Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Rules and Regulations 24547

§§ 1924.123–1924.149 [Reserved]

§ 1924.150 OMB Control Number.

The reporting requirements contained

in this subpart have been approved by

the Office of Management and Budget

(OMB) and have been assigned OMB

control number 0575–0164. Public

reporting burden for this collection of

information is estimated to vary from 5

minutes to 10 minutes per response,

with an average of .13 hours per

response, including time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

Send comments regarding this burden

estimate or any other aspect of this

collection of information, including

suggestions for reducing this burden to

the Department of Agriculture,

Clearance Officer, OIRM, Ag Box 7630,

Washington, D.C. 20250; and to the

Office of Management and Budget,

Paperwork Reduction Project (OMB

#0575–0164), Washington, D.C. 20503.

Exhibit A of Subpart C [Removed and

Reserved]

3. Exhibit A of subpart C is removed

and reserved.

Dated: April 14, 1995.

Michael V. Dunn,

Acting Under Secretary for Rural Economic

and Community Development.

[FR Doc. 95–11309 Filed 5–8–95; 8:45 am]

BILLING CODE 3410–07–U

Animal and Plant Health Inspection

Service

9 CFR Part 78

[Docket No. 94–134–2]

Brucellosis in Cattle; State and Area

Classifications; Colorado

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Affirmation of interim rule as

final rule.

SUMMARY: We are adopting as a final

rule, without change, an interim rule

that amended the brucellosis regulations

concerning the interstate movement of

cattle by changing the classification of

Colorado from Class A to Class Free. We

have determined that Colorado meets

the standards for Class Free status. The

interim rule was necessary to relieve

certain restrictions on the interstate

movement of cattle from Colorado.

EFFECTIVE DATE: June 8, 1995.

FOR FURTHER INFORMATION CONTACT: Dr.

Michael J. Gilsdorf, Senior Staff

Veterinarian, Cattle Diseases and

Surveillance Staff, VS, APHIS, USDA,

Suite 3B08, 4700 River Road Unit 36,

Riverdale, MD 20737–1236; (301) 734–

4918.

SUPPLEMENTARY INFORMATION:

Background

In an interim rule effective and

published in the Federal Register on

January 23, 1995 (60 FR 4371–4372,

Docket No. 94–134–1), we amended the

brucellosis regulations in 9 CFR part 78

by removing Colorado from the list of

Class A States in § 78.41(b) and adding

it to the list of Class Free States in

§ 78.1(a).

Comments on the interim rule were

required to be received on or before

March 24, 1995. We did not receive any

comments. The facts presented in the

interim rule still provide a basis for the

rule.

This action also affirms the

information contained in the interim

rule concerning Executive Order 12866

and the Regulatory Flexibility Act,

Executive Orders 12372 and 12778, and

the Paperwork Reduction Act.

Further, for this action, the Office of

Management and Budget has waived the

review process required by Executive

Order 12866.

List of Subjects in 9 CFR Part 78

Animal diseases, Bison, Cattle, Hogs,

Quarantine, Reporting and

recordkeeping requirements,

Transportation.

PART 78—BRUCELLOSIS

Accordingly, we are adopting as a

final rule, without change, the interim

rule that amended 9 CFR 78.41 and that

was published at 60 FR 4371–4372 on

January 23, 1995.

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).

Done in Washington, DC, this 28th day of

April 1995.

Lonnie J. King,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–11373 Filed 5–8–95; 8:45 am]

BILLING CODE 3410–34–P

9 CFR Part 113

[Docket No. 93–071–2]

Viruses, Serums, Toxins, and

Analogous Products; Detection of

Extraneous Agents by the Fluorescent

Antibody Technique

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Final rule.

SUMMARY: We are amending the

regulations concerning testing by the

fluorescent antibody technique for

extraneous agents (viruses) in cells of

animal origin that are used in the

manufacture of veterinary biologics. The

amendment allows the use of alternative

fluorochromes that may be conjugated

to an antibody, revises the list of

extraneous agents to be tested for, and

includes extraneous agents for which

equine cells are to be tested. In addition,

the word ‘‘agent’’ is replaced with the

word ‘‘virus’’ since this is the agent

being tested for. The amendment is

necessary to update the requirements

related to the testing for extraneous

viruses.

EFFECTIVE DATE: June 8, 1995.

