Recognizing that our business activities benefit from the global environment, we are working to reduce environmental risks that affect biodiversity and contribute to the maintenance and conservation of biodiversity, with the aim of realizing a sustainable and prosperous society. We have endorsed the “Keidanren Initiative for Biodiversity Conservation” by KEIDANREN (Japan Business Federation) and make donations to the Keidanren Nature Conservation Fund.
For information about the “Keidanren Initiative for Biodiversity Conservation” and the list of companies and organizations that have endorsed this initiative, please see here.
We contribute to people's health and strive to maintain an abundant global environment for the next generation under the corporate philosophy “Dedicated to the Fight against Disease and Pain.” An abundant global environment (ecosystem) not only brings food, water, and other blessings to our lives, but it also contributes to mitigating climate change and disasters, restricting the generation of infectious agents, parasitic insects, etc., and stabilizing mental and cultural conditions, as well as plays an extremely important role for our health.
We assess the impact of our business activities on the global environment and promote a range of activities (environmental impact assessment of pharmaceutical products, management of chemical substances, management of living modified organisms and pathogens, pollution control of air, water, and soil, etc.) to minimize this impact. In addition, we do not operate in areas such as national parks or sanctuaries, or in areas with habitats of organisms classified as “Critically Endangered” or “Endangered” on the International Union for Conservation of Nature (IUCN) Red List.
We support the "Kunming-Montreal Global Biodiversity Framework" that was adapted by the 15th meeting of the Convention of Biological Diversity (COP15) held in Montreal, Canada in December 2022. We would like to work together with local governments, NPOs, NGOs, and other stakeholders and help halt biodiversity loss and turn it into a positive (nature positive). In addition, we have started to identify our dependence and impact on nature, including in the supply chain, as well as risks, and we are establishing science-based targets and indices in reference to the latest disclosure framework published by the Taskforce on Nature-related Financial Disclosures (TNFD).
The API (including its metabolites if it was administrated to human) produced by the manufacturing process, or discharged into the environment through excretion after the proper use and disposal of medicines may affect ecosystems due to their physiological effects, as well as their physicochemical and biological properties. In our manufacturing plants we consider the scientific characteristics of API and implement deactivation treatments, such as oxidative decomposition, reduction, and alkaline hydrolysis. We also estimate occupational exposure limit (OEL) based the results of animal testing and human clinical trials and define an API in Category 4 (chemical substances with OEL lower than 10μg/m3) or higher as "highly-active API." All wastewater containing highly-active API is outsourced to be incinerated and we do not discharge it into the environment.
We appropriately conduct the environmental assessment of API in accordance with local guidelines. We predict the hazardousness to the environment of new drug application candidates and launched APIs based on the quantitative structure-activity relationship (QSAR) using a computer simulation, and we list the results on the safety data sheet (SDS). We also implement environmental assessment sequentially for launched APIs and disclose the results on SDS.
We are working to reduce the use of chemical substances. We are also committed to reducing emissions of chemical substances not only in compliance with laws and regulations but also in recognition that these emissions may impact human health and the ecosystem.
In accordance with the Law concerning “Pollutant Release and Transfer Register (PRTR),” we have appropriately controlled chemical substances that may have harmful effects on human health and the ecosystem. In FY2022, the amount of PRTR Class 1 designated chemical substances handled in an amount of 1 ton or more was 8.7 tons and was reduced by 25% compared to FY2021. In the same fiscal year, the emissions into the air and public water/soil were 0.28 tons (reduced by 11% compared to FY2021) and zero (no emission as well as FY2021), respectively. Emissions into the environment remain at a low level. Please refer to the ESG Data for details. We also legally and appropriately manage chemical substances other than those reported. We will continue to work to reduce emissions into the environment through appropriate chemical substance management.
| Target | FY2022 results |
|---|---|
| Reduce the amount of PRTR Class 1 designated chemical substances released into the environment. | Registered emissions of chemical substances into the air and public water/soil were 0.28 tons (reduced by 11% compared to FY2021) and zero (no emission as well as FY2021), respectively; the levels were kept low. |
Waste containing PCB is disposed of appropriately in compliance with the Act on Special Measures concerning Promotion of Proper Treatment of PCB Wastes. As of FY2022, there is no high-level or low-level PCB-containing waste in our storage. We only have two electrical transformers containing low-level PCB (in use). We plan to entrust them to a treatment company that has permission to dispose of low-concentration PCB waste within the treatment deadline of March 31, 2027, which was stipulated in the above law, and dispose of them properly.
