This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

26377

Vol. 60, No. 95

Wednesday, May 17, 1995

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Parts 50, 51, 77 and 78

[Docket No. 95–006–1]

Tuberculosis and Brucellosis in Cattle

and Bison; Identification Requirements

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the tuberculosis and brucellosis

regulations by requiring brands for

certain cattle and bison to be placed on

the hip rather than the jaw. This action

would reduce distress to cattle and

bison that need to be identified with a

brand by moving the brand to a less

sensitive location, but would allow

them to continue to be clearly

identified. We are also proposing to

allow certain cattle and bison to be

moved interstate to slaughter without

branding if they are accompanied

directly to slaughter by an Animal and

Plant Health Inspection Service or State

representative or are moved in vehicles

closed with official seals. This proposed

rule responds to increasing public

concern that branding on the jaw causes

unnecessary distress to cattle and bison.

DATES: Consideration will be given only

to comments received on or before June

16, 1995.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 95–006–1, Regulatory

Analysis and Development, PPD,

APHIS, Suite 3C03, 4700 River Road

Unit 118, Riverdale, MD 20737–1238.

Please state that your comments refer to

Docket No. 95–006–1. Comments

received may be inspected at USDA,

room 1141, South Building, 14th Street

and Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to

inspect comments are requested to call

ahead on (202) 690–2817 to facilitate

entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Dr.

J.D. Kopec, Senior Staff Veterinarian,

Cattle Diseases and Surveillance, VS,

APHIS, Suite 3B08, 4700 River Road

Unit 36, Riverdale, MD 20737–1231;

(301) 734–6188.

SUPPLEMENTARY INFORMATION:

Background

Bovine tuberculosis is a serious

communicable disease of cattle, bison,

and other species, including humans,

caused by Mycobacterium bovis.

Tuberculosis causes weight loss, general

debilitation, and sometimes death.

Brucellosis, also called Bang’s disease

or undulant fever, is a serious infectious

disease of cattle, bison, and other

species, including humans, caused by

bacteria of the genus Brucella.

Brucellosis in cattle and bison is

characterized by the birth of weak or

stillborn calves, slow breeding, abortion,

and loss of milk production.

In accordance with the regulations in

9 CFR parts 50, 51, 77, and 78 (referred

to below as the regulations), the Animal

and Plant Health Inspection Service

(APHIS) administers programs designed

to control and eradicate tuberculosis

and brucellosis in cattle and bison. As

part of these programs, hot-iron

branding on the jaw and on the tailhead

is used to identify certain cattle and

bison. Specifically, hot-iron branding on

the jaw is required or allowed in the

following cases: (1) To identify cattle or

bison that have contracted or been

exposed to tuberculosis or brucellosis;

(2) to identify certain cattle or bison to

be moved interstate to slaughter because

of tuberculosis or brucellosis; and (3) to

identify adult cattle or bison that have

been immunized against brucellosis.

There has been increasing public

concern that hot-iron branding on the

jaw may cause undue distress to cattle

and bison. A number of animal rights

groups and other members of the public

have requested that APHIS remove hotiron branding on the jaw from our

regulatory programs. In response to their

concerns, we are in this document

proposing to remove hot-iron branding

on the jaw from the regulations in 9 CFR

parts 50, 51, 77, and 78. In places where

branding is required to be on the jaw,

we would move the required location of

the brand to high on the hip near the

tailhead. In places where the regulations

offer an owner the option of branding

either on the jaw or on the hip, we

would remove the option of branding on

the jaw, but would retain the brand on

the hip.

We also considered proposing

identification options such as freeze

branding, by requiring that the cattle

and bison be identified by a brand or by

another distinct, permanent, and legible

mark. We chose not to propose these

options. A limitation of freeze branding

is that the brand takes a minimum of 18

to 21 days to become visible. In order

that we may continue to prevent the

spread of tuberculosis and brucellosis, it

is imperative that exposed and affected

animals be instantly recognizable from

the time of their identification until they

are slaughtered, so that they are not

commingled with healthy animals. In

most cases, exposed or affected cattle or

bison would be identified, shipped, and

slaughtered before the freeze brand

becomes visible. To date, an acceptable

alternative to hot-iron branding has not

been found for marking exposed or

affected cattle or bison that satisfies the

criteria of being instantly visible upon

application, as well as distinct,

permanent, and legible. Until an

acceptable alternative is developed, we

have chosen to continue to require that

branding of cattle and bison under the

brucellosis and tuberculosis regulations

be with a hot iron. We believe that

moving the location of the brand from

the jaw to the hip would reduce distress

to cattle and bison, but would allow

them to continue to be identified

distinctly, permanently, legibly, and

instantly.

