Number range CHAPTER**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. Number range CHAPTER 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 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.[^1]

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.[^2] In summary, APHIS determined that Canada
met the standards for a BSE minimal-risk region because:

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 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.[^3] 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.

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.[^4] 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.

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 website at
http://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/\\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.[^5] The
preceding discussion and conclusions provide the foundation for the
finding of no significant impact described below.

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.[^6] 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.

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 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.[^7] Furthermore, as
explained in the exposure assessment 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.

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.[^8] In developing the MRR rule and in preparing the
EA, APHIS consulted with both FSIS and FDA.

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 http://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
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
http://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. (http://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
http://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
http://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
http://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 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.
(http://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 § 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 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 after issuance of the final EA for the MRR 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. R-CALF alleged that the
final EA was inadequate because, among other things, it failed to assess
the environmental effects of transporting what we estimated would be as
many as 2 million head of cattle from farms and feedlots in Canada to
feedlots and slaughterhouses in the United States, as well as the
environmental impacts of feeding and holding these additional feeder
cattle until slaughter. Although the plaintiff filed several comments on
the rule throughout this rulemaking proceeding, it did not include these
concerns in these comments, nor did it file any comment on the final EA
published on January 4, 2005. In addition, no other commenter on the EAs
raised these potential environmental impact issues. Even though the
alleged potential effects pose no significant environmental impact, and
were not raised by R-CALF or any other commenter on the EA, we have
addressed them below.

The two issues raised by R-CALF did not, and do not now, pose
potentially significant impacts. Accordingly, they were not discussed in
the final EA. First, it is important to note that the impacts or effects
alleged by R-CALF to be significant are not brought about or caused by
the MRR final rule. Second, it is also important to understand the MRR
rule within the context of the economic relationship that has existed
between Canada and the United States for many years. Since the 1970\'s,
the U.S. and Canadian cattle and beef industries operated largely as an
integrated North American industry, with both live cattle and processed
beef flowing freely between the two countries. For years prior to May
2003, millions of head of live cattle crossed the border in one
direction or the other. The two countries have become each other's
largest trading partners in agricultural products.

In May 2003, as a result of the finding of BSE in Canada, APHIS
published an interim rule to add Canada to the list of countries in
which BSE exists. APHIS took this action as a temporary measure while it
assessed the facts and circumstances surrounding the BSE situation in
Canada. After evaluating the epidemiological investigation of the May
2003 BSE positive cow and after reviewing the BSE risk mitigation
measures in place in Canada and the United States, USDA announced in
August 2003 that it would begin issuing permits, pursuant to its
existing regulations, to allow the importation of certain low-risk meat
products from Canada. These products included boneless beef from cattle
under 30 months of age, veal, and bovine liver. As a result, within 3
months, a substantial amount of trade in beef and beef products was
resumed with Canada. In November 2003, APHIS issued a proposed rule that
would again allow the importation of certain live animals, including
cattle under 30 months of age, as well as all beef products from cattle
under 30 months of age, from Canada. Therefore, the MRR rule would allow
the restoration of trade in ruminants and ruminant products under
approved mitigations after a temporary suspension of such trade.

The final economic analysis for the MRR rule estimated that as many as 2
million head of cattle could be imported from Canada in 2005, assuming
implementation of the MRR rule at the beginning of the year. This
estimate was based on historical cattle import data from 2001 and 2002,
an estimated backlog of cattle in Canada as a result of the temporary
closure of the border to live cattle in 2003, and an estimate of the
number of cattle under 30 months of age that would be available for
importation into the United States because of an increase in the number
of older cattle that would be slaughtered in Canada for the export of
beef to the United States. We acknowledged that there was a good deal of
uncertainty in projecting the number of cattle that would be imported
from Canada and that changes in production, feeding, slaughter and trade
patterns and circumstances could well affect the result. In recognition
of these uncertainties, we also conducted the analysis using one-half of
the assumed backlog and one-half of the assumed number of imported fed
cattle displaced from slaughter in Canada.