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

In accordance with the regulations

contained in 9 CFR part 113, standard

requirements are prescribed for the

preparation of veterinary biological

products. A standard requirement

consists of specifications, procedures,

and test methods which define the

standards of purity, safety, potency, and

efficacy for a given type of veterinary

biological product. Microorganisms,

animal cells, and ingredients of animal

origin used in production are required

to be tested for extraneous viruses. In

part, this involves testing for the

presence of extraneous viruses by the

fluorescent antibody technique

described in § 113.47. When the current

standard requirement was established,

fluorescent antibodies were constructed

by conjugating antibodies to one of the

fluorochromes, fluorescein.

Fluorochromes are any of a variety of

chemicals used in cytochemistry to

produce a secondary fluorescence in the

specimen. In the intervening years,

additional fluorochromes have been

developed for use as cytochemical

markers or stains.

Standard requirements included in

the regulations specify that cells, master

seed virus, and most ingredients of

animal origin used in the production of

biological products be tested for

contaminating bacteria, fungi,

mycoplasma, cytopathogenic organisms,

viruses, hemadsorbing agents, and

extraneous agents (viruses) detectable

by the fluorescent antibody technique.

The presence of specific fluorescence

associated with the use of certain

antibodies, in comparison with the
24548 Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Rules and Regulations

appropriate controls, is an indication of

the presence of the contaminating

antigen or extraneous virus against

which the antibody was made.

Current § 113.47 lists the types of

extraneous viruses against which

fluorescein-conjugated antibodies are to

be used in testing cells from certain

species of animals. New viruses have

since been identified as animal

pathogens. No viruses which are disease

agents of horses are included in the

current § 113.47. As new knowledge has

developed, testing for these agents has

become necessary.

On March 21, 1994, we published in

the Federal Register (59 FR 13257–

13259, Docket No. 93–071–1) a proposal

to amend the regulations by revising

§ 113.47 to allow the use of additional

fluorescent stains in the testing of

extraneous viruses by the fluorescent

antibody technique. The current

regulations in § 113.47 limit the stain

used in the fluorescent antibody test to

fluorescein (a fluorochrome). Other

fluorochromes, when conjugated to

antibodies, may be expected to perform

as well as fluorescein in the test for

extraneous viruses. The amendment

thus allows for the use of alternative

fluorochromes in such tests. The term

‘‘fluorescein-conjugated antibody’’ is

replaced with ‘‘fluorochromeconjugated antibody’’ everywhere it

appears in §§ 113.47 and 113.52(b)(2) (i)

and (ii).

The current regulations in § 113.47

lists the specific extraneous viruses

against which antibodies are used in the

testing of certain types of cells. We have

revised the list of cell types to be tested

for extraneous viruses to include equine

cells. Those using other cells for the

production of biologics may also be

required to test for specific viruses

before such use is approved.

We solicited comments concerning

our proposal for a 60-day comment

period ending April 20, 1994. We

received one comment by that date from

a manufacturer of veterinary biological

products. We carefully considered the

comment which is discussed below.

The comment was in two parts The

first was that the fluorescent antibody

(FA) test was not as sensitive for

detecting bluetongue virus as

seroconversion in sheep, and the use of

the FA test would require firms to

introduce this organism into their

testing facility. The second was that

testing of bovine cells for bovine

respiratory syncytial virus was also a

new requirement.

In response to the comment, the

Animal and Plant Health Inspection

Service has found that the FA test is a

sensitive, specific, and accurate test for

the detection of extraneous viruses in

seeds, cells and ingredients of animal

origin. When used with the required

controls, the FA test detects the

presence of specific antigens indicative

of the presence of specific extraneous

viruses. The use of positive and negative

controls with the FA test eliminates the

incidence of false positives and false

negatives. The FA test also has the

advantage of relieving the firms from the

need to locate and maintain

seronegative sheep.

APHIS acknowledges that requiring

firms to test for the bluetongue virus

will result in the introduction of the

agent onto their premises. This should,

however, pose no greater problem to the

firms than introducing other viruses for

the purpose of conducting these tests. If

no firm’s biosecurity is adequate to

contain such viruses as those causing

bovine virus diarrhea, canine parvoviral

diarrhea, or pseudorabies, it should be

able to contain bluetongue virus.

