REGULATORY ENFORCEMENT

Target Group 5 Other Population 12 Enforcement / Regulatory Optional 30-50 25... 

As mentioned previously, the remedial actions specified by the enforcing regulatory agencies can vary. Unless the frequency of CCVS analyses within a sample stream is specified by regulations, it becomes a matter of judgement... 

An important aspect of environmental, health, and safety laws and regulations is enforcement. Eederal, state, and local regulatory authorities usually have large enforcement sections. In the environmental area, compliance audits are usually conducted aimually. OSHA, both federal and state, usually audits based on a faciHty s accident/incident rate. 

The most elementary function of an air pollution control agency is its control function, which breaks down into two subsidiary functions enforcement of the jurisdiction s air pollution control laws, ordinances, and regulations and evaluation of the effectiveness of existing regulations and regulatory practices and the need for new ones. 

The CAP can serve as the technical framework for a Corrective Action program. The CAP provides a "menu" of activities or information requirements that may be necessary for each phase of the process. Site-specific conditions and the nature and extent of the contamination will determine which tasks will be necessary. The necessary tasks will be enforceable through permit conditions or by an administrative order or judicial action. The (TAP can serve as a flexible engineering guide for the regulatory community in implementing their own Corrective Action Program. 

Recognizing these problems, UK food regulatory authorities have generally abandoned the use of quantitative microbial counts as enforceable standards of food quality. Despite this, the European Pharmacopoeia has introduced both quantitative and qualitative mierobial standards for non-sterile medicines, which might become enforceable in some member states. It prescribes varying maximum total microbial levels and exclusions of particular species according the routes of administration. The British Pharmacopoeia has now ineluded these tests, but suggest they should be used... 

Alternatively, the regulatory authority may be a department or division of the executive branch. Authorities of this type are headed by a director, who is appointed by the head of the executive branch or ministry. This structural arrangement allows the head of the executive branch/ministry greater influence or control over the decision-making and enforcement activities of a regulatory authority (22). 

Law enforcement is indispensable for regulation. Adequate sanctions help to deter future violations and have a significant impact on regulatory effectiveness. 

Enforcement methods provided by the manufacturer are not generally tested in the laboratories of the European regulatory authorities. Very often, proposed methods are evaluated by assessing the logic of proposed procedures and only for the completeness of validation data. For this theoretical review process, as much information as possible should be available. Recovery data from many validation experiments with different kinds of matrices and the resulting chromatograms of control and fortified samples provide the confidence needed by the referee. In the following sections, the most important aspects of this evaluation will be considered. 

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