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|          |   | **Importation of Certain Commodities From BSE         |
|          |   | Minimal-risk Regions (Canada)**                       |
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|          |   | **Final Environmental Assessment, September 2007**    |
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> Number range CHAPTER**Importation of Certain**
>
> **Commodities From BSE Minimal-risk Regions (Canada)**
>
> **Final Environmental Assessment,**
>
> **September 2007**
>
> **Agency Contact:**
>
> Lisa A. Ferguson
>
> Senior Staff Veterinarian
>
> National Center for Animal Health Programs
>
> Veterinary Services
>
> Animal and Plant Health Inspection Service
>
> U.S. Department of Agriculture
>
> 4700 River Road, Unit 43
>
> Riverdale, MD 20737--1231
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> The U.S. Department of Agriculture (USDA) prohibits discrimination in
> all
>
> its programs and activities on the basis of race, color, national
> origin, sex,
>
> religion, age, disability, political beliefs, sexual orientation, and
> marital or family
>
> status. (Not all prohibited bases apply to all programs.) Persons with
>
> disabilities who require alternative means for communication of
> program
>
> information (Braille, large print, audiotape, etc.) should contact
> USDA's
>
> TARGET Center at (202) 720--2600 (voice and TDD).
>
> To file a complaint of discrimination, write USDA, Director, Office of
> Civil
>
> Rights, Room 326--W, Whitten Building, 1400 Independence Avenue, SW,
>
> Washington, DC 20250--9410 or call (202) 720--5964 (voice and TDD).
>
> USDA is an equal opportunity provider and employer.

**Table of Contents**

[**I. Introduction 1**](#__RefHeading___Toc132018804)

[**A. Need for the Proposed Action 1**](#__RefHeading___Toc132018805)

[**B. Purpose of This Document 3**](#__RefHeading___Toc132018806)

[**C. Alternatives Considered 3**](#__RefHeading___Toc132018807)

[**1. No Action 3**](#__RefHeading___Toc132018808)

[**2. Proposed Action 4**](#__RefHeading___Toc132018809)

[**3. Other Alternatives Considered but Dismissed From Further
Consideration 4**](#__RefHeading___Toc132018810)

[**II. Potential Environmental Impacts
5**](#__RefHeading___Toc132018811)

[**A. Public Health 5**](#__RefHeading___Toc132018812)

[**1. Live Bovines 6**](#__RefHeading___Toc132018813)

[**2. Products 13**](#__RefHeading___Toc132018814)

[**B. Impacts on the Physical
Environment...............................19**](#__RefHeading___Toc132018815)

[**1. Transport of Bovines 20**](#__RefHeading___Toc132018816)

[**2. Holding of Bovines in Feedlots 23**](#__RefHeading___Toc132018817)

[**3. SRMs Generated**](#__RefHeading___Toc132018818) **26**

[**C. Highly Uncertain or Unique or Unknown Risks
30**](#__RefHeading___Toc132018819)

[**D. Endangered or Threatened Species
31**](#__RefHeading___Toc132018820)

[**E. Cumulative Impacts**](#__RefHeading___Toc132018821) **33**

[**F. Other Laws or Requirements 36**](#__RefHeading___Toc132018822)

[**III. Summary of Potential Environmental Impacts by Alternative
36**](#__RefHeading___Toc132018823)

[**IV. Agencies or Persons Contacted 38**](#__RefHeading___Toc132018824)

[**V.** **References 39**](#__RefHeading___Toc132018825)

[]{#__RefHeading___Toc132018804 .anchor}**I. Introduction**

[]{#__RefHeading___Toc132018805 .anchor}**A. Need for the Proposed
Action**

The United States Department of Agriculture (USDA), Animal and Plant
Health Inspection Service (APHIS) regulates the importation of animals
and animal products into the United States to guard against the
introduction of animal diseases. Until May 2003, U.S. regulations
allowed live ruminants[^1] and ruminant products and byproducts to be
imported from Canada with no restrictions related to bovine spongiform
encephalopathy (BSE). At that time, the United States imposed regulatory
restrictions on Canada with regard to the importation of these
commodities because of the first diagnosed case of BSE, also known as
"mad cow disease," in a cow in Alberta, Canada.

On January 4, 2005, APHIS published a final rule[^2] (hereafter referred
to as the Minimal-risk Regions (MRR) rule) that (1) established a BSE
minimal-risk region category, (2) set forth conditions for the
importation of certain live ruminants and ruminant products and
byproducts from such regions, and (3) added Canada to the category of
BSE minimal-risk regions. The criteria for a minimal-risk region include
the following: a minimal-risk region must have had in place, prior to
the detection of BSE, risk mitigation measures---such as import
restrictions, a ruminant-to-ruminant feed ban, and
surveillance---adequate to prevent widespread exposure and/or
establishment of the disease. The region also conducts epidemiological
investigations and risk assessments when BSE cases are identified and
imposes additional risk mitigation measures as necessary. On

July 15, 2005, APHIS implemented the regulations specified in the MRR
rule.

The MRR rule allows, under certain conditions, the importation of the
following commodities from Canada:

> \(1\) bovines[^3] for feeding or immediate slaughter, as long as they
> are less than 30 months of age when slaughtered;
>
> \(2\) ovines and caprines (sheep and goats), for feeding or immediate
> slaughter, as long as they are slaughtered at less than 12 months of
> age;
>
> \(3\) cervids (deer, elk, caribou, moose, and reindeer);
>
> \(4\) camelids (llamas, alpacas, guanacos, and vicunas);
>
> \(5\) meat from bovines, ovines, caprines, and cervids; and
>
> \(6\) certain other products and byproducts, including bovine livers
> and tongues, gelatin, and tallow.

Although implementation of the MRR rule resumed trade with Canada in
certain ruminant commodities, the prohibition on live bovines 30 months
of age and older and other associated commodities, such as bovine blood
and blood products and bovine casings,[^4] continued. As a result,
bovine blood and blood products and the 2004 and 2005 U.S. supplies of
bovine casings derived from the small intestine were constrained by
BSE-related restrictions on the use of the bovine small intestine for
human food. The requirement for the removal and disposal of the entire
small intestine established in the MRR rule was consistent at the time
with the USDA, Food Safety and Inspection Service (FSIS) and the U.S.
Department of Health and Human Services, Food and Drug Administration
(FDA) regulations. However, FSIS and FDA have since modified their
regulations to allow the use of the small intestine, except for the
distal ileum,[^5] for human food and cosmetic use.

The proposed action is needed to allow importation of the commodities
and to allow trade when there is no scientific basis for trade
restriction. The conditions for allowing trade of the bovine commodities
would be consistent with the 2005 World Organization for Animal Health
(commonly referred to as the Office International des Epizooties
(OIE))[^6] Terrestrial Animal Health Code for BSE (chapter 2.3.13.).[^7]
Therefore, USDA, APHIS is proposing to amend the regulations that
establish conditions for the importation of live ruminants and ruminant
products from minimal-risk regions[^8] into the United States. The
proposed action would amend the current regulations to allow, under
certain conditions, the following additional commodities from
minimal-risk regions: live bovines for unrestricted use born after the
date of an effective feed ban, bovine blood and blood products, and
bovine small intestine with the exception of the distal ileum.
Currently, Canada is the only country that has been recognized as a
minimal-risk region.

For purposes of this document, bovines include cattle and bison.
Although the rulemaking for this matter addresses the importation of
live bovines, only a small amount of the bovines from Canada under
consideration for the proposed action would be bison (about 0.9 percent,
or 12,000 of an average of about 1,316,000 million bovines per year);
thus, when this document refers to the term "bovines," it mostly
pertains to cattle.

[]{#__RefHeading___Toc132018806 .anchor}**B. Purpose of This Document**

This environmental assessment will be used to help determine whether or
not to prepare an environmental impact statement, a more comprehensive
study of the proposed action and alternatives considered in this
document. This environmental assessment will be used as a decisionmaking
tool together with the associated risk assessment (USDA, APHIS, 2006)
and economic analysis (USDA, APHIS, 2007a) in determining whether to
implement the rulemaking.

The availability of the environmental assessment, dated October 27,
2006, for the proposed rule to allow the importation of live bovine,
bovine blood and blood products, and bovine casings from Canada into the
United States was published in the [Federal]{.underline}
[Register]{.underline} on January 9, 2007, within the notice of the
proposed rule itself (72 FR 1102-1129), providing for a 60-day public
comment period. The environmental assessment was made available via the
Regulations.gov Web site and in the APHIS public reading room;
information on how to access the environmental assessment on the Web
site and the reading room was provided in the [Federal]{.underline}
[Register]{.underline} notice. The public comment period ended on March
12, 2007. During the 60-day comment period, comments were received on
the environmental assessment. A summary of the comments and responses to
the comments will be incorporated in the final rule and published in the
[Federal]{.underline} [Register]{.underline}. Revisions made to the
final environmental assessment include updated numbers to reflect the
current situation, especially with regard to revised import numbers;
text to clarify information; and updated citations and references, where
applicable.

[]{#__RefHeading___Toc132018807 .anchor}**C. Alternatives Considered**

As a Federal agency subject to compliance with the National
Environmental Policy Act (NEPA),[^9] APHIS must prepare an environmental
assessment to consider the environmental effects under a proposed action
and alternatives to that action consistent with NEPA regulations.[^10]
In addition to the proposed action alternative, this document discusses
the No Action alternative---the current regulations for importation of
live ruminants and ruminant products from minimal-risk regions---because
it is considered as the environmental baseline for discussing the
proposed action.

[]{#__RefHeading___Toc132018808 .anchor}**1. No Action**

Under this alternative, no change would occur to the MRR regulations
published on January 4, 2005, that (1) established the criteria for a
BSE minimal-risk region, (2) determined that Canada meets those
criteria, and (3) specified the commodities allowed for importation from
a BSE minimal-risk region. Commodities listed on page 1 of this document
would continue to be allowed into the United States from regions that
have been designated as minimal-risk regions. In addition, casings made
from bovine small intestines from BSE minimal-risk regions and bovine
blood and blood products would continue to be prohibited under this
alternative.

[]{#__RefHeading___Toc132018809 .anchor}**2. Proposed Action**

APHIS is proposing to add certain commodities to the list of those
commodities that would be allowed under the import regulations for a
minimal-risk region, specific to the consideration of Canada.[^11] The
rulemaking would amend the current regulations to allow the entry of the
following commodities from regions that present a minimal-risk of
introducing BSE into the United States:

\(1\) live bovines born on or after March 1, 1999,[^12] with no
restrictions on their use, destination, or time of slaughter;

\(2\) bovine blood and blood products; and

\(3\) bovine small intestine (with the exception of the distal ileum).

The amendment to allow bovine small intestine would be consistent with
FSIS and FDA regulations[^13] that allow the use of the small intestine
with the exception of the distal ileum.

[]{#__RefHeading___Toc132018810 .anchor}**3. Other Alternatives
Considered but Dismissed From Further Consideration**

A third alternative, Remove All BSE-related Restrictions, was
considered. This alternative would provide that live bovines of any age,
bovine blood and blood products, and bovine small intestines would be
allowed to be imported from Canada with no restrictions related to BSE
much like the conditions that existed prior to May 2003, when BSE was
discovered in Canada. However, FSIS and FDA regulations regarding the
use of the small intestine with the exception of the distal ileum have
changed since 2003, so trade in these commodities would not entirely
return to the pre-May 2003 conditions that were in place before APHIS
implemented regulatory restrictions. This alternative is not considered
further in this document because returning to pre-May 2003 conditions
(without implementing additional requirements to prevent potential
BSE-exposure pathways considering that several BSE cases have been
diagnosed in Canada) would not be consistent with OIE guidelines for
BSE. As a member of OIE, the United States, represented by APHIS, has
been actively involved in the development of OIE guidelines and fully
supports and is committed to maintaining consistency with the OIE
guidelines as much as possible.

[]{#__RefHeading___Toc132018811 .anchor}**II. Potential Environmental
Impacts**[^14]

The NEPA implementing regulations set forth criteria that Federal
agencies should evaluate in an environmental document.[^15] NEPA
criteria that are considered in this section of the document include
potential effects on public health, effects on the physical environment,
highly uncertain or unique or unknown risks on the human
environment,[^16] adverse effects on federally listed endangered or
threatened species, and cumulative impacts.

The potential environmental impacts addressed in this document would
result from effects to public health from BSE exposure pathways and
effects on the physical environment from allowing the importation of
bovines from Canada into the United States. Public health could be
affected by human exposure to bovine-derived products that contain the
BSE-infective agent. It is important to note that other agencies,
specifically FSIS and FDA, have direct authority over public health
issues, including those related to the use of bovine-derived products.
These agencies have regulations in place that are designed to prevent
adverse impacts on public health. FSIS and FDA have been consulted
during the development of the rulemaking associated with the proposed
action.

Although protection of animal health from BSE exposure is the disease
concern related to the scope of the rulemaking and its associated
documents, other potential risks associated with the importation of
cattle and associated meat products that could adversely impact public
health include foodborne pathogens. FSIS has established requirements
that are designed to prevent and reduce microbial pathogens (e.g., *E.
coli* O157:H7 and *Listeria monocytogenes*) on raw products that can
cause illness.[^17] Further, the Centers for Disease Control (CDC) has
attributed the implementation of FSIS' requirements for foodborne
pathogens as an important factor in the overall decline in bacterial
foodborne illnesses from 1996 through 2001 (USDA, FSIS, 2004). This
matter will not be assessed further in this environmental assessment as
a potential environmental impact as a result of the rulemaking. This
document does consider impacts on the physical environment that are
unrelated to BSE exposure but that result from activities associated
with the transport, holding, and slaughter of bovines.

