been effective and has a strong compliance and enforcement 
component. It is also important to note that Canada established its 
feed ban 6 years before identifying its first case of BSE in May 2003.
    4. Epidemiological Investigations--Canada has the capacity to 
conduct, and has conducted, rigorous investigations of its BSE 
findings. These investigations have included trace-outs of cattle that 
may have been exposed to the same feed sources as infected cattle and 
of rendered protein products that could have included the tissues from 
the infected animals. These investigations have been successful due in 
part to the mandatory cattle identification program in Canada.
    5. Removal of SRMs--Both Canada and the United States require the 
removal at slaughter of SRMs--those tissues most likely to harbor the 
BSE infective agent--and prohibit the use of SRMs in human food.
    In addition, there are several biological factors that support the 
finding herein with specific reference to the importation of live 
animals and animal products. These factors include: The age of the 
animal, tissue distribution and infectivity, and feed source and 
exposure. Our findings with respect to these factors are detailed in 
the final risk analysis associated with this final rule.\8\ 
Furthermore, as explained in the exposure assessment

[[Page 18257]]

component of the risk analysis, our evaluation of slaughter controls in 
place in both the United States and Canada, rendering inactivation 
factors, feed manufacturing controls both in the United States and 
Canada, and of the likelihood that an animal would ingest an infectious 
dose and would develop the disease provides further support for our 
finding of no significant impact.
---------------------------------------------------------------------------

    \8\ See ``Analysis of Risk--Update for the Final Rule: Bovine 
Spongiform Encephalopathy; Minimal Risk Regions and Importation of 
Commodities, December 2004,'' pp. 11-17.
---------------------------------------------------------------------------

    Finally, the additional post-entry mitigation measures imposed by 
the final rule enhance protection of animal and human health and 
further ensure that there will be no significant impacts. The MRR rule 
requires that live cattle under 30 months of age can only enter the 
United States for immediate slaughter or for feeding and slaughter. 
Movement of these cattle is carefully controlled by requiring each 
animal to have permanent identification that identifies its country of 
origin, and a special permit designed to account for the inventory of 
cattle consigned to their point of destination. The rule, therefore, 
ensures that those cattle are identified and remain accounted for 
through slaughter.
    Based on all these factors, APHIS concluded that there was no 
scientific basis to believe that the importation from Canada of live 
ruminants (including cattle less than 30 months of age) and ruminant 
products (including beef products and byproducts) in accordance with 
the conditions required in the rule pose any risk of introducing BSE 
into the United States. For all the reasons discussed in section VI.A. 
of the final EA, the safeguards in place in both the United States and 
Canada, coupled with the additional risk mitigation measures required 
in the MRR rule fully protect both animal and public health.

B. The Degree to Which the Effects on the Quality of the Human 
Environment Are Likely To Be Highly Controversial or the Degree to 
Which the Possible Effects on the Human Environment Are Highly 
Uncertain or Involve Unique or Unknown Risks

    Controversy exists when substantial questions are raised as to 
whether an action may cause significant degradation of an environmental 
factor. In the context of an EA under NEPA, controversy refers not to 
the existence of public opposition, but to a substantial dispute about 
the size, nature, or effect of the action. Even if an action is 
projected to have a controversial effect, the agency nonetheless has 
the discretion to be guided by the expertise and judgment, as well as 
the practical experience, of its own experts. There is a presumption in 
favor of the agency's expert advice and guidance.
    In the case of the MRR rule, there is no significant controversy 
with regard to the science underlying the mitigation measures that form 
the basis of the rule, and the effectiveness of the mitigation measures 
that are in place in Canada and the United States or prescribed as 
additional requirements in this rule. While questions remain about BSE 
and research continues on BSE as it does for many animal diseases, 
there is substantial knowledge about the disease and effective 
mitigation measures, and a solid scientific consensus among animal 
health experts both in the United States and internationally. Based 
upon this substantial body of scientific research, field 
epidemiological investigations and years of practical experience and 
observations by animal health authorities, very effective measures have 
been identified to prevent the introduction and spread of BSE and these 
measures have been put in place in the United States and Canada and are 
embodied in the MRR rule.
    Two principal concerns are expressed in comments filed on the EA in 
opposition to the MRR rule. First is the perceived risk that BSE would 
be introduced into domestic cattle and, second, that vCJD could occur 
as a result of such introduction or through the import of meat products 
from Canada. APHIS has concluded that the MRR rule will preclude the 
introduction of BSE and that the comprehensive animal and public health 
measures in place in Canada and in the United States will prevent these 
effects from occurring. In this regard, we must note that while APHIS' 
principal responsibilities encompass animal and plant health, FSIS and 
the FDA are the agencies principally responsible for public health and 
food safety. Both of these agencies have implemented regulations to 
ensure that the BSE agent does not enter either the human or the 
ruminant food chain.\9\ In developing the MRR rule and in preparing the 
EA, APHIS consulted with both FSIS and FDA.
---------------------------------------------------------------------------

