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Material hazard assessment

Hazard assessment and communication
GlaxoSmithKline has a structured approach to assess environment, health and safety (EHS) hazards associated with the materials used in research, development and manufacture of our products.  The information developed by our hazard assessment programme serves as the foundation for activities conducted by GSK Operations in order to meet ethical, producer responsibility and regulatory requirements to ensure the workplace is safe and the environment is unharmed. In 2006 we focused on:

• preparing for the new REACH (Registration, Evaluation and Authorisation of Chemicals) regulation that will be introduced in the EU in 2007
• preparing for the GHS (Global Harmonisation Scheme) that will impact the way we communicate hazards through safety data sheets and labelling
• developing enhanced environmental data on our new products to support recent guidelines introduced by EMEA on environmental risk assessment
• initiating a new programme to improve access to hazard information on the chemicals we buy.

Flammability, dust explosivity and electrostatics behaviour
Our in-house fire and explosion laboratory (FEL) conducts tests to determine fire and explosion  properties of materials handled within research and development and manufacturing operations.  Meeting the requirements of the EU regulations applicable to explosive atmospheres (Directive 99/92/EC, ATEX 137) continues to be one of the driving factors for such testing. Local operations continued to be supported, as requested, to meet their responsibilities to undertake appropriate fire and explosion risk assessments and to implement either effective preventive or protective measures to mitigate against the risk of fires and explosions for existing GlaxoSmithKline processes.

Environmental testing
Consistent with our commitment to product stewardship and sustainable development, GSK works continually to better understand the way in which our drug substances interact with the environment. We utilise the best science available to evaluate the potential environmental impact of our products and manufacturing processes, utilising test methods that meet ethical and international regulatory requirements.  This information is used to assess environmental risks and minimise potential environmental impacts.  Testing involves a tiered approach to assess environmental fate and ecotoxicity, the possible adverse effects on aquatic and terrestrial organisms.

Retrospective analysis of GSK’s environmental data is routinely employed to refine our testing methodology, support the development of improved environmental fate and effects models used for early assessment and improve the quality of our environmental risk assessments.  Material testing strategies are constantly assessed and were recently revised to include chronic testing, both to meet new regulatory guidelines and to improve our understanding of possible environmental effects.

We are committed to making environmental data publicly available.  Examples of this include disclosure of data for drug actives in our Safety Data Sheets (SDS) available on gsk.com and on the Swedish Doctors Prescribing Guide, FASS.se website using the voluntary disclosure system introduced by the Swedish pharmaceutical trade association (LIF).

Occupational and environmental exposure limits
GlaxoSmithKline develops occupational and environmental exposure limits for our materials in order to guide the design and selection of chemical control systems to protect our employees’ health and the environment.  These limits are established based on data from extensive testing of the materials. During 2006, our experts continued their efforts to establish limits for many new and existing chemicals.  They also prepared information and training materials to improve understanding of these workplace and environmental discharge limits and how to interpret them.

Hazard Communication
GlaxoSmithKline uses an internal, intranet system called MSDS@gsk to provide EHS hazard information in a unified format to all global operations. This system provides safety data sheets (SDS) and related information for GlaxoSmithKline materials and products and for key manufacturing and process chemicals. The information for nearly 4500 GlaxoSmithKline materials and products, is available in English, French, German, Italian, Portuguese and Spanish, and is updated regularly with new information available to the company worldwide by the day after the update.

SDSs are created for new products as they progress through the development process, in order to provide EHS information in support of clinical and consumer studies and to be available at the time of product launch.

There are over 2200 Safety Data Sheets available for pharmaceutical, biological and consumer healthcare products sold in many major global markets. These SDSs are distributed throughout the company and externally through numerous routes. For example, SDSs for US marketed products and UK marketed products are available externally on gsk.com for direct access by external customers. They are also accessible through systems GSK commercial operations use to communicate with our customers.

Safe transport of materials
Research and manufacture of pharmaceuticals involves transporting various chemical, biological and radioactive materials and products around the world. To ensure compliance with national and international transportation laws and conventions and to safeguard employees, the public and the environment, GlaxoSmithKline employs site-based transport safety advisors and specialists in business units that transport materials and products.  Dangerous Goods Advisor Safety Forums were held in the US and Europe to provide opportunities for dangerous goods experts to share best practices.

Users for the HazClass™ System launched in 2004, continued to increase through 2006. In 2007, the system’s functionality will be expanded to meet the transport needs of other areas of the business.  This centralized system for transport classification information provides classification support, transportation guidance and tracking, and emergency information for hazardous materials shipments, globally. 

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