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Regulatory Actions for Year 1995

Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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
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
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).

Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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