[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Notices]
[Pages 62845-62847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25676]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP) Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM): Workshop 
Series on Best Practices for Regulatory Safety Testing: Assessing the 
Potential for Chemically Induced Eye Injuries and Chemically Induced 
Allergic Contact Dermatitis (ACD)

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH), Department of Health and Human 
Services.

ACTION: Announcement of a Workshop Series.

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

SUMMARY: NICEATM and the Interagency Coordinating Committee on the 
Validation of Alternative Methods (ICCVAM) announce a planned series of 
workshops on ``Best Practices for Regulatory Safety Testing.'' The 
first two workshops in this series, ``Best Practices for Assessing the 
Potential for Chemically Induced Eye Injuries'' and ``Best Practices 
for Assessing the Potential for Chemically Induced Allergic Contact 
Dermatitis,'' are planned for January 19 and 20, 2011, respectively. 
These one-day workshops will help participants gain a practical 
understanding of the theory and application of available in vitro and 
in vivo alternative test methods that can be used to evaluate the 
hazard potential of chemicals and products while avoiding or minimizing 
animal use and animal pain and distress. Participants will learn the 
strengths and weaknesses of available alternative test methods, become 
familiar with the types of data they provide, and learn how to use 
these data in regulatory safety assessments. Workshop topics will be of 
particular interest to those involved in conducting safety tests for 
chemically induced eye injuries and/or chemically induced ACD, those 
responsible for reviewing and approving study protocols prior to 
testing, and regulators who are expected to review data generated by 
the tests. The workshops are free and open to the public with 
attendance limited only by the space available. Those interested may 
register for one or both workshops.

DATES: The workshop on ``Assessing the Potential for Chemically Induced 
Eye Injuries'' will be held on January 19, 2011. The workshop on 
``Assessing the Potential for Chemically Induced Allergic Contact 
Dermatitis'' will be held on January 20, 2011. Sessions for both 
workshops will begin at 8:30 a.m. and end at approximately 5 p.m. 
Individuals who plan to attend either or both workshops are asked to 
register with NICEATM by January 6, 2011.

ADDRESSES: The workshops will be held at the William H. Natcher 
Conference Center, 45 Center Drive, NIH Campus, Bethesda, MD 20892. 
Persons needing special assistance in order to attend, such as sign 
language interpretation or other reasonable accommodation, should 
contact 919-541-2475 voice, 919-541-4644 TTY (text telephone), through 
the Federal TTY Relay System at 800-877-8339, or e-mail to 
<a href="/cdn-cgi/l/email-protection#aac4c3cfc2d9c5cfcfc5eac4c3cfc2d984c4c3c284cdc5dc"><span class="__cf_email__" data-cfemail="77191e121f041812121837191e121f0459191e1f59101801">[email protected]</span></a>. Requests should be made at least 14 days 
before the event.

FOR FURTHER INFORMATION CONTACT: Correspondence should be sent by mail, 
fax, or e-mail 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, (e-mail) <a href="/cdn-cgi/l/email-protection#9af4f3f9fffbeef7daf4f3fff2e9b4f4f3f2b4fdf5ec"><span class="__cf_email__" data-cfemail="244a4d4741455049644a4d414c570a4a4d4c0a434b52">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Background

    To protect workers and consumers, regulatory agencies require 
testing to determine if chemicals and products may cause illnesses or 
injuries. Each year, approximately 2 million eye injuries occur in the 
U.S., of which more than 40,000 result in permanent visual impairment. 
Data on consumer product-related eye injuries indicate that the most 
common products causing eye injuries in children under the age of 10 
are household cleaning chemicals and other chemical products. ACD is 
also a significant concern because skin diseases, including ACD, 
constitute the second most common category of occupational disease. ACD 
frequently develops in workers and consumers exposed to skin 
sensitizing products and chemicals, results in lost workdays, and can 
significantly diminish quality of life.
    To address these concerns, regulatory authorities require safety 
testing that can identify substances that may present these hazards. 
Tests for ocular and ACD hazards are two of the four most frequently 
conducted product safety

[[Page 62846]]

tests. Test results are used to determine appropriate labeling to warn 
consumers and workers of potential hazards and to communicate 
precautions that should be taken to avoid eye injury or development of 
ACD.
    The U.S. Public Health Service Policy on Humane Care and Use of 
Laboratory Animals and the U.S. Department of Agriculture's Animal 
Welfare Act regulations \1\ require that alternatives to procedures 
that can cause more than slight or momentary pain or distress to test 
animals must be considered and used where appropriate. Substantial 
progress has been made in recent years in the development, validation, 
and regulatory acceptance of alternative test methods that reduce, 
refine (decrease or eliminate pain and distress), or replace the use of 
animals for ocular safety assessments and ACD hazard testing. 
Investigators and Institutional Animal Care and Use Committee (IACUC) 
members need to be aware of currently available alternative methods so 
that they can be considered before animal study protocols are approved.
---------------------------------------------------------------------------

