[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]



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  Federal Register / Vol. 70, No. 239 / Wednesday, December 14, 2005 / 
Rules and Regulations  

[[Page 73905]]


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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.

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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.
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    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.
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    \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.
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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.
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    \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.
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    \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.
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    \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\
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    \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.
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    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