Regulatory Impact Assessment

Health Safety Executive Regulatory Impact Assessments Proposed Maximum Exposure Limit for Piperazine and Piperazine Dihydrochloride. Jan. 2001. Accessed 4/17/02. . 

Inevitably, there will be a need to carry out a regulatory impact assessment on the resources needed to implement REACH. Not only does this have implications on ensuring a level playing field for business across the EU, it may also affect regulatory resources available for promoting international action on chemical control. 

Farmer, D., 2005. Road Safety Bill, Regulatory Impact Assessment. 

Regulatory considerations for environmental analytical methods for environmental fate and water quality impact assessments of agrochemicals... 

Some organizations develop risk assessment systems that first determine the regulatory impact of each computer system by using the following questions. If there is no regulatory impact, no validation activities are required by the regulating agencies. However, those systems can be validated for business or other reasons. 

Regulatory systems, environmental impact assessment, 10 232-233 Rehalogenating bleaches, 19 261 Reheat blow-molding process, 20 47 Rehm-Weller equation, 19 112 Rehydration bonded alumina, 2 395, 396-397... 

The REACH scheme has been controversial, with many suggested changes and improvements, but it now seems certain that it will come into force the best estimate is sometime in 2007 (63,118). Industry has been concerned about the practicalities of the scheme, for example it will often be difficult to find out the necessary but commercially sensitive details of downstream use. Industry is also concerned about the costs of compliance, not only for testing, but also in-house management and administration and scientific and regulatory advice and consultancy. Nevertheless, some of the earlier impact assessments probably over-estimated the costs, because... 

Presented as an overview of the State of Oregon s unique approach to particulate control strategy development, this review was prepared to provide those responsible for airshed management with new information on source impact assessment methods. (This material is available in the form of an audio-visual program suitable for presentation before public, regulatory or private Interest groups). 

Our assessment of the risks posed by incinerators should be the most structured of our Regulatory Impact Analyses. The detail we will be able to achieve in the other areas is uncertain, but we believe our work will represent the best that can be accomplished now. We need better tools to analyze the effects of our programs. Our two primary tools are economic analysis and risk analysis. We plan to rely heavily on them. To do less would be short-sighted and irresponsible. 

Political dimensions of risk management contribute to the quality, type and level of information needed during assessments of hazards, exposures and regulatory impacts. This book illustrates just how Member States may sometimes need to establish different levels of protection within their national territories. The analysis of the national approaches demonstrates why Member States give preference to certain risk management control instruments. 

Where the use of an apphcahon has been assessed as having a GxP impact, it does not necessarily mean that every module or area of funchonality within the software has a regulatory impact. 

It is acceptable for an orgaiuzation to determine that it only needs to validate a subset of the overall software used (that part with functionahty that has GxP impact) and not the whole apphcahon if that software is distinct. Appendix 36B indicates the data within marketing and supply applications that typically have a regulatory impact. However, regulatory authorihes will expect to see evidence of some form of impact or risk assessment that has determined that this segregation wih not present a risk to the successful operation of the system in a regulatory enviromnent. 

An upgrade of any part of a previously validated system does not necessarily mean that full revalidation is required. The Validation Plan that addresses the upgrade should incorporate an impact assessment to determine the exact nature of the change, how much of the validated system will be affected by it, and whether it would be within regulatory expectations to undertake a partial validation only. It is recommended that this assessment should take a documented risk-based approach. 

USNRC. 1986. United States Nuclear Regulatory Comission. Assessment of the public health impact from the accidental release of UP6 at the Sequoyah Fuels Corporation Facility at Gore, Oklahoma. Vol. 1. U.S. Report NUREG-1189. Washington DC. Doc No. 40-8027. 

The provision of goods and services (collectively, products) contributes to environmental impacts. Life cycle assessment (LCA) is a tool for comparing product options and for identifying opportunities for reducing related impacts. LCA provides insights that are complimentary to those of many regulatory and more site- or process-oriented risk and impact assessments. 

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