[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Notices]
[Pages 46016-46022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18814]
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Notices
Federal Register
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This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
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Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 /
Notices
[[Page 46016]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2010-0077]
Notice of Determination of the Foot-and-Mouth Disease Status of
Japan
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination regarding the
foot-and-mouth disease status of Japan. Based on an evaluation that we
made available to the public for review and comment through a previous
notice, the Administrator has determined that Japan is free of foot-
and-mouth disease. As a result, the importation of whole cuts of
boneless beef from Japan may resume. Other ruminant meat and meat
byproducts, as well as fresh pork, live ruminants, and live swine,
remain prohibited due to Japan's status for bovine spongiform
encephalopathy, classical swine fever, and swine vesicular disease.
DATES: Effective Date: This determination is effective August 17, 2012.
FOR FURTHER INFORMATION CONTACT: Dr. Kelly Rhodes, Senior Staff
Veterinarian, Regionalization Evaluation Services, National Center for
Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD
20737-1231; (301) 851-3300.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 94 (referred to below as the
regulations) govern the importation of certain animals and animal
products into the United States to prevent the introduction of various
animal diseases, including rinderpest and foot-and-mouth disease (FMD).
The regulations prohibit or restrict the importation of live ruminants
and swine, and products from these animals, from regions where FMD is
considered to exist. The regulations also restrict the importation of
meat and other products of ruminants and swine from regions that are
considered free of FMD but that supplement their national meat supply
by importing fresh (chilled or frozen) meat of ruminants or swine from
regions that are considered to be affected with FMD, or have a common
land border with such regions, or import ruminants or swine from such
regions under conditions less restrictive than would be acceptable for
importation into the United States.
On April 20, 2010, the Ministry of Agriculture, Forestry, and
Fisheries (MAFF) of Japan reported an outbreak of FMD in that country
to the World Organization for Animal Health (OIE). In response, the
Animal and Plant Health Inspection Service (APHIS) administratively
issued temporary restrictions on commodities from Japan that could
harbor FMD virus. Subsequently, in an interim rule \1\ effective and
published in the Federal Register on October 25, 2010 (75 FR 65431-
65432, Docket No. APHIS-2010-0077), we amended the regulations in part
94 to remove Japan from the list of regions considered free of FMD, and
from the list of regions considered free of FMD and rinderpest but from
which the importation of meat and other products of ruminants and swine
into the United States is restricted because of shared land borders or
trading practices with regions that have one or both of these diseases.
The interim rule also clarified that, as a result of the change in
Japan's FMD status, the importation of whole cuts of boneless beef from
Japan, formerly allowed under Sec. 94.27 of the regulations, was
prohibited due to FMD. These actions were necessary to protect against
the introduction of FMD into the United States. We solicited comments
on the interim rule for 60 days ending December 27, 2010. We received
one comment by that date, from the Government of Japan. The comment
acknowledged the interim rule and encouraged APHIS to begin its
reevaluation of Japan's FMD status as soon as was appropriate.
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\1\ To view the interim rule, the follow-up notice and
evaluation, and the comments we received, go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0077.
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By July 4, 2010, when the last case was detected, Japan had
reported FMD on a total of 292 premises in Miyazaki Prefecture of that
country to the OIE. Although the source of the virus that caused the
outbreak has not been definitively identified, MAFF suspects that it
was introduced by people or personal goods entering Japan from a nearby
country affected with FMD. Japan's official veterinary services
addressed the FMD outbreak through a stamping-out policy that involved
movement restrictions, culling, active surveillance, and ultimately
vaccination. All vaccinated animals were subsequently culled. Intensive
surveillance demonstrated that the virus did not spread outside
Miyazaki Prefecture. On February 4, 2011, the OIE reinstated Japan to
its list of countries that are free of FMD without vaccination.
We stated in our interim rule that, based on Japan's response to
the detection of the disease, we intended to reassess the situation at
a future date in accordance with OIE standards to determine whether we
can restore Japan to the list of regions APHIS considers free of FMD.
On July 26, 2011 (76 FR 44503-44504, Docket No. APHIS-2010-0077),
we published in the Federal Register a notice \2\ announcing the
availability for review and comment of a document titled ``APHIS
Evaluation of the Foot and Mouth Disease Status of Japan.'' This
evaluation examined the events that occurred during and after the
outbreak and assessed the risk of live animals and animal products from
Japan harboring the FMD virus. We stated that the evaluation would
provide a basis for determining whether to reinstate Japan to the list
of regions free of FMD and to the list of regions considered free of
FMD and rinderpest but from which the importation of meat and other
animal products of ruminants and swine into the United States is
subject to additional restrictions.
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\2\ See footnote 1.
