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National Toxicology Program; Call for Additional Public Comments on 21 Substances, Mixtures and Exposure Circumstances Proposed for Review for Listing or Changing the Current Listing in the Report on Carcinogens, Twelfth Edition

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Background

The National Toxicology Program (NTP) initially announced its intent to review additional agents, substances, mixtures and exposure circumstances for possible listing or changing the current listing in the Report on Carcinogens (RoC), Twelfth Edition in a May 19, 2004 Federal Register notice (69 FR 28940 (May 19, 2004)). Based on some of the comments received in response to this notice, the NTP is concerned that there might have been confusion about the procedures that will be used for review of nominations to the 12th RoC. A detailed description of the current review procedures, including the steps in the formal review process, is available on the Web at http://ntp-server.niehs.nih.gov (select on Report on Carcinogens) or can be obtained by contacting: Dr. C.W. Jameson, National Toxicology Program, Report on Carcinogens, 79 Alexander Drive, Building 4401, Room 3118, PO Box 12233, Research Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919) 541-0144, e-mail: jameson@niehs.nih.gov.

Public Comment Requested

Because of the possibility of confusion over the review procedures for the 12th RoC nominations, additional comments concerning the nominations for listing or changing the current listing in the 12th RoC will be accepted by the NTP for a period of 30 days from the publication date of this announcement in the Federal Register. The following table identifies the 21 nominations the NTP may consider for review in 2004 or 2005, as either a new listing in or changing the current listing in the 12th RoC. These nominations are provided with their Chemical Abstracts Services (CAS) Registry numbers (where available) and pending review action. Additional nominations for the 12th RoC or modifications to the nominations in the attached table may be identified and would be announced in future Federal Register notices. The NTP solicits public input on these 21 nominations and asks for relevant information concerning their carcinogenesis, as well as current production data, use patterns, or human exposure information. The NTP also invites interested parties to identify any scientific issues related to the listing of a specific nomination in the RoC that they feel should be addressed during the reviews.

Individuals who submitted comments in response to the May 19, 2004 Federal Register (69 FR 28940 (May 19, 2004)) that initially announced the 12th RoC nominations need not re-submit their comments as they are already part of the public record. Individuals submitting new or additional public comments are asked to include relevant contact information (name, affiliation (if any), address, telephone, fax, and e-mail). Comments or questions should be directed to Dr. C.W. Jameson at the address listed above.

Additional Nominations Encouraged

The NTP solicits and encourages the broadest participation from interested individuals or parties in nominating agents, substances, or mixtures for review for the Twelfth and future RoCs. Nominations should contain a rationale for review. Appropriate background information and relevant data (e.g., journal articles, NTP Technical Reports, IARC listings, exposure surveys, release inventories, etc.), which support the review of a nomination, should be provided or referenced when possible. Contact information for the nominator should also be included (name, affiliation (if any), address, telephone, fax, and email). Nominations should be sent to Dr. Jameson's attention at the address given above.

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Dated: October 15, 2004.

Samuel Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

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Summary for Agents, Substances, Mixtures or Exposure Circumstances To Be Reviewed in 2004-2005 for Possible Listing the Report on Carcinogens, Twelfth Edition

