Mandatory standards

This act selected some dozen key residential appliances and proposed industry-tvide voluntary targets for energy efficiency improvement. If industry could not meet these volnntary targets, which averaged a 20 percent reduction in energy use compared to then-current figures, mandatory standards wonld be estab-... 

The prospect of a patchwork of state standards became a cause of great concern to manufacturers. When President Jimmy Carter was elected, he proposed that mandatoi y standards be set by the Department of Energy (DOE) to replace the voluntary efficiency targets. Wliile opposing mandatory standards at the federal level, manufacturers acquiesced to the National Energy Conservation and Policy Act (NECPA) of 1978, which required DOE to set appliance efficiency standards for residential products. In return, manufacturers were able to obtain a requirement for DOE to evaluate the impacts on manufacturers that standards would impose and to consider them in setting the standards. 

With the promulgation of the OSHA mandatory standards for exposure to cotton dust ( ), it is now assumed that prolonged exposure to cotton dust is a cause of chronic respiratory effects. Thus, there seems to have been a straightforward interpretation of complex and conflicting medical literature. This paper presents a review of the literature with emphasis on cause and effect relationship consistent with reported epidemiological data. 

All values are expressed as ng/ml except alcohol, which is expressed as grams/100 ml. DHHS mandatory standards for federal agencies monitor only for five major drugs of abuse. All laboratories are certified and use the same cutoff values as regulated by SAMHSA. See 49CFR40.87. ... 

Mandatory standard format for text and presentation of results... 

Exchanging best practices, however, is not sufficient. The best companies go beyond that and ensure that best practices are truly applied, by defining clear and mandatory standards which will be redefined as necessary over time and applied throughout the entire organization. Deviation from known best practices for no good reason is well known to be the biggest enemy of an efficient production system. Creativity is still allowed, but not to deviate from a standard, only to improve it. 

It is considered necessary to involve all governmental entities that have the responsibility in conformity assessment to regulations in the establishment of sectorial reference laboratories. From this standpoint, more collaboration is expected between CENAM and public sectorial laboratories, which are the technical authorities in the surveillance of mandatory standards and regulations. The idea is to give them a metrological responsibility in that sector called sectorial reference laboratories. Their functions are expected to be as follows ... 

FIGURE 3.2 Response function superimposed on screening and mandatory standards. 

The difference between decision making on the basis of a standard alone and on the basis of a standard plus other information can be described as one aspect of the direct versus the indirect model. In the direct model, action is defined exactly as that needed to secure compliance with the standard, for example, as permit conditions for discharges to water that are calculated to meet an environmental standard in a river. The classic cases here are substances like ammonia or cadmium in rivers and other mandatory standards in various European directives. 

TABLE 3.1 Examples of meaning of screening and mandatory standards.34... 

After the excipient has seen extensive utilization in multiple marketed products, the regulatory system has a process for review of the data resulting in possible inclusion of the monograph in the Japanese Pharmacopoeia (JP). The JP defines the mandatory standards for substances used in a pharmaceutical product. Inclusion in the JP establishes precedent status for the excipient and this notation permits use of the material in new drug products under defined conditions without the need to submit extensive supporting data. 

The two mandatory standards are Annex 1 of the European Union s GMPs and the FDA s 1987 Guideline on Sterile Drug Products Produced by Aseptic ProcessingS The FDA document is under review at the time of writing this article. 

The first of the two non-mandatory standards is contained in Section 1116 of the USP. It should be explained that this is a general chapter of the USP and is not thereforemandatory unless referenced in a USP monograph. At time of writing. Section 1116 is not referenced in any monographs. 

Both the early Federal regulatory statutes and the more recent ones employ a wide variety of control mechanisms. These include private enforcement, government policing of the marketplace, development of voluntary and mandatory standards, and various forms of premarket notification, testing, and approval. 

The marking must contain, in accordance with the requirements of the Czechoslovakian Pharmacopoeia, or other mandatory standards, the Latin or Slovak name, the composition in the case of other preparations, as well as the batch and the expiration date. 

Section 4.1 consolidates the inventory and tracking requirements for the workplace, and includes specific regulatory reporting requirements. Section 4.2 consolidates those requirements that do not directly require an inventory of hazardous chemicals, but for which use of a chemical inventory and tracking system would be necessary for compliance with mandatory standards, or would facilitate compliance. 

In addition, there are two categories of standards adherence (1) voluntary standards, which carry no inherent power of enforcement, but provide a reference point of mutual understanding, and (2) mandatory standards, which are incumbent upon those to whom the standard is addressed, and enforceable by the authority having jurisdiction. 

Mandatory standards imply that some authority has made them obligatory. Mandatory standards can be written by the authority having jurisdiction, or they can be adapted from documents prepared by others as proprietary or consensus standards. The authority having jurisdiction can be a local hospital or even a department within the hospital, a professional society, a municipal or state government, or an agency of the federal government that has regulatory powers. 

Safety and loss prevention professionals should not be afraid to try new ideas and programs out of fear of failure. Because of the nature of the safety and loss prevention profession, most professionals have been schooled to adhere to the mandatory standards strictly, without deviation, and to always follow the well-worn path. For most situations, this course of action has been successful however, what happens when there is no standard, no track record, or no simple solution ... 

Be knowledgeable of mandatory standards and make copies available to employees for review upon request. 

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