[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Notices]
[Pages 35393-35394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14436]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Biennial Progress Report of the Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM)
AGENCY: Division of the National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS), National Institutes
of Health (NIH).
ACTION: Availability of Report.
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SUMMARY: The NTP Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM) announces the availability of the
Biennial Progress Report 2010-2011: Interagency Coordinating Committee
on the Validation of Alternative Methods. The report was prepared in
accordance with requirements of the ICCVAM Authorization Act of 2000
(42 U.S.C. 285l-3).
The Biennial Progress Report describes activities and progress by
NICEATM and ICCVAM during the period from January 2010 through December
2011. During the past two years, NICEATM, ICCVAM, and ICCVAM member
agencies contributed to the national and international endorsement and
adoption of 14 new and updated alternative safety testing methods.
Since ICCVAM was established, NICEATM, ICCVAM, and the ICCVAM member
agencies have contributed to the regulatory acceptance of over 50
alternative methods that can be used to protect the health of people,
animals, and the environment while reducing, refining, and replacing
animal use.
The Biennial Progress Report is available on the NICEATM-ICCVAM Web
site at http://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm. Copies can
also be requested from NICEATM (see ``ADDRESSES'').
ADDRESSES: Requests for copies of the report should be sent by mail,
fax, or email to Dr. William S. Stokes, Director, NICEATM, NIEHS, P.O.
Box 12233, Mail Stop: K2-16, Research Triangle Park, NC 27709,
(telephone) 919-541-2384, (fax) 919-541-0947, (email)
niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530
Davis Drive, Morrisville, NC 27560.
[[Page 35394]]
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, NICEATM
Director (phone 919-541-2384 or niceatm@niehs.nih.gov).
SUPPLEMENTARY INFORMATION:
Background
The ICCVAM Authorization Act of 2000 established ICCVAM as a
permanent interagency committee of NIEHS under NICEATM. The Act directs
ICCVAM to coordinate interagency technical reviews of proposed new,
revised, and alternative testing methods, including those that may
reduce, refine (enhance animal well-being and lessen or avoid pain and
distress), and replace animal use. ICCVAM prepares test method
recommendations based on their scientific validity for regulatory
safety testing, and submits these recommendations through the HHS
Secretary (or designee) to U.S. Federal Agencies for adoption
decisions.
A provision of the ICCVAM Authorization Act states that ICCVAM
shall prepare ``reports to be made available to the public on its
progress under this Act,'' with the first report to be completed within
12 months of enactment of the Act, and subsequent reports to be made
biennially thereafter. The fifth ICCVAM biennial progress report, which
summarizes ICCVAM activities and accomplishments for the years 2010 and
2011, is now available.
Summary of Report Highlights
The Biennial Progress Report describes new initiatives and progress
by NICEATM and ICCVAM during the period from January 2010 through
December 2011. During the past two years, NICEATM, ICCVAM, and ICCVAM
member agencies contributed to the national and international
endorsement and adoption of 14 new and updated alternative safety
testing methods. Since ICCVAM was established, NICEATM, ICCVAM, and the
ICCVAM member agencies have contributed to the regulatory acceptance of
over 50 alternative methods that can be used to protect and improve the
health of people, animals, and the environment while reducing,
refining, and replacing animal use.
Selected highlights of NICEATM and ICCVAM activities described in
the Biennial Progress Report include:
On behalf of NICEATM and ICCVAM, NIEHS signed an amendment
to an international cooperation agreement to add the Republic of Korea
and its Korean Center for the Validation of Alternative Methods
(KoCVAM) to the International Cooperation on Alternative Test Methods
(ICATM). ICATM was established in 2009 by the United States, the
European Union, Japan, and Canada to expedite the worldwide validation
and regulatory acceptance of improved alternative test methods.
The Organisation for Economic Co-operation and Development
(OECD) adopted an international guidance document prepared by NICEATM
and ICCVAM that describes how to use two cytotoxicity assays to reduce
animal use for testing required to determine the poisoning potential of
chemicals. NICEATM led the international validation studies for the two
cytotoxicity assays, which can reduce animal use by up to 50% for each
test.
Federal agencies and the OECD adopted several new versions
and applications of the murine local lymph node assay (LLNA); an
alternative method recommended by ICCVAM to assess whether substances
may cause allergic contact dermatitis. The test methods reduce animal
use for each test by 20-40% and support expanded use of the LLNA for
nearly all testing situations. Two new ``green'' versions of the LLNA
were adopted that do not require radioactive reagents and will allow
expanded use of the LLNA in laboratories worldwide.
Federal agencies adopted ICCVAM recommended alternative
test methods and procedures that will further reduce, refine, and
replace animal use for eye safety testing. These include the routine
use of medications to avoid most if not all pain and distress when it
is necessary to use animals for required safety testing, and the first
in vitro test method that can be used in a ``bottom-up'' approach to
identify substances that are not considered eye hazards.
NICEATM, ICCVAM, and their ICATM partners convened the
first international workshop on alternative methods for human and
veterinary vaccine potency and safety testing. The workshop reviewed
the state of the science of alternative methods, and recommended
priority research needed to develop improved and more efficient test
methods that can also reduce, refine, and replace animal use. A focused
workshop on human and veterinary rabies vaccine test methods was held
in 2011 and additional focused workshops are planned for 2012 and 2013.
ICCVAM completed international evaluation of an in vitro
test method proposed as a screening test to identify substances with
potential endocrine activity. The test method uses engineered human
cells to identify substances that induce or inhibit activation of the
human estrogen receptor. Use of this test method may reduce the number
of animals necessary for endocrine disruptor screening.
NICEATM and ICCVAM convened two Best Practices for
Regulatory Safety Testing Workshops to promote the use of improved and
more efficient test methods that can also reduce, refine, and replace
animal use. Participants learned how to select and use approved
alternative methods to assess the safety or potential hazards of
chemicals and products.
Background Information on ICCVAM and NICEATM
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.
ICCVAM conducts technical evaluations of new, revised, and alternative
safety 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 (enhance
animal well-being and lessen or eliminate pain and distress), or
replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C.
285l-3) established ICCVAM as a permanent interagency committee of the
NIEHS under NICEATM. NICEATM administers ICCVAM, provides scientific
and operational support for ICCVAM-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 and submission of new,
revised, and alternative test methods and strategies applicable to the
needs of U.S. Federal agencies. Additional information about NICEATM
and ICCVAM can be found on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov).
Dated: June 4, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-14436 Filed 6-12-12; 8:45 am]
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