    \9\ See: FSIS' interim final rule published in the Federal 
Register on January 12, 2004, titled ``Prohibition on the Use of 
Specified Risk Materials for Human Food and Requirements for the 
Disposition of Non-Ambulatory Disabled Cattle'' (69 FR 1874-1885, 
FSIS Docket No. 03-025IF,); FDA interim final rule published in the 
Federal Register on July 14, 2004, titled ``Use of Materials Derived 
from Cattle in Human Food and Cosmetics'' (69 FR 42255, FDA Docket 
No. 2004N-0081); FDA's ruminant feed regulations in 21 CFR 589.2000; 
and an advance notice of proposed rulemaking issued jointly by FDA, 
FSIS, and APHIS in the Federal Register on July 14, 2004, titled 
``Federal Measures to Mitigate BSE Risks: Considerations for Further 
Action'' (69 FR 42288-42300, FDA Docket No. 2004N-0264, FSIS Docket 
No. 04-021ANPR, APHIS Docket No. 04-047-1).
---------------------------------------------------------------------------

    This rule is based upon and is fully consistent with an 
international scientific consensus that is embodied in the guidelines 
and recommendations of the OIE. OIE is the internationally recognized 
authority on animal health issues and currently has 167 member 
countries, including the United States and Canada. OIE develops and 
publishes standards, guidelines and recommendations for international 
trade in animals and animal products. These standards and guidelines 
are recognized by the World Trade Organization as the reference 
international animal health rules for animal diseases and zoonoses and 
they are codified in the Terrestrial Animal Health Code and the Aquatic 
Animal Health Code. The standards, guidelines and recommendations are 
developed by specialist commissions and experts based on the latest and 
best available scientific research and data and are adopted by 
consensus of the OIE member countries. The aim of the Terrestrial 
Animal Health Code is to facilitate the safe international trade of 
animals and animal products. This is achieved through recommendations 
on risk management measures for specific diseases to be used by 
national veterinary authorities or other competent authorities of 
importing and exporting countries when establishing health regulations 
for the safe importation of animals and animal products. The aim of the 
OIE's work in this regard is to avoid the transfer of agents pathogenic 
for animals and humans, without the imposition of unjustified trade 
restrictions. With respect to the OIE guidelines for BSE, it is 
important to note that the OIE does not recommend that an importing 
country completely ban the importation of live cattle and meat products 
even when the importing country determines that the exporting country 
has a high BSE risk status. For the details of the BSE chapter of the 
Terrestrial Animal Health Code, see https://www.oie.int/eng/publicat/
en--code.htm.
    Many of the 13 commenters on the final EA opposed implementation of 
the MRR rule out of a concern that BSE would be introduced into the 
United States, a concern raised in part by the 2 confirmed cases of BSE 
in Canada in January 2005. These commenters did not elaborate on the 
basis for their concern or whether they disagreed with the scientific 
foundation of the MRR rule. On the other hand, some commenters who 
expressed concerns about the implementation of the MRR rule 
acknowledged, implicitly or explicitly, the validity of the scientific

[[Page 18258]]

