Federal Register: April 26, 2000 (Volume 65, Number 81)
DOCID: FR Doc 00-10414
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: Meetings:
SUBJECT CATEGORY:
National Toxicology Program; Meeting of the NTP Board of Scientific Counselors
DOCUMENT SUMMARY:
Pursuant to Public Law 92463, notice is hereby given of a meeting of the National Toxicology Program (NTP) Board of Scientific Counselors, U.S. Public Health Service, in the Rodbell Auditorium, Building 101, South Campus, National Institute of Environmental Health Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, North Carolina, on May 24, 2000.
The NTP Board of Scientific Counselors is composed of scientists from the public and private sector. The Board provides primary scientific oversight to the NTP.
Agenda
The meeting is open to the public from 8:30 a.m. to adjournment with attendance limited only by space available. A draft agenda with a tentative schedule is provided below. There are three primary agenda topics: (1) An update on the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) including a discussion of its progress, the phthalates review, and its procedures for nomination, selection and review of chemicals; (2) presentations about current initiatives for NTP toxicology studies; and (3) recommendations of substances by the Interagency Committee for future NTP studies. Also in the afternoon, there will be reports on activities of the Report on Carcinogens and Technical Reports Review Subcommittees. The Board will review a concept proposal for the continued use of a contract mechanism to perform NTP toxicology and carcinogenesis studies.
Information about the CERHR including the chemicals currently under consideration for Expert Panel evaluation and the evaluation process are described in a Federal Register notice [March 20, 2000, Volume 65, Number 54, pages 1499714998]. The opportunity for submission of written public comments on those candidate chemicals is provided through May 4, 2000. A copy of this notice is available online at the NTP web site (http://ntpserver.niehs.nih.gov) and CERHR web site (http://cerhr.niehs.nih.gov) or by contacting the Executive Secretary (address given below). The chemicals under consideration include: 1 Bromopropane, 2Bromopropane, Dimethyl Methyl Phosphonate, Ethylene glycol, Glycol ethers, Glyphosate, Methanol, Nicotine, Phenol, Thimerosal, and Toluene. This meeting provides an additional opportunity for the public to present any comments to the NTP Board of Scientific Counselors and NTP staff. However, if written comments were submitted in response to the March 20th Federal Register announcement they are being considered and do not need to be resubmitted or readdressed.
The NTP has a broad mandate to provide toxicological characterization for chemicals and agents of public health concern and strives to balance the selection of agents for study. Current NTP initiatives include water disinfection byproducts, DNAbased products, herbal/dietary supplements, phototoxicology studies and occupational exposures and mixtures.
Information about substances nominated to the NTP for toxicology studies and recommendations for testing by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC) are provided in the Federal Register notice dated March 2, 2000 (Volume 65, Number 42, Pages 1132911331). The opportunity for submission of written public comments on those candidate chemicals is provided through April 30, 2000. Substances currently under consideration include: Substances recommended for testing: 1Bromopropane and 2Bromopropane, Chitosan, DNAbased products, Juglone, Potassium ferricyanide, and Radio frequency radiation emissions of wireless communication devices; Substances for which no testing is recommended at this time: Cafestol and Plumbagin; Substances for which a testing recommendation is deferred pending receipt and consideration of additional information: Ethylenebis(tetrabromophthalimide), Terpinolene, Tetrabromophthalic anhydride, and Texanol benzyl phthalate. Testing recommendations from the ICCEC are given in the referenced Federal Register notice. This meeting provides an additional opportunity for the public to comment to the NTP Board and staff. However, if written comments were submitted in response to the March 2nd Federal Register announcement, they are under consideration and do not need to be resubmitted or readdressed. Public Comment Encouraged
Public input at the meeting is welcome and time is set aside in the agenda for presentation of public comments on any agenda topic. Seven minutes are allotted for each formal oral presentation. To facilitate planning for the meeting, persons interested in providing formal written or oral comments are asked to notify the Executive Secretary, Dr. Mary S. Wolfe, NIEHS, P.O. Box 12233 MD A307, Research Triangle Park, NC 27709 (telephone 919/5413971, fax 919/5410295, and email wolfe@niehs.nih.gov). Written comments submitted for consideration by the Board and NTP staff prior to the meeting must be received by May 15, 2000. Persons wishing to register to make a formal presentation during a public comment period are asked to notify the Executive Secretary preferably no later than May 22, 2000, and, if possible, to provide a copy of the statement in advance of the meeting for distribution to the Board and NTP staff. Individuals will also be able to register to give oral public comments onsite at the meeting. However, if registering onsite and reading from written text, please bring 25 copies of the statement to the meeting for distribution to the Board and NTP staff and to supplement the record. Persons registering to make oral comments or submitting written comments are asked to provide their name, affiliation, mailing address, phone, fax, email, and sponsoring organization (if any).
