Regulatory processes

As stated previously, the original OSHA standards and regulations have come from three main sources consensus standards, proprietary standards, and federal laws that existed when the OSH Act became law. 

Another example comes from the NFPA standards. NFPA No. 30-1969, Flammable and Combustible Liquids Code, was the source standard for CFR Part 1910, Section 106. It covers the storage and use of flammable and combustible liquids that have flash points below 200°F. 

Proprietary standards are prepared by professional experts within specific industries, professional societies, and associations. They are determined by a straight membership vote, not by consensus. An example of these standards can be found in the Compressed Gas Association, Pamphlet P-1, Safe Handling of Compressed Gases. This proprietary standard covers requirements for safe handling, storage, and use of compressed-gas cylinders. 

Some of the preexisting federal laws that are enforced by OSHA include the Federal Supply Contracts Act (Walsh-Healey), the Federal Service Contracts Act (McNamara-O Hara), the Contract Work Hours and Safety Standard Act (Construction Safety Act), and the National Foundation on the Arts and Humanities Act. Standards issued under these Acts are now enforced in all industries where they apply. 

When OSHA needs to develop a new regulation or even revise an existing one, it becomes a lengthy and arduous process. This is why it took so long to get the following regulations passed  

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Leukotrienes and Prostanoids. Arachidonic acid (AA) (213) and its metabohtes are iavolved ia cellular regulatory processes ia all three principal chemical signaling systems endocrine (see Hormones), immune, and neuronal (62). FoUowiag receptor activation or iacreased iatraceUular... 

AVP is excitatory in the ventral hippocampus, either directly or by potentiation of glutamatergic responses. An inhibitory effect has been observed in AVP may be involved in the formation of long-term potentiation and thus learning and memory. However, AVP is proconvulsive, may augment the formation of dmg tolerance and dependence, and affects cardiovascular regulatory processes. 

Process systems are broadly categorized as self-regulatory and nonself-regulatory. The former is one in which a change in an external condition can cause the system to move from an initial steady state to another steady state without additional external intervention. The latter, a nonself-regulatory process system, does not achieve another steady state without additional control action once the first external change occurs. 

PMA requirements differ between preamendment and post-amendment devices. Preamendment devices are those in commercial distribution before May 28, 1976 post-amendment devices are those first commercially distributed after the date. Class III post-amendment devices that are not substantially equivalent to preamendment Class III devices are considered new devices. Manufacturers of such devices are required to obtain PMA appHcation approval before marketing these. If the post-amendment device is substantially equivalent to a preamendment device and PDA has not initiated a regulatory process specifically requiring the submission of a PMA for the device category, a 510(k) submission can be made. 

Continuous processes have lower labor costs but have higher failure risk. Batch processes can be started back up in a shorter period of time than can a complex continuous process. Batch processes are easier to take through the regulatory process than are continuous processes. Thus batch processes are often chosen for mammalian ceU culture systems, even though continuous processes can offer significant cost advantages. CeU culture costs constitute only a smaU (10—30%) fraction of the overaU cost of making a product. 

CFTR has a single-channel conductance of about 8 pS. It is present in the apical membranes of many epithelia. Its mutation leads to the potentially lethal disease cystic fibrosis. In addition to acting as a chloride channel, CFTR is also thought to regulate, e.g., the epithelial sodium channel ENaC, a molecularly unknown outwardly-rectifying chloride channel, and possibly also potassium channels and water channels. Some of these potential regulatory processes, however, are controversial. CFTR also acts as a receptor for bacteria. 

Table 3.1 The top 15 therapeutic categories on the basis of new products in the regulatory process in the United States in 2006.

Dick RB, Ahlers H. 1998. Chemicals in the workplace Incorporating human neurobehavioral testing into the regulatory process. Am J Ind Med 33 439-453. 

The Federal Drug Administration (FDA) describes the biopharmaceutical industries as self-regulated, retaining for itself the responsibility of assuring and checking on that self-regulatory process. Not surprisingly, then. 

For a skeletal element to respond to its mechanical environment, the cells in the tissue must regulate their environment in response to the mechanical stimuli they receive. The regulatory process can be thought of as a feedback loop (Figure 7.5) in which the osteocyte senses the stimulus and... 

Once vesicles detach from the cytoskeleton they are free to participate in the release process but our understanding of precisely how this is brought about is still sketchy, despite the wealth of information which has accumulated over recent years. What is clear is that it involves a complex cascade of regulatory processes focusing on proteins bound to vesicle membranes, the axolemma and some cytoplasmic factors (see Calakos... 

We shall first consider those regulatory processes which are distinctive for NCR and which make the expression of permease genes either inducible (i.e., dependent on an inducing effector molecule) or constitutive (i.e., occurring without addition of an exogenous effector). 

The regulatory process should be routinely and systematically monitored in order to identify problems in the process and determine whether the activities actually carried out are consistent with the intended course of action. Several approaches may be employed for assessing the performance of dmg regulatory authorities self-review, supervisory body review and peer review. These approaches can complement one another in appraising the performance of the DRA, as well as assisting it to identify areas for improvement. 

Registration requirements, SOPs and decision criteria are documented to ensure transparency of the regulatory process and to facilitate communication between the regulatory authority, the pharmaceutical industry and the public. 

Standards and guidelines should be established in written form for all dmg regulatory functions. These tools should then be used to guide regulation practice, as well as being made publicly available in order to ensure the transparency of the dmg regulatory process. 

Besides stiuctural constraints, e.g. human and financial resources, the way in which DRA employees perceive their jobs and how they perform are key factors in drug regulation performance. A clear sense of mission on the part of employees is important if regulatory processes are to be pursued consistently. 

Regulatory processes should be systematically monitored in order to identify problems and determine whether the actual activities match the intended actions. 

The task of the DRA is to serve the public. Its operations must therefore be transparent to both clients (e.g. drug manufacturers) and consumers. Communication with clients should be a routine activity throughout the regulatory process. Information regarding its functions and the results of decisions should also be communicated regularly to the public. 

A clear sense of the mission of the regulatory authority is important in motivating DRA staff to pursue regulatory processes in order to achieve dmg regulation. Governments should state clearly the mission and objectives of dmg regulation, so that the attainment of the intended objectives can be easily assessed. 

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