[]{#__RefHeading___Toc132018812 .anchor}**A. Public Health**

BSE is a progressive neurological disorder of cattle. BSE belongs to a
family of diseases known as transmissible spongiform encephalopathies
(TSE). Research suggests that BSE is caused by an abnormal form of a
normally occurring protein known as a prion (Bolton *et al.,* 1982, and
Prusiner, 1994, as cited in USDA, APHIS, 2006). The abnormal prion
protein is both less soluble and more resistant to degradation than the
normal prion protein. The abnormal prion protein also is extremely
resistant to heat and to normal sterilization processes, making it
difficult to inactivate with standard methods used to process human food
and animal feed. Further, the BSE infectious agent does not evoke any
apparent immune response or inflammatory reaction.

The public health concern associated with the importation of live
bovines and bovine products from a BSE minimal-risk region is the
potential for human exposure to BSE-infected materials. Human exposure
to the BSE agent can result in the development of variant
Creutzfeldt-Jakob disease (vCJD) (CDC, 2005a). Such exposure could occur
through the consumption of bovine-derived products (such as meat or meat
products) contaminated with BSE-infected tissues. Various studies
suggest that the infectious agent may be 10 to 10,000 times less
pathogenic in humans than in cattle (EC SSC, 2000). To put infectivity
differences between humans and cattle in perspective, during the BSE
epidemic in the United Kingdom, it was estimated that there were
approximately 1 million infected animals. Worldwide, as of June 2007,
there have been 203 probable and confirmed cases of vCJD (National
Creutzfeldt-Jakob Disease Surveillance Unit, 2007). Of these, 165 cases
were reported in the United Kingdom and 38 cases reported in other
countries. In some of the cases reported as occurring outside of the
United Kingdom, the actual exposure to the BSE agent was likely to have
occurred in the United Kingdom. Human exposure to the BSE agent or BSE
infectivity most likely occurred before mitigation measures, such as
specified risk material (SRM)[^18] removal, were in place to prevent
such exposures. These widely differing numbers---more than 1 million
infected animals, with high infectivity present before control measures
were introduced, and 203 vCJD cases---demonstrates the substantial
species barrier for BSE transmission between cattle and humans.

1.  []{#__RefHeading___Toc132018813 .anchor}**Live Bovines**

    a.  **Background**

For the purpose of this environmental assessment, the main concern with
regard to potential BSE exposure is how the human environment, including
public health, in the United States could be affected by allowing the
importation of live bovines from Canada. The primary source of BSE
transmission in bovines is feed contaminated with the infectious agent.
Mitigations, such as a ruminant-to-ruminant feed ban, are designed to
decrease the possibility that animals will be infected, and, therefore,
decreases the subsequent possibility that humans will be exposed to the
BSE agent via products from infected animals. Canada and the United
States employ several mitigation measures that are designed to protect
animal health but that also protect human health, for example, the
ruminant-to-ruminant feed bans and handling and processing of SRMs,
which are discussed in the following sections.

Transmission of the BSE agent can be prevented by excluding the tissues
that could carry the BSE infective agent from ruminant feed. Experience
in the

United Kingdom demonstrates that implementation of a
ruminant-to-ruminant feed ban results in a decrease in the prevalence of
BSE (DEFRA, 2006, as cited in USDA, APHIS, 2006). A ban on the feeding
of ruminant protein to ruminants is one of the most important barriers
to the dissemination of the BSE agent. Thus, the primary barrier to
curtail BSE exposure of cattle to BSE infectivity that may have entered
the United States is FDA's ruminant feed ban. In addition, as discussed
in the risk assessment for the rulemaking, the interrelated feed ban
measures in place in Canada have resulted in an incremental reduction in
the risk that Canadian cattle will be exposed to the BSE agent (USDA,
APHIS, 2006).

Both FSIS and FDA have implemented regulations that prohibit the use of
SRMs in human food and other products, including dietary supplements and
cosmetics. On January 12, 2004, FSIS implemented a series of three
interim final rules[^19] to minimize human exposure to materials that
scientific studies have demonstrated contain the BSE agent in cattle
infected with BSE. Through these regulations, FSIS designates certain
materials from cattle as SRMs, declares that SRMs are inedible,
prohibits the use of these materials for human food, and requires that
all nonambulatory[^20] disabled cattle presented for slaughter be
condemned. Proper removal, segregation, and disposal are required in
order to mitigate any potential risks to public health. Processes for
removal, segregation, and disposal of SRMs are designed to prevent these
potentially infectious materials from entering into the human food
supply. FSIS[^21] requires SRMs to be rendered as "unfit for human food"
within the meaning of section 1(m)(3) of the adulteration provisions of
the Federal Meat Inspection Act.[^22] Regardless of the selected SRM
disposal method, slaughter establishments must develop Standard
Operating Procedures (SOPs) that detail the method(s) by which SRMs will
be disposed. These FSIS regulations are intended to ensure that SRMs are
not used in human food and that SRMs do not cross-contaminate edible
meat products.

Similarly, on July 14, 2004, to address the potential risk of BSE in
human food, FDA issued an interim final rule[^23] to designate certain
materials from cattle, including the entire small intestine, as
"prohibited cattle materials" and banned the use of such materials in
human food, including dietary supplements and cosmetics. Among the
materials FDA designated as prohibited cattle material are SRMs, the
small intestine from all cattle, and material from cattle not inspected
and passed for human consumption. Through their January and July 2004
regulations, both FSIS and FDA, respectively, prohibited the use of the
entire small intestine for human food; subsequently, on September 7,
2005, both FSIS[^24] and FDA[^25] issued interim final rules amending
these regulations and currently designate only the distal ileum of the
small intestine from cattle as an SRM.

**b. No Action (Live Bovines)**

Under the No Action alternative, the current import regulations for the
MRR rule would continue, as implemented in July 2005. Currently, Canada
is the only country that has been approved as a minimal-risk region
under APHIS regulations.[^26] It is assumed that Canada would continue
to meet the conditions of a BSE minimal-risk region and that APHIS would
make no change to the regulation that allows importation of the
following commodities:

> \(1\) bovines for feeding or immediate slaughter, as long as they are
> slaughtered at less than 30 months of age;
>
> \(2\) ovines and caprines (sheep and goats), for feeding or immediate
> slaughter, as long as they are slaughtered at less than 12 months of
> age;
>
> \(3\) cervids (deer, elk, caribou, moose, and reindeer);
>
> \(4\) camelids (llamas, alpacas, guanacos, and vicunas);
>
> \(5\) meat from bovines, ovines, caprines, and cervids; and
>
> \(6\) certain other products and byproducts, including bovine livers
> and tongues, gelatin, and tallow.

The "Rulemaking to Establish Criteria for the Importation of Designated
Ruminants and Ruminant Products From Canada into the United States,
Final Environmental Assessment, December 2004"[^27] (also referred to as
the MRR EA; USDA, APHIS, 2004a) considered the potential impacts
associated with potential BSE exposure from implementing the MRR rule
(also referred to as the No Action alternative for the purposes of this
document). The MRR EA addressed safeguards that had been implemented in
the interest of protecting animal health, such as the
ruminant-to-ruminant feed ban in place in both Canada and the

United States since 1997, and safeguards that had been implemented to
protect public health from potential BSE exposure, such as proper
removal and disposal of ruminant SRMs at slaughter. The MRR EA referred
to the associated risk assessments for the MRR rule (USDA, APHIS, 2003;
USDA, APHIS, 2004a; and USDA, APHIS, 2004b) that analyzed risk-reduction
strategies and requirements of the rulemaking that provide multiple
safeguards against BSE exposure from imported Canadian cattle. The MRR
EA concluded that the risk of BSE infectivity entering the United States
as a result of the rulemaking was low based on past and more recent
mitigation measures and safeguards implemented in Canada and the United
States.

The MRR EA process concluded with a Finding of No Significant
Impact[^28] (FONSI) that implementation of the rule would not have a
significant effect on the human environment, considering the multiple
and overlapping safeguards in the United States, implemented and
enforced by APHIS, FSIS, and FDA. These safeguards, as well as the
additional risk mitigation measures required in the MRR rule, are
designed to protect animal health and public health. The FONSI for the
MRR EA addressed these issues, in addition to environmental issues,
regarding the transport and holding of cattle.

b.  **Proposed Action (Live Bovines)**

The proposed action would allow the importation of live bovines born on
or after March 1, 1999, bovine small intestine other than distal ileum,
and bovine blood and blood products from Canada into the United States.
According to the risk assessment, Canadian cattle born on or after March
1, 1999, can be imported into the United States with an extremely low
likelihood that they have been exposed to the BSE agent (USDA, APHIS,
2006). This alternative would include certain mitigations that together
with other requirements, including the APHIS, FSIS, FDA, and Canadian
regulations, are designed to control the risk of BSE infectivity
entering the United States.

USDA, Economic Research Service (ERS), provided projections of bovine
imports from Canada based on previous import data and the availability
of cattle in Canada. These projections forecast that up to 82 percent of
the imported cattle (including steers/heifers, cows, bulls, stags, and
calves) from Canada would be intended for immediate slaughter;
approximately 14 percent as feeder animals;[^29] and approximately 4
percent of cattle imports are expected for breeding (dairy
heifers/cows,[^30] beef heifers/cows, and bulls) purposes (as reported
in USDA, APHIS, 2006).

Although most of the bovines expected to enter the United States from
Canada following implementation of the proposed action would be cattle,
some bison will enter as well. Since the October 27, 2007, version of
the environmental assessment, projections for bison have been revised.
About 12,000 bison are projected to be imported annually. As
implementation of the proposed action would once again allow breeding
animals from Canada, about 10 percent (1,200) of the bison imports are
expected to be breeding animals and most likely will be under the age of
30 months. In the absence of evidence to the contrary, the risk
assessment (USDA, APHIS, 2006) assumes that the prevalence of BSE in
bison is the same as that in cattle. Since no cases have been reported
in North American bison, this assumption likely overestimates the risk
associated with importation of this species. Further, the risk
assessment assumes that the conclusion of an extremely low likelihood of
BSE infectivity release for cattle also applies to bison (USDA, APHIS,
2006).

SRMs are required to be removed from cattle at slaughter. FSIS[^31] and
FDA[^32] have regulations that ensure the proper processing and handling
of SRMs removed from cattle. These regulations for SRM removal ensure
that materials potentially infected with BSE do not enter human food
supplies. Thus, this proposed action is not likely to be a risk to
public health as a result of human consumption of food contaminated with
SRMs.

[Estimates of Potentially Available BSE Infectivity to Humans from
Importing Live Bovines]{.underline}

Both qualitative and quantitative methods were used in the risk
assessment prepared for the rulemaking (USDA, APHIS, 2006). As part of
the release assessment, quantitative methods were used to estimate the
current prevalence of BSE in the standing adult cattle population in
Canada. Qualitative methods were then used to describe the most likely
scenario considered in the release assessment, which was that release is
unlikely due to the mitigations imposed and the expectation that the low
prevalence in Canada will decrease. Less likely scenarios were also
considered in the release assessment, based on the assumption that
prevalence stays constant in Canada over the next 20 years.

Both qualitative and quantitative methods were also used in the exposure
assessment to evaluate the likelihood of exposing susceptible animals
given the release of infectivity via imported animals. The most likely
scenario of the release assessment included the assumption that the
prevalence of BSE in the standing adult cattle population will
continuously decrease from the current estimate over 20 years. This
expected decrease could not be incorporated into the quantitative
methods in the release or exposure assessment. In this instance, where
either the expected scenario cannot be numerically represented or where
the numbers would be so low as to prevent their use in further
calculations, the risk assessment qualitatively assesses the possible
exposures. This qualitative exposure assessment, building on the most
likely scenario of the release assessment, demonstrated that the animal
health risk to the United States of BSE---i.e., the likelihood of
establishment and the potential impacts of cases that might occur even
without establishment---is negligible.

Even though the risk assessment concludes that it is most likely that
the prevalence of BSE in Canada will decrease continuously over the next
several years, the assessment considers less likely scenarios and
quantitatively analyzes the impact of an assumed constant prevalence in
Canada to simulate potential BSE exposure in U.S. cattle. Therefore, the
quantitative exposure model and its results by necessity include the
less likely assumption that Canadian BSE prevalence remains constant
through 2027. Thus, as reported in the risk assessment, the low
estimates included in the quantitative exposure model for infected and
clinically affected animals are over-estimates. Further, based on
evidence, not presented in the quantitative exposure model, that BSE
prevalence continues to decrease following implementation of a
ruminant-to-ruminant feed ban, it is estimated that prevalence, release,
and therefore, the number of infected animals occurring in the United
States would be lower than the values derived from the quantitative
exposure model. The quantitative exposure model simulations provide
results for a base case scenario and a sensitivity analysis (which
examines the relative importance of assumptions made for several
uncertain parameters), both of which represent pessimistic values.[^33]
More detail about the models and the assumptions is described in the
associated risk assessment prepared for the rulemaking (USDA, APHIS,
2006).

Assuming the less likely scenario of constant BSE prevalence in Canada
under the base case scenario, the estimated number of infected cattle in
the United States over a 20-year period amounts to 21. The majority of
the 21 cattle would be imported, while approximately 2 of the cattle
would represent secondary (native) cases resulting from exposure of
cattle in the United States to the BSE infective agent that entered the
United States via the imported cattle. From the 21 cattle, the exposure
model estimates that the potential infectivity available for human
exposure over the 20-year period could amount to 45 cattle oral
infectious dose (oral ID~50~) units. BSE infectivity is expressed in
terms of cattle oral infectious dose-50 units (ID~50~). A cattle oral
ID~50~ is defined as the amount of infectivity required to cause
infection in 50 percent of an exposed cattle population (USDA, APHIS,
2006).

