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Regulatory Actions for Years 1990 to 1999


California Office of Environmental Health Hazard Assessment (OEHHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

May 15, 1998 -- Proposition 65
National Toxicology Program (NTP, 1996a). NTP Technical Report on Comparative Toxicity and Carcinogenicity Studies of o-Nitrotoluene and o-Toluidine Hydrochloride (CAS Nos. 88-72-2 and 636-21-5). Administered in Feed to Male F344/N Rats. NTP Toxicity Report Series No. 44. NTIS Publication Number 96-3936. 88-72-2
Notice Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

May 15, 1998 -- Proposition 65
National Toxicology Program (NTP, 1994). Seventh Annual Report on Carcinogens: 1994. Volume 1: 357-362. US Department of Health and Human Services, NTP, Research Triangle Park, NC. 612-83-9
Notice Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

May 15, 1998 -- Proposition 65
National Toxicology Program (NTP, 1981). Carcinogenesis Bioassay of Cytembena (CAS No. 21739-91-3). NTP Technical Report Series No. 207. NTIS Publication No. 81-1763. 21739-91-3
Notice Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

May 15, 1998 -- Proposition 65
National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Methyl Carbamate (CAS No. 598-55-0) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 328. NTIS Publication No. 88-2584. 598-55-0
Notice Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

May 15, 1998 -- Proposition 65
National Toxicology Program (NTP, 1996b). Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS No. 77-09-8) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 465. NTIS Publication No. 97-3390. 77-09-8
Notice Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

May 15, 1998 -- Proposition 65
National Toxicology Program (NTP, 1989a). Toxicology and Carcinogenesis Studies of para-Chloroaniline Hydrochloride (CAS No. 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 351. 20265-96-7
Notice Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

May 15, 1998 -- Proposition 65
National Toxicology Program (NTP, 1989b). Toxicology and Carcinogenesis Studies of Nalidixic Acid (CAS No. 389-08-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 368. NTIS Publication No. 90-2823. 389-08-2
Notice Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

May 15, 1998 -- Proposition 65
National Toxicology Program (NTP, 1982a). Carcinogenesis Bioassay of C.I. Solvent Yellow 14 (CAS No. 842-07-9) in F344/N Rats and B6C3F1 Mice (Feed Study). NTP Technical Report Series No. 226. NTIS Publication No. 82-1782. 842-07-9
Notice Notice to Interested Parties Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity: 28 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 28 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective May 15, 1998. Toxicological Endpoint: Cancer

May 15, 1998 -- Proposition 65
National Toxicology Program (NTP, 1997). Toxicology and Carcinogenesis Studies of Salicylazosulfapyridine (CAS No. 599-79-1) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 457. NTIS Publication No. 97-3373. 599-79-1
Notice Chemicals Listed Effective August 26, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 16 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer

August 15, 1997 -- Proposition 65
National Toxicology Program (NTP, 1992). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 15 (CAS No. 2429-74-5) in F344/N Rats and B6C3F1 Mice (DrinkingWater Studies). NTP Technical Report Series No. 397. NTIS Publication No. 92-2852. 2429-74-5
Notice Chemicals Listed Effective August 26, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 16 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer

August 15, 1997 -- Proposition 65
National Toxicology Program (NTP, 1994a). Toxicology and Carcinogenesis Studies of 1-amino-2,4-dibromoanthraquinone (CAS No. 81-49-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). Board Draft. NTP Technical Report Series No. 383. NTIS Publication No. 94-2838. 81-49-2
Notice Chemicals Listed Effective August 26, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 16 Chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added 18 chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). These chemicals are listed effective August 26, 1997. Toxicological Endpoint: Cancer

August 15, 1997 -- Proposition 65
National Toxicology Program (NTP, 1994b). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 218 (CAS No. 28407-37-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 430. NTIS Publication No. 94-3161. 28407-37-6
Notice Chemicals Listed Effective May 1, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 9 chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added nine chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). These chemicals are listed effective May 1, 1997. Toxicological Endpoint: Cancer

May 01, 1997 -- Proposition 65
National Toxicology Program (NTP, 1995a). Toxicology and Carcinogenesis Studies of Nitromethane (CAS No. 72-52-5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 461. NTIS Publication No. 95-3377. 75-52-5
Notice Chemicals Listed Effective May 1, 1997 as Known to the State to Cause Cancer or Reproductive Toxicity: 9 chemicals The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added nine chemicals to the list of chemicals known to the State to cause cancer or reproductive toxicity, for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). These chemicals are listed effective May 1, 1997. Toxicological Endpoint: Cancer

May 01, 1997 -- Proposition 65
National Toxicology Program (NTP, 1995b). Toxicology and Carcinogenesis Studies of Tetrafluoroethylene (CAS No. 116-14-3) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 450. NTIS Publication No. 95-3366. 75-02-5

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Consumer Product Safety Commission (CPSC)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule Dioxin-containing Wastes Issued guidelines specifying criteria for determining when any customary or reasonably foreseeable use of an art material can result in chronic hazard.

October 09, 1992 -- 57 FR 46624
NTP criteria for assessing the quality and adequacy of animal studies.

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Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule Diflubenzuron; Pesticide Tolerances The EPA established tolerances for residues of the insecticide diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline in/on rice grain at 0.02 ppm and rice straw at 0.8 ppm.

April 19, 1999 -- 64 FR 19050
The 4-chloroaniline (PCA) metabolite was classified as a Group B2 carcinogen (probable human carcinogen) based on the results of the NTP bioassay on PCA (TR-351). The NTP bioassay and the results of several NTP mutagenicity studies on PCA discussed in the bioassay report were part of the information used to estimate dietary risk assessments. 20265-96-7
Notice Acetonitrile: Community Right-to-Know Toxic Chemical Release Reporting The EPA is denying a petition to remove acetonitrile from the list of chemicals subject to the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and section 6607 of the Pollution Prevention Act of 1990 (PPA).

March 05, 1999 -- 64 FR 10597
EPA reviewed all of the available data, including the NTP Technical Report of the Toxicology and Carcinogenesis of Acetonitrile (TR-447), to conclude that acetonitrile can reasonably be anticipated to cause serious or irreversible chronic health effects in humans, including neurotoxicity and death. 75-05-8
Notice Update on the Status of the Superfund Substance-Specific Applied Research Program This Notice provides the status of ATSDR's Superfund mandated Substance-Specific Applied Research Program (SSARP). To date, 188 priority data needs have been identified for the 50 priority hazardous substances frequently found at waste sites.

