Evaluation of an Up-and-Down Procedure for Acute Dermal Systemic Toxicity Testing: Request for Nominations for an Independent Expert Panel and Submission of Relevant Data, 43089-43090 [2012-17787]
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Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Notices
mandated duties of ICCVAM and
activities of NICEATM. SACATM
provides advice on priorities and
activities related to the development,
validation, scientific review, regulatory
acceptance, implementation, and
national and international
harmonization of new, revised, and
alternative toxicological test methods.
Additional information about SACATM,
including the charter, roster, and
records of past meetings, can be found
at https://ntp.niehs.nih.gov/go/167.
References
Chipinda I, Ajibola RO, Morokinyo MK,
Ruwona TB, Simoyi RH, Siegel PD. 2010.
Rapid and simple kinetics screening
assay for electrophilic dermal sensitizers
using nitrobenzenethiol. Chem Res
Toxicol 23: 918–925.
ICCVAM. 2008. The NICEATM–ICCVAM
Five-Year Plan (2008–2012): A Plan to
Advance Alternative Test Methods of
High Scientific Quality to Protect and
Advance the Health of People, Animals,
and the Environment. NIH Publication
No. 08–6410. Research Triangle Park,
NC: NIEHS. Available: https://
iccvam.niehs.nih.gov/docs/
5yearplan.htm.
¨
¨
Karlberg A–T, Bergstrom MA, Borje A,
Luthman, K, Nilsson JLG. 2008. Allergic
Contact Dermatitis––Formation,
Structural Requirements, and Reactivity
of Skin Sensitizers. Chem Res Toxicol
21: 53–69.
Dated: July 11, 2012.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2012–17788 Filed 7–20–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Evaluation of an Up-and-Down
Procedure for Acute Dermal Systemic
Toxicity Testing: Request for
Nominations for an Independent
Expert Panel and Submission of
Relevant Data
Division of the National
Toxicology Program (DNTP), National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH), HHS.
ACTION: Request for Data; Request for
Nominations of Scientific Experts.
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
The NTP Interagency Center
for the Evaluation of Alternative
Toxicological Methods (NICEATM), in
collaboration with the Interagency
Coordinating Committee on the
Validation of Alternative Methods
(ICCVAM), is planning to convene an
independent scientific peer review
SUMMARY:
VerDate Mar<15>2010
19:21 Jul 20, 2012
Jkt 226001
panel (Panel) to assess the validation
status of an up-and-down procedure
(UDP) for acute dermal systemic toxicity
testing. NICEATM requests nominations
of scientific experts who can be
considered for the Panel and submission
of data for substances tested in in vivo
acute dermal and oral systemic toxicity
tests.
DATES: Nominations and test method
data for the acute dermal and oral tests
should be submitted by September 6,
2012. Data submitted after this date will
be considered in the evaluation where
feasible.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION:
Background
Acute poisoning from chemicals and
chemical products, including
pharmaceuticals, is a significant public
health problem. In 2009, 2.5 million
human poisoning cases were reported to
U.S. poison control centers (Bronstein et
al., 2010). Dermal exposures were
involved in 7.25% (179,832 cases) of the
poisonings, which was second in
frequency only to exposures by oral
ingestion (2,080,781 cases). To protect
workers and consumers from acute
dermal poisoning exposures, regulatory
agencies in the U.S. (e.g., the
Environmental Protection Agency
[EPA], the Consumer Products Safety
Commission, Department of
Transportation, Occupational Safety and
Health Administration) use the
information from acute dermal systemic
toxicity tests using rabbits or rodents to
determine the potential of chemicals
and chemical products to cause lifethreatening health effects or death from
acute dermal exposures. Test results are
used as the basis for hazard
classification and labeling and to inform
consumers and workers how to avoid
acute dermal exposures to hazardous
chemicals and products during the
handling, transport, and use of
chemicals and products.
In 2002, ICCVAM recommended the
revised UDP for acute oral systemic
toxicity as a replacement for the
conventional test. The revised oral UDP
was accepted internationally as
Organisation for Economic Co-operation
and Development (OECD) Test
Guideline 425 in 2001 (OECD, 2001).
The oral UDP reduces animal use by up
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
43089
to 70% compared to the traditional
testing procedure. NICEATM is now
developing a UDP procedure for acute
dermal systemic toxicity testing, which
is one of the four most commonly
conducted product safety tests
worldwide. Alternative test methods for
acute dermal systemic toxicity testing
are an ICCVAM priority because such
testing is required by multiple agencies,
can involve large numbers of animals,
and can result in significant pain and
distress to test animals (ICCVAM, 2008).