We are, however, proposing several

alternatives to branding certain cattle

and bison that are to be moved interstate

for slaughter. We would allow

brucellosis reactor and exposed cattle or

bison moving directly to slaughter to be

moved without branding if they are

accompanied directly to slaughter by an

APHIS or State representative. We

would also allow brucellosis reactor and

exposed cattle or bison moving

interstate in slaughter channels (e.g, to

a quarantined feedlot, a specifically

approved stockyard, or an approved

intermediate handling facility, and then

to slaughter) to be moved without

branding if they are moved in vehicles

closed with official seals applied and

removed by an APHIS representative, a

State representative, an accredited
26378 Federal Register / Vol. 60, No. 95 / Wednesday, May 17, 1995 / Proposed Rules

veterinarian, or an individual

authorized for this purpose by an APHIS

representative. For movement in sealed

vehicles, cattle and bison moving

interstate to slaughter because of

brucellosis would have to be

accompanied by a permit or ‘‘S’’ brand

permit, and the official seal numbers

would have to be recorded on the

accompanying permit or ‘‘S’’ brand

permit. (Permit and ‘‘S’’ brand permit

are defined in the regulations, and, in

accordance with the definitions, must

list: The points of origin and

destination, the number of animals

covered, the purpose of movement, and

one of several possible identification

numbers.)

We would allow tuberculosis exposed

cattle and bison moving directly to

slaughter to be moved without branding

if they are accompanied directly to

slaughter by an APHIS or State

representative. We would allow

tuberculosis exposed cattle or bison

moving interstate in slaughter channels

to be moved without branding if they

are moved in vehicles closed with

official seals applied and removed by an

APHIS representative, a State

representative, an accredited

veterinarian, or an individual

authorized for this purpose by an APHIS

representative. For tuberculosis reactor

cattle and bison, we would allow the

same movement without branding as for

tuberculosis exposed cattle and bison,

but we would require that the reactors

be identified by a permanent and legible

‘‘TB’’ tattooed on the left ear, and by

spraying the left ear with yellow paint.

Unlike brucellosis reactor cattle and

bison, tuberculosis reactor cattle and

bison can only be sold for consumption

if the meat is cooked. Presently, there

are only four slaughtering facilities in

the United States that have the capacity

to cook the meat, so this option is not

available to the majority of cattle and

bison owners. Consequently, most

tuberculosis reactor cattle and bison

sent to slaughter constitute a monetary

loss of $500 or more to the owner. Such

monetary loss could provide an

incentive to substitute less valuable

tuberculosis-free animals for more

valuable infected animals, or to

otherwise divert valuable tuberculosis

infected animals from slaughter

channels, impeding tuberculosis

eradication efforts in the United States.

We believe that requiring tuberculosis

reactors to have their left ear tattooed

with a ‘‘TB’’ and spray painted yellow

would make it difficult for these

reactors to be diverted.

These options would provide owners

of cattle and bison with an alternative

to branding, while helping to ensure

that brucellosis- and tuberculosisaffected cattle and bison are handled

and moved to slaughter in a manner that

prevents dissemination of these

diseases.

Miscellaneous

The branding requirements in the

regulations are currently inconsistent,

providing different size specifications

and different descriptions for the

location of the brand. This proposed

rule would revise the branding

requirements not only to remove the

option for branding on the jaw, but to

make the descriptions consistent. All

brands would be required to be

positioned high on the left hip near the

tailhead and to be at least 5 by 5

centimeters (2 by 2 inches) in size.

Executive Order 12866 and Regulatory

Flexibility Act

This proposed rule has been reviewed

under Executive Order 12866. The rule

has been determined to be not

significant for purposes of Executive

Order 12866 and, therefore, has not

been reviewed by the Office of

Management and Budget.