January 15, 1999 -- 64 FR 2759
The ATSDR maintains an interagency agreement (IAG) with NTP to conduct toxicologic testing of substances identified at National Priority List sites.  Under this agreement, the NTP filled the toxicity priority data need for the immunotoxicology study of carbon tetrachloride.  The NTP is currently addressing reproductive toxicity data needs for chlordane, endrin, and heptachor; the bioavailability of PCB's in soil; and dose-response data for di-n-butyl phthalate.
Final Rule Diflubenzuron; Temporary Pesticide Tolerance This regulation establishes a temporary tolerance for residues of the insecticide diflubenzuron and metabolites convertible to p-chloroaniline (PCA) expressed as diflubenzuron on rice grain at 0.01 ppm.

May 13, 1998 -- 63 FR 26481
PCA was classified as a Group B2 carcinogen (probable human carcinogen). The classification for PCA was based on the results of the NTP bioassay on p-chloroaniline hydrochloride (TR-351). The results of several NTP mutagenicity studies on PCA discussed in the bioassay report were also cited. 20265-96-7
Final Rule Organobromine Production Wastes; Identification and Listing of Hazardous Waste; Land Disposal Restrictions; Listing of CERCLA Hazardous Substances, Reportable Quantities EPA is adding tribromophenol and wastes generated from its production to its list of CERCLA hazardous substances. EPA used structure activity relationship (SAR) analysis information in support of its listing of tribromophenol.

May 04, 1998 -- 63 FR 24596
NTP mutagenicity studies are cited to show that a negative in Salmonella does not necessarily predict that 2,4,6-trichlorophenol is not a carcinogen. As part of its validation of the use of SAR analysis for identifying hazardous wastes, EPA cited a comparison of the NTP bioassay of 1,2-dibromoethane (TR-210) with the NCI bioassay of 1,2-dichloroethane (TR-55). The study results showed that carcinogenic activity was retained with the substitution of a chlorine by a bromine.
88-06-2
106-93-4
107-06-2
Notice Announcement of the Drinking Water Contaminant Candidate List The Safe Drinking Water Act (SDWA) requires the EPA to publish a list of contaminants that are known or anticipated to occur in public water systems and which may require regulation under the SDWA. The EPA has reviewed and considered public comments of the draft CCL in creating the final CCL.

March 02, 1998 -- 63 FR 10274
As part of its evaluation of the risk associated with methyl bromide's contamination of drinking water, the EPA cited the results of the NTP 2-year inhalation study (TR-385). 74-83-9
Proposed Rule Addition of Dioxin and Dioxin-Like Compounds; Modification of Polychlorinated Biphenyls Listing; Toxic Chemical Release Reporting; Community Right-to-Know The EPA is proposing to add a chemical category that includes dioxin and 27 dioxin-like compounds to the list of toxic chemicals subject to the reporting requirements under EPCRA.

May 07, 1997 -- 62 FR 24887
As part of the basis for this proposed rule, the EPA noted that the NTP bioassays of 1,2,3,6,7,8- and 1,2,3,7,8,9-hexachlorodibenzo-p-dioxin (TR-198) showed that these compounds are carcinogenic. The EPA also noted that the NTP's Annual Report on Carcinogens listed PCBs as substances which may reasonably be anticipated to be human carcinogens.
Final Rule Indirect Food Additives: Adhesives and Components of Coatings; Adjuvants, Production Aids and Sanitizers Final Rule: The FDA is amending the food additive regulations to provide for the safe use of 2,2-ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite as an antioxidant in adhesives and in the preparation of polymers intended for contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of methylene chloride, which is a carcinogenic impurity resulting from the manufacture of the additive.

January 15, 1997 -- 62 FR 2011
The FDA used data from the NTP Inhalation Bioassay on Methylene Chloride, TR-306, to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of this additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to methylene chloride would result from the proposed use of the additive. 75-09-2
Proposed Rule Supplement to California State Plan; Approval EPA is denying a petition to remove the barium compounds category from the list of chemicals subject to reporting requirements under the Community Right-to-Know Act and the Pollution Prevention Act. The EPA concluded that barium ion can become available from the barium compounds subject to the reporting, and that barium ion can reasonably be anticipated to cause chronic toxicity.

January 03, 1997 -- 62 FR 366
The EPA's toxicological evaluation of barium compounds included review of data from the NTP's Drinking Water Toxicity/Carcinogenicity Studies of Barium Chloride Dihydrate (TR-432). 10326-27-9
Notice Guidelines for Reproduction Toxicity Risk Assessment Notice: The EPA has made available the final Guidelines for Reproductive Toxicity Risk Assessment. The Guidelines include protocols designed to determine the potential of a test substance to produce reproductive toxicity in laboratory animals.

October 31, 1996 -- 61 FR 56274
NTP Work Cited: An NTP continuous breeding protocol, Fertility Assessment by Continuous Breeding, is cited as an example of alternative reproductive tests which the EPA considered in developing the Guidelines.
Final Rule Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra The EPA is promulgating a new use rule which requires persons to notify the EPA at least 90 days before commencing the manufacture, import, or processing of certain (22) benzidine-based chemical substances for significant new use as described in this rule.

October 07, 1996 -- 61 FR 52287
As part of the basis for this significant new use rule, EPA noted that NIOSH and NCI jointly recommended that three benzidine-based dyes, Direct Black 38, Direct Blue 6, and Direct Brown 95, be handled in the workplace as if they were human carcinogens. This recommendation was based on testing data including the NTP/NCI bioassay which confirmed that these dyes cause cancer in rodents. (TR-108) 16071-86-6
2602-46-2
1937-37-7
Proposed Rule Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra EPA is proposing a test rule under section 4(a) of the Toxic Substances Control Act to require manufacturers and processors of 21 hazardous air pollutants (HAPs) to test these substances for certain health effects.

June 26, 1996 -- 61 FR 33178
As part of the process to select which study data were needed for these HAPs, EPA reviewed the NTP's database of ongoing testing to locate unpublished studies.
Proposed Rule Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel EPA proposes to establish a pesticide tolerance for residues of the insecticidal fluorine compounds cryolite and or synthetic cryolite. Fluoride has been identified as the residue of toxicological concern in cryolite and synthetic cryolite.

May 08, 1996 -- 61 FR 20781
The NTP chronic study of sodium fluoride (TR-393) was cited as an example of toxicological data considered in the support of the proposed tolerance and regulation. 7681-49-4
Notice Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel The EPA announced the publication of the new "Proposed Guidelines for Carcinogen Risk Assessment" which replaces the 1986 guidelines.

April 23, 1996 -- 61 FR 17960
Default assumptions are recognized as necessary in risk assessment ( National Research Council report) and the EPA has incorporated into its risk assessment guidelines default assumptions in part using inferences based on general scientific knowledge. The studies and experience of the NTP are cited and referred to throughout this Federal Register notice as part of the scientific knowledge used by the EPA to develop their defaults and how they plan their assessment of evidence of toxicity.
Proposed Rule Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel EPA proposes to establish a tolerance for residues of the insecticide diflubenzuron in or on the raw agricultural commodity artichokes at 6.0 ppm. Para-chloroaniline (PCA) is a metabolite of diflubenzuron.