Using the 2 million number, R-CALF estimated that the resumption of
limited trade in live cattle would result in 35,000 truck round-trips
between Canada and the United States. Assuming these would represent an
actual increase in trips involving live cattle and meat, the truck
traffic represented by this estimation is wholly insignificant. For
2003, the incoming truck crossings from Canada into the United States
totaled 13.3 million crossings, which included 6.7 million truck
crossings, 5.7 million loaded truck container crossings, and 0.9 million
unloaded truck container crossings. (See
http://www.bts.gov/programs/international/border_crossing_entry_data/.)
For 2002, the total incoming truck crossings from Canada into the United
States were 13.7 million crossings, which included 6.9 million truck
crossings, 5.8 million loaded truck container crossings and 1.0 million
unloaded truck container crossings. (*Id.*) For 2001, the total incoming
truck crossings from Canada into the United States were 13.4 million
crossings, which included 6.8 million truck crossings, 5.6 million
loaded truck container crossings, and 1.0 million unloaded truck
container crossings. (*Id*.) There is little variation in the annual
volume of truck traffic entering the United States from Canada over this
3-year period, and, in addition, an increase of 35,000 truck crossings
would be well within the variation shown by the data. Even with an
increase of 35,000 truck round-trips between Canada and the United
States, the total increase would amount to approximately 1/4 of one
percent increase in truck traffic, an amount that is *de minimus* by any
measure. An examination of truck traffic through the 20 ports of entry
through which importations of live ruminants and ruminant products from
Canada are authorized under the MRR rule yields similar conclusions. The
2003 truck crossings at the 20 ports of entry were approximately 11.1
million. (*Id*.) Therefore, an increase of 35,000 truck crossings spread
over just these 20 ports of entry would result in less than 1/3 of a one
percent increase. It is also important to note that truck traffic
between the United States and Canada is merely a subset of all vehicular
traffic between the two countries. When considering the total volume of
all vehicular traffic traveling across the border with Canada, the
environmental impacts associated with an increase of 35,000 truck
round-trips are even less significant. Accordingly, R-CALF's claim that
increased truck traffic would result in environmental damage is without
merit.

R-CALF also alleges that there will be significant environmental effects
attendant to the importation of live animals for feeding and for
slaughter. R-CALF asserts that these live cattle would be required to be
moved to a limited number of feedlots and slaughter facilities in the
United States. However, the final regulation contains no limitation on
the number of feedlots or slaughter facilities. The MRR rule is merely
restoring, for live cattle under 30 months, longstanding trade with
Canada, trade that has persisted for years and was only temporarily
halted in May 2003 due to the finding of BSE in Canada. There is no
reason to believe that these cattle would be destined for a different
set of feedlots or slaughter facilities than cattle imported from Canada
prior to 2003.

Whatever the potential environmental effects that theoretically might be
associated with the importation of live cattle for feeding or for
slaughter, there would be a significant difference in the magnitude of
such potential effects depending on whether the cattle were being
transported directly to slaughter facilities or were destined for
feedlots, where they may be fed for some period of time prior to moving
to slaughter. The potential environmental effects, while
inconsequential, would be significantly less for cattle moved
immediately to slaughter facilities. Based on historical data for cattle
imports from Canada, between 65 percent and 75 percent of imported
cattle have gone directly to slaughter and the remainder (other than the
very small number historically imported for breeding) have been
transported to feedlots and then to slaughter facilities. Based on the
projection in the final economic analysis of 2 million cattle imported,
approximately 1.4 million would be moved immediately to slaughter and
600,000 feeder cattle would be moved to feedlots.

Subsequent to the estimates in the final economic analysis and
publication of the MRR rule, on February 9, 2005, the Secretary
announced that implementation of the part of the MRR rule that would
allow for importation of beef from cattle 30 months of age or older
would be delayed. Therefore, there was no longer a basis for assuming
the displacement from slaughter in Canada of cattle under 30 months of
age by cattle 30 months of age or older. The estimate of the number of
cattle that would be imported from Canada was revised downward. We
further modified the estimate downward to reflect an increase in
Canadian slaughter capacity over the past year. Therefore, based on
these factors, we estimated that as many as 1.4 million cattle could be
imported from Canada in the first year after the effective date of the
MRR rule. Of this number, we estimate that 900,000 fed cattle would be
moved directly to slaughter facilities and that 500,000 feeder cattle
would be sent to feedlots and then to slaughter, further reducing any
potential impacts.

On January 6, 2005, the National Cattlemen's Beef Association (NCBA)
sent a delegation of U.S. cattle producers to Canada on a fact-finding
mission regarding BSE and the MRR rule. One task assigned to the NCBA
delegation was to identify Canadian cattle that would qualify for export
under the MRR rule and determine the impact on U.S. producers. The NCBA
delegation report, dated February 2, 2005
(http://www.beefusa.org/uDocs/acf985911.pdf) stated, based on Can-Fax
data gathered over a 20-month period of time, that there were
approximately 900,000 head of cattle available for export. This
consisted of approximately 600,000-700,000 head of fed cattle and
approximately 200,000-300,000 feeder cattle. The NCBA report suggested
that the import quantities assumed in APHIS' economic analysis were too
high. The NCBA report suggests that the APHIS estimate did not fully
account for the 22 percent increase in Canadian slaughter capacity
between 2003 and 2004. The NCBA report concluded that the delegation
agreed with Can-Fax and other private sector estimates and put the
likely imports of feeder cattle in the range of 200,000-300,000 during
calendar year 2005 and assumed that the MRR rule would be implemented on
March 7, 2005.

