Viruses, Serums, Toxins, and Analogous Products; State-Federal Licensure of Veterinary Biologics

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 102 and 114

[Docket No. 93-136-2]

Viruses, Serums, Toxins, and Analogous Products; State-Federal

Licensure of Veterinary Biologics

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending the regulations concerning State-Federal

licensing of veterinary biological products. The effect of the

amendment is that a Federally licensed establishment will not be

allowed to produce the same veterinary biological product under both a

State and Federal product license. Autogenous biologics will not be

subject to the same requirement in that a Federally licensed

establishment may hold both State and Federal product licenses for

autogenous biologics, but must choose to produce each specific serial

of such biologic under either a State or Federal product license. No

autogenous biologic may be produced at the same time under both a

Federal and State license. The amendment is necessary in order to

ensure the integrity of the Federal licensing system and the safety of

biological products produced in Federally licensed establishments.

We are also removing outdated sections from the regulations

referring to interim establishment licenses and exemption procedures

that were permitted during the 5-year transition period to attain

Federal licensure under the 1985 amendments to the Virus-Serum-Toxin

Act.

EFFECTIVE DATE: October 18, 1995.

FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Deputy

Director, Veterinary Biologics, BBEP, APHIS, USDA, 4700 River Road Unit

148, Riverdale, MD 20737-1237, (301) 734-8245.

SUPPLEMENTARY INFORMATION:

Background

The Animal and Plant Health Inspection Service (APHIS), U.S.

Department of Agriculture (USDA), licenses veterinary biological

products under the Virus-Serum-Toxin Act (21 U.S.C. 151-159,

hereinafter, the Act), as amended by the Food Security Act of 1985.

Veterinary biologics licensed by APHIS include products such as

vaccines, antitoxins, viruses, diagnostics, and autogenous biologics

(vaccines, bacterins, and toxoids) which are normally used in the herd

of origin (the herd from which the disease causing microorganism is

derived) to immunize animals against infectious disease.

Under the Act, veterinary biological products are licensed on the

basis of their purity, safety, potency, and efficacy. The 1985

amendments to the Act exempt certain products from the requirement that

they be produced pursuant to an unsuspended and unrevoked Federal

license. Such products include those which are prepared solely for

distribution within the State of production pursuant to a license

granted by such State under a program approved by the Administrator of

APHIS.

The regulations in 9 CFR part 102 contain Federal licensing

provisions for biological products. The regulations in 9 CFR part 114

prescribe conditions under which an unlicensed product may be prepared

in a USDA-licensed establishment.

On March 6, 1995, we published in the Federal Register (60 FR

12162-12165, Docket No. 93-136-1) a proposal to amend parts 102 and

114.

We proposed to amend part 102 by removing the outdated reference to

Federal interim licenses in Sec. 102.1 and by removing Sec. 102.4(h),

which refers to outdated provisions. We also proposed minor editorial

changes to Sec. 102.4(b)(3) and Sec. 102.6 (introductory paragraph and

paragraph (a)) to reflect organizational changes within APHIS.

We also proposed to amend part 114 by removing outdated provisions

for interim licenses and certain exemption procedures that were used in

implementing the 5-year transition to Federal licensure under the 1985

amendments to the Virus-Serum-Toxin Act. In addition, we proposed to

amend part 114 to establish the conditions that must be maintained when

a State-licensed veterinary biological product is produced in an

establishment holding a U.S. Veterinary Biologics Establishment

License.

Under the proposed amendments, a Federally licensed establishment

would not be allowed to produce the same veterinary biological product

under both a State and Federal product license. Autogenous biologics

would not be subject to the same requirement in that a Federally

licensed establishment could hold both State and Federal product

licenses for autogenous biologics, but would have to choose to produce

each specific serial of such biologic under either a State or Federal

product license. No autogenous biologic

[[Page 48021]]

could be produced at the same time under both a Federal and State

license.

We solicited comments concerning our proposal for 60 days ending

May 5, 1995. We did not receive any comments. The proposed rule

provides the basis for this final rule.

Therefore, based on the rationale set forth in the proposed rule,

we are adopting the provisions of the proposal as a final rule without

change.

Executive Order 12866 and Regulatory Flexibility Act

This 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.

This rule removes outdated sections from the regulations in

Secs. 102.1 and 102.4(h) and Sec. 114.2 (b) and (d). These sections

refer to outdated provisions related to the implementation of the 1985

amendments to the Virus-Serum-Toxin Act. These provisions expired on

June 30, 1991.

This rule also establishes conditions applicable to some 100

producers to prepare a biological product under either a State or USDA

product license in a USDA licensed establishment. An exception is

provided for autogenous biologics. The amendment will not have an

adverse economic impact on these producers of biologics since it still

allows the production of both State and Federally licensed products in

Federally-licensed establishments. Therefore, it is not anticipated

that the amendment will have an economic impact on producers or small

businesses.

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. It is not intended to have retroactive effect.

