Regulatory action

Dmg products must meet the requirements estabUshed by the Center for Dmg Evaluation and Research at FDA. They must comply with the appropriate OTC Dmg Review Fiaal Rule pubHshed ia the Federal Register or must be the subject of an approved New Dmg AppHcation (NDA) filed with FDA. Products not meeting these requirements are considered by FDA to be New Dmgs without an NDA and subject to regulatory action. 

Orga.nic Colora.nts. The importance of coal-tar colorants cannot be overemphasized. The cosmetic industry, in cooperation with the FDA, has spent a great deal of time and money in efforts to estabUsh the safety of these dyes (see Colorants for food, drugs, cosmetics, and medical devices). Contamination, especially by heavy metals, and other impurities arising from the synthesis of permitted dyes are stricdy controlled. Despite this effort, the number of usable organic dyes and of pigments derived from them has been drastically curtailed by regulatory action. 

Known and suspected endocrine disrupting chemicals needed to be ranked in order of priority for possible regulatory action. 

Author s note - The accident at TMI-1 released radioactivity far below lOCFR criteria till the licen was subject to severe regulatory action and suffered severe financial loss. 

The ei feet of alternative regulatory actions on the estimated risk, including costs. md impact. 

Most human or environmental healtli hazards can be evaluated by dissecting tlie analysis into four parts liazard identification, dose-response assessment or hazard assessment, exposure assessment, and risk characterization. For some perceived healtli liazards, tlie risk assessment might stop with tlie first step, liazard identification, if no adverse effect is identified or if an agency elects to take regulatory action witliout furtlier analysis. Regarding liazard identification, a hazard is defined as a toxic agent or a set of conditions that luis the potential to cause adverse effects to hmnan health or tlie environment. Healtli hazard identification involves an evaluation of various forms of information in order to identify the different liaz.ards. Dose-response or toxicity assessment is required in an overall assessment responses/cffects can vary widely since all chemicals and contaminants vary in their capacity to cause adverse effects. This step frequently requires that assumptions be made to relate... 

In comparison to tliese background risks of everyday activities , a lifetime risk of 1 in 100,000 is relatively small. Accordingly, regulatory action will not generally be justifiable unless risks are substantially liighcr tlian this 1 in 100,000 benchmark. ... 

Tn 1985, the Federal Energy Regulatory Commission (FERC) began a series of regulatory actions designed to improve the competitiveness of the natural gas market and give the customers of interstate pipeline companies more seiwice options and thus allow ultimate consumers to benefit from deregulation of wellhead prices. 

Where sufficient toxicologic information is available, we have derived minimal risk levels (MRLs) for inhalation and oral routes of entry at each duration of exposure (acute, intermediate, and chronic). These MRLs are not meant to support regulatory action but to acquaint health professionals with exposure levels at which adverse health effects are not expected to occur in humans. They should help physicians and public health officials determine the safety of a community living near a chemical emission, given the concentration of a contaminant in air or the estimated daily dose in water. MRLs are based largely on toxicological studies in animals and on reports of human occupational exposure. 

And yet, this left the six classes of pesticides which contained detectable levels of N-nitrosamines and had to be regulated. The moratorium on these pesticides still remains in force until a policy has been established. The Agency also could not ignore that some regulatory action might have to be taJten on those pesticides that are already registered and contain detectable levels of nitroso impurities. 

Before the EPA proceeds on a regulatory action, registrants whose products exceed the 10 risk level from nitroso contamination, will be given the opport mity to lower potential exposure to applicators and other users of their pesticides. Reduction of exposure and, thus, reduction of risk can be accomplished by modification of the manufacturing process (see below), improved packaging technology, modification of application technique (e.g. closed systems), or deletion of high-exposure uses. 

Regulatory action has been taken in most countries as a result of ADR reports. This ranges from modification of dmg labels, to reclassification, to withdrawal from the market. 

In Estonia, however, regulatory action is not taken on the basis of ADR reports sent by health professionals. This is because the SAM considers that the small number of reports made in Estonia forms an inadequate basis for regulatory decision-making. 

Certain limitations of this study are worth reviewing. The FDA standard or action level for PCBs in fish sold in interstate commerce was used even though the river is not commercially fished.. In any event, a study of contamination in fish which will result in comparisons with a regulatory action level for justifying a remedial action must provide results which retain some degree of confidence. 

---