    \1\ 7 U.S.C. 2131-2159.
---------------------------------------------------------------------------

    For ocular safety testing, ICCVAM has recommended the bovine 
corneal opacity and permeability, isolated chicken eye, and Cytosensor 
microphysiometer test methods for use in specific circumstances to 
identify ocular corrosives and severe irritants without the use of live 
animals. ICCVAM also recently recommended that pain management 
procedures should always be used whenever it is necessary to use 
rabbits for eye safety testing required by Federal regulatory agencies. 
The ICCVAM recommendations include a test method protocol that 
describes how to use topical anesthetics (similar to those used in 
human eye surgeries) and systemic analgesics prior to and after test 
substance administration in order to avoid or minimize animal pain and 
distress. The report also identifies specific clinical signs and 
lesions that, if observed during animal testing, can be used as humane 
endpoints to allow the investigator to end a study early in order to 
reduce or avoid potential animal pain and distress. Use of the ICCVAM-
recommended ocular safety testing methods (available at http://iccvam.niehs.nih.gov/methods/ocutox/ocutox.htm) may reduce the number 
of animals required to identify substances with the potential to cause 
chemically induced eye injuries, and eliminate pain and distress when 
it is necessary to use animals for such testing.
    To identify substances with the potential to cause ACD, U.S. 
Federal agencies have accepted ICCVAM recommendations on an updated 
murine local lymph node assay (LLNA) protocol that uses 20% fewer 
animals. Federal agencies also accepted ICCVAM recommendations on the 
use of a modified procedure called the reduced LLNA that uses 40% fewer 
animals than the updated 3-dose LLNA protocol. ICCVAM also recently 
recommended two modified versions of the LLNA that do not require 
radioactive reagents, allowing more institutions to take advantage of 
the reduction and refinement benefits afforded by the LLNA compared to 
traditional guinea pig methods. These nonradioactive methods will also 
eliminate the expense and environmental hazard associated with use and 
disposal of radioactive materials used in the traditional LLNA. ICCVAM-
recommended ACD testing methods are available at http://iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm.
    While toxicologists recognize the usefulness and strengths of these 
new approaches, many are unfamiliar with the specific techniques. 
Before a new test method is implemented, the safety community must 
understand the method, as well as the manner in which agencies expect 
the method to be conducted and data interpreted. Users and regulatory 
agency staff need to become familiar with the technical procedures 
required to conduct a new method, and to understand the method's 
usefulness and limitations. Consequently, there is a need for in-depth 
training of individuals in the safety and regulatory community on the 
appropriate use of new tools for hazard, safety, and risk assessment.
    These workshops provide opportunities for such training. They will 
bring together scientific experts from relevant stakeholder 
organizations to discuss available alternative test methods for 
assessing chemicals and products for their ocular and ACD hazard 
potential. The goal is to raise awareness of available alternatives 
that users should consider before using traditional animal methods to 
assess eye injury and ACD hazards. The workshops will also provide 
information about the usefulness and limitations of these test methods. 
Users can then determine whether the methods are appropriate for 
specific testing applications.

Who Should Attend

    Scientists from industry, government, and academia who have an 
interest in learning more about alternative test methods that are 
available for assessing potential eye injury or ACD hazards are 
encouraged to participate. Topics discussed during these workshops will 
be of particular interest to those involved in conducting tests for 
ocular safety and ACD hazards (such as toxicologists and study 
directors), those responsible for reviewing study protocols prior to 
testing (such as chairpersons and members of IACUCs), and regulators 
who will review data generated by such tests. Those interested may 
choose to attend one or both workshops.

Workshop Program

    The workshop on ``Best Practices for Assessing the Potential for 
Chemically Induced Eye Injuries'' will be held on January 19, 2011. The 
workshop on ``Best Practices for Assessing the Potential for Chemically 
Induced Allergic Contact Dermatitis'' will convene on January 20, 2011. 
Sessions are scheduled to run from 8:30 a.m. to 5 p.m. each day. The 
programs will begin with presentations on U.S. requirements for the 
consideration of available alternatives, current regulatory 
requirements for safety testing, and the acceptance status of 
alternative methods. The scientific development of the test methods 
will be described, and the validation status of the test methods will 
be discussed. Detailed presentations will then provide practical 
instruction on application of the test methods, including standard 
protocols and data interpretation. Workshop participants will also have 
an opportunity to apply knowledge gained from the program using case 
studies in breakout group discussion sessions.