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We made the evaluation available for public comment for 60 days
ending September 26, 2011. We received two comments by that date. They
were from a State animal health board and an organization that
represents cattle
[[Page 46017]]
farmers and ranchers. The issues they raised are discussed below.
Comment: One commenter stated that APHIS' evaluation of the FMD
status of Japan is incomplete and inadequate for determining the risk
of introduction and spread of FMD into the United States from Japan
because it is qualitative, rather than quantitative, and because it
does not include either an exposure assessment or a consequence
assessment. The commenter said that APHIS' 2004 Process for Foreign
Animal Disease Status Evaluations, Regionalization, Risk Analysis, and
Rulemaking (Evaluation Process) \3\ explains that quantitative risk
modeling is typically used when a foreign country requests to export a
specific product to the United States, which the commenter said is the
case here where the only product subject to a resumption of exports is
whole muscle cuts of boneless beef from Japan. The commenter said that
APHIS' Evaluation Process also states, ``The risk assessment may
conclude if the release assessment demonstrates no significant risk.
However, some form of exposure and consequence assessment is typically
included for completeness.''
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\3\ Process for Foreign Animal Disease Status Evaluations,
Regionalization, Risk Analysis, and Rulemaking, USDA-APHIS, 2004.
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Response: The 2004 document referenced by the commenter was
intended as a description of general practices rather than as a
statement of future policy. A decision on whether to prepare a
qualitative or quantitative risk assessment for any action must be made
on a case-by-case basis after considering all of the circumstances
involved.
The OIE has established international standards for import risk
analysis.\4\ Article 2.1.1 of the OIE guidelines on import risk
analysis states, ``No single method of risk assessment has proven
appropriate in all situations, and different methods may be appropriate
in different circumstances.'' Article 2.1.1 further states that risk
assessments may be either qualitative or quantitative and that,
particularly for diseases listed in the Terrestrial Animal Health Code,
where there are international standards and broad agreement concerning
likely risks, a qualitative assessment may be all that is required.
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\4\ The Terrestrial Animal Health Code, Chapter 2.1, Import risk
analysis. http://www.oie.int/fileadmin/Home/eng/Health_standards/tahc/2010/en_titre_1.2.htm.
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Most risk evaluations prepared by APHIS are qualitative. In
particular, APHIS has historically used qualitative evaluations to
assess requests from regions to be considered free of a particular
disease, as is the case for Japan. These evaluations are based on
science and conducted according to the factors identified in 9 CFR part
92, Sec. 92.2, which include veterinary infrastructure, biosecurity
measures, livestock demographics, marketing practices, disease
surveillance, and diagnostic laboratory capabilities. Neither these
regulations nor APHIS guidance documents require a quantitative risk
assessment or indicate that one is needed here. The commenter did not
specify how the results of our evaluation would be improved by a
quantitative risk assessment.
Additionally, while reinstatement of FMD-free status for Japan
would allow a resumption of exports of boneless beef from Japan to the
United States, the evaluation prepared for this action was not designed
to evaluate specific mitigation measures for boneless beef or any other
commodity from Japan. Those mitigation measures were developed based on
separate, previous risk assessments and through prior rulemakings.
Regarding the need for exposure and consequence assessments,
Article 2.1.4 of the OIE guidelines on import risk analysis states
that, if the release assessment demonstrates no significant risk, the
risk assessment does not need to continue, meaning that no exposure
assessment or consequence assessment is necessary. While APHIS has
sometimes included exposure and consequence assessments when the
release assessment has demonstrated no significant risk, they provide
no additional value under the circumstances. Therefore, we did not
include them in the evaluation for Japan's FMD status, and, as a
general rule, will not include them in future evaluations when the
release assessment demonstrates no significant risk.
Comment: One commenter said that APHIS does not provide a
scientific basis for recommending the resumption of exports from Japan
within only months following Japan's latest FMD outbreak. The commenter
recommended that APHIS wait at least 3 years following the last case of
FMD that occurs in a foreign country before considering the resumption
of trade in FMD-susceptible products from that country. The commenter
said that Japan's 3-year waiting period before its FMD burial sites can
be disturbed supports this recommendation. He said that APHIS should
explain the security measures in place to prevent wild boars, floods,
earthquakes or other natural phenomenon from prematurely disturbing the
burial sites within 3 years and what risks can be expected if those
security measures fail.
