Astellas' basic stance toward the environment as well as the health and safety of its employees is outlined under the Astellas Environment, Health & Safety Policy. Moreover, Astellas is working organizationally and continuously toward achieving this stance as described in the Astellas Environment, Health & Safety Guidelines.
Astellas Environment, Health & Safety Policy
The Astellas Environment, Health & Safety (EHS) Policy represents Astellas’ universal stance on EHS issues. The policy applies to all domestic and overseas Group companies, and forms the basis of all our corporate activities.
Rules of conduct governing environment and safety activities
At Astellas, the environment is positioned, metaphorically, as a stakeholder in our business philosophy. To conscientiously fulfill our responsibilities to the environment, we implement specific measures and initiatives based on the Astellas Group Code of Conduct.
Astellas Environment, Health & Safety Guidelines
The Astellas Environment, Health & Safety Guidelines provide unified standards to be upheld in our implementation of environmental and safety measures. These guidelines indicate the stance Astellas should aim for in the future.
In fiscal 2016, we revised the contents of the guidelines based on the results of our initiatives to date, and added the "Supply Chain Management" section. The guidelines qualitatively describe our aims, and concrete numerical targets, including their deadlines, will be stipulated through short- and medium-term action plans that will be updated every fiscal year.
|Astellas Environment, Health & Safety Guidelines|
Environmental and Safety Management System
Fundamental policies and action plans relating to EHS matters are positioned as an important issue in CSR management, and are discussed and determined by the CSR Committee. (The committee is chaired by the Chief Administrative Officer & Chief Ethics & Compliance Officer.) Measures for implementing these decisions in specific form are then examined by the Global EHS Sub-committee, which is a subordinate organization under the CSR Committee. Moreover, the CAO & CECO directly receives reports regarding risk management related to EHS, and issues any necessary instructions. In addition, cases such as investment in Climate Change Mitigation Measures and risk response related to EHS are discussed and decisions are made by the Executive Committee* or a meeting of the Board of Directors.
Each business facility formulates their own action plan taking into account such factors as the status of the facility. The facilities conduct activities in accordance with the PDCA cycle, carrying out evaluations by company-wide EHS audits, and the results are reflected in the following fiscal year’s plans and policies. Through this system, Astellas’ own PDCA cycle is rotated.
*An advisory body that discusses important matters related to management of the entire Astellas Group, and makes decisions.
Flow of the environmental management system
Status of obtaining ISO 14001 Certification
Astellas has acquired ISO 14001 certification covering all its production sites in Japan and outside Japan.
In fiscal 2017, we plan to shift to the revised ISO 14001 standard.
Environment, Health & Safety Audits
An audit team led by the officer in charge of CSR has been organized and conducts a company-wide EHS audit every fiscal year, in line with the Astellas EHS Guidelines, in order to evaluate the progress of EHS activities throughout Astellas Group.
The audit sets items to be audited according to the Astellas EHS Guideline and evaluates their level of conformity to the Guideline. It also identifies issues to be resolved and promotes efforts for continuous improvement EHS Audits.
Environment, Health & Safety Assessment System
The total environmental load resulting from the production, sale, distribution and disposal of products can usually be approximated at the research and development stages. With regard to the production and sales of pharmaceutical products, it is necessary to obtain government approval for each product. Since government approval also covers production methods and packaging specifications, when there are changes in either approved production methods or packaging, new approval must be obtained even if the changes are related to work safety or reducing the environmental impact. This entails substantial time and costs. Therefore, Astellas has introduced an EHS assessment system as a tool that requires efforts to minimize the environmental load at all stages, including research and development, production, distribution, and disposal.
Under this assessment system, we examine issues such as the reduction of air pollutant emissions and the excessive use of packaging and various safety measures prior to the commencement of commercial-scale production, including development based on the concept of green chemistry.
Operation of the Environment, Health & Safety assessment system
An assessment team conducts EHS assessments in stages for the development of products. The results determine whether development of the product can move on to the next stage.
Specifically, the assessment must identify raw materials or processes that might have a negative impact on the environment and/or employee health and safety. The progress on remedial measures must be assessed, and action plans evaluated. Countermeasures being considered are evaluated in the subsequent stages of the assessment.
Education and Training
In order to promote further improvements in its EHS activities, the Company acknowledges the critical need to ensure that all employees have a correct understanding of their own roles and responsibilities.
To this end, we are working to develop employees professionally qualified in EHS matters and improve our skill base through a wide variety of training programs, including specialized education for employees engaged in roles requiring specialist knowledge and skills in areas such as environmental conservation or hazardous operations.
We also explain our policies and site rules to construction workers at our plants, raw materials suppliers and waste disposal contractors, and request cooperation with our EHS activities.
Response to Accidents and Emergencies
Being prepared for emergency situations caused by an accident or natural disaster can help to prevent an environmental catastrophe and minimize damage. Accordingly, we have developed specific measures and procedures. Moreover, we conduct regular education sessions and training drills, and reconfirm and test the validity of our procedures, communication networks and the division of roles focusing on risks that are recognized as a high priority. In this manner, we continue to work diligently to reduce environmental risk.
In particular, the discharge of harmful substances could lead to the pollution of rivers and seas as well as cause problems at sewage treatment plants. This in turn could have a grave impact on regional communities.
In preparation for accidents and emergency situations, we are therefore systematically implementing measures for the prevention of environmental pollution, including the installation of backup equipment, while working to reduce the risk of pollution.
In addition, we are bolstering efforts to monitor operations and to measure the quality of water draining out of our plants to confirm compliance with relevant effluent standards.
Compliance with Environmental Laws and Regulations
Over the past five years, there were no infractions of laws or regulations, and no lawsuits, related to environmental issues that were identified at our business sites in Japan or overseas.
However, there was an occurrence in which a noise exceeded the upper limit of the noise agreement values agreed with the local government at the Tsukuba Biotechnology Research Center. We are proceeding with making improvements and confirming matters with the local government.
Environment-Related Accidents and Complaints
In fiscal 2017, there were no environment-related accidents in Japan. In fiscal 2015, there was an accident in which the pressure in the reaction vessel became higher than normal, and a part of the gas being generated was released into the atmosphere, in the pharmaceutical manufacturing process at the Takahagi Facilities. Because exhaust gas falls under the scope of the specific substances of the Air Pollution Control Law, we submitted an accident report, including the measures taken to prevent recurrence.
Except for this accident, Astellas has not recorded an environment-related accident in Japan over the past five years.
We received no environmental-related complaints associated with facilities operations.
Soil Contamination Assessments
In fiscal 2016, we conducted a soil contamination survey at the closed Kashima R&D Center, and reported to the city of Osaka that soil contamination had been discovered. Based on these reported results, in April 2017 the plant was designated as a contaminated area on the basis of the Soil Contamination Countermeasures Act. Astellas will demolish the center and take other appropriate action in consultation with the governmental authorities.
The substances that were discovered to be present in levels that exceeded the standards are as follows:
- Hexavalent chromium compound
- Mercury and its compounds
- Selenium and its compounds
- Lead and its compounds
- Arsenic and its compounds
- Fluorine and its compounds
Drawing on the results of soil contamination assessments completed over the past five years, no instances of contamination were detected other than the case mentioned above.