1718 Federal Register / Vol. 78, No. 6 / Wednesday, January 9, 2013 / Rules and Regulations 

■ 2. Section 925.215 is revised to read 

as follows: 

§ 925.215 Assessment rate. 

On or after January 1, 2012, an 

assessment rate of $0.0150 per 18-pound 

lug is established for grapes grown in a 

designated area of southeastern 

California. 

Dated: January 3, 2013. 

Rex A. Barnes, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2013–00190 Filed 1–8–13; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Part 77 

[Docket No. APHIS–2012–0087] 

Approved Tests for Bovine 

Tuberculosis in Cervids 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Interim rule and request for 

comments. 

SUMMARY: We are adding the CervidTB 

Stat-Pak® and DPP® tests as official 

tuberculosis tests for the following 

species of captive cervids: Elk, red deer, 

white-tailed deer, fallow deer, and 

reindeer. We are taking this action 

because we have determined that the 

tests can reliably detect the presence or 

absence of antibodies to bovine 

tuberculosis in certain species of captive 

cervids. This action is necessary on an 

immediate basis in order to provide 

regulated entities with more options in 

order to meet the testing requirements 

for captive cervids within the 

regulations. 

DATES: This interim rule is effective 

January 9, 2013. We will consider all 

comments that we receive on or before 

March 11, 2013. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to: 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0087- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0087, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road Unit 118, 

Riverdale, MD 20737–1238. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at http:// 

www.regulations.gov/ 

#!docketDetail;D=APHIS-2012-0087 or 

in our reading room, which is located in 

room 1141 of the USDA South Building, 

14th Street and Independence Avenue 

SW., Washington, DC. Normal reading 

room hours are 8 a.m. to 4:30 p.m., 

Monday through Friday, except 

holidays. To be sure someone is there to 

help you, please call (202) 799–7039 

before coming. 

FOR FURTHER INFORMATION CONTACT: Dr. 

C. William Hench, Senior Staff 

Veterinarian, Eradication and 

Surveillance Team, National Center for 

Animal Health Programs, VS, APHIS, 

2150 Centre Avenue, Building B–3E20, 

Fort Collins, CO 80526–8117; (970) 494– 

7378. 

SUPPLEMENTARY INFORMATION: 

Background 

Bovine tuberculosis is a contagious 

and infectious granulomatous disease 

caused by the bacterium Mycobacterium 

bovis. Although commonly defined as a 

chronic debilitating disease, bovine 

tuberculosis can occasionally assume an 

acute, rapidly progressive course. While 

any body tissue can be affected, lesions 

are most frequently observed in the 

lymph nodes, lungs, intestines, liver, 

spleen, pleura, and peritoneum. 

Although cattle are considered to be the 

true hosts of M. bovis, the disease has 

been reported in several other species of 

livestock, most notably bison and 

captive cervids. There have also been 

instances of infection in other domestic 

and nondomestic animals, as well as in 

humans. 

Through the National Cooperative 

State/Federal Bovine Tuberculosis 

Eradication Program, the Animal and 

Plant Health Inspection Service (APHIS) 

of the United States Department of 

Agriculture (USDA) works cooperatively 

with the Nation’s livestock industry and 

State animal health agencies to eradicate 

bovine tuberculosis from domestic 

livestock in the United States and 

prevent its recurrence. 

Federal regulations implementing this 

program are contained in 9 CFR part 77, 

‘‘Tuberculosis’’ (referred to below as the 

regulations) and in the ‘‘Uniform 

Methods and Rules—Bovine 

Tuberculosis Eradication,’’ which is 

incorporated by reference within the 

regulations. The regulations restrict the 

interstate movement of cattle, bison, and 

captive cervids to prevent the spread of 

bovine tuberculosis. Subpart C of the 

regulations (§§ 77.20 to 77.41, referred 

to below as the captive cervid 

regulations) addresses captive cervids. 

Currently, in the captive cervid 

regulations, there are several instances 

in which we require captive cervids to 

be tested with an official tuberculosis 

test. For example, in § 77.35, in order for 

a herd of captive cervids to be 

recognized as accredited, all cervids in 

the herd must have tested negative to at 

least two consecutive official 

tuberculosis tests, conducted at 9 to 15 

month intervals, with certain, limited 

exceptions. 

In § 77.20 of the captive cervid 

regulations, the definition of official 

tuberculosis test has provided that the 

single cervical tuberculin (SCT) test, a 

primary test, and comparative cervical 

tuberculin (CCT) test, a supplemental 

test, are recognized by APHIS as official 

tuberculosis tests, provided that they are 

applied and reported in accordance 

with the captive cervid regulations. 

In the same section, the definitions of 

single cervical tuberculin (SCT) test and 

comparative cervical tuberculin (CCT) 

test provide how to apply each test; the 

sequence in which the tests should be 

administered and the manner in which 

test results should be interpreted are 

specified in § 77.34. The individuals 

who may administer each test and the 

reporting requirements for each test are 

found in § 77.33. 

