Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye Hazards: Revised Criteria Necessary to Maintain Equivalent Hazard Classification; Request for Comments, 50220-50221 [2011-20537]

Download as PDF 50220 Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices There are no significant current capital or other non-labor costs associated with this Rule. Because the Rule has been in effect since 1980, members of the industry are familiar with its requirements and already have in place the equipment for conducting tests and storing records. New products are introduced infrequently. Because the required disclosures are placed on packaging or on the product itself, the Rule’s additional disclosure requirements do not cause industry members to incur any significant additional non-labor associated costs. Willard K. Tom, General Counsel. [FR Doc. 2011–20372 Filed 8–11–11; 8:45 am] BILLING CODE 6750–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye Hazards: Revised Criteria Necessary to Maintain Equivalent Hazard Classification; Request for Comments Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, HHS. AGENCY: Availability of Recommendations; Request for Comments. ACTION: 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), conducted an analysis to determine classification criteria using results from 3-animal tests that would provide eye hazard classification equivalent to testing conducted in accordance with current U.S. Federal Hazardous Substances Act (FHSA) regulations, which require the use of 6 to 18 animals. The results showed that using a classification criterion of at least 1 positive animal in a 3-animal test to identify eye hazards will provide the same or greater level of eye hazard classification as current FHSA requirements, while using 50% to 83% fewer animals. ICCVAM developed draft recommendations based on the results of this analysis. NICEATM invites public comments on these draft ICCVAM recommendations. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:37 Aug 11, 2011 Jkt 223001 Written comments on the draft recommendations should be received by September 26, 2011. ADDRESSES: NICEATM prefers that comments be submitted electronically via the NICEATM–ICCVAM Web site (https://iccvam.niehs.nih.gov/contact/ FR_pubcomment.htm) or via e-mail to niceatm@niehs.nih.gov. Written comments may also be sent by mail or fax to Dr. William S. Stokes, Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2–16, Research Triangle Park, NC 27709; (fax) 919–541–0947. Courier address: NICEATM, NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560. FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes: (telephone) 919–541– 2384, (fax) 919–541–0947, or (e-mail) niceatm@niehs.nih.gov. SUPPLEMENTARY INFORMATION: DATES: Background Testing requirements necessary to determine the eye hazard potential for substances regulated under the FHSA (FHSA, 2008) are provided in 16 CFR 1500.42 (U.S. Consumer Product Safety Commission [CPSC], 2010). Current FHSA regulations provide procedures to determine the eye hazard classification and labeling requirements for chemicals and products to which consumers may be exposed. The current procedure requires a minimum of 6 animals per test and may require up to 3 sequential tests for each substance, thus requiring 6, 12, or 18 animals to reach a hazard classification decision. The requirement for second and third sequential tests is based on the number of positive responses in the previous test. In 2002, the Organisation for Economic Co-operation and Development (OECD) Test Guidelines Program adopted U.S. proposed revisions to Test Guideline 405: Acute Eye Irritation/Corrosion (OECD, 2002) that reduce the maximum number of required animals per test from 6 to 3. The Animal Welfare Act (7 U.S.C. 2131 et seq) and the Public Health Service (PHS) Policy (PHS, 2002) similarly require that only the minimum number of animals necessary to obtain scientifically valid results should be used and that a rationale for the appropriateness of the number of animals used be provided to and approved by the Institutional Animal Care and Use Committee. In light of this policy and regulations, most in vivo ocular safety testing is expected to adhere to the 3-animal procedure described in OECD Test Guideline 405 (OECD, 2002) and in a test guideline issued by the U.S. Environmental PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Protection Agency (EPA, 1998). However, current FHSA regulations do not provide criteria to classify results from a 3-animal test. Therefore, an analysis was conducted to determine classification criteria based on results from a 3-animal test that would provide eye hazard classification equivalent to procedures in current FHSA regulations (Haseman et al., 2011). The results showed that using a classification criterion of at least 1 positive in a 3animal test to identify eye hazards will provide the same or greater level of eye hazard classification as current FHSA requirements, while using 50% to 83% fewer animals. Based on these results, ICCVAM developed draft recommendations to use this classification criterion for ocular safety testing procedures that use only a maximum of 3 animals per test substance. Availability of the Documents The draft ICCVAM recommendations and the supporting publication describing the results of the analysis are available on the NICEATM–ICCVAM Web site (https://iccvam.niehs.nih.gov/ methods/ocutox/reducenum.htm), and may also be obtained by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT). Request for Public Comments NICEATM invites the submission of written comments on the draft ICCVAM recommendations and the extent to which the NICEATM analysis supports the recommendations by September 26, 2011. When submitting written comments, please refer to this Federal Register notice and include appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, if applicable). NICEATM will post all comments on the NICEATM–ICCVAM Web site (https://ntp-apps.niehs.nih.gov/ iccvampb/searchPubCom.cfm) identified