Response: OIE guidelines for reinstatement of FMD freedom are set
out in Article 8.5.9 of the Terrestrial Animal Health Code.\5\ When an
FMD outbreak or FMD virus infection occurs in an FMD-free country or
zone where vaccination is not routinely practiced, such as Japan before
and after the 2010 outbreak, the OIE recommended waiting period to
regain FMD-free status is 3 months after the slaughter of all
vaccinated animals where a stamping-out policy, emergency vaccination,
and serological surveillance are applied consistent with articles
8.5.42 to 8.5.47 and article 8.5.49. The last case of FMD in Japan was
detected on July 4, 2010, and all affected animals on the farm were
destroyed on July 5, 2010. No additional cases were found during
extensive surveillance that included testing of wildlife and testing of
sentinel cattle that were introduced onto previously affected and
depopulated farms. It has now been well over a year since all affected
farms were cleaned and disinfected. There is no scientific basis for a
3-year waiting period.
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\5\ Terrestrial Animal Health Code, Chapter 8.5, Foot and Mouth
Disease. http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.8.5.htm.
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Japan's 3-year prohibition on disturbing FMD burial sites is
required by Japan's Animal Infectious Disease Prevention Law (AIDPL) to
prevent animals from being exposed to carcasses or materials.
Disturbance by wild animals is unlikely, as buried carcasses are
covered with thick layers of slaked lime and under at least 3 feet of
soil. The sites cannot be used for farming or grazing during the 3-year
period, which limits exposure of domestic animals. MAFF told APHIS that
the sites were selected taking environmental factors, such as
underground water and water sources, into account, and that water
quality surveys and regular disinfection are implemented to maintain
the sites properly during the 3-year period. MAFF also said that soil
on the sites would be supplemented or leveled if disturbed by natural
causes during the restricted period. Barriers and standing sign boards
have been placed around the disposal sites to restrict the entrance of
people.
Comment: One commenter stated that APHIS' evaluation contains
overly optimistic and unsupported assumptions regarding Japan's ongoing
risk for FMD given that the source of the 2010 outbreak is not
definitively known, Japan's import policies related to FMD are less
stringent than those of the United States, and wildlife cannot be ruled
out as a potential source of
[[Page 46018]]
another FMD outbreak in Japan. Another commenter said that it is
difficult to judge the risks associated with the introduction of FMD
from Japan without knowing how the FMD virus came in contact with the
index animal, and, thus, how Japan can prevent it from happening again.
Response: While the source of the 2010 outbreak and mode of
introduction have not been definitively identified, the mechanisms and
pathways by which FMD can be transmitted to livestock are well known.
Japan's MAFF conducted an epidemiological investigation that identified
the presumed index herd, the estimated date of introduction, and the
most likely route of infection.
As noted in section 5.1.2 of the evaluation, it is likely that the
virus was brought into Japan from another Asian country through the
movement of people or goods. Japan has implemented additional
biosecurity measures at airports for all persons arriving from
international destinations, from aggressive public awareness campaigns,
including announcements on inbound flights, to floor mats soaked in
disinfectant that travelers must cross. MAFF has also increased
biosecurity measures at the farm level. Additionally, public awareness
of FMD has been heightened by both the outbreak and MAFF's educational
outreach.
Regarding Japan's import policies, MAFF prohibits the importation
of products derived from animals susceptible to FMD from countries with
FMD unless the products are heat treated according to set protocols.
Products are subject to inspection upon arrival, as discussed in
section 9.2.3 of the evaluation. Live susceptible animals must be
accompanied by a health document certified by the veterinary authority
of the exporting region. The animals undergo inspection upon arrival,
as well as quarantine, during which time the animals undergo clinical
inspection and diagnostic testing. Prefectural veterinary officials for
the farm of destination are responsible for follow-up inspections. Live
animals denied entry may be reshipped or destroyed with pathological
examination.
Although Japan allows the importation of live cloven-hoofed
animals, genetic materials, and meat under lesser restrictions from
several regions that APHIS does not recognize as free of FMD--namely,
Bosnia and Herzegovina, Croatia, Northern Mariana Islands, Romania,
Singapore, and Vanuatu--Japan has not received such imports from any of
these countries for at least the past 5 years. Additionally, the last
years that FMD was reported in any of these countries ranges from 1935
to 1978. APHIS evaluates and recognizes foreign regions as free of FMD
only when a foreign government asks us to do so. None of these
countries has requested that APHIS recognize them as FMD free.