We recently received a request to 

evaluate the CervidTB Stat-Pak® test, a 

primary test, and Dual Path Platform 

(DPP)® test, a supplemental test, as 

official tests for bovine tuberculosis in 

the following species of captive cervids: 

Elk, red deer, white-tailed deer, fallow 

deer, and reindeer. Based on our 

evaluation, we have determined that the 

tests can reliably detect the presence or 

absence of antibodies to bovine 

tuberculosis in these species of captive 

cervids. Accordingly, we are amending 

the captive cervid regulations to 

recognize these two tests as official 

tuberculosis tests. We discuss these 

amendments immediately below, by 

section. 

Definitions (§ 77.20) 

As we mentioned previously, prior to 

issuance of this interim rule, the 

definition of official tuberculosis test in 

§ 77.20 of the captive cervid regulations 

specified that only the SCT and CCT 

tests are official tuberculosis tests. We 

are amending the definition of official 

tuberculosis test so that it specifies that 

the CervidTB Stat-Pak® and DPP® tests 

are also official tuberculosis tests. 

We are also adding definitions of 

CervidTB Stat-Pak® test and Dual Path 

Platform (DPP®) test to § 77.20. We are 

defining CervidTB Stat-Pak® test as: ‘‘A 

serological assay to determine the 

presence of antibodies to bovine 

tuberculosis (M. bovis) in elk, red deer, 

white-tailed deer, fallow deer, and 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 6 / Wednesday, January 9, 2013 / Rules and Regulations 1719 

reindeer, in which a blood sample taken 

from a captive cervid is placed on a 

strip containing an antibody-detecting 

reagent. The sample is then diluted by 

using a buffer solution. Once sufficient 

time has elapsed, the strip indicates if 

antibodies are present in the sample.’’ 

We are defining Dual Path Platform 

(DPP®) test as: ‘‘A serological assay to 

determine the presence of antibodies to 

bovine tuberculosis (M. bovis) in elk, 

red deer, white-tailed deer, fallow deer, 

and reindeer, in which a blood sample 

taken from a captive cervid and a buffer 

solution are placed on a strip. The 

diluted sample then migrates to another 

strip, which contains an antibodydetecting reagent. This latter strip 

indicates if antibodies are present in the 

sample.’’ 

The definition of designated 

accredited veterinarian in § 77.20 has 

stated that a designated accredited 

veterinarian is an accredited 

veterinarian who is trained and 

approved by cooperating State and 

Federal animal health officials to 

conduct the SCT test on captive cervids. 

As we discuss at greater length below, 

we are also allowing designated 

accredited veterinarians to draw the 

blood samples needed for the CervidTB 

Stat-Pak® and DPP® tests. Accordingly, 

we are amending the definition of 

designated accredited veterinarian to 

specify that designated accredited 

veterinarians may draw such samples. 

Finally, prior to issuance of this 

interim rule, the definitions of negative, 

reactor, and suspect in § 77.20 

presupposed that only the SCT and CCT 

tests are official tuberculosis tests for 

purposes of classifying captive cervids 

according to these classifications. We 

are amending these definitions to reflect 

that the CervidTB Stat-Pak® and DPP®

tests are now also considered official 

tuberculosis tests for such purposes. 

Testing Procedures for Tuberculosis in 

Captive Cervids (§ 77.33) 

Section 77.33 of the captive cervid 

regulations specifies, among other 

things, who may administer official 

tuberculosis tests, which diagnostic 

laboratories have been approved by 

APHIS, the reporting requirements for 

each test, and how the tests will be 

interpreted. 

Paragraph (a) of § 77.33 provides the 

approved testers for each official 

tuberculosis test. Prior to issuance of 

this interim rule, the section had 

specified that official tuberculosis tests 

may only be given by a veterinarian 

employed by the State in which the test 

is administered or by a veterinarian 

employed by USDA, except that 

designated accredited veterinarians, for 

whom correct application of the SCT 

test is part of their accreditation 

training, could conduct the SCT test. 

Because collecting blood samples is also 

part of such training, and because both 

the CervidTB Stat-Pak® and DPP® test 

are serological assays that rely on blood 

samples, we are amending paragraph (a) 

of § 77.33 to specify that designated 

accredited veterinarians may also draw 

blood for the CervidTB Stat-Pak® or 

DPP® test. The veterinarian who draws 

the sample will then ship it to the 

National Veterinary Services 

Laboratories (NVSL) in Ames, IA, for 

testing using these tests. 

(Paragraph (b) of § 77.33 specifies 

that, with one, limited exception, 

histopathology and culture results for 

all tuberculosis diagnoses will only be 

accepted from NVSL. While we 

recognize that both the CervidTB StatPak® and DPP® tests could be 

administered outside of NVSL, we 

would need to evaluate any use of the 

tests outside of NVSL at length in order 

to assess the likely reliability of test 

results for tests administered in such a 

manner. Pending the conclusion of such 

evaluations, we will require the tests to 

be administered by NVSL.) 

