[Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Rules and Regulations]
[Page 18251-18262]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap05-11]
[[Page 18251]]
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Part VII
Department of Agriculture
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Animal and Plant Health Inspection Service
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9 CFR Part 93, et al.
Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation
of Commodities; Finding of No Significant Impact and Affirmation of
Final Rule; Final Rule
[[Page 18252]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 93, 94, 95, and 98
[Docket No. 03-080-7]
RIN 0579-AB73
Bovine Spongiform Encephalopathy; Minimal-Risk Regions and
Importation of Commodities; Finding of No Significant Impact and
Affirmation of Final Rule
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Affirmation of final rule.
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SUMMARY: We are publishing a finding of no significant impact for a
final rule concerning bovine spongiform encephalopathy minimal risk
regions published January 4, 2005, and, based on that finding, we are
affirming the provisions of the final rule. The finding of no
significant impact is based on an environmental assessment that
documented our review and analysis of potential environmental impacts
associated with the final rule and our review of issues raised by the
public regarding the environmental assessment. Together, the
environmental assessment and our review of the issues raised provide a
basis for our conclusion that the provisions of the final rule will not
have a significant impact on the quality of the human environment and
support our affirmation of the final rule.
DATES: The final rule published January 4, 2005 (70 FR 460), with a
partial delay of applicability published March 11, 2005 (70 FR 12112),
was effective March 7, 2005. This affirmation of the final rule is
effective April 8, 2005.
ADDRESSES: The environmental assessment on which this finding of no
significant impact is based may be accessed by any of the following
methods:
On the EDOCKET Web site at http://docket.epa.gov/ edkfed/
do/ EDKStaff CollectionDetailView?objectId = 0b0007d48055a20d.
On the APHIS Web site at http://www.aphis.usda.gov/lpa/issues/bse/bse.html
.
In the APHIS Reading Room in room 1141 of the USDA South
Building, 14th Street and Independence Avenue, SW., Washington, DC.
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
You may request paper copies of the environmental
assessment and the finding of no significant impact by calling or
writing to the person listed under FOR FURTHER INFORMATION CONTACT.
Please refer to the titles of these documents when requesting copies.
FOR FURTHER INFORMATION CONTACT: Dr. Karen James-Preston, Director,
Technical Trade Services, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.
SUPPLEMENTARY INFORMATION:
Background
On November 4, 2003, the Animal and Plant Health Inspection Service
(APHIS) published in the Federal Register and requested comment on a
proposed rule (68 FR 62386-62405, Docket No. 03-080-1) to amend the
regulations regarding the importation of animals and animal products to
recognize a category of regions that present a minimal risk of
introducing bovine spongiform encephalopathy (BSE) into the United
States via live ruminants and ruminant products, and to add Canada to
this category. The proposed rule also included provisions for the
importation of certain live ruminants and ruminant products and
byproducts from Canada under certain conditions. Also on November 4,
2003, we made available for public comment an environmental assessment
(EA) regarding the potential impact on the quality of the human
environment due to the importation of ruminants and ruminant products
and byproducts under the conditions of the proposed rule. We carefully
considered all comments that addressed the EA, along with those that
addressed the proposed rule itself.
On January 4, 2005, we published in the Federal Register (70 FR
460-553, Docket No. 03-080-3) a final rule to the proposed rule, to
become effective March 7, 2005.\1\
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\1\ On March 11, 2005, the Department published a document in
the Federal Register (70 FR 12112-12113, Docket No. 03-080-6),
effective March 7, 2005, that delayed until further notice the
applicability of certain provisions of the final rule. On March 2,
2005, Judge Richard F. Cebull of the U.S. District Court for the
District of Montana ordered that the implementation of the final
rule is preliminarily enjoined.
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Also in the January 4, 2005, issue of the Federal Register, we
published a notice (70 FR 554, Docket No. 03-080-4) announcing the
availability of, and requesting comments on, a final EA regarding the
potential impact on the quality of the human environment due to the
importation of ruminants and ruminant products and byproducts from
Canada under the conditions specified in the final rule. APHIS' review
and analysis of the potential environmental impacts associated with
those importations were documented in the final EA, titled ``Rulemaking
to Establish Criteria for the Importation of Designated Ruminants and
Ruminant Products from Canada into the United States, Final
Environmental Assessment (December 2004).'' We announced that the EA
would be available to the public for review and comment until February
3, 2005.
We became aware, however, that the version of the EA that was made
available on January 4, 2005, contained some transcription errors that
resulted in the omission of several references to an updated APHIS risk
analysis regarding the final rule, as well as the incorrect formatting
of several source citations. We corrected those errors and, on January
21, 2005, published a notice in the Federal Register (70 FR 3183-3184,
Docket No. 03-080-5) announcing the availability to the public of the
corrected EA and extending the comment period on the EA until February
17, 2005.
We reviewed and considered all issues raised by commenters on the
final EA. Of the issues raised by the commenters, some addressed the
potential effects of the rule on the environment, while others
addressed issues unrelated to such potential effects. Most of these
issues had been raised by commenters on the proposed rule and had been
previously considered and addressed in our final rule and supporting
analyses.
Additionally, shortly after issuance of the final rule, the
Ranchers-Cattlemen Action Legal Fund, United Stockgrowers of America
(R-CALF), filed a complaint challenging the rule in the United States
District Court for the District of Montana. In that complaint, R-CALF
raised several issues regarding the EA that it had not included in
either its comments on the proposed rule or in any comment on the final
EA. In addition, no other commenter on the EA raised those potential
environmental impact issues. Nonetheless, we addressed those issues in
our finding of no significant impact (FONSI), discussed below.
We carefully considered environmental issues throughout the
rulemaking. Based on the EA and on our review of the comments received
on the original and final EAs, on the proposed rule, and in litigation,
we have determined that the provisions of our January 4, 2005, final
rule will not
[[Page 18253]]
significantly impact human health or the environment, and that there is
no basis in the comments we received and the issues that have been
raised to alter the rule. Therefore, we are affirming the final rule as
published.
Our FONSI is included in this document under the heading ``Bovine
Spongiform Encephalopathy: Minimal-Risk Regions and Importation of
Commodities (Final Rule; APHIS Docket No. 03-080-3), Finding of No
Significant Impact.'' The FONSI includes a discussion of the comments
received on the final EA. The EA and FONSI may also be accessed by any
of the means listed above under the heading ADDRESSES.
The EA and FONSI have been prepared in accordance with: (1) The
National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C.
4321 et seq.), (2) regulations of the Council on Environmental Quality
for implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1), and (4)
APHIS' NEPA Implementing Procedures (7 CFR part 372).
Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation
of Commodities (Final Rule; APHIS Docket No. 03-080-3)
Finding of No Significant Impact
United States Department of Agriculture, Animal and Plant Health
Inspection Service, Veterinary Services, National Center for Import and
Export, Technical Trade Services, 4700 River Road, Unit 38, Riverdale,
MD 20737
This finding concludes the environmental assessment process
undertaken for the rulemaking, Bovine Spongiform Encephalopathy;
Minimal-Risk Regions and Importation of Commodities (``MRR rule''). An
environmental assessment (``EA''), dated October 2003, was prepared for
this rulemaking and it was made available to the public for comment on
November 4, 2003. Comments on the EA were received and carefully
considered. A final EA was completed and it was made available to the
public on January 4, 2005, for a 30-day comment period. On January 21,
2005, a corrected final EA was made available to the public and the
comment period was extended for an additional 14 days until February
17, 2005. The corrected final EA had no changes or additions to the
version issued on January 4, 2005, other than some specific references
to the latest risk analysis for the MRR rule that had been
inadvertently omitted from the final EA. This finding summarizes and
incorporates by reference the final EA.