The acute dermal systemic toxicity
UDP protocol is expected to reduce the
number of animals used compared with
current EPA (EPA, 1998) and OECD
(OECD, 1987) test guidelines. A draft
background review document (BRD)
will include a proposed dermal UDP
test method protocol and analyses
comparing the results of simulated
testing using the UDP protocol with the
standard acute dermal systemic toxicity
reference test described in EPA Health
Effects Test Guidelines OPPTS 870.1200
(EPA, 1998) and OECD Test Guideline
402 (OECD, 1987). The draft BRD will
form the basis for the ICCVAM draft test
method recommendations for the
proposed UDP method. Draft
recommendations on usefulness and
limitations, standardized test method
protocol, and future studies will be
provided to the Panel and made
available to the public.
The Panel will meet in public session
to review the validation status of the
UDP for acute dermal systemic toxicity
testing. The Panel will comment on the
extent to which the BRD supports the
draft ICCVAM test method
recommendations. Meeting information,
including dates, locations, and public
availability of the meeting documents
will be announced in a future Federal
Register notice and will also be posted
on the NICEATM–ICCVAM Web site
(https://iccvam.niehs.nih.gov).
Request for Nominations of Scientific
Experts
NICEATM requests nominations of
scientists with relevant knowledge and
expertise to serve on the Panel. Areas of
relevant expertise include, but are not
limited to biostatistics; human and
veterinary dermatology, with an
emphasis on evaluation and treatment
of chemical injuries that produce
systemic effects; human and animal
toxicology, especially systemic effects
due to dermal exposures; in vivo dermal
and oral toxicity testing; and test
method validation. Each nomination
should include the nominee’s name,
affiliation, contact information (i.e.,
mailing address, email address,
telephone and fax numbers), curriculum
E:\FR\FM\23JYN1.SGM
23JYN1
43090
Federal Register / Vol. 77, No. 141 / Monday, July 23, 2012 / Notices
vitae, and a brief summary of relevant
experience and qualifications.
mstockstill on DSK4VPTVN1PROD with NOTICES
Request for Data
NICEATM invites the submission of
data for substances tested in
standardized in vivo acute dermal
systemic toxicity tests. Corresponding
acute oral LD50 data for the same
compounds tested dermally would be
particularly useful. Oral data from rat
tests and dermal data from rat and/or
rabbit tests are preferred. Although data
can be accepted at any time, please
submit data by September 6, 2012 to
ensure consideration during the
ICCVAM evaluation process. Relevant
data received after this date will be
considered where feasible. All
information submitted in response to
this notice will be made publicly
available and may be incorporated into
future NICEATM and ICCVAM reports
and publications, as appropriate.
When submitting data, please
reference this Federal Register notice
and provide appropriate contact
information (name, affiliation, mailing
address, phone, fax, email, and
sponsoring organization, as applicable).
NICEATM prefers that data be
submitted electronically as copies of
pages from study notebooks,
spreadsheets, and/or study reports. Each
submission for a substance should
preferably include the following
information, as appropriate: common
and trade name, Chemical Abstracts
Service Registry Number (CASRN),
commercial source, in vivo test
protocols used, extent to which the data
were collected in accordance with
national or international Good
Laboratory Practice guidelines, date and
testing organization, physical and
chemical properties (e.g., molecular
weight, pH, water solubility, log Kow,
etc.), estimated LD50, and incidence of
death and other adverse effects.
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
and integrated testing strategies with
regulatory applicability and promotes
the scientific validation and regulatory
acceptance of testing methods that more
accurately assess the safety and hazards
of chemicals and products and that
reduce, refine (enhance animal wellbeing and lessen or avoid pain and
distress), or replace animal use. The
VerDate Mar<15>2010
19:21 Jul 20, 2012
Jkt 226001
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 of new, revised, and
alternative test methods and strategies
for validation studies and technical
evaluations. Additional information
about NICEATM and ICCVAM can be
found on the NICEATM–ICCVAM Web
site (https://iccvam.niehs.nih.gov).
References
Bronstein AC, Spyker DA, Cantilena LR, Jr,
Green JL, Rumack BH, Giffin SL. 2010.
2009 Annual Report of the American
Association of Poison Control Centers’
National Poison Data System (NPDS):
27th Annual Report. Clinical Toxicology
48: 979–1178.
EPA. 1998. Health Effects Test Guidelines:
OPPTS 870.1200—Acute Dermal
Toxicity. EPA 712–C–98–192.
Washington, DC:U.S. Environmental
Protection Agency. Available: https://
www.epa.gov/ocspp/pubs/frs/
publications/Test_Guidelines/
series870.htm.
ICCVAM. 2008. NICEATM–ICCVAM FiveYear Plan (2008–2012): A Plan to
Advance Alternative Test Methods of
High Scientific Quality to Protect and
Advance the Health of People, Animals
and the Environment. Research Triangle
Park, NC: National Institute of
Environmental Health Sciences.
Available: https://iccvam.niehs.nih.gov/
docs/5yearplan.htm.