Paragraph (d) of § 77.33 provides 

reporting requirements for the various 

official tuberculosis tests for captive 

cervids. Paragraph (d)(1) of § 77.33 

contains reporting requirements for the 

SCT and CCT tests. A number of these 

reporting requirements pertain only to 

tests that are intradermally administered 

and require interpretation of palpation 

at the injection site, as both the SCT and 

CCT tests are, and are thus not 

applicable to the CervidTB Stat-Pak®

and DPP® tests. 

Accordingly, we are adding a 

paragraph (d)(2) to § 77.33. This 

paragraph provides that, for the 

CervidTB Stat-Pak® and DPP® tests, the 

veterinarian who draws blood from the 

captive cervid must submit a request to 

NVSL to perform the CervidTB StatPak® and, if necessary, the DPP® test on 

the blood sample. 

The request must be on a form 

specified by APHIS for such requests. 

The form, currently Veterinary Services 

(VS) form 10–4, ‘‘Specimen 

Submission,’’ is available at: http:// 

www.aphis.usda.gov/library/forms/#vs. 

The completed form, including 

appendices, must be sent along with the 

blood samples to the address provided 

by NVSL on their Web site, http:// 

www.aphis.usda.gov/animal_health/lab

_info_services/about_nvsl.shtml. The 

veterinarian must also fill out the 

relevant portions of a test record; this 

record is currently VS form 6–22, 

‘‘Tuberculosis Test Record.’’ The form 

may be obtained by contacting the local 

area VS office, information regarding 

which is available at http://www.aphis.

usda.gov/animal_health/area_offices/. 

This record must be sent to the offices 

of the State and Federal animal health 

officials in the State. 

Paragraph (e) of § 77.33 contains 

information regarding interpretation of 

test results. We are amending paragraph 

(e) to specify that interpretation of 

CervidTB Stat-Pak® and DPP® test 

results will be in accordance with the 

relevant paragraphs of § 77.34. 

Official Tuberculosis Tests (§ 77.34) 

As we mentioned previously, § 77.34 

of the captive cervid regulations 

contains requirements regarding the 

sequence in which official tuberculosis 

tests should be administered and the 

manner in which test results should be 

interpreted for purposes of the captive 

cervid regulations. Requirements 

regarding the SCT test, a primary test for 

tuberculosis, are contained in paragraph 

(a) of § 77.34; requirements regarding 

the CCT, a supplemental test, are in 

paragraph (b). We are adding 

requirements regarding the CervidTB 

Stat-Pak® test, a primary test, to 

paragraph (a) of § 77.34, and 

requirements regarding the DPP® test, a 

supplemental test, to paragraph (b). 

As amended, paragraph (a) of § 77.34 

specifies that the CervidTB Stat-Pak®

test is a primary test that may be used 

in individual captive elk, red deer, 

white-tailed deer, fallow deer, and 

reindeer, and in herds of these species 

that are of unknown tuberculous status. 

It further requires, with limited 

exceptions, that each captive cervid that 

has non-negative test results to the 

CervidTB Stat-Pak® test must be 

classified as a suspect and retested with 

the DPP® test; a captive cervid that has 

non-negative test results to the 

CervidTB Stat-Pak® test must not be 

retested using the SCT or CCT test. (We 

are also adding reciprocal language to 

the paragraph to specify that each 

captive cervid that responds to the SCT 

test must not be retested with the 

CervidTB Stat-Pak® or DPP® tests.) 

Finally, it allows the CervidTB StatPak® test to be used in affected herds of 

captive elk, red deer, white-tailed deer, 

fallow deer, and reindeer, and in herds 

of these species that have received 

captive cervids from an affected herd; in 

such instances, each captive cervid that 

has non-negative test results to the 

CervidTB Stat-Pak® test must be 

classified as a reactor, unless the 

designated tuberculosis epidemiologist 

(DTE), the State or Federal 

epidemiologist designated by the 

Administrator of APHIS to make 


srobinson on DSK4SPTVN1PROD with 
1720 Federal Register / Vol. 78, No. 6 / Wednesday, January 9, 2013 / Rules and Regulations 

decisions concerning the interpretation 

of diagnostic tests in a State, determines 

that the captive cervid should be 

classified as a suspect because of 

possible exposure to a tuberculous 

animal. This is consistent with our 

current protocol for interpretation of test 

results for SCT tests administered to 

captive cervids from such herds. 

We are specifying that most captive 

cervids that have non-negative test 

results to the CervidTB Stat-Pak® test 

must be classified as suspects and 

retested using the DPP® test. This is 

because of the nature of the CervidTB 

Stat-Pak® test. The CervidTB Stat-Pak®

test produces results that indicate the 

presence or absence of antibodies for 

bovine tuberculosis in blood drawn 

from a captive cervid. It does not, 

however, indicate the level at which 

these antibodies have been determined 

to be present in the blood. Moreover, 

because the CervidTB Stat-Pak® test 

does not have a specificity level of 100 

percent, there is a degree of uncertainty 

regarding non-negative test results 

provided by the test. 