Additional Information About Meeting
Prior to the meeting, a copy of the agenda and a roster of the
Board members will be available from the Executive Secretary. Following
the meeting, summary minutes will be prepared and available upon
request to Central Data Management, NIEHS, P.O. Box 12233 MD E102,
Research Triangle Park, NC 27709; telephone 919/5413419; fax 919/541
3687; and email CDM@niehs.nih.gov. [[Page 24496]]
Dated: April 19, 2000.
Samuel H. Wilson,
Deputy Director, National Institute for Environmental Health Sciences.
Draft Agenda; National Toxicology Program (NTP) Board of Scientific Counselors
May 24, 2000
Rodbell Auditorium, Building 101, South Campus, National Institute of
Environmental Health Sciences (NIEHS), Research Triangle Park, North Carolina
8:30 a.m.Welcome
8:50 a.m.NTP Update
9:00 a.m.NTP Center for the Evaluation of Risks to Human Reproduction (CERHR)
9:30 a.m.CERHR Processes and Criteria
10:00 a.m.Break
10:15 a.m.Public Comments
10:30 a.m.Board Discussion
11:00 a.m.Perspectives on the Process (e.g. Phthalates Review)
NoonLunch
1:00 p.m.Current Trends in NTP Toxicology Testing
2:15 p.m.Break
2:30 p.m.Current Trends in NTP Toxicology Testing (continued)
3:20 p.m.Concept Review
3:50 p.m.Testing Recommendations from the Interagency Committee for Chemical Evaluation and Coordination
4:35 p.m.NTP Board Subcommittee ReviewsUpdates
5:20 p.m.Adjourn
Substances Nominated to the NTP for Study and Testing
Recommendations Made by the ICCEC on December 13, 1999
Table 1.Substances Recommended for Testing Study rationale; other Substance [CAS No.] Nominated by ICCEC recommendations information 1Bromopropane [106945] and 2 OSHA 1Bromopropane....... Reported increasing Bromopropane [75263]. NIOSH Carcinogenicity.... production and use in Reproductive and many industrial developmental applications as an toxicity. alternative to ozone Toxicokinetics..... depleting substances; Mechanistic studies available data from Neurotoxicity...... limited repeat dose Genotoxicity....... studies indicate toxicity Exposure studies in to multiple organ workers. systems. 2Bromopropane is a contaminant in reagent grade. 1Bromopropane with known reproductive toxicity. ........................ 2Bromopropane....... Subchronic toxicity Chitosan [9012764]............... NCI Mechanistic studies Significant human exposure to evaluate vitamin through use as a dietary E and mineral supplement and other depletion. commercial applications; potential for toxicity from interference with dietary fat absorption. DNAbased products................. FDA Establish joint Rapidly growing market for NIEHS/FDA program to DNAbased therapeutic evaluate longterm agents and a lack of toxicity in adequate mechanisms and anticipation of methodologies for regulatory needs. evaluating safety. Juglone [481390]................. NCI Mechanistic studies Potential human exposure Metabolism studies. resulting from use of Mouse lymphoma walnutbased products as assay. dietary supplements and Mammalian natural dyes and stains; mutagenicity. suspicion of Carcinogenicity carcinogenicity based on testing pending quinone structure. results of preliminary studies. Potassium ferricyanide [13746662] NCI Genotoxicity....... Potential consumer and Subchronic toxicity worker exposure resulting from use in photographic processing; suspicion of toxicity based on potential for redox cycling; inadequate toxicity information available. Radio frequency radiation emissions FDA Establish Widespread consumer and of wireless communication devices. interagency program worker exposure; to design studies available data is assessing cancer and inadequate to properly noncancer health assess safety. effects to fulfill regulatory needs. [[Page 24497]]
Table 2.Substances for Which No Testing Is Recommended at This Time Substance [CAS No.] Nominated by Nominated for Rationale for not testing Cafestol [469830] and Kahweol Private individual...... Toxicity and Anticarcinogenic effects [6894435]. carcinogenicity demonstrated in animal testing. studies; limited data indicate low potential for toxicity; other natural products with higher potential for toxicity and human exposure exist; ongoing research efforts as opposed to new testing may provide basis for determining relevance of metabolic modulatory effects to chronic toxicity. Plumbagin [481425]............... NCI..................... Mechanistic studies Structurally similar to Metabolism studies. Juglone which is selected Mouse lymphoma for study; low magnitude assay. and/or prevalence of Mammalian human exposure; adequate mutagenicity. evidence of acute and Carcinogenicity.... reproductive toxicity.