Further, there is no threat of human

disease from the use of bluetongue virus

in association with this test as

bluetongue virus is not known to affect

humans.

With respect to the requirement for

testing bovine cells for bovine

respiratory syncytical virus, APHIS has

determined that this virus may be

present as an extraneous agent in cells

of bovine origin. One of the major

purposes of the rule is to update the list

of extraneous viruses for which seeds,

cells, and ingredients of animal origin

are tested. The new requirements are

based on current knowledge of animal

diseases. No changes are made to the

regulations in response to the

commenter.

Therefore, based on the rationale set

forth in the proposed rule and in this

document, we are adopting the

provisions of the proposal as a final rule

with one conforming change in

§ 113.300(c)(1).

Executive Order 12866 and Regulatory

Flexibility Act

This final rule has been reviewed

under Executive Order 12866. This rule

has been determined to be not

significant for the purposes of Executive

Order 12866, and, therefore, has not

been reviewed by the Office of

Management and Budget.

These amendments should not have a

significant economic impact on

manufacturers since they will broaden

the range of fluorochrome stains that

may be used in conducting the

fluorescent antibody test and will revise

the list of extraneous agents for which

various cell types are to be tested with

the fluorescent antibody technique. The

amendments will thus remove outdated

requirements and provide flexibility in

the types of antibody that may be used

in tests for extraneous agents. On

balance, therefore, there should be no

net increase in testing requirements over

the current requirements.

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 12778

This final rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. This rule: (1) Preempts

all State and local laws and regulations

that are inconsistent with this rule; (2)

has no retroactive effect; and (3) does

not require administrative proceedings

before parties may file suit in court

challenging this rule.

Paperwork Reduction Act

This 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 in 9 CFR Part 113

Animal biologics, Exports, Imports,

and Reporting and recordkeeping

requirements.

Accordingly, 9 CFR part 113 is

amended as follows:

PART 113—STANDARD

REQUIREMENTS

1. The authority citation for part 113

continues to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

2. Section 113.47 is revised to read as

follows:

§ 113.47 Detection of extraneous viruses

by the fluorescent antibody technique.

The test for detection of extraneous

viruses by the fluorescent antibody

technique provided in this section shall

be conducted when prescribed in an

applicable Standard Requirement or in

a filed Outline of Production for a

product.

(a) Monolayer cultures of cells

(monolayers), at least 7 days after the
Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Rules and Regulations 24549

last subculturing, shall be processed and

stained with the appropriate antiviral

fluorochrome-conjugated antibody as

specified in paragraph (b) of this

section.

(1) Three groups of one or more

monolayers shall be required for each

specific virus prescribed in paragraph

(b) of this section.

(i) At the time of the last subculturing,

one group of test monolayers shall be

inoculated with approximately 100–300

FAID50 of the specific virus being tested

for as positive controls.

(ii) One group of monolayers shall be

the ‘‘material under test.’’

(iii) One group of monolayers, that are

of the same type of cells as the test

monolayers and that have been tested as

prescribed in §§ 113.51 or 113.52

(whichever is applicable), shall be

prepared as negative controls.

(2) Each group of monolayers shall

have a total area of at least 6 cm2.

(3) Positive control monolayers may

be fixed (processed so as to arrest

growth and assure attachment of the

monolayer to the surface of the vessel in

which they are grown) before 7 days

after subculturing if fluorescence is

enhanced by doing so, Provided, That a

monolayer of the material under test is

also fixed at the same time as the

positive control and a monolayer of the

material under test is also fixed at least

seven days after subculturing.

Monolayers that are fixed before 7 days

after subculturing shall be stained at the

same time as the test monolayers and

negative controls fixed at least 7 days

after subculturing.

(b) The antiviral fluorochromeconjugated antibodies to be used shall

depend on the type of cells required to

be tested for extraneous viruses as

specified in an applicable Standard

Requirement or in a filed Outline of

Production. Antiviral fluorochromeconjugated antibodies specific for the

extraneous viruses shall be applied to

each respective type of cell in

accordance with the following list.

Under certain circumstances, additional

tests may need to be conducted, as

determined by the Administrator. When

a specific antiviral fluorochromeconjugated antibody is used in testing

for the listed extraneous viruses

specified in more than one cell type, it

need only be applied to the most

susceptible cell type.

