Health advisories, regulatory

Regulatory position Regulated metabolites in groundwater include the parent, urea, guanidine and guanidine olefin metabolites. The drinking water health advisory level (HAL) is 399 M.g L T... 

Although much of the clinical data on most of these cases are either incomplete or generally unavailable (Blumenthal, 2002), relatively detailed information has been published for six of them (Strahl etal., 1998 Brauer etal., 2002 Escher etal., 2001 Kraft etal., 2001 Russmann etal., 2001 Sass etal., 2001). These reports and the alarm caused by them in the print and electronic media have prompted a number of countries in 2002 to take regulatory action to suspend or ban the sale of kava products or issue consumer health advisories on their use (Reuters, 2002). At the time of writing, efforts are under way in a number of laboratories to scientifically substantiate these claims, but it will be some time before the controversy is adequately resolved. 

REGULATORY STATUS Criterion to protect freshwater aquatic life 0.080 pg/L/24 hr avg., concentration not to exceed 2.0 pg/L any time Criterion to protect saitwater aquatic iife concentration not to exceed 0.16 pg/L any time Criterion to protect human health preferably 0 lifetime cancer risk of 1 in 100,000 0.186 pg/L Mexico set allowable limits in coastal waters and in estuaries of 0.2 pg/L and 2.0 pg/L respectively WHO 3.0 pg/L in drinking water long term health advisory by the EPA 120 pg/L lifetime health advisory 2 pg/L for adults Maine set a guideline in drinking water of 4.0 pg/L maximum level in drinking water posed by EPA 0.2 pg/L... 

REGULATORY STATUS Criterion to protect freshwater aquatic life 35,200 pg/L based on acute toxicity Criterion to protect saltwater aquatic life 50,000 pg/L based on acute toxicity Criterion to protect human health preferably 0 MCGL 0 MCL 0.005 mg/L HAL 1 day 4 mg/L, 10 day 0.2 mg/L concentration calculated to keep the lifetime cancer risk level to 1 in 100,000 4.0pg/L USSR/UNEP MAC 0.3 mg/L lifetime health advisory by EPA 0.0007 mg/kg/day, and a drinking water equivalent of 25 pg/L the following are guidelines in drinking water set by some states 2 pg/L(New Jersey), 3 pg/L (Florida) 10 pg/L (New Mexico) 2.7 pg/L (Minnesota), 5 pg/L (California, Kansas, and Maine)... 

REGULATORY STATUS Criterion to protect freshwater aquatic life 17,500 pg/L based on acute toxicity Criterion to protect saitwater aquatic life 6,300 pg/L based on acute toxicity, 5,000 pg/L based on chronic toxicity Criterion to protect human health 14.3 mg/L lifetime health advisory 2.42 mg/L drinking water standard 2.0 mg/L USSR MAC 5 mg/L in water bodies used for household and fishery purposes the following are guidelines set by some states in drinking water 2000 pg/L (Arizona, Kansas, Minnesota, and Vermont), 100 pg/L (California and Maine), 7.0 pg/L (Kansas and Vermont), 340 pg/L (Massachusetts), 343 pg/L (Wisconsin), 750 pg/L (New Mexico), 1000 pg/L (Connecticut)... 

Regulatory and advisory bodies publish methods for ambient air analysis sueh as those issued by the British Standards Institute and the US Environment Proteetion Ageney (Tables 10.24 and 10.25, respeetively). Methods for assessment of workplace air are published by the Health and Safety Exeeutive. Some of these are generie methods (Table 10.26) whilst others are eompound speeifie (Table 10.27). Examples of other offieial methods for monitoring workplaee air quality are those published by the British Standards Institute (Table 10.28), and the US National Institute of Oeeupational Safety and Health (Table 10.29). Table 10.30 provides additional guidanee on analytieal teehniques for a seleetion of substanees. 

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. 

The consumer movement, particularly the Consumers Health Fomm, also has considerable political influence. As a result of political pressure exerted by HIV/AIDS pressure groups and industry, the DRA was reviewed, new legislation introduced and new committees established to ensure that the regulatory authority responded more efficiently to public and political needs. Professional associations, especially the Pharmacy Guild of Australia, have traditionally played an active role in decisions related to pharmaceutical regulation. The Australian Pharmaceutical Advisory Council was established by the Australian Government to advise the Commonwealth Minister for Health on pharmaceutical policy. 

Analysis of the study reports shows that the MEB in the Netherlands and the dmg regulatory authorities of Uganda and Zimbabwe are organized in a board format. The MEB, which is the main DRA in the Netherlands, is organized as a board whose members are appointed directly by the Crown. This appointment procedure makes it relatively free from the influence of other Government bodies. The MCAZ and the Ugandan NDA are also established as statutory authorities, with executive committees plus some specialized advisory committees. Although board members are appointed by the Minister of Health, their independence is established by statute. 

NICHOLAS A. ASHFORD (Chemistry, Law) is Assistant Director of the MIT Center for Policy Alternatives. He has worked at the ITT Research Institute, serves as the Chairman of the National Advisory Committee on Occupational Safety and Health, and is a consultant to several regulatory agencies. 

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