We do not anticipate that this

proposed rule would have an economic

impact on any entities, large or small.

Cattle and bison that have contracted or

been exposed to tuberculosis or

brucellosis, or that have been

immunized against brucellosis, are

already required to be identified by a

brand; this rule would simply change

the location of the brand. Under the

tuberculosis and brucellosis eradication

programs, the Animal and Plant Health

Inspection Service (APHIS) and

cooperating States bear the costs of

branding cattle and bison, and changing

the location of the brand would not

result in any change in costs to APHIS

or the States. Further, although branding

is generally done on the ranch or farm

where the cattle or bison are located, no

new equipment would be necessary for

branding the cattle or bison on the hip,

so there would be no new costs to the

owner of the animals.

This rule would also allow certain

cattle and bison to be moved interstate

to slaughter without branding if they are

accompanied directly to slaughter by an

APHIS or State representative, or if they

are moved in vehicles closed with

official seals applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

Such movement would be a voluntary

alternative to branding, and would not

impose any additional costs to owners

of cattle or bison that are to be moved

interstate.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action would not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12778

This proposed rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are in conflict with this

rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.

Paperwork Reduction Act

This proposed rule contains no

information collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1980 (44 U.S.C. 3501

et seq.).

List of Subjects

9 CFR Part 50

Animal diseases, Bison, Cattle, Hogs,

Indemnity payments, Reporting and

recordkeeping requirements,

Tuberculosis.

9 CFR Part 51

Animal diseases, Cattle, Hogs,

Indemnity payments, Reporting and

recordkeeping requirements.

9 CFR Part 77

Animal diseases, Bison, Cattle,

Reporting and recordkeeping

requirements, Transportation,

Tuberculosis.

9 CFR Part 78

Animal diseases, Bison, Cattle, Hogs,

Quarantine, Reporting and

recordkeeping requirements,

Transportation.

Accordingly, 9 CFR parts 50, 51, 77,

and 78 would be amended as follows:

PART 50—ANIMALS DESTROYED

BECAUSE OF TUBERCULOSIS

1. The authority citation for part 50

would continue to read as follows:

Authority: 21 U.S.C. 111–113, 114, 114a,

114a-1, 120, 121, 125, and 134b; 7 CFR 2.17,

2.51, and 371.2(d).

2. In § 50.6, paragraphs (a) and (b)

would be revised to read as follows:

§ 50.6 Identification of animals to be

destroyed because of tuberculosis.

* * * * *

(a) Reactor cattle and bison. Reactor

cattle and bison shall be identified by
Federal Register / Vol. 60, No. 95 / Wednesday, May 17, 1995 / Proposed Rules 26379

branding the letter ‘‘T,’’ at least 5 by 5

centimeters (2 by 2 inches) in size, high

on the left hip near the tailhead and by

attaching to the left ear an approved

metal eartag bearing a serial number and

the inscription ‘‘U.S. Reactor’’, or a

similar State reactor tag. Reactor cattle

and bison may be moved interstate to

slaughter without branding if they are

permanently identified by the letters

‘‘TB’’ tattooed legibly on the left ear,

they are sprayed on the left ear with

yellow paint, and they are either

accompanied by an APHIS or State

representative or moved directly to

slaughter in vehicles closed with official

seals. Such official seals must be

applied and removed by an APHIS

representative, State representative,

accredited veterinarian, or an individual

authorized for this purpose by an APHIS

representative.

(b) Exposed cattle and bison. Exposed

cattle and bison shall be identified by

branding the letter ‘‘S,’’ at least 5 by 5

centimeters (2 by 2 inches) in size, high

on the left hip near the tailhead and by

attaching to the left ear an approved

metal eartag bearing a serial number.

Exposed cattle and bison may be moved

interstate to slaughter without branding

if they are either accompanied by an

APHIS or State representative or moved

directly to slaughter in vehicles closed

with official seals. Such official seals

must be applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

* * * * *

PART 51—ANIMALS DESTROYED

BECAUSE OF BRUCELLOSIS

3. The authority citation for part 51

would continue to read as follows:

Authority: 21 U.S.C. 111–113, 114, 114a,

114a-1, 120, 121, 125, and 134b; 7 CFR 2.17,

2.51, and 371.2(d).