We are requiring that this 

corroboratory testing use the DPP® test 

because both the CervidTB Stat-Pak®

and the DPP® are serological tests that 

can be conducted in succession within 

a laboratory environment, and because 

the specificity of the DPP® test, in 

conjunction with the sensitivity of the 

CervidTB Stat-Pak®, gives us a high 

degree of confidence regarding our 

ultimate determination of the tested 

cervid’s disease status. 

As amended, paragraph (b) of § 77.34 

specifies that the DPP® test is a 

supplemental test that may only be used 

in order to retest captive cervids that 

have been classified as suspects after 

being tested with the CervidTB StatPak® test, and may not be used as a 

primary test. It further specifies that a 

captive cervid that has non-negative test 

results to its first DPP® test must be 

classified as a suspect, unless the DTE 

determines, based on epidemiological 

evidence, that the captive cervid should 

be classified as a reactor. 

A captive cervid classified as a 

suspect on its first DPP® test may be 

retested using the DPP® test to evaluate 

a new blood sample drawn from the 

cervid no less than 30 days after this 

first DPP® test. A captive cervid that has 

non-negative test results on two 

successive DPP® tests must be classified 

as a reactor. 

If a captive cervid has non-negative 

test results to its first DPP® test and is 

classified as a suspect, the owner of the 

cervid will have the option of having 

the cervid taken for slaughter or 

necropsy for a final determination of 

status or of having the cervid retested, 

using the DPP® test, no less than 30 

days later. (In the intervening period, a 

quarantine of the herd will remain in 

effect prohibiting the interstate 

movement of captive cervids from the 

herd. We discuss this at greater length 

later in this document.) If the cervid 

again has non-negative test results to the 

DPP® test after 30 days, it is reasonable 

to classify the cervid as a reactor. This 

is consistent with our current policy for 

captive cervids that have non-negative 

test results to the CCT test. 

Interstate Movements (§ 77.39) 

Section 77.39 of the captive cervid 

regulations contains restrictions on the 

interstate movement of captive cervid 

herds involved in an epidemiological 

investigation or subject to affected herd 

management. 

Paragraph (a) of § 77.39 contains 

restrictions on the interstate movement 

of herds containing a cervid classified as 

a suspect. Paragraph (a)(1) of § 77.39 

contains restrictions on the movement 

of the suspect itself. We are amending 

paragraph (a)(1) to specify that, if a 

captive cervid is classified as a suspect 

on the CervidTB Stat-Pak® test, it must 

be quarantined until it is slaughtered or 

retested and found negative for 

tuberculosis based on the DPP® test. It 

further specifies that, if a captive cervid 

is classified as a suspect on an initial 

DPP® test, it must be slaughtered or 

quarantined for no less than 30 days and 

retested using the DPP® test. If it has 

non-negative test results to this second 

DPP® test, it must be classified as a 

reactor, with the attendant movement 

restrictions of such a classification. 

We are requiring cervids classified as 

suspects to be quarantined because any 

cervid classified as a suspect may 

potentially be infected with bovine 

tuberculosis. Allowing its interstate 

movement other than directly to 

slaughter or necropsy may contribute to 

the spread of tuberculosis. 

Paragraph (a)(2) of § 77.39 contains 

restrictions on the interstate movement 

of all other cervids in a herd that 

contains a suspect. Prior to issuance of 

this interim rule, the paragraph had 

specified that a herd containing a 

suspect must remain under quarantine 

until the suspect is retested using a 

supplemental test or is inspected at 

slaughter or necropsied and found 

negative. However, it did not specify 

that the DPP® test is one of the 

supplemental tests that may be 

administered to the animal. We are 

amending paragraph (a)(2) accordingly. 

Paragraph (e) of § 77.39 contains 

restrictions on the interstate movement 

of herds that have received captive 

cervids from an affected herd. Prior to 

issuance of this interim rule, the 

introductory text of the paragraph had 

specified that if a herd receives captive 

cervids from an affected herd, the 

receiving herd must be placed under 

quarantine, and the captive cervids from 

the affected herd of origin must be 

considered exposed to tuberculosis, and 

must be slaughtered, necropsied, or 

tested with the SCT test. We are 

amending the paragraph so that it 

provides that the exposed cervids may 

also be tested using the CervidTB StatPak® test. 

Paragraph (e)(3) of § 77.39 has 

provided that, if all these exposed 

captive cervids test negative for 

tuberculosis, the receiving herd may be 

released from quarantine, but must be 

retested with the SCT test 1 year after 

release from quarantine in order for 

captive cervids from the herd to 

continue to be moved interstate. We are 

amending the paragraph so that it also 

allows the cervids to be retested using 

the CervidTB Stat-Pak® test. 

Paragraph (f) of § 77.39 contains 

restrictions on the movement of captive 

cervids from herds suspected of being 

the source of tuberculosis. Prior to 

issuance of this interim rule, the 

paragraph had specified the restrictions 

that must be placed on the herd if any 

of the captive cervids in the herd 

respond to the SCT test. The paragraph 

now also specifies the restrictions that 

must be placed on the herd if any of the 

animals in the herd have non-negative 

test results to the CervidTB Stat-Pak®

test. 

