Regulatory impediments

In addition to the effort required to develop a comprehensive and risk-based hazardous waste classification system based on NCRP s recommendations, several legal and regulatory impediments would need to be addressed. However, the resulting classification system would be more transparent and understandable than the separate classification systems for radioactive and hazardous chemical wastes... 

The provision of the National Energy Policy Act (NEPA, 1992) that prohibits NRC from establishing dose criteria that could be used to exempt radioactive wastes from licensing requirements for disposal clearly is an impediment to development of generally applicable exemption levels for radioactive waste. An exempt class of radioactive and hazardous chemical waste is the cornerstone of the risk-based waste classification system developed in this Report, and any legal and regulatory impediments to establishment of generally applicable exemption levels would need to be removed. 

Tsuji, H. (2001). Key transportation corridors in Northeast Asia Overcoming physical and regulatory impediments - ERINA REPORT - erina.or.jp. 

Vaccine development involves a substantial investment in time, effort, and resources. Any public or private research and producing facility should allocate huge financial and human rescues when development of vaccine is decided. The cost from research to licensure, the risks inherent in vaccine development (e.g. technological constraints, regulatory approval) and short- or long-term evaluations of scientific and financial results may constrain this activity. In the developing world, the price has been a major impediment to the introduction of new vaccines. 

However, given the current state of knowledge and methods of dose-response assessment for substances that cause stochastic responses, there appear to be important technical and institutional impediments to the use of either incidence or fatalities exclusively. Data on radiation-induced cancer incidence and chemical-induced cancer fatalities for use at the low doses and dose rates relevant to health protection are not readily available, and current regulatory guidance calls for calculation of cancer incidence for hazardous chemicals. Since use of a common measure of response for all substances that cause stochastic responses may not be practical in the near term, both measures (fatalities for radionuclides and incidence for hazardous chemicals) could be used in the interest of expediency. The primary advantage of this approach is that the measures of stochastic response for radionuclides and hazardous chemicals would be based on the best available information from studies in humans and animals, and it would involve the fewest subjective modifying factors. This approach also would be the easiest to implement. 

The FDA expects (and many other regulatory authorities require) that the QCU will have full independence from other units. This is to provide the maximum degree of assurance that the QCU s decisions will be free of conflicts of interest and other impediments. Normally, the expectation is that the head of the QCU will report to a very senior level person (CEQ, President, COO, etc.) of the company, and that there will not be a situation where the head of the QCU reports to manufacturing, marketing, or other similar functions. 

There may also be regulatory and even legal impediments to evidence-based, cost-effective best practice, which undermine one of the main advantages of demand-side subsidies. Ministries of health frequendy have norms for treating health problems—norms that do not always represent evidence-based best practice or the most cost-effective way of addressing a problem. In some cases, the norms may not have kept up with new technologies. Ministerial norms do not always apply to the private sector. Al-... 

To an extent, this impediment can be overcome by identifying convenient points for consumers to drop off their spent batteries. These can be operated by government, the private sector or both. Unfortunately, however, the initial experience of most used Ni-Cd battery collection programs has been that regulatory constraints greatly impede this effort. 

Experiments in which suspect carcinogens are administered to animals in massive quantities over relatively short periods of time have been challenged on scientific grounds and are confusing and often distrusted by laymen who myopically can only see the differences between the experimental process and real life. It is true to say that the "800 cans of diet soda" perception has been a serious impediment to the credibility of modern toxicology and the resultant regulatory processes. There can be no doubt that in the environment and in certain occupational situations, there are chemical agents which can increase the likelihood or threat of human cancer. 

The topic REACH will not be covered in this chapter because of its complexity and too many open questions and answers respectively at the time of this writing. I hope, however, that in exchange a brief introduction to the historic development of the existing regulatory framework can be of help to understand the Safety Aspects, which are the background of the actual regulations as well as the forthcoming impediments in connection with REACH. 

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