4. In § 51.5, paragraph (b) would be

revised to read as follows:

§ 51.5 Identification of animals to be

destroyed because of brucellosis.

* * * * *

(b) Except as in paragraph (b)(4),

cattle and bison to be destroyed because

of brucellosis shall be individually

identified prior to moving interstate by

attaching to the left ear a metal tag

bearing a serial number and the

inscription ‘‘U.S. Reactor,’’ or a similar

State reactor tag, and must be:

(1) ‘‘B’’ branded (as defined in § 78.1);

or

(2) Accompanied directly to slaughter

by an APHIS or State representative; or

(3) Moved in vehicles closed with

official seals applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

The official seal numbers must be

recorded on the accompanying permit.

(4) Reactor and exposed cattle and

bison in herds scheduled for herd

depopulation may be moved interstate

without eartagging or branding if they

are identified by USDA approved

backtags and either accompanied

directly to slaughter by an APHIS or

State representative or moved directly to

slaughter in vehicles closed with official

seals. Such official seals must be

applied and removed by an APHIS

representative, State representative,

accredited veterinarian, or an individual

authorized for this purpose by an APHIS

representative.

* * * * *

PART 77—TUBERCULOSIS

5. The authority citation for part 77

would continue to read as follows:

Authority: 21 U.S.C. 111, 114, 114a, 115–

117, 120, 121, 134b, and 134f; 7 CFR 2.17,

2.51, and 371.2(d).

6. In § 77.5, the heading would be

amended by removing the word

‘‘comtaining’’ and adding the word

‘‘containing’’ in its place, and

paragraphs (a)(1) and (b)(1) would be

revised to read as follows:

§ 77.5 Interstate movement of cattle and

bison that are exposed, reactors, or

suspects, or from herds containing

suspects.

(a) Reactor cattle and bison. * * *

(1) Reactor cattle and bison must be

individually identified by attaching to

the left ear an approved metal eartag

bearing a serial number and the

inscription ‘‘U.S. Reactor’’, or a similar

State reactor tag, and must be:

(i) Branded with the letter ‘‘T,’’ at

least 5 by 5 centimeters (2 by 2 inches)

in size, high on the left hip near the

tailhead; or

(ii) Permanently identified with the

letters ‘‘TB’’ tattooed legibly on the left

ear and sprayed on the left ear with

yellow paint, and either accompanied

directly to slaughter by an APHIS or

State representative or moved directly to

slaughter in vehicles closed with official

seals. Such official seals must be

applied and removed by an APHIS

representative, State representative,

accredited veterinarian, or an individual

authorized for this purpose by an APHIS

representative.

* * * * *

(b) Exposed cattle and bison. * * *

(1) Exposed cattle and bison must be

individually identified by attaching to

the left ear an approved metal eartag

bearing a serial number, and must be:

(i) Branded with the letter ‘‘S,’’ at

least 5 by 5 centimeters (2 by 2 inches)

in size, high on the left hip near the

tailhead; or

(ii) Accompanied directly to slaughter

by an APHIS or State representative; or

(iii) Moved directly to slaughter in

vehicles closed with official seals. Such

official seals must be applied and

removed by an APHIS representative,

State representative, accredited

veterinarian, or an individual

authorized for this purpose by an APHIS

representative.

* * * * *

PART 78—BRUCELLOSIS

7. The authority citation for part 78

would continue to read as follows:

Authority: 21 U.S.C. 111–114a–1, 114g,

115, 117, 120, 121, 123–126, 134b, and 134f;

7 CFR 2.17, 2.51, and 371.2(d).

Subpart A—General Provisions

§ 78.1 [Amended]

8. Section 78.1 would be amended as

follows:

a. In the definition for ‘‘B’’ branded,

the phrase ‘‘at least 5 sq. cm. (2 × 2

inches) in size on the left jaw’’ would

be removed and ‘‘high on left hip near

the tailhead and at least 5 by 5

centimeters (2 by 2 inches) in size’’

would be added in its place.

