Federal Register: December 17, 2002 (Volume 67, Number 242)
DOCID: FR Doc 02-31629
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
NOTICE: NOTICES
ACTION: Reports and guidance documents; availability, etc.:
SUBJECT CATEGORY:
The National Toxicology Program (NTP) Announces the Availability of the Report on Carcinogens, Tenth Edition
DOCUMENT SUMMARY:
The Report on Carcinogens, Tenth Edition was submitted to the
Congress by the Secretary HHS and also released publicly on December
11, 2002. It is available on the Internet and can be accessed from the
Environmental Health Perspectives web site at: http://www.ehponline.org or from the NTP
[[Page 77284]]
Web site at: http://ntpserver.niehs.nih.gov. Hard copies of the Report
on Carcinogens, Tenth Edition can also be obtained by contacting
Environmental Health Perspectives, ATTN: Order Processing, 1001
Winstead Drive Suite 355, Cary, NC 27513; Telephone: 8665413841 or
9196532586; Fax (919) 6788696; email: ehponline@niehs.nih.gov. Background
The Report on Carcinogens (RoC) (previously known as the Annual Report on Carcinogens) is a Congressionally mandated listing of known human carcinogens and reasonably anticipated human carcinogens whose preparation is delegated to the National Toxicology Program by the Secretary, Department of Health and Human Services (DHHS). Section 301(b)(4) of the Public Health Service Act, as amended, provides that the Secretary, (DHHS), shall publish a biennial report which contains a list of all substances (1) which either are known to be human carcinogens or may reasonably be anticipated to be human carcinogens; and (2) to which a significant number of persons residing in the United States are exposed. The law also states that the reports should provide available information on the nature of exposures, the estimated number of persons exposed and the extent to which the implementation of Federal regulations decreases the risk to public health from exposure to these chemicals.
The RoC is an informational scientific and public health document that identifies and discusses agents, substances, mixtures, or exposure circumstances that may pose a carcinogenic hazard to human health. It serves as a meaningful and useful compilation of data on the (1) carcinogenicity, genotoxicity, and biologic mechanisms of the listed substances in humans and/or animals, (2) the potential for exposure to these substances, and (3) the regulations promulgated by Federal agencies to limit exposures. The report does not present quantitative assessments of carcinogenic risk, an assessment that defines the conditions under which the hazard may be unacceptable. Listing of substances in the report, therefore, does not establish that such substances present carcinogenic risks to individuals in their daily lives. Such formal risk assessments are the purview of the appropriate Federal, State, and local health regulatory and research agencies. New Listings to the RoC, Tenth Edition
The RoC, Tenth Edition, contains 228 entries, 15 of which have not
appeared in earlier RoCs. The Tenth Edition of the RoC also changes the
listing of beryllium and beryllium compounds from reasonably
anticipated to be human carcinogens to known to be human carcinogens,
with corresponding revisions of the earlier profile for these
chemicals. The Tenth Edition of the RoC lists estrogens, steroidal as
known human carcinogens. This listing of steroidal estrogens supersedes
the previous listing of individual estrogens in the RoC (including
conjugated estrogens, estradiol17[beta], estrone, ethinylestradiol,
and mestranol) and applies to all chemicals of this steroid class. The profile for steroidal estrogens includes information on
carcinogenicity, properties, use, production, exposure, and regulations
for steroidal estrogens as a class, as well as some specific
information for individual estrogens. The table below summarizes the
actions taken for the substances or exposure circumstances reviewed for
possible listing in or change in the listing in the RoC, Tenth Edition.
The new entries for the Report on Carcinogens, Tenth Edition, including those whose listing changed, underwent a multiphase peer review. This review included three scientific peer reviews, two consisting of scientists within the Federal government and the other consisting of an outside peer review by both government and non government scientists. During the entire review period, there was extensive opportunity for public comment and stakeholder review. The three scientific review committees evaluated all available data relevant to the criteria for inclusion of candidate nominations in the report. The criteria used in the review process and a detailed description of the review procedures, including the steps in the current formal review process, can be obtained from the NTP Web site at http://ntpserver.niehs.nih.gov/ or by contacting: Dr. C. W. Jameson, HeadReport on Carcinogens, National Toxicology Program, MD EC14, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541 4096, fax: (919) 5410144, email: jameson@niehs.nih.gov.
