[Federal Register Volume 70, Number 239 (Wednesday, December 14, 2005)]
[Rules and Regulations]
[Pages 73905-73919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-24057]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 70, No. 239 / Wednesday, December 14, 2005 /
Rules and Regulations
[[Page 73905]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 94
[Docket No. 05-004-2]
RIN 0579-AB93
Importation of Whole Cuts of Boneless Beef From Japan
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the regulations governing the importation of
meat and other edible animal products by allowing, under certain
conditions, the importation of whole cuts of boneless beef from Japan.
We are taking this action in response to a request from the Government
of Japan and after conducting a risk analysis and considering public
comments. This action will allow the importation of beef from Japan
while continuing to protect against the introduction of bovine
spongiform encephalopathy into the United States.
EFFECTIVE DATE: December 12, 2005, 11:30 a.m.
FOR FURTHER INFORMATION CONTACT: Dr. Gary Colgrove, Director, National
Center for Import and Export, VS, APHIS, 4700 River Road Unit 38,
Riverdale, MD 20737-1231; (301) 734-4356.
SUPPLEMENTARY INFORMATION:
Background
The Animal and Plant Health Inspection Service (APHIS) of the
United States Department of Agriculture (USDA or the Department)
regulates the importation of animals and animal products into the
United States to guard against the introduction of animal diseases. The
regulations in 9 CFR parts 93, 94, 95, and 96 (referred to below as the
regulations) govern the importation of certain animals, birds, poultry,
meat, other animal products and byproducts, hay, and straw into the
United States in order to prevent the introduction of various animal
diseases, including bovine spongiform encephalopathy (BSE), a chronic
degenerative disease affecting the central nervous system of cattle.
On August 18, 2005, we published in the Federal Register (70 FR
48494-48500, Docket No. 05-004-1) a proposed rule to amend the
regulations governing the importation of meat and other edible animal
products by allowing, under certain conditions, the importation of
whole cuts of boneless beef from Japan. In that document, we explained
that the proposed rule was developed in response to a request from the
Government of Japan and after conducting an analysis of the risk that
indicated that whole cuts of boneless beef that are derived from cattle
born, raised, and slaughtered in Japan, could be imported into the
United States, provided that the following conditions have been met:
The beef is prepared in an establishment that is eligible
to have its products imported into the United States under the Federal
Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the regulations
in 9 CFR 327.2 and the beef meets all other applicable requirements of
the FMIA and regulations thereunder (9 CFR chapter III), including the
requirements for removal of specified risk materials (SRMs) and the
prohibition on the use of air-injection stunning devices prior to
slaughter on cattle from which the beef is derived.
The beef is derived from cattle that were not subjected to
a pithing process at slaughter.
An authorized veterinary official of the Government of
Japan certifies on an original certificate that the above conditions
have been met.
In our August 2005 proposed rule we explained that these conditions
would continue to protect against the introduction of BSE into the
United States.
We solicited comments concerning the proposed rule and supporting
risk analysis for 30 days ending September 19, 2005. We received 28
comments by that date. They were from cattlemen's associations,
producers, representatives of foreign governments, and private
citizens.
A number of commenters supported the rule in general but
recommended certain changes to the proposed provisions. Others comments
consisted only of recommended changes, objections to the rule in
general or to specific provisions, or requests for clarification. In
general, the comments we received on the proposed rule can be
categorized as follows:
Comments on the risk analysis;
Comments on the economic analysis;
Comments on the environmental analysis;
Comments on the proposed standards for the importation of
whole cuts of boneless beef from Japan; and
Comments on miscellaneous issues related to the proposed
rule.
We discuss these comments by topic below.
Risk Analysis for the Rulemaking
Incubation Period and Distribution of BSE in Cattle
Issue: One commenter stated that the APHIS risk analysis relied on
outdated and incomplete scientific evidence to conclude that BSE
infectivity is confined only to certain tissues and that infectivity in
such tissues does not occur until cattle reach the age of 32 months.
The commenter requested that, before APHIS proceeds with this
rulemaking, the Agency explain: (1) Why cattle under 30 months of age
do not present a risk of BSE, (2) why it is appropriate to base risk
management strategies on equivocal science, (3) why additional risk
mitigation measures are not needed to address the equivocal nature of
the science, and (4) why APHIS is not imposing additional measures to
address the potential risk of BSE infectivity in tissues that have not
been designated by the USDA's Food Safety and Inspection Service (FSIS)
as SRMs.
Response: We consider the BSE research upon which we based the
proposed rule and this final rule to be substantial and current, and
consider the mitigation measures in this rule to be appropriate based
on the research. We discussed the research upon which we based this
rulemaking in the risk document we made available with our August 2005
proposed rule. The key points are as follows:
[[Page 73906]]
The scope of this rulemaking is limited to whole cuts of boneless
beef derived from cattle born, raised, and slaughtered in Japan. BSE
infectivity has never been demonstrated in the muscle tissue of cattle
experimentally or naturally infected with BSE at any stage of the
disease. In tissues that have demonstrated BSE infectivity,
pathogenesis studies have illustrated that levels of infectious BSE
agent in certain tissues vary with the age of an animal. Infectivity
was not detected in most tissues in cattle until at least 32 months
post-exposure. The exception to this is the distal ileum (a part of the
intestines), where infectivity was confirmed in experimentally infected
cattle as early as 6 months post-exposure, and the tonsils, where
infectivity was confirmed at 10 months post-exposure. Consistent with
requirements established by FSIS and contained in 9 CFR part 310, we
proposed to require the removal of tissues that have demonstrated BSE
infectivity. (FSIS is the public health agency within USDA responsible
for ensuring the food safety of beef.) These tissues (referred to as
specified risk materials or SRMs) are the brain, skull, eyes,
trigeminal ganglia, spinal cord, vertebral column (excluding the
vertebrae of the tail, the transverse process 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 tonsils and distal ileum
of the small intestine of all cattle. In addition to requiring the
removal of SRMs, we proposed mitigation measures to address the
potential risk of cross-contamination of the beef with SRMs. These
requirements are based on currently available science and are
consistent with the international guidelines on BSE established by the
World Organization for Animal Health (formerly known as the Office
International des Epizooties (OIE)), which is recognized by the World
Trade Organization (WTO) as the international organization responsible
for the development of standards, guidelines, and recommendations with
respect to animal health and zoonoses (diseases that are transmissible
from animals to humans).\1\ For these reasons, we are not making any
changes to the rule based on this comment.
---------------------------------------------------------------------------
\1\ The OIE guidelines for trade in terrestrial animals
(mammals, birds, and bees) are detailed in the Terrestrial Animal
Health Code (available on the Internet at http://www.oie.int). The
guidelines on BSE are contained in Chapter 2.3.13 of the Code and
supplemented by Appendix 3.8.4 of the Code.
---------------------------------------------------------------------------
Peripheral Nerves
Issue: Two commenters stated that the underlying assumption of the
proposed rule, that whole cuts of boneless beef from Japan will not
contain tissues that may carry the BSE agent, is no longer valid
because researchers have found peripheral nervous system tissues,
including facial and sciatic nerves, that contain BSE infectivity.\2\
One of these commenters requested APHIS to explain whether and what
additional mitigation measures are needed to reduce the risks that
these tissues may be present in Japanese beef. This commenter further
requested an additional comment period to obtain public comment
regarding the manner by which APHIS intends to treat this new
scientific finding.
---------------------------------------------------------------------------
\2\ Bushmann, A., and Gruschup, M.; Highly Bovine Spongiform
Encephalopathy-Sensitive Transgenic Mice Confirm the Essential
Restriction of Infectivity to the Nervous System in Clinically
Diseased Cattle. The Journal of Infectious Diseases, 192: 934-42,
September 1, 2005.
---------------------------------------------------------------------------
Response: APHIS is familiar with the results of the study mentioned
by the commenters in which mice, genetically engineered to be highly
susceptible to BSE and to overexpress the bovine prion protein, were
inoculated with tissues from a BSE-infected cow. This study
demonstrated low levels of infectivity in the mouse assay in the facial
and sciatic nerves of the peripheral nervous system. APHIS has
evaluated these findings in the context of the potential occurrence of
infectivity in the peripheral nerves of cattle and the corresponding
risks of the presence of infectivity in such tissues resulting in
cattle or human exposure to the BSE agent. The results from these
experiments in genetically engineered mice should be interpreted with
caution, as the findings may be influenced by the overexpression of
prion proteins and may not accurately predict the natural distribution
of BSE infectivity in cattle. Further, the overexpression of prion
proteins in transgenic mice may not accurately mimic the natural
disease process because the transgenic overexpressing mice have been
shown to develop spontaneous lethal neurological disease involving
spongiform changes in the brain and muscle degeneration.\3\ In
addition, the route of administration to the mice was both
intraperitoneal and intracerebral, which are two very efficient routes
of infection as compared to oral consumption. Given these factors,
APHIS has determined that the finding of BSE infectivity in facial and
sciatic nerves of the transgenic mice is not directly applicable to
cattle naturally infected with BSE. Therefore, we do not consider it
necessary to make any adjustments to the risk analysis for this
rulemaking or to extend the comment period to solicit additional public
comment on this issue.
---------------------------------------------------------------------------
\3\ Westaway, D., et al.; (1994) Degeneration of Skeletal
Muscle, Peripheral Nerves, and the Central Nervous System in
Transgenic Mice Overexpressing Wild-type Prion Proteins. Cell 76,
117-129.
---------------------------------------------------------------------------
Blood
Issue: Two commenters expressed concern that there has been a
limited amount of research conducted on BSE infectivity in blood. One
of these commenters cited a report that discussed, among other things,
the detection of infectivity in sheep experimentally infected with BSE
via blood transfusions.\4\ This commenter also stated that the agent
that causes Creutzfeldt-Jakob disease (CJD), a chronic and fatal
neurodegenerative disease of humans, was detected in blood, and
questioned whether the BSE agent could be detected in blood as well.
The other commenter cited a study that detected infectivity in hamsters
experimentally infected with scrapie.\5\ This commenter requested that
APHIS ban the use of blood in cattle feed.
---------------------------------------------------------------------------
\4\ Pattison, J., et al.; UK Strategy for Research and
Development on Human and Animal Health Aspects of Transmissible
Spongiform Encephalopathies, 2005-2008. Available at http://www.mrc.ac.uk/pdf-about-tse_uk_strategy_june2005.pdf.