April 17, 1996 -- 61 FR 16745
The EPA's Health Effects Division Peer Review Committee classified PCA as a Group B2 carcinogen (probable human carcinogen) based on the results of the NTP chronic study of p-chloroaniline hydrochloride (TR-351). 20265-96-7
Notice Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel EPA's issued this Notice to inform the public that the Agency has, after reviewing additional study date, reassessed the potential adverse effects and the benefits associated with the use of pesticide products containing dichlorvos. The Agency has preliminarily determined that, unless the terms and conditions of registration are modified as proposed in this Notice, the risks from the use of dichlorvos outweigh the benefits of their continued use.

September 28, 1995 -- 60 FR 50337
As part of the relevant data, the EPA has classified dichlorvos as a Group C (possible human) carcinogen based on the results of the NTP bioassay (TR-342) and on the conclusions of a special NTP Panel of Experts convened April 1988 to further assess the incidence of pancreatic lesions observed in the 2-year rat studies. 62-73-7
Proposed Rule Diethyl Phthalate; Toxic Chemical Release Reporting: Community Right-to-Know EPA is proposing to delete diethyl phthalate (DEP) from the list of chemicals subject to reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990.

September 05, 1995 -- 60 FR 46076
As part of the relevant data, EPA used results of the NTP dermal bioassay to conclude that there is insufficient evidence to establish that DEP is likely to cause cancer. TR-429. 84-66-2
Final Rule Benzidine-Based Chemical Substances; Proposed Significant New Uses of Certain Chemical Substances The EPA is proposing a significant new use rule under section 5(a)(2) of TSCA which would require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of benzidine-based chemical substances. The EPA believes that benzidine-based chemical substances may be hazardous to human health and that the proposed rule will protect against potentially adverse exposure.

August 30, 1995 -- 60 FR 45119
EPA supported, in part, their conclusion about the potential hazard of benzidine-based chemical substances on the results of three benzidine-based dye rodent studies reported by the NTP. TR-108. 16071-86-6
2602-46-2
1937-37-7
Notice Thirty-Sixth Report of the TSCA ITC; Revision of Priority Testing List The ITC is revising its Priority Testing List including the removal of butyraldehyde; sulfonyl bis(4-chlorobenzene); 2-propenoic acid,2-cyanoethyl ester; and dipropylene glycol from the List as a result of NTP testing.

August 17, 1995 -- 60 FR 42981
The NTP has sponsored a reproductive screening test of butyraldehyde; has developed most of the screening test data and will be conducting health effects testing for sulfonyl bis(4-chlorobenzene); is currently testing a dipropylene glycol mixture; and is evaluating the practical problems which may prevent effective health effects testing of ethyl cyanoacrylate. 123-72-8
25265-71-8
80-07-9
7085-85-0
Proposed Proposal to delist di-(2-ethylhexyl) adipate from the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of1990

August 01, 1995 -- 60 FR 39132
As part of the relevant data, EPA used results of the NTP bioassay to conclude that, overall, the evidence is too limited to establish that di-(2-ethylhexyl) adipate is likely to cause cancer. TR 212. 103-23-1
Proposed Rule Food Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium The EPA proposes to establish a tolerance for residues of the insecticide dimethoate in or on the raw agricultural commodities blueberries and asparagus (see Federal Register July 5, 1995, p. 34945)

June 23, 1995 -- 60 FR 32640
The NTP has concluded that dimethoate is a "mutagenic" compound based on its testing for gene mutation and chromosomal aberrations. 60-51-5
Final Rule Reportable Quantity Adjustments The EPA has taken final action on reportable quantities (RQs) for hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act. The person in charge of a facility or vessel from which a hazardous substance is released in excess of its RQs must notify appropriate authorities, who can then evaluate whether a response is needed.

June 12, 1995 -- 60 FR 30926
The Agency has promulgated a final RQ of 100 pounds (as proposed) based on chronic toxicity. Because no chronic toxicity studies have been reported for diethanolamine, both EPA and commenters used data from a NTP 13-week subchronic study (TOX-20) to develop their respective conclusions. 111-42-2
Final Rule Diflubenzuron: Pesticide Tolerances The EPA established tolerances for residues of the insecticide diflubenzuron in or on raw agricultural commodities. Para-chloroaniline (PCA) is a metabolite of diflubenzuron.

May 10, 1995 -- 60 FR 24785
Information from the NTP bioassay on PCA was used to help establish maximum permissible levels (TR-351). 20265-96-7
Other Monosodium Methanearsonate and Disodium Methanearsonate: Toxic Chemical Release Reporting; Community Right-to-Know EPA is denying a petition to delist monosodium methanearsonate and disodium methanearsonate from the reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986.

April 20, 1995 -- 60 FR 19702
The EPA and the NTP have classified inorganic arsenicals, including arsenate, as known human carcinogens. (NTP 7th Annual Report on Carcinogens)
Proposed Rule Test Rule; Office of Water Chemicals Proposed Withdrawal of Certain Testing Requirements The EPA is proposing to withdraw certain testing requirements for two chemical substances listed in the Office of Water chemicals test rule. This proposal includes the withdrawal of the 90-day subchronic testing requirements for 1,1,2,2-tetrachloroethane.

April 10, 1995 -- 60 FR 18079
The NTP's 90-day subchronic toxicity drinking water study of 1,1,2,2-tetrachloroethane meets the 90-day subchronic toxicity test required under the test rule and can be used to establish long-term Health Advisories for the Office of Water. (TOX-45) 79-34-5
Final Rule Food and Feed Additive Regulations for d-Limonene, Dihydro-5-Pentyl-2(3H)-Furanone, and Dihydro-5-Heptyl-2(3H)-Furanone EPA proposes to establish food/feed additive regulations for residues of the insecticide d-limonene when used as an active ingredient in insect-repellent tablecloths and in insect repellent strips used in food/feed-handling establishments.

February 08, 1995 -- 60 FR 7511
Data on the oral toxicity of d-limonene was summarized in the NTP 2-year bioassay and comprehensive literature review. TR-347 5989-27-5
Proposed Rule Acephate, Triadimefon, Iprodione, and Imazalil; Revocation of Food Additive Regulations EPA is proposing to revoke food additive regulations for five pesticides which EPA has determined "induce cancer" within the meaning of the Delaney clause of section 409 of the Federal Food, Drug and Cosmetic Act (FFDCA). After a full evaluation of all the data and supporting information regarding animal carcinogenicity, the EPA has concluded that exposure to triadimefon results in the induction of hepatocellular adenomas in NMRI mice. Hepatocellular adenomas are considered to be evidence of cancer because hepatocellular adenomas can progress to hepatocellular carcinomas.