Thirteen comments were received in response to our request for
comments on the final EA. One was submitted by a state farm bureau
federation with certain specific suggestions. This comment counseled
caution in implementing the rule for the following reasons. It pointed
to the four confirmed cases of bovine spongiform encephalopathy (BSE)
in cows of Canadian origin'particularly the most recent diagnosis in a
cow that was determined to have been born after implementation of a
feed ban in Canada--and recommended that USDA confirm that the Canadian
feed ban is being effectively enforced before resuming imports of
Canadian cattle under 30 months of age and beef from such younger
cattle. Additionally, the comment requested that an effective feed ban
have been in place in Canada for a full 8 years before cattle over 30
months of age, and meat from such cattle, are allowed to be imported
into the United States. It recommended further review of Canada's
surveillance program and asked whether the current level of
surveillance in Canada is adequate. The comment supported the animal
identification provisions in the rule and recommended that appropriate
steps be taken to ensure that all imported cattle were slaughtered
before 30 months of age. Finally, the comment noted concerns, which we
believe are outside the scope of the environmental assessment, about
consumer confidence, our ability to regain access to export markets,
and potential impacts on producer returns.
One comment, filed by an individual consumer of beef products who
asserted he was not associated with any cattle production or processing
business, raised five concerns or issues. These included that there was
no quantitative risk assessment in the EA, concern about the duration
and effectiveness of Canada's feed ban, concern about the tissues
defined as specified risk materials (SRMs) under international
standards, concern that public health risk was not adequately analyzed
in light of recent diagnoses of BSE in Canada and the levels of feed
ban compliance and surveillance in that country, and, finally, a
recommendation that an environmental impact statement be completed to
study the effect of BSE and TSE disease agents in soil, water, air, and
the food chain.
Eight comments--one from a South Dakota organization, one from an
Oregon organization, and six from individuals, including an assistant
state veterinarian--raised a generally similar array of concerns. The
thrust of these eight comments is that the commenters believe the risk
of introducing BSE into the United States weighs against implementation
of the rule. The comments noted support for maintaining the current
prohibitions on imports of live animals and beef products from Canada,
concerns about the effect of importation into the United States of
Canadian cattle and cattle products on U.S. export markets, concern
about the effectiveness of the Canadian feed ban and the adequacy of
Canada's surveillance program, concerns about feeding animal protein of
any kind to cows or sheep, a recommendation for country-of-origin
labeling, and support for testing for BSE all cattle of Canadian origin
that are in the United States. Again, certain of these issues are
outside the scope of the EA. Several of the comments also raised
questions about the implications of the most recently confirmed BSE-
positive animals in Canada on January 2 and January 11, 2005, including
the fact that one of these animals was born shortly after
implementation of the Canadian feed ban in 1997.
A comment from a pharmaceutical association noted the importance of
animal-derived materials in numerous products. This comment was
received on February 24, 2005, 7 days after the close of the extended
comment period for the final EA. Nevertheless, because, as the
commenter pointed out, it had commented in a timely fashion on the
proposed rule and its EA comment was intended to update its
recommendations based on recent developments, we will respond to this
comment. The comment supported the need to revise what it termed the
``binary system'' of BSE classification of countries and the adoption
of what it termed a science-based approach to identifying minimal-risk
regions for BSE as outlined in the rule. The comment, therefore,
supported implementation of the rule. It recommended permanently
identifying cattle from Canada and distinguishing Canadian and U.S.-
origin cattle for the sourcing of bovine raw materials, which would
allow companies to make sourcing decisions to satisfy BSE regulatory
requirements in the countries to which these companies would ship their
products. The association supported the implementation of a national
animal identification system.
One comment took issue with the notation in the final EA that
alkaline hydrolysis tissue digesters were a preferred method of
disposal for BSE-contaminated carcasses. It took issue with that
conclusion and suggested the commenter's validated protocol and
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process for enzymatic prion degradation was perhaps equally effective.
We acknowledge this comment and would welcome more information and data
regarding this technology. It is our view, however, that it does not
raise an issue that requires discussion in this document. One comment
urged the lifting of the prohibitions on camelids because camelids have
no demonstrated history of being susceptible to any type of TSE and
because these animals are not used for human consumption. We agree with
this comment and note that the MRR rule so provided.
Of the issues raised by the commenters, many concerned topics other
than the potential effects of the rule on the environment (for example,
comments regarding country-of-origin labeling, market access, and
consumer confidence). These issues had been raised by commenters on the
proposed rule and were considered and addressed by APHIS in its final
rule and supporting analyses. Likewise, most of the commenters who did
address the potential effects of the rule on the environment raised
issues that had already been raised and addressed at considerable
length in the final rule and supporting analyses. This fact illustrates
the substantial identity of the central animal and public health issues
of the rule and the issues evaluated in the environmental assessments.
It is important to note that issues raised in relation to the two
most recent BSE-positive cows in Canada on January 2 and January 11,
2005, will be discussed below. Certain commenters observed that these
incidents would call into question the effectiveness and adequate
duration of the Canadian feed ban. Because these incidents occurred
either after or immediately before the publication of the final EA, we
welcome the opportunity to respond in this document.
On January 4, 2005, APHIS issued a final rule to amend regulations
regarding the importation of animals and animal products to establish a
category of regions that present a minimal-risk of introducing BSE into
the United States by way of live ruminants and ruminant products and
byproducts, and to add Canada to that category. (70 FR 460-553.) The
final rule also established conditions for the importation of certain
live ruminants and ruminant products and byproducts from minimal-risk
regions. Under the Animal Health Protection Act (7 U.S.C. 8301 et
seq.), the Secretary of Agriculture may prohibit or restrict the
importation or entry of any animal, article, or means of conveyance, or
use of any means of conveyance or facility, if the Secretary determines
that the prohibition or restriction is necessary to prevent the
introduction into or dissemination within the United States of any pest
or disease of livestock. (7 U.S.C. 8303.) The MRR rule will regulate
the importation of ruminants and ruminant products and byproducts from
Canada in a manner that prevents the introduction of BSE into the
United States.
The rule defines a BSE minimal-risk region as one that:
1. Maintains, and, in the case of regions where BSE was detected,
had in place prior to the detection of BSE in an indigenous ruminant,
risk mitigation measures adequate to prevent widespread exposure and/or
establishment of the disease. Such measures include the following:
Restrictions on the importation of animals sufficient to
minimize the possibility of infected ruminants being imported into the
region, and on the importation of animal products and animal feed
containing ruminant protein sufficient to minimize the possibility of
ruminants in the region being exposed to BSE;
Surveillance for BSE at levels that meet or exceed
recommendations of the World Organization for Animal Health (Office
International des Epizooties or OIE) for surveillance for BSE; and
A ruminant-to-ruminant feed ban that is in place and is
effectively enforced.
2. In regions where BSE was detected, conducted an epidemiological
investigation following detection of BSE sufficient to confirm the
adequacy of measures to prevent the further introduction or spread of
BSE, and continues to take such measures.
3. In regions where BSE was detected, took additional risk
mitigation measures, as necessary, following the BSE outbreak based on
risk analysis of the outbreak, and continues to take such measures.
These standards are based upon, and are consistent with,
international guidelines issued by OIE. For a full analysis and
discussion of these standards, see APHIS' November 4, 2003, proposed
rule (68 FR 62388-62389) (please note that some revisions were made to
the wording of the proposed standards in the final rule) and the update
to our risk analysis.\2\
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\2\ See ``Analysis of Risk-Update for the Final Rule: Bovine
Spongiform Encephalopathy; Minimal Risk Regions and Importation of
Commodities, December 2004.'' pp. 2-5. This update can be viewed on
the Internet at http://www.aphis.usda.gov/lpa/issues/bse/bse.html.