\5\ Castilla, J., et al.; Detection of Prions in Blood. Nature
Medicine, doi: 10.1038/nm1286, August 28, 2005, at 3.
---------------------------------------------------------------------------
Response: As stated in our risk analysis, the pathogenesis studies
of naturally and experimentally infected cattle have not detected BSE
infectivity in blood.
The first study mentioned by the commenter above demonstrated
transmission of disease from sheep experimentally infected with BSE to
another sheep via blood transfusions. We note that there are widely
acknowledged differences between the distribution of BSE infectivity in
the tissues of cattle and sheep. In addition, there is a significant
difference in susceptibility to infection based on the route of
transmission. Infection via oral consumption may be 10,000 times less
efficient than infection via intravenous injection, such as a blood
transfusion.
Both the United Kingdom's Department for Environment, Food and
Rural Affairs' Spongiform Encephalopathy Advisory Committee (SEAC) and
the European Commission's Scientific Steering Committee (SSC), which
are scientific advisory committees, evaluated the findings of
transmission of infectivity via blood transfusions in sheep
experimentally infected with BSE and concluded that
[[Page 73907]]
these findings did not indicate that additional mitigation measures
were necessary to protect public health.\6\ Therefore, based on
currently available information, APHIS considers it unlikely that the
experimental observations in sheep reflect a biologically significant
event for cattle or affect the safety of whole cuts of boneless beef
derived from cattle born, raised, and slaughtered in Japan.
---------------------------------------------------------------------------
\6\ Spongiform Encephalopathy Advisory Committee, Oct. 19, 2000,
Summary of SEAC Committee Meeting 29 September 2000. Available at
http://www.defra.gov.uk/news/seac/seac500.htm.
European Commission Scientific Steering Committee; The
Implications of the Recent Papers on Transmission of BSE by Blood
Transfusion in Sheep (Houston et al., 2000; Hunter et al., 2002),
Adopted by the SSC at its Meeting of 12-13 September. Available at
http://europa.eu.int/comm/food/fs/sc/ssc/out280_en.pdf.
---------------------------------------------------------------------------
The study on scrapie-infected hamsters noted by the commenter
describes a process by which the abnormal prion protein can be
amplified and detected using current testing methods, such as a Western
blot. In this study, blood from hamsters experimentally infected with a
scrapie strain was collected when the animals demonstrated clinical
signs of disease. These blood samples were incubated with excess normal
prion protein from brain tissue for multiple cycles. If abnormal
protein is present in blood, it will convert the normal brain prion to
abnormal prion, yielding an increased amount of abnormal prion that can
be more easily detected. In this manner, the presence of abnormal prion
protein in the initial blood samples, which was present in levels too
low to detect using routine test methods, was demonstrated. While this
finding has many possibilities related to the development of diagnostic
tests, it does not demonstrate BSE infectivity in blood. We also note
that the international community largely considers that studies using
transmissible spongiform encephalopathies (TSEs) other than BSE in non-
bovine animals cannot be directly extrapolated to BSE in cattle because
of the significant interactions between the host species and the prion
strain involved.
Feed regulations in the United States are under the authority of
the Food and Drug Administration (FDA), not APHIS. Therefore, the
commenter's request that APHIS ban the use of blood in cattle feed
falls outside the scope of this rulemaking. For these reasons, we are
not making any changes to the rule based on these comments.
Low Dose Exposure
Issue: One commenter cited new research indicating that infection
by the disease agent that causes BSE may be reached through the
accumulation of subinfectious doses over time.\7\ The commenter
expressed concern that this finding undercuts the risk analysis
prepared for this rulemaking, which, according to the commenter,
discussed evidence that BSE infectivity is caused by the consumption of
a single dose of infected tissue and that a low dose exposure has a
longer incubation period. This commenter requested APHIS to explain the
impact of these findings on its assessment of the risk posed by the
importation of boneless beef from Japan.
---------------------------------------------------------------------------
\7\ Jacquemot, C., et al.; High Incidence of Scrapie Induced by
Repeated Injections of Subinfectious Prion Doses. Journal of
Virology, July 2005, p. 8904-8908.
---------------------------------------------------------------------------
Response: Our risk analysis does not state, as stated by the
commenter, that ``BSE infectivity is caused by the consumption of a
single dose of infected tissue.'' Our risk analysis states that ``the
incubation period [of the BSE agent] is inversely related to dose
(i.e., low dose exposures have a long incubation period before clinical
signs of disease become apparent).'' This statement is based on
research conducted on BSE and is not meant to make a statement about
the number of doses necessary for cattle to become affected by the BSE
agent. Further, the findings noted by the commenter would not affect
the critical evaluation of risk on which our mitigation measures are
based. This rule will allow the importation of whole cuts of boneless
beef derived from cattle. Regardless of the infective dose or period of
incubation, BSE infectivity has never been demonstrated in the muscle
tissue of cattle experimentally or naturally infected with BSE at any
stage of the disease. Therefore, we are not making any changes to the
rule based on this comment.
Findings Related to Tissue Inflammation
Issue: One commenter requested that APHIS discuss the implications
of a recent study \8\ indicating that inflammation may act as a
modifier of natural and iatrogenic (experimental) prion transmission to
other organs and tissues not presently listed as SRMs and whether those
findings necessitate the implementation of additional risk mitigation
measures to reduce the risk of introducing BSE into the United States
from Japan.
---------------------------------------------------------------------------
\8\ Heikenwalder, M., et al.; Chronic Lymphocytic Inflammation
Specifies the Organ Tropism of Prions. Science, Vol. 37, February
18, 2005, 1107-1110.
---------------------------------------------------------------------------
Response: APHIS reviewed the study referred to by the commenter.
The study authors present results that show that chronic lymphocytic
inflammation enabled prion accumulation in certain otherwise prion-free
organs. The study authors postulate that chronic inflammatory condition
may act to modify natural and iatrogenic prion transmission by
expanding tissue distribution of prions. According to the authors, in
the inflammatory conditions studied, expression in two specific types
of lymphotoxins and a secondary lymphoid organ chemokine in certain
tissues was enough to establish ``unexpected'' prion reservoirs. APHIS
reviewed the findings from this study, which used transgenic mice, in
the context of the potential occurrence in cattle. We do not believe
that the study results can be extrapolated to cattle naturally infected
with BSE. First, the study used several transgenic and spontaneous
mouse models of chronic inflammation that were inoculated with scrapie
infectivity rather than BSE infectivity. The pathogenesis and
infectivity distribution of the scrapie agent in mice is different from
the BSE agent in cattle. Second, the mice in this study were injected
with scrapie prions through intraperitoneal and/or intracerebral routes
of inoculation, which are much more efficient routes than oral
consumption of a disease agent, the natural route for exposure of
cattle to the BSE agent. Finally, the study authors themselves did not
claim that the mouse models and results obtained in the study represent
a model for the pathogenesis of BSE in cattle. They stated that direct
evidence from similar studies using the BSE agent in cattle are needed
prior to concluding that chronic inflammatory conditions in cattle can
alter the distribution of the BSE agent. Therefore, we are making no
changes in the rule in response to this comment.
TSE Working Group
Issue: One commenter stated that the proposed rule and supporting
risk analysis should be evaluated by APHIS' TSE Working Group. The
commenter further requested that APHIS make available to the public a
report of the TSE Working Group's evaluation of the risk of BSE arising
from the proposed rule along with the Group's recommendations regarding
the actions that should be taken in response to these risks.
Response: APHIS has proceeded in a thorough and deliberative
manner, in cooperation with FSIS and FDA, to define the steps necessary
to protect animal and public health. The APHIS
[[Page 73908]]
TSE Working Group consists of APHIS employees with expertise in
veterinary science, epidemiology, import/export issue management,
pathobiology, veterinary biologics, and TSE program management. The
group has met in the past to assist and make recommendations to the
Deputy Administrator for APHIS' Veterinary Services, as well as other
managers, regarding animal health programs. The TSE Working Group is
not solely responsible for evaluating information and data regarding
BSE/TSE import regulations. That said, members of the TSE Working Group
who have special expertise in BSE participated in the development of
the risk analysis, either as contributing writers or reviewers of the
document. Their input was, therefore, considered by the Agency during
development of the proposed rule. Under these circumstances, we do not
believe it would be appropriate for the TSE Working Group to take on
the role suggested by the commenter.
Harvard-Tuskegee Investigation of BSE Risk in the United States
In April 1998, USDA contracted with the Harvard Center for Risk
Analysis (HCRA) at Harvard University and the Center for Computational
Epidemiology at Tuskegee University to conduct a comprehensive
investigation of BSE risk in the United States. The report,\9\ widely
referred to as the Harvard Risk Assessment or the Harvard Study, is
referred to in this document as the Harvard-Tuskegee Study. It was
completed in 2001 and released by the USDA. Following a peer review of
the Harvard-Tuskegee Study in 2002, the authors responded to the peer
review comments and released a revised risk assessment in 2003.\10\
---------------------------------------------------------------------------
\9\ Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University; Evaluation of the
Potential for Bovine Spongiform Encephalopathy in the United States.
Available at http://www.aphis.usda.gov/lpa/issues/bse/risk_assessment/mainreporttext.pdf, 2001.
\10\ Research Triangle Institute; Review of the Evaluation of
the Potential for Bovine Spongiform Encephalopathy in the United
States. Accessed online at http://www.aphis.usda.gov/lpa/issues/bse/BSE_Peer_Review.pdf, 2002.
Harvard Center for Risk Analysis, Harvard School of Public
Health; Evaluation of the Potential for Bovine Spongiform
Encephalopathy in the United States: Response to Reviewer Comments
Submitted by Research Triangle Institute. Available at http://www.aphis.usda.gov/lpa/issues/bse/ResponsetoComments.pdf, 2003.
Harvard Center for Risk Analysis, Harvard School of Public
Health, and Center for Computational Epidemiology, College of
Veterinary Medicine, Tuskegee University; Evaluation of the
Potential for Bovine Spongiform Encephalopathy in the United States.
Available at http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf,
2003.
---------------------------------------------------------------------------
Issue: One commenter expressed concern about the Harvard-Tuskegee
Study. In our risk analysis, we refer to the Harvard-Tuskegee Study in
our discussion of the risks associated with plate waste. The commenter
disagreed with the study's conclusion that the risk of BSE becoming
established in the United States is ``extremely unlikely.''