Questions or comments concerning the RoC, Tenth Edition should be
directed to: Dr. Mary Wolfe, Office of Scientific Review and NTP
Liaison, MDA301, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 5410530, fax: (919) 5410295, email:
wolfe@niehs.nih.gov.
Dated: December 9, 2002.
Kenneth Olden,
Director, National Toxicology Program.
Summary for Agents, Substances, Mixtures or Exposure Circumstances Being Added to or Changing the Listing in the
Tenth Edition of the Report on Carcinogens
Nominations Primary uses or exposures Action
2Amino3methylimidazo[4,5f] One of a series of heterocyclic amines Listed as reasonably
quinoline (IQ)/CAS
Beryllium and Beryllium Compounds...... Used in fiber optics and cellular Listing changed to known to be
network communications systems, human carcinogens.
aerospace, defense and other industry applications.
2,2bis(Bromomethyl)1,3propanediol Used as a flame retardant in Listed as reasonably
(Technical Grade)/CAS
[[Page 77285]]
2,3Dibromo1Propanol/CAS
Nickel and Nickel Compounds............ Used in many industrial and commercial Metallic Nickel listed as
applications including alloys, reasonably anticipated to be
catalysts, batteries, pigments, and a human carcinogen,
ceramics. Nickel Compounds listed as
known to be human
carcinogens,
Nickel alloys not listed.
Styrene7,8oxide/CAS
Trichloroethylene/CAS
Wood Dust.............................. Created when machines or tools are used Listed as a known to be a
to cut or shape wood. High amounts of human carcinogen.
wood dust are produced in sawmills,
dimension mills, furniture making
industries, cabinetmaking, and carpentry.
[FR Doc. 0231629 Filed 121602; 8:45 am]
BILLING CODE 414001P
SUMMARY:
National Toxicology Program—; Carcinogens, Tenth Edition,
DOCUMENT BODY 2:
The Report on Carcinogens, Tenth Edition was submitted to the
Congress by the Secretary HHS and also released publicly on December
11, 2002. It is available on the Internet and can be accessed from the
Environmental Health Perspectives web site at: http://www.ehponline.org or from the NTP
[[Page 77284]]
Web site at: http://ntpserver.niehs.nih.gov. Hard copies of the Report
on Carcinogens, Tenth Edition can also be obtained by contacting
Environmental Health Perspectives, ATTN: Order Processing, 1001
Winstead Drive Suite 355, Cary, NC 27513; Telephone: 8665413841 or
9196532586; Fax (919) 6788696; email: ehponline@niehs.nih.gov. Background
The Report on Carcinogens (RoC) (previously known as the Annual Report on Carcinogens) is a Congressionally mandated listing of known human carcinogens and reasonably anticipated human carcinogens whose preparation is delegated to the National Toxicology Program by the Secretary, Department of Health and Human Services (DHHS). Section 301(b)(4) of the Public Health Service Act, as amended, provides that the Secretary, (DHHS), shall publish a biennial report which contains a list of all substances (1) which either are known to be human carcinogens or may reasonably be anticipated to be human carcinogens; and (2) to which a significant number of persons residing in the United States are exposed. The law also states that the reports should provide available information on the nature of exposures, the estimated number of persons exposed and the extent to which the implementation of Federal regulations decreases the risk to public health from exposure to these chemicals.