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APHIS conducted a comprehensive examination and evaluation of all
the relevant risk factors in determining whether Canada qualified as a
BSE minimal-risk region. A complete discussion of this evaluation can
be found in the risk analysis.\3\ In summary, APHIS determined that
Canada met the standards for a BSE minimal-risk region because:
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\3\ Ibid, pp. 5-18.
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1. Canada has implemented comprehensive, effective measures for
preventing BSE introduction and the potential for spread within Canada
in order to minimize the possibility that infected ruminants, ruminant
products, byproducts, or contaminated feedstuffs enter the country. The
potential for introduction of the BSE agent into Canada has been
limited by import restrictions on meat-and-bone meal (MBM) and live
animals. Canada's Animal Disease and Protection Regulations (1978) and
Health of Animals Regulations (1991) prohibited importation of MBM from
countries other than the United States and, later, from Australia and
New Zealand. These rules were first initiated in response to foot-and-
mouth disease and later extended to address BSE issues. Canada has not
imported live cattle from the United Kingdom (UK) since 1990. In 1994,
an import ban was imposed on all countries where BSE had been detected
in native cattle, and from 1996 live cattle could only be imported from
countries that Canada designated as free from BSE following a
comprehensive risk assessment. After detection of BSE in an imported
animal in 1993, Canada traced and destroyed and incinerated or
repatriated all surviving cattle imported from the UK.
2. Canada has an adult cattle population of approximately 5.5
million cattle older than 24 months of age. The 2004 OIE Code, Appendix
3.8.4, references adult cattle populations as those greater than 30
months and recommends examining at least 300 samples per year from
high-risk animals in a country with an adult cattle population of 5
million, or 336 samples per year in a country with an adult cattle
population of 7 million. Even though the adult cattle population in
Canada is defined as greater than 24 months of age and OIE defines it
as greater than 30 months, Canada has met or exceeded this level of
surveillance for the past 7 years, thus exceeding the OIE guidelines.
Since 1992, the surveillance has been targeted surveillance, with
samples obtained from adult animals exhibiting some type of clinical
signs or considered high risk for other reasons that could be
considered consistent with BSE. From January 2004 through March
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2005, over 37,000 samples were obtained. Canadian Food Inspection
Agency (CFIA) officials have stated that this surveillance program is
designed to detect one case of BSE in one million adult cattle.
3. Since August 4, 1997, Canada has implemented a ruminant-to-
ruminant feed ban that is comparable to that existing in the United
States and prohibits the feeding of proteins from ruminant species to
ruminant animals. Based on CFIA inspections since 2003, virtually 100
percent of Canadian rendering facilities are in compliance with the
ruminant-to-ruminant feed ban requirements applicable to this industry.
With regard to inspections of feed mills, CFIA reported that, for an
annual inspection period of April to March, the fraction of mills
reportedly in compliance was 92 percent, 99 percent, and 95 percent for
2002, 2003, and 2004, respectively.\4\ CFIA has identified
noncompliance of ``immediate concern'' in fewer than 2 percent of feed
mills inspected during 2003-2004. Those instances of noncompliance of
``immediate concern'' are dealt with rapidly when identified.
Noncompliance of ``immediate concern'' includes situations where direct
contamination of ruminant feed with prohibited materials has occurred,
as identified through inspections of production documents or visual
observation, and where a lack of appropriate written procedures,
records, or product labeling by feed manufacturers may expose ruminants
to prohibited animal proteins. Accordingly, it is clear that Canada's
feed ban is effective.
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\4\ Canadian Food Inspection Agency (CFIA). Memorandum from Dr.
Brian Evans, Chief Veterinary Officer, to Dr. John Clifford, Deputy
Administrator, VS, APHIS. July 30, 2004.
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4. Canada conducted rigorous epidemiological investigations after
the BSE cases were detected in May 2003 and December 2003 and after the
detections in January 2005.\5\ In all but the most recent detection,
the cases were animals that were born before the implementation of the
feed ban in 1997, with exposure assumed to occur prior to or near the
time of the imposition of the feed regulations. The cow in the last
detected case was born within a year after implementation of the
Canadian feed ban. Although a specific source of infection was not
identified, the most likely possibility was the introduction of a low
level of infectivity into the animal feed supply originating from an
infected animal imported from the UK in the period between 1982 and
1989. These investigations have resulted in the destruction and
sampling of a large number of potentially exposed cattle, and results
from all testing have yielded no further evidence of infection. CFIA
has traced and destroyed the majority of surviving cattle that were
birth cohorts of each of the cases of Canadian origin.
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\5\ Canadian reports of the investigations can be accessed at
http://www. inspection. gc. ca/ english/ anima/ heasan/ disemala/
bseesb/ bseesbindexe. shtml.
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5. CFIA imposed new regulations to further strengthen its
safeguards against BSE. Measures taken included requiring the removal
of bovine SRMs; enhancing enforcement activities associated with the
existing cattle identification system; and increasing the level of BSE
testing.
Canada has provided comprehensive information throughout this
rulemaking regarding its BSE status and the actions it has taken to
protect animal and public health and food safety. The most recent
Canadian status update can be accessed through the CFIA 2 Web site at
http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/200503canadae.shtml
.
In summary, the essential factors that led us to conclude that
Canada qualified as a BSE minimal-risk region include longstanding
Canadian import restrictions, an effective ban on the feeding of
ruminant protein to ruminants, the quality of Canada's surveillance and
monitoring program, and other measures, such as the required removal of
SRMs from cattle at the time of slaughter and enhanced enforcement of
Canada's existing mandatory cattle identification system.
APHIS has concluded that the animal and public health measures that
Canada has in place to prevent BSE, combined with existing U.S.
domestic safeguards and additional safeguards provided in the final
rule, provide the utmost protection to U.S. consumers and livestock.
With respect to Canadian cattle, the MRR rule will allow the
importation of:
Bovines, for immediate slaughter, or for feeding, as long
as they are slaughtered at less than 30 months of age;
Meat from bovines; and
Certain other products and byproducts, including bovine
livers and tongues, gelatin, and tallow.
The final rule provides the following additional requirements for
live Canadian feeder cattle that will ensure they are slaughtered
before they reach 30 months of age:
Feeder cattle must be permanently marked with a brand to
identify the BSE minimal-risk region of origin before entering the
United States. Feeder cattle exported from Canada will be branded with
``C/[Lambda]N'';
Cattle must be individually identified with an ear tag
before entering the United States. This ear tag allows the animal to be
traced back to the premises of origin (birth herd);
Information must be included on the cattle's animal health
certification, relating to animal identification, origin, destination,
and responsible parties;
Cattle must be moved to feedlots in sealed containers and
cannot go to more than one feedlot; and
SRMs will be removed from Canadian cattle slaughtered in
the United States in accordance with FSIS regulations.
Based on our risk analyses, APHIS concluded that the cumulative
effect of all of the measures in place in Canada and the United States,
and the additional measures imposed by the final rule, is an extremely
effective set of interlocking, overlapping and sequential barriers to
the introduction and establishment of BSE in the United States.\6\ The
preceding discussion and conclusions provide the foundation for the
finding of no significant impact described below.
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\6\ See ``Analysis of Risk-Update for the Final Rule: Bovine
Spongiform Encephalopathy; Minimal Risk Regions and Importation of
Commodities, December 2004.'' pp. 25-27.
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The final rule was scheduled to become effective on March 7, 2005.
On February 9, 2005, the Secretary of Agriculture announced that the
provisions of the final rule allowing the importation of beef products
from cattle over 30 months of age would be delayed.\7\ On March 2,
2005, the United States District Court for the District of Montana
issued a preliminary injunction that enjoined implementation of the MRR
rule.
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\7\ On March 11, 2005, APHIS published a notice in the Federal
Register delaying the applicability of the provisions of the rule
relating to beef products and byproducts from bovines 30 months of
age or older (70 FR 12112).