Specifically, this commenter noted that, with respect to the United
States' potential exposure to BSE before the 1989 import ban and 1997
feed ban, the Harvard-Tuskegee Study stated that, ``Exposure to
infectivity among U.S. cattle could not have been substantial because
in the years prior to the 1997 FDA feed ban, such exposure would have
eventually resulted in a substantial number of clinical cases, a
prediction that is inconsistent with the fact that BSE has not been
identified in the United States to date. There is therefore, a small
chance that BSE could have been introduced into the U.S. and remained
undetected.'' The commenter stated that the detection of a 12-year-old
BSE-positive cow native to the United States in June 2005 proves that
the Harvard-Tuskegee Study's assumption was in error, and that the
chance that BSE could have been introduced into the United States was
not small. The commenter also stated that, until and unless the
Secretary revises the Harvard-Tuskegee Study to correct the known,
erroneous assumptions underpinning the study, the Harvard-Tuskegee
Study is an inappropriate tool for accurately ascertaining the degree
of increased risk the United States would be subject to under the
proposed rule.
Response: We disagree with this commenter's interpretation of the
Harvard-Tuskegee Study's conclusion regarding the risk of BSE
establishment in the United States. First, the text extracted from the
Harvard-Tuskegee Study and quoted by the commenter states that `` * * *
such exposure would have eventually resulted in a substantial number of
clinical cases * * *.'' We do not consider one native case of BSE to
constitute a substantial number. In addition, the model used by the
Harvard-Tuskegee Study did not rely on a zero probability of BSE
incidence in the United States. The detection of BSE in a 12-year-old
cow does not invalidate the conclusions of the study nor our
conclusions about the level of risk posed by the importation of beef
from Japan under the proposed conditions. Furthermore, because this
rule applies only to whole cuts of boneless beef, and muscle tissue of
cattle has never demonstrated BSE infectivity, it is highly unlikely
that this meat will introduce BSE into the United States. The Harvard-
Tuskegee Study is referenced in the risk analysis only to address this
already remote risk.
APHIS considers the assumptions underpinning the study to be valid
and based on currently available science. As mentioned above, the USDA
commissioned the HCRA and the Center for Computational Epidemiology at
Tuskegee University to conduct what we now refer to as the Harvard-
Tuskegee Study in 1998. The objective of the Harvard-Tuskegee Study was
to analyze and evaluate the measures implemented by the U.S. Government
to prevent the spread of BSE in the United States and to reduce the
potential exposure of Americans to the BSE agent. The Harvard-Tuskegee
Study reviewed available scientific information related to BSE and
other TSEs, assessed pathways by which BSE could potentially spread in
the United States, and identified measures that could be taken to
protect human and animal health in the United States. The Harvard-
Tuskegee Study concluded that, if introduced, BSE is extremely unlikely
to become established in the United States. The Harvard-Tuskegee Study
also concluded that, should BSE enter the United States, only a small
amount of potentially infective tissues would likely reach the human
food supply and be available for human consumption. The HCRA recently
revised its model using updated estimates for some of the model
parameters, based on new data about compliance with feed restrictions.
The results are even lower estimates of risk than previously predicted.
Risk of BSE in General
Issue: Several commenters expressed concern regarding the risk
posed by boneless beef imported into the United States from Japan. One
commenter asked why the U.S. Government would propose to allow the
importation of boneless beef from Japan if there is any risk that it
could introduce BSE into the United States. One commenter stated that
APHIS failed to provide a basis for its conclusion that this increased
risk is acceptable.
Response: Zero risk is virtually, if not absolutely, impossible to
achieve. If we were to make trade dependent on zero risk, foreign, as
well as interstate, trade in animals and animal products would cease.
Consistent with international trade agreements, such as the WTO's
``Agreement on the Application of Sanitary and Phytosanitary Measures''
(WTO-SPS Agreement) and the North American Free Trade Agreement, APHIS
agrees that measures to protect human,
[[Page 73909]]
animal, and plant health should be no more trade restrictive than
necessary to achieve an appropriate level of protection. Under these
agreements, participating nations, including the United States and U.S.
trading partners, have agreed to base their measures, such as
conditions for importation, on science-based risk assessments and
international standards.
As discussed in our risk analysis, BSE infectivity has never been
demonstrated in the muscle tissue of cattle experimentally or naturally
infected with BSE at any stage of the disease. Therefore, if BSE is
present in a country's cattle population, as it is in Japan, the most
significant risk mitigation measure for ensuring the safety of whole
cuts of boneless beef is the prevention of cross-contamination of the
beef with SRMs during stunning and slaughter of cattle. The proposed
rule and this final rule include mitigation measures that address such
risks and are consistent with the international guidelines on BSE
established by the OIE.
U.S. Feed Ban
Issue: One commenter stated that the level of risk posed by beef
imported from Japan is unacceptable because the U.S. feed ban could
potentially result in the recycling of BSE in the United States. This
commenter requested that APHIS define ``small fraction'' and ``highly
diluted'' in our statements in the risk analysis about the amount of
imported beef that might, hypothetically, be fed to cattle, and the
potential concentration of any BSE agent, if present, that might be
available. The commenter further questioned whether these terms
describe an infectious level below 0.001 gram, which is the amount of
infected tissue research has shown to cause BSE infectivity. In
addition, the commenter asked how many doses may be expected to enter
the animal food chain, if the dose is greater than 0.001 gram.
Response: We disagree that the current feed regulations could
result in the recycling of BSE if introduced into the United States by
whole cuts of boneless beef from Japan. In our risk analysis, we
considered possible direct and indirect pathways by which whole cuts of
boneless beef imported from Japan might expose U.S. cattle to BSE if
the product contained the BSE agent. We discussed these pathways in the
context of barriers that exist to prevent these types of exposures. Our
discussion of these barriers was specifically prefaced by the fact that
whole cuts of boneless beef are an inherently low risk commodity
because BSE infectivity has never been demonstrated in muscle tissue in
cattle. In fact, we clearly stated that the primary barriers limiting
the likelihood that whole cuts of boneless beef imported from Japan
would expose the U.S. cattle population to BSE are the inherently low
risk of the product, the mitigation measures included in this rule to
prevent contamination, and the fact that the product is unlikely to be
fed to cattle. We further stated that although the product is not
intended for animal consumption, we evaluated pathways by which some
small fraction or amount of the product might inadvertently be fed to
cattle.
The amount of boneless beef that would be imported from Japan is
relatively small and the amount of material likely to be disposed of is
even smaller, given that household and restaurant food waste are
rarely, if ever, fed to cattle or rendered. These types of waste become
municipal garbage and are disposed of in landfills. Further, because
the FDA requires that plate waste be further heat processed before it
can be incorporated into ruminant feed, any potential plate waste
derived from boneless beef from Japan would most likely be subject to
rendering processes that would inactivate significant levels of the BSE
agent, thereby further reducing the level of infectivity in the feed.
Therefore, our risk analysis concluded that it is extremely unlikely
that imported material containing an infectious level of the BSE agent
will enter the ruminant feed chain. Because we do not consider these
pathways to be epidemiologically significant for exposure of the U.S.
cattle population to BSE infectivity in products imported under this
rule, we do not believe it is necessary to quantify a level of
infectious material that is theoretically possible, but highly
unlikely, to be present. For these reasons, we are making no changes to
the rule in response to this comment.
With regard to the commenter's request for APHIS to define ``small
fraction'' and ``highly diluted,'' in our statements in the risk
analysis about the amount of imported beef that might, hypothetically,
be fed to cattle, these terms were used to describe a small amount of
material and a small amount of material that is not concentrated,
respectively.
Issue: One commenter stated that APHIS' reliance upon heat-
processed rendering to inactivate BSE infectivity is misplaced because
the Harvard-Tuskegee Study makes no definitive finding that the
rendering processes used in the United States will inactivate the BSE
agent. This commenter stated that, in order to meet its duty to protect
the livestock in the United States from the introduction of BSE, the
FDA must first modify the U.S. feed ban to prevent the possible
recycling of any BSE infectivity imported from Japan. According to the
commenter, the U.S. feed ban includes exceptions for the feeding of
blood, poultry litter, and plate waste, the feeding of SRMs to farmed
animals, and does not require segregated facilities in the
manufacturing of animal feed. This commenter stated that these elements
of the feed ban must be eliminated before APHIS begins accepting beef
or cattle from any country where BSE is known to exist, including
Japan.
Response: The model used by the Harvard-Tuskegee Study included
assumptions about the types of rendering processes used in the United
States, and the amount of material subjected to these processes. There
are only a limited number of rendering processes in use, and research
has demonstrated that, with one exception, these processes inactivate
significant levels of the BSE agent. The one type of rendering system
that does not inactivate significant levels of the BSE agent, the low-
temperature vacuum system, is not widely used in the United States, if
at all. In fact, the Harvard-Tuskegee Study assumed that only 5 percent
of cattle carcasses rendered in the United States may be subject to
this process. APHIS does not rely solely on this inactivation, however,
in the analysis. A series of barriers, of which inactivation at
rendering is only one, must each be crossed in sequence for
transmission of BSE to occur. In fact, inactivation by rendering would
only be relevant if BSE-contaminated beef entered the United States and
entered the ruminant feed supply. Our analysis shows that neither event
is likely.
With regard to the commenter's statement that the FDA must modify
and broaden the U.S. feed ban to prevent the possible recycling of any
BSE infectivity imported from Japan, the Harvard-Tuskegee Study
demonstrates that with the existing feed ban, even with incomplete
compliance, the level of transmission of BSE from infected animals is
minimal, if it occurs at all. This rule only allows the importation of
whole cuts of boneless beef, a product that presents a very low risk of
BSE infectivity. Even if beef were imported with infectivity, all of
the sequential barriers to transmission-of which the feed ban is only
one-must be crossed in order for transmission to occur. Therefore, we
are making no changes to the rule in response to this comment.
[[Page 73910]]
Cross-Contamination
Issue: One commenter expressed concern that the current FSIS
regulations and policies do not fully address the possibility of cross-
contamination between SRMs and edible product in plants that
predominately slaughter cattle over 30 months of age. This commenter
stated that, although the current policies address the use of separate
equipment in cattle under 30 months versus those that are over this
age, they do not specifically address the issue of dedicated equipment
for the removal and trim of SRMs in plants slaughtering over-30-month-
old cattle. The commenter urged the USDA to include more specific
requirements in its regulations to prevent cross contamination between
SRMs and edible products. The commenter stated that these should
include, but not be limited to, requiring the use of separate
equipment, such as knives and blades, and utilizing effective TSE
disinfection procedures for equipment used to handle SRMs.
