[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We are also removing outdated sections from the regulations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]
BILLING CODE 3410-34-M