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Pursuant to the National Environmental Policy Act (NEPA) (42 U.S.C.
4321 et seq.), the purpose of an environmental assessment is to provide
sufficient information and analysis to agency decision makers to allow
them to determine whether the proposed agency action will have a
significant effect on the human environment. If a determination is made
that the action would have a significant effect on the human
environment, the agency is obligated to prepare an environmental impact
statement. If a determination is made that the action will not have a
significant effect on the human environment, a finding of no
significant impact is issued.
The two EAs issued for the MRR rule considered two alternatives:
(1) The ``No
[[Page 18256]]
Action'' alternative, which would maintain the continued regulatory
prohibition of the importation of ruminants, ruminant products,
ruminant by-products from Canada and from any other country or region
that could eventually be classified as a BSE minimal-risk region
pursuant to the rulemaking and (2) the preferred alternative, which
will allow for the importation of certain ruminant products and by-
products and certain ruminants, providing the country or region seeking
recognition as a BSE minimal-risk region demonstrates that it meets the
relevant factors consistent with standards recommended by the OIE.
The environmental issues involved in this rulemaking, including
those raised in comments on the two EAs as well as in litigation, are
discussed below.
A. The Degree to Which the Action May Affect Public Health or Safety
The introduction of BSE into the United States has the potential to
affect both human and animal health. BSE, commonly known as ``mad cow
disease,'' is a disease that belongs to a family of mostly very rare
diseases known as TSEs. Cases of BSE in cattle were first reported in
the UK in 1986. To date, over 95 percent of all known BSE cases
worldwide have occurred in the UK. Within cattle herds, BSE is not
contagious and does not spread from animal to animal. It is spread to
cattle primarily through the consumption of animal feed containing
protein from ruminants infected with BSE. In 1996, a new disease,
variant Creutzfeldt-Jakob disease or vCJD, was detected in humans and
linked to the BSE epidemic in cattle. Consumption of cattle products
contaminated with the BSE agent is reported to be the cause of vCJD.
Approximately 153 cases of vCJD have been identified worldwide and 95
percent of these cases have been linked to exposure in the UK. When
compared with the significant number of cattle exposed to BSE, the
relatively small number of cases of vCJD indicates a substantial
species barrier that protects humans from widespread illness due to BSE
exposure.
As previously discussed, the MRR rule amends APHIS' regulations to
allow the importation of certain ruminants, ruminant products and by-
products from regions that pose a minimal risk for BSE. The rule will
preclude introduction of BSE into the United States and will ensure the
protection of domestic livestock and the food supply. The MRR rule is
fully consistent with the guidelines and recommendations of the OIE for
trade in animals and animal products from BSE-affected countries.
In determining whether it was necessary to continue the
prohibitions and restrictions on imports from Canada pursuant to the
Animal Health Protection Act, APHIS analyzed the risks associated with
such imports. The analysis is consistent with OIE guidelines and the
internationally recommended components for animal health import risk
analysis. The risk analysis drew on a number of sources of information,
including: Previous analyses of risk conducted by APHIS; scientific
literature; results of epidemiological investigations; data provided by
the Canadian Government; a quantitative analysis of the risk of BSE in
Canada; quantitative analyses of the consequences of BSE being
introduced into the United States; measures implemented by USDA's Food
Safety and Inspection Service (FSIS) and the U.S. Department of Health
and Human Services' Food and Drug Administration (FDA) to protect
against human exposure to the BSE agent in the United States; reports
by international review teams; and the BSE guidelines adopted by the
OIE. The determination to allow imports of certain Canadian ruminants
and ruminant products was based on a thorough evaluation of the BSE
risk in Canada, the potential for BSE infectivity to be introduced into
the United States, the potential spread of BSE in cattle and possible
human exposure if BSE infectivity were introduced into the United
States, and the likelihood that BSE could become established in the
United States.
A great deal is now known about BSE. There is a strong scientific
consensus about the BSE agent, the mechanisms for its spread, and the
tissues that are most likely to harbor the infective agent. Scientific
research, backed by practical experience, has resulted in a defined
series of measures that countries can use to keep the BSE agent out of
the food and feed chain and thus ensure the safety of animal and public
health. APHIS has concluded that such measures are in place in Canada
and the United States. The risk analysis contains a comprehensive
discussion of the facts and circumstances relevant to Canada's BSE
status and of the mitigation measures in place in both Canada and the
United States that will ensure that BSE is not introduced into the
United States. The critical country-of-origin factors leading to APHIS'
conclusion and this finding of no significant impact are:
1. Import Restrictions--Canada has implemented effective methods
for preventing the introduction of BSE into its herd by restricting the
importation of live ruminants and meat-and-bone meal from any country
that had not been recognized as BSE-free following a comprehensive risk
assessment.
2. Surveillance--Canada has been actively monitoring for BSE in its
herd since 1992 and has met or exceeded the OIE recommended level of
BSE surveillance for the past 7 years. The number of cattle tested
annually has steadily increased over the years, and in 2003,
approximately 5,700 cattle were tested. In 2004, more than 23,500
animals were tested. In 2005, more than 14,000 samples were tested as
of March 23.
3. Feed Ban--Canada and the United States implemented substantially
identical feed bans simultaneously in 1997 that prohibit the feeding of
mammalian protein to ruminants. Canada's feed ban is more stringent
than the feed ban in the United States, as it prohibits the use of
plate waste and poultry litter in ruminant feed. The Canadian feed ban
has been effective and has a strong compliance and enforcement
component. It is also important to note that Canada established its
feed ban 6 years before identifying its first case of BSE in May 2003.
4. Epidemiological Investigations--Canada has the capacity to
conduct, and has conducted, rigorous investigations of its BSE
findings. These investigations have included trace-outs of cattle that
may have been exposed to the same feed sources as infected cattle and
of rendered protein products that could have included the tissues from
the infected animals. These investigations have been successful due in
part to the mandatory cattle identification program in Canada.
5. Removal of SRMs--Both Canada and the United States require the
removal at slaughter of SRMs--those tissues most likely to harbor the
BSE infective agent--and prohibit the use of SRMs in human food.
In addition, there are several biological factors that support the
finding herein with specific reference to the importation of live
animals and animal products. These factors include: The age of the
animal, tissue distribution and infectivity, and feed source and
exposure. Our findings with respect to these factors are detailed in
the final risk analysis associated with this final rule.\8\
Furthermore, as explained in the exposure assessment
[[Page 18257]]
component of the risk analysis, our evaluation of slaughter controls in
place in both the United States and Canada, rendering inactivation
factors, feed manufacturing controls both in the United States and
Canada, and of the likelihood that an animal would ingest an infectious
dose and would develop the disease provides further support for our
finding of no significant impact.
---------------------------------------------------------------------------
\8\ See ``Analysis of Risk--Update for the Final Rule: Bovine
Spongiform Encephalopathy; Minimal Risk Regions and Importation of
Commodities, December 2004,'' pp. 11-17.
---------------------------------------------------------------------------
Finally, the additional post-entry mitigation measures imposed by
the final rule enhance protection of animal and human health and
further ensure that there will be no significant impacts. The MRR rule
requires that live cattle under 30 months of age can only enter the
United States for immediate slaughter or for feeding and slaughter.
Movement of these cattle is carefully controlled by requiring each
animal to have permanent identification that identifies its country of
origin, and a special permit designed to account for the inventory of
cattle consigned to their point of destination. The rule, therefore,
ensures that those cattle are identified and remain accounted for
through slaughter.
Based on all these factors, APHIS concluded that there was no
scientific basis to believe that the importation from Canada of live
ruminants (including cattle less than 30 months of age) and ruminant
products (including beef products and byproducts) in accordance with
the conditions required in the rule pose any risk of introducing BSE
into the United States. For all the reasons discussed in section VI.A.
of the final EA, the safeguards in place in both the United States and
Canada, coupled with the additional risk mitigation measures required
in the MRR rule fully protect both animal and public health.
