Regulatory requirements warnings

Regulatory requirements the world over dictate that hazardous chemicals and chemical products carry warning labels on them that convey health hazard information about such chemicals and products. Well-communicated warnings are instrumental in saving lives and protecting the health of people who use or are incidentally exposed to hazardous chemicals. Chemical product warnings that fail to warn, on the other hand, are often responsible for serious injuries and even death. 

Current regulatory requirements and chemical product warnings, for the most part, address the single chemicals in the product being addressed. There are no requirements for the consideration of the context in which the product can be reasonably expected to be used and the multiple exposures that may ensue. Benzene use provides an example. 

Part IV is devoted to regulatory requirements for toxic chemical warnings for chemicals and chemical products and the need to adjust recommended exposure levels for products containing chemical mixtures. This part also contains suggestions for limiting mixture exposures in the products we use and recommendations for limiting environmental exposures to toxic chemical mixtures. 

Pharmacists should be aware of the differences in safety standards and regulatory control between drugs and dietary supplements (Table 1). When counseling people about dietary products, pharmacists must be aware that the DSHEA allows the promotion of substances that may have variable potency, unidentified components, unproven efficacy, and unknown adverse effects. The DSHEA does not require warnings about drug interactions or medical conditions under which a dietary supplement should not be used. In view of the liberal labeling provisions of the DSHEA, pharmacists cannot trust dietary supplement company literature and should consult reliable information sources (Table 2)." ... 

A range of enforcement actions should be available to the regulatory body, such as the issuing of written requirements, warnings or directives or orders to curtail activities, the modification or revocation of licences or authorizations and the imposition of penalties. The enforcement should depend on consideration of the factors listed in para. 

Any written requirement, warning or directive should specify the nature of and the regulatory basis for each violation, deviation or unsatisfactory situation it should also specify a period of time for taking corrective action and may provide guidance on the nature of the corrective action. This is the most common form of enforconent action and should, in most cases, suffice to remedy the safety issue. 

Formal safety education for advanced students and laboratory workers should be made as relevant to their work activities as possible. Training that is conducted simply to satisfy regulatory requirements tends to subordinate the relevant safety issues to details associated with compliance. Such bureaucratic safety management has actually worked against fostering positive safety attitudes in many well-experienced laboratory workers and has undermined the credibility of warnings about bona fide hazards by emphasizing pro forma violation of rules. 

The consequences for drivers found to have an alcohol concentration of 0.02 or greater but less than 0.04. (10) At a minimum, drivers who test with a BAG of between 0.02 and 0.04 are prohibited from performing any safety-sensitive function for a minimum of 24 hours. This is a regulatory requirement. But are there any other consequences, as a matter of company policy, for these drivers Any additional consequence — whether in the form of a written warning, suspension, etc. — must be listed in your policy. 

The compressed gas industry has for many years recognized the value of precautionary labels on portable containers of compressed gases and cryogenic liquids. These labels identify the contents of the container and warn of the principal hazards. In preparing labels, the regulatory requirements set forth by the U.S. Department of Transporta-... 

Due to their reactivity, reactive adhesives and hardeners have to be stored according to special regulatory requirements. The containers of such materials should be labeled with the appropriate warning symbols and possible hazards associated with the content, as indicated in the safety data sheets. Nonetheless, under normal storage in their original packaging, they are not expected to pose any hazards. 

A warning letter is distinguishable from a notice of violation, also called an untitled letter. An untitled letter cites violations that do not meet the threshold of regulatory significance for a warning letter, but the FDA has a need nevertheless to communicate. Unlike a warning letter, an untitled letter does not include a warning statement that failure to take prompt correction may result in enforcement action and does not evoke a mandated FDA follow-up. Further, the untitled letter requests (rather than requires) a written response (from the manufacturer) within a reasonable amount of time (e.g., Please respond within 45 days ). 

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