[Federal Register: June 13, 2003 (Volume 68, Number 114)]
[Rules and Regulations]
[Page 35282-35283]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn03-4]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 113
[Docket No. 01-091-2]
Viruses, Serums, Toxins, and Analogous Products; Standard
Requirements for Determination of Residual Free Formaldehyde Content of
Biological Products
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the Virus-Serum-Toxin Act regulations for the
determination of residual free formaldehyde in veterinary biologics to
specify that such determinations be made using the ferric chloride
method, and that the residual free formaldehyde content be measured in
grams per liter. The ferric chloride method has been adopted as an
international standard by scientific experts and regulatory authorities
in the United States, Canada, Japan, and the European Union. The effect
of this rule will be to reduce the differences in technical
requirements for veterinary biologics among regulatory agencies in
different countries and further ensure the safety and shelf life of
veterinary biologics by adopting a method that has been standardized
and accepted internationally.
EFFECTIVE DATE: July 14, 2003.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff
Officer, Operational Support Section, Center for Veterinary Biologics,
Licensing and Policy Development, VS, APHIS, 4700 River Road Unit 148,
Riverdale, MD, 20737-1231; (301) 734-8245.
SUPPLEMENTARY INFORMATION:
Background
The Virus-Serum-Toxin Act regulations in 9 CFR part 113 (referred
to below as the regulations) prescribe standard requirements for the
preparation and testing of veterinary biological products. Standard
requirements consist of test methods, procedures, and criteria that
define the standards for purity, safety, potency, and efficacy for a
given type of veterinary biological product. When a standard procedure
for testing veterinary biological products is validated and approved by
the Animal and Plant Health Inspection Service (APHIS) for general use,
it is proposed for codification in the regulations. Sections 113.100
and 113.200 of the regulations prescribe the requirement for
determination of residual free formaldehyde content in inactivated
bacterial products and killed virus vaccines, respectively.
On April 5, 2002, we published in the Federal Register (67 FR
16327-16329, Docket No. 01-091-1) a proposal to amend to amend the
regulations for determination of residual free formaldehyde content in
inactivated bacterial products and killed virus vaccines to specify
that such determinations be made using the ferric chloride method, and
that the residual free formaldehyde content be measured in grams per
liter. The proposed rule was intended to reduce the differences in
technical requirements for veterinary biologics among regulatory
agencies in different countries and further ensure the safety and shelf
life of veterinary biologics by adopting a method which has been
standardized and accepted internationally.
We solicited comments concerning our proposal for 60 days ending on
June 4, 2002. We received one comment by that date, from a national
trade association representing veterinary biologics manufacturers. The
commenter expressed support for the efforts of APHIS and the
International Cooperation on Harmonization of Technical Requirements
for the Registration of Veterinary Medicinal Products (VICH) to
harmonize the technical requirements for product registration among the
participating regions and recommended that APHIS adopt the provisions
of the proposed rule.
Therefore, for the reasons given in the proposed rule, we are
adopting the proposed rule 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 the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
We are amending the Virus-Serum-Toxin Act regulations for
determination of residual free formaldehyde content in biological
products to require that such free formaldehyde determinations be made
using the ferric chloride method, which determines residual free
formaldehyde content by measuring the quantity of coloring matter in
solution by the quantity of light absorbed in passing through the
solution. In addition, this rule provides that the maximum allowable
residual free formaldehyde content of veterinary
[[Page 35283]]
biologics be measured in grams per liter, rather than equivalent
percent or parts per million. The effect of this action will be to
provide a standardized method that has been shown to be more accurate
than the basic fuchsin method and that has been standardized and
adopted internationally.
This rule will affect all licensed manufacturers of veterinary
biologics that test inactivated bacterial products and killed virus
vaccines for free formaldehyde content. Currently, there are
approximately 135 veterinary biologics establishments, including
permittees. According to the standards of the Small Business
Administration, most veterinary biologics establishments would be
classified as small entities.
We do not expect that this rule will impose any additional testing
or economic burden on these manufacturers because manufacturers
currently test their products for free formaldehyde content using the
basic fuchsin and other methods, and the reagents and equipment
necessary to perform the ferric chloride test for free formaldehyde
content that will be required under this rule are expected to be
comparable in cost.
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 12988
This final rule has been reviewed under Executive Order 12988,
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. The Act does not provide administrative procedures which must be
exhausted prior to a judicial challenge to the provisions of this rule.
Paperwork Reduction Act
This final rule contains no new information or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq).
List of Subjects in 9 CFR Part 113
Animal biologics, Exports, Imports, Reporting and recordkeeping
requirements.
0
Accordingly, we are amending 9 CFR part 113 as follows:
PART 113--STANDARD REQUIREMENTS
0
1. The authority citation for part 113 continues to read as follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
0
2. In Sec. 113.100, paragraph (f) is revised to read as follows:
Sec. 113.100 General requirements for inactivated bacterial products.
* * * * *
(f) If formaldehyde is used as the inactivating agent, and the
serial has not been found satisfactory by the viricidal activity test,
bulk or final container samples of completed product from each serial
must be tested for residual free formaldehyde content using the ferric
chloride test.\2\ Firms currently using tests for residual free
formaldehyde content other than the ferric chloride test have until
July 14, 2004 to update their Outline of Production to be in compliance
with this requirement.
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\2\ The procedures for performing the ferric chloride test for
residual free formaldehyde may be obtained from USDA, APHIS, Center
for Veterinary Biologics-Laboratory, 1800 Dayton Road, P.O. Box 844,
Ames, IA 50010.
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(1) The residual free formaldehyde content of biological products
containing clostridial antigens must not exceed 1.85 grams per liter
(g/L).
(2) The residual free formaldehyde content of bacterins, bacterin-
toxoids, and toxoids, other than those containing clostridial antigens,
must not exceed 0.74 grams per liter (g/L).
0
3. In Sec. 113.200, paragraph (f) is revised to read as follows:
Sec. 113.200 General requirements for killed virus vaccines.
* * * * *
(f) Formaldehyde content. If formaldehyde is used as the killing
agent, the residual free formaldehyde content must not exceed 0.74
grams per liter (g/L) as determined using the ferric chloride test.\3\
Firms currently using tests for residual free formaldehyde content
other than the ferric chloride test have until July 14, 2004 to update
their Outline of Production to be in compliance with this requirement.
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\3\ The procedures for performing the ferric chloride test for
residual free formaldehyde may be obtained from USDA, APHIS, Center
for Veterinary Biologics-Laboratory, 1800 Dayton Road, P.O. Box 844,
Ames, IA 50010.
Done in Washington, DC, this 10th day of June 2003.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-14957 Filed 6-12-03; 8:45 am]
BILLING CODE 3410-34-P