(1) All cells shall be tested for:

(i) Bovine virus diarrhea virsus;

(ii) Reovirus; and

(iii) Rabies virus.

(2) Bovine, caprine, and ovine cells

shall, in addition, be tested for:

(i) Bluetongue virus;

(ii) Bovine adenoviruses;

(iii) Bovine parvovirus; and

(iv) Bovine respiratory syncytial virus.

(3) Canine cells shall, in addition, be

tested for:

(i) Canine coronavirus;

(ii) Canine distemper virus; and

(iii) Canine parvovirus.

(4) Equine cells shall, in addition, be

tested for:

(i) Equine herpesvirus; and

(ii) Equine viral arteritis virus.

(5) Feline cells shall, in addition, be

tested for:

(i) Feline infectious peritonitis virus;

and

(ii) Feline panleukopenia virus.

(6) Porcine cells shall, in addition, be

tested for:

(i) Porcine adenovirus;

(ii) Porcine parvovirus;

(iii) transmissible gastroenteritis

virus; and

(iv) Porcine hemagglutinating

encephalitis virus.

(7) Firms that do not have rabies virus

on premises either for research or

production purposes are exempt

from having to produce positive

rabies virus control monolayers.

Fixed positive rabies virus control

monolayers will be provided by the

National Veterinary Services

Laboratories.

(c) After staining, each group of

monolayers shall be examined for the

presence of specific fluorescence

attributable to the presence of

extraneous viruses.

(1) If the material under test shows

any evidence of specific viral

fluorescence, it is unsatisfactory and

may not be used; Provided, That, if

specific fluorescence attributable to the

virus being tested for is absent in the

positive control monolayers, the test is

inconclusive and may be repeated.

(2) If the fluorescence of the

monolayers inoculated with the specific

virus as positive controls is equivocal,

or if the negative monolayers show

equivocal fluorescence indicating

possible viral contamination, or both,

the test shall be declared inconclusive,

and may be repeated; Provided, That, if

the test is not repeated, the material

under test shall be regarded as

unsatisfactory for use in the production

of biologics.

3. Section 113.52, paragraph (b)(2)(i)

and (ii), is revised to read as follows:

§ 113.52 Requirements for cell lines used

for production of biologics.

* * * * *

(b) * * *

(2) * * *

(i) At least two monolayers shall be

stained with an antispecies

fluorochrome-conjugated antibody

unrelated to the species of origin of the

MCS.

(ii) At least two monolayers shall be

stained with an antispecies

fluorchrome-conjugated antibody

specific to the species of origin of the

MSC.

* * * * *

§§ 113.51, 113.52 and 113.53 [Amended]

4. In the following places, the word

‘‘agents’’ are removed and the word

‘‘viruses’’ added in its place:

a. Section 113.51, paragraph (c)(3)(ii).

b. Section 113.52, paragraph (f)(4)(ii).

c. Section 113.53, paragraph (c)(6)(ii).

5. In § 113.300, paragraph (c)(1), the

term ‘‘fluorescein’’ is removed and the

term ‘‘fluorochrome’’ added in its place.

Done in Washington, DC, this 1st day of

May 1995.

B. Glen Lee,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–11294 Filed 5–8–95; 8:45 am]

BILLING CODE 3410–34–M

NUCLEAR REGULATORY

COMMISSION

10 CFR Parts 2, 19, 20, 30, 32, 40, 50,

51, 60, 61, 70, 71, 72, 73, 74, 76, and

150

RIN 3150–AF34

Changes to NRC Addresses and

Telephone Numbers

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is amending its

regulations to indicate the current

addresses, telephone numbers, and

organizational titles within the NRC.

These changes reflect the agency’s

consolidation of headquarters

employees to Rockville, Maryland.

EFFECTIVE DATE: May 9, 1995.

FOR FURTHER INFORMATION CONTACT:

Michael T. Lesar, Chief, Rules Review

Section, Rules Review and Directives

Branch, Division of Freedom of

Information and Publications Services,

Office of Administration, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555, Telephone (301) 415–7163.

SUPPLEMENTARY INFORMATION:

Background

The Nuclear Regulatory Commission

is revising the regulations in 10 CFR

Parts 2, 19, 20, 30, 32, 40, 50, 51, 60, 61,

70, 71, 72, 73, 74, 76, and 150 to provide