Federal Register: September 20, 2002 (Volume 67, Number 183)
DOCID: FR Doc 02-23874
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: Meetings:
SUBJECT CATEGORY:
National Toxicology Program (NTP) Board of Scientific Counselors' Meeting; Review of Nominations for Listing in the 11th Report on Carcinogens
DOCUMENT SUMMARY:
Pursuant to Public Law 92463, notice is hereby given of the next meeting of the NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (``the NTP RoC Subcommittee'') to be held on November 19 & 20, 2002, at the Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. On November 19, registration will begin at 9 a.m. and the meeting will begin at 9:30 a.m. On November 20, the meeting will begin at 8:30 a.m. Preregistration is not required; however, persons requesting time to make oral, public comments are asked to notify Dr. Mary S. Wolfe, Executive Secretary, prior to the meeting (contact information given below). The agenda covers the peer review of 10 nominations for possible listing in the 11th Report on Carcinogens, and includes an opportunity for public input.
Background
The Department of Health and Human Services (DHHS) Report on Carcinogens (RoC) is a public information document prepared by the National Toxicology Program (NTP) in response to Section 301(b)(4) of the Public Health Service Act, as amended. The intent of the document is to provide a listing of those agents, substances, mixtures or exposure circumstances that are either ``known'' or ``reasonably anticipated'' to cause cancer in humans and to which a significant number of people in the United States are exposed. The process for preparation of the RoC has three levels of scientific peer review. Central to the evaluations of the review groups is the use of criteria for inclusion in or removal of listings from the RoC. The current criteria for listing in or delisting from the report is available on the Internet at the following website: http://ntpserver.niehs.nih.gov/ NewHomeRoc/ListingCriteria.html, or can be obtained in hard copy by contacting Dr. Jameson at the address listed below. The review process for listing in or delisting from the RoC begins with initial scientific review by the National Institute of Environmental Health Sciences (NIEHS)/NTP Report on Carcinogens Review Committee (RG1), which is comprised of NIEHS/NTP staff scientists. The second scientific review group (RG2) is comprised of representatives from the Federal health research and regulatory agencies that are members of the NTP Executive Committee. The third step is external public peer review by the NTP RoC Subcommittee. Following completion of these reviews and solicitation of public comments through announcements in the Federal Register and other media, the independent recommendations of the three scientific peer review groups and all public comments are presented to the NTP Executive Committee for review and comment. All recommendations and public comments are submitted to the Director, NTP, who reviews them and makes a final recommendation to the Secretary, DHHS, concerning the listing or delisting of substances or exposure circumstances in the RoC. The Secretary has final review and approval for the 11th RoC. Agenda
The meeting of the NTP RoC Subcommittee is scheduled for November 19 & 20, 2002. Tentatively scheduled to be peer reviewed are 10 nominated chemicals or exposure circumstances. These nominations are listed alphabetically in the attached table, along with supporting information and a tentative order of presentation and review. Background summary documents for each of the nominations are available to the public and include a summary of the scientific data and information being used to evaluate the nomination. A copy of the draft background summary document for each of these nominations is available electronically through the NTP's homepage at http://ntp server.niehs.nih.gov/ (select Report on Carcinogens) or can be obtained on CD or in hard copy, as available, from: Dr. C.W. Jameson, Report on Carcinogens, NIEHS, MD EC14, 79 Alexander Drive, Building 4401, Room 3118, P.O. Box 12233, Research Triangle Park, NC 27709 (919/5414096; FAX 919/5410144; email jameson@niehs.nih.gov).
Previous announcements in the Federal Register (July 24, 2001: Volume 66, Number 142, Pages 3843038432 and March 28, 2002: Volume 67, Number 60, Page 14957) called for public comments on the nominations to be reviewed for possible listing in the 11th RoC. These announcements identified a total of 17 nominations. This review by the NTP RoC Subcommittee is for the first set of 10 nominations identified in those Federal Register announcements that have completed review by the RG1 and the RG2. The remaining 7 nominations for the 11th RoC will be reviewed by the NTP RoC Subcommittee in 2003. The date and details about that meeting will be published in a future Federal Register notice.
Solicitation of Public Comment
The NTP RoC Subcommittee meeting is open to the public, and time
will be provided for oral public comment on each of the nominations
under review. In order to facilitate planning for the meeting, persons
requesting time for an oral presentation regarding a particular
nomination should notify the Executive Secretary, Dr. Mary S. Wolfe,
P.O. Box 12233, A301, Research Triangle Park, NC 27709 (telephone 919/
5413971; FAX 919/5410295; email wolfe@niehs.nih.gov) no later than
November 4, 2002. Each organization is allowed one time slot for an
oral presentation per nomination. Persons registering to make comments
are asked to provide, if possible, a written copy of their statement by
November 4th so copies can be made and distributed to NTP RoC
Subcommittee members for their timely review prior to the meeting.
