Regulatory jurisdictions

For submissions involving medical devices and/or drugs that are not clearly addressed in this agreement, sponsors are referred to the product jurisdiction regulations (21 CFR Part 3). These regulations have been promulgated to facilitate the determination of regulatory jurisdiction but do not exclude the possibility for a collaborative review between the centers. 

One particularly vexing problem for waste management professionals is that of mixed wastes (radioactive plus RCRA and/or TSCA waste) disposal. Caught between conflicting regulatory jurisdictions and remediation options, which frequently prove to be mutually exclusive, mixed waste streams and matrices contaminated with two or more types of contaminant represent a... 

As many studies submitted to pesticide regulatory jurisdictions use in vivo methodologies, but an increasing number of studies employ in vitro techniques, this section addresses data interpretation challenges with both study types. Discussion... 

Currently, for pesticide registration, there is an increasing consideration by regulatory jurisdictions of in vitro data as an alternative to in vivo dermal absorption data. At present, based on the OECD inventory and provided that levels of the pesticide remaining in the skin are included as absorbed, the results from in vitro methods seem to adequately reflect those from in vivo experiments, so supporting their use as a replacement test to measure percutaneous absorption (OECD, 2000 van de Sandt et al., 2004). This calculation, i.e. the inclusion of the amount... 

Although a comprehensive survey of occupational and residential exposure data requirements across all regulatory jurisdictions is beyond the scope of this chapter, it is evident that the majority of jurisdictions require an assessment of exposure for conventional pesticides if the proposed use pattern indicates potential handler exposure (either occupational and residential) or agricultural re-entry exposure. The extent to which exposure assessments are required/conducted for residential re-entry scenarios or bystanders, however, is less uniform. Although most jurisdictions require/conduct assessments for residential re-entry scenarios (e.g. treated turf, carpeL etc.), exposure assessment methodology for other types of bystander exposure scenarios (e.g. residential exposure in agricultural areas, direct exposure to drift, exposures from the use of pesticides in schools, daycare centers and other public places) is less mature and requires further collaboration. 

Most regulatory jurisdictions will consider a science-based rationale to waive an occupational or residential exposure data requirement. For example, under NAFTA, the USEPA and Health Canada s PMRA have agreed upon guidance for considering a waiver for inhalation exposure data. Considerations are based on volatility, engineering considerations and particle size, and are outlined in Table 10.1. 

The term biocides (referred to as antimicrobials in North America) is not defined consistently across all countries. In some regulatory jurisdictions, this term includes all non-agricultural uses associated with the control of a variety of pests, including microbes, insects, rodents, etc., which are found in industrial and residential settings. In certain jurisdictions, biocides can also include products regulated as public health products e.g. disinfectants. In other jurisdictions, biocides only include industrial and residential pesticides used to control... 

Microbial pesticides are evaluated for toxicity and infectivity prior to making regulatory decisions. As traditional dose-response-based risk assessments are not considered appropriate for microbial pesticides, regulatory jurisdictions do not typically require occupational and bystander exposure data. However, a small number of studies have monitored airborne concentrations (colony forming units/m ) of microbial pesticides following application (Teschke et al 2001), and the utility of these data should be considered by the regulatory community. 

Availability of guidance does not preclude consultation with regulatory jurisdictions during study-specific protocol development. In order to ensure that the study is applicable to multiple jurisdictions, co-operative consultation should take place. In North America, for example, protocols for exposure studies were recently finalized for heavy-duty wood preservatives, with co-operative input from both the USEPA and PMRA of Health Canada. Selection of representative USA and Canadian sites ensured that the results would be applicable to both countries. Increased co-operative consultation at the protocol development phase will increase utility of data across multiple jurisdictions and will facilitate harmonization. 

It is recognized that harmonized formats for data submissions are beneficial. Detailed guidance in this area wiU lead to a lower submission rejection rate by regulatory jurisdictions, will facilitate electronic submission, and will result in efficiency gains. There are several initiatives underway in this area. 

Most regulatory jurisdictions assume complete retention and absorption of inspirable and respirable particulates and gases. In a route-specific risk assessment... 

What are the choices for competition and security of supply on the European gas pipeline network The contractualization route in Europe would require the definition and distribution of property rights and the imposition of meticulous accounting regulations currently foreign to European regulators. It would require the synchronization of pipeline capacity across national borders within Europe and a single regulatory jurisdiction for the major trunk gas pipeline companies that requires vastly enhanced market information requirements. It would also perhaps require the structural separation of pipeline companies (critical in the US, virtually... 

A split of American regulatory jurisdictions exists for electricity transmission, and it greatly complicates the job of promulgating a single set of rules that could transform that business into a reliable inland transport network in its own right. 

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