This rule will not preempt any State or local laws, regulations, or

policies, unless they present an irreconcilable conflict with this

rule. There are no administrative procedures which must be exhausted

prior to a judicial challenge to the provisions of this rule.

Paperwork Reduction Act

This document contains no new 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 102

Animal biologics, Reporting and recordkeeping requirements.

9 CFR Part 114

Animal biologics, Reporting and recordkeeping requirements.

Accordingly, 9 CFR parts 102 and 114 are amended as follows:

PART 102--LICENSES FOR BIOLOGICAL PRODUCTS

1. The authority citation for part 102 continues to read as

follows:

Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).

2. Section 102.1 is revised to read as follows:

Sec. 102.1 Licenses issued by the Administrator.

Each establishment qualified to prepare biological products under

the Virus-Serum-Toxin Act shall hold an unexpired and unrevoked U.S.

Veterinary Biologics Establishment License issued by the Administrator

and a U.S. Veterinary Biological Product License for each product

prepared in such establishment unless the product is subject to the

provisions of 9 CFR parts 103 or 106 of this subchapter.

Sec. 102.4 [Amended]

3. In Sec. 102.4, paragraph (b)(3), the words ``Veterinary

Services'' are removed and the words ``Animal and Plant Health

Inspection Service'' are added in their place.

4. In Sec. 102.4, paragraph (h) is removed.

Sec. 102.6 [Amended]

5. In Sec. 102.6, in the introductory paragraph and paragraph (a),

the term ``Deputy'' is removed.

PART 114--PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS

6. The authority citation for part 114 is revised to read as

follows:

Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).

7. In Sec. 114.2, paragraphs (b) and (d) are removed; paragraph (c)

is redesignated as paragraph (b) and revised; and a new paragraph (c)

is added to read as follows:

Sec. 114.2 Products not prepared under license.

* * * * *

(b) Except as provided in 9 CFR part 103, a biological product

shall not be prepared in a licensed establishment unless the person to

whom the establishment license is issued holds an unexpired,

unsuspended, and unrevoked product license issued by the Administrator

to prepare such biological product, or unless the products prepared are

subject to the provisions of Sec. 107.2 of this subchapter.

(c) A biological product produced in a USDA-licensed establishment

shall be produced under a U.S. Veterinary Biological Product License or

a license granted by a State under Sec. 107.2 (referred to as a State

biological product license and the products prepared pursuant thereto

as State-licensed biological products, including autogenous biologics),

but not under both a U.S. Veterinary Biological Product License and a

State biological product license. Before a U.S. Veterinary Biological

Product License (including a conditional license) is issued, the

licensee shall relinquish its State license for that product: Provided,

That autogenous biologics shall not be subject to this provision when

they are prepared in accordance with the provisions of paragraph (c)(5)

of this section.

(1) State-licensed biological products (including autogenous

biologics) shall only be distributed or shipped intrastate, must not

bear a U.S. Veterinary Biologics Establishment License Number, and must

not otherwise be represented in any manner as having met the

requirements for a U.S. Veterinary Biological Product license. Labeling

of State- and USDA-licensed biological products produced in the same

establishment must be distinctly different in color and design.

(2) All biological products in USDA-licensed establishments,

whether licensed by USDA or by the State, shall be prepared only in

locations indicated in legends filed in accordance with 9 CFR part 108.

A description of each State-licensed product must be filed with the

Animal and Plant Health Inspection Service as part of the blueprint

legends and must be sufficient for Animal and Plant Health Inspection

Service to determine any risk to the production of other products in

the licensed establishment and to determine that adequate procedures

are followed

[[Page 48022]]

to prevent contamination during production.

(3) Records in such establishments must be maintained in accordance

with Secs. 116.1 and 116.2 of this subchapter and shall include all

products licensed by the State or USDA.

(4) Reports prescribed in Sec. 116.5 of this subchapter for USDA-

licensed establishments shall be submitted for all veterinary

biological products in the establishment.

(5) Under the following conditions, an autogenous biologic may be

produced in a USDA-licensed establishment under either a State or U.S.

Veterinary Biological Product License:

(i) When a culture of microorganisms, isolated from a herd in a

State, is received at a USDA-licensed establishment that is in the same

State but that holds both a State and a U.S. Veterinary Biological

Products License for autogenous biologics, the isolate shall be

designated by the licensee for use in the production of an autogenous

biological product under either the State product license, or the U.S.

Veterinary Biological Product License: Provided, That the isolate meets

the requirements of the respective regulatory authority for an

autogenous biologic. If, after producing the product pursuant to one

license, the licensee elects to produce an autogenous biologic from the

same isolate under provisions of the other license, the licensee may do

so only with the approval of the other licensing authority.

(ii) The true name of a State-licensed autogenous biologic shall

specify the State of licensure: e.g.

`` __________ Autogenous Bacterin'' -------------------------------

(State)

or __________ Autogenous Vaccine''. ---------------------------------

(State)

Done in Washington, DC, this 11th day of September 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 95-23032 Filed 9-15-95; 8:45 am]

BILLING CODE 3410-34-P