Table 3.Substances for Which a Testing Recommendation is Deferred Pending Receipt and Consideration of Additional Information Additional information Substance [CAS No.] Nominated by Nominated for needed Ethylenebis(tetrabromophthalimide) NIEHS Toxicity and Ongoing and planned [32588764]. carcinogenicity industry testing efforts; testing. better characterization of uses and potential human exposures. Terpinolene [586629]............. NIEHS Toxicity and Ongoing and planned carcinogenicity industry testing efforts; testing. better characterization of uses and potential human exposures; study results for structurally related compounds. Tetrabromophthalic anhydride [632 NIEHS Toxicity and Ongoing and planned 791]. carcinogenicity industry testing efforts; testing. better characterization of uses and potential human exposures. Texanol benzyl phthalate [1688383 NIEHS Toxicity and Ongoing and planned 3] or [32333996]. carcinogenicity industry testing efforts; testing. better characterization of uses and potential human exposures. [FR Doc. 0010414 Filed 42500; 8:45 am] BILLING CODE 414001P
SUMMARY:
National Toxicology Program—; Scientific Counselors Board,
DOCUMENT BODY 2:
Pursuant to Public Law 92463, notice is hereby given of a meeting of the National Toxicology Program (NTP) Board of Scientific Counselors, U.S. Public Health Service, in the Rodbell Auditorium, Building 101, South Campus, National Institute of Environmental Health Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, North Carolina, on May 24, 2000.
The NTP Board of Scientific Counselors is composed of scientists from the public and private sector. The Board provides primary scientific oversight to the NTP.
Agenda
The meeting is open to the public from 8:30 a.m. to adjournment with attendance limited only by space available. A draft agenda with a tentative schedule is provided below. There are three primary agenda topics: (1) An update on the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) including a discussion of its progress, the phthalates review, and its procedures for nomination, selection and review of chemicals; (2) presentations about current initiatives for NTP toxicology studies; and (3) recommendations of substances by the Interagency Committee for future NTP studies. Also in the afternoon, there will be reports on activities of the Report on Carcinogens and Technical Reports Review Subcommittees. The Board will review a concept proposal for the continued use of a contract mechanism to perform NTP toxicology and carcinogenesis studies.
Information about the CERHR including the chemicals currently under consideration for Expert Panel evaluation and the evaluation process are described in a Federal Register notice [March 20, 2000, Volume 65, Number 54, pages 1499714998]. The opportunity for submission of written public comments on those candidate chemicals is provided through May 4, 2000. A copy of this notice is available online at the NTP web site (http://ntpserver.niehs.nih.gov) and CERHR web site (http://cerhr.niehs.nih.gov) or by contacting the Executive Secretary (address given below). The chemicals under consideration include: 1 Bromopropane, 2Bromopropane, Dimethyl Methyl Phosphonate, Ethylene glycol, Glycol ethers, Glyphosate, Methanol, Nicotine, Phenol, Thimerosal, and Toluene. This meeting provides an additional opportunity for the public to present any comments to the NTP Board of Scientific Counselors and NTP staff. However, if written comments were submitted in response to the March 20th Federal Register announcement they are being considered and do not need to be resubmitted or readdressed.
