[Federal Register Volume 60, Number 43 (Monday, March 6, 1995)]
[Proposed Rules]
[Pages 12162-12165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5407]



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DEPARTMENT OF AGRICULTURE
9 CFR Parts 102 and 114

[Docket No. 93-136-1]


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

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations concerning State-
Federal licensing of veterinary biological products. The effect of the 
amendment would be that 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 must choose to produce each specific serial 
of such biologic [[Page 12163]] under either a State or Federal product 
license. No autogenous biologic could 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    We are also removing outdated sections from the regulations 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.

DATES: Consideration will be given only to comments received on or 
before May 5, 1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 93-136-1, Animal and Plant Health Inspection service, 
Regulatory Analysis and Development, Program and Policy Development, 
4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that 
your comments refer to Docket No. 93-136-1. 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 requests to call ahead on (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, USDA, 4700 River Road Unit 148, Riverdale, MD 20723-1237, (301) 
734-8245.

SUPPLEMENTARY INFORMATION: 

Background

    The Animal and Plant Health Inspection Service (APHIS), U.S. 
Department of Agriculture, 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. This proposed rule would amend the 
regulations in 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 would also be making minor editorial 
changes to Sec. 102.4(b)(3) and Sec. 102.6 (introductory paragraph and 
paragraph (a)) to reflect organizational changes within APHIS.
    The regulations in 9 CFR part 114 prescribe conditions under which 
an unlicensed product may be prepared in a USDA-licensed establishment. 
Section 114.2(c) prohibits the production of unlicensed veterinary 
biological products in licensed establishments, except when an 
establishment is licensed by USDA for an interim period as provided in 
Sec. 114.2(b), when production of an experimental biological product is 
authorized in accordance with 9 CFR part 103, or when biological 
products are subject to the provisions of Sec. 107.2 (products produced 
under State license).
    The proposed rule would amend part 114 by removing from Sec. 114.2 
paragraphs (b) and (d) which refer to outdated provisions for interim 
licenses and to 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.
    The proposed rule would also 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. The proposed rule would require that an 
establishment holding a U.S. Veterinary Biologics Establishment License 
that is also producing products licensed by a State may produce a 
product either under a U.S. Veterinary Biological Product License or a 
State product license, but the establishment cannot produce the same 
product under both USDA and State product licenses. It should be noted 
that in order to be Federally licensed, an establishment must hold at 
least one Federal product license. Autogenous biologics would not be 
subject to the proposed requirement in that an establishment may hold 
both a State and Federal product license for autogenous biologics but 
each serial of an autogenous biologic must either be produced pursuant 
to the State license or the Federal license. The wide variety of 
different autogenous biologics that are made and the different 
conditions for their use dictate the need for choosing to produce some 
of these products under a State product license and others under a USDA 
product license. This choice would permit such establishments to 
produce autogenous biologics for intrastate use only, under a State 
product license, or for both intrastate or interstate use, under a U.S. 
Veterinary Biological Product License, provided that certain conditions 
of production are maintained. This proposed rule would define such 
conditions and ensure that the primary regulatory responsibility for 
each serial of product is clearly identified prior to production.
    Under the proposed amendments, a biological product produced in a 
USDA-licensed establishment could be produced under either a State or 
U.S. Veterinary Biological Product License, but not both. Prior to the 
issuance of a U.S. Veterinary Biological Product License (including a 
conditional license), any State product license for the same product 
would have to be surrendered to the State licensing authority. As 
explained previously, autogenous biologics would not be subject to 
these requirements.
    Under the proposed amendments, State-licensed products (including 
autogenous biologics) would only be allowed to be distributed or 
shipped intrastate, would not be allowed to bear a U.S. Veterinary 
Biological Product License Number, or otherwise be represented as 
having met the requirements for USDA product licensure. Labeling of 
State- and USDA-licensed products produced in the same establishment 
would be required to be distinctly different in color and design.
    All biological products in USDA-licensed establishments, whether 
State- or USDA-licensed, would only be prepared in locations indicated 
in legends filed in accordance with 9 CFR part 108. A description of 
each State-licensed product would have to be filed with APHIS as part 
of the blueprint legends that is sufficient for APHIS to determine any 
risk to other products in the establishment and to ensure that 
contamination does not occur during production.
    The proposed amendments would also specify that certain reporting 
and recordkeeping requirements have to be met for both State- and USDA-
licensed products. [[Page 12164]] 
    The proposed amendments under Sec. 114.2(c) would require that 
autogenous biological products produced in a USDA-licensed 
establishment be identified as produced under the provisions of the 
State license or the Federal license at the time that a culture of 
microorganisms (the isolate) is received at the establishment. If, 
after producing the product pursuant to one license, the licensee 
elects to produce an autogenous biologic from the same isolate under 
the other license, approval of the other licensing authority would have 
to be obtained.
    In addition, the proposed amendment would require that a State-
licensed autogenous biologic prepared in a Federally licensed 
establishment bear a ``true name'' indicating the State of licensure, 
such as ``(name of State) Autogenous Bacterin'' or ``(name of State) 
Autogenous Vaccine.''

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.
    The effect of the proposed rule would be to remove 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.
    The proposed rule would also establish 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 
would be provided for autogenous biologics. The proposed amendment 
would not have an adverse economic impact on these producers of 
biologics since it would still allow the production of both State and 
Federally licensed products in Federally licensed establishments. 
Therefore, it is not anticipated that the amendment would impose 
economic burdens on producers or small businesses.
    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 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 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 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 would be amended as follows:

PART 102--LICENSES FOR BIOLOGICAL PRODUCTS

    1. The authority citation for part 102 would continue to read as 
follows:

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


Sec. 102.1   [Revised]

    2. Section 102.1 would be revised to read as follows:
    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) would be 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 would be revised to read as 
follows:

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

    7. Section 114.2, paragraphs (b) and (d) would be removed; 
paragraph (c) would be redesignated paragraph (b) and revised; and a 
new paragraph (c) would be 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. [[Page 12165]] 
    (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 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. ``(State) Autogenous Bacterin'' or 
``(State) Autogenous Vaccine''.

    Done in Washington, DC, this 28th day of February 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-5407 Filed 3-3-95; 8:45 am]
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