Immediate Action 

Immediate action is warranted to 

provide regulated entities who must 

have their captive cervids tested in 

order to comply with the captive cervid 

regulations with additional testing 

options. Under these circumstances, the 

Administrator has determined that prior 

notice and opportunity for public 

comment are contrary to the public 

interest and that there is good cause 

under 5 U.S.C. 553 for making this rule 

effective less than 30 days after 

publication in the Federal Register. 

We will consider comments we 

receive during the comment period for 

this interim rule (see DATES above). 

After the comment period closes, we 

will publish another document in the 

Federal Register in which we will 

respond to the comments we receive 

and finalize or, as necessary, revise the 

provisions of this interim rule. 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 6 / Wednesday, January 9, 2013 / Rules and Regulations 1721 

Executive Order 12866 and Regulatory 

Flexibility Act 

This interim rule is subject to 

Executive Order 12866. However, for 

this action, the Office of Management 

and Budget has waived its review under 

Executive Order 12866. 

In accordance with the Regulatory 

Flexibility Act, we have analyzed the 

potential economic effects of this action 

on small entities. 

This rule adds the CervidTB Stat-Pak®

and DPP® tests as official tuberculosis 

tests for captive cervids. The current 

official tuberculosis tests are the SCT 

and CCT tests. It is APHIS policy that 

owners are responsible for assuming the 

costs associated with primary official 

tuberculosis tests for bovine 

tuberculosis in captive cervids; the 

Agency assumes the cost of 

corroboratory testing. Bovine 

tuberculosis testing using the SCT test, 

including veterinary fees, costs about 

$10 to $15 per head. We have estimated 

bovine tuberculosis testing using the 

CervidTB Stat-Pak® test, including 

veterinary fees, to cost approximately 

$13 to $15 per head. Owners of captive 

cervids will not be required to now use 

the CervidTB Stat-Pak® test instead of 

the SCT test, but may choose to do so 

if they determine such use to be costeffective for their operations. 

That being said, we do anticipate that 

producers may, in certain instances, 

experience benefits because of the 

availability of the CervidTB Stat-Pak®

and DPP® tests as official tuberculosis 

tests for captive cervids. This is because 

of the nature of the CervidTB Stat-Pak®

and DPP® tests. As serological tests, 

they are relatively easy to administer, in 

comparison to the SCT and CCT tests, 

and do not require the animals to be 

held for a significant period of time 

while the test is applied. There is thus 

a lower risk of misapplication of the 

tests and morbidity due to handling of 

the animals during application. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. It has no preemptive effect. 

Paperwork Reduction Act 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection or recordkeeping 

requirements included in this rule have 

been submitted for approval to the 

Office of Management and Budget 

(OMB). Please send written comments 

to the Office of Information and 

Regulatory Affairs, OMB, Attention: 

Desk Officer for APHIS, Washington, DC 

20503. Please state that your comments 

refer to Docket No. APHIS–2012–0087. 

Please send a copy of your comments to: 

(1) Docket No. APHIS–2012–0087, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A–03.8, 4700 

River Road, Unit 118, Riverdale, MD 

20737–1238, and (2) Clearance Officer, 

OCIO, USDA, room 404–W, 14th Street 

and Independence Avenue SW., 

Washington, DC 20250. A comment to 

OMB is best assured of having its full 

effect if OMB receives it within 30 days 

of publication of this rule. 

This rule requires individuals who 

wish to have their cervids tested to fill 

out an application. 

We are soliciting comments from the 

public (as well as affected agencies) 

concerning our proposed information 

collection and recordkeeping 

requirements. These comments will 

help us: 

(1) Evaluate whether the proposed 

information collection is necessary for 

the proper performance of our agency’s 

functions, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of our 

estimate of the burden of the proposed 

information collection, including the 

validity of the methodology and 

assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

information collection on those who are 

to respond (such as through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology; e.g., permitting 

electronic submission of responses). 

Estimate of burden: Public reporting 

burden for this collection of information 

is estimated to average 0.13 hours per 

response. 

Respondents: Captive cervid 

producers. 

Estimated annual number of 

respondents: 975. 

Estimated annual number of 

responses per respondent: 2. 

Estimated annual number of 

responses: 1,950. 

Estimated total annual burden on 

respondents: 253 hours. (Due to 

averaging, the total annual burden hours 

may not equal the product of the annual 

number of responses multiplied by the 

reporting burden per response.) 

Copies of this information collection 

can be obtained from Mrs. Celeste 

Sickles, APHIS’ Information Collection 

Coordinator, at (301) 851–2908. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this rule, please contact Mrs. Celeste 

Sickles, APHIS’ Information Collection 

Coordinator, at (301) 851–2908. 

List of Subjects in 9 CFR Part 77 

Animal diseases, Bison, Cattle, 

Reporting and recordkeeping 

requirements, Transportation, 

Tuberculosis. 