approach embodied in the rule but urged the agency to ensure that the 
measures the agency relies upon have been effectively implemented. For 
example, the state farm bureau federation urged that USDA ``investigate 
and confirm'' that the current feed ban is being effectively enforced 
prior to opening the border with Canada. Additionally, the federation 
urged that USDA assess whether Canada's surveillance program is 
adequate.
    Four cases of BSE have been detected in Canadian-origin cattle. The 
first two positive cases were detected in 2003 and two cases have been 
detected in 2005. On January 2, 2005, Canada announced that it had 
confirmed a case of BSE in an 8-year-old dairy cow in Alberta, Canada.
    The following week, on January 11, 2005, Canada announced that it 
had confirmed a case of BSE in a beef cow in Alberta that was born 
shortly after the implementation of the feed ban in 1997. Because the 
cow was born shortly after the implementation of the feed ban and, in 
addition, to determine if there were any previously unidentified 
potential links, the USDA sent two technical teams to Canada to 
evaluate the circumstances surrounding these two recent BSE findings. 
One team, consisting of USDA and FDA officials, was responsible for 
conducting an in-depth assessment of Canada's feed ban, and the other 
team focused on the epidemiological investigations of the positive 
cases.
    In preparing the MRR rule, Canada's compliance with the feed ban 
was thoroughly considered and discussed. Canada implemented its feed 
ban in 1997 to prohibit the feeding of most mammalian protein to 
ruminants. Canada's feed ban is virtually identical to the feed ban in 
place in the United States, except that Canada has extended its ban by 
prohibiting plate waste and poultry litter from being fed to ruminants. 
APHIS concluded, based on this thorough assessment, that Canada has had 
an effective feed ban in place in the rendering, feed manufacturing and 
livestock industries. (70 FR 467-468, APHIS Docket No. 03-080-3; 
``Analysis of Risk-Update for the Final Rule: Bovine Spongiform 
Encephalopathy; Minimal Risk Regions and Importation of Commodities, 
December 2004,'' pp. 7-10; see also BSE in Canada Status Update--March, 
2005, which can be found at https://www.inspection.gc.ca/english/anima/
heasan/disemala/bseesb/200503canadae.shtml.)
    On February 25, 2005, USDA published its assessment of the Canadian 
feed ban. The team concluded, based on its review of inspection records 
for the last 3 years and on-site inspections of commercial feed mills 
and rendering facilities, that Canada has a robust inspection program 
with strong enforcement, that overall compliance with the feed ban is 
good, and that the feed ban is effectively reducing the risk of 
transmission of BSE. (https://www.aphis.usda.gov/lpa/issues/bse/
bse.html.) The team's report confirmed the APHIS evaluation of Canada's 
feed ban which supported the MRR rule.
    It is important to note that in 1997, BSE had not been detected in 
North America, and the feed bans implemented by Canada and the United 
States were precautionary measures. As a result, neither government 
required that existing feed stocks be recalled. In Canada specifically, 
the feed ban was implemented with provisions for a phase-in period so 
that existing stocks of feed material could be depleted. It is likely 
that the Canadian feed ban took some time to be implemented completely 
throughout the feed manufacturing industry, as did the United States' 
feed ban. This would be expected in implementing a new, comprehensive 
regulatory program.
    With respect to the two most recent positive BSE cases, the 
Canadian government confirmed that the animal identified as positive on 
January 2nd was exposed to feed rations containing meat and bone meal 
that was produced prior to the 1997 feed ban. This animal was born in 
October 1996 and was exposed to rations that contained meat and bone 
meal in early 1997, before the feed ban was implemented. In the case 
confirmed on January 11th, the Canadian investigation concluded that 
BSE may have been transmitted to the affected animal through feed 
produced shortly after the feed ban was implemented. As described in 
the previous paragraph, since an extensive change in industry practices 
cannot be expected to be completed immediately, a finding of BSE in an 
animal born shortly after the feed ban would not be unexpected and 
would not be inconsistent with the risk analysis supporting the final 
rule. (See BSE in Canada Status Update--March, 2005, which can be found 
at https://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/
200503canadae.shtml. See also the summary report of the CFIA 
investigation of the January 2, 2005, case of BSE at https://
www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/ab2005/
2investe.shtml and the summary report of the CFIA investigation of the 
January 11, 2005, case of BSE at https://www.inspection.gc.ca/english/
anima/heasan/disemala/bseesb/ab2005/3investe.shtml.)
    The possibility of additional BSE positive animals was understood 
and carefully considered by APHIS in the risk analysis and in our 
determination that Canada qualifies as a minimal-risk region. In our 
final rule (70 FR 514), we acknowledged the possibility that additional 
BSE-infected cattle might exist in Canada and explained the reason for 
our confidence that the number of such additional infected animals, if 
any, would be small. First, Canada has not imported ruminant MBM from 
any country with BSE since 1978. Second, Canada has prohibited the 
feeding of ruminant MBM to ruminants since 1997, and CFIA has verified 
high levels of compliance with the feed ban by routine inspections of 
both renderers and feed mills. Third, Canada has traced and destroyed 
all remaining cattle imported from the UK. Fourth, Canada has traced 
and destroyed the majority of the cattle that comprised the birth 
cohorts of the two initial Canadian BSE cases, as it has subsequently 
done with the birth cohorts of the two most recent cases. Fifth, Canada 
has conducted surveillance for BSE since 1992 and has conducted 
targeted surveillance at levels that have met or exceeded OIE 
guidelines since 1995.
    As we explained in our final rule, even if BSE-infected cattle do 
remain in Canada, they are likely to be older animals that were exposed 
before Canada's feed ban in 1997. Because this rule requires that 
imported animals be less than 30 months old, such animals could not 
legally enter the United States under this rule. Further, even if an 
infected animal did enter the United States, the science, the research, 
and the experience of animal and public health authorities, supported 
by the Harvard-Tuskegee Study indicates it would be very unlikely to 
lead to the introduction of BSE into domestic cattle or to human 
exposure to the BSE agent.
    Several commenters on the EA questioned Canada's feed ban due to 
press reports published in December 2004 that revealed that animal 
protein of undetermined origin had been found by CFIA in ruminant feed. 
As part of its ongoing compliance and enforcement program, the CFIA 
conducted a small feed sampling and testing program to evaluate the 
usefulness of direct microscopy. CFIA concluded that microscopy was not 
capable of distinguishing between animal tissues that pose no animal 
health risk and those that are prohibited under Canada's