Nomination to be reviewed/CAS numberPrimary uses or exposuresNominated byBasis for nomination
Aristolochia-Related Herbal RemediesSeveral Aristolochia species (notably A. contorta, A. debilis, A. fangchi and A. manshuriensis) have been used in traditional Chinese medicine as anti-rheumatics, as diruretics, in the treatment of edema and for other conditions such as hemorrhoids, coughs and asthmaNIEHS 1Herbal remedies containing the plant genus Aristolochia: IARC 2 finding evidence of carcinogenicity in humans (Vol. 83, 2002).
Aristolochic AcidAristolochic acid, the principle extract from Aristolochia, is a mixture of nitrophenanthrene carboxylic acidsNIEHS 1Naturally occurring mixtures of aristolochic acids: IARC 2 finding of sufficient evidence of carcinogenicity in animals and limited evidence in humans (Vol. 83, 2002).
Asphalt fumesAsphalt is a petroleum product used in paving and roofing operations. Asphalt fumes are a cloud of small particles generated from the gaseous state after volatilization of asphalt aggregatesJohn Schelp of NAACP-Durham ChapterHuman epidemiological studies have reported an increased risk in lung cancer among workers exposed to asphalt fumes and asphalt fumes caused skin tumors in experimental animals. Additionally, known human carcinogens (PAHs) have been found in asphalt fumes.
Atrazine (192-24-9)Atrazine is an herbicide used to control grass and broad-leaved weeks. Atrazine has been detected at levels that exceeded or approached the MCL for atrazine in 200 community surface drinking water systemsNIEHS 1IARC 2 finding of sufficient evidence of carcinogenicity in animals (Vol. 73, 1999).
Benzofuran (271-89-6)Benzofuran is produced by isolation from coal-tar oils. Benzofuran is used in the manufacture of coumarone-indene resins, which harden when heated and are used to make floor titles and other productsNIEHS 1Results of a NTP bioassay (TR 370, 1989), which reported clear evidence of carinogenicity in male and female mice and some evidence of carcinogenicity in female rats.
Captafol (2425-06-01)Captafol is a fungicide that has been widely used since 1961 for the control of fungal diseases in fruits, vegetables and some other plants. Use of captafol in the United States was banned in 1999NIEHS 1IARC 2 finding of sufficient evidence of carcinogenicity in animals (Vol. 53, 1991). IARC also noted that captafol is positive in many genetic assays, including the in-vivo assay for dominant lethal mutation.
Cobalt/Tungsten-Carbide Hard Metal ManufacturingHard-metals are manufactured by a process of powder metallurgy from tungsten and carbon (tungsten carbide), and small amounts of other metallic compounds using cobalt as a binder. Hard metals are used to make cutting and grinding tools, dies, and wear products for a broad spectrum of industries including oil and gas drilling, and miningNIEHS 1Recent human cancer studies on the hard metal manufacturing industry showing an association between exposure to hard metals (cobalt tungsten-carbide) and lung cancer.
Di (2-Ethylhexyl) phthalate (DEHP) (117-81-7)DEHP is mainly used as a plasticizer in polyvinyl chloride (PVC) resins for fabricating flexible vinyl products. PVC resins have been used to manufacture toys, dolls, vinyl upholstery, tablecloths and many other productsJun Ki-Chul, President of Aekyung Petrochemical Co., LTD of Seoul, Korea (for delisting)Currently listed in the RoC as reasonably anticipated to be a human carcinogen. IARC reclassification as not classifiable as to its carcinogenicity to humans (Group 3) (Vol. 73, 2000). IARC stated that there was sufficient evidence for the carcinogenicity in experimental animals; however, the mechanism for liver tumor involves peroxisome proliferation that is not relevant to humans.
Etoposide in combination with cisplatin and bleomycinEtoposide in combination with cisplating and bleomycin is used to treat testicular germ cell cancersNIEHS 1IARC 2 finding of sufficient evidence of carcinogenicity in humans (Vol. 76, 2000).
Etoposide (33419-42-0)Etoposide is a DNA topoisomerase II inhibitor used in chemotherapy for non-Hodgkin's lyumphoma, small-cell lung cancer, testicular cancer, lymphomas and a variety of childhood malignanciesNIEHS 1IARC 2 finding of limited evidence of carcinogenicity in humans (Vol. 76, 2000).