Accordingly, we are amending 9 CFR 

part 77 as follows: 

PART 77—TUBERCULOSIS 

■ 1. The authority citation for part 77 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 

2.22, 2.80, and 371.4. 

■ 2. Section 77.20 is amended as 

follows: 

■ a. In the definition of designated 

accredited veterinarian, by adding the 

words ‘‘or draw blood for the CervidTB 

Stat-Pak® test and DPP® test’’ after the 

words ‘‘(SCT) test’’; 

■ b. In the definitions of negative, 

reactor, and suspect, by removing the 

words ‘‘the SCT test or the CCT test,’’ 

and adding the words ‘‘an official 

tuberculosis test’’ in their place; 

■ c. By revising the definition of official 

tuberculosis test; and 

■ d. By adding, in alphabetical order, 

definitions of CervidTB Stat-Pak® test 

and Dual Path Platform (DPP®) test. 

The revision and additions read as 

follows: 

§ 77.20 Definitions. 

* * * * * 

CervidTB Stat-Pak® test. A serological 

assay to determine the presence of 

antibodies to bovine tuberculosis (M. 


srobinson on DSK4SPTVN1PROD with 
1722 Federal Register / Vol. 78, No. 6 / Wednesday, January 9, 2013 / Rules and Regulations 

bovis) in elk, red deer, white-tailed deer, 

fallow deer, and reindeer, in which a 

blood sample taken from a captive 

cervid is placed on a strip containing an 

antibody-detecting reagent. The sample 

is then diluted by using a buffer 

solution. Once sufficient time has 

elapsed, the strip indicates if antibodies 

are present in the sample. 

* * * * * 

Dual Path Platform (DPP®) test. A 

serological assay to determine the 

presence of antibodies to bovine 

tuberculosis (M. bovis) in elk, red deer, 

white-tailed deer, fallow deer, and 

reindeer, in which a blood sample taken 

from a captive cervid and a buffer 

solution are placed on a strip. The 

diluted sample then migrates to another 

strip, which contains an antibodydetecting reagent. This latter strip 

indicates if antibodies are present in the 

sample. 

* * * * * 

Official tuberculosis test. Any of the 

following tests for bovine tuberculosis 

in captive cervids, applied and reported 

in accordance with this part: 

(1) The single cervical tuberculin 

(SCT) test. 

(2) The comparative cervical 

tuberculin test (CCT) test. 

(3) The CervidTB Stat-Pak® test. 

(4) The Dual Path Platform (DPP®) 

test. 

* * * * * 

■ 3. Section 77.33 is amended as 

follows: 

■ a. In paragraph (a), introductory text, 

by removing the words ‘‘paragraph 

(a)(1)’’ and adding the words 

‘‘paragraphs (a)(1) or (a)(2)’’ in their 

place; 

■ b. In paragraph (a)(1), by removing the 

words ‘‘in § 77.34(a)(2)’’ and adding the 

words ‘‘in § 77.34(a)(1)(ii)’’ in their 

place; 

■ c. By adding a new paragraph (a)(2); 

■ d. By adding a new paragraph (d)(2); 

and 

■ e. By adding new paragraphs (e)(3) 

and (e)(4). 

The additions read as follows: 

§ 77.33 Testing procedures for 

tuberculosis in captive cervids. 

(a) * * * 

(2) A designated accredited 

veterinarian may draw blood for the 

CervidTB Stat-Pak® or DPP® test. 

* * * * * 

(d) * * * 

(2) CervidTB Stat-Pak® and DPP® test. 

For the CervidTB Stat-Pak® and DPP®

test, the veterinarian who draws blood 

from the captive cervid must submit a 

form specified by APHIS for such 

requests to NVSL to perform the 

CervidTB Stat-Pak® and, if necessary, 

DPP® test on the blood sample. The 

form is available at http:// 

www.aphis.usda.gov/library/forms/#vs. 

The completed form, including any 

appendices, must be sent along with the 

blood samples to the address provided 

at the following Web site: http:// 

www.aphis.usda.gov/animal_health/ 

lab_info_services/about_nvsl.shtml. The 

veterinarian must also fill out the 

relevant portions of a test record. This 

form may be obtained by contacting the 

local area VS office, information 

regarding which is available at http:// 

www.aphis.usda.gov/animal_health/ 

area_offices/. This record must be sent 

to the offices of the State and Federal 

animal health officials in the State. 

(e) * * * 

(3) Interpretation of CervidTB StatPak® test results will be in accordance 

with the classification requirements 

described in § 77.34(a). 

(4) Interpretation of DPP® test results 

will be in accordance with the 

classification requirements described in 

§ 77.34(b). 

* * * * * 

■ 4. Section 77.34 is revised to read as 

follows: 

§ 77.34 Official tuberculosis tests. 