Response: The FSIS regulations contained in 9 CFR part 310 require
that establishments that slaughter/process cattle develop, implement,
and maintain written procedures for the removal, segregation, and
disposition of SRMs. These procedures address appropriately potential
cross-contamination of edible product with SRMs. FSIS inspectors are
responsible for verifying the effectiveness of the establishment's
procedures. If FSIS personnel determine that an establishment's
procedures are not effective in preventing cross-contamination, the
inspectors will take appropriate action.
Issue: One commenter expressed concern that infective tissue could
potentially contaminate additional carcasses via the use of saws in
carcass splitting. This commenter stated that this risk is too great
for consumers and the U.S. cattle industry. Another commenter requested
that APHIS explain the risk of introducing BSE into the United States
that may result from the potential for boneless beef to be contaminated
with BSE-infected tissues during the carcass-splitting process.
Response: As discussed in our risk analysis, cross-contamination
events represent potential pathways to contaminate whole cuts of
boneless beef. One potential event for such beef is cross-contamination
of carcasses with spinal cord during carcass splitting, as the saw cuts
the carcass in half.
FSIS has determined that the Japanese meat inspection system is
equivalent to that of the United States, and that the slaughter
mitigations applied in both systems would work similarly to reduce the
potential for contamination of whole cuts of boneless beef. For
example, the Japanese establishments, like U.S. establishments, remove
the vertebral column as a unit to reduce the likelihood of potentially
infective tissues contaminating the beef. The establishments also
remove spinal cord dura matter and wash the dressed carcasses after
splitting, and inspectors confirm that the carcasses are free of all
visually detectable evidence of contamination by spinal cord fragments.
Some establishments in Japan carry out suction removal of spinal cords
prior to carcass splitting, which further reduces the risk of
contamination. Finally, it should be noted that the whole cuts of
boneless beef that will be imported into the United States from Japan
are trimmed further, which again reduces any potential for
contamination.
Issue: One commenter stated that the proposed rule is arbitrary and
capricious because APHIS has not quantified the number of infectious
doses of BSE-infected material that can be expected to contaminate
boneless beef based on the scientifically known occurrence of
contamination resulting from carcass splitting. This commenter stated
that APHIS provides no basis for its conclusion that the increased risk
associated with importing meat from Japan that may be contaminated with
high risk tissues is acceptable.
Response: We disagree with the comment. Our proposed rule and the
risk analysis are scientifically sound. Many regulatory decisions do
not depend on numerical calculations or quantifications. What is
important is a careful, comprehensive characterization and evaluation
of the risk involved. Such an evaluation has been accomplished by APHIS
and is consistent with the methodology used in the risk analysis for
this rulemaking. With respect to the commenter's specific concern,
i.e., the quantification of infectious doses of BSE-infected material
that can be expected to contaminate whole cuts of boneless beef, there
currently is no reliable information to support a precise
quantification of a human infectious dose. However, there is a wide
body of independently verifiable scientific evidence regarding BSE,
including how to control and eliminate the disease. This rule requires
mitigation measures consistent with that information.
Issue: One commenter expressed concern that the proposal did not
address the risk of acceptable methods of stunning (other than air-
injection stunning and pithing, which are prohibited under this rule).
This commenter cited a report by the European Commission's TSE BSE Ad
Hoc Group that noted a theoretical risk that, when a healthy animal
that nevertheless has infectivity in the brain is stunned using a
penetrative method, there is the possibility that the bolt of the gun
could be contaminated and could introduce that infectivity into one or
more sequentially stunned animals, if stunned with the same gun.\11\
The commenter requested APHIS to specifically address what measures it
will put in place to address this risk.
---------------------------------------------------------------------------
\11\ Scientific Report on Stunning Methods and BSE Risks, TSE
BSE Ad Hoc Group, European Commission, December 13, 2001, at 41.
---------------------------------------------------------------------------
Response: We acknowledge the theoretical possibility that
infectivity in the brain of a BSE-infected bovine could potentially be
transferred from the head of one animal to the head of another animal
through the use of penetrating stunning methods. However, there is
currently no evidence that such contamination occurs during the
slaughter process. Further, as discussed in the background section of
our August 2005 proposed rule, we use the term, ``whole cuts of
boneless beef,'' to refer to meat derived from the skeletal muscle of a
bovine carcass, excluding all parts of the animal's head and diaphragm.
These restrictions ensure that penetrative stunning methods not
prohibited under this rule are not a risk factor for whole cuts of
boneless beef from Japan.
BSE Incidence in Japan
Issue: One commenter stated that the proposed rule did not take
into consideration the present and future BSE incidence rate in Japan.
This commenter stated that the rule should require that Japan
demonstrate that the incidence of BSE is declining and that no new
cases are discovered in animals born after the implementation of the
feed ban. The commenter stated that sufficient time has not yet lapsed
since Japan implemented its feed ban and other risk mitigation measures
to determine whether such measures have effectively arrested the spread
of BSE. Another commenter stated that Japanese beef is not safe based
on the incidence of BSE in Japan. Finally, one commenter stated that
Japan should be proven to be free from BSE for 7 years before the
United States should consider importing from Japan.
Response: We concur that at present it is not possible to know with
certainty whether any additional animals in Japan are infected with
BSE. However, as documented in our risk analysis, we
[[Page 73911]]
analyzed the likelihood that whole cuts of boneless beef imported from
Japan would: (1) Contain infectious levels of the BSE agent; and (2)
present a risk of exposing U.S. consumers or cattle to BSE, if the
imported beef product was contaminated with BSE. Based on the potential
pathways, we then determined appropriate mitigation measures to address
the risks associated with whole cuts of boneless beef imported from
Japan. BSE infectivity has never been demonstrated in the muscle tissue
of cattle infected with BSE at any stage of the disease. Therefore, the
most significant risk management strategy for ensuring the safety of
whole cuts of boneless beef is the prevention of cross-contamination of
the beef with SRMs during stunning and slaughter of the animal.
Mitigation measures that prevent contamination of such beef involve
procedures for the removal of SRMs and carcass splitting and
prohibitions on air-injection stunning and pithing. This rule requires
such mitigation measures. While our risk analysis considered the
incidence of BSE in Japan in its discussion of the OIE recommendations
on BSE, it did not play a central role in our evaluation of the risk
posed by whole cuts of boneless beef. Our evaluation was based on the
nature of the commodity and the potential pathways for exposure.
Economic Analysis
Issue: One commenter asked what assurances there are in the rule
that Wagyu beef will be the only beef exported, since Japan also
produces Holstein beef, which appears to be where Japan is experiencing
the highest rate of BSE.
Response: This rule allows the importation of whole cuts of
boneless beef from all cattle breeds, including Holstein, provided that
certain conditions are met. These conditions, which include removal of
SRMs and prohibitions on the use of air-injection stunning and pithing,
will continue to protect against the introduction of BSE into the
United States, regardless of the breed of cattle from which the beef is
derived. As a practical matter, the export of Holstein beef to the
United States is unlikely, since it is unlikely that Japan will try to
compete in the U.S. import market for lower-grade beef from culled
dairy cattle against such established suppliers as Australia and New
Zealand. We expect only Wagyu beef to be imported under the rule.
Issue: One commenter stated that the impact of the rule on the
domestic Wagyu beef industry should be thoroughly analyzed because this
rule has the potential to have the most impact on that segment of the
beef industry.
Response: Our assessment of the rule's potential impact on U.S.
producers of Wagyu beef was as thorough as possible given the available
data. In the proposed rule, we stated that we did not have all of the
data necessary for a comprehensive analysis, and invited the public to
provide information that would enable us to better assess the rule's
potential impact, including information on the number of domestic Wagyu
producers and their production. None of the comments received from the
public in response to the proposed rule included that information.
Issue: One commenter stated that domestic producers will lose
economically from this rule because the initial regulatory flexibility
analysis noted that consumers may benefit if the price of domestic
Wagyu beef goes down due to the resumption of trade in Japanese
boneless beef.
Response: The economic impact of the rule on domestic Wagyu
producers is unclear. This is because the extent to which Wagyu beef
imports from Japan and domestically produced Kobe-style beef compete
for the same group of buyers is not known. It is conceivable that
demand for, and prices of, domestic Kobe-style beef could decline if
consumers switched to Wagyu beef from Japan once that product becomes
available in the U.S. market. On the other hand, it is possible that
the importation of Wagyu beef from Japan could stimulate additional
interest in, and demand for, high-end beef in general, thereby
benefitting U.S. producers of Kobe-style beef. That domestic Kobe-style
beef will likely sell at a lower average price than Wagyu beef from
Japan suggests that the two commodities are not perfect substitutes.
Issue: One commenter expressed concern that the most serious
economic impact of the rule has not been addressed, that is, the
possibility of an American consumer contracting variant CJD (vCJD),
which has been linked via scientific and epidemiological studies to
exposure to the BSE agent. The commenter stated that this rule would
unfairly reduce demand for beef from American cattle producers because
country of origin labeling has not yet been enforced and consumers will
not be able to differentiate Japanese beef from American beef.
Response: The possibility of an American consumer contracting vCJD
from infected meat imported from Japan is extremely unlikely. FSIS,
which assessed the human health risks associated with the rule,
concluded that the beef imported under the conditions described in the
rule will pose no greater level of risk as products produced for human
consumption in the United States. Matters relating to country of origin
labeling are beyond the scope of this rule.
Environmental Assessment
Issue: One commenter stated that APHIS should prepare an
environmental impact statement (EIS) that shows the effects of a range
of potential risks including low risk, moderate risk, and high risk.
Response: APHIS prepared an environmental assessment in order to
determine whether or not there could be significant environmental
impacts associated with allowing the importation of whole cuts of
boneless beef from Japan based upon conditions specified in the
rulemaking. The purpose of an environmental assessment is to provide
sufficient information and analysis to agency decisionmakers to allow
them to determine whether a proposed agency action will have a
significant effect on the human environment, including public health
and safety. The decisionmaker reviews the environmental assessment and
any associated public comments and then makes a determination on
whether there will be adverse impacts significantly affecting the human
environment. This determination is based on the consequences of
associated risks and on safeguards that are designed to prevent those
risks from occurring and causing significant adverse impacts on the
human environment. If a determination is made that a proposed action
would have a significant effect on the human environment, the agency is
obligated to prepare an EIS. 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 in connection with any final rule
and an environmental impact statement is unnecessary. That is the case
with this rulemaking.