Contaminated straw was implicated in the last previous outbreak of
FMD in Japan (2000), and Japan currently allows importation of grain
straw and hay for animal feed from regions that APHIS does not consider
free of FMD. Most notably, Japan imports substantial amounts of rice
straw from China each year because there is not enough arable land to
grow sufficient forage for livestock in Japan. However, Japan requires
the straw to be produced, processed, and stored in an area that has
been free from FMD, rinderpest, and African swine fever for at least 3
years, and strictly enforces requirements that the hay and straw be
heat treated to inactivate the FMD virus and stored afterward in a
manner that prevents recontamination. Rice straw from China is
processed in dedicated plants with a Japanese inspector on site whose
sole job is to check the core temperature of each lot. The straw is
shipped to Japan in sealed containers and tested upon arrival. The
failure rate for compliance in 2010 was 0.15 percent, due to a missing
seal on one container, and 0.06 during the first three quarters of
2011, because Japanese officials could not confirm that the rice straw
had been properly stored following treatment in order to prevent
recontamination.
Regarding the potential for wildlife to be a source of another FMD
epidemic, Japan collected and tested 159 samples from susceptible
wildlife with negative results. The samples were taken from animals
hunted as nuisance species, as well as from the carcasses of dead and
injured wildlife. Of the 159 samples, 145 came from hunted nuisance
species, including sika deer (46) and wild boar (99). The remaining 14
samples were taken from carcasses of dead and injured wildlife: 5 were
from sika deer, 7 from wild boar, and 2 from Japanese serows. Japan
estimates that there are about 70,000 deer and 65,000 wild pigs in
Miyazaki Prefecture. The wildlife surveillance conducted by Japan
during and after the 2010 outbreak was statistically sufficient to
detect a 7 percent or higher prevalence level of FMD with 95 percent
confidence. We consider Japan's surveillance to be adequate due to the
highly contagious nature of FMD, which would normally produce much
higher prevalence than 7 percent if it was present. To provide
additional assurance of the absence of FMD in wildlife in Miyazaki
Prefecture, Japan initiated another round of wildlife sampling and
testing during the 2011 hunting season that began in October.
Comment: One commenter, observing that the 2000 FMD outbreak in
Japan was linked to contaminated straw/feedstuffs imported into that
country, asked whether the recent reported low refusal rate for
incoming shipments of straw was the result of good mitigation methods
or just luck. He noted the refusal rate of 0.15 percent in 2010, due to
rejection of one container because it did not have a seal. Estimating
that this meant one container was rejected out of 667, he asked whether
667 was the number of containers imported per year.
Response: The low refusal rate is based on a high level of
compliance with import requirements, as determined through inspections
conducted prior to shipment and again upon arrival. Japan told APHIS
that it does not record the number of containers imported, but said it
imported 175,233,764 kilograms of straw in 2010 and 148,226,568
kilograms in the first three quarters of 2011. The rejection rate for
January through September of 2011 was 0.06 percent (1 inspection
testing case out of 1,550). In that instance, Japanese officials said
that the straw had been heat treated as required, but they were unable
to confirm that the treated straw had been properly protected after
treatment to prevent recontamination.
Comment: One commenter asked, ``Does the new path towards
liberalization, in light of an unidentified source, of normalized trade
practices allow for adequate opportunity to find disease if it were
present in a species that would not normally show outward signs?'' The
commenter expressed concern about the rate at which depopulated farms
were restocking. He suggested that a low concentration of animals
provides fewer opportunities to determine whether the disease is still
present and asked how effective the sentinel cow program could be with
only a 3-month waiting period. He asked how long it is expected to take
to repopulate the farms and how that process might affect, or be
affected by, the ``post quarantine timeframe of active and passive
surveillance.''
Response: APHIS disagrees with the notion that there is a new path
towards liberalization of trade practices. We have not changed any of
our criteria for determining whether a region can be reinstated as FMD
free following an outbreak. We are satisfied that FMD has been
eradicated in Japan. During the 2010 outbreak, veterinary officials in
Japan conducted active surveillance for
[[Page 46019]]
FMD, both in Miyazaki Prefecture and throughout the country to ensure
detection of FMD. Investigators assumed an average incubation period of
10 days for swine and 7 days for cattle, with a maximum of 14 days for
both species. However, each epidemiological investigation traced animal
movements onto and off of the farm for 21 days prior to detection of
infection. The last case of FMD in Japan was detected on July 4, 2010,
and all susceptible animals on the farm were destroyed the next day. By
August 26, 2010, all affected farms had completed cleaning and
disinfection procedures. Japan conducted clinical and serological
surveillance around previously affected farms prior to lifting movement
restrictions and throughout Miyazaki Prefecture to reestablish freedom
from FMD. Japan also introduced sentinel cattle onto 175 previously
affected farms beginning on August 31, 2010, to assist in determining
whether any FMD virus remained in the environment. Farmers were
required to conduct daily clinical observations of the cattle, and
local veterinary officers conducted clinical inspections 3 to 4 weeks
after the cattle were introduced onto the premises. Serum samples were
collected on the day of introduction and 3 to 4 weeks after, in
accordance with international recommendations.\6\ The samples were
subject to liquid-phase blocking enzyme-linked immunosorbent assay
testing, with negative results. Finally, Japan collected and tested
samples from susceptible wildlife species in Miyazaki Prefecture, also
with negative results. Even if the disease were present in animals that
did not show outward signs, those animals would have spread the disease
long before now to susceptible species that show clinical signs.