In the sensitivity analysis, the relative importance of five uncertain
parameters was determined by setting each of these parameters (e.g.,
mislabeling and contamination of feed, the rate of on-farm misfeeding of
prohibited feed to cattle, render reduction factor, the proportion of
poultry litter (which could contain prohibited ruminant materials) that
is used in cattle feed, and Canadian BSE prevalence), individually, to
its higher plausible (pessimistic) level, while keeping all other
parameters at the base-case level. Even when simultaneously setting all
uncertain parameters to their pessimistic values, the estimated number
of infected cattle occurring in the United States over a 20-year period
is approximately 150. The majority of these cattle would be imported,
while approximately 42 of the cattle would represent secondary cases
resulting from exposure of cattle in the United States to the BSE
infective agent from the imported cattle. With these combined
pessimistic assumptions, the exposure model estimates that the potential
infectivity available for human exposure over the 20-year period could
amount to 290 cattle oral ID~50~ units (see attachment 2 of USDA, APHIS,
2006).

Comparison of the Exposure Model Results to Human Exposure and the UK
Experience

The significance of cattle oral ID~50~ units to human exposure and
susceptibility is not known; however, various studies suggest that the
infectious agent may be

10 to 10,000 times less pathogenic in humans than in cattle because of a
species barrier (EC SSC, 2000). Thus, if the cattle−human species
barrier were 100, it would mean that 100 times more infective material
would be required in order to have a similar probability of infecting a
human as a bovine. Comer and Huntly (2003) estimated, after an
evaluation of available literature, that 54 million bovine oral ID~50~
units were available for human consumption in Great Britain[^34] from
1980 to 2003. This extremely large amount of available infectivity has
resulted in 165 cases of vCJD identified in the United Kingdom through
April 2007, plus a few additional cases identified in other countries
but attributed to exposure in the United Kingdom. Thus, when compared to
the United Kingdom's BSE experience and the associated estimate of
available bovine oral ID~50~ units, the expected, or average value of 45
cattle oral ID~50~ units as estimated by the exposure model for the base
case scenario, and the average value of 290 cattle oral ID~50~ units as
estimated by the exposure model for the combined pessimistic assumptions
in the sensitivity analysis would result in a miniscule amount of the
BSE infective agent that could possibly be available for potential human
exposure over a 20-year period (USDA, APHIS, 2006).

Based on the qualitative exposure assessment for the most likely
scenario, the likelihood of human exposure is even lower than that
estimated for cattle. Even in the less likely scenarios used in the
quantitative exposure model (USDA, APHIS, 2006), while the model
estimates that there is potential infectivity available for human
exposure over a 20-year period, the potential exposure amount is
negligible. We note that the potential for human exposure under the base
case scenario is estimated at 1,200,000[^35] times less in the United
States than what the United Kingdom experienced during its BSE epidemic.
The estimated potentially available cattle oral ID~50~ units for the
base case scenario and the sensitivity analysis are much lower than what
occurred in the United Kingdom because of the extremely low BSE
prevalence in Canada[^36] and the numerous mitigation measures that both
Canada and the United States have implemented because of the science on
BSE that has evolved as a result of the United Kingdom's experience.

[]{#__RefHeading___Toc132018814 .anchor}**2. Products**

The proposed action would allow the importation of bovine small
intestines other than the distal ileum and blood and blood products from
Canadian bovines. This section will discuss the potential environmental
impacts associated with the importation of these commodities.

a.  **Bovine Small Intestines, With the Exception of the Distal Ileum**

    i.  **Background**

Transmission of the BSE agent to humans is believed to occur via
ingestion of cattle products contaminated with the BSE agent (CDC,
2005a). The contamination of beef products would be the result of
improper slaughter and processing (e.g., segregation, removal, and
disposal of SRMs, including the distal ileum). However, slaughter and
processing mitigations in the United States and in Canada have been
designed to prevent contamination of beef products intended for human
consumption. As discussed above, FDA and FSIS have determined that if
the distal ileum is removed from the small intestine of cattle, the
remainder of the small intestine can be used for human food. Further,
the distal ileum is the only portion of the small intestine for which
OIE recommends any trade restrictions because of BSE (OIE, 2005).

On July 14, 2004, FDA issued an interim final rule entitled, "Use of
Materials Derived from Cattle in Human Food and Cosmetics" (also
referred to as "interim final rule"),[^37] to address the potential risk
of the BSE agent in human food and cosmetics. Through this rule, FDA
prohibited the use of the entire small intestine in human food and
cosmetics even though the agency (at the time the interim final rule was
issued) considered, and currently considers, that only the distal ileum
portion of the small intestine is an SRM.

After considering the public comments submitted on the removal of the
distal ileum, FDA issued an interim final rule[^38] on September 7,
2005, amending the July 14, 2004, FDA interim final rule discussed in
the preceding paragraph, which became effective October 7, 2005. FDA
concluded that processors have the technology to effectively remove the
distal ileum portion from the remainder of the small intestine. These
amendments to FDA's interim final rule are consistent with amendments
that FSIS made to its interim final rule[^39] (discussed in the
following paragraph) regarding the use of beef small intestine.

On September 7, 2005, FSIS issued an interim final rule[^40] prohibiting
the use of SRMs for human food and requirements for the disposition of
nonambulatory disabled cattle, amending the January 12, 2004, FSIS
interim final rule.[^41] This interim final rule became effective
October 7, 2005. In this interim final rule, FSIS amended the January
12, 2004, SRM interim final rule to permit, for use as human food, beef
small intestine, excluding the distal ileum, derived from cattle
slaughtered in official U.S. establishments[^42] or in certified foreign
establishments in countries listed by FSIS[^43] as eligible to export
meat products to the

United States. This is a requirement that all meat and meat food
products must comply with in order to be eligible for use as human food
in the United States. In addition, FSIS regulations do not permit
natural casings derived from beef small intestine (minus the distal
ileum) to be used as containers for meat food products unless the
casings are derived from cattle that have been inspected and passed in
an official U.S. establishment or in a certified foreign establishment.

BSE infectivity has not been confirmed in any portion of the intestinal
tract of cattle other than the distal ileum. FSIS concluded that bovine
intestinal tissues, other than the distal ileum, are either unlikely to
contain BSE infectivity or contain infectivity below the level of
detection using mouse bioassay studies.[^44] Furthermore, the fact that
infectivity has been confirmed only in the distal ileum indicates that
the distal ileum, as opposed to the entire small intestine, has the most
significant implications for public health.

The FSIS regulation amendment also requires establishments that process
beef small intestine for human food to have in place procedures to
ensure that the distal ileum is effectively removed. As provided in FSIS
regulations,[^45] the establishment must incorporate these procedures
into its Hazard Analysis and Critical Control Point plan or Sanitation
SOPs or other prerequisite program. FSIS also has requirements for the
removal of at least 80 inches of the uncoiled and trimmed small
intestine. This standard is sufficiently conservative to ensure removal
of the distal ileum despite differences in length of the intestinal
tract or its segments between breeds or variations from animal to animal
of the same breed. This rulemaking also would require the removal of the
distal ileum, in accordance with these FSIS regulations (e.g., the
removal of at least

80 inches of the uncoiled and trimmed small intestine) as discussed
above, from all small intestines imported from Canada. However,
establishments may propose alternative standards if they can demonstrate
that such standards are as effective as the standards described above in
ensuring that the entire distal ileum is completely removed.[^46]

ii. **No Action**

Bovine small intestines (excluding distal ileum) were not considered in
the MRR rule because at that time they were prohibited along with the
distal ileum portion of the small intestine and other SRMs for use in
human food. The SRM rule implemented by FSIS on January 12, 2004,
prohibited the small intestine for use in human food, and a rule
implemented by FDA on July 14, 2004, extended the measures to
FDA-regulated human food and cosmetics. However, both FSIS and FDA
implemented rules on September 7, 2005, that amended their rules to
permit beef casings derived from small intestine, excluding the distal
ileum, to be used for human food and cosmetics. As discussed earlier,
these amendments were made after further research was conducted and FDA
and FSIS evaluated these issues and received public comments on them.

iii. **Proposed Action**

The release assessment section of the risk assessment for this proposed
action states that we conclude that the likelihood of BSE release via
bovine small intestine other than distal ileum imported from Canada is
negligible (USDA, APHIS, 2006). In addition to this negligible
likelihood of release, regulations and controls implemented by FSIS and
FDA are in place to mitigate risks to public health. FSIS has concluded
that, "when the distal ileum is effectively removed, beef small
intestine that complies with the requirements of this interim final rule
presents no greater risk of introducing the BSE agent into the human
food supply than do other beef products permitted for use as human food
in the United States."[^47]

b.  **Blood and Blood Products**

    i.  **Background**

The potential effects of the consumption of bovine blood on the human
environment will not be analyzed in this section. The consumption of
bovine blood has been discussed within the context of consuming any
bovine product, and that discussion has already taken place earlier
within the public health section of this document. Blood is not
classified as an SRM and is not prohibited from bovine products meant
for consumption. The main concern with the use of bovine blood is its
use in vaccinations and thus will be discussed in more detail below.

Bovine blood and blood products may be used in a variety of ways. Fetal
bovine serum (FBS), also known as fetal calf serum (FCS), and bovine
serum albumin (BSA) are the primary products derived from cattle blood
for use in animal vaccine and drug production. FBS is derived from the
plasma of blood from a fetal bovine (a calf *in utero*) and BSA is
derived from the plasma from a calf or adult bovine. These products are
potentially used as components in growth media in the production of
animal and human vaccines and drugs. BSA can also be used potentially as
a stabilizer or protein carrier in these products.

BSE infectivity has never been found in cattle blood. Studies conducted
specifically in cattle infected with BSE detected no infectivity in
cattle blood or any tested derivatives (EC SSC, 2002). There is evidence
that BSE infectivity was transmitted to sheep by transfusion of whole
blood from sheep experimentally infected with BSE (Houston *et al.,*
2000, and Hunter *et al*., 2002, as cited in USDA, APHIS, 2006). The
Scientific Steering Committee of the European Commission examined these
studies and determined that the finding of BSE infectivity in the blood
of sheep could not be related to BSE in cattle (EC SSC, 2002 as cited in
USDA, APHIS, 2006).

Blood easily coagulates and produces two parts, a cellular component and
a plasma component. Most products utilizing cattle blood are derived
from the plasma as opposed to the cellular component. In animals
infected with TSEs that do develop infectivity in the blood, studies
have suggested that the infectivity is higher in the cellular component
of the blood rather than in the plasma component (Brown, 1998; Brown,
1999; EC SSC, 2002; and Comer, 2004, as cited in USDA, APHIS, 2006).
Although BSE has never been detected in any bovine blood or blood
product, should cattle with BSE have some undetected low amount of
infectivity in the blood, products derived from the plasma component of
the blood, such as FBS and BSA, would be expected to have a lower
infectivity level than the cellular component of blood (USDA, APHIS,
2006). When FBS and BSA are harvested for use in the preparation of
vaccines and drugs, both the red and white cells are excluded from these
products (USDA, APHIS, 2006).

As APHIS' authority related to the rulemaking is to protect animal
health, the associated risk assessment evaluates the risk of the blood
and blood products used in the production of veterinary vaccines and
drugs and the pathways that may influence animal health. FDA evaluates
human health concerns relating to the use of blood and blood products in
human products. APHIS has involved FDA in discussions during the
development of the rulemaking.

**ii. No Action**

Under the No Action alternative, bovine blood and blood products would
continue to be prohibited from importation into the United States from
Canada. Prior to the 2003 ban on Canadian bovine and bovine products,
some of the U.S. import supply of blood and blood products was generated
in Canada by the collection of such products from cattle, then imported
from Canada. Currently, the

United States receives blood and blood products from other countries
that are not restricted due to animal disease concerns.

Blood and blood products were not addressed in the original MRR rule
because APHIS did not have adequate information necessary to evaluate
the risks of allowing blood and blood products into the United States
from Canada. Since then, APHIS has been working with FDA to coordinate
regulatory efforts.

**iii. Proposed Action**

Under the proposed action, APHIS would allow bovine blood and blood
products from Canada to enter the United States according to certain
mitigations. Bovine blood and blood products for animal health uses are
regulated by APHIS. As APHIS' regulations with regard to animal diseases
are for the purpose of protecting animal health, the risk assessment
prepared for the rulemaking evaluates the animal health risks associated
with the imported commodities and the likelihood that these commodities
from a minimal-risk region would release BSE infectivity into the United
States and expose the U.S. cattle population.

The risk assessment analyzes the pathways of exposure and the
mitigations that would be required to prevent the likelihood of BSE
entering the United States via blood and blood products used for
animals. The mitigations are intended to prevent cross-contamination of
the blood with SRMs, such as central nervous system tissue. These
mitigations, as discussed in the risk assessment, include the following:

For all blood:

> 1\. the blood is collected in a closed system.

For blood collected at slaughter, the slaughtered animal:

> 2\. must have passed ante-mortem inspection and
>
> 3\. was not subjected to a stunning process with a device injecting
> compressed air or gas into the cranial cavity, or to a pithing
> process.

For fetal bovine serum:

> 4\. the dam must have passed ante-mortem inspection and was not
> subjected to a stunning process with a device injecting compressed air
> or gas into the cranial cavity, or to a pithing process, and
>
> 5\. the uterus is removed from the dam's abdominal cavity intact and
> taken to a separate area away from the kill floor.

For blood collected from live donor animals:

> 6\. the donor must be free of clinical signs of disease.

The BSE prevalence in Canada is extremely low and is expected to
decrease further over time. Even if one of the very few potentially
infected animals were a source for blood or blood products, additional
steps in the production of blood products help to diminish the
infectivity (USDA, APHIS, 2006).

Although BSE infectivity has never been found in cattle blood (EC SSC,
2002), a possibility of cross-contamination with high-risk materials
exists during the slaughter process. However, the mitigations described
above minimize this potential.

The risk assessment states that "bovine blood is highly unlikely to
contain BSE infectivity . . . and that USDA-specified mitigations will
prevent cross-contamination." Thus, there is a negligible likelihood of
BSE release into the United States via blood and blood products imported
from Canada (USDA, APHIS, 2006).