b. In the definition for Official adult

vaccinate, paragraph (b)(1) would be

amended by removing ‘‘on the right jaw

or’’ and by adding ‘‘at least 5 by 5

centimeters (2 by 2 inches) in size’’

immediately after ‘‘tailhead’’.

c. In the definition for ‘‘S’’ branded,

the phrase ‘‘at least 5 sq. cm. (2 ×2

inches) in size on the left jaw or high

on the tailhead (over the fourth to the

seventh coccygeal vertebrae)’’ would be

removed and ‘‘high on left hip near the

tailhead and at least 5 by 5 centimeters

(2 by 2 inches) in size’’ would be added

in its place.

Subpart B—Restrictions on Interstate

Movement of Cattle Because of

Brucellosis

9. In § 78.7, paragraph (b) would be

revised to read as follows:

§ 78.7 Brucellosis reactor cattle.

* * * * *

(b) Identification. Brucellosis reactor

cattle must be individually identified

prior to moving interstate by attaching

to the left ear a metal tag bearing a serial

number and the inscription ‘‘U.S.
26380 Federal Register / Vol. 60, No. 95 / Wednesday, May 17, 1995 / Proposed Rules

Reactor,’’ or a metal tag bearing a serial

number designated by the State animal

health official for identifying brucellosis

reactors, and must be:

(1) ‘‘B’’ branded (as defined in § 78.1);

or

(2) Accompanied directly to slaughter

by an APHIS or State representative; or

(3) Moved in vehicles closed with

official seals applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

The official seal numbers must be

recorded on the accompanying permit.

* * * * *

10. Section 78.8 would be amended

by removing the period at the end of

paragraphs (a)(3)(iii)(C), (a)(5)(iii)(C),

and (b)(3)(ii) and adding ‘‘; or’’ in its

place; and by adding new paragraphs

(a)(3)(iii)(D), (a)(5)(iii)(D), and (b)(3)(iii)

to read as follows:

§ 78.8 Brucellosis exposed cattle.

* * * * *

(a) * * *

(3) * * *

(iii) * * *

(D) Moved in vehicles closed with

official seals applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

The official seal numbers must be

recorded on the accompanying permit

or ‘‘S’’ brand permit.

* * * * *

(5) * * *

(iii) * * *

(D) Moved in vehicles closed with

official seals applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

The official seal numbers must be

recorded on the accompanying permit

or ‘‘S’’ brand permit.

* * * * *

(b) * * *

(3) * * *

(iii) Moved in vehicles closed with

official seals applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

The official seal numbers must be

recorded on the accompanying permit

or ‘‘S’’ brand permit.

* * * * *

11. Section 78.9 would be amended

by removing the period at the end of

paragraphs (c)(1)(v)(C), (c)(1)(vii)(C),

(c)(2)(i)(C), (c)(2)(ii)(B), (d)(1)(v)(C),

(d)(1)(vii)(C), (d)(2)(i)(C), and

(d)(2)(ii)(B) and adding ‘‘; or’’ in its

place; and by adding new paragraphs

(c)(1)(v)(D), (c)(1)(vii)(D), (c)(2)(i)(D),

(c)(2)(ii)(C), (d)(1)(v)(D), (d)(1)(vii)(D),

(d)(2)(i)(D), and (d)(2)(ii)(C) to read as

follows:

§ 78.9 Cattle from herds not known to be

affected.

* * * * *

(c) * * *

(1) * * *

(v) * * *

(D) They are accompanied by an ‘‘S’’

brand permit and moved in vehicles

closed with official seals applied and

removed by an APHIS representative,

State representative, accredited

veterinarian, or an individual

authorized for this purpose by an APHIS

representative. The official seal numbers

must be recorded on the accompanying

‘‘S’’ brand permit.

* * * * *

(vii) * * *

(D) They are accompanied by an ‘‘S’’

brand permit and moved in vehicles

closed with official seals applied and

removed by an APHIS representative,

State representative, accredited

veterinarian, or an individual

authorized for this purpose by an APHIS

representative. The official seal numbers

must be recorded on the accompanying

‘‘S’’ brand permit.

