Regulatoiy processes

From all these factors, it is clear that the approval and construction of major new industrial plants or expansions is a far more complicated operation than it has been in the past, even the recent past. Stringent environmental restric tions are hkely to preclude construction of certain facilities at locations where they otherwise might have been built. In other cases, acquisition of required approves mav generate a heated technical and pohtical debate that can drag out the regulatoiy process for several years. 

Appropriate standards and guidelines should be developed and used as tools for the application of all regulatoiy processes. They should be freely available to all stakeholders, including the public, in order to increase the transparency of the DRA s operations. The same standard of regulation should be applied to all dmgs, whether they are imported and/or manufactured by the public or the private sector, and destined for domestic consumption or for export. 

A probabilistic safety analysis has been performed for all large US nuclear power plants in response to the need to perform Individual Plant Evaluations (IPEs). The NRC has issued a policy statement on the use of probabilistic analyses in the regulatoiy process. A recent document has been issued summarizing initial results from IPEs received and reviewed by the NRC. This document, NUREG-I560, Parts 1 and 2, also provides a discussion of the attributes that contribute to a high quality PSA. 

There are many other chemicals which probably should be identified as carcinogens, but have not stood the scrutiny of the regulatoiy process to make them such. This is probably, in many cases, due to special interest hy manulacturers and other groups. 

For regulatory control, repeatability is of major interest. The basic-objective of regulatory control is to maintain uniform process operation. Suppose that on two different occasions, it is desired that the temperature in a vessel be 80°C. The regulatoiy control system takes appropriate actions to bring the measured variable to 80°C. The difference between the process conditions at these two times is determined by the repeatability of the measurement device. 

The regulatoiy environment will continue to change. As of this writing, the key regulatory instrument is OSHA 29 CFR 1910.119 that pertains to process safety management within plants in which certain chemicals are present. 

Hygiene and Regulation Almost unique to MF is the influence of regulatoiy concerns in selec tion and implementation of a suitable microfilter. Since MF is heavily involved with industries regulated by the Food and Drug Administration, concerns about process stabihty, consistency of manufacture, virus reduc tion, pathogen control, and material safety loom far larger than is usually found in other membrane separations. 

Regulatory Direction There is no doubt that pollution prevention continues to be the regulatoiy direction. The development of new and more efficient processes and waste minimization technologies will be essential to support this effort. 

The issues of regulatoiy compliance, local infrastructure, and logistic concerns cannot be readily changed to achieve vastly different requirements. These concerns need be identified early in a qualification process to assure they are adequately understood and addressed. 

Since 1970 tlie field of healtli risk assessment Itas received widespread attention witliin both tlie scientific and regulatoiy committees. It has also attracted tlie attention of the public. Properly conducted risk assessments have received fairly broad acceptance, in part because they put into perspective the terms to. ic, Itazard, and risk. Toxicity is an inlierent property of all substances. It states tliat all chemical and physical agents can produce adverse healtli effects at some dose or under specific exposure conditions. In contrast, exposure to a chemical tliat lias tlie capacity to produce a particular type of adverse effect, represents a health hazard. Risk, however, is tlie probability or likelihood tliat an adverse outcome will occur in a person or a group tliat is exposed to a particular concentration or dose of the hazardous agent. Tlierefore, risk can be generally a function of exposure and dose. Consequently, healtli risk assessment is defined as tlie process or procedure used to estimate tlie likelihood that... 

The development of new processes for new functional molecules or materials, in which case a major problem is the costs and time required to achieve regulatoiy approval for the product. 

This chapter is split into three independent sections. Section 13.2 presents the ubiquitous or even universal nature of material component migration. It does not give an alarmist point of view, but instead suggests that this risk, just like other food hazards involving chronic chemical contaminants (environmental, components produced by processing of food, natural toxins), requires special attention and careM consideration beyond the regulatoiy constraints. 

As a result of regulatoiy changes in the U.S., the pipeline industry needed an alternative method to pressure testing on in-line tool inspection to assess buried pipelines [33], EDCA is a four-step process consisting of ... 

The first APIOOO plant is already under construction in China. The design has also undergone design certification by the United States (US) Nuclear Regulatoiy Commission (NRC), albeit with some work still ongoing. This assessment shows that the design and development process of the APIOOO led to outcomes that are consistent with UK ALARP expectations. 

The Regulatoiy Program of the Atomic Energy Commission," in JCAE print. Improving the AEC Regulatory Process 2 130-131, 146. 

---