The RoC is an informational scientific and public health document that identifies and discusses agents, substances, mixtures, or exposure circumstances that may pose a carcinogenic hazard to human health. It serves as a meaningful and useful compilation of data on the (1) carcinogenicity, genotoxicity, and biologic mechanisms of the listed substances in humans and/or animals, (2) the potential for exposure to these substances, and (3) the regulations promulgated by Federal agencies to limit exposures. The report does not present quantitative assessments of carcinogenic risk, an assessment that defines the conditions under which the hazard may be unacceptable. Listing of substances in the report, therefore, does not establish that such substances present carcinogenic risks to individuals in their daily lives. Such formal risk assessments are the purview of the appropriate Federal, State, and local health regulatory and research agencies. New Listings to the RoC, Tenth Edition
The RoC, Tenth Edition, contains 228 entries, 15 of which have not
appeared in earlier RoCs. The Tenth Edition of the RoC also changes the
listing of beryllium and beryllium compounds from reasonably
anticipated to be human carcinogens to known to be human carcinogens,
with corresponding revisions of the earlier profile for these
chemicals. The Tenth Edition of the RoC lists estrogens, steroidal as
known human carcinogens. This listing of steroidal estrogens supersedes
the previous listing of individual estrogens in the RoC (including
conjugated estrogens, estradiol17[beta], estrone, ethinylestradiol,
and mestranol) and applies to all chemicals of this steroid class. The profile for steroidal estrogens includes information on
carcinogenicity, properties, use, production, exposure, and regulations
for steroidal estrogens as a class, as well as some specific
information for individual estrogens. The table below summarizes the
actions taken for the substances or exposure circumstances reviewed for
possible listing in or change in the listing in the RoC, Tenth Edition.
The new entries for the Report on Carcinogens, Tenth Edition, including those whose listing changed, underwent a multiphase peer review. This review included three scientific peer reviews, two consisting of scientists within the Federal government and the other consisting of an outside peer review by both government and non government scientists. During the entire review period, there was extensive opportunity for public comment and stakeholder review. The three scientific review committees evaluated all available data relevant to the criteria for inclusion of candidate nominations in the report. The criteria used in the review process and a detailed description of the review procedures, including the steps in the current formal review process, can be obtained from the NTP Web site at http://ntpserver.niehs.nih.gov/ or by contacting: Dr. C. W. Jameson, HeadReport on Carcinogens, National Toxicology Program, MD EC14, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541 4096, fax: (919) 5410144, email: jameson@niehs.nih.gov.
Questions or comments concerning the RoC, Tenth Edition should be
directed to: Dr. Mary Wolfe, Office of Scientific Review and NTP
Liaison, MDA301, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 5410530, fax: (919) 5410295, email:
wolfe@niehs.nih.gov.
Dated: December 9, 2002.
Kenneth Olden,
Director, National Toxicology Program.
Summary for Agents, Substances, Mixtures or Exposure Circumstances Being Added to or Changing the Listing in the
Tenth Edition of the Report on Carcinogens
Nominations Primary uses or exposures Action
2Amino3methylimidazo[4,5f] One of a series of heterocyclic amines Listed as reasonably
quinoline (IQ)/CAS
Beryllium and Beryllium Compounds...... Used in fiber optics and cellular Listing changed to known to be
network communications systems, human carcinogens.
aerospace, defense and other industry applications.
2,2bis(Bromomethyl)1,3propanediol Used as a flame retardant in Listed as reasonably
(Technical Grade)/CAS
[[Page 77285]]
2,3Dibromo1Propanol/CAS
Nickel and Nickel Compounds............ Used in many industrial and commercial Metallic Nickel listed as
applications including alloys, reasonably anticipated to be
catalysts, batteries, pigments, and a human carcinogen,
ceramics. Nickel Compounds listed as
known to be human
carcinogens,
Nickel alloys not listed.
Styrene7,8oxide/CAS
Trichloroethylene/CAS
Wood Dust.............................. Created when machines or tools are used Listed as a known to be a
to cut or shape wood. High amounts of human carcinogen.
wood dust are produced in sawmills,
dimension mills, furniture making
industries, cabinetmaking, and carpentry.
[FR Doc. 0231629 Filed 121602; 8:45 am]
BILLING CODE 414001P