This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

46016 

Vol. 77, No. 149 

Thursday, August 2, 2012 

1To 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=APHIS2010-0077. 2See footnote 1. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2010–0077] 

Notice of Determination of the Footand-Mouth Disease Status of Japan 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our determination regarding the footand-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-andmouth 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 § 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. 

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. 

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 

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Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices 46017 

3Process for Foreign Animal Disease Status 

Evaluations, Regionalization, Risk Analysis, and 

Rulemaking, USDA–APHIS, 2004. 

4The 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. 

5Terrestrial 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. 

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.’’ 

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. 

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, 

§ 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 stampingout 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. 

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 

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46018 Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices 

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 

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Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices 46019 

6FAO 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. 

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. 

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 FMDexposed 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 highvalue 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 

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46020 Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices 

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 Takanabecho 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 buffalotype 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 slaughterweight 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 

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Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices 46021 

7WAHID Interface, Veterinarians and 

paraveterinarians. http://web.oie.int/wahis/

public.php?selected_start_year=2010&

display_class=ah_gov&page=country_

personnel&sort=1. 

8See http://www. regulations.gov/ 

#!docketDetail;D=APHIS-2009-0035. 

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 governmentemployed 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. 

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 FMDfree 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 

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46022 Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / Notices 

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 

§ 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 

§ 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. 

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. 

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 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Manti-La Sal National Forest Resource 

Advisory Committee 

AGENCY: Forest Service, USDA. 

ACTION: Notice of meeting. 

SUMMARY: The Manti-La Sal National 

Forest Resource Advisory Committee 

will meet in Price, Utah. The committee 

is meeting as authorized under the 

Secure Rural Schools and Community 

Self-Determination Act (Pub.L. 110–343) 

and in compliance with the Federal 

Advisory Committee Act. The purpose 

of the meeting is to consider Secure 

Rural Schools Act Title II project 

proposals. 

DATES: The meeting will be held 

September 13, 2012, and will begin at 9 

a.m. 

ADDRESSES: The meeting will be held in 

the conference room of the Utah 

Division of Wildlife Resources, 319 

North Carbonville Road, Price, Utah. 

Written comments should be sent to 

Rosann Fillmore, Manti-La Sal National 

Forest, 599 West Price River Drive, 

Price, UT 84501. Comments may also be 

sent via email to rdfillmore@fs.fed.us or 

via facsimile to 435–637–4940. 

All comments, including names and 

addresses when provided, are placed in 

the record and are available for public 

inspection and copying. The public may 

inspect comments received at the MantiLa Sal National Forest, 599 West Price 

River Drive, Price, UT 84501. Visitors 

are encouraged to call ahead to 435– 

636–3525 to facilitate entry into the 

building. 

FOR FURTHER INFORMATION CONTACT: 

Rosann Fillmore, RAC coordinator, 

USDA, Manti-La Sal National Forest, 

599 West Price River Drive, Price, UT 

84501; 435–636–3525; Email 

rdfillmore@fs.fed.us. 

Individuals who use 

telecommunication devices for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877–8339 

between 8 a.m. and 8 p.m., Eastern 

Standard Time, Monday through Friday. 

SUPPLEMENTARY INFORMATION: The 

meeting is open to the public. The 

following business will be conducted: 

(1) Consideration of Project Funding 

Proposals (2) Plans for Monitoring 

Projects (3) Other business (4) Public 

comment. Persons who wish to bring 

related matters to the attention of the 

Committee may file written statements 

with the Committee staff before or after 

the meeting. Public input sessions will 

be provided and individuals who made 

written requests by September 12, 2012 

will have the opportunity to address the 

Comittee at those sessions. 

Dated: July 27, 2012. 

Thomas W. Lloyd, 

Acting Forest Supervisor. 

[FR Doc. 2012–18849 Filed 8–1–12; 8:45 am] 

BILLING CODE 3410–11–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Lincoln County Resource Advisory 

Committee Meeting 

AGENCY: Forest Service, USDA. 

ACTION: Notice of meeting. 

SUMMARY: The Lincoln County Resource 

Advisory Committee will meet in Libby, 

MT. The committee is authorized under 

the Secure Rural Schools and 

Community Self-Determination Act 

(Pub. L. 110–343) (the Act) and operates 

in compliance with the Federal 

Advisory Committee Act. The purpose 

of the committee is to improve 

collaborative relationships and to 

provide advice and recommendations to 

the Forest Service concerning projects 

and funding consistent with the title II 

of the Act. The meeting is open to the 

public. The purpose of the meeting is to 

review status of project implementation 

and review of status of funds for 2008– 

2011 Secure Rural Schools and 

Community Self-Determination Act. 

DATES: August 29, 2012 @ 6 p.m. 

ADDRESSES: Forest Supervisor’s Office, 

31374 Hwy. 2, Libby, Montana. Written 

comments may be submitted as 

described under SUPPLEMENTARY

INFORMATION. 

All comments, including names and 

addresses when provided, are placed in 

the record and are available for public 

inspection and copying. The public may 

inspect comments received at the Forest 

Supervisor’s Office. Please call ahead to 

406–283–7764 to facilitate entry into the 

building to view comments. 

FOR FURTHER INFORMATION CONTACT: 

Janette Turk, Committee Coordinator, 

Kootenai National Forest at (406) 283– 

7764, or email jturk@fs.fed.us. 

Individuals who use 

telecommunication devices for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877–8339 

between 8 a.m. and 8 p.m., Eastern 

Standard Time, Monday through Friday. 

Requests for reasonable accommodation 

for access to the facility or proceedings 

may be made by contacting the person 

listed under FOR FURTHER INFORMATION. 

SUPPLEMENTARY INFORMATION: The 

following business will be conducted: 

Status of project implementation and 

review of status of funds for 2008–2011 

Secure Rural Schools and Community 

Self-Determination Act. If the meeting 

date or location is changed, notice will 

be posted in the local newspapers, 

including the Daily Interlake, based in 

Kalispell, Montana. Anyone who would 

like to bring related matters to the 

attention of the committee may file 

written statements with the committee 

staff before or after the meeting. The 

agenda will include time for people to 

make oral statements of three minutes or 

less. Individuals wishing to make an 

oral statement should request in writing 

by August 27 to be scheduled on the 

agenda. Written comments and requests 

for time for oral comments must be sent 

to Forest Supervisor’s Office, 31374 

Hwy. 2, Libby, Montana, or by email to 

jturk@fs.fed.us, or via facsimile to 406– 

283–7709. 

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