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\6\ FAO Animal Health Manual No. 16: Preparation of Foot-and-
Mouth Disease Contingency Plans. Food and Agriculture Organization
of the United Nations, Rome, 2002. http://www.fao.org/DOCREP/006/Y4382E/y4382e09.htm.
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Restocking of affected premises has proceeded slowly, in large part
due to economic concerns related to the natural disasters Japan
experienced in 2011. According to MAFF, 58 percent of depopulated
cattle farms and 47 percent of depopulated swine farms--57 percent of
the total number of depopulated farms--had restocked or started
restocking as of the last day of August 2011. MAFF told APHIS that many
farmers have delayed restocking because of a decline in livestock
prices following the great earthquake of 2010 in eastern Japan.
The 3-month waiting period mentioned by the commenter appears to
refer to MAFF's declaring Japan once again free of FMD on October 6,
2010, 3 months after the animals on the last affected farm were
destroyed. A 3-month waiting period is in line with OIE recommendations
for reinstatement of FMD-free status in a previously free country where
a stamping-out policy is followed and all vaccinated animals are
destroyed.
As discussed previously, while the specific source of this outbreak
has not been identified, the mechanisms and pathways by which FMD can
be transmitted to livestock are well known. Japan has identified the
most likely route of infection and has implemented measures to prevent
another introduction.
Comment: One commenter said that it would be helpful to get an idea
of what biosecurity measures were in place prior to March 19, 2010,
what measures are new since the disease was identified, and what
measures will continue to be in place after recognition of FMD freedom.
Response: Biosecurity measures prior to the outbreak varied from
farm to farm, as is typical in many other countries, including the
United States. Neighboring cattle farmers commonly visited each other's
premises and shared farm equipment. Swine farms generally had better
biosecurity with disinfecting footbaths in place and restricted access
to areas where the animals were kept. Since the outbreak, many of the
biosecurity measures employed during the emergency are now required by
law. Standards of biosecurity for farming include defining areas of
increased biosecurity on the farm where persons entering are required
to wear particular clothing, requiring people and vehicles entering the
biosecurity area to be disinfected, and preventing contact between
domestic and wild animals.
Comment: One commenter asked how APHIS can be comfortable with
Japan's process for dealing with the outbreak when the prefectural
government's Livestock Hygiene Service Center was notified about the
first animal on March 31, 2010, notified about a second farm with oral
lesions on April 9, 2010, and no samples were submitted for FMD testing
until April 16, 2010. The commenter stated that the lack of astuteness
to the symptoms of the disease present illustrate that all aspects of
disease prevention, detection, and mitigation must be fully understood
and employed or response and recovery are all that is left.
Response: There is no question that delayed detection was a major
cause of virus spread during the 2010 FMD outbreak in Japan. As
discussed in section 7.1 of the evaluation, prior to confirmation of
the first FMD case on April 20, 2010, Japan relied on passive
surveillance for detection and reporting of suspect FMD cases. Passive
surveillance depends on awareness of FMD, however, and local
veterinarians who initially saw cattle with clinical signs compatible
with the disease apparently did not suspect FMD and, therefore, did not
act quickly. As a result of the outbreak, the level of awareness among
farmers and veterinarians throughout Japan is now quite high.
Additionally, government officials and an independent committee
established by the Japanese Government to look into the 2010 outbreak
and make recommendations have noted the high cost of delays in
detecting FMD, and the committee has made several recommendations for
improving passive surveillance and emergency preparedness, as well as
other aspects of FMD prevention, detection, and mitigation. APHIS is
confident that veterinary officials would react far more promptly today
should clinical signs compatible with FMD be observed in a susceptible
animal.
Comment: One commenter stated that APHIS' evaluation deceives the
public by falsely claiming that all FMD-exposed livestock in Japan have
been depopulated. Evidence of this deception is the discussion in the
evaluation concerning six bulls that were removed from a farm just 3
days before the farm experienced an outbreak. According to the
evaluation, one of the bulls became infected with FMD, and the five
other bulls were spared. Since the average incubation period for cattle
is assumed to be 7 days, FMD was likely incubating on the farm before
the bulls were removed.
Response: APHIS did not claim that all FMD-exposed livestock were
depopulated. The evaluation stated that all FMD cases and susceptible
animals kept in the same and epidemiologically related farms, as well
as all susceptible animals on unaffected, vaccinated farms, were
depopulated. Additionally, the evaluation included an extensive
discussion of the disposition of the bulls referenced by the commenter.
