Regulatory authorities

The USSR Academy of Sciences Interdepartmental Commission on r-DNA works as a consultative body and passes on its findings to the Central Regulatory Commissions. It is appointed by the Presidium of the USSR Academy of Sciences in agreement with the departments.  

Control at the institute and factory level is to be enforced by the Local Commissions on Recombinant DNA Mestnaya komissiya po rekombinantnym DNK). These are appointed by the director of an institute or factory and their function is to register work being carried out which involves the use of r-DNA and to enforce adherence to the new guidelines. The directors of institutes or factories (or their representatives) are responsible for the observance of these rules in establishments which come under their jurisdiction.  

The deliberate release into the environment of organisms containing r-DNA requires the authorization of the Central Regulatory Commission of the USSR Ministry of Health and/or USSR Gosagroprom and a resolution of the USSR Academy of Sciences Interdepartmental Commission on Recombinant DNA.  

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An important aspect of environmental, health, and safety laws and regulations is enforcement. Eederal, state, and local regulatory authorities usually have large enforcement sections. In the environmental area, compliance audits are usually conducted aimually. OSHA, both federal and state, usually audits based on a faciHty s accident/incident rate. 

Reportable releases under CERCLA must be reported to the National Response Center, at (800) 424-8802. Reporting under EPCRA requires notifying the facihty s LEPC (or relevant local emergency response personnel if there is no LEPC) and the SERC of any state likely to be affected. If a faciUty is near the border of another state, that state may have to be notified as well. Notification is required to be immediate, which is usually defined as within 30 minutes of the release. State or local authorities may have additional or different reporting requirements. Eailure to report release in a timely manner can result in severe penalties from the regulatory authorities. 

The Chemical Abstracts Services Registry Number and lUPAC nomenclature for PVP are [9003-39-8] and l-ethenyl-2-pyrrohdinone homopolymer, respectively however, it is known by a variety of approved names by foreign and domestic regulatory authorities. For example ... 

Sodium chlorite is not Hsted by the USEPA or any regulatory authority as a carcinogen. Studies conducted ia mice and rats did not show an increase in tumors in animals exposed to sodium chlorite in thek drinking water. Sodium chlorite has been found to have mutagenic activity in some in vitro test systems such as the Ames Salmonella reverse mutation assay without the presence of metaboHc activators. The significance of these test results in regard to human health is not clear because of the oxidizing effects of the chlorite ion (149). 

Corporate environmentalism is an evolving concept for environmental protection. In this case, business takes a pro-active stance independent of regulatory authorities. This can be in recognition of social responsibilities, but is more successful when compelled by competition in the market place. Thus, a hrm can conscientiously target environmentally aware consumers (through marketing environmentally friendly products or processes) or can be better placed for hnancial support from ethical investment funding bodies. 

Not all cyanobacterial blooms and scums contain detectable levels of toxins. Indeed, the incidence of toxicity detection by mouse bioassay, and toxin detection by HPLC among environmental samples, ranges from about 40% to However, in view of this high occurrence, it is the policy of regulatory authorities and water supply operators in some countries to assume that blooms of cyanobacteria are toxic until tested and found to be otherwise. In the absence of available analytical facilities or expertise or for logistical reasons, this precautionary principle should be regarded as sensible and prudent. 

Do employee exposures to hazardous agents exceed applicable occupational exposure limits, including those of the ACGIH and the applicable local regulatory authority If yes, explain. 

OSHA personnel or other federal, state, or loeal ageneies with regulatory authority ... 

Under certain situations, for specific equipment configurations, it may be possible to safely operate above the NFPA limit of 60% of the LFL. If this method of operation is to be considered, system-specific test data should be generated which demonstrates dial the combusdble concentradon can be controlled in a safe manner, and only then in consultadon with appropriate company and (where required) regulatory authorities. 

An additional reason for investing resources in error reduction measures is to improve the ability of the industry to conform to regulatory standards. It is likely that as the relationship between hximan error and safety becomes more widely recognized, regulatory authorities will place more emphasis on the reduction of error-inducing conditions in plants. It is therefore important that the Chemical Process Industries take the lead in developing a systematic approach and a defensible position in this area. 

Tlie views expressed in this chapter are those of the author and do not necessarily represent the views or the opinions of the Medicines Control Agency, other regulatory authorities or any of dieir advisory committees. 

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

Pharmacopoeia publications provide a final important source of information for the pharmaceutical industry, regulatory authorities, and the healthcare professions. These are concerned with establishing quality standards. These publications include monographs that define specifications for the purity and identity of established pharmaceutical ingredients, both active and non-active, together with recognised analytical methods that may be used to evaluate them. The most relevant are the United States Pharmacopoeia (USP) and the European Pharmacopoeia (Ph.Eur). 

This requires agreement from the Steering Gommittee, which then signs off the draft and releases it to the three regulatory authorities. 

The working group takes comments into consideration in preparing a revised draft. The topic leader must be a representative of a regulatory authority at this stage. 

A final recommendation and proposed implementation date are circulated to the relevant regulatory authorities. 

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