Achieving and maintaining a high level of safety over the lifetime of nuclear facilities and activities requires a sound legal and regulatory framework. The IAEA seeks to strengthen such a framework in its member States through its security standards and verification services. As an assessment methodology, the Global CCS Institute indicator uses a comparison between different models and contrasts national circumstances to determine the scope of a single structural legal and regulatory responsibility for the implementation of CCUS projects. All RAW must be identified and checked and the amount of RAW must be kept to a minimum. In the various stages of pre-RAW pre-elimination management, RAW must be characterized and classified according to the requirements set or approved by the regulatory authority. Similar to the FDA in the United States, if there is insufficient data to demonstrate substantial equivalence with an existing approved device, clinical trials may be required. An ethics committee and the MHRA or other body must approve the studies conducted and studies must be conducted according to strict standards of confidentiality and ethics. Once the MHRA has approved a device, the manufacturer is also responsible for ensuring that the device is safe through post-market surveillance, complaint handling, documentation and other processes. In order to harmonise broad aspects of medical device regulation, such as software as medical devices, the International Medical Device Regulatory Forum was founded in February 2011. This voluntary collective of medical device regulators from around the world, including Europe, Asia, America and Africa, works to harmonize regulatory positions and concepts. Unfortunately, there are few equivalent organizations that attempt to harmonize other aspects of health legislation and regulations. Each of these functions will operate within a framework that will determine (1) the principles followed, (2) the necessary policies and regulations, (3) the guidelines provided to institutions and individuals, (4) the standard documents and SOPs applicable at the operational level, and (5) the human resources competencies required at all levels.
The Legal and Regulatory Framework Matrix category covers general issues related to laws, regulations and policies adopted by governments, including stakeholder participation and input into the decision-making process. the impact or absence of these government efforts on citizens; and mechanisms for citizens to provide feedback. The regulator must establish rules for the development of RAW management facilities and activities and establish procedures to meet the requirements of the various stages of the licensing process. It shall review and assess the safety case for RAW management facilities and activities prepared by the operator, both prior to approval and at regular intervals during operation. It is also necessary to make arrangements for the issuance, amendment, suspension or withdrawal of authorisations under the necessary conditions and the regulatory body shall carry out activities to verify that the operator complies with those conditions. Operators` organizations have primary responsibility for safety and are required to conduct safety assessments and develop a safety case to demonstrate safety. They must also ensure that activities necessary for site selection, planning, construction, commissioning, operation, shutdown and decommissioning are carried out in accordance with legal and regulatory requirements. The interdependencies between all stages of pre-disposal management of RAW and the impact of the planned disposal option must be duly taken into account, and regulators must ensure that different operators` organisations are responsible for different aspects of waste management such as treatment, transport, storage and disposal. An integrated approach must also be taken in terms of safety and security when disposing of RAW prior to disposal.
The quality of all work affecting safety must be of a high standard and, in this regard, appropriate management systems must be applied at all stages and elements of the work performed. Thus, the yawning gap between political declarations, legal objectives and mandates, on the one hand, and local economic reality, on the other, must be placed in a distinctive trilemmatic Indian context. The enormous constraints on India`s land and water resources to meet both endemic food poverty and growing food demand are exacerbated by almost insurmountable obstacles to agricultural development, including land fragmentation and political corruption. The focus on food security and its current link to economic development, based on a carbon-intensive fossil energy pathway, created an almost hostile environment for biofuel development and prevented India from turning sweetness into energy (with an apology to Mintz, 1985). While this chapter has focused on the United States, it is important to recognize that each country has a different regulatory and legal framework.