Written statements can supplement and expand the oral presentation, and
each speaker is asked to provide his/her name, affiliation, mailing
address, phone, fax, email and supporting organization (if any). At
least 7 minutes will be allotted to each speaker, and if time permits,
can be extended to 10 minutes. Individuals who register to make oral
presentations by November 4th will be notified about the time available
for their presentation at least one week prior to the meeting.
Registration for making public comments will also be available onsite.
Time allowed for presentation by onsite registrants may be less then
that for preregistered speakers and will be determined by the number
who have registered at the meeting. If registering onsite to speak and
reading oral comments from printed copy, the speaker is asked to bring
25 copies of the text. These copies will be distributed to the NTP RoC
Subcommittee members and supplement the record. All comments [[Page 59302]]
received in response to this Federal Register notice will be posted on the NTP RoC web site.
Written comments, in lieu of making oral comments, are welcome. All comments must include name, affiliation, mailing address, phone, fax, email and sponsoring organization (if any) and should be received by November 4, 2002 for distribution to the NTP RoC Subcommittee. Written comments received after November 4th will not be considered by NTP RoC Subcommittee members in their reviews.
Solicitation of Additional Information
The NTP would welcome receiving information from completed human or experimental animal cancer studies or studies of mechanism of cancer formation, as well as current production data, human exposure information, and use patterns for any of the nominations listed in this announcement. Organizations or individuals that wish to provide information should contact Dr. C.W. Jameson at the address given above.
The agenda and a roster of NTP RoC Subcommittee members will be
available prior to the meeting on the NTP homepage at http://ntp
server.niehs.nih.gov/ and upon request from Dr. Wolfe. Following the
meeting, summary minutes will also be available on the NTP web site
(http://ntpserver.niehs.nih.gov, select Meetings) and upon request from Dr. Wolfe.
Dated: September 12, 2002.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
Summary Data for Nominations Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific
Counselors Report on Carcinogens Subcommittee November 19 and 20, 2002
Tentative
Nomination to be reviewed CAS Primary uses or exposures To be reviewed for review
number order
1Amino2,4dibromoanthraquinone/.. 1Amino2,4 Listing in the 11th RoC........... 1
(81492).......................... dibromoanthraquinone is
an anthraquinonederived
vat dye that is used in
the textile industry.
Cobalt Sulfate/(10124433)........ Cobalt sulfate is used in Listing in the 11th RoC........... 6 electroplating and
electrochemical
industries. It is also
used as a colorinig agent
for ceramics, a drying
agent in inks, paints,
varnishes and linoleum,
and has been added to
animal feed as a mineral supplement.
Diethanolamine (DEA)/(111422).... DEA is used in the Listing in the 11th RoC........... 5 preparation of
surfactants used in
liquid laundry,
dishwishing detergents,
cosmetics, shampoos, and hair conditioners.
DEA is also used in metal working fluids, in
textile processing,
industrial gas
purification and as an anticorrosin agent.
Naphthalene/(91203).............. Naphthalene is used as an Listing in the 11th RoC........... 2 intermediate in the
synethesis of many
industrial chemicals, an
ingredient in some moth
repellants and toilet
bowl deodorants, as an antiseptics for
irragatinig animal wounds
and to control lice on
livestock and poultry.
Nitrobenzene/(98953)............. Nitrobenzene is used Listing in the 11th RoC........... 8
mainly in the produdction of aniline, itself a
major chemical
intermediate in the
production of dyes.
Nitromethane/(75525)............. Nitromethane is used in Listing in the 11th RoC........... 4
specialized fuels, in
explosives and in the
synthesis of nitromethane derivatives,
pharmaceuticals,
agricultural soil
fumigants and industrial
antimicrobials. In the
past it was used as a
chemical stabilizer to
prevent the decomposition
of various halogenated hydrocarbons such as
metal degreasers and
aerosol propellants.
Selected Heterocyclic Animes MeIQ, MeIQx, and PhIP are Listing in the 11th RoC........... \1\3
(Three Nominations): heterocyclic amines that
(1) 2Amino3,4dimethylimidazo[4,5 are formed during heating
f] or cooking and are found
quinoline (meIQ)/(77094112) in cooked meats and fish. (2) 2Amino3,8dimethylimidazo[4,5
f]
quinoxaline (MeIQx)/(77500040)
(3) 2Amino1methyl6
phenylimidazo[4,5b]
pyridine (PhIP)/(105650235)
4,4'Thiodianiline/(139651) 4,4'Thiodianiline has Listing in the 11th RoC........... 7 been produced
commercially since the early 1940s as an
intermediate of several diazo dyes.
