[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4150-01-P