(a) Primary tests. (1) Single cervical 

tuberculin (SCT) test. (i) The SCT test is 

a primary test that may be used in 

individual captive cervids and in herds 

of unknown tuberculous status. Each 

captive cervid that responds to the SCT 

test must be classified as a suspect until 

it is retested with the CCT test and is 

either found negative for tuberculosis or 

is classified as a reactor, unless, with 

exception of a designated accredited 

veterinarian, the testing veterinarian 

determines that the captive cervid 

should be classified as a reactor based 

on its response to the SCT test. A 

designated accredited veterinarian must 

classify a responding captive cervid as 

a suspect, unless the DTE determines, 

based on epidemiological evidence, that 

the captive cervid should be classified 

as a reactor. A captive cervid that 

responds to the SCT test must not be 

retested using the CervidTB Stat-Pak® or 

DPP® tests. 

(ii) The SCT test is a primary test that 

may be used in affected herds and in 

herds that have received captive cervids 

from an affected herd. When used with 

affected herds or in herds that have 

received a captive cervid from an 

affected herd, the SCT test may only be 

administered by a veterinarian 

employed by the State in which the test 

is administered or employed by USDA. 

In affected herds or herds that have 

received captive cervids from an 

affected herd, each captive cervid that 

responds to the SCT test must be 

classified as a reactor, unless the DTE 

determines, based on epidemiological 

evidence, that the cervid should be 

classified as a suspect because of 

possible exposure to a tuberculous 

animal. 

(2) CervidTB Stat-Pak® test. (i) The 

CervidTB Stat-Pak® test is a primary test 

that may be used in individual captive 

elk, red deer, white-tailed deer, fallow 

deer, and reindeer, and in herds of these 

species that are of unknown tuberculous 

status. Except as specified in paragraph 

(a)(2)(ii) of this section, each captive 

cervid that has non-negative test results 

to the CervidTB Stat-Pak® test must be 

classified as a suspect and retested with 

the DPP® test. A captive cervid that has 

non-negative test results to the 

CervidTB Stat-Pak® test must not be 

retested using the SCT or CCT test. 

(ii) The CervidTB Stat-Pak® test is a 

primary test that may be used in 

affected herds of captive elk, red deer, 

white-tailed deer, fallow deer, and 

reindeer, and in herds of these species 

that have received captive cervids from 

an affected herd. In such herds, each 

captive cervid that has non-negative test 

results to the CervidTB Stat-Pak® test 

must be classified as a reactor, unless 

the DTE determines that the captive 

cervid should be classified as a suspect 

because of possible exposure to a 

tuberculous animal. 

(b) Supplemental tests. (1) 

Comparative cervical tuberculin (CCT) 

test. 

(i) The CCT test is a supplemental test 

that may only be used in order to retest 

captive cervids that have been classified 

as suspects after being tested with the 

SCT test. The CCT test may be used in 

affected herds only after the herd has 

tested negative to at least two whole 

herd SCT tests and only with the prior 

written consent of the DTE. The CCT 

test may not be used as a primary test. 

(ii) A captive cervid tested with the 

CCT test must be classified as negative 

if it has a response to the bovine PPD 

tuberculin that is less than 1 mm. 

(iii) Unless the testing veterinarian 

determines that the captive cervid 

should be classified as a reactor because 

of possible exposure to a tuberculous 

animal, a captive cervid tested with the 

CCT test must be classified as a suspect 

if: 

(A) It has a response to the bovine 

PPD tuberculin that is greater than 2 

mm and that is equal to the response to 

the avian PPD tuberculin; or 

(B) It has a response to the bovine 

PPD tuberculin that is equal to or greater 

than 1 mm and equal to or less than 2 

mm and that is equal to or greater than 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 6 / Wednesday, January 9, 2013 / Rules and Regulations 1723 

the response to the avian PPD 

tuberculin. 

(iv) A captive cervid tested with the 

CCT test must be classified as a reactor 

if: 

(A) It has a response to the bovine 

PPD tuberculin that is greater than 2 

mm and that is at least 0.5 mm greater 

than the response to the avian PPD 

tuberculin; or 

(B) It has been classified as a suspect 

on two successive CCT tests. 

(C) Any exceptions to the reactor 

classification under the conditions in 

paragraph (b)(1)(iv) of this section must 

be justified by the testing veterinarian in 

writing and have the concurrence of the 

DTE. 

(2) Dual Path Platform (DPP®) test. (i) 

The DPP® test is a supplemental test 

that may only be used in order to retest 

captive cervids that have been classified 

as suspects after being tested with the 

CervidTB Stat-Pak® test. The DPP® test 

may not be used as a primary test. 

(ii) A captive cervid that has nonnegative test results to its first DPP® test 

must be classified as a suspect, unless 

the DTE determines, based on 

epidemiological evidence, that the 

captive cervid should be classified as a 

reactor. A captive cervid classified as a 

suspect on its first DPP® test may be 

retested using the DPP® test to evaluate 

a new blood sample drawn from the 

cervid no less than 30 days after this 

first DPP® test. 

(iii) A captive cervid that has nonnegative test results on two successive 

DPP® tests must be classified as a 

reactor. 

