Federal Agency Responses to Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Recommendations on the Usefulness and Limitations of the LUMI-CELL® ER (BG1Luc ER TA) Test Method, An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals, 50510-50511 [2012-20549]

Download as PDF 50510 Federal Register / Vol. 77, No. 162 / Tuesday, August 21, 2012 / Notices Federal Agency Responses to Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Recommendations on the Usefulness and Limitations of the LUMI-CELL® ER (BG1Luc ER TA) Test Method, An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), HHS. ACTION: Availability of Agency Responses. AGENCY: The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of U.S. Federal agency responses to ICCVAM test method recommendations on the usefulness and limitations of the LUMICELL® ER (BG1Luc ER TA) test method to identify human estrogen receptor (ER) agonist and antagonist activity of chemicals. ICCVAM forwarded the recommendations to Federal agencies and made these recommendations available to the public (77 FR 8258). ICCVAM agencies responded with their concurrence on the technical aspects of the BG1Luc ER transcriptional activation (TA) test method recommendations and their agreement that the ICCVAM BG1Luc ER TA test method is a validated screening test to identify substances with in vitro ER agonist activity or ER antagonist activity. The U.S. Environmental Protection Agency (EPA) responded that they regard the BG1Luc ER TA test method as an alternative to the Office of Chemical Safety and Pollution Prevention (OCSPP) 890.1300 (Organization for Economic Cooperation and Development [OECD] TG455) test guideline for transcriptional activation currently used in their Endocrine Disruptor Screening Program (EDSP). Several agencies also indicated that they would communicate the ICCVAM recommendations to stakeholders and encourage their appropriate use. Complete Federal agency responses are available at https://iccvam.niehs.nih.gov/methods/ endocrine/end_eval.htm. The ICCVAM recommendations are provided in the ICCVAM test method evaluation report (ICCVAM, 2011), available at: https:// iccvam.niehs.nih.gov/methods/ endocrine/ERTA-TMER.htm. pmangrum on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:31 Aug 20, 2012 Jkt 226001 Dr. Warren M. Casey, Deputy Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2–16, Research Triangle Park, NC 27709, (telephone) 919–316– 4729, (fax) 919–541–0947, (email) niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2032, 530 Davis Drive, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Background In 2002, ICCVAM evaluated the validation status of in vitro ER and androgen receptor (AR) binding and TA test methods for potential use in the EPA EDSP. The evaluation indicated that no in vitro ER- or AR-based test methods were adequately validated for this purpose. In response to an ICCVAM request for nominations, Xenobiotic Detection Systems, Inc. (XDS, Durham, NC) nominated the in vitro LUMICELL® ER (BG1Luc ER TA) test method for an interlaboratory validation study. ICCVAM and the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) recommended that the nominated method should be considered a high priority based on the lack of adequately validated test methods and the regulatory and public health need for such test methods. NICEATM led the international validation study with its partners in Japan (JaCVAM) and Europe (ECVAM), using laboratories sponsored by each validation organization. ICCVAM also proposed the development of BG1Luc ER TA test method performance standards. Following completion of the validation study, the ICCVAM Interagency Endocrine Disruptor Working Group, working with NICEATM, prepared a draft background review document (BRD) and draft recommendations for use of the BG1Luc ER TA test method. The draft BRD and draft ICCVAM recommendations were reviewed in a public meeting (76 FR 4113) of an international independent scientific peer review panel in March 2011. The peer review panel agreed with the draft ICCVAM recommendations that the BG1Luc ER TA test method could be used as a screening test to identify substances with in vitro ER agonist activity or ER antagonist activity and that the accuracy of this assay is at least equivalent to that of EPA OCSPP 890.1300, part of the EDSP Tier 1 screening battery. The final ICCVAM recommendations are included in the ICCVAM Test Method Evaluation Report: The LUMICELL® ER (BG1Luc ER TA) Test Method, An In Vitro Assay for Identifying PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals (NIH Publication No. 11–7850). The test method evaluation report also includes the updated ICCVAM-recommended BG1Luc ER TA test method protocol and performance standards that are applicable to functionally and mechanistically similar test methods. The final BRD, including the data and analyses on which the recommendations are based, is included as an appendix to the test method evaluation report. Agency Responses to ICCVAM Recommendations In February 2012, ICCVAM forwarded final test method recommendations on the BG1Luc ER TA test method to U.S. Federal agencies for consideration (77 FR 8258), in accordance with the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3). The ICCVAM Authorization Act requires member agencies to review ICCVAM test method recommendations and notify ICCVAM in writing of their findings no later than 180 days after receipt of