B. The Degree to Which the Effects on the Quality of the Human
Environment Are Likely To Be Highly Controversial or the Degree to
Which the Possible Effects on the Human Environment Are Highly
Uncertain or Involve Unique or Unknown Risks
Controversy exists when substantial questions are raised as to
whether an action may cause significant degradation of an environmental
factor. In the context of an EA under NEPA, controversy refers not to
the existence of public opposition, but to a substantial dispute about
the size, nature, or effect of the action. Even if an action is
projected to have a controversial effect, the agency nonetheless has
the discretion to be guided by the expertise and judgment, as well as
the practical experience, of its own experts. There is a presumption in
favor of the agency's expert advice and guidance.
In the case of the MRR rule, there is no significant controversy
with regard to the science underlying the mitigation measures that form
the basis of the rule, and the effectiveness of the mitigation measures
that are in place in Canada and the United States or prescribed as
additional requirements in this rule. While questions remain about BSE
and research continues on BSE as it does for many animal diseases,
there is substantial knowledge about the disease and effective
mitigation measures, and a solid scientific consensus among animal
health experts both in the United States and internationally. Based
upon this substantial body of scientific research, field
epidemiological investigations and years of practical experience and
observations by animal health authorities, very effective measures have
been identified to prevent the introduction and spread of BSE and these
measures have been put in place in the United States and Canada and are
embodied in the MRR rule.
Two principal concerns are expressed in comments filed on the EA in
opposition to the MRR rule. First is the perceived risk that BSE would
be introduced into domestic cattle and, second, that vCJD could occur
as a result of such introduction or through the import of meat products
from Canada. APHIS has concluded that the MRR rule will preclude the
introduction of BSE and that the comprehensive animal and public health
measures in place in Canada and in the United States will prevent these
effects from occurring. In this regard, we must note that while APHIS'
principal responsibilities encompass animal and plant health, FSIS and
the FDA are the agencies principally responsible for public health and
food safety. Both of these agencies have implemented regulations to
ensure that the BSE agent does not enter either the human or the
ruminant food chain.\9\ In developing the MRR rule and in preparing the
EA, APHIS consulted with both FSIS and FDA.
---------------------------------------------------------------------------
\9\ See: FSIS' interim final rule published in the Federal
Register on January 12, 2004, titled ``Prohibition on the Use of
Specified Risk Materials for Human Food and Requirements for the
Disposition of Non-Ambulatory Disabled Cattle'' (69 FR 1874-1885,
FSIS Docket No. 03-025IF,); FDA interim final rule published in the
Federal Register on July 14, 2004, titled ``Use of Materials Derived
from Cattle in Human Food and Cosmetics'' (69 FR 42255, FDA Docket
No. 2004N-0081); FDA's ruminant feed regulations in 21 CFR 589.2000;
and an advance notice of proposed rulemaking issued jointly by FDA,
FSIS, and APHIS in the Federal Register on July 14, 2004, titled
``Federal Measures to Mitigate BSE Risks: Considerations for Further
Action'' (69 FR 42288-42300, FDA Docket No. 2004N-0264, FSIS Docket
No. 04-021ANPR, APHIS Docket No. 04-047-1).
---------------------------------------------------------------------------
This rule is based upon and is fully consistent with an
international scientific consensus that is embodied in the guidelines
and recommendations of the OIE. OIE is the internationally recognized
authority on animal health issues and currently has 167 member
countries, including the United States and Canada. OIE develops and
publishes standards, guidelines and recommendations for international
trade in animals and animal products. These standards and guidelines
are recognized by the World Trade Organization as the reference
international animal health rules for animal diseases and zoonoses and
they are codified in the Terrestrial Animal Health Code and the Aquatic
Animal Health Code. The standards, guidelines and recommendations are
developed by specialist commissions and experts based on the latest and
best available scientific research and data and are adopted by
consensus of the OIE member countries. The aim of the Terrestrial
Animal Health Code is to facilitate the safe international trade of
animals and animal products. This is achieved through recommendations
on risk management measures for specific diseases to be used by
national veterinary authorities or other competent authorities of
importing and exporting countries when establishing health regulations
for the safe importation of animals and animal products. The aim of the
OIE's work in this regard is to avoid the transfer of agents pathogenic
for animals and humans, without the imposition of unjustified trade
restrictions. With respect to the OIE guidelines for BSE, it is
important to note that the OIE does not recommend that an importing
country completely ban the importation of live cattle and meat products
even when the importing country determines that the exporting country
has a high BSE risk status. For the details of the BSE chapter of the
Terrestrial Animal Health Code, see http://www.oie.int/eng/publicat/en_code.htm
.
Many of the 13 commenters on the final EA opposed implementation of
the MRR rule out of a concern that BSE would be introduced into the
United States, a concern raised in part by the 2 confirmed cases of BSE
in Canada in January 2005. These commenters did not elaborate on the
basis for their concern or whether they disagreed with the scientific
foundation of the MRR rule. On the other hand, some commenters who
expressed concerns about the implementation of the MRR rule
acknowledged, implicitly or explicitly, the validity of the scientific
[[Page 18258]]
approach embodied in the rule but urged the agency to ensure that the
measures the agency relies upon have been effectively implemented. For
example, the state farm bureau federation urged that USDA ``investigate
and confirm'' that the current feed ban is being effectively enforced
prior to opening the border with Canada. Additionally, the federation
urged that USDA assess whether Canada's surveillance program is
adequate.
Four cases of BSE have been detected in Canadian-origin cattle. The
first two positive cases were detected in 2003 and two cases have been
detected in 2005. On January 2, 2005, Canada announced that it had
confirmed a case of BSE in an 8-year-old dairy cow in Alberta, Canada.
The following week, on January 11, 2005, Canada announced that it
had confirmed a case of BSE in a beef cow in Alberta that was born
shortly after the implementation of the feed ban in 1997. Because the
cow was born shortly after the implementation of the feed ban and, in
addition, to determine if there were any previously unidentified
potential links, the USDA sent two technical teams to Canada to
evaluate the circumstances surrounding these two recent BSE findings.
One team, consisting of USDA and FDA officials, was responsible for
conducting an in-depth assessment of Canada's feed ban, and the other
team focused on the epidemiological investigations of the positive
cases.
In preparing the MRR rule, Canada's compliance with the feed ban
was thoroughly considered and discussed. Canada implemented its feed
ban in 1997 to prohibit the feeding of most mammalian protein to
ruminants. Canada's feed ban is virtually identical to the feed ban in
place in the United States, except that Canada has extended its ban by
prohibiting plate waste and poultry litter from being fed to ruminants.
APHIS concluded, based on this thorough assessment, that Canada has had
an effective feed ban in place in the rendering, feed manufacturing and
livestock industries. (70 FR 467-468, APHIS Docket No. 03-080-3;
``Analysis of Risk-Update for the Final Rule: Bovine Spongiform
Encephalopathy; Minimal Risk Regions and Importation of Commodities,
December 2004,'' pp. 7-10; see also BSE in Canada Status Update--March,
2005, which can be found at http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/200503canadae.shtml.
)
On February 25, 2005, USDA published its assessment of the Canadian
feed ban. The team concluded, based on its review of inspection records
for the last 3 years and on-site inspections of commercial feed mills
and rendering facilities, that Canada has a robust inspection program
with strong enforcement, that overall compliance with the feed ban is
good, and that the feed ban is effectively reducing the risk of
transmission of BSE. (http://www.aphis.usda.gov/lpa/issues/bse/bse.html.
) The team's report confirmed the APHIS evaluation of Canada's
feed ban which supported the MRR rule.