Issue: The same commenter stated that the proposed rule should be
afforded even greater scrutiny from an environmental perspective than
APHIS afforded the minimal risk region rule because of the cumulative
effects of the two rules.
Response: The minimal-risk region rule (see 70 FR 360-553, Docket
No. 03-080-3, January 4, 2005) allows the importation of live bovines
less than 30 months of age when imported and when slaughtered, sheep
and goats less than 12 months of age when imported and when
slaughtered, and certain bovine meat, meat byproducts, and meat food
[[Page 73912]]
products, from regions recognized as minimal-risk for BSE, provided
that certain conditions are met. The environmental assessment for the
minimal-risk region rule and a review of the issues raised by public
comment provided the basis for a finding of no significant impact on
the quality of the human environment, i.e., public health and safety
(see 70 FR 18252-18262, Docket No. 03-080-7, April 8, 2005). The rule
for Japanese beef will only allow whole cuts of boneless beef, which
have not demonstrated BSE infectivity at any stage of the disease. The
conditions contained in this rule for whole cuts of boneless beef, such
as the appropriate removal of SRMs from the carcass, address the
potential risk for BSE contamination. Thus, it is highly unlikely that
the importation of such beef from Japan would result in the
introduction of BSE into the United States. Therefore, from an
environmental perspective, an environmental assessment is the
appropriate level of environmental documentation.
Proposed Regulations
BSE Regulations (General Approach)
Issue: Several commenters expressed concern that APHIS' import
policy with regard to BSE and, more specifically, BSE-related
restrictions for the importation of whole cuts of boneless beef from
Japan, seems to differ from its regionalization approach found in the
current BSE regulations and the general policy with regard to
recognition of regions for other foreign animal diseases. One commenter
stated that, with most diseases, APHIS does not allow importation until
adequate surveillance has been done to prove freedom of a region from
the disease. However, with regard to BSE, stated the commenter, APHIS
allows imports from a region until a case of BSE is identified in that
region. The commenter stated that APHIS should define standards for all
levels of trade with various countries concerning BSE. The commenter
suggested that APHIS conduct or peer review the proper risk evaluations
to determine a country's BSE risk category based upon OIE guidance and
to classify all countries that have not been evaluated as undetermined
risk regions.
Similarly, another commenter expressed concern that APHIS does not
have a standard for protecting the United States against the
introduction and spread of BSE, and potentially other communicable
diseases, because Japan does not meet the criteria for a minimal-risk
region. Finally, one commenter stated that no reason was provided in
the proposal for APHIS' departure from previous policies to deny the
importation of commodities from BSE-affected regions.
Response: With regard to trade from BSE-affected regions, Sec.
94.18(a)(1) lists regions where BSE is known to exist. Paragraph (a)(2)
of Sec. 94.18 lists regions that present an undue risk of BSE because
their import requirements are less restrictive than those that would be
acceptable for import into the United States and/or because the regions
have inadequate surveillance for BSE. Additionally, Sec. 94.18(a)(3)
lists regions that present a minimal risk of introducing BSE into the
United States. APHIS prohibits the importation of live ruminants and
certain ruminant products and byproducts both from regions where BSE is
known to exist (and that are not considered BSE minimal-risk regions)
and from regions of undue risk, even though BSE has not been diagnosed
in a native animal in the latter regions. The minimal-risk regions rule
provided the basis for allowing the importation of various commodities
from regions in which BSE has been detected but that have been
evaluated as minimal-risk regions for BSE.
With respect to the issue about Japan meeting the requirements for
a minimal-risk region as defined in Sec. 94.0, as mentioned
previously, the situation in Japan represents conditions consistent
with a controlled-risk region as outlined in the OIE guidelines. We did
not evaluate Japan as a minimal-risk region. This rule is commodity-
based. The requirements for importing that commodity-whole cuts of
boneless beef-protect against the introduction of BSE. Other provisions
in APHIS' regulations address risks associated with other diseases. For
example, if Japan were to experience an outbreak of foot-and-mouth
disease, the requirements of Sec. 94.4, which require cooking or
curing, would apply.
With respect to the approach to BSE differing from the approach to
other diseases, when it was newly discovered, BSE was limited in its
geographic distribution to the United Kingdom and certain other
countries in Europe. There was no evidence to suggest the disease
existed elsewhere in the world. Designating regions as affected could
be done quickly by interim rule as cases were detected. Evaluation of
countries for lower risk status (e.g., minimal risk or unaffected),
usually involves a risk analysis as well as a rulemaking. The BSE
approach (i.e., designation as affected) is consistent with our
approach to other diseases, such as African horsesickness, which has
never been shown to exist in countries other than in Africa and some
countries on the Arabian Peninsula. Also, in contrast to infectious
diseases that can be diagnosed relatively quickly, BSE has an extremely
long incubation period. Therefore, our regulations for BSE are designed
to protect against the introduction of BSE from regions where BSE
exists or that present an undue risk of introducing BSE.
An alternative approach to assigning status to a region is to
follow a commodity-based approach in which mitigations are defined that
are appropriate to the commodity (and the region, if relevant).
Existing examples of this include the regulations in Sec. 94.18(b)
that allow for the importation of gelatin and milk under certain
conditions from any region listed in Sec. 94.18(a). Similarly, this
rule will allow the importation of whole cuts of boneless beef from
Japan, under the conditions contained in this rule, while continuing to
protect against the introduction of BSE into the United States.
The import request submitted to APHIS by the Government of Japan
lent itself to a commodity-based approach because it was limited in
scope to boneless beef from Japanese cattle. Because Japan was not
requesting the importation of live animals, we only considered the risk
associated with the importation of that commodity, rather than the risk
associated with the importation of live animals and other commodities
from Japan. Because whole cuts of boneless beef present a low risk of
BSE, we determined that it was not necessary to evaluate the country in
light of the minimal-risk region criteria.
OIE Recommendations on BSE
Issue: Several commenters expressed concern that the proposed
conditions for whole cuts of boneless beef from Japan are less
restrictive than the recommended export conditions contained in Article
2.3.13.1 of the OIE's 2005 Terrestrial Animal Health Code for deboned
skeletal muscle meat from anywhere. These commenters pointed out that
the proposal did not require that the beef be derived from cattle that
are less than 30 months of age and that the cattle be subject to ante-
and post-mortem inspections and were not suspect or confirmed BSE
cases. The commenters stated that these conditions are contained in the
OIE recommendations for the export of deboned skeletal muscle meat from
any region. One commenter requested that these additional restrictions
be added to the rule. Finally, one commenter also noted that the
proposed rule would allow for the importation of boneless beef from
cattle over 30 months of age,
[[Page 73913]]
which is not allowed from minimal-risk regions.
Response: We appreciate the commenter's question regarding
consistency with the current OIE recommendations on BSE. As discussed
in the proposed rule and the risk analysis, the conditions for the
importation of whole cuts of boneless beef from Japan are consistent
with the recommendations for the export of meat and meat products from
controlled-risk regions, which are contained in Article 2.3.13.10 of
the OIE's 2005 Terrestrial Animal Health Code, not those
recommendations for the export of deboned beef from any region. Unlike
the OIE recommendations for the free trade of deboned beef from any
region, the OIE recommendations for commodities exported from
controlled-risk regions do not contain a 30-month-age restriction.
The OIE recommendations, as noted by the commenter, include
conditions that the commodity be derived from cattle that were subject
to ante- and post-mortem inspections and were not suspect or confirmed
BSE cases. These requirements are consistent with FSIS requirements
under the Federal Meat Inspection Act (FMIA). In 9 CFR parts 309 and
310, for example, FSIS requires that all livestock offered for
slaughter must receive (and pass) ante- and post-mortem inspections. As
part of FSIS' equivalence determination process, countries that export
commodities to the United States must have meat inspection systems that
provide the same level of protection as that provided by systems in the
United States. Because the OIE recommendations noted by the commenter
are already established requirements under FSIS' regulations, and are,
moreover, requirements that pertain to all livestock regardless of the
BSE risk status of a region, it was not necessary to include those same
requirements in our regulations.
Issue: One commenter asked for clarification on how APHIS
determined that Japan could be considered as having controlled-risk
status under the OIE guidelines.
Response: APHIS personnel requested written documentation on the
BSE status of and conditions in Japan and conducted a site visit to
verify the information and gather additional data. We then evaluated
the country-specific information in the context of the OIE
recommendations on BSE and found that the BSE conditions in Japan are
consistent with those conditions for a controlled-risk region contained
in Article 2.3.13.4 of the 2005 Terrestrial Animal Health Code. For
example, Japanese authorities had conducted an appropriate risk
assessment to identify the historical and existing BSE risk factors;
the country's surveillance program was consistent with Type A
surveillance as defined by OIE in Appendix 3.8.4 of the Code; and the
BSE conditions for controlled-risk regions relative to BSE cases, a
feed ban, importation of meat-and-bone meal or greaves, epidemiological
tracing, and disposition of affected and contact animals were met.
It is important to note that, while we considered the OIE
recommendations on BSE in the development of the risk analysis, we
based our mitigation measures on a careful analysis of the risk posed
by the importation of whole cuts of boneless beef from Japan. BSE
infectivity has never been demonstrated in the muscle tissue of cattle
infected with BSE at any stage of the disease. Therefore, the most
significant risk management strategy for ensuring the safety of whole
cuts of boneless beef is the prevention of cross-contamination of the
beef with SRMs during stunning and slaughter of the animal. Mitigation
measures that prevent contamination of such beef involve procedures for
the removal of SRMs and carcass splitting and prohibitions on air-
injection stunning and pithing. This rule requires such mitigation
measures.
Age Restriction
Issue: One commenter expressed concern that the proposal did not
contain an age limitation on whole cuts of boneless beef from Japan and
stated that there should be such a restriction, especially since
Japan's control measures for BSE have not been in place for a long
period of time. Other commenters stated that the lack of a 30-month age
restriction on cattle from which the beef is derived for export from
Japan is inconsistent with APHIS' rulemakings, specifically, the age
restriction for cattle and cattle products contained in the minimal-
risk rule. Some of these commenters stated that APHIS provided no
justification for allowing imports of beef from animals over 30 months
of age from Japan or any other country where BSE is known to exist.
