Test rules

In 1987 the U.S. Environmental Protection Agency (EPA) pubhshed a test rule under Section 4 of TSCA, 40 CFR Parts 707 and 766. This test rule... 

All the PMBs are Hsted on the U.S. EPA s Toxic Substances Control Act NonConfidential Chemical Substances Inventory (Table 8). In the early to mid-1980s, pseudocumene, mesitylene, hemimellitene, and trimethylbenzene were coveted by TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) reporting requirements (22) and by TSCA Section 8(d) for health and safety data (23). Mesitylene is the subject of a test rule subacute oral toxicity and subchtonic oral toxicity in tats were underway in 1994 (24). The Safe Drinking Water Act (SDWA) allows monitoring for pseudocumene and mesitylene at the discretion of the State (25). Of the PMBs, only pseudocumene is subject to SARA Tide III section 313 annual release reporting (26). 

False negative muscle contraction tests are very rare. To date, a negative muscle contraction test rules out MH. A false negative test can be explained by the presence of two types of muscle fibers in a MH susceptible patient the response being dependent on the proportion of the two types of muscle fibers. The K-type designation is used to describe a patient who has a positive joint halothane-caffeine contracture, but a negative separate halothane or caffeine contracture. Whether K-type individuals are MH-susceptible or not is a controversial issue. 

EPA/OPPT Test Rule Including Reporting and Recordkeeping (proposed) (aryl phosphates) Yes 40 CFR 704 and 799 57 FR 2138 EPA1992... 

Second, EPA could issue rules under S 8(a) to require periodic reports concerning the commercial development of certain new substances once they enter production. Unlike SNUR s, S 8(a) requirements would not prevent companies from continuing their production and marketing activities. Rather, EPA would review information contained in the 8(a) reports, and then could pursue control actions under its other TSCA authorities for regulating existing chemicals (i.e. 4 test rules, or 6(a) "unreasonable risk" regulat ions). 

Under TSCA, EPA also will turn its attention to requiring additional up-front testing and other data development for certain categories of new substances that consistently lack data (in the PMN s), and which are known to be inherently toxic. The primary vehicle for these additional requirements will be the 5(b)(4) "risk list," although some 4 test rules also may be used. 

These sections are all inter-related. They were intended to be that way. It should not be and is not the intent of the law that the Agency would administer each section separately. For example, Section 8 should not be used to gather information for information sake only. Section 8 is designed to help focus on those chemicals selected for consideration under a testing rule (Section 4) or regulation (Section 6). 

Proposed Test Rules. 7/18/80 - Chloromethane. 7/18/80 - Chlorinated Benzenes. 

Haworth S, Lawlor T, Mortelmas K, et al. 1983. Salmonella mutagenicity test rules for 250 chemicals. Environ Mutagen 5(Suppl. 1) 21, 37-38, 102. 

Draft Trial Assessment for Test Rule Support ... 

Specific bans on chemicals or uses have not been the most important outcome of TSCA. Only one type of chemical, PCBs, was specifically targeted in the original law and they are now outlawed in most of their uses. EPA administration of the law in its early years led to a ban of chlorofluorocarbons as aerosol propellants, restrictions on dioxin waste disposal, rules on asbestos use, and testing rules on chlorinated solvents. It has led to a central bank of information on existing commercial chemicals, procedures for further testing of hazardous chemicals, and detailed permit requirements for submission of proposed new commercial chemicals. 

Phenylhydrazone formation indicates a carbonyl compound. Since the negative Tollens test rules out an aldehyde, (A) must be a ketone. A negative iodoform test rules out the CH,C=0 group, and the reduction product, pentane, establishes the C s to be in a continuous chain. The compound is CHjCHjCOCHjCH,. 

EPA OTS Preliminary assessment information rul e Health and safety data reporting rul e Final test rule... 

EPA. 1980a. TSCA chemical assessment series, assessment of testing needs chlorinated benzenes, support document for proposed health effects test rule. Washington, DC U.S. Environmental Protection Agency. EPA 560/11-80-014. NTIS No. PB80-220296. 

Freitag, D., Lay, J.P., Korte, F. (1984) Environmental hazard profile-test rules as related to structures and translation into the environment. In QSAR Environ. Toxicol. Pmc. Workshop Quant. Struct-Act. Relat. Kaiser, K.L.E., Editor, pp. 111-136. Reidell Publ., Dordrecht. 

U.S. Environmental Protection Agency, Office of the Testing and Evaluation. Proposed Health Effects Test Standards for Toxic Substances Control Act Test Rules, 40 CFR, Part 772, Standards for Development of Test Data sub part D- Chronic Health Effects. Fed. Reg. 44(91) 27350, 1979. 

On July 24, 2008, the EPA published a proposed test rule under Section 4 of TSCA for 19 chemical substances.33 The proposed testing for each chemical under the proposed rule is deemed necessary by EPA to inform various data needs that will provide critical information about the environmental fate and potential hazards associated with these chemicals. The data will be used in conjunction with data on exposure and uses to evaluate potential health and environmental risks. 

The proficiency test rules accept three methods of identification (1) interpretation of spectrum,... 

FDA tightens testing rules in response to Lilly drug. (1994, October 29). Port Wayne Journal-Gazette, p. 3A. 

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