Regulatory impact statements

VWA (Victorian WorkCover Authority). (1999). Proposed Occupational Health and Safety (Major Hazard Facilities) Regulations Regulatory Impact Statement. Melbourne VWA. 

Technical standards are issued through notice-and-comment rulemaking. After hazard identification and expert discussion, draft standards are published for public comments, which are considered in formulation of the final rule. Draft standards must be accompanied by a regulatory impact statement, including a cost-benefit analysis for standards involving substantial economic impact. 

NZ Ministry of Transport. 2010. Regulatory impact statement. Safer journeys—New Zealand s Road Safety Strategy 2010 to 2020 Increasing the safety of young drivers. Wellington, New Zealand NZ Ministry of Transport. 

The tendency in post-disaster situations is often to revise building codes and standards in order to enhance the resilience of stmctures to future disasters. However, this regulatory change induces the changes to the requirement of materials, skills, tools, and techniques in new constmction. New materials and skills may not be available in the time of reconstmction as it requires a considerable time for manufacturers to undertake the research and development, to test and release these new materials onto the market. The additional costs of the new constmction requirements are often not well reflected in the regulatory impact statement due to uncertainties and the real-time nature of disaster events. 

NRC (1982b). U.S. Nuclear Regulatory Commission. Final Environmental Impact Statement on 10 CFR Part 61 Licensing Requirements for Land Disposal of Radioactive Waste, NUREG-0945 (National Technical Information Service, Springfield, Virginia). 

USNRC. U.S. Nuclear Regulatory Commission. 1996. Generic Environmental Impact Statement for License Renewal of Nuclear Plants (NUREG-1437 Vol. 1). Washington D.C. USNRC. 

NRC. 1978. Final envinmmental impact statement related to the Wyoming Mineral Corp. Irigaray Uranium Solution Mining Project (W/oming, U.SA.). Report NUREG-0481. U.S. Nuclear Regulatory Commission. 

NYDEC. (2009). Draft Supplemental Generic Environmental Impact Statement on the Oil, Gas and Solution Mining Regulatory Program. New York Department of Environmental Conservation, Depew, NY (http //www.dec.ny.gov/energy/ 58440. html). 

Draft Regulatory Guide and Value/Impact Statement, TASK IC 010-5, Proposed Revision 2 to Regulatory Guide 1.105, Instrument setpoints, US Nuclear Regulatory Commission, December 1981. 

Loss of software support for aging versions of business critical systems can create significant business continuity and regulatory risks. Pharmaceutical and healthcare companies should provide a definitive statement on how they will maintain critical systems where support has historically been provided by third parties but that support is no longer available or set to expire. Measures need to be established to prevent adverse impact to product quality and product data and how they will ensure business continuity during any system outage. 

Figure 29.2 shows how a high-level risk assessment may be documented (see Chapter 6 for Validation Determination Statement). The seven questions cover virtually every contingency that could necessitate validation. A yes answer to any of the questions indicates that the system requires validation. The integrated chromatography data system used as an example in this case study clearly meets a regulatory documentation expectation and impacts release decisions, and thus must be validated. 

Statements made by, or on behalf of, marketing organizations during promotional audio conferences will also attract regulatory attention if they minimize crucial risk information and promote a drug or device for an unapproved new use. Incorrect, misleading, or incomplete artwork and medical information could lead to the inappropriate use of a drug or medical, device, in which case a recall of that product is usually required. These systems should therefore be validated as they can impact public health. 

CED s recent policy statement, Redefining Government s Role in the Market System, contains an extensive analysis of regulatory policies and the need to assess their impact on the economy. 

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