OECD. 1987. Test No. 402. Acute Dermal
Toxicity [adopted 24 February 1987]. In:
OECD Guidelines for the Testing of
Chemicals, Section 4: Health Effects.
Paris:OECD Publishing. Available: https://
dx.doi.org/10.1787/9789264070585-en.
OECD. 2001. Test No. 425. Acute Oral
Toxicity—Up-and-Down Procedure
[adopted 17 December 2001]. In: OECD
Guidelines for the Testing of Chemicals,
Section 4: Health Effects. Paris:OECD
Publishing. Available: www.oecd.org/
dataoecd/17/51/1948378.pdf.
Dated: July 12, 2012.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2012–17787 Filed 7–20–12; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Safety and Occupational Health Study
Section: Notice of Charter Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Safety
and Occupational Health Study Section,
Centers for Disease Control and
Prevention, Department of Health and
Human Services, has been renewed for
a 2-year period through June 30, 2014.
For more information contact: Price
Connor, Ph.D., Executive Secretary,
Safety and Occupational Health Study
Section, Department of Health and
Human Services, 1600 Clifton Road NE.,
Mailstop E74, Atlanta, Georgia 30333,
telephone 404/498–2511 or fax 404/
498–2571.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: July 16, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–17879 Filed 7–20–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Board on Radiation and
Worker Health (ABRWH or Advisory
Board), National Institute for
Occupational Safety and Health
(NIOSH); Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
TIME AND DATE: 11:00 a.m.–3:00 p.m.,
August 15, 2012.
PLACE: Audio Conference Call via FTS
Conferencing. The USA toll-free, dial-in
number is 1–866–659–0537 and the pass
code is 9933701.
STATUS: Open to the public, but without
a verbal public comment period.
E:\FR\FM\23JYN1.SGM
23JYN1
]]>Agencies
[Federal Register Volume 77, Number 141 (Monday, July 23, 2012)]
[Notices]
[Pages 43089-43090]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17787]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Evaluation of an Up-and-Down Procedure for Acute Dermal Systemic
Toxicity Testing: Request for Nominations for an Independent Expert
Panel and Submission of Relevant Data
AGENCY: Division of the National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS), National Institutes
of Health (NIH), HHS.
ACTION: Request for Data; Request for Nominations of Scientific
Experts.
-----------------------------------------------------------------------
SUMMARY: The NTP Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM), in collaboration with the Interagency
Coordinating Committee on the Validation of Alternative Methods
(ICCVAM), is planning to convene an independent scientific peer review
panel (Panel) to assess the validation status of an up-and-down
procedure (UDP) for acute dermal systemic toxicity testing. NICEATM
requests nominations of scientific experts who can be considered for
the Panel and submission of data for substances tested in in vivo acute
dermal and oral systemic toxicity tests.
DATES: Nominations and test method data for the acute dermal and oral
tests should be submitted by September 6, 2012. Data submitted after
this date will be considered in the evaluation where feasible.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION:
Background
Acute poisoning from chemicals and chemical products, including
pharmaceuticals, is a significant public health problem. In 2009, 2.5
million human poisoning cases were reported to U.S. poison control
centers (Bronstein et al., 2010). Dermal exposures were involved in
7.25% (179,832 cases) of the poisonings, which was second in frequency
only to exposures by oral ingestion (2,080,781 cases). To protect
workers and consumers from acute dermal poisoning exposures, regulatory
agencies in the U.S. (e.g., the Environmental Protection Agency [EPA],
the Consumer Products Safety Commission, Department of Transportation,
Occupational Safety and Health Administration) use the information from
acute dermal systemic toxicity tests using rabbits or rodents to
determine the potential of chemicals and chemical products to cause
life-threatening health effects or death from acute dermal exposures.
Test results are used as the basis for hazard classification and
labeling and to inform consumers and workers how to avoid acute dermal
exposures to hazardous chemicals and products during the handling,
transport, and use of chemicals and products.
In 2002, ICCVAM recommended the revised UDP for acute oral systemic
toxicity as a replacement for the conventional test. The revised oral
UDP was accepted internationally as Organisation for Economic Co-
operation and Development (OECD) Test Guideline 425 in 2001 (OECD,
2001). The oral UDP reduces animal use by up to 70% compared to the
traditional testing procedure. NICEATM is now developing a UDP
procedure for acute dermal systemic toxicity testing, which is one of
the four most commonly conducted product safety tests worldwide.
Alternative test methods for acute dermal systemic toxicity testing are
an ICCVAM priority because such testing is required by multiple
agencies, can involve large numbers of animals, and can result in
significant pain and distress to test animals (ICCVAM, 2008).
