[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2064-2065]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-563]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Availability of the Report on the International Workshop on
Alternative Methods To Reduce, Refine, and Replace the Use of Animals
in Vaccine Potency and Safety Testing: State of the Science and Future
Directions
AGENCY: Division of the National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS), National Institutes
of Health (NIH).
ACTION: Availability of workshop report.
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SUMMARY: The NTP Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM) announces availability of the report on
the ``International Workshop on Alternative Methods To Reduce, Refine,
and Replace the Use of Animals in Vaccine Potency and Safety Testing:
State of the Science and Future Directions.'' The report was published
as an issue of the journal Procedia in Vaccinology, and is available on
the journal's Web site at http://www.sciencedirect.com/science/journal/1877282X. A limited number of CDs and printed copies of the report are
available from NICEATM (see ADDRESSES).
ADDRESSES: Requests for copies of the report should be sent by mail,
fax, or email to Dr. William S. Stokes, NICEATM Director, NIEHS, P.O.
Box 12233, MD K2-16, Research Triangle Park, NC, 27709, (phone) (919)
541-2384, (fax) (919) 541-0947, (email) niceatm@niehs.nih.gov.
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes: (telephone)
(919) 541-2384, (fax) (919) 541-0947, or (email) niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
Regulatory authorities require post-licensing potency and safety
testing of human and veterinary vaccines to ensure their effectiveness
and minimize potential adverse health effects. However, such testing
requires large numbers of animals and accounts for the majority of
animals reported to the USDA with unrelieved pain and distress.
Accordingly, identification and promotion of alternative methods that
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can reduce, refine, or replace the use of animals for vaccine potency
and safety testing is one of the four highest priorities of the
Interagency Coordinating Committee on the Validation of Alternative
Methods (ICCVAM), an interagency committee of the Federal government
administered by NICEATM.
To address this priority, NICEATM and ICCVAM, along with
international partners organized an ``International Workshop on
Alternative Methods To Reduce, Refine, and Replace the Use of Animals
in Vaccine Potency and Safety Testing: State of the Science and Future
Directions,'' which took place on September 14-16, 2010 at NIH in
Bethesda, Maryland. The report of the workshop is now available.
Workshop Goals and Outcomes
The goals of the workshop were to (1) review the state of the
science of alternative methods currently available and/or accepted for
use that can reduce, refine (enhance animal well-being and lessen or
avoid pain and distress), and replace animal use in vaccine potency and
safety testing, and discuss ways to promote their implementation; (2)
identify knowledge and data gaps that should be addressed to develop
alternative methods that can further reduce, refine, and/or replace the
use of animals in vaccine potency and safety testing; and (3) identify
and prioritize research, development, and validation efforts needed to
address these knowledge and data gaps in order to advance alternative
methods for vaccine potency and safety testing while ensuring the
protection of human and animal health.
The workshop report is comprised of 27 papers that summarize the
plenary session presentations and the conclusions and recommendations
developed by the workshop participants during six breakout group
sessions. The report recommends vaccines that should have the highest
priority for future reduction, refinement, and replacement efforts.
Other key recommendations include:
Procedures such as earlier humane endpoints should be
developed and implemented immediately to reduce or avoid the pain and
distress experienced by animals for vaccines that still require live-
agent challenge testing. Until non-animal tests are available,
development of serological assays should also be considered as a way to
avoid challenge testing.
Specific non-animal approaches that have successfully
replaced animals for some vaccine potency testing should be developed
for vaccines currently requiring animals through identification,
purification, and characterization of vaccine protective antigens.
International harmonization and cooperation efforts and
closer collaborations between human and veterinary vaccine researchers
should be enhanced in order to support more rapid progress towards
reduction, refinement, and replacement of animal use for vaccine
testing.
The workshop was organized by NICEATM and ICCVAM in partnership
with the European Centre for the Validation of Alternative Methods, the
Japanese Center for the Validation of Alternative Methods, and Health
Canada. The workshop was co-sponsored by the Society of Toxicology.
Background Information on NICEATM and ICCVAM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that require, use,
generate, or disseminate toxicological and safety testing information.
The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) established
ICCVAM as a permanent interagency committee of the NIEHS under NICEATM.
ICCVAM conducts technical evaluations of new, revised, and alternative
testing methods with regulatory applicability and promotes the
scientific validation and regulatory acceptance of toxicological and
safety testing methods that more accurately assess the safety and
hazards of chemicals and products and that reduce, refine, or replace
animal use.
NICEATM administers ICCVAM, provides scientific and operational
support for ICCVAM technical evaluations and related activities, and
conducts independent validation studies to assess the usefulness and
limitations of new, revised, and alternative test methods and
strategies. NICEATM and ICCVAM welcome the public nomination of new,
revised, and alternative test methods and strategies applicable to the
needs of Federal agencies. Additional information about NICEATM and
ICCVAM can be found on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov).
Dated: January 6, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-563 Filed 1-12-12; 8:45 am]
BILLING CODE 4140-01-P