[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Pages 2064-2065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-563]



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 

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.


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.



    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

[[Page 2065]]

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 
    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]