Under either of APHIS' two estimates, any environmental effects would
not be significant. The average annual number of fed cattle slaughtered
for the years 2002 and 2003 in the United States was 29 million. Total
cattle slaughter, which includes fed cattle, cows and bulls, averaged
35.6 million head annually for the same period. Thus, the estimated
maximum imports of cattle for immediate slaughter would amount to
approximately 4.8 percent of the total fed cattle slaughter and 3.9
percent of total cattle slaughter spread over a 12-month period. For the
years 2003 and 2004, an average of 26.9 million cattle were marketed by
U.S. feedlots annually. The estimated number of feeder cattle that may
be imported from Canada in the first year (500,000-600,000 head) would
represent between 1.8 and 2.2 percent of fed cattle marketed annually in
the United States. Even assuming that Canadian feeder cattle actually
imported after implementation of the MRR rule represented an actual
increase in the number of cattle on feed in the United States, the
potential effects would not be significant. The transitory nature of
even this volume of imports from Canada is discussed in the final EA,
where estimates that imports would decline over the years 2006-2009 are
discussed and displayed.

Furthermore, any potential impacts on air and water quality associated
with the importation of cattle from Canada are addressed under an array
of existing statutes and regulations in the United States. These
regulations include the National Pollutant Discharge Elimination System
Permit regulations and Effluent Limitation Guidelines and Standards for
Concentrated Animal Feeding Operations (CAFO) under the Clean Water Act,
as well as State environmental regulations for proper management of
manure and wastewater from animal feedlot operations. In addition to
state laws and regulations for air emissions, there are a variety of
provisions under the Clear Air Act that could address air emissions
relating to this activity. The U.S. Environmental Protection Agency has
also established requirements for CAFOs under the Clean Water Act and
regarding nitrate contamination of underground sources of drinking water
under the Safe Drinking Water Act. The United States' Clean Air Act and
Canadian environmental protection laws have vehicle emissions
requirements that are designed to prevent harmful air emissions from
vehicles, including transport trucks. These activities have a very low
potential to negatively affect human health and safety since each is
subject to comprehensive environmental regulation in this country and in
Canada. Compliance with these requirements by transporters, feedlot
operators, and slaughterhouses assures that the quality of the human
environment will be safeguarded in all respects. Our border ports are
adequately staffed and capable of handling movement of cattle into this
country, which will not concentrate at a single border port.
Historically, Canadian cattle imported into the United States for
slaughter have been shipped to numerous States throughout the United
States. Because cattle are not required to be shipped to specific
feedlots or slaughter facilities, it is expected that trucks will
utilize all available border crossings and highway routes. There is no
evidence or data to suggest that our roadways, feedlots, and
slaughterhouses, as currently operated, cannot accommodate the
resumption of Canadian cattle imports in a manner that fully protects
all potentially impacted environmental quality values.

I have determined that the final BSE MRR rule will not have a
significant effect on the human environment and accordingly I have
decided that it is appropriate to issue a finding of no significant
impact for the final MRR rule. Thus, having fully considered the two
environmental assessments prepared for the MRR rule, as well as all of
the comments submitted on them, along with the reports and analyses
referenced in the EA and in the MRR rule, I conclude that the

MRR rule will protect animal and human health and the environment.
Accordingly, I find that adoption of the MRR final rule and the
recognition of Canada as a BSE minimal-risk region will not
significantly affect the quality of the human environment.

[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

W. Ron DeHaven Date

Administrator

Animal and Plant Health Inspection Service

[^1]: ^?^ 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 http://www.aphis.usda.gov/lpa/issues/bse/bse.html.

[^2]: ^?^ Ibid, pp. 5-18.

[^3]: ^?^ Canadian Food Inspection Agency (CFIA). Memorandum from Dr.
    Brian Evans, Chief Veterinary Officer, to Dr. John Clifford, Deputy
    Administrator, VS, APHIS. July 30, 2004.

[^4]: ^?^ Canadian reports of the investigations can be accessed at
    http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/bseesbindexe.shtml.

[^5]: ^?^ See "Analysis of Risk-Update for the Final Rule: Bovine
    Spongiform Encephalopathy; Minimal Risk Regions and Importation of
    Commodities, December 2004." pp. 25-27.

[^6]: ^?^ 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).

[^7]: ^?^ See "Analysis of Risk---Update for the Final Rule: Bovine
    Spongiform Encephalopathy; Minimal Risk Regions and Importation of
    Commodities, December 2004," pp. 11-17.

[^8]: ^?^ 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).