The NTP has a broad mandate to provide toxicological characterization for chemicals and agents of public health concern and strives to balance the selection of agents for study. Current NTP initiatives include water disinfection byproducts, DNAbased products, herbal/dietary supplements, phototoxicology studies and occupational exposures and mixtures.
Information about substances nominated to the NTP for toxicology studies and recommendations for testing by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC) are provided in the Federal Register notice dated March 2, 2000 (Volume 65, Number 42, Pages 1132911331). The opportunity for submission of written public comments on those candidate chemicals is provided through April 30, 2000. Substances currently under consideration include: Substances recommended for testing: 1Bromopropane and 2Bromopropane, Chitosan, DNAbased products, Juglone, Potassium ferricyanide, and Radio frequency radiation emissions of wireless communication devices; Substances for which no testing is recommended at this time: Cafestol and Plumbagin; Substances for which a testing recommendation is deferred pending receipt and consideration of additional information: Ethylenebis(tetrabromophthalimide), Terpinolene, Tetrabromophthalic anhydride, and Texanol benzyl phthalate. Testing recommendations from the ICCEC are given in the referenced Federal Register notice. This meeting provides an additional opportunity for the public to comment to the NTP Board and staff. However, if written comments were submitted in response to the March 2nd Federal Register announcement, they are under consideration and do not need to be resubmitted or readdressed. Public Comment Encouraged
Public input at the meeting is welcome and time is set aside in the agenda for presentation of public comments on any agenda topic. Seven minutes are allotted for each formal oral presentation. To facilitate planning for the meeting, persons interested in providing formal written or oral comments are asked to notify the Executive Secretary, Dr. Mary S. Wolfe, NIEHS, P.O. Box 12233 MD A307, Research Triangle Park, NC 27709 (telephone 919/5413971, fax 919/5410295, and email wolfe@niehs.nih.gov). Written comments submitted for consideration by the Board and NTP staff prior to the meeting must be received by May 15, 2000. Persons wishing to register to make a formal presentation during a public comment period are asked to notify the Executive Secretary preferably no later than May 22, 2000, and, if possible, to provide a copy of the statement in advance of the meeting for distribution to the Board and NTP staff. Individuals will also be able to register to give oral public comments onsite at the meeting. However, if registering onsite and reading from written text, please bring 25 copies of the statement to the meeting for distribution to the Board and NTP staff and to supplement the record. Persons registering to make oral comments or submitting written comments are asked to provide their name, affiliation, mailing address, phone, fax, email, and sponsoring organization (if any).
Additional Information About Meeting
Prior to the meeting, a copy of the agenda and a roster of the
Board members will be available from the Executive Secretary. Following
the meeting, summary minutes will be prepared and available upon
request to Central Data Management, NIEHS, P.O. Box 12233 MD E102,
Research Triangle Park, NC 27709; telephone 919/5413419; fax 919/541
3687; and email CDM@niehs.nih.gov. [[Page 24496]]
Dated: April 19, 2000.
Samuel H. Wilson,
Deputy Director, National Institute for Environmental Health Sciences.
