Regulations mandatory standards

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. ... 

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 ... 

One serious discrepancy exists between requirements in this Pharmacopeia and ICH guidelines beyond the relative mandatory status. USP-NF requirements are enforceable by U.S. federal and state laws and regulations. The standards give the attributes of acceptable articles already used in healthcare. A key contrast can be seen in the strict focus of the ICH, which is explicit in treating new drugs, that is, those not yet in use. The situations differ dramatically in practical consequences and breadth of application. Therefore, the goal of harmonization in some cases is not currently achievable because justification does not exist to disturb many established products in favor of the most recent new drug approval practices. 

Direct requirements for acquisition are found in Federal Acquisition Regulations (FAR) and Department of Energy Acquisition Regulations (DEAR). In addition, there are many regulations and standards that include implied requirements for the acquisition of chemicals and chemical products. Therefore, implied requirements are summarized here but are not included as mandatory requirements in this chapter. Requirements for on-site transportation of chemicals and chemical products can be found in Chapter 4 of this document. 

Conforming to mandatory and voluntary regulations and standards, incident and injury histories, the courts, and custom and practices. 

The level at which specific technical data generally appear first is that of so-called administrative regulations. There it is frequently stated that requirements of the law or of the regulation will be considered to have been complied with when the technical product corresponds to the individual specifications of the administrative regulation. Administrative regulations are standards for internal use, binding only on the administration, and are not directly mandatory for manufacturers or operators. They may, however, become indirectly mandatory. 

The focus of mine safety and health regulation is always the safety and health of persons at mines. Thus, compliance with mandatory standards developed pursuant to the Mine Act is the central responsibihty of mine operators and miners. Mandatory standards are the dos and don ts of mine safety and health. The standards are pubhshed in the Code of Federal Regulations (CER). Also pub-hshed in this same volume are various administrative regulations associated with enforcement. 

The foregoing is simply an overview of the types of regulations promulgated under the Mine Act. This chapter will not provide more details on regulations as the purpose of this chapter is not to review specific mandatory standards or administrative rules, but rather to explain the scheme developed in the Mine Act and how standards and regulations are enforced, as well as how enforcement and other administrative actions are subject to legal challenge and review. 

The content scope of allergens for labeling was established based on the Japan Standard Commodity Classification. Japan is the first country to set up mandatory food allergy labeling and to regulate it under national law. 

Various relationships have been recommended for computing the heat added to a vessel that is engulfed in fire. For regulated materials the OSHA 1910.106 criterion20 is mandatory. Other standards are also available.21 Crozier,22 after analysis of the various standards, recommended the following equations for determining the total heat input Q ... 

Petroleum pipe lines before 1969 were built to ASA (now ANSI) Standard B31.4 for hquids and Standard B31.8 for gas. These standards were seldom mandatory becanse few states adopted them. The U.S. Department of Transportation (DOT), which now has responsibility for pipe-hne regulation, issned Title 49, Part 192— Transportation of Natural Gas and Other Gas by Pipeline Minimnm Safety Standards, and Part 195— Transportation of Liqnids by Pipeline. These contain considerable material from B31.4 and B31.8. They allow generally higher stresses than the ASME Pressnre Vessel Code would allow for steels of comparable strength. The enforcement of their regulations is presently left to the states and is therefore somewhat uncertain. 

Specific adherence to mandatory regulations or recommended operating standards for the safe and effective operation of cooling systems, especially those pertaining to the control of legionellosis... 

---