WP198 (ALS-1117-729076) Environmental Hazard Assessment Strategies for Materials Used in Global Manufacturing Operations.
Start time: 8:00 AM
Alston, S¹, Hannah, R², ¹ GlaxoSmithKline, Research Triangle Park, NC, USA² GlaxoSmithKline, Philadelphia, PA, USA
As part of an overall materials hazard assessment strategy, GSK has been developing ecotoxicity and environmental fate data on process materials, active ingredients, and drug product excipients. Updated hazard assessments were needed for GSK supply chain materials after the merger between GlaxoWellcome and SmithKline Beecham. A coordinated strategy was developed incorporating testing schemes, financial support, identification of key manufacturing processes, associated materials and transfer sites, regular communication with team members, and progress reports. To efficiently assess these materials for environmental hazards, a tiered approach was applied. Material assessments were prioritized based on available data, preliminary ecotoxicity QSAR estimates, timing of process transfers, and quantities utilized within the supply chain. Preliminary assessments were conducted and data gaps identified. Gaps were closed through testing schemes involving fundamental subsets of environmental fate and effects tests based on material class (actives, reagents, excipients, etc.).Test data were compiled to produce environmental hazard assessments which were distributed through the supply chain via GSK Hazard Assessment and Communication documents. Overall strategy elements, prioritization criteria, testing subsets and example data sets will be presented.

WP199 (OKO-1117-824345) Progress on the Ecological Categorization of UVCBs on the Domestic Substances List.
Start time: 8:00 AM
Okonski, A.¹, Lin, M.², Schnabel, S.³, MacDonald, D.⁴, Robinson, P.⁵, Morin, D.⁶, Costa, P.⁷, Eggleton, M.⁸, ¹ Environment Canada, Gatineau (Hull), QC, CANADA² Environment Canada, Gatineau (Hull), QC, CANADA³ Environment Canada, Gatineau (Hull), QC, CANADA⁴ Environment Canada, Gatineau (Hull), QC, CANADA⁵ Environment Canada, Gatineau (Hull), QC, CANADA⁶ Environment Canada, Gatineau (Hull), QC, CANADA⁷ Environment Canada, Gatineau (Hull), QC, CANADA⁸ Environment Canada, Gatineau (Hull), QC, CANADA
The DSL consists of approximately 23,000 substances that were in Canadian commerce during 1984-1986. Around 4400 substances are represented by UVCBs (Unknown or Variable Composition, Complex Reaction Products, and Biological Materials). According to CEPA 1999, all the DSL substances must be categorized by September 2006. Environment Canada developed a strategic approach for UVCB ecological categorization. First, UVCBs were sorted into six major streams: organics, organometallics, organic metal salts, inorganics, polymers, and biologicals. Since approaches for the ecological categorization of non-UVCB discrete organics, organometallics, inorganics, and other chemicals have already been developed, they are being implemented to categorize UVCBs that fall into these groups. Using a qualitative approach based on readily available information and expert judgment, UVCBs were further separated into two major categories: 1) low ecotoxicological concern (850 substances); 2) under review for PBiT (persistence, bioaccumulation, and aquatic toxicity). The second category represents UVCBs which require further considerations. Experimental information was used to identify pivotal values for iT, P, and B for 296, 175, and 33 UVCBs, respectively. The critical review of all these studies is continuing. In addition, attempts to derive representative molecular structures for some UVCBs were undertaken, and modeled data were produced for around 800 substances. Category approaches were also developed by Environment Canada to identify small groups of substances with similar structures and physico-chemical properties, where the ecotoxicity and environmental fate of the substances within such sub-groups would be assumed to be relatively similar. Therefore, when data are available for some of the substances from the sub-group, they are used to categorize the whole sub-group. To date, Environment Canada made categorization decisions for 1400 UVCBs, for which PBiT profiles were required, and work is on-going on the others.

WP199b (BAR-1117-825657) NEMI-CBR: National Environmental Methods Index for Chemical, Biological, and Radiological Methods.
Start time: 8:00 AM
Brass, H¹, Allgeier, S², Sullivan, D³, Keith, L⁴, Diamond, J⁵, Barbour, C⁶, ¹ USEPA, Cincinnati, OH, USA² USEPA, Cincinnati, OH, USA³ USGS, Madison, WI, USA⁴ Instant Reference Sources Inc., Monroe, GA, USA⁵ Tetra Tech Inc., Owings Mills, MD, USA⁶ Tetra Tech Inc., Owings Mills, MD, USA
The terrorist attacks of 9/11/2001 resulted in an evaluation of security risks in the many infrastructures that our Nations health and wellbeing depend upon, including contamination of public water supplies. In the event of an actual or suspected case of contamination, whatever the cause, a critical first step is the identification and analytical confirmation of the contaminant. Although it is neither possible nor necessary to plan for an attack involving all possible CBR contaminants, the World Health Organization advises water suppliers to target preparations and training on a limited, but well chosen subgroup of them, thus providing the necessary capability to deal with a far wider range of possible contaminants. By having knowledge of how to analyze for a representative group, it will enable analytical protocols to be used, perhaps with modifications, to detect many other CBR contaminants. To help meet this need, NEMI-CBR and a companion expert system, CBR Methods Advisor were developed for EPAs Water Security Division. NEMI-CBR is a compendium of analytical methods for chemical, biological, and radiological contaminants that could pose a threat to public water supplies. It is a modification of the National Environmental Methods Index (NEMI), a freely accessible database of environmental methods searchable on the Internet at (www.nemi.gov). The companion expert system, the CBR Methods Advisor, can be used to quickly guide a user to assess a threat, safely evaluate the site, collect samples, and to select the best method for a given situation in which limited information is available regarding the possible identity of an intentional contaminant. These new software tools are designed to help safeguard public water supplies.