by the individual’s name and affiliation or sponsoring organization (if applicable). ICCVAM will consider all public comments and comments made by the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) at the June 17–18, 2010 meeting (75 FR 26757) when finalizing its recommendations. Final ICCVAM recommendations will be forwarded to relevant Federal agencies for their consideration. These recommendations will also be available to the public on the NICEATM–ICCVAM Web site (https://iccvam.niehs.nih.gov/methods/ ocutox/reducenum.htm). E:\FR\FM\12AUN1.SGM 12AUN1 Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices Background Information on ICCVAM, NICEATM, and SACATM mstockstill on DSK4VPTVN1PROD with NOTICES 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 (decrease 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 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). SACATM was established in response to the ICCVAM Authorization Act [Section 285l–3(d)] and is composed of scientists from the public and private sectors. SACATM advises ICCVAM, NICEATM, and the Director of the NIEHS and NTP regarding statutorily 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 AWA. 2010. Animal Welfare Act. 7 U.S.C. 2131 et seq. Public Law 89–544. Available: https://www.aphis.usda.gov/ animal_welfare/downloads/awa/awa.pdf. CPSC. 2010. Hazardous Substances and Articles; Administration and Enforcement Regulations. 16 CFR part 1500. Available: https://www.gpo.gov/fdsys/pkg/CFR-2010- VerDate Mar<15>2010 16:37 Aug 11, 2011 Jkt 223001 title16-vol2/xml/CFR-2010-title16-vol2part1500.xml. EPA. 1998. Health Effects Test Guideline, OPPTS 870.2400 Acute Eye Irritation. Washington, DC: U.S. Environmental Protection Agency. Available: https:// iccvam.niehs.nih.gov/SuppDocs/FedDocs/ EPA/EPA_870_2400.pdf. FHSA. 2008. 15 U.S.C. 1261–1278. Public Law 86–613. Available: https:// www.cpsc.gov/businfo/fhsa.pdf. Haseman JK, Allen DG, Lipscomb EA, Truax JF, Stokes WS. 2011. Using fewer animals to identify chemical eye hazards: Revised criteria necessary to maintain equivalent hazard classification [published online ahead of print]. Regul Toxicol Pharmacol. Available: https://dx.doi.org/10.1016/ j.yrtph.2011.06.006. OECD. 2002. Test No. 405: Acute Eye Irritation/Corrosion. In: OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects. Paris:OECD Publishing. Available: https://www.oecd-ilibrary.org/ content/book/9789264070646-en. PHS. 2002. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Bethesda, MD: Office of Laboratory Animal Welfare, National Institutes of Health. Available: https:// grants.nih.gov/grants/olaw/references/ phspol.htm. Dated: August 3, 2011. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2011–20537 Filed 8–11–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning the Way Forward Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), HHS. ACTION: Announcement of a Workshop; Call for Abstract Submissions. AGENCY: The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an ‘‘International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning The Way Forward.’’ This workshop will bring together scientists from government, industry, and academia to review the current state of the science and validation status of methods and approaches that may reduce, refine, or replace animal use in human and veterinary rabies vaccine potency testing, and to develop an SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 50221 implementation strategy to achieve global acceptance and use of these alternatives. Attendance is open to the public at no charge and limited only by the available space. Abstracts for scientific posters for display at the workshop are also invited (see SUPPLEMENTARY INFORMATION). DATES: The workshop is scheduled for October 11–13, 2011. Sessions will begin at 8:30 a.m. each day and end at approximately 6 p.m. on October 11 and 12 and at 12 p.m. on October 13. The deadline for registration is September 30, 2011. Due to U.S. Department of Agriculture (USDA) security requirements, onsite registration at the workshop will not be available. The deadline for submission of poster abstracts is September 16, 2011. ADDRESSES: The workshop will be held at the Center for Veterinary Biologics at the USDA National Centers for Animal Health, 1920 Dayton Avenue, Ames, Iowa 50010. Individuals with disabilities who need accommodation to participate in this event should contact Ms. Debbie McCarley at voice telephone: 919–541–2384 or e-mail: mccarley@niehs.nih.gov. TTY users should contact the Federal TTY Relay Service at 800–877–8339. Requests should be made at least 5 business days in advance of the event. 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, (e-mail) niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: Background Rabies is one of the oldest known zoonotic diseases and is responsible for at least 55,000 human deaths worldwide each year (World Health Organization [WHO], 2010). Rabies vaccines serve a vital role in preventing further deaths and controlling the disease in certain animal populations. An estimated 15 million people receive post-exposure vaccine prophylaxis each year due to actual or suspected exposures to the rabies virus. In the United States and other developed countries, rabies vaccines have effectively eliminated domestic rabies virus strains. Prior to the release of each production lot of vaccine, regulatory authorities require demonstration of potency and safety. Potency and safety testing of rabies vaccines requires large numbers of laboratory animals and involves significant pain and distress. New E:\FR\FM\12AUN1.SGM 12AUN1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Notices]
[Pages 50220-50221]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20537]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Availability of Draft ICCVAM Recommendations on Using Fewer 
Animals to Identify Chemical Eye Hazards: Revised Criteria Necessary to 
Maintain Equivalent Hazard Classification; Request for Comments