The acute dermal systemic toxicity UDP protocol is expected to
reduce the number of animals used compared with current EPA (EPA, 1998)
and OECD (OECD, 1987) test guidelines. A draft background review
document (BRD) will include a proposed dermal UDP test method protocol
and analyses comparing the results of simulated testing using the UDP
protocol with the standard acute dermal systemic toxicity reference
test described in EPA Health Effects Test Guidelines OPPTS 870.1200
(EPA, 1998) and OECD Test Guideline 402 (OECD, 1987). The draft BRD
will form the basis for the ICCVAM draft test method recommendations
for the proposed UDP method. Draft recommendations on usefulness and
limitations, standardized test method protocol, and future studies will
be provided to the Panel and made available to the public.
The Panel will meet in public session to review the validation
status of the UDP for acute dermal systemic toxicity testing. The Panel
will comment on the extent to which the BRD supports the draft ICCVAM
test method recommendations. Meeting information, including dates,
locations, and public availability of the meeting documents will be
announced in a future Federal Register notice and will also be posted
on the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov).
Request for Nominations of Scientific Experts
NICEATM requests nominations of scientists with relevant knowledge
and expertise to serve on the Panel. Areas of relevant expertise
include, but are not limited to biostatistics; human and veterinary
dermatology, with an emphasis on evaluation and treatment of chemical
injuries that produce systemic effects; human and animal toxicology,
especially systemic effects due to dermal exposures; in vivo dermal and
oral toxicity testing; and test method validation. Each nomination
should include the nominee's name, affiliation, contact information
(i.e., mailing address, email address, telephone and fax numbers),
curriculum
[[Page 43090]]
vitae, and a brief summary of relevant experience and qualifications.
Request for Data
NICEATM invites the submission of data for substances tested in
standardized in vivo acute dermal systemic toxicity tests.
Corresponding acute oral LD50 data for the same compounds
tested dermally would be particularly useful. Oral data from rat tests
and dermal data from rat and/or rabbit tests are preferred. Although
data can be accepted at any time, please submit data by September 6,
2012 to ensure consideration during the ICCVAM evaluation process.
Relevant data received after this date will be considered where
feasible. All information submitted in response to this notice will be
made publicly available and may be incorporated into future NICEATM and
ICCVAM reports and publications, as appropriate.
When submitting data, please reference this Federal Register notice
and provide appropriate contact information (name, affiliation, mailing
address, phone, fax, email, and sponsoring organization, as
applicable). NICEATM prefers that data be submitted electronically as
copies of pages from study notebooks, spreadsheets, and/or study
reports. Each submission for a substance should preferably include the
following information, as appropriate: common and trade name, Chemical
Abstracts Service Registry Number (CASRN), commercial source, in vivo
test protocols used, extent to which the data were collected in
accordance with national or international Good Laboratory Practice
guidelines, date and testing organization, physical and chemical
properties (e.g., molecular weight, pH, water solubility, log
Kow, etc.), estimated LD50, and incidence of
death and other adverse effects.
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 and integrated testing strategies with
regulatory applicability and promotes the scientific validation and
regulatory acceptance of 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 avoid 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 of new, revised, and alternative test methods and strategies
for validation studies and technical evaluations. Additional
information about NICEATM and ICCVAM can be found on the NICEATM-ICCVAM
Web site (https://iccvam.niehs.nih.gov).
References
Bronstein AC, Spyker DA, Cantilena LR, Jr, Green JL, Rumack BH,
Giffin SL. 2010. 2009 Annual Report of the American Association of
Poison Control Centers' National Poison Data System (NPDS): 27th
Annual Report. Clinical Toxicology 48: 979-1178.
EPA. 1998. Health Effects Test Guidelines: OPPTS 870.1200--Acute
Dermal Toxicity. EPA 712-C-98-192. Washington, DC:U.S. Environmental
Protection Agency. Available: https://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series870.htm.
ICCVAM. 2008. NICEATM-ICCVAM Five-Year Plan (2008-2012): A Plan to
Advance Alternative Test Methods of High Scientific Quality to
Protect and Advance the Health of People, Animals and the
Environment. Research Triangle Park, NC: National Institute of
Environmental Health Sciences. Available: https://iccvam.niehs.nih.gov/docs/5yearplan.htm.
OECD. 1987. Test No. 402. Acute Dermal Toxicity [adopted 24 February
1987]. In: OECD Guidelines for the Testing of Chemicals, Section 4:
Health Effects. Paris:OECD Publishing. Available: https://dx.doi.org/10.1787/9789264070585-en.
OECD. 2001. Test No. 425. Acute Oral Toxicity--Up-and-Down Procedure
[adopted 17 December 2001]. In: OECD Guidelines for the Testing of
Chemicals, Section 4: Health Effects. Paris:OECD Publishing.
Available: www.oecd.org/dataoecd/17/51/1948378.pdf.
Dated: July 12, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-17787 Filed 7-20-12; 8:45 am]
BILLING CODE 4140-01-P