[Animal Products Derived From Bovine Blood and Blood
Products]{.underline}

The risk assessment identified animal vaccinations as one potential
pathway for BSE exposure. The risk assessment determined that multiple
steps in the risk pathway act as safeguards against the release of BSE
infectivity through the importation of blood and blood products.
Canadian bovines, from which blood is collected, are unlikely to be
infected with BSE due to the low prevalence of BSE in Canada. BSE
infectivity has not been detected in cattle blood. In addition, blood
collected at slaughtering establishments is unlikely to have BSE
infectivity because of the mitigations imposed for the collection of
blood. Moreover, the steps in the production and use of products
manufactured with bovine blood or its derivatives are likely to further
reduce any possible infectivity USDA, APHIS, 2006).

The risk assessment concludes that "Given the negligible likelihood of
both release of BSE via the importation of bovine blood and blood
products from Canada and exposure of bovines to any such introduced
infectivity, we conclude that extremely few or no U.S. cases of BSE
would result. Therefore, the BSE risk associated with their importation
is negligible, as well." (USDA, APHIS, 2006).

[FDA Oversight of Products Derived From Bovine Blood and Blood
Products]{.underline}

Bovine blood and blood products used for human medical products are
regulated by FDA. FDA oversees the safety of vaccines and drugs given to
consumers and continually reviews the potential risk of products in
relation to new entities, including the BSE agent. FDA has looked at the
benefit of vaccines and the risk of contamination of vaccines with the
BSE agent. Both FDA and FDA's joint advisory committees, Transmissible
Spongiform Encephalopathy Advisory Committee and Vaccines and Related
Biological Products Advisory Committee, have considered the risks posed
by bovine materials in vaccines and concluded that the risk that anyone
will acquire vCJD from a vaccine is remote and theoretical (USDHHS, FDA,
2004). This conclusion was based on the inherent low risk of the bovine
materials involved (e.g., type and amount of tissues used, specific
time, and country or herd of origin) and/or the dilutions of materials
during manufacture (USDHHS, FDA, 2004).

FDA prepared a risk estimation for the use of FCS in the production of
human vaccines. The estimate was based on the high infectivity levels in
the UK cattle population during the UK BSE epidemic in the mid-1980s. In
calculating the risks, FDA used the highest estimate consistent with
infectivity experiments. The risk estimate did not include steps that
would probably remove infectivity, and disregarded any species barrier
that may exist between cattle and humans because this has not been
quantified. The estimate also assumed a 10 percent rate of maternal
transmission. However, the risk assessment prepared for the rulemaking
states that although there was a suggestion that maternal transmission
can occur, more recent work has failed to demonstrate evidence of
maternal transmission (Hill, 2005, as cited in USDA, APHIS 2006a).

Even with these overestimates of the risks, FDA was aware that, because
blood used to create FCS is pooled from approximately 1,500 calves, any
amount of infectivity in the blood would be diluted to lower levels. In
addition, they knew that the amount of FCS (4 milliliters) used to
produce a viral culture is a small fraction from the pooled blood that
produces approximately 500,000 doses of vaccine, limiting the amount of
infectivity given to a single person. Using these numbers, FDA concluded
that the risk to humans is about one case of vCJD arising every 5,000
years. FDA further concluded that "because of the assumptions used, this
is an overestimate of the risk and the true risk is likely to be
significantly less" (USDHHS, FDA, 2001).

FDA reviews drugs and vaccines on a product by product basis. Each
product must be approved by FDA before it can be marketed. FDA not only
looks at the product itself but also the processes involved in making
the product. It is during this overview process that risks are evaluated
and mitigations may be placed on these processes to ensure the product
is safe for humans to use or consume.

Although Canada and the United States have reported BSE cases and USDA
has placed Canada on the list of regions that present a minimal-risk of
introducing BSE into the United States via live ruminants and ruminant
products, FDA has not recommended that manufacturers find a new source
for bovine-derived materials obtained from Canada or the United States
for use in manufacture of drugs or biological products. FDA has
expressed that the control measures in place, such as the
ruminant-to-ruminant feed ban that is similar in the

United States and Canada, assure the safety of bovine-derived materials
originating from these countries for use in the manufacture of vaccines
(USDHHS, FDA, 2004).

**B. Impacts on the Physical Environment**

[]{#__RefHeading___Toc132018816 .anchor}**1. Transport of Bovines**

**a. Background**

Cattle imported from Canada to the United States must transit through 1
of

20 approved ports of entry at the Canada-U.S. border. [^48] Cattle are
transported by heavy-duty trucks that vary in size. The number of cattle
transported on a truck depends upon the truck size and the size of the
animals. Environmental impacts from the transport of cattle would stem
from pollutants that result from truck transport. The types of
pollutants from heavy-duty trucks that would impact air quality include
nitrous oxide emissions and particulate matter. Heavy-duty commercial
trucks are believed to be responsible for 40 percent of nitrous oxide
emissions and 60 percent of particulate matter emissions from all
vehicles, although studies have been implemented to determine the amount
of emission pollutants released under different transport scenarios.

[Efforts Regulating Pollutants of the Physical Environment From Truck
Transports]{.underline}

Since the Clean Air Act of 1970, emissions standards for cars and
trucks, forcing improved engine technology and reformulated gasolines,
have greatly reduced the amount of air pollution. Today's truck engines
emit nearly 70 percent less nitrous oxide and 90 percent less
particulates than in 1987. Environmental quality issues related to
commercial truck transport are being studied and addressed at Federal,
State, and local levels. For example, the U.S. Environmental Protection
Agency (EPA) is addressing the increase in emissions from the growth in
transport freight within the United States. EPA developed a strategy to
reduce diesel emissions by requiring new diesel engine standards
beginning in 2004 vehicle models and by initiating a program requiring
U.S. refiners to provide cleaner diesel fuels. Similar to the United
States, Canadian environmental protection laws have vehicle emissions
requirements that are designed to prevent harmful air emissions from
vehicles, including transport trucks. Truck transport activities are
subject to comprehensive environmental regulation in both the United
States and Canada.

**b. No Action**

Shortly after the issuance of the final MRR EA for the MRR rule, a
litigant filed a complaint challenging the rule in the United States
District Court for the District of Montana. In the complaint, the
litigant alleged that the final MRR EA failed to assess the
environmental effects of transporting an estimated 2 million head of
cattle from farms and feedlots in Canada to feedlots and slaughter
establishments in the United States, as well as the environmental
impacts of holding the additional feeder cattle until slaughter.

The FONSI[^49] that concluded the MRR EA process addressed the
allegations and concluded that the issues raised did not pose
potentially significant impacts on the environment, as follows.

The FONSI for the MRR EA based its consideration of the allegation of
environmental impacts from the transport of cattle on an estimated
number of 2 million cattle (provided by the economic analysis for the
MRR rule) that could be imported in 2005, provided implementation would
occur in January 2005.[^50] Based on 2 million cattle being imported,
the litigant estimated that the resumption of limited trade in live
cattle would result in 35,000 truck round-trips between Canada and the
United States. According to data, truck crossings from Canada into the
United States for 2001 totaled approximately 6.8 million, for 2002
totaled 6.9 million, and for 2003 totaled 6.7 million (U.S. Department
of Transportation, Bureau of Transportation Standards (U.S. DOT, BTS),
2006).[^51]

As presented in the allegation, an additional 2 million cattle would
result in the resumption of 35,000 truck round-trips (averaging 57
animals per truckload) annually. In comparing the overall truck
transport totals for recent years, 35,000 truck round-trips equates to
approximately 0.5 percent (½ of 1 percent) of the overall average annual
truck crossings (6.9 million) and about 0.6 percent (less than 1
percent) of the annual truck crossings (5.6 million) through the 20
ports of entry authorized for importation of ruminants under the MRR
rule.

**Table 1. Truck Crossings From Canada to the United States (in
millions) for 2001-2003**

+---------------+------------------------+-----------------------------+
| **Truck       | **All U.S.-Canadian    | **Total Truck Crossings at  |
| Crossing**    | Border Truck           | Approved Ports of Entry for |
|               | Crossings**            | Cattle**                    |
| **Year:**     |                        |                             |
+---------------+------------------------+-----------------------------+
| 2001          | 6.8                    | 5.5                         |
+---------------+------------------------+-----------------------------+
| 2002          | 6.9                    | 5.7                         |
+---------------+------------------------+-----------------------------+
| 2003          | 6.7                    | 5.6                         |
+---------------+------------------------+-----------------------------+

More recent projections of bovine imports under the age of 30 months for
a 20-year period (2008 through 2027) (USDA, ERS, 2007), considering that
no bovines of 30 months of age and older were imported, give a range of
approximately 973,000 (0.97 million) to 1,107,000 (1.1 million) animals
from Canada annually. Using a conservative number of 50 animals per
transport truck, this equates to an estimated 19,460 to 22,140
round-trip truck crossings that would resume from Canada to the United
States. This is about 0.3 percent of the overall average annual truck
crossings (6.8 million) for 2001 through 2003 and about 0.3-0.4 percent
of the average annual truck crossings (5.6 million) at the 20 ports of
entry authorized for importation of ruminants under the MRR rule. The
truck crossings, which represent a subset of all vehicular traffic
between the two countries, resulting from transport of bovines under 30
months of age do not represent a significant proportion of the overall
annual truck transport traffic from Canada to the United States.

**c. Proposed Action**

The rulemaking to allow bovines 30 months of age and older from Canada
born on or after March 1, 1999, will eventually restore trade in this
commodity to historical import amounts prior to the United States'
prohibition of these animals in May 2003. Since the October 2006 version
of this environmental assessment, USDA's Economic Research Service (ERS)
has provided revised projections for the annual cattle imports from
Canada under the rulemaking. (See table iii, 2007 updates for projected
imports of various cattle use types for years 1 through 20, in the
updated risk assessment (USDA, APHIS, 2007b).) Based on revised
projections, the annual number of cull cattle imported at 30 months of
age and older plus projected imports of younger breeding cattle are
expected to range between 0.13 million and 0.45 million head
(130,000--446,000 head) during the 20 years after implementation of the
rulemaking.

[]{.mark}

Using a conservative number of 50 head per transport truck, the number
of round-trip truck transports that would resume would range from 2,600
to 8,920, based on imports ranging from 130,000 to 446,000 head per year
of cull cattle 30 months of age and older plus younger breeding cattle.
This represents a proportion of about 0.05-0.16 percent when considering
the overall average annual truck transports from Canada to the United
States (5.6 million annually for 2001-2005) at the approved ports of
entry; the truck transports resulting from the proposed action are *de
minimus* by measure.[^52]

[]{.mark}

The resumption in trade of 0.13--0.45 million head of cattle resulting
in 2,600 to 8,920 round-trip truck transports through the 20 possible
ports of entry at the Canada-U.S. border will not result in an
unmanageable burden on U.S. Customs Border Patrol or the APHIS
inspectors who oversee animal imports at the border. The amount of truck
transports that would resume for the imported Canadian bovines under the
rulemaking would eventually return the inspection load at the border to
a level similar to levels before May 2003.

[]{#__RefHeading___Toc132018817 .anchor}**2. Holding of Bovines in
Feedlots**

**a. Background**

The types of environmental impacts associated with holding cattle in
feedlots include air and water pollutant discharges and emissions, such
as nutrients, organic matter, pathogens, and odorous/volatile compounds,
such as ammonia, associated with holding feeder cattle in feedlots.
Pollutants from animal feeding operations can impact surface water,
groundwater, air, and soil (EPA, 1997). Waste disposal practices used by
animal feeding operations can contribute to water quality degradation.
Many of these operations collect manure from animal confinement areas in
solid or liquid form and apply it to farmland as a nutrient for crops or
simply as a disposal method (EPA, 1997). In groundwater, pathogens and
nitrates from manure can impact public health and animal health via
drinking water (EPA, 1997). Nitrate contamination is more prevalent in
ground waters than in surface waters (EPA, 1997). In addition to adverse
impacts, animal manure has environmental benefits; if applied under
proper conditions, animal manure is a valuable fertilizer and soil
conditioner.

Number range CHAPTERThe processing of cattle results in waste products
that are potentially damaging to the environment. Animal byproducts and
waste products become available through the slaughter process. These
byproducts and products include manure, contents of rumen (the first
stomach compartment of ruminants) and intestines, edible products such
as blood and liver, inedible products such as bones, fat recovered from
waste water, and waste water.

We note that the annual total U.S. commercial cattle slaughter for 2002
through 2006 averaged 34 million head (USDA, ERS, 2006), which we use as
our baseline for discussion in some of the following sections. Past
numbers reported for U.S. commercial cattle slaughter are as follows:
2002, 35.7 million; 2003, 35.5 million; 2004, 32.7 million; 2005, 32.4
million; and 2006, 33.7 million. Canadian cattle imports, which included
cattle (fed/feeder cattle) under and cattle (culled) over 30 months of
age, are a proportion of the slaughter numbers for 2002 through May
2003, representing about 5 percent (1.67 million) and 1 percent (0.5
million), respectively, of the annual U.S. slaughter. No Canadian cattle
were imported in 2004. Canadian imports of cattle under 30 months of age
resumed in July 2005 and are a proportion of U.S. slaughter numbers for
2005 and 2006, representing about 2 percent (0.56 million) and 3 percent
(1 million), respectively, of the annual U.S. slaughter.

[Efforts Regulating Pollutants of the Physical Environment From
Livestock Impacts]{.underline}

Potential impacts on air and water quality associated with livestock are
addressed under an array of existing environmental statutes,
regulations, and guidelines in the United States. Some of the Federal
regulatory efforts related to controlling pollutants resulting from
livestock and slaughter operations are discussed below.

Since 1974, EPA has promulgated effluent guidelines for more than 50
industrial categories. Effluent guidelines are national regulations that
control the discharge of pollutants from industrial facilities to
surface waters (EPA, 2004). 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 waste water and
manure from animal feedlot operations.