AGENCY: Division of the National Toxicology Program (DNTP), National 
Institute of Environmental Health Sciences (NIEHS), National Institutes 
of Health, HHS.

ACTION: Availability of Recommendations; Request for Comments.

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

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), conducted an analysis to determine classification criteria 
using results from 3-animal tests that would provide eye hazard 
classification equivalent to testing conducted in accordance with 
current U.S. Federal Hazardous Substances Act (FHSA) regulations, which 
require the use of 6 to 18 animals. The results showed that using a 
classification criterion of at least 1 positive animal in a 3-animal 
test to identify eye hazards will provide the same or greater level of 
eye hazard classification as current FHSA requirements, while using 50% 
to 83% fewer animals. ICCVAM developed draft recommendations based on 
the results of this analysis. NICEATM invites public comments on these 
draft ICCVAM recommendations.

DATES: Written comments on the draft recommendations should be received 
by September 26, 2011.

ADDRESSES: NICEATM prefers that comments be submitted electronically 
via the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm) or via e-mail to niceatm@niehs.nih.gov. Written 
comments may also be sent by mail or fax to Dr. William S. Stokes, 
Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research 
Triangle Park, NC 27709; (fax) 919-541-0947. Courier address: NICEATM, 
NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes: (telephone) 
919-541-2384, (fax) 919-541-0947, or (e-mail) niceatm@niehs.nih.gov.

SUPPLEMENTARY INFORMATION:

Background

    Testing requirements necessary to determine the eye hazard 
potential for substances regulated under the FHSA (FHSA, 2008) are 
provided in 16 CFR 1500.42 (U.S. Consumer Product Safety Commission 
[CPSC], 2010). Current FHSA regulations provide procedures to determine 
the eye hazard classification and labeling requirements for chemicals 
and products to which consumers may be exposed. The current procedure 
requires a minimum of 6 animals per test and may require up to 3 
sequential tests for each substance, thus requiring 6, 12, or 18 
animals to reach a hazard classification decision. The requirement for 
second and third sequential tests is based on the number of positive 
responses in the previous test.
    In 2002, the Organisation for Economic Co-operation and Development 
(OECD) Test Guidelines Program adopted U.S. proposed revisions to Test 
Guideline 405: Acute Eye Irritation/Corrosion (OECD, 2002) that reduce 
the maximum number of required animals per test from 6 to 3. The Animal 
Welfare Act (7 U.S.C. 2131 et seq) and the Public Health Service (PHS) 
Policy (PHS, 2002) similarly require that only the minimum number of 
animals necessary to obtain scientifically valid results should be used 
and that a rationale for the appropriateness of the number of animals 
used be provided to and approved by the Institutional Animal Care and 
Use Committee. In light of this policy and regulations, most in vivo 
ocular safety testing is expected to adhere to the 3-animal procedure 
described in OECD Test Guideline 405 (OECD, 2002) and in a test 
guideline issued by the U.S. Environmental Protection Agency (EPA, 
1998). However, current FHSA regulations do not provide criteria to 
classify results from a 3-animal test. Therefore, an analysis was 
conducted to determine classification criteria based on results from a 
3-animal test that would provide eye hazard classification equivalent 
to procedures in current FHSA regulations (Haseman et al., 2011). The 
results showed that using a classification criterion of at least 1 
positive in a 3-animal test to identify eye hazards will provide the 
same or greater level of eye hazard classification as current FHSA 
requirements, while using 50% to 83% fewer animals. Based on these 
results, ICCVAM developed draft recommendations to use this 
classification criterion for ocular safety testing procedures that use 
only a maximum of 3 animals per test substance.