As described in section 5.3.3, six high-value bulls from the Miyazaki
Livestock Improvement Association (MLIA), which supplies semen to
Miyazaki producers of Wagyu beef, were removed from the MLIA during the
outbreak in Miyazaki Prefecture. FMD virus was subsequently detected at
the MLIA and all remaining animals were depopulated.
APHIS agrees that FMD was likely incubating on the MLIA premises
when
[[Page 46020]]
the six bulls were removed. However, the six bulls tested negative for
FMD on May 13, 2010, the day they were removed from the MLIA. As
described in the evaluation, once on the new premises, the bulls were
kept isolated from each other and underwent daily clinical inspections
and repeated testing for FMD. One bull tested positive and was
destroyed. For the next 14 days, the remaining bulls were each tested
daily using reverse transcription polymerase chain reaction on nasal
swabs with negative results, and serum samples taken on June 4, June
10, and August 27, 2010, were also negative. In light of these results,
the statistical probability of a bull being infected but not detected
approaches zero.
Comment: One commenter stated that section 5.3.2 of the evaluation
mentions that six bulls were depopulated and buried on July 17, 2010,
yet section 5.3.3 indicates that the bulls were serologically tested on
September 4, 2010, with two subsequently moved to another location.
Response: Section 5.3.2 discusses six bulls belonging to a farmer
in Takanabe-cho who refused to allow the bulls to be vaccinated and
depopulated. All of those bulls were depopulated and buried on July 17,
2010. The six bulls discussed in section 5.3.3 are not the same bulls.
These bulls belonged to the MLIA. Only one of those bulls was
destroyed. The other five bulls remained isolated and underwent testing
for FMD, with negative results.
Comment: One commenter said that many sources report the presence
of wild boar in the area, but only seven wild boar were tested. When
the average time to depopulate from time of identification of virus on
a farm was 9 days (range of 0-30), how does testing of only seven wild
boar provide any assurance that no virus was or is circulating within
the population?
Response: The commenter refers to section 7.2.4 of the evaluation,
which indicates that Japanese officials tested seven samples from the
carcasses of dead or injured wild boar for FMD, with negative results.
However, that same section states that negative results were obtained
on serologic testing of samples from 99 wild boar that were hunted as
nuisance species (MAFF has since updated this number to 106). Sampling
was sufficient to detect 10 percent prevalence with 95 percent
confidence which, along with the fact that no clinical signs of FMD
have been reported, provides assurance that the virus is not
circulating within the wild boar population of Miyazaki Prefecture.
Comment: One commenter, noting that table 4.1 in the evaluation
showed the number of dairy cattle, beef cattle, and swine in Miyazaki
Prefecture, asked for the total population of each susceptible species
in the prefecture, including ``those species which tend to mask the
virus,'' and wildlife. He questioned whether dairy cattle meant
Holstein-type cattle or water buffalo-type cattle. The commenter also
asked for the population of animals within identified zones.
Response: Sheep and goats are not commercially produced in Miyazaki
Prefecture, thus the numbers are quite low. Figures available from
February 2010 show only 28 sheep and 74 goats. Water buffalo were not
included in the count of cattle. At the time of the outbreak, there
were 42 water buffalo in Miyazaki Prefecture. Japan estimates a
wildlife population in Miyazaki Prefecture of approximately 70,000 deer
and 65,000 wild pigs. Sheep and goats, and possibly deer, are the most
likely species that could become infected without showing clinical
signs. Clinical signs in water buffalo were apparent but not classic,
according to reports from the one affected farm with water buffalo.
MAFF noted that there was a high incidence of clinical signs among
infected cattle and swine with this particular strain of virus.
Comment: One commenter, noting the discussion of penalties for non-
reporting in section 3.2 of the evaluation, asked about the
relationship of the penalty to the range of values of animals involved.
For example, how many slaughter-weight pigs does a 1 million yen fine
buy? The commenter said that a producer making 20 percent profit will
have a very different risk tolerance to being fined than will a
producer making a 2 percent profit margin. He said the outlook for
stability within the marketplace will have a large impact on the risk
tolerance a producer is willing to take as well.
Response: The comment refers to penalties for violating Japan's
AIDPL. The AIDPL requires animal owners, caretakers, and veterinarians
to immediately report a suspect or confirmed case of a foreign animal
disease, including FMD, to prefectural authorities, who must then
notify MAFF and others. The AIDPL also provides for payment of
compensation to owners of animals on affected farms up to 80 percent of
market value; in this outbreak, the prefecture provided the remaining
20 percent. We do not have the data to determine whether the penalty is
sufficient to induce reporting, or the extent to which economic
considerations factor into reporting. Compensation tends to encourage
reporting. Evidence suggests that the delay in detecting the first case
of FMD in the 2010 outbreak was the result of a failure to suspect FMD
rather than a failure to report a suspected case.