EPA also has established requirements for CAFOs under the Clean Water
Act and, with regard to nitrate contamination of underground sources of
drinking water, under the Safe Drinking Water Act. In February 2004, EPA
established new waste water discharge standards for the meat and poultry
products industry, including slaughter establishments that slaughter
more than 50 million pounds of meat per year and, further, meat
processors that generate more than 50 million pounds per year of
finished products (such as bacon or sausage). State and Federal
regulations in the United States are designed to encourage sound
management practices for animal feeding operations and discourage
polluting activities.

Number range CHAPTERAdditionally, USDA's Environmental Quality Incentive
Program (EQIP), administered by the Natural Resources Conservation
Service, can help CAFOs meet manure application standards proposed by
EPA (USDA, ERS, 2003). This program provides technical and financial
assistance in developing nutrient management plans, cost-share payments
for waste management structures, and incentive payments to assist crop
and livestock producers with environmental and conservation improvements
on the farm. EQIP also provides financial help to transport manure to
off-farm locations (USDA, ERS, 2003).

In addition to State laws and regulations for air emissions, a variety
of provisions under the Clean Air Act address air emissions relating to
animal feedlot activities. In January 2005, EPA announced an air quality
compliance agreement to address emissions from Number range
CHAPTERcertain animal feeding operations. This agreement is part of a
national farm air emissions study, which is a part of EPA's ongoing
effort to minimize air emissions from animal feeding operations and to
ensure that those operations comply with applicable provisions under the
Clean Air Act, the Comprehensive Environmental Response, Compensation
and Liability Act, and the Environmental Planning and Community
Right-to-Know Act. The agreement will help in gathering scientific data
that EPA needs to make informed regulatory and policy determinations and
will establish an industry-funded emissions monitoring program that will
help provide information, leading to better tools to help the farm
industry, USDA, and EPA determine the compliance status of animal
feeding operations (EPA, 2006).

The array of environmental laws and their regulations---Federal, State,
and local---is intended to protect the human environment in the United
States.

**b. No Action**

The number of cattle imported from Canada annually for slaughter
represents

a minor amount of overall annual cattle slaughter numbers in the United
States, and thus, is unlikely to contribute significantly toward any
potential environmental effects. The average annual cattle imports for
2001 and 2002 totaled nearly 1.5 million head of bovines (USDA, APHIS,
2004c). The average annual number of cattle under the age of 30 months
projected for importation from Canada during the years 2008 through 2027
ranges between 0.97--1.1 million (USDA, ERS, 2007).[^53] The United
States is fourth in the world in cattle population with nearly 97
million cattle. As stated above, the average U.S. annual commercial
cattle slaughter (for 2002 through 2006) is about 34 million (USDA, ERS,
2006), which for 2002, part of 2003, and 2005 and 2006 include cattle
imported for slaughter from Canada. The average number of cattle
projected to be imported annually for slaughter from Canada under the
MRR rule (ranging from 0.97--1.1 million) is about 3 percent of the
overall total U.S. cattle population slaughtered annually, not a
significant proportion of the overall annual commercial cattle
slaughter. The FONSI associated with the environmental assessment for
the MRR rule to again allow importation of cattle under the age of 30
months from Canada concluded that any environmental effects related to
the importation of live animals for feeding and for slaughter would not
be significant (70 FR 18261, published April 8, 2005).

**c. Proposed Action**

Cattle that would be imported under the proposed action would be sent
directly to slaughter, fed at feedlots and then sent to slaughter (with
backgrounding prior to feedlot feeding an option), or integrated into
U.S. cattle herds for breeding purposes. Cattle sent directly to
slaughter could be held for a short duration at slaughter facilities,
perhaps several days, for conditioning purposes before being
slaughtered. Thus, cattle sent directly to slaughter would not
contribute to waste and other environmental concerns associated with
being held in feedlots for

120--200 days before slaughter. Breeder animals, which would comprise
about 4.5 percent of the animals projected for import under the proposed
action between 2008 and 2027, would be integrated into U.S. cattle herds
for production purposes and would not be sent to feedlots.

As mentioned previously, total cattle slaughter in the United States
averaged

34 million head annually for 2002 through 2006. The rulemaking to allow
the importation for any use of live bovines from Canada born after March
1, 1999, would contribute to the annual slaughtered number of cattle by
0.13--0.45 million (130,000--446,000) head of animals, a minimal
proportion (about 1 percent) of the overall slaughter total. We note
that this annual slaughter number includes 55,000--64,000 breeder
animals that, after import, would be integrated into U.S. herds and then
would most likely become culled cattle that would become a part of U.S.
commercial slaughter numbers in several years when they exceed their
productive life. There is no evidence indicating that waste and disposal
systems for slaughter establishments would not be able to accommodate
the resumption in trade of 0.13--0.45 million bovines from Canada.

As a result of the availability of these animals for import if the
rulemaking is implemented, U.S. businesses would likely not request more
cattle than they can process. Prior to the import prohibition to allow
bovines from Canada in May 2003, the feedlots and slaughter
establishments were able to handle the imports that were available from
Canada. As a result of the decrease in imported animals, some businesses
that processed bovines were affected and had to adjust their labor
forces to accommodate for the decrease in business. The amount of
bovines that a feedlot or a slaughter establishment imports for
processing would not be more than their capacity for handling them;
thus, the supply of bovines going to feedlots and slaughter
establishments would not exceed the demand for them, nor is there
evidence that their systems for handling of waste would be overwhelmed
by the amount of animals they request from producers in Canada.

**3. SRMs Generated**

**a. Background**

The amount of SRMs that would be generated from the importation of live
bovines leads to the need to assess potential impacts on the human
environment (which includes the natural or physical environment) from
their disposal. An allegation made after the issuance of the MRR EA
claimed that APHIS did not attempt to assess the environmental impacts
of disposing of SRMs from imported Canadian cattle, indicating that an
analysis of the amount of SRMs generated was warranted. While the MRR EA
discussed the number of live cattle expected to be imported to the
United States from 2005 until 2009 under the MRR rule,[^54] the MRR EA
did not address the amounts of SRMs these animals would generate and
whether the amount generated would present any environmental impacts
attendant to their disposal. Therefore, this section of the document
estimates the amount of additional SRMs generated from bovines under the
No Action and the Proposed Action alternatives and compares the SRM
amounts generated under each alternative with the overall annual SRM
amount generated in the United States. Information for arriving at the
estimated amounts is provided below, and a discussion on the estimate
specific to each alternative is provided in the appropriate alternative
section.

In order to calculate how many pounds of SRMs would be generated under
both the No Action and the Proposed Action alternatives, one must know
how many pounds of SRMs are generated by each individual animal.
According to FDA, "cattle not over 30 months of age" (in other words,
cattle 30 months of age and under) generate approximately 28.3 pounds of
SRMs while cattle over 30 months of age generate approximately 88.5[^55]
pounds of SRMs (USDHHS, FDA, 2005). For these calculations FDA included
the entire small intestines. However, as previously discussed, BSE
infectivity has not been confirmed in any portion of the intestinal
tract of cattle other than the distal ileum. FSIS regulations permit
beef small intestines, excluding the distal ileum, to be used for human
food.[^56] The FDA regulations permit the manufacture and use of beef
casings derived from beef small intestines, excluding the distal ileum,
for human food and cosmetics.[^57] Therefore, for APHIS' purposes, it is
inappropriate to consider the entire small intestines when calculating
the weight of SRMs generated during slaughter.

For cattle 30 months of age and younger, the entire small intestine
(with distal ileum) weighs about 28 pounds. For cattle over 30 months of
age, the entire small intestine (with distal ileum) weighs about 35
pounds. According to industry sources, the distal ileum comprises
roughly 10 percent[^58] of the small intestine by weight (USDA, FSIS,
2005). By multiplying FDA's estimate for the weight of the small
intestines[^59] (which includes the distal ileum) by 10 percent, cattle
under

30 months would generate approximately 2.8 pounds of distal ileum, while
cattle over 30 months would generate approximately 3.5 pounds of distal
ileum. Using these weights for the distal ileum instead of the weight of
the entire small intestine, cattle under 30 months of age would generate
approximately 3.1 pounds of SRMs[^60] while cattle over 30 months of age
would generate approximately

57.0 pounds of SRMs.[^61] FDA estimates that cattle 30 months of age
would generate the same amount of SRMs as cattle under 30 months of age.
However, as per the definition of SRMs in 9 CFR § 310.22(a) (see
footnote number 55), cattle 30 months of age would generate an equal
amount of SRMs as cattle over 30 months of age.

**b. No Action**

USDA's Economic Research Service (ERS) projected the number of cattle
that would enter the United States from Canada under the No Action
alternative from 2008 to 2027 (USDA, ERS, 2007). Based on their
projections, a range of 973,000 to 1,107,000 live cattle would enter the
United States each year from 2008 to 2027[^62], which would generate
about 3,016,000[^63] to 3,432,000 [^64] pounds of SRMs annually. See
table 2 below.

Table 2. The Range (Lowest and Highest Amounts) of SRMs Generated in the
United States From Cattle Entering From Canada Under the No Action
Alternative

+--------------+---------------------------------------+---------------+
| **Year**     | **Number of Cattle Entering**         | **Pounds of   |
|              |                                       | SRMs          |
|              | **the United States from Canada**     | Generated**   |
+--------------+---------------------------------------+---------------+
| 2009         | 973,000                               | 3,016,000     |
+--------------+---------------------------------------+---------------+
| 2013         | 1,107,000                             | 3,432,000     |
+--------------+---------------------------------------+---------------+

To put into perspective the amount of SRMs generated from cattle
entering from Canada under the No Action alternative, the United States
slaughtered an average of 28.4 million steers and heifers and an average
of 5.7 million cull beef and dairy cows annually during the period
ranging from 2002 to 2004[^65] (USDA, ERS, 2006). Assuming that all
steers and heifers were under 30 months of age and all cull beef and
dairy cows were 30 months of age and older, and assuming that SRMs were
required to be removed of and disposed of in 2002 and 2003, which they
were not, the average amount of SRMs generated annually would have been
about 412 million pounds.[^66] SRMs from Canadian cattle imports would
comprise 1 percent[^67] of the SRMs generated[^68] annually in the
United States and is not expected to overburden U.S. disposal
facilities.[^69]

**c. Proposed Action**

Similar to the No Action alternative for the importation of live cattle,
ERS estimated the number of cattle that would enter the United States
from Canada under the rulemaking from 2008 to 2027 (USDA, ERS, 2007).
Based on ERS projections, a range of 1,062,000[^70] to 1,457,000[^71]
feeder, fed, and cull cattle[^72] born after the effectively enforced
feed ban date would enter the United States in 2007 for slaughter. We
estimate that these cattle would generate about 7,335,000[^73] to
25,107,000 [^74] pounds of SRMs. See table 3 below.

Table 3. The Range (Lowest and Highest Amounts) of SRMs Generated in the
United States From Cattle Entering From Canada Under the Proposed Action
Alternative.

+-----------+--------------------------------+------------------------+
| **Year**  | **Number of Cattle Entering**  | **Pounds of SRMs       |
|           |                                | Generated**            |
|           | **the United States**          |                        |
+-----------+--------------------------------+------------------------+
| 2008      | 1,062,000                      | 7,335,000              |
+-----------+--------------------------------+------------------------+
| 2027      | 1,457,000                      | 25,107,000             |
+-----------+--------------------------------+------------------------+

To put into perspective the amount of SRMs generated from cattle under
the proposed action, the average amount of SRMs that would have been
generated from cattle annually in the United States between 2002 and
2004 would have been about 412 million pounds (see footnote number 66
for an explanation of this estimate). The amount of SRMs that is
predicted to be generated from cattle imported from Canada under the
Proposed Action alternative is approximately

6 percent[^75] of the total amount estimated to have been generated in
the

United States.[^76]

The amount of SRMs that would be generated from cattle imported from
Canada from 2008 to 2027 ranges from 4,194,000 [^77] to 21,827,000[^78]
pounds. The difference between the quantities of SRMs generated from
imports of Canadian cattle under the rulemaking and under the no action
alternative is expected to equal 5 percent or less of the total amount
of SRMs that would have been generated based upon the average U.S.
cattle slaughter numbers for 2002 to 2004 (see table 4). That difference
is not expected to overburden U.S. disposal facilities. In addition, the
live bovines expected to be imported into the United States under the
rulemaking may reduce the supply of U.S.-sourced slaughter cattle.
Therefore, some of the additional SRMs generated from Canadian imports
under the rulemaking may be offset by a decrease in SRMs generated
domestically.

Table 4. The Range (Lowest and Highest) of the Difference in the Amount
of SRMs Generated in the United States From Cattle Entering From Canada
Under the No Action and Proposed Action Alternatives

+-----+---------------+---------------+------------+------------------+
| **  | **Pounds of   | **Pounds of   | **         | **Difference as  |
| Yea | SRMs          | SRMs          | Difference | a Percent of     |
| r** | Generated     | Generated     | in Pounds  | Total SRMs       |
|     | Under         | Under**       | of SRMs    | Disposed         |
|     | Proposed      |               | G          | (2002--2004)**   |
|     | Action**      | **No Action** | enerated** |                  |
+-----+---------------+---------------+------------+------------------+
| 2   | 7,335,000     | 3,140,000     | 4,194,000  | 1%[^79]          |
| 007 |               |               |            |                  |
+-----+---------------+---------------+------------+------------------+
| 2   | 25,107,000    | 3,280,000     | 21,827,000 | 5%[^80]          |
| 027 |               |               |            |                  |
+-----+---------------+---------------+------------+------------------+

[]{#__RefHeading___Toc132018819 .anchor}**C. Highly Uncertain or Unique
or Unknown Risks**

The NEPA implementing regulations require consideration of the degree to
which the possible effects on the human environment are highly uncertain
or involve unique or unknown risk.[^81]

The exact relationship between human exposure to the BSE agent and the
likelihood that humans will develop vCJD cannot be quantified in terms
of risk because the human oral infectious dose (the dose able to cause
infection) is not known at this time (EC SSC, 2000). Although there are
still some unknown facts with regard to the infective BSE agent, there
is a great deal now known about BSE.[^82] While it is known that the
control of SRMs is a measure designed to protect public health, there
are other unknown issues that could arise in the future.