* * * * *

(2) * * *

(i) * * *

(D) A quarantined feedlot, a

specifically approved stockyard and

then directly to a quarantined feedlot, or

an approved intermediate handling

facility and then directly to a

quarantined feedlot if the cattle are

accompanied by an ‘‘S’’ brand permit

and moved in vehicles closed with

official seals applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

The official seal numbers must be

recorded on the accompanying ‘‘S’’

brand permit.

* * * * *

(ii) * * *

(C) They are accompanied by an ‘‘S’’

brand permit and moved in vehicles

closed with official seals applied and

removed by an APHIS representative,

State representative, accredited

veterinarian, or an individual

authorized for this purpose by an APHIS

representative. The official seal numbers

must be recorded on the accompanying

‘‘S’’ brand permit.

* * * * *

(d) * * *

(1) * * *

(v) * * *

(D) They are accompanied by an ‘‘S’’

brand permit and moved in vehicles

closed with official seals applied and

removed by an APHIS representative,

State representative, accredited

veterinarian, or an individual

authorized for this purpose by an APHIS

representative. The official seal numbers

must be recorded on the accompanying

‘‘S’’ brand permit.

* * * * *

(vii) * * *

(D) They are accompanied by an ‘‘S’’

brand permit and moved in vehicles

closed with official seals applied and

removed by an APHIS representative,

State representative, accredited

veterinarian, or an individual

authorized for this purpose by an APHIS

representative. The official seal numbers

must be recorded on the accompanying

‘‘S’’ brand permit.

* * * * *

(2) * * *

(i) * * *

(D) A quarantined feedlot, a

specifically approved stockyard and

then directly to a quarantined feedlot, or

an approved intermediate handling

facility and then directly to a

quarantined feedlot if the cattle are

accompanied by an ‘‘S’’ brand permit

and moved in vehicles closed with

official seals applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

The official seal numbers must be

recorded on the accompanying ‘‘S’’

brand permit.

* * * * *

(ii) * * *

(C) They are accompanied by an ‘‘S’’

brand permit and moved in vehicles

closed with official seals applied and

removed by an APHIS representative,

State representative, accredited

veterinarian, or an individual

authorized for this purpose by an APHIS

representative. The official seal numbers

must be recorded on the accompanying

‘‘S’’ brand permit.

* * * * *

Subpart C—Restrictions on Interstate

Movement of Bison Because of

Brucellosis

12. In § 78.22, paragraph (b) would be

revised to read as follows:

§ 78.22 Brucellosis reactor bison.

* * * * *

(b) Identification. Brucellosis reactor

bison must be individually identified
Federal Register / Vol. 60, No. 95 / Wednesday, May 17, 1995 / Proposed Rules 26381

prior to moving interstate by attaching

to the left ear a metal tag bearing a serial

number and the inscription ‘‘U.S.

Reactor,’’ or a metal tag bearing a serial

number designated by the State animal

health official for identifying brucellosis

reactors, and must be:

(1) ‘‘B’’ branded (as defined in § 78.1);

or

(2) Accompanied directly to slaughter

by an APHIS or State representative; or

(3) Moved in vehicles closed with

official seals applied and removed by an

APHIS representative, State

representative, accredited veterinarian,

or an individual authorized for this

purpose by an APHIS representative.

The official seal numbers must be

recorded on the accompanying permit.

* * * * *

Done in Washington, DC, this 11th day of

May 1995.

Lonnie J. King,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–12150 Filed 5–16–95; 8:45 am]

BILLING CODE 3410–34–P

9 CFR Parts 101 and 113

[Docket No. 94–051–1]

RIN 0579–AA66

Viruses, Serums, Toxins, and

Analogous Products; In Vitro Tests for

Serial Release

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the regulations regarding the use of in

vitro potency tests in place of animal

tests for immunogenicity to: change the

title of the section; prescribe

requirements for in vitro immunoassays

used to determine the relative antigen

content of inactivated biological

products; require that such

immunoassays be parallel line assays

based upon unexpired reference

preparations; require that in vitro tests

for relative antigen content be converted

to parallel line assays within 2 years;

specify procedures and requirements for

qualifying or requalifying reference

preparations for inactivated products;

and add certain definitions to the

regulations.