It is important to note that in 1997, BSE had not been detected in
North America, and the feed bans implemented by Canada and the United
States were precautionary measures. As a result, neither government
required that existing feed stocks be recalled. In Canada specifically,
the feed ban was implemented with provisions for a phase-in period so
that existing stocks of feed material could be depleted. It is likely
that the Canadian feed ban took some time to be implemented completely
throughout the feed manufacturing industry, as did the United States'
feed ban. This would be expected in implementing a new, comprehensive
regulatory program.
With respect to the two most recent positive BSE cases, the
Canadian government confirmed that the animal identified as positive on
January 2nd was exposed to feed rations containing meat and bone meal
that was produced prior to the 1997 feed ban. This animal was born in
October 1996 and was exposed to rations that contained meat and bone
meal in early 1997, before the feed ban was implemented. In the case
confirmed on January 11th, the Canadian investigation concluded that
BSE may have been transmitted to the affected animal through feed
produced shortly after the feed ban was implemented. As described in
the previous paragraph, since an extensive change in industry practices
cannot be expected to be completed immediately, a finding of BSE in an
animal born shortly after the feed ban would not be unexpected and
would not be inconsistent with the risk analysis supporting the final
rule. (See BSE in Canada Status Update--March, 2005, which can be found
at http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/200503canadae.shtml.
See also the summary report of the CFIA
investigation of the January 2, 2005, case of BSE at http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/ab2005/2investe.shtml
and the summary report of the CFIA investigation of the
January 11, 2005, case of BSE at http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/ab2005/3investe.shtml.
)
The possibility of additional BSE positive animals was understood
and carefully considered by APHIS in the risk analysis and in our
determination that Canada qualifies as a minimal-risk region. In our
final rule (70 FR 514), we acknowledged the possibility that additional
BSE-infected cattle might exist in Canada and explained the reason for
our confidence that the number of such additional infected animals, if
any, would be small. First, Canada has not imported ruminant MBM from
any country with BSE since 1978. Second, Canada has prohibited the
feeding of ruminant MBM to ruminants since 1997, and CFIA has verified
high levels of compliance with the feed ban by routine inspections of
both renderers and feed mills. Third, Canada has traced and destroyed
all remaining cattle imported from the UK. Fourth, Canada has traced
and destroyed the majority of the cattle that comprised the birth
cohorts of the two initial Canadian BSE cases, as it has subsequently
done with the birth cohorts of the two most recent cases. Fifth, Canada
has conducted surveillance for BSE since 1992 and has conducted
targeted surveillance at levels that have met or exceeded OIE
guidelines since 1995.
As we explained in our final rule, even if BSE-infected cattle do
remain in Canada, they are likely to be older animals that were exposed
before Canada's feed ban in 1997. Because this rule requires that
imported animals be less than 30 months old, such animals could not
legally enter the United States under this rule. Further, even if an
infected animal did enter the United States, the science, the research,
and the experience of animal and public health authorities, supported
by the Harvard-Tuskegee Study indicates it would be very unlikely to
lead to the introduction of BSE into domestic cattle or to human
exposure to the BSE agent.
Several commenters on the EA questioned Canada's feed ban due to
press reports published in December 2004 that revealed that animal
protein of undetermined origin had been found by CFIA in ruminant feed.
As part of its ongoing compliance and enforcement program, the CFIA
conducted a small feed sampling and testing program to evaluate the
usefulness of direct microscopy. CFIA concluded that microscopy was not
capable of distinguishing between animal tissues that pose no animal
health risk and those that are prohibited under Canada's
[[Page 18259]]
feed ban regulations. In following up on the microscopy results, the
CFIA concluded the great majority of samples did not contain prohibited
material. Of the 110 samples tested, 65 samples were of Canadian
origin, 44 samples were from the United States, and one was from
France. Of the 65 samples of Canadian origin, the CFIA was unable to
rule out the possibility that some incidental level of prohibited
material may have been present in 11 samples. Of the 45 imported
samples, animal material was detected in 18. With respect to the
Canadian origin samples, the CFIA has taken action to ensure that the
establishments involved have improved their recordkeeping, flushing,
and/or sequencing procedures. (http://www.inspection.gc.ca/english/anima/feebet/rumin/microe.shtml.
) Based on our extensive experience and
interaction with CFIA program officials over many years, the thorough
Canadian report on the microscopy sampling and testing program, as well
as the results of the APHIS feed team inquiry, APHIS has concluded that
the Canadian feed ban is effective and will accomplish its objective of
reducing and eliminating any BSE infectivity that may remain in Canada.
As noted above, several commenters expressed concern that the MRR
rule could result in the introduction of BSE into the domestic herd and
that vCJD could occur as a result of such introduction or through the
import of meat products from Canada. With regard to this concern, there
is a solid scientific consensus regarding our knowledge of the cattle
tissues that contain BSE infectivity and our knowledge of the modes of
transmission of that infectivity. While it is likely that ongoing
research will increase our knowledge of the disease agent, APHIS, along
with FSIS and FDA, are confident that the measures in place will
protect animal and human health. In addition, it seems clear that there
is a significant species barrier that protects humans from illness due
to exposure to the BSE agent. European scientists working on the
outbreak in the UK and subsequent BSE research have suggested that the
amount of infective tissue required to infect humans may be 10,000
times greater than the amount needed to infect cattle. During the
epidemic in the UK, it was estimated that there were approximately 1
million infected animals and yet, to date, there have been only
approximately 153 vCJD cases worldwide, 95 percent of which have
occurred in the UK. Current research does not suggest the need for
further food safety mitigations and does not alter the conclusion that
the appropriate tissues that can carry levels of infectivity sufficient
to cause human or animal illness are, in fact, being removed from the
animal and human food supply under U.S. and Canadian regulations.
One commenter suggested the need for further assessment of the
persistence of the BSE agent in soil, water and air. To date, there is
no evidence of environmental transmission of the BSE agent. While such
transmission could be theoretically possible, epidemiological reviews
do not indicate that such transmissions, even if they occurred, would
be a significant issue. In the UK, which has experienced the largest
and most significant outbreak, early epidemiological investigations
pinpointed feed as the route of transmission. In response to these
findings, the UK authorities instituted feed ban regulations that have
been strengthened over the years. The feed restrictions have clearly
had an effect in preventing transmission of disease, with the number of
cases identified annually continuing to decrease from a peak in 1992-
1993. Investigations have been done on animals born after the
reinforced ban went into effect. These have included evaluating all
possible routes of transmission, and they continue to conclude that
environmental contamination is an unlikely risk factor. Therefore,
based on the best available science, the ability of the BSE agent to
persist in soil, water and air is not a significant issue.
While there is evidence that scrapie disease in sheep and chronic
wasting disease (CWD) in cervids can be transmitted by environmental
contamination, there is no basis for extrapolating these data to BSE in
cattle. Research has demonstrated that the distribution of scrapie
infectivity in sheep is different than the BSE agent in cattle. For
example, infectivity has been found in the placenta of sheep infected
with scrapie. This contributes to the lateral transmission (animal-to-
animal) of scrapie in sheep, and if placental tissue remains in the
environment, it can contribute to environmental contamination.
Conversely, in cattle infected with BSE, no infectivity has been
demonstrated in placenta and there is no evidence of lateral
transmission of the disease. Similarly, animal-to-animal contact
appears to contribute to the spread of CWD in cervids, and
environmental contamination also appears to be a factor, although the
specific means of transmission is unknown. However, these findings
cannot be extrapolated to cattle with BSE, as there is no evidence of
lateral transmission of BSE or of transmission by environmental
contamination.
C. The Degree to Which the Action May Establish a Precedent for Future
Action With Significant Effects or Represent a Decision in Principle
About a Future Consideration
This criterion requires consideration of whether an action may
establish an authoritative rule, pattern, or practice for similar cases
that may follow and whether the precedent thereby established could
have significant effects on the quality of the human environment.
