Data protection considerations

Two examples of alternative approaches to cancer risk assessment would be estimations based on threshold-response (EPA, 2005a) and benchmark dose modeling (EPA, 1995, 2000). As a practical matter, if the proposed basis of safety relies on a threshold or mode-of-action characterization to dismiss or mitigate animal tumor data, PDA would reconunend that the safety narrative clearly discuss the scientific rationale and present all relevant data for consideration. In the absence of adequate evidence to the contrary, PDA presumes that certain assumptions are appropriately protective of safety, namely that (i) the induction of tumors in animals is relevant to human... 

The Commission in consultation with MS has published detailed guidance documents on the application format, documentation to be submitted in an application for an IEC s opinion paying particular attention to the information given to subjects and on appropriate safeguards for the protection of personal data. Some MS already have data protection legislation in place and the reader is encouraged to check this within each MS under consideration. 

As will be appreciated after the consideration of the provisions of the 1998 Act in Section 12.6, the standards required for obtaining and processing information form the basic building blocks of data protection and these decisions are likely to remain important and influential. On the other hand, the only case under the Data Protection Act 1984 to reach the House of Lords, R v Brown ([1996] 1 All ER 545), although containing some authoritative statements about privacy and data protection is unlikely to remain of direct relevance. The central issue in the case was the meaning of use in the context of unauthorized use which was a criminal offence by virtue of the provisions of Section 5(2) (b), and was also in the third data protection principle (see Table 12.4). In contrast, the criminal offences in the 1998 Act no longer contain this constraction and neither is it a feature of the new data protection principles. 

These issues are under consideration by the various parties involved and the Working Party on the protection of individuals with regard to the processing of personal data (set up by the Data Protection Directive) adopted a working document Processing of personal data on the Internet in February 1999. The matter has also been discussed in the... 

The next topic to address is the process of setting OELs. The rationale for setting OELs has no basis in absolute information, and the procedure to be followed may differ from country to country and from substance to substance. Scientific criteria for health protection should be used in combination with considerations of their technical and economic feasibility in a dynamic process in which the development of scientific knowledge underlies rapid changes entailing the need to periodically review the data. 

The exposure value thus yielded provides a measure of the skin exposure with and without consideration of a protective garment and gloves (personal protective equipment = PPE), and may be taken directly for comparison with appropriate data from relevant toxicity studies for assessment of the risk via the dermal route. 

If the risk assessment based on generic data and default values (after consideration of protective measures) does not provide a sufficient margin of safety, compound-specific data on the DFR will have to be developed. These data will afterwards be used in the above outlined procedure instead of generic data from literature. 

We reported an extensive LIE study of 6 and 11 analogs that included consideration of the alternative amine epimers and protonation states.28 The MC simulations were initiated from the crystal structure for the complex of 8-C1-TIBO and HIV-1 RT.50 Partial charges came from RHF/6-31G CHELPG calculations for each inhibitor. The experimental data are IC50 values for the effective concentration required to achieve 50% protection of MT- 4 cells against the cytopathic effect of HIV-1.51... 

Reliability Has to be guaranteed by statistical tests, available low-cost sensors have to be protected in order to meet the requirements, many years of experience and data available Logistics/strategic considerations No extra protection necessary, inbuilt media separation and device design for high stability and reliability possible... 

US Environmental Protection Agency (2010) Pyrethroids evaluation of data from developmental neurotoxicity studies and consideration of comparative sensitivity. EPA-HQ-OPP-2010-0378-0010. http //www.regulations.gov/ documentDetail D=EPA-HQ-OPP-2010-0378-0010. Accessed 15 Feb 2011... 

---