recommendations. The Act also requires ICCVAM to make ICCVAM recommendations and agency responses available to the public. Agency responses are to include identification of relevant test methods for which the ICCVAM test method recommendations may be added or substituted and indicate any revisions or planned revisions to existing guidelines, guidances, or regulations to be made in response to these recommendations. ICCVAM agencies responded with their concurrence on the technical aspects of the BG1Luc ER TA test method recommendation and their agreement that the ICCVAM BG1Luc ER TA test method is a validated screening test to identify substances with in vitro ER agonist activity or ER antagonist activity. The EPA responded that they regard the BG1Luc ER TA test method as an alternative to the OCSPP 890.1300 test guideline for transcriptional activation currently used in their EDSP. Several agencies also indicated that they would communicate the ICCVAM recommendations to stakeholders and encourage their appropriate use. Complete agency responses are available at https://iccvam.niehs.nih.gov/methods/ endocrine/end_eval.htm. 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 E:\FR\FM\21AUN1.SGM 21AUN1 Federal Register / Vol. 77, No. 162 / Tuesday, August 21, 2012 / Notices The average cost per inspection is multiplied by size and cost factors to determine the fee for vessels in each size category. The size and cost factors were established in the fee schedule published in the Federal Register on July 17, 1987 (52 FR 27060). The fee schedule was most recently published in the Federal Register on March 2, 2012 (77 FR 12843). The current size VerDate Mar<15>2010 15:31 Aug 20, 2012 Jkt 226001 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 ICCVAM. 2011. ICCVAM Test Method Evaluation Report: The LUMI–CELL® ER (BG1Luc ER TA) Test Method: An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals. NIH Publication No. 11–7850. Research Triangle Park, NC: NIEHS. Available: https://iccvam.niehs.nih.gov/ methods/endocrine/ERTA-TMER.htm. Dated: August 13, 2012. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2012–20549 Filed 8–20–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Fees for Sanitation Inspections of Cruise Ships Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: General notice. AGENCY: In this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces fees for vessel sanitation inspections for Fiscal Year (FY) 2013. These inspections are conducted by HHS/ CDC’s Vessel Sanitation Program (VSP). VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly inspections and, when necessary, reinspection. SUMMARY: and cost factors are presented in Appendix A. Fee The fee schedule (Appendix A) will be effective October 1, 2012 through September 30, 2013. The fee schedule has not changed since October 1, 2006. The cruise ship industry should be aware that if travel expenses for VSP PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 These fees are effective October 1, 2012 through September 30, 2013. DATES: FOR FURTHER INFORMATION CONTACT: CAPT Jaret T. Ames, Chief, Vessel Sanitation Program, National Center for Environmental Health, Centers for Disease Control and Prevention, 4770 Buford Highway NE., MS–F–59, Atlanta, Georgia 30341–3717, phone: 800–323– 2132 or 954–356–6650, email: vsp@cdc.gov. SUPPLEMENTARY INFORMATION: Purpose and Background HHS/CDC established the Vessel Sanitation Program (VSP) in the 1970s as a cooperative activity with the cruise ship industry. VSP helps the cruise ship industry prevent and control the introduction, transmission, and spread of gastrointestinal illnesses on cruise ships. VSP operates under the authority of the Public Health Service Act (42 U.S.C. 264, ‘‘Control of Communicable Diseases’’). Regulations found at 42 CFR 71.41 (Foreign Quarantine— Requirements Upon Arrival at U.S. Ports: Sanitary Inspection; General Provisions) state that carriers arriving at U.S. ports from foreign areas are subject to sanitary inspections to determine whether rodent, insect, or other vermin infestations exist, contaminated food or water, or other sanitary conditions requiring measures for the prevention of the introduction, transmission, or spread of communicable diseases are present. The fee schedule for sanitation inspections of passenger cruise ships by VSP was first published in the Federal Register on November 24, 1987 (52 FR 45019). HHS/CDC began collecting fees on March 1, 1988. This notice announces fees that are effective for FY 2013, beginning on October 1, 2012 through September 30, 2013. The following formula is used to determine the fees: increase, the fees may need to be adjusted before September 30, 2013; travel expenses constitute a sizable portion of VSP’s costs. If a fee adjustment is necessary, HHS/CDC will publish a notice 30 days before the effective date. E:\FR\FM\21AUN1.SGM 21AUN1 EN21AU12.000</GPH> pmangrum on DSK3VPTVN1PROD with NOTICES 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 welfare and lessen or avoid unrelieved 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 work collaboratively to evaluate new and improved test methods and strategies applicable to the needs of U.S. Federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies applicable to the needs of Federal agencies. 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 (42 U.S.C. 285l–3) 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. 50511