Future research has been recommended by the European Union Scientific
Steering Committee, which includes cattle bioassay and more sensitive
prion detection testing of many of the cattle tissues. Stored tissue is
available for this purpose in the United Kingdom. A pathogenesis study
underway in Germany will also provide tissue from cattle incubating BSE
for additional testing. Funds for BSE research will be used for newly
funded BSE projects and facilities. Many of these newly funded projects
involve international collaboration with researchers from the United
Kingdom and other European countries. While the primary tissues of
concern for spreading the BSE agent have been identified, the research
results of future studies on BSE may further refine this determination
and inform policies with regard to BSE.[^83] The Department of Health
and Human Services also has issued a department-wide action plan
outlining steps to improve scientific understanding of BSE and other
TSEs (CDC, 2005b).

There is 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.[^84]

Gaps exist in the knowledge about the BSE agent. However, based on
current knowledge about the BSE agent, the APHIS rulemaking for which
this environmental analysis is prepared and earlier rulemakings by
APHIS, FSIS, and FDA include mitigations that are designed to protect
animal health and public health from the possibility of exposure to the
BSE agent. Although our knowledge of BSE is not complete, our current
understanding allows us to conclude that the described uncertainties
will not have a significant adverse impact on the human environment.

[]{#__RefHeading___Toc132018820 .anchor}**D. Endangered or Threatened
Species**

Number range CHAPTERSection 7 of the Endangered Species Act (ESA) and
ESA's implementing regulations require Federal agencies to ensure that
their actions are not likely to jeopardize the continued existence of
endangered or threatened species or result in the destruction or adverse
modification of critical habitat. TSEs have been reported in European
zoos in wild ruminants, cats, and monkeys (Cunningham

*et al.*, 2004) and are believed to have resulted from BSE-contaminated
feed. Thus, for both alternatives, six endangered ruminant species were
considered as potentially at risk as a result of the possibility of
ingestion of contaminated ruminant feed (see table 5).

**Table 5. Endangered Wild Ruminant Species in the United States
Potentially At Risk From Transmissible Spongiform Encephalopathies.**

  -------------------------- ------------------------------- ------------
  **Common Name**            **Scientific Name**             **Listing
                                                             Status**

  Woodland caribou           *Rangifer tarandus caribou*     Endangered

  Columbian white-tailed     *Odocoileus virginianus         
  deer                       leuceurus*                      

  Key deer                   *Odocoileus virginianus         
                             clavium*                        

  Sonoran pronghorn          *Antilocapra americana          
                             sonoriensis*                    

  Bighorn sheep              *Ovis Canadensis*               

  Sierra Nevada bighorn      *Ovis canadensis californiana*  
  sheep                                                      
  -------------------------- ------------------------------- ------------

Also, for both alternatives, one threatened and six endangered wild cats
were considered for risk of infection from BSE because of the
possibility that they could feed on [BSE-infected]{.mark} bovine or
bovine [carcasses]{.mark} (see table 6).

**Table 6. Listed Wild Cats Known to Feed on B[ovine
Carcasses]{.mark}.**

  -------------------- ------------------------------ -------------------
  **Common Name**      **Scientific Name**            **Listing Status**

  Canada lynx          *Lynx Canadensis*              Threatened

  Eastern puma         *Puma (=Felis) concolor        Endangered
  (=cougar)            cougar*                        

  Florida panther      *Puma (=Felis) concolor coryi* 

  Gulf Coast           *Herpailurus (=Felis)          
  jaguarundi           yagouaroundi cacomitli*        

  Jaguar               *Panthera onca*                

  Ocelot               *Leopardus (=Felis) pardalis*  

  Sinaloan jaguarundi  *Herpailurus (=Felis)          
                       yagouaroundi tolteca*          
  -------------------- ------------------------------ -------------------

Impact of the No Action alternative on endangered and threatened species
was analyzed in the MRR EA (USDA, APHIS, 2004a). In that environmental
analysis, APHIS determined that the importation of certain ruminants and
ruminant products (the No Action alternative in this environmental
analysis) would have no effect on federally listed wild cats or
ruminants.

For the proposed action, bovine, bovine carcasses, or SRMs are unlikely
to expose federally listed species to BSE because of the multiple
mitigation measures in place, which include disposal methods that would
prevent direct exposure of these materials to wildlife. The disposal of
carcasses outside of slaughter channels is regulated by local and/or
state requirements. In certain areas, disposal methods such as on-farm
burial may be prohibited. Such carcasses could be rendered, landfilled,
or composted. In the unlikely event that a carcass left lying in the
field is infected with BSE, very few animals that would feed on a cattle
carcass are capable of becoming infected with BSE. Therefore, such
carcasses are not likely to transmit BSE to the human environment.

Exposure of listed species to ruminant feed containing BSE-contaminated
SRMs, blood and blood products, or casings would also be extremely
unlikely since these products are prohibited from being included in
ruminant feed. Therefore, it would be unlikely that listed wild cats
would be exposed to BSE-contaminated bovine or bovine carcasses and SRMs
or that federally listed ruminants would be exposed to BSE-contaminated
ruminant feed as a result of the implementation of this proposed action.

Based on the low prevalence of BSE in Canada and the multiple barriers
in place to reduce the level of BSE infectivity in the system (USDA,
APHIS, 2006), implementation of the proposed action is expected to have
no effect on federally listed wild cats or ruminants.

**E. Cumulative Impacts**

Under NEPA, Federal agencies must analyze the potential cumulative
impacts of a proposed action. The Council on Environmental Quality (CEQ)
defines cumulative impacts as impacts on the environment that result
from the incremental impact of an action when added to other past,
present, and reasonably foreseeable future actions. Actions resulting in
a cumulative impact may or may not be generated by the same agency.
Cumulative impacts can result from individually minor but collectively
significant actions taking place over a period of time.[^85]

[Public Health]{.underline}

BSE-infected bovines may affect the human environment, which includes
public health, if SRMs with infectious levels of the agent enter the
food chain. Proper SRM removal and segregation are essential mitigation
measures for preventing impacts on public health and have been discussed
previously in this document as well as in the MRR EA. The cumulative
impacts of importing live bovines and certain properly processed
low-risk bovine products from BSE-affected countries into the United
States under current regulations, the proposed action, and any future
proposed actions should not have a significant impact on the human
environment in the United States.

Multiple mitigation measures prescribed by the proposed action and
previous actions would have to substantially fail in order for the BSE
agent to find its way into the animal and human food supplies, and there
is no evidence to conclude that such a significant breakdown in the
system of interlocking and overlapping measures could occur. Even if
SRMs from imported Canadian bovines were infected with BSE, any
potential cumulative risk of removing and segregating these SRMs,
combined with the removal and segregation of SRMs from U.S. bovines,
would not increase potential public health risks from BSE exposure
provided that U.S. facilities adhere to FSIS and FDA requirements.

[Other Agency Regulations]{.underline}

FDA and FSIS contribute to the overlapping safeguards that are currently
in place to protect animal health and to ensure that public health
within the United States is not affected by minimizing human exposure to
materials that could contain the BSE agent. These agencies' regulations
are discussed in the MRR EA (USDA, APHIS, 2004a) as well as the Public
Health section of this document. See the following bulleted list for a
summary.

Overlapping safeguards:

-   FDA ruminant-to-ruminant feed ban regulation.

-   FDA and FSIS regulations for SRM removal, segregation, and
    disposition intended to ensure SRMs are not used in human food and
    do not cross-contaminate edible meat products.

-   FSIS regulations on nonambulatory disabled cattle. These cattle must
    be condemned and may not be used for edible products. Their
    carcasses must be disposed of by tanking (i.e., inedible rendering),
    incineration, or denatured by the materials approved by the
    Administrator of FSIS.

-   FSIS regulations that prohibit the incorporation of mechanically
    separated meat in human food.

-   FSIS regulations that prohibit the use of certain stunning devices
    and pithing during slaughter.

FDA is currently proposing to amend its regulations[^86] to prohibit the
use of certain cattle-origin materials in the food or feed of all
animals.[^87] FDA stated that the purpose of the additional prohibitions
and restrictions is to strengthen existing safeguards designed to help
prevent the spread of BSE in U.S. cattle (USDHHS, FDA, 2005).

Additionally, the Canadian Food Inspection Agency, has implemented
regulations that prohibit feeding most mammalian proteins and all plate
waste and poultry litter to ruminants.

[Physical Environment]{.underline}

BSE-infected bovines may affect the human environment, which includes
the natural or physical environment, if the SRMs generated within the
United States overwhelm the ability of facilities to properly dispose of
the material. The actions that could contribute to an increase in the
amount of SRMs generated from the U.S. bovine population are the
importation of live bovines currently being imported under the MRR rule
and the additional live bovines that APHIS is proposing to allow from
Canada. In viewing each action and its incremental effect on the amount
of SRMs to be disposed of, there is no evidence to suggest that the
expected increase in the quantity of SRMs could not be appropriately
handled by U.S. facilities.

Other aspects of the proposed action that may affect the physical
environment include impacts that may result from the transport and
holding of additional bovines. Since the cumulative impacts of this
aspect of the proposed action have previously been discussed in depth in
this document, this section will focus on the impacts to the physical
environmental that are related specifically to the amount of SRMs
generated within the United States.

On July 15, 2005, the MRR rule went into effect. In December 2004, prior
to finalizing the rule, an environmental assessment was prepared and
made available to the public (USDA, APHIS, 2004a). The cumulative
impacts section analyzed the amount of SRMs to be imported (SRMs are
imported within live bovines) and the ability of the United States to
handle any potential increase in the amount of SRMs disposed. The
analysis relied on historical import quantities of cattle, as well as
projected changes in U.S. importation and Canadian exportation trends.
While the estimate of the number of cattle that would be imported from
Canada was eventually revised downward,[^88] the cumulative impacts
analysis still found that there was no evidence to suggest that the
United States would be unable to handle the projected increase in the
amount of SRMs to be disposed and that risks to the human environment
would not increase.

Under the proposed action, there exists the potential for an increase in
the quantity of SRMs to be disposed of in the United States. Based on
the data generated earlier in the physical environmental impact section
of this document, an additional 4,194,000 to 21,827,000 pounds of SRMs
would be generated as a result of imported cattle from Canada each year
from 2008 to 2027. The difference between the quantities of SRMs
generated from imports of Canadian cattle with the rulemaking and under
the no action alternative is expected to equal 5 percent or less of the
total amount of SRMs that would have been generated based on the average
U.S. cattle slaughtered numbers for 2002 to 2004. This amount of SRMs
should not overburden the United States' ability to properly dispose of
the material.

The cumulative impacts of importing live bovines from BSE-affected
countries into the United States under current regulations and the
proposed action should not have an additive impact on the natural or
physical environment. Live bovines are currently not imported from any
BSE-affected country other than Canada. If, in the future, APHIS were to
recognize any other regions in addition to Canada 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 potential adverse impacts on the natural or
physical environment. Additionally, the public would have the
opportunity to participate in future rulemaking changes related to
importing live bovines and bovine products from countries that present a
risk of introducing BSE into the United States.

[]{#__RefHeading___Toc132018822 .anchor}**F. Other Laws or
Requirements**

The CEQ NEPA regulations require Federal agency consideration of whether
a proposed action threatens a violation of Federal, State, or local law
or requirements imposed for the protection of the environment.[^89]

While indirect environmental impacts, such as the addition of
environmental pollutants from trucks transporting cattle, waste from
imported live cattle held in feedlots and slaughtered in U.S. slaughter
establishments, and SRM disposal from slaughter of imported cattle,
could result from the proposed action, the action itself does not
threaten a violation of laws or requirements that are designed to
protect the environment. Potential indirect environmental impacts extend
beyond the scope of the rulemaking.

Some executive orders such as Executive Order 13045, Protection of
Children From Environmental Health Risks and Safety Risks, and Executive
Order 12898, Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations, and departmental or
agency directives require special environmental reviews in certain
circumstances. In considering these additional review requirements, no
circumstance that would trigger the need for special environmental
reviews is involved in implementing the proposed action considered in
this document.

[]{#__RefHeading___Toc132018823 .anchor}**III. Summary of Potential
Environmental Impacts by Alternative**

This section provides a summary table of the potential environmental
impacts considered in this document to show a comparison of the impacts
between the

No Action alternative and the Proposed Action alternative by commodity.

