Approach to Environmental Risk Reduction

Approach to Reduction of Environmental Risks in Business Operations

In order to reduce impacts on the environment, as well as risks related to accidents, we continue to implement the assessment and audit at each stage of the business activities.

Research and Development Stage

The volumes of materials used in pharmaceutical products are small relative to many consumer chemicals; meaning they are generally considered to have decreased environmental impacts. However, there is a need to recognize the effects that pharmaceutical products would have on the ecosystem, since they are biologically active agents and concerns about residual agents in the environment have become a significant issue to be highlighted with the development of analytical technology. Guidelines on environmental assessments for drugs were established in 1998 by the U.S. Food and Drug Administration (FDA) and in 2006 by the European Medicines Evaluation Agency (EMEA) respectively. Since then applicants have been required to provide data on environmental assessments for drugs as well as data concerning the efficacy and safety in the process of the new drug application. Takeda implements appropriate actions in accordance with the guidelines of respective countries, regarding the new products in a phase of preparation for application. In addition, in the course of the development of new products and new production processes, Takeda evaluates their environmental impacts during cycle of manufacture, use, and disposal of the products according to the environmental evaluation list from the perspectives of environmental load, waste generation, energy conservation and the preventive depletion of natural resources conservation. In this way we develop products and production processes with minimal impacts on the environment.

Production Stage

The production stage requires the greatest energy consumption and also discharges the most environmentally burdensome substances of all Takeda business activities. Therefore, we promote a reduction in the amount of environmental loads, based on the activity promotion program specifically formed by respective manufacturing sites, while accurately understanding the state of environmental loads, including energy usage, waste generation, etc. at the global production bases. As for the management of chemical substances, Takeda promotes the thorough storage management of hazardous materials and toxic substances, as well as improvement of the MSDS (Material Safety Data Sheet), while engaging in efforts toward the reduction of emissions of these chemical substances (in August 2006, catalytic combustor was introduced at the Hikari Plant to treat exhaust gas containing toluene) and reporting to government authorities in line with so-called PRTR (Pollutant Release and Transfer Register) Law in Japan. As for the global warming issue, Takeda set numerical goals in the 9th energy conservation program and as part of the efforts of the program, we have been promoting policies for fuel conversion to the one with less greenhouse gas emissions. In fiscal 2007, the fuel conversion from coal to gas is scheduled for implementation at Tianjin Takeda Pharmaceuticals Co., Ltd. in China. At each production base, we step up efforts to control any impacts on local communities and the natural environment by thoroughly implementing accident prevention measures, during both normal operation and emergency, including the occurrences of earthquake and fire.

Market

Pharmaceutical products themselves cannot be either collected or recycled. However, we strive to ensure appropriate handling of the containers and packaging materials of pharmaceutical products after their administration to patients, in accordance with relevant laws and regulations such as the Containers and Packaging Recycling Law. In addition, we have proactively introduced low-emission vehicles to be used for business purposes, including sales activities, etc. in order to limit the impact on air pollution; and consequently, 96 percent of total vehicles were rendered the government accredited low-emission vehicle as of April 2007.

Environmental Protection and Accident Prevention Audit

Takeda's environmental protection and accident prevention measures attach the most importance to reduce any risks related to environmental protection, as well as safety and accident prevention activities, with efforts made in a step-by-step fashion, in addition to fully enforcing compliance with relevant laws and ordinances. Namely, we consider the impacts on the environment to be immeasurable when involving environmental pollution and/or the occurrence of any accident, even with an aggressive target. Takeda set up a full-time audit team, whereby expert auditors conduct an environmental protection and accident prevention audit, which is designed to implement periodic checkups on environmental protection and accident prevention, at all group production and research sites, including overseas subsidiaries. Through such efforts, Takeda promotes the reduction of potential risks in the course of environmental protection and accident prevention activities for the group as a whole.
The environmental protection and accident prevention audit is implemented for each site of the Takeda group, starting with an assessment of the environmental protection and accident prevention sheet, using uniform forms filled and submitted by each site. After such preparatory assessment, the auditors are dispatched at relevant sites, whereby they perform audit activities that require several days to complete.
The environmental protection and accident prevention audit consists of two aspects, namely the "system audit" and "process audit." The system audit confirms the regulatory compliance status in terms of environmental protection and accident prevention, as well as the operation status for the management system, while the process audit verifies the status of operation of the environmental facilities and safety measures in terms of the production procedures and the operation and maintenance of manuals, etc. In addition, the "Takeda Group's Standard for Environmental Protection and Accident Prevention Work" was established as a uniform criterion, whereby each site implements environmental protection and accident prevention operation and the operational status of each site is evaluated based on this criterion through the environmental protection and accident prevention audit.

Risk Management Structure

Although it is indeed vital to discover problems through the environmental protection and accident prevention audit; it is also essential to build a structure to confirm the results and whether the reduction of any risks in the course of environmental protection and accident prevention activities has been accomplished after taking measures to improve the status. Takeda confirms the "corrective action plan" created by each site, in terms of problems highlighted through the environmental protection and accident prevention audit, and implements follow-up measures, aiming to further ensure Takeda's environmental protection and accident prevention measures by requiring a progress report for related problems, via the Monthly Report on Environmental Protection and Accident Prevention, which is submitted by each site. In addition, the audit results are combined and described in the audit report and then the report is issued to the management.

The Implementation In Fiscal 2006

In fiscal 2006, the environmental protection and accident prevention audits were implemented at six sites including U.S. and Indonesian sites. The audit requires a structure to focus on compliance issues, such as a double-check structure for measured data, and it was confirmed that operations were being conducted in line with the Takeda Group's Standard for Environmental Protection and Accident Prevention Work at each site. Furthermore, preparation for an "internal audit," scheduled for introduction in fiscal 2007, has been proceeding. This internal audit is designed to verify compatibility with the Takeda Group's Standard for Environmental Protection and Accident Prevention Work, which will be carried out by the sites themselves respectively. We aim to further improve our operations by implementing the environmental protection and accident prevention audit, as well as such self-reliant risk management conducted by each site.

Items to be audited during the environmental protection and accident prevention audit

1. System audit

• Environmental protection and accident prevention management
• Compliance assessments
• Waste
• Management of chemical substances
• Soil and groundwater contamination
• Equipment maintenance
• Accident prevention measures for manufacturing processes
• Antiearthquake measures
• Education and training
• Evaluation on progress of the corrective action plans provided at the previous audit

2. Process audit

• Overall
• Environmental aspect
• Accident prevention aspect