\1\ These three nominations will be reviewed together.
[[Page 59303]]
[FR Doc. 0223874 Filed 91902; 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 the next meeting of the NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (``the NTP RoC Subcommittee'') to be held on November 19 & 20, 2002, at the Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. On November 19, registration will begin at 9 a.m. and the meeting will begin at 9:30 a.m. On November 20, the meeting will begin at 8:30 a.m. Preregistration is not required; however, persons requesting time to make oral, public comments are asked to notify Dr. Mary S. Wolfe, Executive Secretary, prior to the meeting (contact information given below). The agenda covers the peer review of 10 nominations for possible listing in the 11th Report on Carcinogens, and includes an opportunity for public input.
Background
The Department of Health and Human Services (DHHS) Report on Carcinogens (RoC) is a public information document prepared by the National Toxicology Program (NTP) in response to Section 301(b)(4) of the Public Health Service Act, as amended. The intent of the document is to provide a listing of those agents, substances, mixtures or exposure circumstances that are either ``known'' or ``reasonably anticipated'' to cause cancer in humans and to which a significant number of people in the United States are exposed. The process for preparation of the RoC has three levels of scientific peer review. Central to the evaluations of the review groups is the use of criteria for inclusion in or removal of listings from the RoC. The current criteria for listing in or delisting from the report is available on the Internet at the following website: http://ntpserver.niehs.nih.gov/ NewHomeRoc/ListingCriteria.html, or can be obtained in hard copy by contacting Dr. Jameson at the address listed below. The review process for listing in or delisting from the RoC begins with initial scientific review by the National Institute of Environmental Health Sciences (NIEHS)/NTP Report on Carcinogens Review Committee (RG1), which is comprised of NIEHS/NTP staff scientists. The second scientific review group (RG2) is comprised of representatives from the Federal health research and regulatory agencies that are members of the NTP Executive Committee. The third step is external public peer review by the NTP RoC Subcommittee. Following completion of these reviews and solicitation of public comments through announcements in the Federal Register and other media, the independent recommendations of the three scientific peer review groups and all public comments are presented to the NTP Executive Committee for review and comment. All recommendations and public comments are submitted to the Director, NTP, who reviews them and makes a final recommendation to the Secretary, DHHS, concerning the listing or delisting of substances or exposure circumstances in the RoC. The Secretary has final review and approval for the 11th RoC. Agenda
The meeting of the NTP RoC Subcommittee is scheduled for November 19 & 20, 2002. Tentatively scheduled to be peer reviewed are 10 nominated chemicals or exposure circumstances. These nominations are listed alphabetically in the attached table, along with supporting information and a tentative order of presentation and review. Background summary documents for each of the nominations are available to the public and include a summary of the scientific data and information being used to evaluate the nomination. A copy of the draft background summary document for each of these nominations is available electronically through the NTP's homepage at http://ntp server.niehs.nih.gov/ (select Report on Carcinogens) or can be obtained on CD or in hard copy, as available, from: Dr. C.W. Jameson, Report on Carcinogens, NIEHS, MD EC14, 79 Alexander Drive, Building 4401, Room 3118, P.O. Box 12233, Research Triangle Park, NC 27709 (919/5414096; FAX 919/5410144; email jameson@niehs.nih.gov).
Previous announcements in the Federal Register (July 24, 2001: Volume 66, Number 142, Pages 3843038432 and March 28, 2002: Volume 67, Number 60, Page 14957) called for public comments on the nominations to be reviewed for possible listing in the 11th RoC. These announcements identified a total of 17 nominations. This review by the NTP RoC Subcommittee is for the first set of 10 nominations identified in those Federal Register announcements that have completed review by the RG1 and the RG2. The remaining 7 nominations for the 11th RoC will be reviewed by the NTP RoC Subcommittee in 2003. The date and details about that meeting will be published in a future Federal Register notice.
Solicitation of Public Comment
The NTP RoC Subcommittee meeting is open to the public, and time
will be provided for oral public comment on each of the nominations
under review. In order to facilitate planning for the meeting, persons
requesting time for an oral presentation regarding a particular
nomination should notify the Executive Secretary, Dr. Mary S. Wolfe,
P.O. Box 12233, A301, Research Triangle Park, NC 27709 (telephone 919/
5413971; FAX 919/5410295; email wolfe@niehs.nih.gov) no later than
November 4, 2002. Each organization is allowed one time slot for an
oral presentation per nomination. Persons registering to make comments
are asked to provide, if possible, a written copy of their statement by
November 4th so copies can be made and distributed to NTP RoC
Subcommittee members for their timely review prior to the meeting.