**Table 7. Summary of Potential Impacts by Commodity and Alternative**

+---------------------+------------------------+----------------------+
| **Environmental     | **No Action            | **Proposed Action    |
| Impacts**           | Alternative**          | Alternative**        |
+---------------------+------------------------+----------------------+
| Public Health       |                        |                      |
+---------------------+------------------------+----------------------+
| > \- Live cattle    | Currently 0.97−1.1     | Increase of          |
|                     | million cattle under   | 0.13−0.45 million    |
|                     | the age of 30 months   | cattle imported      |
|                     | imported annually.     | annually.            |
|                     |                        |                      |
|                     | No adverse impacts on  | Estimated            |
|                     | the human environment  | potentially          |
|                     | provided that          | available 45−290     |
|                     | mitigations and other  | cattle               |
|                     | requirements are       |                      |
|                     | adhered to.            | oral ID~50~s.\*      |
|                     |                        |                      |
|                     |                        | No adverse impacts   |
|                     |                        | on the human         |
|                     |                        | environment provided |
|                     |                        | that mitigations and |
|                     |                        | other requirements   |
|                     |                        | are adhered to.      |
+---------------------+------------------------+----------------------+
| \- Bovine small     | No adverse impacts on  | No adverse impacts   |
| intestines          | the human              | on the human         |
|                     | environment.[^90]      | environment provided |
| (except the distal  |                        | that mitigations and |
| ileum)              |                        | other requirements   |
|                     |                        | are adhered to.      |
+---------------------+------------------------+----------------------+
| \- Bovine blood and | No adverse impacts on  | No adverse impacts   |
| blood               | the human              | on the human         |
|                     | environment.[^91]      | environment provided |
| products            |                        | that mitigations and |
|                     |                        | other requirements   |
|                     |                        | are adhered to.      |
+---------------------+------------------------+----------------------+
| Physical            |                        |                      |
| Environment         |                        |                      |
+---------------------+------------------------+----------------------+
| \- Transport of     | Air quality            | Slight increase in   |
| cattle              | degradation from       | air quality          |
|                     | 19,460--22,140 resumed | degradation from     |
|                     | truck transports       | resumed 2,600 to     |
|                     | annually.[^92]         | 8,920 truck          |
|                     |                        | transports annually. |
+---------------------+------------------------+----------------------+
| > \- Holding of     | Air quality and water  | Slight increase in   |
| > cattle in         | quality degradation.   | air quality and      |
|                     |                        | water quality        |
| feedlots            | Beneficial increase in | degradation.         |
|                     | fertilizer and soil    |                      |
|                     | conditioner.           | Beneficial increase  |
|                     |                        | in fertilizer and    |
|                     |                        | soil conditioner.    |
+---------------------+------------------------+----------------------+
| \- SRMs generated   | \~1 % increase in the  | \<5% or less         |
| and                 | amount of SRMs         | increase in the      |
|                     | estimated to have been | amount of SRMs       |
| > disposed          | previously generated   | estimated to have    |
|                     | in the U.S.            | been previously      |
|                     |                        | generated in the     |
|                     | This amount is not     | United States.       |
|                     | expected to overburden |                      |
|                     | U.S. disposal          | This amount is not   |
|                     | facilities.            | expected to          |
|                     |                        | overburden U.S.      |
|                     |                        | disposal facilities. |
+---------------------+------------------------+----------------------+
| Federally listed    | No effect.             | No effect.           |
| endangered or       |                        |                      |
| threatened species  |                        |                      |
+---------------------+------------------------+----------------------+
| Cumulative impacts  | No adverse impact on   | No adverse impact on |
|                     | the human environment. | the human            |
|                     |                        | environment.         |
+---------------------+------------------------+----------------------+

\*Based on less likely scenarios quantitatively analyzed through an
exposure model.

[]{#__RefHeading___Toc132018824 .anchor}**IV. Agencies or Persons
Contacted**

Dr. Eric Flamm

Senior Advisor

Office of the Commissioner

Food and Drug Administration (HF--23)

Room 1561, Parklawn Building

Rockville, MD 20857

Number range CHAPTERDr. Daniel Engeljohn

Deputy Assistant Administrator

Office of Policy, Program, and Employee Development

Food Safety and Inspection Service, USDA

1400 Independence Avenue, S.W.

Washington, DC 20250--3700

[]{#__RefHeading___Toc132018825 .anchor}**V. References**

CDC---See Centers for Disease Control.

Centers for Disease Control, 2005a. Bovine Spongiform Encephalopathy and
Creutzfeldt-Jakob Disease: Chapter 4 -- Prevention of specific
infectious diseases. Available at
<http://www2.ncid.cdc.gov/travel/yb/utils/ybGet.asp?section=dis&obj=madcow.htm&cssNav=browsecyb>
Accessed on February 15, 2006.

Centers for Disease Control, 2005b. Probable variant Creutzfeldt-Jakob
Disease in a U.K. citizen who had temporarily resided in Texas. November
18, 2005. Available at
<http://www.cdc.gov/ncidod/dvrd/vcjd/other/probablevcjd_texas2001_2005_111805.htm>.
Accessed on February 13, 2006.

Centers for Disease Control, 2005c. Fact Sheet: Variant
Creutzfeldt-Jakob Disease. Available at
<http://www.cdc.gov/ncidod/dvrd/vcjd/factsheet_nvcjd.htm>

Accessed on February 13, 2006.

Comer, P.J., and Huntly, P.J., 2003. Exposure of the human population to
BSE infectivity over the course of the BSE epidemic in Great Britain and
the impact of changes to the Over Thirty Month Rule.

Cunningham, A.A., Kirkwood, J.K., Dawson, M., Spencer, Y.I., Green,
R.B., and Wells, G.A.H., 2004. Distribution of bovine spongiform
encephalopathy in greater kudu (*Tragelaphus strepsiceros*). Emerging
Infectious Diseases 10(6):1044--1049.

EC SSC---See European Commission, Scientific Steering Committee.

EPA---See U.S. Environmental Protection Agency.

ERS---See U.S. Department of Agriculture, Economic Research Service.

European Commission, Scientific Steering Committee, 2000. Opinion. Oral
exposure of humans to the BSE agent: infective dose and species barrier.
(Adopted by the Scientific Steering Committee at its meeting of April
13-14, 2000, following a public consultation via Internet between March
6--27, 2000). European Commission, Scientific Steering Committee, Health
and Consumer Protection Directorate General. Available at
<http://europa.eu.int/comm/food/fs/sc/ssc/out79_en.pdf>. Accessed on
January 19, 2006.

European Commission, Scientific Steering Committee, 2002. Report on the
monitoring and testing of bovine animals for the presence of bovine
spongiform encephalopathy (BSE) in 2001, European Commission Health and
Consumer Protection Directorate-General.
([http://europa.eu.int/comm/food/fs/bse/bse45_en.pdf]{.underline})

National Creutzfeldt-Jakob Disease Surveillance Unit, 2007. Variant
Creutzfeldt-Jakob Disease Current Data (June 2007). The University of
Edinburgh, Edinburgh, Scotland. Available at
<http://www.cjd/ed.ac.us/vcjdworld.htm>. Accessed on June 14, 2007.

OIE---See Office of International Des Epizooties

Office of International Des Epizooties. 2005. Terrestrial Animal Health
Code 2005: Chapter 2.3.13. Bovine Spongiform Encephalopathy. Available
at <http://www.oie.int/eng/normes/mcode/en_chapitre_2.3.13.htm> Accessed
on February 13, 2006.

Office of International Des Epizooties. 2006. Number of cases of bovine
spongiform encephalopathy (BSE) reported in the United Kingdom.
Available at <http://www.oie.int/eng/info/en_esbru.htm>. Updated October
12, 2006. Accessed on October 24, 2006, and May 18, 2007.

USDA, APHIS---See U.S. Department of Agriculture, Animal and Plant
Health Inspection Service.

USDA, ERS---See U.S. Department of Agriculture, Economic Research
Service.

USDA, FSIS---See U.S. Department of Agriculture, Food Safety and
Inspection Service.

USDA, NASS---See U.S. Department of Agriculture, National Agricultural
Statistics Service.

USDHHS, FDA---See U.S. Department of Health and Human Services, Food and
Drug Administration.

U.S. Department of Agriculture, Animal and Plant Health Inspection
Service, 2003. Risk analysis: BSE risk from importation of designated
ruminants and ruminant products from Canada. Riverdale, MD. Available at
http://www.aphis.usda.gov/newsroom/hot_issues/bse/background.

U.S. Department of Agriculture, Animal and Plant Health Inspection
Service, 2004a. Final rulemaking to establish criteria for the
importation of designated ruminants and ruminant products from Canada
into the United States. Final Environmental Assessment---December 2004.
Riverdale, MD. Available at

http://www.aphis.usda.gov/newsroom/hot_issues/bse/background.

U.S. Department of Agriculture, Animal and Plant Health Inspection
Service, 2004b. Explanatory Note. Risk analysis: BSE risk from
importation of designated ruminants and ruminant products from Canada
into the United States. February 2004. Available at
http://www.aphis.usda.gov/newsroom/hot_issues/bse/background.

U.S. Department of Agriculture, Animal and Plant Health Inspection
Service, 2004c. Economic analysis. Final rule. Bovine spongiform
encephalopathy: minimal-risk regions and importation of commodities
(APHIS Docket No. 03--080--3). Appendix E. 2001--2002 average annual,
first-quarter, and second-quarter cattle imports from Canada, excluding
cattle imported for breeding or backgrounding, head. Riverdale, MD.
Available at
http://www.aphis.usda.gov/newsroom/hot_issues/bse/background.

U.S. Department of Agriculture, Animal and Plant Health Inspection
Service, 2006. Assessment of bovine spongiform encephalopathy (BSE)
risks associated with the importation of certain commodities from BSE
minimal-risk regions (Canada). October 27, 2006. Riverdale, MD.
Available at <http://www.aphis.usda.gov/>newsroom/hot_issues/bse.shtml.

U.S. Department of Agriculture, Animal and Plant Health Inspection
Service, 2007a. Regulatory impact analysis and final regulatory
flexibility analysis. Final rule. Bovine spongiform encephalopathy;
Minimal-risk regions; Importation of live bovines and products derived
from bovines (Docket no. APHIS-2006-0041). September 2007. Riverdale,
MD. Available at
<http://www.aphis.usda.gov/newsroom/hot_issues/bse.shtml>.

U.S. Department of Agriculture, Animal and Plant Health Inspection
Service, 2007b. Revised assessment of bovine spongiform encephalopathy
(BSE) risks associated with the importation of certain commodities from
BSE minimal risk regions (Canada). September 2007. Riverdale, MD.
Available at <http://www.aphis.usda.gov/newsroom/hot_issues/bse.shtml>.

U.S. Department of Agriculture, Economic Research Service, 2003.
Managing manure: new Clean Water Act regulations create imperative for
livestock producers. Amber Waves, February 2003. Available at
<http://www.ers.usda.gov/AmberWaves/Feb03/Features/ManagingManure.htm>.
Accessed on December 12, 2005.

U.S. Department of Agriculture, Economic Research Service, 2006.
Background statistics: U.S. beef and cattle industry, 2002--2005. U.S.
commercial slaughter. Available at
<http://www.ers.usda.gov/news/BSECoverage.htm>. Accessed onSeptember 21,
2006.

U.S. Department of Agriculture, Food Safety and Inspection Service,
2004. About FSIS: Agency History. Available at
<http://www.fsis.usda.gov/About_FSIS/Agency_History/index.asp> Accessed
on February 21, 2006.

[]{.mark}

U.S. Department of Agriculture, Food Safety and Inspection Service,
2005. Internal correspondence: Casings. November 21, 2005.

U.S. Department of Agriculture, Foreign Agricultural Service, 2005. U.S.
trade imports data. Available at
<http://www.fas.usda.gov/ustrade/USTImHS10.asp?QI>=. Accessed on
November 2005.

U.S. Department of Health and Human Services, Food and Drug
Administration, Center for Biologics Evaluation and Research, 2001.
Estimating Risks for vCJD in Vaccines Using Bovine Derived Materials.
March 2001. Available at
[www.fda.gov/cber/bse/risk.htm](http://www.fda.gov/cber/bse/risk.htm).
Accessed on January 19, 2006.

U.S. Department of Health and Human Services, Food and Drug
Administration, 2004. Bovine spongiform encephalopathy. Questions and
answers on bovine spongiform encephalopathy. Center for Biologics
Evaluation and Research, Food and Drug Administration. Updated September
20, 2004. Available at <http://www.fda.gov/cber/bse/bseqa.htm>. Accessed
on March 13, 2006.

U.S. Department of Health and Human Services, Food and Drug
Administration, 2005. Environmental Assessment for Amendments to 21 CFR
589, Substances Prohibited from Use in Animal Food or Feed. September
22, 2005.

U.S. Department of Transportation, Bureau of Transportation Standards,
2006. Available at
<http://www.bts.gov/programs/international/border_crossing_entry_data/>.

USDHHS, FDASee U.S. Department of Health and Human Services, Food and
Drug Administration.

U.S. DOT, BTS---See U.S. Department of Transportation, Bureau of
Transportation Standards.

U.S. Environmental Protection Agency, 1997. Animal waste management
issues: a Federal perspective. Ira Linville, Chief, Watershed Unit, EPA.
In Publications of the Southeastern Sustainable Animal Waste Management
Workshop, The University of Georgia, Tifton, GA, Feb. 11--13, 1997.
Available at
[http://www.engr.uga.edu/service/extension/publications/linville.html.]{.underline}
Accessed on December 12, 2005.

U.S. Environmental Protection Agency, 2004. Effluent guidelines. Meat
and poultry products (MPP). Fact sheet: final rule. EPA 821--F--04--004,
February 2004. Available at <http://epa.gov/guide/mpp/final-fs.htm>.
Accessed on January 19, 2006.

U.S. Environmental Protection Agency, 2006. Air quality agreement with
animal feeding operations. Available at
[http://www.epa.gov/compliance/resources/agreements/caa/cafo-agr-0501.html]{.underline}.
Accessed January 20, 2006.

[^1]: Any of various hoofed, even-toed, usually horned mammals such as
    cows, bison, sheep, goats, deer, giraffes, and camels. They
    characteristically have a stomach divided into four compartments and
    chew cud.

[^2]: 70 FR 459-553, January 4, 2005.

[^3]: *Bos* *taurus* (domestic cattle), *Bos indicus* (zebu cattle), and
    *Bison bison* (American bison).

[^4]: According to 9 Code of Federal Regulations (CFR) § 96.1, animal
    casings are defined as "intestines, stomachs, esophagi, and urinary
    bladders from cattle, sheep, swine, or goats that are used to encase
    processed meats in foods such as sausage."

[^5]: The distal ileum is the very straight, terminal portion of the
    small intestine, ranging in length from 12 to

    18 inches, depending upon the size of the animal.

[^6]: The World Trade Organization (WTO) recognizes the OIE as the
    international organization for

    development of standards, guidelines, and recommendations with
    regard to animal health

    and zoonoses (diseases that are transmissible from animals to
    humans).

[^7]: Available on the Internet at
    [http://www.oie.int/eng/normes/mcode/en chapitre
    2.3.13.htm](http://www.oie.int/eng/normes/mcode/en chapitre 2.3.13.htm).