The MRR rule establishes standards for recognizing regions as
presenting a minimal risk of introducing BSE into the United States and
provides for the importation of certain ruminants, ruminant products
and byproducts from such regions. The minimal-risk region standards and
import conditions established by APHIS are designed to prevent the
introduction of BSE into the United States. These standards and
conditions are buttressed by a series of interlocking, overlapping risk
mitigations in place in the United States. The addition of this
minimal-risk category to the agency's BSE rules will permit regions
that believe they meet the standards to request recognition as a BSE
minimal-risk region. We would expect and require that any such request
will, in the first instance, comply with Sec. 92.2 of the APHIS
regulations, which contains the general procedures for requesting the
recognition of regions. (9 CFR 92.2.) The MRR rule, however, designates
Canada as the only minimal-risk region for BSE. Before another country
or region would be recognized as a BSE minimal-risk region, APHIS would
conduct an assessment of all risks involved. If the risk assessment
indicated that the region meets the standards and appropriate
requirements, APHIS would publish a proposal in the Federal Register.
At that point, the public would have an opportunity to participate
fully and all pertinent issues, questions, and concerns would be
addressed in the rulemaking process. Needless to say, any unusual or
unique facts or circumstances related to a particular region's request
would be carefully evaluated by APHIS as well. For example, the animals
or animal products allowed to be imported and the required risk
mitigation measures could and would be tailored to each specific region
considered. Accordingly, the MRR rule does not establish a precedent
for future actions with significant effects or represent a decision in
principle about future
[[Page 18260]]
approval of additional minimal-risk regions.
D. Whether the Action Is Related to Other Actions With Individually
Insignificant but Cumulatively Significant Impacts
The term cumulative impact is defined as an impact on the
environment that results from the incremental impact of the action when
added to other past, present, and reasonably foreseeable future actions
regardless of what agency or person undertakes such other actions.
Cumulative impacts can result from individually minor but collectively
significant actions taking place over a period of time.
The potential for harm to the quality of the human environment lies
in the introduction of the BSE agent into the United States and
subsequently finding its way into the animal and human food supply
where it could be ingested and result in infection. For this chain of
events to occur, the multiple animal and human health mitigation
measures in place in Canada and the United States, as well as the
additional mitigations prescribed by the MRR rule, would have to
substantially fail. There is no basis to conclude that such a
significant breakdown in the system of interlocking and overlapping
measures could ever occur. Similarly, if the agency were to recognize
any other regions as minimal-risk regions, there is no reason to
believe that the mitigation measures and other requirements imposed in
such a rulemaking would be any more likely to be breached and result in
harm to animal or human health. It must be remembered that our MRR rule
is designed to preclude the introduction of BSE into the United States
and APHIS has concluded that the rule will achieve that result.
Accordingly, there is no basis to believe that this action, or future
actions that the agency may take, could result in cumulatively
significant environmental impacts.
Additional Issues: Allegations of Environmental Impacts Raised in
Litigation
Shortly after issuance of the final EA for the MRR rule, the
Ranchers-Cattlemen Action Legal Fund, United Stockgrowers of America
(``R-CALF''), filed a complaint challenging the rule in the United
States District Court for the District of Montana. R-CALF alleged that
the final EA was inadequate because, among other things, it failed to
assess the environmental effects of transporting what we estimated
would be as many as 2 million head of cattle from farms and feedlots in
Canada to feedlots and slaughterhouses in the United States, as well as
the environmental impacts of feeding and holding these additional
feeder cattle until slaughter. Although the plaintiff filed several
comments on the rule throughout this rulemaking proceeding, it did not
include these concerns in these comments, nor did it file any comment
on the final EA published on January 4, 2005. In addition, no other
commenter on the EAs raised these potential environmental impact
issues. Even though the alleged potential effects pose no significant
environmental impact, and were not raised by R-CALF or any other
commenter on the EA, we have addressed them below.
The two issues raised by R-CALF did not, and do not now, pose
potentially significant impacts. Accordingly, they were not discussed
in the final EA. First, it is important to note that the impacts or
effects alleged by R-CALF to be significant are not brought about or
caused by the MRR final rule. Second, it is also important to
understand the MRR rule within the context of the economic relationship
that has existed between Canada and the United States for many years.
Since the 1970's, the U.S. and Canadian cattle and beef industries
operated largely as an integrated North American industry, with both
live cattle and processed beef flowing freely between the two
countries. For years prior to May 2003, millions of head of live cattle
crossed the border in one direction or the other. The two countries
have become each other's largest trading partners in agricultural
products.
In May 2003, as a result of the finding of BSE in Canada, APHIS
published an interim rule to add Canada to the list of countries in
which BSE exists. APHIS took this action as a temporary measure while
it assessed the facts and circumstances surrounding the BSE situation
in Canada. After evaluating the epidemiological investigation of the
May 2003 BSE positive cow and after reviewing the BSE risk mitigation
measures in place in Canada and the United States, USDA announced in
August 2003 that it would begin issuing permits, pursuant to its
existing regulations, to allow the importation of certain low-risk meat
products from Canada. These products included boneless beef from cattle
under 30 months of age, veal, and bovine liver. As a result, within 3
months, a substantial amount of trade in beef and beef products was
resumed with Canada. In November 2003, APHIS issued a proposed rule
that would again allow the importation of certain live animals,
including cattle under 30 months of age, as well as all beef products
from cattle under 30 months of age, from Canada. Therefore, the MRR
rule would allow the restoration of trade in ruminants and ruminant
products under approved mitigations after a temporary suspension of
such trade.
The final economic analysis for the MRR rule estimated that as many
as 2 million head of cattle could be imported from Canada in 2005,
assuming implementation of the MRR rule at the beginning of the year.
This estimate was based on historical cattle import data from 2001 and
2002, an estimated backlog of cattle in Canada as a result of the
temporary closure of the border to live cattle in 2003, and an estimate
of the number of cattle under 30 months of age that would be available
for importation into the United States because of an increase in the
number of older cattle that would be slaughtered in Canada for the
export of beef to the United States. We acknowledged that there was a
good deal of uncertainty in projecting the number of cattle that would
be imported from Canada and that changes in production, feeding,
slaughter and trade patterns and circumstances could well affect the
result. In recognition of these uncertainties, we also conducted the
analysis using one-half of the assumed backlog and one-half of the
assumed number of imported fed cattle displaced from slaughter in
Canada.
Using the 2 million number, R-CALF estimated that the resumption of
limited trade in live cattle would result in 35,000 truck round-trips
between Canada and the United States. Assuming these would represent an
actual increase in trips involving live cattle and meat, the truck
traffic represented by this estimation is wholly insignificant. For
2003, the incoming truck crossings from Canada into the United States
totaled 13.3 million crossings, which included 6.7 million truck
crossings, 5.7 million loaded truck container crossings, and 0.9
million unloaded truck container crossings. (See http://www.bts.gov/programs/international/border_crossing_entry_data/.
) For 2002, the
total incoming truck crossings from Canada into the United States were
13.7 million crossings, which included 6.9 million truck crossings, 5.8
million loaded truck container crossings and 1.0 million unloaded truck
container crossings. (Id.) For 2001, the total incoming truck crossings
from Canada into the United States were 13.4 million crossings, which
included 6.8 million truck crossings, 5.6 million loaded truck
container crossings, and 1.0 million unloaded truck container
crossings. (Id.)
[[Page 18261]]
There is little variation in the annual volume of truck traffic
entering the United States from Canada over this 3-year period, and, in
addition, an increase of 35,000 truck crossings would be well within
the variation shown by the data. Even with an increase of 35,000 truck
round-trips between Canada and the United States, the total increase
would amount to approximately 1/4 of one percent increase in truck
traffic, an amount that is de minimus by any measure. An examination of
truck traffic through the 20 ports of entry through which importations
of live ruminants and ruminant products from Canada are authorized
under the MRR rule yields similar conclusions. The 2003 truck crossings
at the 20 ports of entry were approximately 11.1 million. (Id.)