Response: Prior to developing the proposed rule for this action, we
analyzed the likelihood that boneless beef imported from Japan would:
(1) Contain infectious levels of the BSE agent; and (2) present a risk
of exposing U.S. consumers or cattle to BSE, if the imported beef was
contaminated with BSE. Based on the potential pathways, APHIS then
determined what mitigation measures should be imposed to address the
risks associated with whole cuts of boneless beef from Japan. We did
not attempt to classify Japan as a minimal-risk region, nor did we
include live animals or other meat and meat products. Rather, we
limited our analysis to the BSE risk associated with whole cuts of
boneless beef. Scientific data show that BSE infectivity in the muscle
tissue of cattle examined in either the mouse bioassay or the cattle
assays have not been demonstrated to date, regardless of the age of the
animal. For these reasons, we consider whole cuts of boneless beef to
be inherently low-risk for BSE and determined that it can be safely
traded provided that measures are taken to prevent cross-contamination
during processing. Such measures are contained in this rule and an age
restriction is not necessary.
County of Origin Labeling
Issue: A number of commenters recommended that country of origin
labeling be required in the United States so that beef imported from
Japan would be so labeled. Some commenters suggested APHIS postpone
implementation of this rule until such labeling is in place in this
country. Several commenters raised concerns about how the United States
would be able to verify the requirement that the beef be derived from
cattle born, raised, and slaughtered in Japan without a country of
origin labeling requirement. Finally, one commenter expressed concern
that, because the proposal did not contain a country-of-origin
requirement, any stigma associated with imported Japanese beef would be
transferred to the entire U.S. beef supply if the BSE or vCJD incidence
in Japan increases.
Response: Under the Farm Security and Rural Investment Act of 2002
and the 2002 Supplemental Appropriations Act, USDA is required to
implement a mandatory country of origin labeling program (COOL).\12\
USDA's Agricultural Marketing Service (AMS) published a proposed rule
on the COOL program on October 30, 2003 (68 FR 61944-61985, Docket No.
LS-03-04). Under the proposal, retailers would be required to notify
their customers of the country of origin of all beef (including veal),
lamb, pork, fish, and selected other perishable commodities being
marketed in their stores. In addition, the AMS proposal identified
criteria that these commodities must meet to be considered of U.S.
origin. In November
[[Page 73914]]
2005, President Bush signed Public Law 109-197, which includes a
provision to extend a previous delay of implementation of mandatory
COOL for all covered commodities except wild and farm-raised fish and
shellfish until September 2008. The COOL program, when implemented,
will address the labeling concerns raised by commenters with regard to
APHIS' proposed rule. APHIS does not consider it necessary to delay
implementation of this rule until those labeling provisions are
implemented. In its October 30, 2004, proposal, AMS noted, in
discussing Section 10816 of Public Law 107-171 (7 U.S.C. 1638-1638d)
regarding COOL that the ``intent of the law is to provide consumers
with additional information on which to base their purchasing
decisions. It is not a food safety or animal health measure. COOL is a
retail labeling program and as such does not address food safety or
animal health concerns.''
---------------------------------------------------------------------------
\12\ AMS USDA; Country of Origin Labeling--Current Status of
Country of Origin Labeling. Available at http://www.ams.usda.gov/cool/status.htm.
---------------------------------------------------------------------------
With respect to the concern expressed about verifying that the beef
is derived from cattle born, raised, and slaughtered in Japan, this
rule will require that an authorized veterinary official of the
Government of Japan certify on an original certificate that the
conditions contained in this rule have been met.
BSE Testing
Issue: One commenter requested that, before proceeding with this
rule, APHIS explain why the rule does not require BSE testing of cattle
slaughtered in Japan in the rule. This commenter stated that the use of
rapid tests could assist in eliminating from the food chain clinically
healthy cattle with PrPsc (abnormal prion protein) in the
central nervous system. The commenter stated that such a mandatory
testing requirement must be included in any rule to resume imports from
BSE-affected countries or else the United States would have no means of
ensuring the continuation of current mitigation measures currently
practiced in countries like Japan.
Response: We understand the interest expressed by some commenters
in testing certain cattle for slaughter. However, no live animal tests
exist for BSE and the currently available postmortem tests, although
useful for disease surveillance (i.e., in determining the rate of
disease in the cattle population), are not appropriate as food safety
indicators. Studies have demonstrated that the earliest point at which
current testing methods can detect a positive case of BSE is 2 to 3
months before the animal begins to demonstrate clinical signs. Research
also indicates that the incubation period for this disease--the time
between initial infection and the manifestation of clinical signs--is
generally very long, on the average of about 5 years. Accordingly, we
know there is a long period during which, using the current
methodology, testing an infected animal that has not demonstrated
clinical signs of the disease or is not at the end of the incubation
period would, incorrectly, produce negative results. If, however, the
infected animal is already exhibiting some type of clinical signs that
could be consistent with BSE, then the test is not likely to produce
false negative results.
BSE infectivity has never been demonstrated in the muscle tissue of
cattle experimentally or naturally infected with BSE at any stage of
the disease. Therefore, if BSE is present in a country's cattle
population, the most significant risk mitigation measure for ensuring
the safety of whole cuts of boneless beef is the prevention of cross-
contamination of the beef with SRMs during stunning and slaughter of
the animal. This rule includes such risk mitigation measures. For
example, this rule requires the removal of SRMs and prohibits the use
of air-injection stunning devices and pithing processes on cattle from
which the beef is derived.
For these reasons, we do not consider the testing of bovines at
slaughter to be scientifically justified or meaningful in the context
of either human or animal health. Making this a criterion for the
importation of beef from Japan would not contribute to human or animal
health protection. A statistically and epidemiologically valid
surveillance plan is crucial to monitoring the success of risk
mitigation measures, such as a feed ban, but surveillance is not a
mitigation measure.
Miscellaneous Comments
Harmonized Two-Way Trade
Issue: Many commenters requested that APHIS not finalize the
proposed rule until two-way, harmonized trade can be resumed between
the United States and Japan. These commenters expressed concern that
Japan has not provided adequate assurances that U.S. producers will be
allowed to export beef to Japan. Further, several of these commenters
were concerned that U.S. producers would be subject to more stringent
export conditions than those faced by exporters of boneless beef from
Japan. For example, some commenters expressed concern that U.S.
producers will only be allowed to export beef to Japan if the beef is
derived from cattle less than 20 months of age. No such age restriction
was contained in the proposed rule regarding the importation of
boneless beef from Japan. These commenters stated that the export
conditions for beef between the two nations should be the same.
In addition, one commenter noted that the proposed rule did not
address potential impacts the rule could have on the United States'
ability to restore the export markets that remain closed to the U.S.
cattle and beef industries. This commenter asked if APHIS has consulted
with South Korea and other importing nations that continue to ban U.S.
beef and cattle to determine whether the rule would enhance or impede
the reopening of these markets. This commenter expressed concern that
the rule would be viewed by other nations as exposing the United States
to an unacceptable risk. This commenter requested that APHIS provide
the public with a list of nations that currently allow the importation
of Japanese beef and stated that APHIS should not proceed with the rule
until and unless a firm commitment is obtained from all countries that
formerly accepted U.S. beef exports that they will-in a timely fashion-
reopen their borders to U.S. beef, even if the U.S. resumes imports of
Japanese beef.
Response: APHIS does not have authority to restrict trade based on
its potential market access effects. Under its statutory authority,
APHIS may prohibit or restrict the importation or entry of any animal
or article when the agency determines it is necessary to prevent the
introduction or dissemination of a pest or disease of livestock.
However, APHIS is actively negotiating with trading partners to
reestablish our export markets.
Trade With Other BSE-Affected Regions
Issue: One commenter suggested that APHIS make explicit in its
final rule that, based on the logic and reference to the new OIE
guidelines in the proposal, the United States is now ready to accept
safe products from countries that have experienced BSE but have
stringent risk mitigation measures in place, following separate risk
analyses to be carried out by APHIS. This commenter stated that it
expects APHIS is now prepared to use the same approach when evaluating
a specific request to authorize the import of whole cuts of boneless
beef from the European Union, in particular. In contrast, another
commenter expressed concern that the rule would establish a precedent
for allowing the importation of commodities from other BSE-affected
regions that pose a greater risk of introducing BSE into the United
States than does boneless beef from Japan.
Response: As mentioned above, under its statutory authority, APHIS
may
[[Page 73915]]
prohibit or restrict the importation or entry of any animal or article
when the agency determines it is necessary to prevent the introduction
or dissemination of a pest or disease of livestock. When we receive a
request from a country to allow the importation of commodities, we
carefully and thoroughly consider the risk associated with the
commodity and the country. In addition, APHIS is currently considering
developing a comprehensive set of regulations consistent with the OIE
recommendations on BSE.
Importation of Commodities From Minimal-Risk Regions and/or Canada
Issue: One commenter stated that the risk analysis and the OIE
guidelines used in support of the proposed rule would also allow the
importation of cattle over 30 months of age and beef from those cattle
from any minimal-risk region. This commenter stated that, as a result,
there is no justified reason to allow the importation of beef from
Japan to enter the United States and not provide the same treatment for
Canadian cattle and beef. The commenter stated that Canada and other
minimal-risk regions should be afforded treatment consistent with Japan
and that Canadian cattle over 30 months of age and beef derived from
those cattle should be allowed to be imported by APHIS.
Response: APHIS recognizes that the OIE guidelines address the
importation of live cattle over 30 months of age and beef from such
cattle from regions of different status. However, the scope of this
rulemaking is limited to whole cuts of boneless beef derived from
cattle born, raised, and slaughtered in Japan. Therefore, the issue of
imports of live cattle over 30 months of age and beef from those cattle
from minimal-risk regions, including Canada, falls outside the scope of
this rulemaking. Nevertheless, as noted in the minimal-risk region
rule, APHIS is committed to dealing with the issue of imports of live
bovines 30 months of age and over from Canada in further rulemaking.
Issue: One commenter stated that the BSE minimal-risk regions rule
should be withdrawn, and that the U.S. geographical BSE risk assessment
(GBR) should immediately be raised to BSE GBR IV. This commenter
further requested that the United States adhere to the BSE GBR and that
USDA work to enhance those assessments to include all animal TSEs.
Response: Consideration of changes to the minimal-risk rule are
outside the scope of this rulemaking. The BSE GBRs are conducted by the
European Commission. These assessments were initially begun in the late
1990's, under the auspices of the European Commission's Scientific
Steering Committee (SSC). Since the functions of the former SSC have
now been taken up by the European Food Safety Authority (EFSA), the GBR
assessments are done under the EFSA. This assessment process is not a
process supervised by the USDA or APHIS, and we cannot change any
assessments previously done by the European Commission. It is not clear
what the commenter means by requesting that the United States adhere to
the BSE GBRs, as these are documents created internally by the European
Union for its purposes. APHIS conducts its own risk assessments as
necessary for specific rulemaking efforts, incorporating all available
information. Such information may refer to an assessment conducted by
the country requesting a regulatory change, but it generally would not
depend on third party assessments.