[^8]: 9 CFR § 94.18(a)(3).

[^9]: 42 United States Code (U.S.C.) 4321 *et seq.*

[^10]: 40 CFR parts 1500--1508, 7 CFR 1b, and 7 CFR part 372.

[^11]: 9 CFR parts 93--96.

[^12]: APHIS determined that cattle born on or after March 1, 1999, are
    unlikely to have been exposed to the BSE agent by animal feed (USDA,
    APHIS, 2006).

[^13]: 7 CFR § 310.22(a)(3) and 21 CFR § 189.5(b)(2), respectively.

[^14]: A summary of potential environmental impacts considered in this
    environmental assessment by commodity and alternative is provided in
    table 7 of this document.

[^15]: 40 CFR § 1508.27(b).

[^16]: Under NEPA regulations, the "human environment" includes the
    natural and physical environment and the relationship of people with
    that environment" (40 CFR § 1508.14).

[^17]: 61 FR 38805, July 25, 1996.

[^18]: SRMs are tissues that are considered at particular risk of
    containing infectious levels of the BSE agent in BSE-infected
    cattle. The following tissues are designated as SRMs: the brain,
    skull, eyes, trigeminal ganglia, spinal cord, vertebral column
    (excluding the vertebrae of the tail, the transverse processes of
    the thoracic and lumbar vertebrae, and the wings of the sacrum), and
    dorsal root ganglia of cattle 30 months of age and older, and the
    distal ileum of the small intestine and tonsils from all cattle (9
    CFR § 310.22(a)).

[^19]: 69 FR 1862, January 12, 2004.

[^20]: Nonambulatory disabled livestock is defined by FSIS as livestock
    that cannot rise from a recumbent position or that cannot walk,
    including, but not limited to, those with broken appendages, severed
    tendons or ligaments, nerve paralysis, fractured vertebral column,
    or metabolic conditions (69 FR 1861, January 12, 2004).

[^21]: In accordance with 9 CFR part 314.

[^22]: 21 U.S.C. 601(m)(3).

[^23]: 69 FR 42256, July 14, 2004.

[^24]: 70 FR 53043, September 7, 2005.

[^25]: 70 FR 53063, September 7, 2005.

[^26]: 9 CFR § 94.18(a)(3).

[^27]: Available at
    http://www.aphis.usda.gov/newsroom/hot_issues/bse/background

[^28]: 70 FR 18252, April 8, 2005.

[^29]: Feeder cattle are destined for feedlot finishing and slaughter
    but may be placed on pasture for several months of gain before
    feedlot placement. Feeder cattle are generally placed on feed for
    120 days to more than

    200 days before being slaughtered at a quality grade of select or
    higher (USDA, APHIS, 2007a).

[^30]: Milk and milk products are internationally recognized (according
    to OIE guidelines) to present a negligible risk of transmitting the
    BSE agent. FDA's interim final rule of September 7, 2005 (amending
    provisions in FDA's July 14, 2004, interim final rule), clarified
    that milk and milk products are not prohibited cattle materials (21
    CFR § 189.5(a)(1) and 700.27(a)(1)).

[^31]: 69 FR 1862, January 12, 2004, and 70 FR 53043, September 7, 2005.

[^32]: 69 FR 42256, July 14, 2004, and 70 FR 53063, September 7, 2005.

[^33]: In order to be consistent with the historic use of the term
    "pessimistic" in the Harvard model and Attachment 2 of the risk
    assessment, the term "pessimistic values" is used in this context to
    refer to the plausible higher values used in the sensitivity
    analysis.

[^34]: BSE in cattle was first diagnosed in Great Britain in 1986; from
    then til the end of 2002 there were more than 178,000 confirmed
    clinical cases (Comer and Huntly, 2003).

[^35]: 54,000,000/45 = 1,200,000.

[^36]: A total of 11 Canadian-born BSE cases have been identified by May
    2007, compared to the United Kingdom which has detected 184,954
    cases by passive and active surveillance through April 2007 (OIE,
    2006).

[^37]: 69 FR 42256, July 14, 2004.

[^38]: 70 FR 53063, September 7, 2005.

[^39]: 70 FR 53043, September 7, 2005.

[^40]: Ibid.

[^41]: 69 FR 1862, January 12, 2004.

[^42]: 9 CFR § 301.2.

[^43]: 9 CFR § 327.2(b).

[^44]: 70 FR 53043, September 7, 2005.

[^45]: 9 CFR § 310.22(d)(1).

[^46]: 70 FR 53043, September 7, 2005.

[^47]: 70 FR 53043, September 7, 2005.

[^48]: Eastport, ID; Houlton and Jackman, ME; Detroit, Port Huron, and
    Sault Ste. Marie, MI; Baudette, MN; Opheim, Raymond, and Sweetgrass,
    MT; Alexandria Bay, Buffalo, and Champlain, NY; Dunseith, Pembina,
    and Portal, ND; Derby Line and Highgate Springs, VT; and Oroville
    and Sumas, WA (9 CFR 93.403(b)).

[^49]: 70 FR 18252, April 8, 2005.

[^50]: This amount was based on historical 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
    estimated number of cattle under 30 months of age that would have
    been 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. The estimated
    backlog of cattle was later adjusted downward to 900,000 when the
    Secretary announced that implementation of part of the MRR rule that
    would allow for importation of beef from cattle

    30 months of age or older would be delayed; this estimated decrease
    in imports reflected an increase in Canadian slaughter capacity
    during 2004.

[^51]: Confirmation with the U.S. Department of Transportation revealed
    that the categories of loaded and unloaded truck containers should
    not be included for truck transport calculations, as was done for
    the Finding of No Significant Impact (FONSI) for the MRR
    environmental assessment. In revising the information discussed in
    the FONSI and using the truck transport category only, the
    percentage of annual truck transports for cattle under 30 months of
    age changes from 0.25 percent to 0.5 percent.

[^52]: Since the earlier version of the environmental assessment, the
    projected bison imports increased from 2,500 to 12,000 annually.
    Although bison were not factored into the overall transport numbers,
    we estimate that bison, essentially all under the age of 30 months
    (80 percent imported for immediate slaughter, 10 percent for feeding
    and then slaughter, and 10 percent for breeding stock), could add
    about 300 truck transports each year. This amount of truck
    transports does not appreciably affect the total truck transports
    for bovines under 30 months of age, especially when comparing it to
    the baseline number (5.6 million) of the total annual U.S.-Canada
    truck transports through the 20 approved ports of entry for
    ruminants.

[^53]: The number of bovines to be imported from Canada that was
    originally cited in the MRR EA has been updated based on current
    projections.

[^54]: The number of bovines that was originally cited in the MRR EA has
    been updated based on current projections.

[^55]: The following tissues are designated as SRMs: the brain, skull,
    eyes, trigeminal ganglia, spinal cord, vertebral column (excluding
    the vertebrae of the tail, the transverse processes of the thoracic
    and lumbar vertebrae, and the wings of the sacrum), and dorsal root
    ganglia of cattle 30 months of age and older, and the distal ileum
    and tonsils of all cattle (9 CFR § 310.22(a)).

[^56]: 70 FR 53043, September 7, 2005.

[^57]: 70 FR 53063, September 7, 2005.

[^58]: The weight of the distal ileum is highly variable from one animal
    to the next. However, the estimate that the distal ileum comprises
    10 percent of the entire small intestine is a conservative estimate.

[^59]: 28.0 pounds in cattle under 30 months and 35.0 pounds in cattle
    over 30 months.

[^60]: 2.8 pounds of distal ileum + 0.3 pounds of tonsils (USDHHS, FDA,
    2005) = 3.1 pounds of SRMs.

[^61]: 3.5 pounds of distal ileum + 0.3 pounds of tonsils (USDHHS, FDA,
    2005) + 0.936 pounds of brain (USDHHS, FDA, 2005) + 0.374 pounds of
    spinal cord (USDHHS, FDA, 2005) + 0.22 pounds of eyes (USDHHS, FDA,
    2005) +15.2 pounds of skull (including trigeminal ganglia) (USDHHS,
    FDA, 2005) + 36.5 pounds of vertebral column (USDHHS, FDA, 2005) =
    57.0 pounds of SRMs.

[^62]: The number of bovines to be imported from Canada that was
    originally cited in the MRR EA and the October 2006 version of this
    document have been updated based on current projections.

[^63]: 973,000 cattle under 30 months of age (USDA, ERS, 2007) × 3.1
    pounds of SRMs = 3,016,000 pounds of SRMs.

[^64]: 1,107,000 cattle under 30 months of age (USDA, ERS, 2007) × 3.1
    pounds of SRMs = 3,432,000 pounds of SRMs.

[^65]: Note that the changing status of cattle imported from Canada to
    the United States is reflected in the average number of cattle
    slaughtered from 2002 to 2004. In all of 2002 and part of 2003, the
    United States was importing Canadian cattle. For the latter half of
    2003 and all of 2004, the United States was not importing Canadian
    cattle.

[^66]: 28.4 million cattle (USDA, ERS, 2006) × 3.1 pounds of SRMs + 5.69
    million cattle (USDA, ERS, 2006) × 57 pounds of SRMs = 412 million
    pounds of SRMs.

[^67]: 3.4 million pounds of SRMs generated under the No Action
    alternative during 2013 (2013 data was used in the calculation since
    this year would generate the greatest amount of SRMs) ÷ 412 million
    pounds of SRMs that would have been generated based on the average
    annual U.S. cattle slaughter amount for 2002 to 2004 = 0.01 (1 %).

[^68]: Since SRMs were not prohibited from use in human food in 2002 and
    2003 and therefore were not required to be removed (FSIS implemented
    the regulatory requirement for SRM removal on July 14, 2004), the
    amount of SRMs that would have been generated from 2002-2004 is
    theoretical.

[^69]: Since the earlier version of the environmental assessment, the
    projected bison imports increased from 2,500 to 12,000 annually.
    Although bison were not factored into the overall SRMs generated,
    APHIS estimates that bison (essentially all under the age of 30
    months) projected to be imported could add about 37,200 pounds of
    SRMs each year. This amount of additional SRMs from bison, which
    would constitute 1% of the total amount of bovine SRMs generated, is
    not expected to overburden U.S disposal facilities.

[^70]: 2008: A total of 1,117,000 cattle imported (USDA, ERS, 2007) --
    55,000 breeding cattle imported (USDA, ERS, 2007) = 1,062,000
    feeder, feed, and cull cattle.

[^71]: 2027: A total of 1,521,000 cattle imported (USDA, ERS, 2007) --
    64,000 breeding cattle imported (USDA, ERS, 2007) = 1,457,000
    feeder, feed, and cull cattle.

[^72]: This number does not include about 55,000 to 64,000 head of
    cattle forecast to be imported annually into the United States from
    Canada for breeding between 2008 and 2027 (USDA, ERS, 2007).

[^73]: 75,000 cattle 30 months of age and over \[*63,000 cows for
    slaughter + 12,000 bulls and stags for slaughter,* USDA, ERS, 2007\]
    × 57.0 pounds of SRMs + 987,000 cattle under 30 months of age
    \[*1,062,000 feeder, feed, and cull cattle -- 75,000 cattle 30
    months of age and over\]* × 3.1 pounds of SRMs = 7,335,000 pounds of
    SRMs.

[^74]: 382,000 cattle 30 months of age and over \[*322,000 cows for
    slaughter + 60,000 bulls and stags for slaughter,* USDA, ERS, 2007\]
    × 57.0 pounds of SRMs + 1,075,000 cattle under 30 months of age
    \[*1,457,000 feeder, feed, and cull cattle -- 382,000 cattle 30
    months of age and over\]*× 3.1 pounds of SRMs = 25,107,000 pounds of
    SRMs.

[^75]: 25.0 million pounds of SRMs generated under the Proposed Action
    alternative during 2027 (2017 data was used in the calculation since
    this year would generate the greatest amount of SRMs)÷ 412 million
    pounds of SRMs estimated to have been generated annually from 2002
    to 2004 = 0.06 (6 percent).

[^76]: Since SRMs were not prohibited from use in human food in 2002 and
    2003 and therefore were not required to be removed (FSIS implemented
    the regulatory requirement for SRM removal on July 14, 2004), the
    amount of SRMs that would have been generated from 2002-2004 is
    theoretical.

[^77]: 7,335,000 pounds of SRMS under the Proposed Action -- 1,013,000
    cattle (USDA, ERS, 2007)× 3.1 pounds per head under the No Action
    alternative = 4,194,000 pounds of SRMs.

[^78]: 25,107,000 pounds of SRMs under the Proposed Action -- 1,058,000
    cattle (USDA, ERS, 2007) x 3.1 pounds per head under the No Action
    alternative = 21,827,000 pounds of SRMs.

[^79]: 4,195,000 pounds of SRMs ÷ 412,000,000 pounds of SRMs estimated
    to have been generated = 0.01(1%).

[^80]: 21,827,000 pounds of SRMs ÷ 412,000,000 pounds of SRMs estimated
    to have been generated = 0.05 (5%).

[^81]: 40 CFR § 1508.27(b)(5).

[^82]: 70 FR 18252, April 8, 2005.

[^83]: 70 FR 53043, September 7, 2005.

[^84]: 70 FR 18252, April 8, 2005.

[^85]: 40 CFR § 1508.7.

[^86]: 21 CFR § 589.000

[^87]: 70 FR 58569, October 6, 2005.

[^88]: 70 FR 18252, April 8, 2005.

[^89]: 40 CFR § 1508.27(b)(10).

[^90]: Bovine small intestines (except for the distal ileum) are not
    allowed for importation under the no action alternative.

[^91]: Bovine blood and blood products are not allowed for importation
    under the no action alternative.

[^92]: Compared to 5.6 million average annual truck crossings from
    Canada to the United States for 2001 through 2005 (through the 20
    ports of entry authorized for importation of ruminants under the MRR
    rule).