Third drafts

In June 1992, the American Law Institute undertook the task of drafting the Restatement (Third) of Torts "Products LiabiUty." Tentative Draft No. 2 takes the position that different HabiUty rules must apply for manufacturing defects and defects based on inadequate design or failure to warn ... 

We are grateful to the many instructors, colleagues, and students who have contributed their expertise to this edition. We would like above all to thank those who carefully evaluated the third edition and commented on drafts of this edition ... 

Profile Status Third Draft Post Public... 

In short, we return to C. P. Snow s recommendation that the scientist and humanist converse more. The conversations, analysis, and discussion should include the third culture, the technologist. Therefore, although we have not provided specihc and detailed analysis of issues related to computer use in the pharmaceutical industry, believing as we do that that sort of analysis is for the specialized philosopher doing conceptual analysis in computers ethics, we do urge that applied philosophers be part of the research team. Also, in the dynamic and flexible world of technology, applied philosophers—not just the people in the held of computers—should help draft policy statements and codes of conduct. 

ECHA (2011) Recommendation of the European Chemicals Agency (ECHA) of 20 December 2011 for inclusion of substances in Annex XIV. http //echa.europa.eu/documents/10162/ 13640/opinion draft recommendation annex xiv third en.pdf... 

Third, pharmaceutical advertisements increasingly are targeted directly to consumers. The major impetus for an increase in this technique was publication of a draft guidance by the FDA in 1997 and a final guidance in 1999 that permitted advertisements to include the purpose of the product (FDA, 1999). From 1997 to 2000, direct-to-consumer advertising in the U.S. increased from 860 million to 2.5 billion (Lancet, 2002). It must be assumed... 

Careful scrutiny of their publications, draft manuscripts, correspondence, record books, idea and plan books along with marginal notes made on their copies of various journal articles has resulted in an hypothesis that is too long to be elaborated in its entirety. A few bits and pieces will suffice for now. First of all, Osborne and Mendel believed their own experimental results and conclusions to be more correct than others unless the others agreed with them completely (not an unusual phenomenon). Second, they were convineed that Hopkins experiments were of too short a duration to truly compare his results with theirs in which p. f. m. had been used as a successful supplement for up to 80 days. Third, Osborne and Mendel were convineed of the purity of the diets they used. They prepared most of the proteins in their own labs in addition to the p. f. m. It must have been with some reluctance that they finally admitted that commerical lactose or even some of their home-made lactose carried growth promoters. 

Dr. Harold Abramson, under a contract with the CIA in 1954, had reached a similar conclusion from a preliminary trial with four subjects. Based on his clinical judgment of response intensity, he estimated the inhalation dose to be only about one-third as effective as the same oral dose. In 1966, he gave me a hand-typed draft CIA report he had never published. The ingenuity of the technique he describes, using a rudimentary aerosol chamber, is evident in the report, which is provided on the following pages. 

Harmonization of pharmacopeial standards as a practical matter began at the International Congresses of Pharmacy between 1865 and 1910 [2], but the first formal attempt can be traced to 1902. Both USP President Horatio C. Wood, M.D., and Frederick M. Power, Ph.D., an American chemist of the Wellcome Chemical Research Laboratories of London, were appointed by the U.S. Secretary of State as delegates to represent the United States government at the International Conference for the Unification of the Formulae for Heroic Medicines, a conference of 19 countries from Europe and North America [3]. The second conference occurred in 1918. The 3rd in 1925 was attended by 31 countries from all continents except Asia and Australia. They drafted a new International Convention, which came in force in 1929. It revised the 1902 agreements on 77 heroic medicines and introduced the concept of maximum dose. It also requested that the League of Nations create a permanent secretariat of pharmacopeias [4]. Andrew G. DuMez, Ph.D., represented the USP, and was officially appointed by the U.S. Public Health Service to represent the United States at this conference [4,5]. An expert committee of the League of Nations planned a third conference for 1938, but it was never convened because of World War II [2]. 

The intention of this section is to provide to the reader a rapid and comprehensive reference for the most common definitions and acronyms used in mass spectrometry. Currently lUPAC has initiated a project to update and extend the definitions of terms related to the field of mass spectrometry. The definitions presented here (Table 1.6) are from the third draft document [16]. For more details and the latest updates, please consult www.msterms.com. 

At the time of completing this book, the third edition of the VIM was in its last draft before publication. Unfortunately it was not released and so cannot be quoted as such. Some definitions in this book lean heavily on the thoughts of the VIM revisers but without attribution. Otherwise the second edition is quoted. 

Source Draft for Scientific Review, Intergovernmental Panel on Climate Change, Third Assessment Report. 

In November, 1985, the Commission submitted to the Council a draft regulation that would ban natural hormones, except for therapeutic purposes, and banned synthetic hormones altogether. In December, 1985, the Commission s proposal to amend Directive 81/602 to prohibit use of anabolics was adopted by the Council and became Council directive EC 85/649. The directive banned the use of natural hormones except for therapeutic purposes and absolutely banned the use of synthetic hormones. The directive also imposed a trade clause that required Member States to prohibit importation from third countries of live animals and of meat from animals to which have been administered in any way whatever substances with a thyreostatic, estrogenic, androgenic, or gestagenic action. Member States were required to bring this directive into force no later than January 1, 1988. 

In the United States, contaminant levels in drinking water are regulated under the Safe Drinking Water Act. The EPA regularly reviews these contaminants, and in 2008 they released a third draft Contaminant Candidate List for public review and comment [34], As part of the process to develop the list, the Agency evaluated pharmaceuticals and personal care products to identify those that had the potential to occur in drinking water provided by pubhc utilities. EPA considered 287 chemicals identified as pharmaceuticals and personal care products however, only one, nitroglycerin, was included on the draft list because most occurred at levels far below those currently associated with any adverse health effects, based on the best available human health effects data... 

ITF 2005. Third Meeting of the International Task Force on Harmonisation and Equivalence in Organic Agriculture - Report, Second Draft for Comments. FAO/IFOAM/UNCTAD, Bonn. 

I am grateful for the additional material that appears in this third edition courtesy of David Chung of the US Environmental Protection Agency, from Douglas S. Giles and Peter N. Lodal of Eastman Chemical Company, from Dr. Trevor A. Kletz, from Nir Keren of the Mary Kay O Connor Process Safety Center, from Catherine Vickers of PPG and countless others who are referenced throughout the text. I was also lucky to get talented drafting help from Manuel David. Manuel created easy-to-understand illustrations to support the narratives of the incidents. 

In response to these developments, the Organic Trade Association in the US has once more returned to developing its own independent national standards. A third draft of the American Organic Standards is being prepared at the time of writing. The aims of the American Organic Standards, as stated in draft 2 (September 1999), are to ... 

Once included in Annex XIV, the manufacturers, importers, and/or downstream users of the affected substance must request authorisation. The application is directly submitted to ECHA, which forwards the dossier to its Committee for Risk Assessment (CRA) and its Committee for Socio-Economic Analysis (CSEA) to produce a draft opinion within 10 months of submission. Applicants and interested third parties receive an opportunity to comment on the draft, whereafter the now finalised opinion is forwarded to the Commission, the Member States, and the applicant. The Commission then decides on the authorisation request following the regulatory committee procedure,27 which gives the Council veto power, but only in the rare instances where it can muster a qualified majority against the Commission measure.28... 

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