January 18, 1995 -- 60 FR 3607
EPA supports its conclusion that hepatocellular adenomas can progress to hepatocellular carcinomas with NTP's rationale for combining tumor types for an overall analysis of carcinogenicity (in addition to analyzing them separately).
Final Rule Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know EPA is taking this action pursuant to its authority to add to the list those chemicals and chemical categories that meet the EPCRA section 313(d)(2) criteria for addition to the list of toxic chemicals.

November 30, 1994 -- 59 FR 61432
Long-chain chlorinated paraffins have not been classified as "probable human carcinogens" by NTP or IARC and the NTP bioassay (TR-305) showed insufficient evidence. Therefore the EPA concludes that there is insufficient evidence to list long-chain chlorinated paraffins on the EPCRA section 313 list. 108171-27-3
Proposed Rule Asbestos Worker Protection; Asbestos-Containing Materials in Schools; Proposed Amendment The proposed rule would generally extend the coverage provided under the 1986 OSHA Asbestos Standard for Construction to State and local government employees who are not covered by OSHA- or EPA-approved State plans. It also proposes to extend coverage provided under the OSHA Asbestos Standard for General Industry for automotive brake and clutch repair.

November 01, 1994 -- 59 FR 54746
The EPA classifies asbestos as a Group A carcinogen as cited in the NTP's 7th Annual Report on Carcinogens. (TR-280) (TR-279) (TR-277) (TR-295) 12001-28-4
12172-73-5
14567-73-8
12001-29-5
Proposed Rule Drinking Water; National Primary Drinking Water Regulations: Disinfectants and Disinfection Byproducts Includes establishment of maximum residual disinfectant level goals (MRDLGs) for chlorine, chloramines, and chlorine dioxide and maximum contaminant level goals (MCLGs) for bromodichloromethane, dibromochloromethane, and bromoform.

July 29, 1994 -- 59 FR 38668
Data from the NTP toxicology and carcinogenesis studies of bromodichloromethane (TR-321), chlorinated and chloraminated water (TR-392), bromoform (TR-350), and dibromochloromethane (TR-282) were used as part of the evaluation to set maximum residual disinfectant level goals for these substances. 75-25-2
75-27-4
124-48-1
CHLORWATERMX
Notice Thirty-Fourth Report of the TSCA Interagency Testing Committee to the Administrator: Receipt of Report and Request for Comments Receipt of report of the TSCA Interagency Testing Committee to the Administrator. The ITC revised the Priority Testing List including the removal of eight chemicals from the List.

July 13, 1994 -- 59 FR 35720
The negative results of the NTP toxicology and carcinogenesis study of the structurally-related N-phenyl-2-napththylamine (TR-333) was used by the ITC in developing its rationale for removing N-phenyl-1-napththylamine from the List. 135-88-6
Proposed Rule Pesticides; Proposed Rule Revoking Certain Food Regulations Revocation of certain food additive regulations for several pesticides which EPA has determined "induce cancer" within the meaning of the Delaney Clause of section 409 of the Federal Food, Drug and Cosmetic Act.

July 01, 1994 -- 59 FR 33941
NTP toxicology and carcinogenesis study of ethylene oxide (TR-326) is cited as one of the studies used for conclusions that ethylene oxide induces cancer in animals. 75-21-8
Final Rule Fuels and Fuel Additives Registration Regulations Establishment of new requirements for the registration of designated fuels and fuel additives as authorized by sections of the Clean Air Act.

June 27, 1994 -- 59 FR 33042
NTP 13-week inhalation study of N-Hexane in B6C3F1 mice is cited as a reference for the neuropathology assessment. (TOX-02) 110-54-3
Final Rule Dicofol; Revocation of Food Additive Tolerance Revocation of the food additive tolerance for residues of the pesticide dicofol in or on dried tea.

March 09, 1994 -- 59 FR 10993
Data from the NTP toxicology and carcinogenesis study of dicofol (TR-90) showed a statistically significant increase of hepatocellular adenomas and combined hepatocellular adenomas and carcinomas in male mice (B6C3F1) at two doses tested.
115-32-2
Proposed Rule d_Limonene; Tolerance Exemption Exemption from the requirement of a tolerance be established for residues of d-limonene when used as an inert ingredient in pesticide formulations applied to growing crops or raw agricultural commodities after harvest.

February 23, 1994 -- 59 FR 8581
The NTP toxicology and carcinogenesis study of d-Limonene showed no carcinogenic activity in female rats and mice and in male mice. Clear evidence of kidney-associated carcinogenic activity was noted in male rats. However, the NTP concluded that the male rat kidney carcinogenicity is not predictive of mammalian carcinogenicity. (TR-347) 5989-27-5
Final Rule Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the Counter Human Use; Amendment of Final Monograph of OTC Antihistamine Drug Products Establishment of conditions under which over-the-counter antihistamine drug products are generally recognized as safe and effective and not misbranded. Dec. 9, 1992. Amendment of final rule to include doxylamine succinate.

January 28, 1994 -- 59 FR 4216
Data from the NTP toxicology and carcinogenesis study on pyrilamine (TRs 408, 409) was used to determine that pyrilamine maleate is safe for OTC use. The results of an NCTR-toxicology and carcinogenesis study of doxylamine succinate conducted under the auspices of the NTP were used in developing a talk paper concerning the NCTR-findings in animals to inform consumers of these data and the uncertainty of their relevance to humans. 469-21-6
91-84-9
Final Rule Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know Addition of 313 chemicals and chemical categories to the list of toxic chemicals required to be reported on under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 and section 6607 of the Pollution Prevention Act of 1990.

January 12, 1994 -- 59 FR 1788
EPA considered chemicals designated as possible, probable, or known carcinogens in the Monographs of IARC and the 6th Annual Report on Carcinogens published by the NTP. Also, used results of the NTP toxicology and carcinogenesis studies of C.I. Acid Red 114 (TR-405), C.I. Direct Blue 218 (TR-430), Chlorendic acid (TR-304), 3-Chloro-2-methyl-1-propene (TR-300), Diglycidyl resorcinol ether, (TR-257), 3,3-Dimethoxybenzidine dihydrochloride (TR-372), 3,3-Dimethylbenzidine dihydrochloride (TR-390), and 5,5-Diphenylhydantoin (phenytoin) (TR-404). 115-28-6
57-41-0
28407-37-6
6459-94-5
101-90-6
563-47-3
20325-40-0
612-82-8
Notice Drinking Water Maximum Contaminant Level Goal; Fluoride Announcement of decision not to revise the maximum contaminant level goal (MCLG) for fluoride after consideration of recent reports concerning the health effects of fluoride.