The effect of the amendment would

be to standardize the methods used to

determine the relative potency of

inactivated biological products.

DATES: Consideration will be given only

to comments received on or before

August 15, 1995.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 94–051–1, Regulatory

Analysis and Development, PPD,

APHIS, Suite 3C03, 4700 River Road

Unit 118, Riverdale, MD 20737–1238.

Please state that your comments refer to

Docket No. 94–051–1. Comments

received may be inspected at USDA,

room 1141, South Building, 14th Street

and Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to

inspect comments are requested to call

ahead (202) 690–2817 to facilitate entry

into the comment reading room.

FOR FURTHER INFORMATION CONTACT:

Dr. David A. Espeseth, Deputy Director,

Veterinary Biologics, BBEP, APHIS,

4700 River Road Unit 148, Riverdale,

MD 20737–1237, (301) 734–8245.

SUPPLEMENTARY INFORMATION:

Background

The regulations pertaining to the

testing of biologics provide that no

biological product shall be released (for

sale) prior to the completion of tests

prescribed to establish the product to be

pure, safe, potent, and efficacious (9

CFR 113.5). Efficacy refers to the

specific ability of the product to effect

the result for which it is offered when

used as recommended by the

manufacturer. Studies conducted to

establish efficacy include

immunogenicity tests in host animals

using product manufactured according

to specific requirements which include

specifications for antigen content and/or

animal potency. These requirements

apply to every serial of product which

is produced. Therefore, if a product has

been tested for immunogenicity in

animals and shown to have the desired

effect, it follows that subsequent serials

(batches) of the product manufactured

to the same specifications should also

have the same effect.

Once immunogenicity is established

in relation to a specific minimum

antigen content in a product, it should

no longer be necessary to test every

subsequent serial for potency in animals

if an evaluation can be made with

reasonable certainty of the relative

antigen content by testing the serial or

subserial in an acceptable in vitro test

system. Therefore, when properly

qualified and validated, in vitro

immunoassays that determine relative

antigen content of the product can serve

as acceptable substitutes for potency

tests that otherwise would need to be

performed in animals.

The regulations in 9 CFR 113.8

pertain to the use of in vitro tests in

place of animal tests for determining the

potency of veterinary biological

products. Currently, the in vitro tests

prescribed in § 113.8 which include

determining the log10 virus titer and

performing live bacterial counts are only

applicable to veterinary biologicals

which contain live microorganisms. The

changes and test procedures prescribed

in this proposal would make § 113.8

applicable to both live and inactivated

products by prescribing validity

requirements for in vitro test systems

used, in place of animal tests, to test for

the potency of inactivated products.

We are proposing to amend the title

of § 113.8 to read: ‘‘In vitro potency tests

for serial release.’’ This change is

intended to clarify the fact that the in

vitro procedures described in § 113.8 are

applicable to in vitro tests used to

release serials or subserials of veterinary

biological products after the prescribed

animal protection studies required for

licensing have been completed. In the

case of inactivated products, the

proposal specifies that in vitro

immunoassays (test systems) which

compare the relative antigen content

(relative potency) of a test serial to a

reference preparation must be parallel

line assays using an unexpired reference

preparation whose potency has been

correlated directly or indirectly to

immunogenicity in host animals.

In addition, the proposal would

require: confirming the accuracy of the

protective dose established for live

products 3 years after the initiation of

the host animal immunogenicity study;

and confirming the immunogenicity of

reference preparations used in

immunoassays for inactivated biological

products prior to their expiration. The

expiration date for a reference would be

equal to the dating of the product or as

supported by data acceptable to APHIS.

APHIS is proposing these

amendments because current

requirements for many of the

immunoassays being used to release

serials or subserials of product do not

have uniform validity criteria and do

not include a provision to confirm

periodically the immunogenicity of the

reference used in such immunoassays.

The proposed amendment would

standardize the requirements for in vitro

potency tests for relative antigen content

and update and improve the reliability

of such tests that are currently included

in filed outlines of production. The

proposed amendment does not specify a

particular immunoassay provided that it

is a parallel line assay using an

unexpired reference preparation. While

there is not a generally accepted ‘‘best’’

immunoassay, there is general

agreement that an acceptable