Therefore, an increase of 35,000 truck crossings spread over just these
20 ports of entry would result in less than 1/3 of a one percent
increase. It is also important to note that truck traffic between the
United States and Canada is merely a subset of all vehicular traffic
between the two countries. When considering the total volume of all
vehicular traffic traveling across the border with Canada, the
environmental impacts associated with an increase of 35,000 truck
round-trips are even less significant. Accordingly, R-CALF's claim that
increased truck traffic would result in environmental damage is without
merit.
R-CALF also alleges that there will be significant environmental
effects attendant to the importation of live animals for feeding and
for slaughter. R-CALF asserts that these live cattle would be required
to be moved to a limited number of feedlots and slaughter facilities in
the United States. However, the final regulation contains no limitation
on the number of feedlots or slaughter facilities. The MRR rule is
merely restoring, for live cattle under 30 months, longstanding trade
with Canada, trade that has persisted for years and was only
temporarily halted in May 2003 due to the finding of BSE in Canada.
There is no reason to believe that these cattle would be destined for a
different set of feedlots or slaughter facilities than cattle imported
from Canada prior to 2003.
Whatever the potential environmental effects that theoretically
might be associated with the importation of live cattle for feeding or
for slaughter, there would be a significant difference in the magnitude
of such potential effects depending on whether the cattle were being
transported directly to slaughter facilities or were destined for
feedlots, where they may be fed for some period of time prior to moving
to slaughter. The potential environmental effects, while
inconsequential, would be significantly less for cattle moved
immediately to slaughter facilities. Based on historical data for
cattle imports from Canada, between 65 percent and 75 percent of
imported cattle have gone directly to slaughter and the remainder
(other than the very small number historically imported for breeding)
have been transported to feedlots and then to slaughter facilities.
Based on the projection in the final economic analysis of 2 million
cattle imported, approximately 1.4 million would be moved immediately
to slaughter and 600,000 feeder cattle would be moved to feedlots.
Subsequent to the estimates in the final economic analysis and
publication of the MRR rule, on February 9, 2005, the Secretary
announced that implementation of the part of the MRR rule that would
allow for importation of beef from cattle 30 months of age or older
would be delayed. Therefore, there was no longer a basis for assuming
the displacement from slaughter in Canada of cattle under 30 months of
age by cattle 30 months of age or older. The estimate of the number of
cattle that would be imported from Canada was revised downward. We
further modified the estimate downward to reflect an increase in
Canadian slaughter capacity over the past year. Therefore, based on
these factors, we estimated that as many as 1.4 million cattle could be
imported from Canada in the first year after the effective date of the
MRR rule. Of this number, we estimate that 900,000 fed cattle would be
moved directly to slaughter facilities and that 500,000 feeder cattle
would be sent to feedlots and then to slaughter, further reducing any
potential impacts.
On January 6, 2005, the National Cattlemen's Beef Association
(NCBA) sent a delegation of U.S. cattle producers to Canada on a fact-
finding mission regarding BSE and the MRR rule. One task assigned to
the NCBA delegation was to identify Canadian cattle that would qualify
for export under the MRR rule and determine the impact on U.S.
producers. The NCBA delegation report, dated February 2, 2005 (http://www.beefusa.org/uDocs/acf985911.pdf
) stated, based on Can-Fax data
gathered over a 20-month period of time, that there were approximately
900,000 head of cattle available for export. This consisted of
approximately 600,000-700,000 head of fed cattle and approximately
200,000-300,000 feeder cattle. The NCBA report suggested that the
import quantities assumed in APHIS' economic analysis were too high.
The NCBA report suggests that the APHIS estimate did not fully account
for the 22 percent increase in Canadian slaughter capacity between 2003
and 2004. The NCBA report concluded that the delegation agreed with
Can-Fax and other private sector estimates and put the likely imports
of feeder cattle in the range of 200,000-300,000 during calendar year
2005 and assumed that the MRR rule would be implemented on March 7,
2005.
Under either of APHIS' two estimates, any environmental effects
would not be significant. The average annual number of fed cattle
slaughtered for the years 2002 and 2003 in the United States was 29
million. Total cattle slaughter, which includes fed cattle, cows and
bulls, averaged 35.6 million head annually for the same period. Thus,
the estimated maximum imports of cattle for immediate slaughter would
amount to approximately 4.8 percent of the total fed cattle slaughter
and 3.9 percent of total cattle slaughter spread over a 12-month
period. For the years 2003 and 2004, an average of 26.9 million cattle
were marketed by U.S. feedlots annually. The estimated number of feeder
cattle that may be imported from Canada in the first year (500,000-
600,000 head) would represent between 1.8 and 2.2 percent of fed cattle
marketed annually in the United States. Even assuming that Canadian
feeder cattle actually imported after implementation of the MRR rule
represented an actual increase in the number of cattle on feed in the
United States, the potential effects would not be significant. The
transitory nature of even this volume of imports from Canada is
discussed in the final EA, where estimates that imports would decline
over the years 2006-2009 are discussed and displayed.
Furthermore, any potential impacts on air and water quality
associated with the importation of cattle from Canada are addressed
under an array of existing statutes and regulations in the United
States. These regulations include the National Pollutant Discharge
Elimination System Permit regulations and Effluent Limitation
Guidelines and Standards for Concentrated Animal Feeding Operations
(CAFO) under the Clean Water Act, as well as State environmental
regulations for proper management of manure and wastewater from animal
feedlot operations. In addition to state laws and regulations for air
emissions, there are a variety of provisions under the Clear Air Act
that could address air emissions relating to this activity. The U.S.
Environmental Protection Agency has also established requirements for
CAFOs under the
[[Page 18262]]
Clean Water Act and regarding nitrate contamination of underground
sources of drinking water under the Safe Drinking Water Act. The United
States' Clean Air Act and Canadian environmental protection laws have
vehicle emissions requirements that are designed to prevent harmful air
emissions from vehicles, including transport trucks. These activities
have a very low potential to negatively affect human health and safety
since each is subject to comprehensive environmental regulation in this
country and in Canada. Compliance with these requirements by
transporters, feedlot operators, and slaughterhouses assures that the
quality of the human environment will be safeguarded in all respects.
Our border ports are adequately staffed and capable of handling
movement of cattle into this country, which will not concentrate at a
single border port. Historically, Canadian cattle imported into the
United States for slaughter have been shipped to numerous States
throughout the United States. Because cattle are not required to be
shipped to specific feedlots or slaughter facilities, it is expected
that trucks will utilize all available border crossings and highway
routes. There is no evidence or data to suggest that our roadways,
feedlots, and slaughterhouses, as currently operated, cannot
accommodate the resumption of Canadian cattle imports in a manner that
fully protects all potentially impacted environmental quality values.
I have determined that the final BSE MRR rule will not have a
significant effect on the human environment and accordingly I have
decided that it is appropriate to issue a finding of no significant
impact for the final MRR rule. Thus, having fully considered the two
environmental assessments prepared for the MRR rule, as well as all of
the comments submitted on them, along with the reports and analyses
referenced in the EA and in the MRR rule, I conclude that the MRR rule
will protect animal and human health and the environment. Accordingly,
I find that adoption of the MRR final rule and the recognition of
Canada as a BSE minimal-risk region will not significantly affect the
quality of the human environment.
The finding of no significant impact was signed by Dr. W. Ron
DeHaven, Administrator, Animal and Plant Health Inspection Service, on
April 5, 2005.
Done in Washington, DC, this 5th day of April 2005.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 05-7141 Filed 4-7-05; 8:45 am]
BILLING CODE 3410-34-P