■ 5. Section 77.39 is amended as 

follows: 

■ a. By adding new paragraphs (a)(1)(iii) 

and (a)(1)(iv); 

■ b. In paragraph (a)(2), by removing the 

words ‘‘CCT test or the BTB test’’ and 

adding the words ‘‘CCT test, DPP® test, 

or the BTB test’’ in their place; 

■ c. By revising paragraph (e), 

introductory text; 

■ d. By revising paragraph (e)(3); 

■ e. By revising paragraph (f)(1); and 

■ f. In paragraph (f)(2), by adding the 

words ‘‘or the CervidTB Stat-Pak® test’’ 

after the words ‘‘SCT test’’. 

The revisions and additions read as 

follows: 

§ 77.39 Other interstate movements. 

(a) * * * 

(1) * * * 

(iii) A captive cervid classified as a 

suspect on the CervidTB Stat-Pak® test 

must be quarantined until it is 

slaughtered or retested using the DPP®

test and found negative for tuberculosis 

based on the DPP® test. 

(iv) A captive cervid classified as a 

suspect on an initial DPP® test must be 

slaughtered or otherwise must be 

quarantined until it is retested using the 

DPP® test. A captive cervid that has 

negative test results to this second DPP®

test may be released from quarantine. A 

captive cervid that has non-negative test 

results to this second DPP® test must be 

classified as a reactor and may only be 

moved in accordance with paragraph (b) 

of this section. 

* * * * * 

(e) Herds that have received captive 

cervids from an affected herd. If a herd 

has received captive cervids from an 

affected herd, the captive cervids from 

the affected herd of origin will be 

considered exposed to tuberculosis. The 

exposed captive cervids and the 

receiving herd must be quarantined. The 

exposed captive cervids must be 

slaughtered, necropsied, or tested with 

the SCT test by a veterinarian employed 

by the State in which the test is 

administered or employed by USDA, or 

tested with the CervidTB Stat-Pak® test. 

Any exposed captive cervid that 

responds to the SCT test must be 

classified as a reactor and must be 

inspected at slaughter or necropsied. 

Any exposed captive cervid that has 

non-negative test results to the 

CervidTB Stat-Pak® test must be 

classified as a reactor and must be 

inspected at slaughter or necropsied. 

Any exposed captive cervid that tests 

negative to the SCT or CervidTB StatPak® test will be considered as part of 

the affected herd of origin for purposes 

of testing, quarantine, and the five 

annual whole herd tests required for 

affected herds in paragraph (d) of this 

section. 

* * * * * 

(3) If all the exposed captive cervids 

test negative for tuberculosis, the 

receiving herd will be released from 

quarantine if it is given a whole herd 

test and is found negative for 

tuberculosis and will return to the herd 

classification in effect before the herd 

was quarantined. In addition, the 

receiving herd will must be retested 

with the SCT or CervidTB Stat-Pak® test 

1 year after release from quarantine in 

order for captive cervids from the herd 

to continue to be moved interstate. 

Supplemental diagnostic tests may be 

used if any captive cervids in the herd 

show a response to the SCT test or have 

non-negative test results to the 

CervidTB Stat-Pak® test. 

(f) * * * 

(1) If the herd is identified as the 

source of captive cervids having lesions 

of tuberculosis and M. bovis has been 

confirmed by bacterial isolation from 

the slaughter animal, all captive cervids 

in the herd that respond to the SCT 

must be classified as reactors. All 

captive cervids in the herd that respond 

to the CervidTB Stat-Pak® test must be 

classified as reactors. If none respond to 

the SCT test or have non-negative test 

results to the CervidTB Stat-Pak® test, 

the herd may be released from 

quarantine and will return to the herd 

classification status in effect before the 

herd was quarantined, unless the DTE 

determines that additional testing is 

appropriate to ensure the herd’s 

freedom from tuberculosis. 

* * * * * 

Done in Washington, DC, this 2nd day of 

January 2013. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2013–00208 Filed 1–8–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2012–1314; Directorate 

Identifier 2012–NM–227–AD; Amendment 

39–17312; AD 2012–26–51] 

RIN 2120–AA64 

Airworthiness Directives; Airbus 

Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for all 

Airbus Model A318, A319, A320, and 

A321 series airplanes. This emergency 

AD was sent previously to all known 

U.S. owners and operators of these 

airplanes. This AD requires revising the 

airplane flight manual (AFM) to advise 

the flight crew of emergency procedures 

for addressing Angle of Attack (AoA) 

sensor blockage. This AD also provides 

for optional terminating action for the 

AFM revision, which involves replacing 

AoA sensor conic plates with AoA 

sensor flat plates. This AD was 

prompted by a report that an airplane 

equipped with AoA sensors installed 

with conic plates recently experienced 

blockage of all sensors during climb, 

leading to autopilot disconnection and 

activation of the alpha protection 

(Alpha Prot) when Mach number was 

increased. We are issuing this AD to 

prevent reduced control of the airplane. 

DATES: This AD is effective January 24, 

2013 to all persons except those persons 


srobinson on DSK4SPTVN1PROD with