National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/719266

Regulatory Actions for Year 2002




California Office of Environmental Health Hazard Assessment (OEHHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Chemical Listed Effective May 17, 2002 as Known to the State of California to Cause Cancer: Pyridine The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding pyridine to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of pyridine is effective May 17, 2002. Toxicological Endpoint: Cancer

May 17, 2002 -- Proposition 65
National Toxicology Program (NTP, 2000). Toxicology and Carcinogenesis Studies of Pyridine (CAS No. 110-86-1) in F344/N Rats, Wistar Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 470. NIH Publication No. 97-3960. 110-86-1
Notice Chemical Listed Effective April 19, 2002 as Known to the State of California to Cause Cancer: Naphthalene The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding naphthalene to the list of chemicals known to the State to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of naphthalene is effective April 19, 2002. Toxicological Endpoint: Cancer

April 19, 2002 -- Proposition 65
National Toxicology Program (NTP, 2000). Toxicology and Carcinogenesis Studies of Naphthalene (CAS No. 91-20-3) in F344/N Rats (Inhalation Studies). NTP Technical Report Series No. 500. NIH Publication No. 01-4434. 91-20-3

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Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice Sucrose Octanoate Esters; Exemption from the Requirement of a Tolerance The EPA has established an exemption from the tolerance requirements pursuant to FFDCA 408(c) and 9(d) for residues of certain Sucrose Octanoate Esters (SOEs) in or on all food commodities when applied/used in accordance with good agricultural practices.

September 25, 2002 -- 67 FR 60146
The EPA has determined, based on available toxicology data including data from an NTP genetic toxicology study, that no harm will result from aggregate exposure of residues of SOEs to the U.S. population. 124-07-2
Notice Indirect Food Additives: Polymers The EPA is soliciting public comment on whether a preliminary determination that nine contaminants do not meet all three Safe Drinking Water Act requirements is appropriate, and thus no National Primary Drinking Water Regulations (NPDWR) should be considered for these contaminants.

June 03, 2002 -- 67 FR 38222
The EPA used data from the NTP Toxicity Studies of Hexachloro-1,3-butadiene, (TOX- 1) and Naphthalene (TR-410) & (TR-500) in determining that NPDWRs should not be considered for these contaminants. 91-20-3
87-68-3
Final Rule Indirect Food Additives: Polymers EPA intends to reclassify eight inert ingredients from List 2, Potentially Toxic Inerts/High Priority for Testing to List 1 Inerts of Toxicological Concern. One of the criteria for being considered a List 1 inert ingredient is to be characterized by the NTP as an animal carcinogen in at least one species and sex.

March 08, 2002 -- 67 FR 10718
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of 2-Benzyl-4-chlorophenol (TR-424), 2-Butoxyethanol (TR-484), Butyl benzyl Phthalate (TRs 213 & 458), Diethanolamine (TR-478), Ethylbenzene (TR-466), 1,2-Epoxybutane (TR-329), 2-Mercaptobenzothiazole (TR-332), and Nitromethane (TR-461) to support its reclassification of these inert ingredients to List 1. (TR-444) 100-41-4
106-88-7
149-30-4
120-32-1
85-68-7
111-42-2
75-52-5
111-76-2
Final Rule International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures for Two Solvents,N-Methylpyrrolidone and Tetrahydrofuran. The EPA established tolerances for combined residues of the insecticide diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline (PCA) in or on pear.

February 15, 2002 -- 67 FR 7085
Information from the NTP bioassay of p-Chloroaniline Hydrochloride, TR-351, was used to establish the tolerance of diflubenzuron and its metabolites 4-chlorophenylurea and 4-chloroaniline at .50 ppm in or on pears. 20265-96-7
Notice International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures for Two Solvents,N-Methylpyrrolidone and Tetrahydrofuran. The EPA is proposing AEGLs for 8 chemicals to provide Federal, State, and local agencies with threshold short-term exposure to hazardous airborne chemicals.

February 15, 2002 -- 67 FR 7164
The EPA used data from the NTP Toxicology and Carcinogenesis Studies of Propylene Oxide (TR-267) in determining the proposed AEGL values for propylene oxide. 75-56-9

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Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
Notice International Conference on Harmonisation; Draft Recommendations for the Revision of the Permitted Daily Exposures for Two Solvents, N-Methylpyrrolidone and Tetrahydrofuran. The Food and Drug Administration is announcing the availability of draft recommendations for the revision of the permitted daily exposures (PDE) for n-methylpyrrolidone and tetrahydrofuran.

February 12, 2002 -- 67 FR 6542
Based on data from NTP Carcinogenicity Studies of Tetrahydrofuran, (TR-475), the ICH Steering Committee recommended that tetrahydrofuran be moved from class 3 into class 2. 109-99-9

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NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.