December 29, 1993 -- 58 FR 68826
NTP toxicology and carcinogenesis study of fluoride (TR-393) cited. Study concluded that there was equivocal evidence in male F344/N rats, and no evidence in female F344/N rats or male or female mice. 7681-49-4
Final Rule Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Significant New Use Rule Final Rule: Addition of 21 chemicals and 2 chemical categories to the list of toxic chemicals under section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA).

December 01, 1993 -- 58 FR 63500
NTP toxicity study of formic acid (TOX-19) demonstrated sufficient evidence to establish that formic acid can reasonably be anticipated to cause in humans chronic health effects as described in EPCRA section 313(d)(2)(B). 64-18-6
Final Rule Pesticide Tolerances for Dicamba Establishment of a tolerance for the combined residues of the herbicide dicamba and its 5-hydroxy metabolite.

November 24, 1993 -- 58 FR 62039
Negative results of NTP toxicology and carcinogenesis study of dichlorodibenzo-p-dioxin (TR-123) cited. The Agency has concluded that there is no potential carcinogenic risk to humans from a DCDD impurity in the dicamba to be used on cotton. 33857-26-0
Final Rule Acetophenone, Phenol, N,N-Dimethylaniline, Ethyl Acetate, and 2,6-Dimethylphenol; Proposed Test Rule, Notice of Opportunity to Initiate Negotiations for TSCA Section 4 Testing Consent Agreements Proposed Rule: Proposed test rule under section 4(a) of the Toxic Substances Control Act (TSCA) that would require manufacturers and processors of five chemicals, acetophenone, phenol, n, n-dimethylaniline, ethyl acetate, and 2,6-dimethylphenol, to conduct testing for certain chemical fate, health and environmental effects.

November 22, 1993 -- 58 FR 61654
The proposed rule reflects EPA's current thinking in the area of mutagenicity testing, both as an endpoint and as it leads to oncogenicity testing. This new information is partially based on data from the NTP's study of the ability of short-term tests to predict carcinogenic potential. For phenol, no additional testing for developmental effects is being proposed because NTP studies are adequate for this endpoint. For N,N-dimethylaniline, the NTP toxicology and carcinogenesis study (TR-360) identified the rat as more sensitive than the mouse to the noncarcinogenic effects on erythrocytes and spleen. 121-69-7
Proposed Rule Significant New Uses of Certain Acrylate Esters Proposed a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act for all acrylate esters falling within the definition proposed in this rule (acrylate substances).

November 22, 1993 -- 58 FR 61649
The EPA has concluded certain acrylates may present a risk of cancer. This conclusion is based primarily upon data available for a subset of acrylates which have demonstrated positive results. The NTP toxicology and carcinogenesis study of ethyl acrylate (TR-259) used to support conclusion. 140-88-5
Final Rule Dichlorvos: Revocation of Food Additive Tolerance Revocation of the food additive regulation for residues of the pesticide dichlorvos in or on packaged or bagged non perishable processed food.

November 10, 1993 -- 58 FR 59663
Data from the NTP toxicology and carcinogenesis study of dichlorvos (TR-342) in F344 rats showing statistically significant increases in leukemia in males at 2 dose levels was used. 62-73-7
Proposed Rule Pesticide Tolerance for Dimethoate Establishment of a tolerance for residues of the insecticide dimethoate in or on raw Brussels sprouts.

September 01, 1993 -- 58 FR 46147
NTP concluded that dimethoate is a mutagenic compound based on its testing for gene mutation and chromosomal aberrations. 60-51-5
Final Rule Revocation of Food Additive Regulations for Benomyl, Mancozeb, Phosmet, and Trifluralin Revocation of certain food additive regulations for four pesticides, benomyl, mancozeb, phosmet, and trifluralin, which were included in a 1989 petition.

July 14, 1993 -- 58 FR 37862
Ethylene thiourea (ETU), a major contaminant, metabolite and breakdown product of mancozeb has been shown in the NTP toxicology and carcinogenesis study (TR-388) to induce cancer in animals. 96-45-7
Proposed Rule C.I. Pigment Violet #23 (Carbazole Violet), C.I. Pigment Blue #15, C.I. Pigment Green #7, and FD & C Red No. 40; Tolerance Exemptions Exemption from the requirement of a tolerance be established for residues of C.I. Pigment Violet #23, C.I. Pigment Blue #15, C.I. Pigment Green #7 and FD Red No. 40 when used as inert ingredients in pesticide formulations applied to growing crops only.

June 30, 1993 -- 58 FR 34973
NTP data used to support the proposed tolerance exemptions for C.I. Pigment Blue #15 and C.I. Pigment Green #7. The NTP decided not to perform toxicology and carcinogenesis studies of C.I. Pigment Green #7 and C.I. Pigment Blue #15 based on the lack of absorption or adverse effects in a 90-day feed study in rats and mice. 147-14-8
1328-53-6
Final Rule Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds Establishment of a 3-year time-limited tolerance for residues of cryolite and/or synthetic cryolite.

May 05, 1993 -- 58 FR 26687
Data from the NTP toxicology and carcinogenesis study of sodium fluoride (TR-393) was considered in support of the tolerances. 7681-49-4
Final Decision National Ambient Air Quality Standards For Ozone. Announcement that revisions of the national ambient air quality standards for ozone are not appropriate at this time.

March 09, 1993 -- 58 FR 13008
Substantial new information has been published since the last criteria document. The NTP toxicology and carcinogenesis study on ozone (TR-440) to be peer-reviewed 11/93 was cited as an example of a study which may yield significant new information. 10028-15-6
Final Rule Chemicals: Toxic Chemical Release Reporting; Community Right-To-Know; Proposed Significant New Use Rule The EPA is partially granting a petition submitted by the Governor of New York to add 80 chemicals and 2 chemical categories to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-To-Know Act by proposing to add 68 chemicals and 2 chemical categories.

September 08, 1992 -- 57 FR 41020
The EPA used several NTP bioassays as sources of information. (TOX-18) (TR-403) (TR-314) (TR-237) (TR-039) (TR-00A) 1338-23-4
108-46-3
80-62-6
630-20-6
303-34-4
148-82-3
Final Rule Drinking Water: National Primary Drinking Water Regulations-Synthetic Organic Chemicals and Inorganic Chemicals; National Primary Drinking Water Regulations Implementation EPA is promulgating maximum contaminant level goals and National Primary Drinking Water Regulations for 18 synthetic organic and 5 inorganic chemicals.