Draft Agenda; National Toxicology Program (NTP) Board of Scientific Counselors
May 24, 2000
Rodbell Auditorium, Building 101, South Campus, National Institute of
Environmental Health Sciences (NIEHS), Research Triangle Park, North Carolina
8:30 a.m.Welcome
8:50 a.m.NTP Update
9:00 a.m.NTP Center for the Evaluation of Risks to Human Reproduction (CERHR)
9:30 a.m.CERHR Processes and Criteria
10:00 a.m.Break
10:15 a.m.Public Comments
10:30 a.m.Board Discussion
11:00 a.m.Perspectives on the Process (e.g. Phthalates Review)
NoonLunch
1:00 p.m.Current Trends in NTP Toxicology Testing
2:15 p.m.Break
2:30 p.m.Current Trends in NTP Toxicology Testing (continued)
3:20 p.m.Concept Review
3:50 p.m.Testing Recommendations from the Interagency Committee for Chemical Evaluation and Coordination
4:35 p.m.NTP Board Subcommittee ReviewsUpdates
5:20 p.m.Adjourn
Substances Nominated to the NTP for Study and Testing
Recommendations Made by the ICCEC on December 13, 1999
Table 1.Substances Recommended for Testing Study rationale; other Substance [CAS No.] Nominated by ICCEC recommendations information 1Bromopropane [106945] and 2 OSHA 1Bromopropane....... Reported increasing Bromopropane [75263]. NIOSH Carcinogenicity.... production and use in Reproductive and many industrial developmental applications as an toxicity. alternative to ozone Toxicokinetics..... depleting substances; Mechanistic studies available data from Neurotoxicity...... limited repeat dose Genotoxicity....... studies indicate toxicity Exposure studies in to multiple organ workers. systems. 2Bromopropane is a contaminant in reagent grade. 1Bromopropane with known reproductive toxicity. ........................ 2Bromopropane....... Subchronic toxicity Chitosan [9012764]............... NCI Mechanistic studies Significant human exposure to evaluate vitamin through use as a dietary E and mineral supplement and other depletion. commercial applications; potential for toxicity from interference with dietary fat absorption. DNAbased products................. FDA Establish joint Rapidly growing market for NIEHS/FDA program to DNAbased therapeutic evaluate longterm agents and a lack of toxicity in adequate mechanisms and anticipation of methodologies for regulatory needs. evaluating safety. Juglone [481390]................. NCI Mechanistic studies Potential human exposure Metabolism studies. resulting from use of Mouse lymphoma walnutbased products as assay. dietary supplements and Mammalian natural dyes and stains; mutagenicity. suspicion of Carcinogenicity carcinogenicity based on testing pending quinone structure. results of preliminary studies. Potassium ferricyanide [13746662] NCI Genotoxicity....... Potential consumer and Subchronic toxicity worker exposure resulting from use in photographic processing; suspicion of toxicity based on potential for redox cycling; inadequate toxicity information available. Radio frequency radiation emissions FDA Establish Widespread consumer and of wireless communication devices. interagency program worker exposure; to design studies available data is assessing cancer and inadequate to properly noncancer health assess safety. effects to fulfill regulatory needs. [[Page 24497]]
Table 2.Substances for Which No Testing Is Recommended at This Time Substance [CAS No.] Nominated by Nominated for Rationale for not testing Cafestol [469830] and Kahweol Private individual...... Toxicity and Anticarcinogenic effects [6894435]. carcinogenicity demonstrated in animal testing. studies; limited data indicate low potential for toxicity; other natural products with higher potential for toxicity and human exposure exist; ongoing research efforts as opposed to new testing may provide basis for determining relevance of metabolic modulatory effects to chronic toxicity. Plumbagin [481425]............... NCI..................... Mechanistic studies Structurally similar to Metabolism studies. Juglone which is selected Mouse lymphoma for study; low magnitude assay. and/or prevalence of Mammalian human exposure; adequate mutagenicity. evidence of acute and Carcinogenicity.... reproductive toxicity.
Table 3.Substances for Which a Testing Recommendation is Deferred Pending Receipt and Consideration of Additional Information Additional information Substance [CAS No.] Nominated by Nominated for needed Ethylenebis(tetrabromophthalimide) NIEHS Toxicity and Ongoing and planned [32588764]. carcinogenicity industry testing efforts; testing. better characterization of uses and potential human exposures. Terpinolene [586629]............. NIEHS Toxicity and Ongoing and planned carcinogenicity industry testing efforts; testing. better characterization of uses and potential human exposures; study results for structurally related compounds. Tetrabromophthalic anhydride [632 NIEHS Toxicity and Ongoing and planned 791]. carcinogenicity industry testing efforts; testing. better characterization of uses and potential human exposures. Texanol benzyl phthalate [1688383 NIEHS Toxicity and Ongoing and planned 3] or [32333996]. carcinogenicity industry testing efforts; testing. better characterization of uses and potential human exposures. [FR Doc. 0010414 Filed 42500; 8:45 am] BILLING CODE 414001P