Written statements can supplement and expand the oral presentation, and
each speaker is asked to provide his/her name, affiliation, mailing
address, phone, fax, email and supporting organization (if any). At
least 7 minutes will be allotted to each speaker, and if time permits,
can be extended to 10 minutes. Individuals who register to make oral
presentations by November 4th will be notified about the time available
for their presentation at least one week prior to the meeting.
Registration for making public comments will also be available onsite.
Time allowed for presentation by onsite registrants may be less then
that for preregistered speakers and will be determined by the number
who have registered at the meeting. If registering onsite to speak and
reading oral comments from printed copy, the speaker is asked to bring
25 copies of the text. These copies will be distributed to the NTP RoC
Subcommittee members and supplement the record. All comments [[Page 59302]]
received in response to this Federal Register notice will be posted on the NTP RoC web site.
Written comments, in lieu of making oral comments, are welcome. All comments must include name, affiliation, mailing address, phone, fax, email and sponsoring organization (if any) and should be received by November 4, 2002 for distribution to the NTP RoC Subcommittee. Written comments received after November 4th will not be considered by NTP RoC Subcommittee members in their reviews.
Solicitation of Additional Information
The NTP would welcome receiving information from completed human or experimental animal cancer studies or studies of mechanism of cancer formation, as well as current production data, human exposure information, and use patterns for any of the nominations listed in this announcement. Organizations or individuals that wish to provide information should contact Dr. C.W. Jameson at the address given above.
The agenda and a roster of NTP RoC Subcommittee members will be
available prior to the meeting on the NTP homepage at http://ntp
server.niehs.nih.gov/ and upon request from Dr. Wolfe. Following the
meeting, summary minutes will also be available on the NTP web site
(http://ntpserver.niehs.nih.gov, select Meetings) and upon request from Dr. Wolfe.
Dated: September 12, 2002.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
Summary Data for Nominations Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific
Counselors Report on Carcinogens Subcommittee November 19 and 20, 2002
Tentative
Nomination to be reviewed CAS Primary uses or exposures To be reviewed for review
number order
1Amino2,4dibromoanthraquinone/.. 1Amino2,4 Listing in the 11th RoC........... 1
(81492).......................... dibromoanthraquinone is
an anthraquinonederived
vat dye that is used in
the textile industry.
Cobalt Sulfate/(10124433)........ Cobalt sulfate is used in Listing in the 11th RoC........... 6 electroplating and
electrochemical
industries. It is also
used as a colorinig agent
for ceramics, a drying
agent in inks, paints,
varnishes and linoleum,
and has been added to
animal feed as a mineral supplement.
Diethanolamine (DEA)/(111422).... DEA is used in the Listing in the 11th RoC........... 5 preparation of
surfactants used in
liquid laundry,
dishwishing detergents,
cosmetics, shampoos, and hair conditioners.
DEA is also used in metal working fluids, in
textile processing,
industrial gas
purification and as an anticorrosin agent.
Naphthalene/(91203).............. Naphthalene is used as an Listing in the 11th RoC........... 2 intermediate in the
synethesis of many
industrial chemicals, an
ingredient in some moth
repellants and toilet
bowl deodorants, as an antiseptics for
irragatinig animal wounds
and to control lice on
livestock and poultry.
Nitrobenzene/(98953)............. Nitrobenzene is used Listing in the 11th RoC........... 8
mainly in the produdction of aniline, itself a
major chemical
intermediate in the
production of dyes.
Nitromethane/(75525)............. Nitromethane is used in Listing in the 11th RoC........... 4
specialized fuels, in
explosives and in the
synthesis of nitromethane derivatives,
pharmaceuticals,
agricultural soil
fumigants and industrial
antimicrobials. In the
past it was used as a
chemical stabilizer to
prevent the decomposition
of various halogenated hydrocarbons such as
metal degreasers and
aerosol propellants.
Selected Heterocyclic Animes MeIQ, MeIQx, and PhIP are Listing in the 11th RoC........... \1\3
(Three Nominations): heterocyclic amines that
(1) 2Amino3,4dimethylimidazo[4,5 are formed during heating
f] or cooking and are found
quinoline (meIQ)/(77094112) in cooked meats and fish. (2) 2Amino3,8dimethylimidazo[4,5
f]
quinoxaline (MeIQx)/(77500040)
(3) 2Amino1methyl6
phenylimidazo[4,5b]
pyridine (PhIP)/(105650235)
4,4'Thiodianiline/(139651) 4,4'Thiodianiline has Listing in the 11th RoC........... 7 been produced
commercially since the early 1940s as an
intermediate of several diazo dyes.
\1\ These three nominations will be reviewed together.
[[Page 59303]]
[FR Doc. 0223874 Filed 91902; 8:45 am]
BILLING CODE 414001P