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Notices]
[Pages 50510-50511]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20549]



[[Page 50510]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Federal Agency Responses to Interagency Coordinating Committee on 
the Validation of Alternative Methods (ICCVAM) Recommendations on the 
Usefulness and Limitations of the LUMI-CELL[supreg] ER (BG1Luc ER TA) 
Test Method, An In Vitro Assay for Identifying Human Estrogen Receptor 
Agonist and Antagonist Activity of Chemicals

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

ACTION: Availability of Agency Responses.

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

SUMMARY: The NTP Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM) announces availability of U.S. Federal 
agency responses to ICCVAM test method recommendations on the 
usefulness and limitations of the LUMI-CELL[supreg] ER (BG1Luc ER TA) 
test method to identify human estrogen receptor (ER) agonist and 
antagonist activity of chemicals. ICCVAM forwarded the recommendations 
to Federal agencies and made these recommendations available to the 
public (77 FR 8258). ICCVAM agencies responded with their concurrence 
on the technical aspects of the BG1Luc ER transcriptional activation 
(TA) test method recommendations and their agreement that the ICCVAM 
BG1Luc ER TA test method is a validated screening test to identify 
substances with in vitro ER agonist activity or ER antagonist activity. 
The U.S. Environmental Protection Agency (EPA) responded that they 
regard the BG1Luc ER TA test method as an alternative to the Office of 
Chemical Safety and Pollution Prevention (OCSPP) 890.1300 (Organization 
for Economic Co-operation and Development [OECD] TG455) test guideline 
for transcriptional activation currently used in their Endocrine 
Disruptor Screening Program (EDSP). Several agencies also indicated 
that they would communicate the ICCVAM recommendations to stakeholders 
and encourage their appropriate use. Complete Federal agency responses 
are available at https://iccvam.niehs.nih.gov/methods/endocrine/end_eval.htm. The ICCVAM recommendations are provided in the ICCVAM test 
method evaluation report (ICCVAM, 2011), available at: https://iccvam.niehs.nih.gov/methods/endocrine/ERTA-TMER.htm.

FOR FURTHER INFORMATION CONTACT: Dr. Warren M. Casey, Deputy Director, 
NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research Triangle 
Park, NC 27709, (telephone) 919-316-4729, (fax) 919-541-0947, (email) 
niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2032, 530 
Davis Drive, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:

Background

    In 2002, ICCVAM evaluated the validation status of in vitro ER and 
androgen receptor (AR) binding and TA test methods for potential use in 
the EPA EDSP. The evaluation indicated that no in vitro ER- or AR-based 
test methods were adequately validated for this purpose. In response to 
an ICCVAM request for nominations, Xenobiotic Detection Systems, Inc. 
(XDS, Durham, NC) nominated the in vitro LUMI-CELL[supreg] ER (BG1Luc 
ER TA) test method for an interlaboratory validation study. ICCVAM and 
the Scientific Advisory Committee on Alternative Toxicological Methods 
(SACATM) recommended that the nominated method should be considered a 
high priority based on the lack of adequately validated test methods 
and the regulatory and public health need for such test methods. 
NICEATM led the international validation study with its partners in 
Japan (JaCVAM) and Europe (ECVAM), using laboratories sponsored by each 
validation organization. ICCVAM also proposed the development of BG1Luc 
ER TA test method performance standards.
    Following completion of the validation study, the ICCVAM 
Interagency Endocrine Disruptor Working Group, working with NICEATM, 
prepared a draft background review document (BRD) and draft 
recommendations for use of the BG1Luc ER TA test method.
    The draft BRD and draft ICCVAM recommendations were reviewed in a 
public meeting (76 FR 4113) of an international independent scientific 
peer review panel in March 2011. The peer review panel agreed with the 
draft ICCVAM recommendations that the BG1Luc ER TA test method could be 
used as a screening test to identify substances with in vitro ER 
agonist activity or ER antagonist activity and that the accuracy of 
this assay is at least equivalent to that of EPA OCSPP 890.1300, part 
of the EDSP Tier 1 screening battery.
    The final ICCVAM recommendations are included in the ICCVAM Test 
Method Evaluation Report: The LUMI-CELL[supreg] ER (BG1Luc ER TA) Test 
Method, An In Vitro Assay for Identifying Human Estrogen Receptor 
Agonist and Antagonist Activity of Chemicals (NIH Publication No. 11-
7850). The test method evaluation report also includes the updated 
ICCVAM-recommended BG1Luc ER TA test method protocol and performance 
standards that are applicable to functionally and mechanistically 
similar test methods. The final BRD, including the data and analyses on 
which the recommendations are based, is included as an appendix to the 
test method evaluation report.

Agency Responses to ICCVAM Recommendations

    In February 2012, ICCVAM forwarded final test method 
recommendations on the BG1Luc ER TA test method to U.S. Federal 
agencies for consideration (77 FR 8258), in accordance with the ICCVAM 
Authorization Act of 2000 (42 U.S.C. 285l-3). The ICCVAM Authorization 
Act requires member agencies to review ICCVAM test method 
recommendations and notify ICCVAM in writing of their findings no later 
than 180 days after receipt of recommendations. The Act also requires 
ICCVAM to make ICCVAM recommendations and agency responses available to 
the public. Agency responses are to include identification of relevant 
test methods for which the ICCVAM test method recommendations may be 
added or substituted and indicate any revisions or planned revisions to 
existing guidelines, guidances, or regulations to be made in response 
to these recommendations.
    ICCVAM agencies responded with their concurrence on the technical 
aspects of the BG1Luc ER TA test method recommendation and their 
agreement that the ICCVAM BG1Luc ER TA test method is a validated 
screening test to identify substances with in vitro ER agonist activity 
or ER antagonist activity. The EPA responded that they regard the 
BG1Luc ER TA test method as an alternative to the OCSPP 890.1300 test 
guideline for transcriptional activation currently used in their EDSP. 
Several agencies also indicated that they would communicate the ICCVAM 
recommendations to stakeholders and encourage their appropriate use. 
Complete agency responses are available at https://iccvam.niehs.nih.gov/methods/endocrine/end_eval.htm.

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

[[Page 50511]]

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 welfare and lessen or avoid 
unrelieved 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 work 
collaboratively to evaluate new and improved test methods and 
strategies applicable to the needs of U.S. Federal agencies. NICEATM 
and ICCVAM welcome the public nomination of new, revised, and 
alternative test methods and strategies applicable to the needs of 
Federal agencies. 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 
(42 U.S.C. 285l-3) 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

    ICCVAM. 2011. ICCVAM Test Method Evaluation Report: The LUMI-
CELL[supreg] ER (BG1Luc ER TA) Test Method: An In Vitro Assay for 
Identifying Human Estrogen Receptor Agonist and Antagonist Activity 
of Chemicals. NIH Publication No. 11-7850. Research Triangle Park, 
NC: NIEHS. Available: https://iccvam.niehs.nih.gov/methods/endocrine/ERTA-TMER.htm.

    Dated: August 13, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-20549 Filed 8-20-12; 8:45 am]
BILLING CODE 4140-01-P

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