[[Page 18259]]

feed ban regulations. In following up on the microscopy results, the 
CFIA concluded the great majority of samples did not contain prohibited 
material. Of the 110 samples tested, 65 samples were of Canadian 
origin, 44 samples were from the United States, and one was from 
France. Of the 65 samples of Canadian origin, the CFIA was unable to 
rule out the possibility that some incidental level of prohibited 
material may have been present in 11 samples. Of the 45 imported 
samples, animal material was detected in 18. With respect to the 
Canadian origin samples, the CFIA has taken action to ensure that the 
establishments involved have improved their recordkeeping, flushing, 
and/or sequencing procedures. (https://www.inspection.gc.ca/english/
anima/feebet/rumin/microe.shtml.) Based on our extensive experience and 
interaction with CFIA program officials over many years, the thorough 
Canadian report on the microscopy sampling and testing program, as well 
as the results of the APHIS feed team inquiry, APHIS has concluded that 
the Canadian feed ban is effective and will accomplish its objective of 
reducing and eliminating any BSE infectivity that may remain in Canada.
    As noted above, several commenters expressed concern that the MRR 
rule could result in the introduction of BSE into the domestic herd and 
that vCJD could occur as a result of such introduction or through the 
import of meat products from Canada. With regard to this concern, there 
is a solid scientific consensus regarding our knowledge of the cattle 
tissues that contain BSE infectivity and our knowledge of the modes of 
transmission of that infectivity. While it is likely that ongoing 
research will increase our knowledge of the disease agent, APHIS, along 
with FSIS and FDA, are confident that the measures in place will 
protect animal and human health. In addition, it seems clear that there 
is a significant species barrier that protects humans from illness due 
to exposure to the BSE agent. European scientists working on the 
outbreak in the UK and subsequent BSE research have suggested that the 
amount of infective tissue required to infect humans may be 10,000 
times greater than the amount needed to infect cattle. During the 
epidemic in the UK, it was estimated that there were approximately 1 
million infected animals and yet, to date, there have been only 
approximately 153 vCJD cases worldwide, 95 percent of which have 
occurred in the UK. Current research does not suggest the need for 
further food safety mitigations and does not alter the conclusion that 
the appropriate tissues that can carry levels of infectivity sufficient 
to cause human or animal illness are, in fact, being removed from the 
animal and human food supply under U.S. and Canadian regulations.
    One commenter suggested the need for further assessment of the 
persistence of the BSE agent in soil, water and air. To date, there is 
no evidence of environmental transmission of the BSE agent. While such 
transmission could be theoretically possible, epidemiological reviews 
do not indicate that such transmissions, even if they occurred, would 
be a significant issue. In the UK, which has experienced the largest 
and most significant outbreak, early epidemiological investigations 
pinpointed feed as the route of transmission. In response to these 
findings, the UK authorities instituted feed ban regulations that have 
been strengthened over the years. The feed restrictions have clearly 
had an effect in preventing transmission of disease, with the number of 
cases identified annually continuing to decrease from a peak in 1992-
1993. Investigations have been done on animals born after the 
reinforced ban went into effect. These have included evaluating all 
possible routes of transmission, and they continue to conclude that 
environmental contamination is an unlikely risk factor. Therefore, 
based on the best available science, the ability of the BSE agent to 
persist in soil, water and air is not a significant issue.
    While there is evidence that scrapie disease in sheep and chronic 
wasting disease (CWD) in cervids can be transmitted by environmental 
contamination, there is no basis for extrapolating these data to BSE in 
cattle. Research has demonstrated that the distribution of scrapie 
infectivity in sheep is different than the BSE agent in cattle. For 
example, infectivity has been found in the placenta of sheep infected 
with scrapie. This contributes to the lateral transmission (animal-to-
animal) of scrapie in sheep, and if placental tissue remains in the 
environment, it can contribute to environmental contamination. 
Conversely, in cattle infected with BSE, no infectivity has been 
demonstrated in placenta and there is no evidence of lateral 
transmission of the disease. Similarly, animal-to-animal contact 
appears to contribute to the spread of CWD in cervids, and 
environmental contamination also appears to be a factor, although the 
specific means of transmission is unknown. However, these findings 
cannot be extrapolated to cattle with BSE, as there is no evidence of 
lateral transmission of BSE or of transmission by environmental 
contamination.