July 17, 1992 -- 57 FR 31776
The MCLG for Di(2-ethylhexyl)adipate was derived from the NTP 2-year dietary study, TR-212. The classification of DEHP as a Group B2 (probable human) carcinogen was based on the NTP 2-year study, (TR-217) 117-81-7
103-23-1
Notice Thirtieth Report of the Interagency Testing Committee: Request for Comments Regarding Priority Testing List of Chemicals The Priority Testing List was revised by adding one chemical group, the siloxanes, and four chloralkyl phosphates.

July 09, 1992 -- 57 FR 30608
At the request of the NTP, TSCA Section 8(d) reports on health effects of bis-(4-chlorophenyl) sulfone were provided to facilitate NTP's evaluation of this chemical. 80-07-9
Notice Draft Report: A Cross-Species Scaling Factor for Carcinogen Risk Assessment Based on Equivalence of mg/kg 3/4/day The EPA, FDA, and CPSC are asking for public comments on a draft report: A Cross-Species Scaling Factor for Carcinogen Risk Assessment Based on Equivalence of mg/kg/3/4/day.

June 05, 1992 -- 57 FR 24152
Data from NCI/NTP bioassays were used to develop the report.
Notice Ethylene Bisdithiocarbamates: Notice of Intent to Cancel; Conclusion of Special Review The EPA concludes the Special Review and risk/benefit analysis of EBDCs and announces the intent to cancel registrations and to deny applications for registration for all pesticide products containing EBDCs as an active ingredient unless the registrations/applications comply with the terms and conditions of registration set forth in this Notice. The Agency has determined that use will result in unreasonable adverse effects to humans or the environment.

March 02, 1992 -- 57 FR 7484
Data from the NTP bioassay on ethylene thiourea (ETU) were used by the EPA (TR-388) 96-45-7
Proposed Rule Aryl Phosphate Base Stocks; Proposed Test Rule Including Reporting and Record-keeping Requirements EPA proposes that manufacturers, importers and processors of chemical substances in the category of aryl phosphate base stocks be required, under section 4 of the Toxic Substances Control Act to conduct testing.

January 17, 1992 -- 57 FR 2138
Reproductive toxicity was demonstrated in the continuous breeding protocol in Swiss mice (1988). The EPA will examine the results of the NTP 2-year bioassay on TCP before deciding whether further oncogenicity testing on any other aryl phosphate is needed. (TR-433) 1330-78-5
Final Rule Identification and Listing of Hazardous Waste; Wood Preserving The EPA is amending its regulations under the Resource Conservation and Recovery Act by listing as hazardous three categories of wastes from wood preserving operations.

December 06, 1990 -- 55 FR 50450
Data from the NTP bioassay on commercial grade pentachlorophenol was used for designating pentachlorophenol as a Class B sub 2 carcinogen. TR-349 87-86-5
Proposed Rule Pesticide Tolerances for Oxytetracycline This document proposes that tolerances be established for residues of the pesticide oxytetracycline in or on the raw agricultural commodities cherries and tomatoes.

August 01, 1990 -- 55 FR 31194
Data from the NTP oncogenicity study in rats fed oxytetracycline was used in support of the proposed tolerances. (TR-315) 2058-46-0
Final Rule National Primary and Secondary Drinking Water Regulations; Synthetic Organic Chemicals and InorganicChemicals EPA is proposing maximum contaminant level goals and National Primary Drinking Water Regulations for organic and inorganic chemicals.

July 25, 1990 -- 55 FR 30370
The EPA used data from the following NTP studies: di(ethylhexyl)adipate, dichloromethane, hexachlorocyclopentadiene, di(2-ethylhexl)phthalate, butylbenzyl phthalate,and tetrachlorodibenzo-p-dioxin. (TR-306) (TR-201) (TR-209) (TR-217) (TR-213) (TR-212) 75-09-2
77-47-4
1746-01-6
117-81-7
85-68-7
103-23-1
Other Chrome Antimony Titanium Buff Rutile; Toxic Chemical Release Reporting; Community Right-to-Know EPA is denying a petition to exempt Chrome Antimony Titanium Buff Rutile from reporting under the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA)

January 08, 1990 -- 55 FR 650
Based on the 4th Annual Report on Carcinogens, the NTP considers all chromium compounds to be potential carcinogens. (ROC) N/A
Other National Primary and Secondary Drinking Water Regulations; Fluoride EPA is soliciting information that has a bearing on the current standards for fluoride in drinking water.

January 03, 1990 -- 55 FR 160
EPA notes that the NTP is in the process of completing a two-year bioassay on fluoride which may provide additional insights. (TR-393) 7681-49-4

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Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Final Rule Diflubenzuron; Pesticide Tolerances The FDA is amending the food additive regulations to provide for the safe use of 4,5-dichloro-1,2-dithiol-3-one as a slimicide in the manufacture of food-contact paper and paperboard. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of tetrachloroethylene, a carcinogenic impurity resulting from the manufacture of the additive

December 15, 1999 -- 64 FR 69898
The FDA used data from the NTP Carcinogenicity Study of Tetrachloroethylene (TR-311), to estimate the upper-bound limit of lifetime human risk from exposure resulting from the use of the additive. And based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to tetrachloroethylene would result from the proposed use of the additive. 127-18-4
Final Rule Diflubenzuron; Pesticide Tolerances The FDA is issuing a final rule establishing that the over-the-counter stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded.

January 29, 1999 -- 64 FR 4535
After reviewing all of the available data, including the NTP phenolphthalein studies, the FDA concluded that phenolphthalein caused chromosome aberrations, cell transformation, and mutagenicity in mammalian cells and is reasonably anticipated to have human carcinogenic potential. TR 465: Toxicology and Carcinogenesis Studies of Phenolphthalein in F344/N Rats and B6C3F1 Mice (Feed Studies) Dunnick JK et al.,; Phenolphthalein Induces Thymic Lymphomas Accompanied By Loss Of The P53 Wild Type Allele In Heterozygous P53-Deficient (+/-) Mice,; Toxicologic Pathology 1997, 25(6): 533-540.
Final Rule Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers The FDA is amending the food additive regulations to provide for the safe use of 2,9-dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. Pigment Red 202) as a colorant for polymers used in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of para-chloroaniline, a carcinogenic impurity resulting from the manufacture of the additive.

November 03, 1998 -- 63 FR 59213
The FDA used data from the NTP carcinogenicity study of para-Chloroaniline Hydrochloride (TR-351) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed  use of the additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to para-chloroaniline would result from the proposed use of the additive
Proposed Rule Laxative Drug Products for Over-the-Counter Human Use: Proposed Amendment to the Tentative Final Monograph As part of its ongoing review of OTC drug products, the FDA is proposing to amend the tentative final monograph for over-the-counter laxative drug products by reclassifying phenolphthalein from Category I (generally recognized as safe and effective) to Category II (not generally recognized as safe and effective).

