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Regulatory Actions for Year 1996


Environmental Protection Agency (EPA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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to select which study data were needed for these HAPs, EPA reviewed the NTP's database of ongoing testing to locate unpublished studies.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

Food and Drug Administration (FDA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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.

Occupational Safety and Health Administration (OSHA)

Notice Type Title Summary of Notice NTP Information Cited CASRN
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