C. The Degree to Which the Action May Establish a Precedent for Future 
Action With Significant Effects or Represent a Decision in Principle 
About a Future Consideration

    This criterion requires consideration of whether an action may 
establish an authoritative rule, pattern, or practice for similar cases 
that may follow and whether the precedent thereby established could 
have significant effects on the quality of the human environment.
    The MRR rule establishes standards for recognizing regions as 
presenting a minimal risk of introducing BSE into the United States and 
provides for the importation of certain ruminants, ruminant products 
and byproducts from such regions. The minimal-risk region standards and 
import conditions established by APHIS are designed to prevent the 
introduction of BSE into the United States. These standards and 
conditions are buttressed by a series of interlocking, overlapping risk 
mitigations in place in the United States. The addition of this 
minimal-risk category to the agency's BSE rules will permit regions 
that believe they meet the standards to request recognition as a BSE 
minimal-risk region. We would expect and require that any such request 
will, in the first instance, comply with Sec.  92.2 of the APHIS 
regulations, which contains the general procedures for requesting the 
recognition of regions. (9 CFR 92.2.) The MRR rule, however, designates 
Canada as the only minimal-risk region for BSE. Before another country 
or region would be recognized as a BSE minimal-risk region, APHIS would 
conduct an assessment of all risks involved. If the risk assessment 
indicated that the region meets the standards and appropriate 
requirements, APHIS would publish a proposal in the Federal Register. 
At that point, the public would have an opportunity to participate 
fully and all pertinent issues, questions, and concerns would be 
addressed in the rulemaking process. Needless to say, any unusual or 
unique facts or circumstances related to a particular region's request 
would be carefully evaluated by APHIS as well. For example, the animals 
or animal products allowed to be imported and the required risk 
mitigation measures could and would be tailored to each specific region 
considered. Accordingly, the MRR rule does not establish a precedent 
for future actions with significant effects or represent a decision in 
principle about future

[[Page 18260]]

approval of additional minimal-risk regions.

D. Whether the Action Is Related to Other Actions With Individually 
Insignificant but Cumulatively Significant Impacts

    The term cumulative impact is defined as an impact on the 
environment that results from the incremental impact of the action when 
added to other past, present, and reasonably foreseeable future actions 
regardless of what agency or person undertakes such other actions. 
Cumulative impacts can result from individually minor but collectively 
significant actions taking place over a period of time.
    The potential for harm to the quality of the human environment lies 
in the introduction of the BSE agent into the United States and 
subsequently finding its way into the animal and human food supply 
where it could be ingested and result in infection. For this chain of 
events to occur, the multiple animal and human health mitigation 
measures in place in Canada and the United States, as well as the 
additional mitigations prescribed by the MRR rule, would have to 
substantially fail. There is no basis to conclude that such a 
significant breakdown in the system of interlocking and overlapping 
measures could ever occur. Similarly, if the agency were to recognize 
any other regions as minimal-risk regions, there is no reason to 
believe that the mitigation measures and other requirements imposed in 
such a rulemaking would be any more likely to be breached and result in 
harm to animal or human health. It must be remembered that our MRR rule 
is designed to preclude the introduction of BSE into the United States 
and APHIS has concluded that the rule will achieve that result. 
Accordingly, there is no basis to believe that this action, or future 
actions that the agency may take, could result in cumulatively 
significant environmental impacts.

Additional Issues: Allegations of Environmental Impacts Raised in 
Litigation

    Shortly afte