September 02, 1997 -- 62 FR 46223
Based on the results of NTP studies, the FDA considers use of phenolphthalein a potential risk to humans. The NTP findings of rodent carcinogenicity and genotoxicity in several test systems indicate that chronic use of phenolphthalein could lead to damage to the human genome and could increase the risk of malignancy. 77-09-8
Final Rule Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers Final Rule: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of 1,2-benzisothiazolin-3-one as a biocide in rubber latex for use in the manufacture of rubber articles intended for repeated use in contact with food. In its evaluation of the safety of this additive, the FDA has reviewed the safety of the additive itself and that of polychlorinated dibenzo-p-dioxins (PCDD) and dibenzo-p-dioxins impurities resulting from the manufacturing process.

November 29, 1996 -- 61 FR 231
An independent pathology review reanalyzed slides of the liver tumors observed in a bioassay of TCDD using the NTP's 1986 classification system for liver tumors. The FDA used this classification to estimate carcinogenic risk.
Final Rule Indirect Food Additives: Polymers The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a copolymer of ethyl acrylate, methyl methacrylate, and methacrylamide in combination with melamine-formaldehyde resin as a coating for polyethylene phthalate films intended for use in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of unreacted ethyl acrylate, which is a carcinogenic impurity resulting from the manufacture of the additive.

September 05, 1996 -- 61 FR 46719
The FDA used the data from the NTP Bioassay on Ethyl Acrylate (TR-259) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of the additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to ethyl acrylate would result from the proposed use of the additive. 140-88-5
Final Rule Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of phosphorylated tall oil fatty acids as pigment dispersants in polymeric films intended for use in contact with food. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of dimethyl hydrogen phosphite, which is a carcinogenic impurity resulting from the manufacture of the additive.

August 21, 1996 -- 61 FR 43156
The FDA used the data from the NTP Bioassay on Dimethyl Hydrogen Phosphite (TR-287) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of the additive.  And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to dimethyl hydrogen phosphite would result from the proposed use of the additive.
Final Rule Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of polyaryletherketone resins as a basic resin for use in food-contact materials. Although the additive itself has not been shown to cause cancer, it has been found to contain minute amounts of methylene chloride, which is a carcinogenic impurity resulting from the manufacture of the additive.

August 15, 1996 -- 61 FR 42379
The FDA used data from the NTP Bioassay on Methylene Chloride (TR-306) to estimate the upper-bound limit of lifetime human risk from exposure resulting from the proposed use of this additive. And, based on its estimates of worst case exposure, the FDA concluded that there is reasonable certainty that no harm from exposure to methylene chloride would result from the proposed use of the additive. 75-09-2
Final Rule Food Additives Permitted for Direct Addition to Food for Human Consumption: Olestra The FDA is amending the food additive regulations to provide for the safe use of sucrose esterified with medium and long chain fatty acids (olestra) as a replacement for fats and oils.

January 30, 1996 -- 61 FR 3117
The FDA used data from the NTP historical pathology database to support its rationale that there was no association between treatment with olestra and the incidence of leukemia developed by male rats during a 2-year carcinogenicity study.
Final Rule Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel The FDA is amending the food additive regulations to provide for the safe use of C.I. Pigment Yellow 138 as a colorant for all food-contact polymers. In its evaluation of the safety of this additive, the FDA has reviewed the safety of the additive itself and that of polychlorinated dibenzo-p-dioxins (PCDD) impurities resulting from the manufacturing process.

January 25, 1996 -- 61 FR 2113
An independent pathology review analyzed slides of the liver tumors observed in the bioassay of TCDD using the NTP's 1986 classification system for liver tumors. The FDA used this classification to estimate carcinogenic risk.
Proposed Rule Gastroenterology-Urology Devices; Effective Date of the Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device The FDA is proposing to require the filing of a premarket approval application for a medical device. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced.

February 15, 1995 -- 60 FR 08595
The FDA used the NTP bioassay on 4,4-Methylenedianiline Dihydrochloride in their evaluation of potential risk of polyurethane elastomer materials which may be present in the devices and may degrade over time and release degradation products which are potential carcinogens in animals. (TR-248) 13552-44-8
Final Rule Food Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium Methylene chloride is used as a solvent in the initial step in the manufacturing process of acesulfame potassium and may be present as an impurity in the additive. The FDA used risk assessment procedures to estimate the upper-bound limit of risk presented by methylene chloride.

December 01, 1994 -- 59 FR 61538
The FDA used data from the NTP bioassay on methylene chloride to calculate the potency, or unit risk, from exposure to this chemical. TR-306 75-09-2
Notice International Conference on Harmonisation; Draft Guideline on Specific Aspects of Regulatory Genotoxicity Tests; Availability Notification of publication of draft guideline "Notes for Guidance on Specific Aspects of Regulatory Genotoxicity Tests" to provide guidance on genotoxicity testing.

September 22, 1994 -- 59 FR 48734
The test battery approach is designed to reduce the risk of false negative results. However, genotoxicity test batteries as described will only detect carcinogens that act primarily via a mechanism involving direct genetic damage. According to results of the NTP (Haseman, et al, 1990), approximately 15 percent of carcinogens are not detected by the commonly used batteries of genotoxicity tests. N/A
Final Rule Secondary Direct Food Additives Permitted in Food for Human Consumption: Cellulose Triacetate Amendment of food additive regulations to provide for the safe use of cellulose triacetate as an immobilizing agent for lactase for use in reducing the lactose content of milk.

July 20, 1994 -- 59 FR 36935
Data from the NTP toxicology and carcinogenesis study of dichloromethane (TR-306) was used to calculate the risk from exposure to dichloromethane as an impurity in cellulose triacetate. 75-09-2
Proposed Rule Oral Health Care Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Oral Antiseptic Drug Products Notification of proposed rulemaking in the form of a tentative final monograph that would establish conditions under which over-the-counter oral antiseptic drug products are generally recognized as safe and effective and not misbranded.

February 09, 1994 -- 59 FR 6084
The FDA noted that benzethonium chloride is currently being evaluated for carcinogenic potential by the NTP. The agency also nominated gentian violet for study by the NTP after reviewing the available data and deciding that a definitive conclusion regarding its carcinogenic activity could not be reached. (TR-438) 121-54-0
Final Rule Food Additives Permitted for Direct Addition to Food for Human Consumption; Dimethyl Dicarbonate Amendment to the food additive regulations to provide for the safe use of dimethyl dicarbonate as a yeast inhibitor in dealcoholized and low alcohol wines, Jan 26, 1993, and in ready-to-drink tea beverages.

