Statutory changes

Nowadays, few would challenge Alice Hamilton s position that chemists should intentionally design chemicals to be safe in addition to being efficacious with regard to use. However, until statutory changes are made in the TSCA that authorize the EPA to require that chemical manufacturers provide evidence of safety of new industrial chemical substances before such substances can be marketed, the concept of designing safer chemicals will never fully be adopted, regardless of how many more well-written papers or books are published on the topic. 

Since accession to the EU, medicines legislation in the UK has been largely derived from the pharmaceutical directives. Very little scope exists for national changes. Consultation on any statutory changes proposed is undertaken by the... 

The committee recognizes that some of its recommendations may require statutory changes. Even with this limitation, the committee encourages dialogue among members of government agencies, the public, industry, and academia to act on the recommendations set forth by this report in the best interest of our most vulnerable members of society—our infants. 

While each submission is unique and a reflection of the ingredient and its intended use, there is an opportunity to standardize the format and approach to the submission that would streamline its preparation and evaluation. The committee recommends amplifying the current approach without being prescriptive. It should be noted that some of the elements of the system proposed here are currently in place. The committee recognizes that some of its recommendations may require statutory changes. 

There are occasions where rather less serious problems are encountered and the client refuses to take any action. In these circumstances, statutory bodies like the OSHA or the fire department can enforce their views through legislation. Insurers are not in that position. They can and do increase premiums for bad risks, but they also try to persuade management by commonsense argument that changes should be made, even if this is not necessarily an economic proposition from the point of view of insurance cost. 

Part III re-enacted the law on statutory nuisance with changes to the Public Health Act 1936, controls over offensive trades being transferred to Part 1. 

The Safe Drinking Water Act (SDWA), enacted in 1974 to assure high-quality water supplies through public water system. The act is truly the first federal intervention to set the limits of contaminants in drinking water. The 1986 amendments came two years after passage of the Hazardous and Solid Waste Amendments (HSWA) or the RCRA amendments of 1984. As a result, certain statutory provisions were added to these 1986 amendments to reflect the changes made in the underground injection control (UIC) systems. 

A right to be free from unreasonable searches and seizures is declared by the Fourth Amendment, but how this right translates into substantive actual terms is not specified. Traditional constitutional and statutory legal analyses of the Fourth Amendment are heavily affected by rapidly changing societal values, fears, and security interests after the World Trade Center and Pentagon terrorist attacks of September 11, 2001. 

Drug-dependence clinics need to develop full assessment procedures and be very familiar with the changing local drug scenes so that needs can be identified early and met. Knowledge of other local services provided by both statutory and voluntary bodies is essential to avoid duplication of services and to link the facilities available. If possible the size and nature of the local drug problem should be ascertained. Surveys in East Dorset have been used to involve probation and social services and to emphasise the important needs of comprehensive school children (Pritchard et al. 1985,1986). 

A statement of the grounds of that action, which addresses the basis for the petitioner s conclusion that the changes proposed in the petition meet the statutory criteria for acceptance... 

Pharmacokinetic Measures of Systemic Exposure Both direct (e.g., rate constant, rate profile) and indirect (e.g., Cmax, Tmax, mean absorption time, mean residence time, Cmax normalized to AUC) pharmacokinetic measures are limited in their ability to assess rate of absorption. This guidance, therefore, recommends a change in focus from these direct or indirect measures of absorption rate to measures of systemic exposure. Cmax and AUC can continue to be used as measures for product quality BA and BE, but more in terms of their capacity to assess exposure than their capacity to reflect rate and extent of absorption. Reliance on systemic exposure measures should reflect comparable rate and extent of absorption, which in turn should achieve the underlying statutory and regulatory objective of ensuring comparable therapeutic effects. Exposure measures are defined relative to early, peak, and total portions of the plasma, serum, or blood concentration-time profile, as follows ... 

Under section 314.70(c) (2) (iii) of the final rule, the relaxation of acceptance criteria or deletion of a test to comply with an official compendium that is consistent with FDA statutory and regulatory requirements must be submitted as a supplement—CBE-30 (see section VUI.C.l.e of the Changes guidance). Under 314.70(d)(2)(i) of the final rule, any change in a specification made to comply with an official compendium, except the relaxation of acceptance criteria or deletion of a test that is consistent with FDA statutory and regulatory requirements, is to be submitted as an Annual Report (see section VIII.D.1 of the Changes guidance). 

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