REGULATORY ACTION INDICATORS

A hypothetical example of the application of the methodology follows in Table 5.9. The relevant data from chemical risk assessments and socio-economic analyses are entered into three columns corresponding to hazard, exposure and social mobilisation. For each of the two substances, the first row characterises the relevant scenarios according to the regulatory action indicators from Table 5.7. The second row, which is shaded in grey, then describes the key parameters that influence the probabilities associated with each action indicator. The corresponding ratings for the action indicators and the probability of occurrence indicators are presented in bold italics. 

Substance A Regulatory action indicator Medium threshold carcinogen and irritant some evidence genotoxicity Medium commonly used as a solvent for cleaning industrial equipment in all manufacturing sectors not contained in consumer products or professional products Medium evidence that the chemical can be commonly detected in environmental media, organisms or humans not persistent or bioaccumuladve substance has low substitute availability... 

Regulatory action indicator High non-threshold carcinogen mutagen Low mostly used as an intermediate open-batch use limited to a few sites not contained in professional or consumer products High persistent and bioaccumulative properties but there are no relevant monitoring data high production and import volumes technical reports indicate that several substitutes exist... 

Table 5.9 Hypothetical example of the priority-rating scheme used to compare two substances - clear cells correspond to regulatory action indicators and shaded cells to probability indicators - ratings are shown in bold italics...

Another site of action for opioids is through the regulatory actions of the central nervous system (CNS) on the immune system. Substantial evidence supports the existence of a complex, bidirectional link between the CNS and the immune system (e.g., [65]). Experimental evidence indicates that morphine s immunomodulatory effects involve central opioid receptors. An initial study by Shavit and colleagues [12] found that systemic administration of morphine, but not N-methylmorphine (a form of morphine which does not readily penetrate the blood-brain barrier), produces a naltrexone-reversible suppression of splenic natural killer cell activity in the rat. That same study showed that intracerebroventricular (icv) administration of morphine dose-dependently suppresses... 

In the first section of my talk I hope to show why measurement of these effects as a function of regulatory actions under TSCA is not practical. If such effects are not measurable, then for regulatory purposes they must be estimated, usually by extrapolation from animal experiments. I will briefly indicate that quantitative extrapolation is an uncertain business. In the second section, I will summarize TSCA s probable impact on health, methodological difficulties in measurement notwithstanding. I will conclude with some remarks about recent regulatory pronouncements which seem to indicate that if past policies have had little discernible health impact, future ones may have even less. 

Surveillance is biased sampling directed at particular carcasses or products. Surveillance comes into play when the Program receives information from monitoring or other sources, e.g., from slaughter inspection, indicating that adulterating residues may be present. Product may be held until laboratory tests determine the appropriate regulatory action. 

The FDA Web site contains a list of the testing facilities that have been inspected since October 1,1989 [39], The list provides the current name and former (if known) names of the testing facility, the dates the facility has been inspected, and the classification of the inspection results. Active toxicology laboratories, university laboratories, foreign laboratories, and inactive laboratories are listed. The list is updated quarterly. The most common outcome of inspections include NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated). For inspections with an OAI classification, regulatory and administrative actions will be recommended. Warning letters may or may not be issued with an OAI classification. 

For evaluating the extent of regulatory action based on exposure and social mobilisation, this thesis has devised a set of most-probable events that can be evaluated in terms of their potential for being of general regulatory concern, which form indicators for extent of regulatory action based on exposure or extent of regulatory action based on social mobilisation . As a separate step, it is proposed that those events be evaluated in terms of the probability of exposure... 

Table 5.7 Indicators of potential extent of regulatory action...

Qualitative rules are used for determining an overall rating for extent of regulatory action and an overall rating for the probability associated with that extent of action being necessary. The qualitative ratings for the three action indicators or the indicators for the associated probabilities are separately combined using the rules exemplified in Table 5.8. 

Indicator rating for extent of regulatory action = medium... 

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