Requirements of the Act

Congress enacted the Indoor Radon Abatement Act of 1988 and set a national goal that indoor air be as free from radon as the outside air. The Act provided incentives for states to establish radon programs, conduct surveys, and develop information on the public health hazard of radon, and directed the EPA to support those programs by developing information, standards, and 

Erik Eckholm, Radon Threat is Real, But Scientists Argue Over its Severity, N.Y. Times, Sept 2, 1986, available at http //queryjiytimes.coin/gst/fullpage.htnil res=9A0DE5D71E3EF931A3 575AC0A960948260 sec=health spon=8(pagewanted=l.  

Because radon is a naturally occurring substance and the health concerns it presents are not directly caused by human intervention, the federal government could not easily propose the standard regulatory framework to deal with the evolving radon issues. Since industry had not generally caused the problem of heath risks from indoor radon, there was no industry or industry group that could be expected to remediate the problem at its own expense. 

No one had put radon, or a substance containing radon, into homes, schools, and other buildings. Unlike the preceding titles of TSCA, which mandated the EPA to regulate the culpable industries, this new amendment to TSCA mandated EPA to develop and provide information and expertise to the public and the states. The alternative of the federal government regulating the behavior of individual homeowners in this respect was not one that Congress had the will or the resomces to implement. 

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The Emergency Planning and Community Right-to-know Act (EPCRA) is administered by the ERA and state and local agencies. It affects virtually all facilities that manufacture, use, or store hazardous chemicals. The following are the reporting requirements of the Act ... 

Sections 20 and 21 - authorize citizen action to compel compliance with the regulatory requirements of the Act. 

Section 5 deals with the notification to EPA of new substances or significant new uses of existing chemicals. Table 2 outlines the information requirements of this section. The Premanufacturing Notice (PMN) requirement of the act, as required under section 5(a)(1)(A), went into effect, as mandated by Congress, 30 days after the TSCA inventory was published, according to Section 8(b). Since taking effect on July 1, 1979, over 1250 PMN s have been submitted. This activity has been one of the top agency priorities. 

It is a requirement of the Act that no changes may be made to any of the detail contained in the application without prior approval. The secretariat has been entrusted to process such applications in house. These relate to, amongst others, changes regarding the technical part of the dossier such as testing and other details, formulation cind specifications of raw materials, finished products cmd packaging materials and also include changes to the method of manufacture. 

Simplistically, approval to market a drug could be based on one positive, adequate, and well-controlled phase III study supported by a phase II study where the endpoint was a surrogate endpoint marker. For example, if it is accepted that chest x-ray findings may be indicative of pulmonary function deterioration and the claim for the drug will be preservation of pulmonary function, one adequate and well-controlled phase III study with a pulmonary function endpoint supported by one phase II chest x-ray positive finding adequately fulfills the requirements of the act. 

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