The United States considers all animal TSEs in developing
regulations related to BSE. However, it should be noted that the
various animal TSEs are generally caused by different agents (i.e.,
scrapie in sheep is different from chronic wasting disease (CWD) in
cervids, which is different from BSE in cattle) with different routes
of transmission and unique characteristics. Sometimes these processes
may be similar, but one cannot automatically assume, for example, that
if a country has identified scrapie in sheep that they are therefore at
significant risk for other animal TSEs such as CWD or BSE.
CJD and Domestic Compliance With FSIS' BSE-Related Regulations
Issue: One commenter noted that the number of probable and
confirmed cases of vCJD cited in the proposed rule was greater than the
number of cases cited in the minimal-risk regions final rule and raised
questions regarding the significance of this increase in cases over a
several month period. This commenter requested that APHIS provide a
comparison between the number of deaths attributable to the consumption
of beef contaminated with BSE and the number of deaths attributable to
the consumption of beef contaminated with other food-borne contaminates
such as Escherichia coli (E. coli) in order to place this increase in
vCJD cases in context for the beef and cattle industries.
Response: To date, there have been a total of approximately 170
cases of vCJD reported worldwide since 1996. Most of these cases have
been in the United Kingdom. In the United Kingdom, it is estimated that
the incidence of deaths from vCJD reached a peak in mid-2000, with 28
deaths that year. For comparison, the Centers for Disease Control (CDC)
estimates that foodborne diseases cause approximately 76 million
illnesses, 350,000 hospitalizations, and 5,000 deaths in the United
States alone each year. Of these, known pathogens account for an
estimated 14 million illnesses, 60,000 hospitalizations, and 1,800
deaths annually. These estimates are not attributed to specific food
products implicated in each outbreak, but rather to the specific
pathogens. The variation in number of reported vCJD cases cited in our
minimal-risk regions final rule and the proposed rule for this
rulemaking and noted by the commenter is attributable to an update in
figures obtained by APHIS and not a spike in the number of vCJD cases
reported worldwide.
Issue: Two commenters raised questions regarding the origin of CJD
in humans. One commenter noted that there are different strains of TSEs
being discovered in ruminants, and that new atypical strains of TSE in
cattle look similar to sporadic CJD in humans. Another commenter asked
if APHIS has considered whether sporadic CJD in humans might be caused
by atypical cases of TSEs that have been found in animals. This
commenter further questioned whether blood and other tissues may carry
BSE infectivity in cattle infected with atypical strains of the BSE
agent or other TSE agents.
Response: Sporadic CJD is the most common form of CJD. It has been
found in every country in the world where it has been looked for
including countries that are generally considered by the international
scientific community to be free of BSE and other TSEs (for example,
Australia and New Zealand). In general, it affects about one person per
million. No association between sporadic CJD and consumption of animal
products in general and/or infected or contaminated bovine products has
ever been documented. It is currently believed that sporadic CJD arises
through the spontaneous conversion of PrPC (normal cellular
prion protein) to PrPSC in an individual.\13\ In contrast,
atypical cases of BSE in cattle are rare and have been reported in only
few countries that experience BSE, such as Italy, Belgium, Japan, and
France. It has been speculated that the spontaneous or sporadic form of
BSE could exist in cattle, as well as humans.\14\
---------------------------------------------------------------------------
\13\ Stahl, N. and Prusiner, S.B.; (1991) FASEB-J. 5: 2799-807.
\14\ Biacabe; 2004 EMBO reports, Vol. 5, No. 1.
---------------------------------------------------------------------------
[[Page 73916]]
APHIS agrees with the commenter that reports indicate that some of
the atypical BSE cases, in particular the bovine amyloidotic spongiform
encephalopathy (BASE), and sporadic CJD have similar PrPSC
patterns. APHIS evaluated the findings in the context of risk of
exposure to cattle and humans. Currently, the relevance of the atypical
cases is unknown, but at this time there is no indication that any
control measures--such as feed bans or SRM requirements--should be
modified based on these cases. Additionally, although atypical cases of
BSE and sporadic CJD share similarities at this point, there is no
evidence that they are linked.
Issue: One commenter expressed concern over the number of citations
issued for various SRM violations during the June 2004 enhanced BSE
surveillance program in the United States. This commenter questioned
whether these incidents of noncompliance may have led to infective
materials entering the human or animal food chains. This commenter
cited the case of BSE detected in a 12-year-old cow in Texas as
evidence that infective materials may have entered the food chain. The
commenter suggested that noncompliance reports should be made more
easily available to the public in the future.
Response: FSIS inspectors are responsible for verifying the
effectiveness of an establishment's procedures. If FSIS personnel
determine that an establishment's procedures are ineffective in
preventing cross-contamination, the inspectors will take appropriate
action. We note that none of the meat from the 12-year-old BSE-infected
cow in Texas mentioned by the commenter entered the human food or
animal feed chains.
Issue: One commenter stated that the domestic BSE mitigation
measures, including the U.S. ruminant feed ban, border controls, and
BSE surveillance program, must be strengthened in order to protect
public health. The commenter further requested that USDA's Office of
the Inspector General (OIG) hold an inquiry into the effectiveness of
the BSE surveillance program.
Response: APHIS considers the measures in place to be adequate and
based on the best available science. First, available evidence suggests
that the feed ban which FDA implements is a critical safeguard against
the spread of BSE in the United States. FDA has recently issued a
proposed rule to further strengthen the feed ban (70 FR 58570-58601,
October 6, 2005). Domestic BSE mitigation measures for border controls
are based on risk analyses conducted using the best scientific
information available. These are made available for public comment in
association with regulations implementing these controls. The BSE
surveillance program in the United States was developed by technical
experts to help determine whether BSE is present in the U.S. cattle
population, and if so, to help estimate at what level. The USDA's OIG
is conducting an ongoing audit of the BSE surveillance program.
Other Comments
Issue: One commenter stated that there was no background or
supporting information provided along with the proposed rule.
Response: The background information in support of the proposal was
provided in our risk analysis and other supporting analyses that were
made available to the public concurrent with the proposal. These
documents remain available at http://www.regulations.gov.
Issue: Several commenters raised issues that fall outside the scope
of this rulemaking, including the impact of eating meat on the health
of American consumers, the relative quality of beef produced in Japan
and the United States, and the necessity and market effects of
importing beef from Japan when the United States produces beef
domestically.
Response: APHIS does not have authority to restrict trade based on
these considerations. Under its statutory authority, APHIS may prohibit
or restrict the importation or entry of any animal or article when the
Secretary determines it is necessary to prevent the introduction or
dissemination of a pest or disease of livestock. While the United
States does not have direct control over the quality of products
produced in other countries, FSIS requires that the food it regulates
be produced under conditions that will provide at least an equivalent
level of safety as that produced in the United States. Therefore, we
are not making any changes to the rule based on this comment.
Issue: One commenter stated that it would be helpful if the OIE or
USDA would define ``controlled BSE-risk country'' and ``effectively
enforced ban.''
Response: Article 2.3.13.4 of the OIE's 2005 Terrestrial Animal
Health Code lists recommended conditions that a country, zone, or
compartment should meet to be considered as controlled BSE risk. These
conditions include a consideration of whether a country has identified
indigenous cases of BSE and what risk mitigation measures have been
imposed. Neither USDA nor the OIE have strictly defined an
``effectively enforced ban.'' The OIE has indicated that it may
consider developing such a definition, but this process may take some
time. USDA considers effective enforcement of the feed ban as an
important measure to control BSE in a specific region. In previous
rulemaking, we noted that determining whether a feed ban had been
effectively enforced involved a review by APHIS of a number of
interrelated factors, including: The existence of a program to gather
compliance information and statistics; whether appropriate regulations
are in place in the region; the adequacy of enforcement activities
(e.g., whether sufficient resources and commitment are dedicated to
enforcing compliance); a high level of facility inspections and
compliance; accountability of both inspectors and inspected facilities;
and adequate recordkeeping.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, without
change.
Effective Date
This is a substantive rule that relieves restrictions and, pursuant
to the provisions of 5 U.S.C. 553, may be made effective less than 30
days after publication in the Federal Register. The Administrator of
the Animal and Plant Health Inspection Service has determined that
immediate implementation of this rule is warranted to relieve certain
restrictions on the importation of whole cuts of boneless beef from
Japan that are no longer necessary.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for the purposes of Executive
Order 12866 and, therefore, has been reviewed by the Office of
Management and Budget.
Under the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et
seq.), the Secretary of Agriculture is authorized to promulgate
regulations that are necessary to prevent the introduction or
dissemination of any pest or disease of livestock into the United
States.
This final rule will amend the regulations governing the
importation of meat and other edible animal products by allowing, under
certain conditions, the importation of whole cuts of boneless beef
derived from cattle born, raised, and slaughtered in Japan. This action
is taken in response to a request
[[Page 73917]]
from the Government of Japan and after conducting an analysis of the
risk that indicates that such beef can be imported from Japan under the
conditions described in this final rule. These conditions will continue
to protect against the introduction of BSE into the United States.
In accordance with 5 U.S.C. 604, we have performed a final
regulatory flexibility analysis, which is summarized below, regarding
the impact of this rule on small entities.\15\ This analysis also
serves as our cost-benefit analysis under Executive Order 12866.
---------------------------------------------------------------------------
\15\ A copy of the full economic analysis is available for
review on the Regulations.gov Web site. Go to http://www.regulations.gov, click on the ``Advanced Search'' tab and select
``Docket Search.'' In the Docket ID field, enter APHIS-2005-0073
then click on ``Submit.'' The economic analysis will appear near the
end of the resulting list of documents.
---------------------------------------------------------------------------
We expect that this rule will have little or no economic impact on
the majority of consumers and beef producers in the United States
because the volume of beef imported from Japan is likely to be small
and have only a minor impact on the overall domestic beef market.