February 04, 1994 -- 59 FR 5317
NTP toxicology and carcinogenesis study on methyl carbamate (TR-328) was used to estimate the human cancer risk from the potential exposure to methyl carbamate stemming from the proposed use of dimethyl dicarbonate as a yeast inhibitor in wine. 598-55-0
Final Rule Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers Amendment of food additive regulations to provide for the safe use of 3,5-di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine-2,4,6-(1H,3H,5H)-trione as an antioxidant for polyester elastomers in contact with dry food and rubber articles intended for repeated use in contact with food.

January 19, 1994 -- 59 FR 2733
Because ethyl acrylate may be present in the additive, data from the NTP toxicology and carcinogenesis study on ethyl acrylate (TR-259) were used to estimate the upper-bound limit of lifetime human risk. 140-88-5
Tentative Final Rule Pesticide Tolerance and Animal Feed Additive Regulation for Fluoride Compounds Tentative Final Rule: Tentative affirmation that gelatin is generally recognized as safe (GRAS) for use as a direct human food ingredient.

May 12, 1993 -- 58 FR 27959
Data from the NTP toxicology and carcinogenesis study on pentachlorophenol (TR-349) showing PCP induces carcinogenic neoplasms in mice was used in modifying the regulation to state that there shall be no detectable levels of PCP in gelatin when tested by the method referenced in this regulation. 87-86-5
Final Rule Indirect Food Additives: Paper and Paperboard Components The FDA is amending the food additive regulations to provide for the safe use of ethyl acrylate in the manufacture of paper and paperboard intended for use in contact with food.

August 07, 1992 -- 57 FR 34865
The FDA used data from TR-259 on ethyl acrylate to estimate the upper-bound limit of lifetime human risk from exposure. 140-88-5
Final Rule Indirect Food Additives: Polymers The FDA is amending the food additive regulations to provide for the safe use of polyestercarbonate resin.

February 03, 1992 -- 57 FR 3938
Residual amounts of methylene chloride have been found in the additive. The FDA estimated the worst-case exposure to methylene chloride from the use of polyestercarbonate resin food-contact articles to be less than 15 micrograms per person per day. The FDA used data from TR-306 to estimate the upper-bound limit of lifetime human risk exposure to methylene chloride. 75-09-2
Proposed Rule Topical Acne Drug Products for Over-The Counter Human Use; Amendment of Tentative Final Monograph Proposed Rule: Amendment to final monograph for over-the counter topical acne products. This amendment reclassifies the topical acne active ingredient benzoyl peroxide to a "more-data-needed" category.

August 07, 1991 -- 56 FR 37622
Reference to NTP Init-Prom Comparative Mouse Study using different combinations of initiators and promoters including benzoyl peroxide. (TR-441) INIT/PROM
Proposed Rule General and Plastic Surgery Devices; Effective Date of Requirement for Premarket Approval of Silicone Gel-filled Breast Prosthesis. FDA is proposing to require the filing of a premarket approval application for the silicone gel-filled breast prosthesis.

May 17, 1990 -- 55 FR 20568
Any PMA must include acute, subchronic, and chronic toxicity in vitro and in vivo studies. These studies should include a separate assessment of the carcinogenic risk for each substance contained in the implant. Studies should be performed in accordance with the guide-lines issued by the NTP for all aspects of conducting the assay. N/A
Notice Urethane in Alcoholic Beverages; Research and Survey Reports The FDA announced the availability of research and survey reports on urethane in alcoholic beverages.

March 23, 1990 -- 55 FR 10816
The FDA asked NTP to initiate research to provide the toxicology data necessary to estimate the risk from urethane in alcoholic beverages. 51-79-6

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Occupational Safety and Health Administration (OSHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Supplement to California State Plan; Approval OSHA approves, subject to certain conditions, the California Hazard Communication Standard, including Proposition 65 -- the California Safe Drinking Water and Toxic Enforcement Act.

June 06, 1997 -- 62 FR 31159
In accordance with Proposition 65, California annually publishes a list of chemicals known to cause cancer or reproductive toxicity. This list includes chemicals identified as carcinogens by IARC and the NTP. N/A
Proposed Rule Dichlorvos; Notice of Preliminary Determination to Cancel Certain Registrations and Draft Notice of Intent to Cancel Proposed Rule: OSHA reopened the record for proposed revisions of the 1,3-Butadiene (BD) standard to solicit public comment on a joint labor/industry agreement recommending that OSHA reduce the permissible exposure limits and expand on some provisions that should be included in the standard.

March 08, 1996 -- 61 FR 9381
Representatives of major unions and industry groups submitted a voluntary agreement based in part, on new NTP 1,3-Butadiene data (TR-434). The recommended regulatory requirements can lead to lower and less frequent exposures for employees who work with or near BD. 106-99-0
Proposed Rule Respiratory Protection OSHA is proposing to modify its existing standards on respiratory protection so that employers will provide effective protection for employees who wear respirators. agents include saccharin and di-2-ethylhexyl phthalate (DEHP).

November 15, 1994 -- 59 FR 58884
One of the respiratory protection testing agents was di-2-ethylhexyl phthalate (DEHP). OSHA cites positive carcinogenic findings of DEHP in two rodent species by NTP as sufficient evidence to preclude its use in respirator quantitative fit testing. TR-217 117-81-7
Final Rule Hazard Communication Requirement of employers to establish hazard communication programs to transmit information on the hazards of chemicals to their employees by means of labels on containers, material safety data sheets, and training programs.

February 09, 1994 -- 59 FR 6126
Annual Report on Carcinogens published by the NTP is used by OSHA in identifying toxic substances to be regulated. N/A
Final Rule Occupational Exposure to Cadmium OSHA publishes a new standard for occupational exposure to cadmium.

September 14, 1992 -- 57 FR 42102
Clear evidence of carcinogenicity of cadmium in animals was based on NTP's definition of clear evidence of carcinogenicity from the Report of the NTP Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation.
Proposed Rule Air Contaminants Health Effects of Substances to be Regulated

June 12, 1992 -- 57 FR 26042
OSHA used data from several NTP studies. (TR-363) (TR-228) (TR-263) (TR-382) (TR-273) (TR-311) (TR-362) (TR-217) (TR-267) (TR-314) (TR-349) (TR-251) (TR-376) 74-96-4
75-35-4
78-87-5
98-01-1
79-01-6
127-18-4
106-87-6
96-18-4
117-81-7
75-05-8
75-56-9
80-62-6
87-86-5
26471-62-5
106-92-3
Proposed Rule Occupational Exposure to Methylene Chloride Notice of informal public hearings concerning OSHA's proposal to modify the existing provisions for controlling employee exposure to methylene chloride.

June 09, 1992 -- 57 FR 24438
OSHA based its preliminary estimate of human cancer risk on the NTP mouse study. (TR-306) 75-09-2

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