Availability of the Documents

    The draft ICCVAM recommendations and the supporting publication 
describing the results of the analysis are available on the NICEATM-
ICCVAM Web site (https://iccvam.niehs.nih.gov/methods/ocutox/reducenum.htm), and may also be obtained by contacting NICEATM (see FOR 
FURTHER INFORMATION CONTACT).

Request for Public Comments

    NICEATM invites the submission of written comments on the draft 
ICCVAM recommendations and the extent to which the NICEATM analysis 
supports the recommendations by September 26, 2011. When submitting 
written comments, please refer to this Federal Register notice and 
include appropriate contact information (name, affiliation, mailing 
address, phone, fax, e-mail, and sponsoring organization, if 
applicable). NICEATM will post all comments on the NICEATM-ICCVAM Web 
site (https://ntp-apps.niehs.nih.gov/iccvampb/searchPubCom.cfm) 
identified by the individual's name and affiliation or sponsoring 
organization (if applicable). ICCVAM will consider all public comments 
and comments made by the Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM) at the June 17-18, 2010 meeting (75 FR 
26757) when finalizing its recommendations. Final ICCVAM 
recommendations will be forwarded to relevant Federal agencies for 
their consideration. These recommendations will also be available to 
the public on the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov/methods/ocutox/reducenum.htm).

[[Page 50221]]

Background Information on ICCVAM, NICEATM, and SACATM

    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 (decrease 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 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).
    SACATM was established in response to the ICCVAM Authorization Act 
[Section 285l-3(d)] and is composed of scientists from the public and 
private sectors. SACATM advises ICCVAM, NICEATM, and the Director of 
the NIEHS and NTP regarding statutorily 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

AWA. 2010. Animal Welfare Act. 7 U.S.C. 2131 et seq. Public Law 89-
544. Available: https://www.aphis.usda.gov/animal_welfare/downloads/awa/awa.pdf.
CPSC. 2010. Hazardous Substances and Articles; Administration and 
Enforcement Regulations. 16 CFR part 1500. Available: https://www.gpo.gov/fdsys/pkg/CFR-2010-title16-vol2/xml/CFR-2010-title16-vol2-part1500.xml.
EPA. 1998. Health Effects Test Guideline, OPPTS 870.2400 Acute Eye 
Irritation. Washington, DC: U.S. Environmental Protection Agency. 
Available: https://iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/EPA_870_2400.pdf.
FHSA. 2008. 15 U.S.C. 1261-1278. Public Law 86-613. Available: 
https://www.cpsc.gov/businfo/fhsa.pdf.
Haseman JK, Allen DG, Lipscomb EA, Truax JF, Stokes WS. 2011. Using 
fewer animals to identify chemical eye hazards: Revised criteria 
necessary to maintain equivalent hazard classification [published 
online ahead of print]. Regul Toxicol Pharmacol. Available: https://dx.doi.org/10.1016/j.yrtph.2011.06.006.
OECD. 2002. Test No. 405: Acute Eye Irritation/Corrosion. In: OECD 
Guidelines for the Testing of Chemicals, Section 4: Health Effects. 
Paris:OECD Publishing. Available: https://www.oecd-ilibrary.org/content/book/9789264070646-en.
PHS. 2002. Public Health Service Policy on Humane Care and Use of 
Laboratory Animals. Bethesda, MD: Office of Laboratory Animal 
Welfare, National Institutes of Health. Available: https://grants.nih.gov/grants/olaw/references/phspol.htm.

    Dated: August 3, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-20537 Filed 8-11-11; 8:45 am]
BILLING CODE 4140-01-P

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