In 2001, APHIS placed a ban on the importation of ruminants and
most ruminant products from Japan following the confirmation of one
case of BSE in a native-born animal in that country. Prior to that ban,
U.S. imports of boneless beef from Japan were negligible when compared
to total imports of that commodity. Over a 4-year period, 1997-2000,
for example, the volume of U.S. imports of boneless beef from Japan--
reported to be entirely fresh/chilled, as opposed to frozen--averaged a
little less than 9 metric tons per year. This amount was less than
0.005 percent of average annual U.S. imports of fresh/chilled boneless
beef worldwide for the same period (202,540 metric tons).\16\ The
average annual value of U.S. imports of boneless beef from Japan over
this 4-year period was $808,000, less than 0.2 percent of the 4-year
average annual value of U.S. imports of fresh/chilled boneless beef
from all regions ($600 million). Including frozen boneless beef in the
comparison over the same 4-year period diminishes Japan's annual
average percentage share all the more, to about 0.001 percent of the
quantity and about 0.05 percent of the value of all U.S. boneless beef
imports. This impact would be further reduced if Japan's share of the
U.S. total beef supply (domestic production plus imports minus exports,
disregarding carryover stocks) were considered.
---------------------------------------------------------------------------
\16\ Trade statistics, unless otherwise indicated, are taken
from the World Trade Atlas or the Global Trade Atlas (Global Trade
Information Services), which report data from the Department of
Commerce, U.S. Bureau of the Census. The Harmonized Tariff Schedule
(HTS) 6-digit code for fresh/chilled boneless beef cuts is 020130;
the HTS code for frozen boneless beef is 020230.
---------------------------------------------------------------------------
Based on the unit price of beef imported into the United States
from Japan prior to the 2001 ban on the importation of ruminants and
most ruminant products from Japan, it is assumed that all of the
boneless beef imported from Japan prior to the ban was Wagyu beef. (The
term ``Wagyu,'' which literally translates to Japanese cattle, refers
to purebred Japanese Black or Japanese Brown breeds of cattle. Wagyu
beef is a high-priced specialty meat widely acclaimed for its flavor
and tenderness. ``Kobe beef'' refers to Wagyu beef that is produced in
the Kobe area of Japan.) Japan also produces Holstein breed dairy
cattle, but it is unlikely that Japan would try to compete in the U.S.
import market for lower-grade beef from culled dairy cattle.
Accordingly, we expect only Wagyu beef to be imported under the final
rule.
We expect that Japan will continue to be a minor supplier of beef
to the United States after this final rule becomes effective. We
estimate that the volume of imports is likely to range between about 8
metric tons and 15 metric tons per year, a quantity aligned with import
levels in the years immediately prior to the ban. There are three
reasons for the small import volume. First, the demand for Japanese
Wagyu beef in the United States will likely be small, because the beef
is expensive. In October 2004, for example, the average actual selling
price of Wagyu sirloin in Japanese supermarkets was just under $50 per
pound.\17\ The price of Japanese Wagyu beef would be higher in the
United States because of transportation and other costs associated with
the importation of the beef from Japan.
---------------------------------------------------------------------------
\17\ Source: ``Monthly Statistics,'' January 2005, Agricultural
& Livestock Industries Corporation. The selling price was calculated
using an exchange rate of 105 yen per U.S. dollar, and it is the
price for Wagyu sirloin from all regions in Japan, including Kobe.
---------------------------------------------------------------------------
Second, Japanese agricultural officials have indicated to APHIS
staff that they expect the volume of Wagyu exports to the United States
to be approximately 10 metric tons per year. This quantity aligns with
historic import levels, as described above, and would be well below the
annual tariff rate quota for Japan of 200 metric tons.\18\ Over the 10-
year period from 1991 to 2000, U.S. imports of boneless beef--both
fresh/chilled and frozen--from Japan never exceeded 27.0 metric tons in
any one year.
---------------------------------------------------------------------------
\18\ Harmonized Tariff Schedule of the United States (2005),
Chapter 2, Meat and Edible Meat Offal.
---------------------------------------------------------------------------
Finally, Japan's boneless beef exports to countries other than the
United States have also been minor. Over the 4-year period 1997-2000,
Japan's exports of boneless beef to the world--both fresh/chilled and
frozen--averaged only 81 metric tons per year, and the largest export
volume in any one of those years was 95 metric tons (in 1999). For
fresh/chilled boneless beef alone, the 4-year annual average was 37
metric tons, with no one year exceeding 47 metric tons.\19\
---------------------------------------------------------------------------
\19\ Foreign Agricultural Service, USDA.
---------------------------------------------------------------------------
Because we expect that Japan will export only Wagyu beef under this
final rule, this action has the potential to affect farmers and
ranchers in the United States who raise Wagyu and Wagyu hybrid cattle
for the high-end domestic beef market. However, the impact, if any, on
these so-called ``Kobe-style'' beef producers is unclear, without an
approximation of the quantity of Kobe-style beef sold in the United
States and information on the extent to which the two products would
directly compete. The number of these producers is unknown, but it is
believed to be very small.
Cost-Benefit Analysis
Given the high price and small quantity of Wagyu beef expected to
be imported, this final rule is likely to have little impact for most
U.S. consumers. A relatively small segment of beef consumers will
benefit because they would be allowed, once again, to buy this product
in the United States. Importers, brokers and others in the United
States who will participate in the importation of Wagyu beef from Japan
also stand to benefit, due to the increased business activity.
U.S. beef producers, in general, will not be affected by this final
rule; demand is expected to remain low reflecting pre-ban consumption
patterns, with a minor impact on less expensive domestically produced
beef. Any producer impact of the rule will likely fall upon producers
of Kobe-style beef, and then only to the extent that the commodities
will be competing for the same niche market.
In general, trade of a commodity increases social welfare. To the
extent that consumer choice is broadened and the increased supply of
the imported commodity leads to a price decline, gains in consumer
surplus will outweigh losses in domestic producer surplus.\20\ Although
the rule's impact on
[[Page 73918]]
the relatively small number of U.S. producers of Kobe-style beef is
uncertain, it is expected to provide benefits to consumers (domestic
importers, wholesalers, retailers, as well as final consumers) that
will exceed any potential losses to domestic producers. The net welfare
effect for the United States of reestablished Wagyu beef imports from
Japan will be positive.
---------------------------------------------------------------------------
\20\ Consumer surplus is the difference between the amount a
consumer is willing to pay for a good and the amount actually paid.
Producer surplus is the amount a seller is paid for the good minus
the seller's cost.
---------------------------------------------------------------------------
Effects on Small Entities
We do not expect that this final rule will have significant
economic impact on a substantial number of small entities. As discussed
above, this rule has the potential to primarily affect farmers and
ranchers in the United States who produce Kobe-style beef. The number
of these producers is unknown, but it is believed to be very small. The
American Wagyu Association, a Wagyu breeder group, lists approximately
75 members in the United States.\21\
---------------------------------------------------------------------------
\21\ Source: American Wagyu Association Web site.
---------------------------------------------------------------------------
The size distribution of Kobe-style beef producers in the United
States is also unknown, but it is reasonable to assume that most are
small, under the U.S. Small Business Administration's (SBA) standards.
This assumption is based on composite data for all beef producers in
the United States. In 2002, there were 664,431 U.S. farms in North
American Industry Classification System (NAICS) 112111, a
classification comprised of establishments primarily engaged in raising
cattle. Of the 664,431 farms, 659,009 (or 99 percent) had annual
receipts that year of less than $500,000.\22\ The SBA's small entity
threshold for farms in NAICS 112111 is annual receipts of $750,000.
---------------------------------------------------------------------------
\22\ 2002 Census of Agriculture, National Agricultural
Statistics Service.
---------------------------------------------------------------------------
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
National Environmental Policy Act
An environmental assessment and finding of no significant impact
have been prepared for this final rule. The environmental assessment
provides a basis for the conclusion that the importation of whole cuts
of boneless beef from Japan under the conditions specified in this rule
will not have a significant impact on the quality of the human
environment. Based on the finding of no significant impact, the
Administrator of the Animal and Plant Health Inspection Service has
determined that an environmental impact statement need not be prepared.
The environmental assessment and finding of no significant impact
were 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 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).
The environmental assessment and finding of no significant impact
may be viewed on the Internet at http://www.regulations.gov. Go to
http://www.regulations.gov, click on the ``Advanced Search'' tab and
select ``Docket Search.'' In the Docket ID field, enter APHIS-2005-0073
then click on ``Submit.'' The environmental assessment and finding of
no significant impact will appear near the end of the resulting list of
documents. Copies of the environmental assessment and finding of no
significant impact are also available for public inspection at USDA,
room 1141, South Building, 14th Street and Independence Avenue SW.,
Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday,
except holidays. Persons wishing to inspect copies are requested to
call ahead on (202) 690-2817 to facilitate entry into the reading room.
In addition, copies may be obtained by writing to the individual listed
under FOR FURTHER INFORMATION CONTACT.
Paperwork Reduction Act
This final rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
0
Accordingly, we are amending 9 CFR part 94 as follows:
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL
SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND
RESTRICTED IMPORTATIONS
0
1. The authority citation for part 94 continues to read as follows:
Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21
U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0
2. In Sec. 94.18, paragraph (b) is revised to read as follows:
Sec. 94.18 Restrictions on importation of meat and edible products
from ruminants due to bovine spongiform encephalopathy.
* * * * *
(b) Except as provided in paragraph (d) of this section or in
Sec. Sec. 94.19 or 94.27, the importation of meat, meat products, and
edible products other than meat (except for gelatin as provided in
paragraph (c) of this section, milk, and milk products) from ruminants
that have been in any of the regions listed in paragraph (a) of this
section is prohibited.
* * * * *
0
3. A new Sec. 94.27 is added to read as follows:
Sec. 94.27 Importation of whole cuts of boneless beef from Japan.
Notwithstanding any other provisions of this part, whole cuts of
boneless beef derived from cattle that were born, raised, and
slaughtered in Japan may be imported into the United States under the
following conditions:
(a) The beef is prepared in an establishment that is eligible to
have its products imported into the United States under the Federal
Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations in 9
CFR 327.2 and the beef meets all other applicable requirements of the
Federal Meat Inspection Act and regulations thereunder (9 CFR chapter
III), including the requirements for removal of SRMs and the
prohibition on the use of air-injection stunning devices prior to
slaughter on cattle from which the beef is derived.
(b) The beef is derived from cattle that were not subjected to a
pithing process at slaughter.
(c) An authorized veterinary official of the Government of Japan
certifies on an original certificate that the above conditions have
been met.
[[Page 73919]]
Done in Washington, DC, this 12th day of December 2005.
Charles D. Lambert,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 05-24057 Filed 12-12-05; 11:30 am]
BILLING CODE 3410-34-P