[Federal Register Volume 60, Number 180 (Monday, September 18, 1995)]
[Rules and Regulations]
[Pages 48020-48022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23032]



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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.

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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    We are also removing outdated sections from the regulations 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]
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