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Glass wool (respirable size): Two nominations: (1) Insulation glass wool fibers. (2) Special purposes glass fibers.The major uses of glass wool are in thermal, electrical, and acoustical insulation, weatherproofing, and filtration media. In 1980, approximately 80% of the glass wool produced for structural insulation was used in houses. Special purpose fibers are used for high-efficiency air filtration media, and acid battery separatorsNorth American Insulation Manufacturers Association nominated glass wool (respirable size) for delisting Special purpose glass wool fibers: NIEHS 1Glass wool (respirable size) is currently listed in the RoC as reasonably anticipated to be a human carcinogen. Insulation glass wool: IARC 2 finding of limited evidence of carcinogenicity in animals and evaluation as not classifiable as to its carcinogenicity to humans (Group 3) (Vol. 81, 2002). Special-purpose glass fibers: IARC 2 finding of sufficient evidence of carcinogenicity in animals (Vol. 81, 2002).
Metalworking FluidsMetal working fluids are complex mixtures that may contain mixtures of oil, emulsifiers, anti-weld agents, corrosion inhibitors, extreme pressure additives, buffers biocides and other additives. They are used to cool and lubricate tools and working surfaces in a variety of industrial machining and grinding operationsNIEHS 1Recent human cancer studies of metal working fluid that show an association between exposure to these materials and cancer at several tissue sites.
otho-Nitrotolume (88-72-2)ortho-Nitrotoluene is used to synthesize agricultural and rubber chemicals, azo and sulfur dyes, and dyes for cotton, wool, silk, leather, and paperNIEHS 1Results of a NTP bioassay (TR 504, 2002), which reported clear evidence of carcinogenicity in rats and mice.
Oxazepam (604-75-1)Oxazepam is a benzodiazepine used extensively since the 1960s for the treatment of anxiety and insomnia and in the control of symptoms of alcohol withdrawalNIEHS 1Results of a NTP bioassay (TR 443, 1993), which reported clear evidence of carcinogenicity in male and female mice.
Riddelliine (23246-96-0)Riddelliine is found in class of plants growing in western US. Cattle, horses and sheep ingest these toxic plants. Residues have been found in milk and honeyNIEHS 1Results of a NTP bioassay (TR 508, 2003), which reported clear evidence of carcinogenicity in male and female rats and mice.
Styrene (100-42-5)Styrene is used in the production of polystyrene, acrylonitrile-butadiene-styreen resins, styrene-butadiene rubbers and latexes, and unsaturated polystyrene resinsLorenzo TomatisIARC 2 finding of limited evidence of carcinogenicity in animals and limited evidence of carcinogenicity in humans (Vol. 82, 2002).
Talc—Two nominations (1) Cosmetic talc Occupational exposure to talcTalc occurs in various geological settings around the world. Exposure to general population occurs through use of products such as cosmetics. Occupational exposure occurs during mining, milling and processingNIEHS 1The NTP deferred consideration of listing talc (asbestiform and non-asbestiform talc) in the 20th RoC because its 2000 review of talc found confusion in the scientific literature over the mineral nature of talc. Given the confusion over defining exposure to talc based on asbestiform fibers, the NTP has decided that the most appropriate approach would be to characterize talc exposure as cosmetic talc and occupational exposure to talc. The basis for the review of talc is as follows:
Cosmetic talc: Human epidemiological studies reporting an increased risk of ovarian cancer among women using talc for personal use.
Occupational exposure to talc: Human epidemiological studies reporting an increase risk of cancer among workers exposed to talc.
Teniposide (29767-20-2)Teniposide is a DNA topoisomerase II inhibitors used mainly in the treatment of adult and childhood leukemiaNIEHS 1IARC 2 finding of limited evidence of carcinogenicity in humans (Vol. 76, 2000).
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Vinyl Mono-Halides as a classVinyl halides are used in the production of polymers and copolymers. Vinyl bromide is mainly used in polymers as a flame retardant and in the production of monoacrylic fibers for carpet-backing materials. Vinyl Chloride is used to produced polyvinyl chloride and copolymers. Vinyl Fluoride is used in the production of polyvinyl fluoride, which when laminated with aluminum, steel and other materials is used as a protective surface for the exteriors of residential and commercial buildingsNIEHS 1Vinyl Fluoride and Vinyl Bromide are currently listed in the RoC as reasonably anticipated to be a human carcinogen and Vinyl Chloride is currently listed in the RoC as known to be a human carcinogen in the Reports on Carcinogens. Vinyl Mono-Halides: Structural similarities and common mechanisms of tumor formation.
1 The National Institute of Environmental Health Sciences (NIEHS).
2 International Agency for Research on Cancer (IARC).
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[FR Doc. 04-23788 Filed 10-22-04; 8:45 am]

BILLING CODE 4140-01-P