Other Statutory Requirements

Substanees hazardous to health inelude substanees labelled as dangerous (i.e. very toxie, toxie, harmful, irritant or eoiTosive) under any other statutory requirements, agrieultural pestieides and other ehemieals used on farms, and substanees with oeeupational exposure limits. They inelude harmful miero-organisms and substantial quantities of dust. Indeed any material, mixture or eompound used at work, or arising from work aetivities, whieh ean harm people s health is apparently eovered. 

Site needs should be established and documented in central URS and site-specific URS as appropriate. Wherever possible a common set of user requirements should be developed between sites using the same system. Specific local regulatory requirements should be clearly stated in addition to any other statutory requirements necessary to satisfy other bodies such as the financial reporting requirements of the Inland Revenue within the U.K. 

General compliance to standards and other statutory requirements... 

Each refiner has the flexibiUty to choose the specific formulation to produce based on the economics of the individual refineries. REG meeting the statutory requirements must be sold in the nine areas of the country which have the worst ozone (qv) problem. In addition, all other areas of the country which exceed the ozone NAAQS may elect the REG regulations, and EPA has estimated that 40% of the nation s gasoline should be subject to REG rules (66). 

The Act also places a responsibility on the employees in that they must take reasonable care to avoid injury to themselves or to others by their work activities, and cooperate with their employer and others in meeting all statutory requirements. The Act also requires that employees do not interfere with or misuse anything designed to protect their health, safety or welfare. 

Certain medicines are required to show an inverted black triangle on their promotional material, other than promotional aids, to denote that special reporting is required in relation to adverse reactions. This is not a Code of Practice or a statutory requirement. 

Other material issued by companies which relates to medicines but which is not intended as promotional material for those medicines per se, for example, corporate advertising, press releases, market research material, financial information to inform shareholders, the stock exchange and the like, and educational material for patients etc, should be examined to ensure that it does not contravene the Code or the relevant statutory requirements. 

Prior to 1976, in total contrast to the extensive testing and other pre-market approval requirements established under the FFDCA for new substances intended to be marketed as drugs, and under the FIFRA for new substances intended to be marketed as pesticides, there were no pre-market statutory requirements for new industrial chemicals to protect human health and the environment from the risks posed by such substances. In the USA, chemical manufacturers could produce and market any new industrial chemical at will and without notifying the EPA. 

Aside from the statutory requirements of utility, the other important test of patentability is novelty or unobviousness—whether the substance actually existed in nature and whether or not its isolation was obvious from the prior art. Reverting to the tungsten and aspirin cases, tungsten did exist as such in nature whereas aspirin existed previously only as part of a medically unusable crude composite. 

In all instances other than these two exceptions, safety/risk standards have uniformly been interpreted to incorporate a standard of relative safety/risk under actual conditions of use. Nowhere is this clearer than in the statutory requirement that all new drugs be proved "safe," a requirement that has existed from 1938 to this day. 

The entry into force in 2005 of the third AVIG/LACI Revision established the statutory requirements for inter-cantonal and inter-institutional cooperation. Thus, on the one hand, the cantons have been authorised under Article 85e AVIG/LACI to operate joint institutions, notably the RAV/ORP. On the other hand, their cooperation with the bodies of other social security systems, in particular social assistance agencies and IV/AI offices, are now permitted under Articles 85f AVIG/ LACI. These forms of cooperation are likewise intended to make the unemployment insurance system more efficient and to counteract the previous rigidity of the labour market integration framework (Nussbaumer 2007 2461-2462). 

The main themes for development of a sound IT architecture include (1) usability for intuitive and personalized interfaces as natural as possible to human behavior, (2) accessibility through various communication channels and devices, (3) performance for peak volumes, (4) scalability to future growth, (5) availability for access at any time and at any place as per the business needs, (6) reliability, (7) manageability for business continuity with minimal human intervention, (8) flexibility and adaptability to future business and technology changes, (9) adherence to security policies, (10) compliance to the statutory requirements for protection of privacy, and (11) viability for development and deployment in a reasonable time and at a reasonable cost with minimal risks, among others. 

The components can be extended for machine learning based on cybernetics by reflecting the output from the component on the control input so that the component can adjust the functional behavior based on the result of the previous processing. This facility enables the component to learn from experience and dynamically adjust its behavior and thus improve the intelligence and dynamic adaptability of the software component as shown in the Figure 8.10. For example, a software component for de-identification of protected personal information to comply with the privacy laws in one country or a specific industry may need to be re-developed, as shown in the Figure 8.11, to address the specific requirements in other countries, since de-identification rules are subject to the statutory requirements in each country and to the institutional privacy policies. 

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