Preliminary Workshop Agenda: Best Practices for Assessing the Potential 
for Chemically Induced Eye Injuries (January 19, 2011)

    <bullet> Welcome, Introduction, and Public Health Impact of 
Chemically Induced Eye Injuries.
    <bullet> Review of Alternative Test Methods and Integrated 
Strategies for Ocular Safety Assessments.
    <bullet> Consideration and Use of Available Reduction, Refinement, 
and Replacement Alternative Test Methods: Study Director and IACUC 
Responsibilities.
    <bullet> Current Guidelines for Ocular Safety Testing.
    <bullet> Regulatory Agency Requirements and Acceptable Alternative 
Test Methods for Ocular Safety Assessments.
    <bullet> ICCVAM Evaluation and Recommendations on Best Practices 
for Incorporating Pain Management and Humane Endpoints in Ocular Safety 
Testing.
    <bullet> The Bovine Corneal Opacity and Permeability Test Method.

[[Page 62847]]

    <bullet> The Isolated Chicken Eye Test Method.
    <bullet> The Cytosensor Microphysiometer Test Method.
    <bullet> Case Studies in Breakout Groups.
    <bullet> New Models and Strategies in the Validation Pipeline for 
Ocular Safety Testing.
    <bullet> Roundtable Discussion and Summary Question-and-Answer 
Session.
    <bullet> Closing Comments.

Preliminary Workshop Agenda: Best Practices for Assessing the Potential 
for Chemically Induced Allergic Contact Dermatitis (January 20, 2011)

    <bullet> Welcome, Introduction, and Public Health Impact of 
Chemically Induced ACD.
    <bullet> Review of Alternative Test Methods and Integrated 
Strategies for ACD Hazard Assessments.
    <bullet> Consideration and Use of Available Reduction, Refinement, 
and Replacement Alternative Test Methods: Study Director and IACUC 
Responsibilities.
    <bullet> Current Guidelines for ACD Hazard Testing.
    <bullet> Regulatory Agency Requirements and Acceptable Alternative 
Test Methods for ACD Hazard Assessments.
    <bullet> The Reduced LLNA.
    <bullet> The LLNA: Bromodeoxyuridine Enzyme-linked Immunosorbent 
Assay (BrdU-ELISA).
    <bullet> The LLNA: Daicel Adenosine Triphosphate (DA).
    <bullet> Application of Peptide Reactivity for Screening ACD Hazard 
Potential.
    <bullet> Case Studies in Breakout Groups.
    <bullet> New Models and Strategies in the Validation Pipeline for 
ACD Hazard Testing.
    <bullet> Roundtable Discussion and Summary Question-and-Answer 
Session.
    <bullet> Closing Comments.

Registration

    Registration information, a tentative agenda for each workshop, and 
additional information for both workshops are available on the NICEATM-
ICCVAM Web site (http://iccvam.niehs.nih.gov/meetings/Implement-2011/ImplmtnWksp.htm) and upon request from NICEATM (see FOR FURTHER 
INFORMATION CONTACT).

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 U.S. Federal regulatory and research agencies that require, use, or 
generate toxicological and safety testing information for chemicals, 
products, and other substances. ICCVAM conducts technical evaluations 
of new, revised, and alternative methods with regulatory applicability, 
and promotes the scientific validation, regulatory acceptance, and 
national and international harmonization of toxicological and safety 
testing methods that more accurately assess the safety and health 
hazards of chemicals and products while reducing, refining (decreasing 
or eliminating pain and distress), or replacing animal use. The ICCVAM 
Authorization Act of 2000 (42 U.S.C. 285l-2, 285l-5 [2000], available 
at http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf) 
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 coordinates international 
validation studies of new and improved test methods. NICEATM and ICCVAM 
work collaboratively to evaluate new and improved test methods 
applicable to the needs of U.S. Federal agencies. NICEATM and ICCVAM 
welcome the public nomination of new, revised, and alternative test 
methods for validation studies as well as technical evaluations. 
Additional information about NICEATM and ICCVAM can be found on the 
NICEATM-ICCVAM Web site (http://www.iccvam.niehs.nih.gov).

    Dated: October 1, 2010.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2010-25676 Filed 10-12-10; 8:45 am]
BILLING CODE 4140-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>