Comment: One commenter referred to section 3.3.1 of the evaluation,
which contains information about the relative numbers of male and
female graduates of veterinary medical schools in Japan who become
licensed veterinarians each year. He asked what difference it makes,
when responding to FMD and protecting the food supply, whether the
veterinarian is a male or female?
Response: None.
Comment: One commenter said that section 3.4 of the evaluation
contains statements about confusion concerning the prefecture's roles
and responsibilities, with obvious changes made during and after the
response. He asked if enough time has passed to know whether the
implemented changes are effective.
Response: Section 3.4 states that it appeared that the practical
roles and responsibilities of MAFF and the prefectures were not clearly
defined prior to the 2010 outbreak, which caused some confusion in the
initial stages. Japanese officials say that roles were clarified,
rather than changed, following the 2010 outbreak. Local veterinary
officers in Japan participate in foreign animal disease simulations and
training organized by MAFF and the National Institute of Animal Health,
Japan's national reference laboratory. MAFF conducted quality control
exercises with all prefectures in late 2010, after the FMD outbreak,
and also in February 2011. The purpose was to verify details of the
emergency response plans and address any weaknesses detected.
Comment: One commenter asked what the basis is for APHIS' last
statement in section 3.4 of the evaluation, which the commenter said
appears to be directly related to response, when prevention is more
important.
Response: The last statement under section 3.4 of the evaluation is
``APHIS concludes that the authority, organization, and infrastructure
of Japan's veterinary services were sufficient to address the 2010 FMD
outbreak, although opportunities for improvement exist.''
APHIS evaluates veterinary authority, organization, and
infrastructure to determine whether the veterinary services in a region
have the capability and resources to effectively investigate, diagnose,
and report the disease under evaluation, if detected. The sentence
referenced by the commenter is our finding in this area. We also
evaluated
[[Page 46021]]
other factors pertaining to FMD risk in Japan, including measures to
prevent the introduction of the disease. These are described in section
9 of the evaluation.
Comment: One commenter, referring to a discussion of animal
identification and traceability in section 4.4 of the evaluation, asked
how effective the animal identification system was in Japan in helping
to stop/prevent the spread of disease.
Response: We found that animal identification practices in Japan
allowed officials to effectively trace animals to investigate the
source and potential spread of infection. Once the location of affected
and at-risk animals was known, they were targeted for destruction, and
officials established movement restriction zones around the involved
farms to prevent further spread of the disease. In this way, animal
identification practices helped officials contain and eventually stamp
out the disease.
Comment: One commenter stated that the word ``sufficient'' is used
several times throughout the evaluation and asked: How is sufficient
determined, by whom, and by what definition?
Response: APHIS used the term ``sufficient'' seven times in the
evaluation. As used, the word has the standard dictionary meaning,
i.e., enough to meet the needs of a situation or proposed end. In each
case, the word was used in a context that identified the situation or
proposed end. For example, ``Active clinical and serological
surveillance within the restricted zones proved sufficient for
detection of additional case farms within Miyazaki Prefecture''
(section 7.3). The context indicates how ``sufficient'' was determined.
In this sentence, for example, the use of the word sufficient suggests
that the surveillance found all of the remaining cases in the Miyazaki
Prefecture, and, in fact, no additional cases have been detected. The
answer to the question ``by whom'' also depends on context. In the
sentence just quoted, APHIS has made the determination.
Comment: One commenter asked, when the time to depopulate confirmed
herds becomes delayed, what is the appropriate time lag whereby it
becomes more beneficial to vaccinate than depopulate? The commenter
stated that having knowingly positive animals potentially spreading
virus through incubation and amplification while waiting to be
depopulated cannot be good, especially with operations being separated
by just over a quarter of a mile.
Response: The decision to vaccinate rather than depopulate is a
difficult one that may have long-term effects on trade in susceptible
animals and products from those animals. The determination of when that
is the best course of action must be made on a case-by-case basis. That
was not the question in Japan, however. Rather, the question in the
2010 outbreak was whether to vaccinate as part of the stamping-out
program, when lack of burial grounds led to delays in depopulation. The
government recognized that those delays increased the risk that the
disease would spread. The difficulty with the decision to vaccinate or
not was that the Japanese government did not have the authority at the
time to kill apparently healthy, but vaccinated, animals. Japan would
need to destroy the vaccinated animals in order to regain its status as
FMD-free without vaccination. Recognizing that vaccination was the only
way to keep the disease from spreading while additional burial sites
were located, the government passed emergency legislation authorizing
the precautionary depopulation of susceptible animals in areas
designated by the MAFF Minister.
Comment: One commenter expressed concern that reestablishing trade
with Japan would subject U.S. industry to greater risks than it can
bear. As evidence, the commenter pointed to a 30 percent restocking
rate in Japan 6 months after depopulation. The same commenter asked
several questions about the number of veterinarians available to deal
with livestock disease in both Japan and the United States: What is the
per capita ratio of government (all levels) employed veterinarians to
livestock in Japan, and how does that ratio compare to that of the
United States? Is Japan's incident command structure too top heavy? Is
the declining number of food animal veterinarians in Japan, as in the
United States, due to declining economic incentive within the industry
to sustain interest in the field? The commenter also said that without
having a clear and distinct picture of what the APHIS response would be
in the United States to FMD, it is impossible for the industry or the
States to calculate the risk APHIS is requesting them to take.
Response: As discussed previously, Japanese producers continue to
make progress in restocking of farms, which was slowed largely by a
decline in livestock prices following the 2010 earthquake. Fifty-seven
percent had restocked by the end of August 2011.
Regarding the decline in the number of food animal veterinarians--
and not just in the United States and Japan--a number of factors have
contributed, including burdensome student loans, low starting salaries,
the decline of family farms, and a preference among many professionals
to live in areas with urban lifestyle choices. We do not have data on
per capita ratio of government-employed veterinarians to livestock in
the form requested by the commenter, but the World Animal Health
Information Database (WAHID) on the OIE Web site \7\ provides
information on the relative numbers of veterinarians and
paraveterinarians by country. According to WAHID, Japan had 3,465
public sector veterinary personnel in 2010, an average of 0.0092 per
square kilometer or 7.92 per livestock unit, for a country ranking of
6th. The United States is ranked 98th, with 1,874 public sector
veterinary personnel in 2010, an average of 0.0002 per square kilometer
or 0.01 per livestock unit. Differences among countries in the
organization of their veterinary infrastructures, additional resources
in the event of an emergency, size and nature of geographical areas,
population densities (human and livestock), and other factors would
have to be explored to provide context for these numbers.
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\7\ WAHID Interface, Veterinarians and paraveterinarians. http://web.oie.int/wahis/public.php?selected_start_year=2010&display_class=ah_gov&page=country_personnel&sort=1.
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The commenter's questions about the numbers of livestock
veterinarians and what the APHIS response would be to an outbreak of
FMD in the United States are based on the commenter's concern that a
decision to reinstate Japan's FMD-free status would result in an
unacceptable risk of FMD being introduced into the United States. As
discussed earlier, APHIS has not changed any of its criteria for
determining whether a region can be reinstated as FMD-free following an
outbreak. For the reasons given in the evaluation and this document, we
are satisfied that FMD has been eradicated in Japan and that products
authorized by the regulations may be safely imported.
Therefore, based on the evaluation and the reasons given in this
document in response to comments, we are reinstating Japan's status as
FMD-free.
A final rule \8\ published in the Federal Register on January 10,
2012 (77 FR 1388-1396, Docket No. APHIS-2009-0035) and effective on
February 9, 2012, removed lists of regions classified with respect to
certain animal diseases and pests from our animal and animal product
import regulations in 9 CFR parts 92, 93, 94, 96, and 98. The lists are
now posted on APHIS' Web site, rather
[[Page 46022]]
than published in the Code of Federal Regulations. Accordingly, we are
adding Japan to the list of regions that APHIS has declared free of FMD
(formerly in Sec. 94.1) and to the list of FMD-free regions that are
subject to additional restrictions because they supplement their
national meat supply by the importation of fresh (chilled or frozen)
meat of ruminants or swine from regions that APHIS considers to be
affected with rinderpest or FMD, or have a common land border with such
regions, or import ruminants or swine from such regions under
conditions less restrictive than would be acceptable for importation
into the United States (formerly in Sec. 94.11). These lists are
maintained on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. Copies of the lists are
also available via postal mail, fax, or email upon request to the
Sanitary Trade Issues Team, National Center for Import and Export,
Veterinary Services, Animal and Plant Health Inspection Service, 4700
River Road Unit 38, Riverdale, Maryland 20737.
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\8\ See http://www. regulations.gov/#!docketDetail;D=APHIS-2009-
0035.
Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21
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U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
Done in Washington, DC, this 27th day of July, 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-18814 Filed 8-1-12; 8:45 am]
BILLING CODE 3410-34-P