| PCB waste | Type | Classification | Number of units |
|---|---|---|---|
| High-concentration PCBs waste (PCB concentration: Greater than 0.5%) |
Capacitor, etc. | In use | 0 |
| Strage | 0 | ||
| Low-concentration PCBs waste (PCB concentration: 0.5% or less) |
Transformers, etc. | In use | 2 |
| Strage | 0 |
The management of radioisotopes is conducted appropriately in accordance with the "Act on Prevention of Radiation Hazards due to Radioisotopes, etc." and the results are reported to the Nuclear Regulation Authority as a radiation management status report every fiscal year.
As for living modified organisms and pathogens used in drug discovery research and manufacturing activities, we are preventing their spread into the environment and their leakage by complying with in-house regulations based on relevant laws and regulations such as the “Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms” (Cartagena Act) and the “Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases” (Infectious Diseases Control law). In addition, to promote the appropriate use of these research samples, the In-house Safety Committee continues to provide education and training to laboratory staff and conduct examinations on the experimental applications.
In the manufacturing plants and research institutes, we comply with the Air Pollution Control Act, the Water Pollution Control Act, the Sewerage Act, the Soil Contamination Countermeasures Act, the Act on the Assessment of Releases of Specified Chemical Substances in the Environment and the Promotion of Management Improvement, and conclude agreements on pollution prevention with local governments, in order to reduce our environmental impact.
Nitrogen oxides (NOx), sulfur oxides (SOx), and smoke dust (particulate matter: PM) are measured as air pollution indices. NOx emissions in FY2022 were reduced by 40% from the previous fiscal year to 4.9 tons in order to the introduction of high-efficiency boilers and the revision of operation conditions for facilities using city gas. Since we have no facilities using high-sulfur content fuels (heavy oil, coal, etc.), we are maintaining SOx emissions at a very low level. In addition, PM emissions in FY2022 were reduced by 12% from the previous fiscal year to 0.26 tons. Please refer to the ESG Data for details.
In order to prevent water pollution, effluent from manufacturing plants and research institutes is controlled by the stricter standard agreed with local governments or by our voluntary and stricter standard in addition to standards related to relevant laws and regulations. The public sewerage system has not been developed at Fujiyama Plant and Yamaguchi Plant. Therefore, wastewater generated from business activities at both facilities is treated with sedimentation, activated sludge, pH adjustment and disinfection at our on-site wastewater treatment facility. After cleaning wastewater, its water quality is checked, and then discharged to rivers. The biochemical oxygen demand (BOD), an index of effluent water quality, of effluent discharged to public rivers in FY2022 was at a low level of 0.15 tons. In addition, we conduct Whole Effluent Toxicity (WET) tests, which are toxicity tests using the biological response of daphnia, algae and fish, for effluent discharged into rivers from Fujiyama Plant to comprehensively assess the environmental burden caused by manufacturing plant effluent. We plan to conduct the WET tests in all manufacturing plants and research institutes by FY2025.
| Drainage site | Scope | Unit | FY2018 | FY2019 | FY2020 | FY2021 | FY2022 | |
|---|---|---|---|---|---|---|---|---|
| BOD | Total | Production and research sites | Ton | 2.2 | 1.3 | 1.2 | 1.3 | 1.2 |
| Sewerage system | 2.0 | 1.1 | 1.0 | 1.1 | 1.0 | |||
| River | 0.21 | 0.20 | 0.21 | 0.22 | 0.15 |
We provide thorough control of hazardous substances in order to prevent soil pollution. Measures are taken to prevent reagent bottles from falling over on storage shelves for reagents containing dangerous materials and hazardous materials. We also implement regular leakage checks on drainpipes and replace them with quake-resistant flexible pipes. If soil pollution is found, we will consult with the government and take appropriate measures, such as for the prevention of spreading and purification measures, etc.
In recent years, extreme weather events are occurring as a result of global warming. We have formulated manuals to prepare for accidents and emergency situations caused by such weather, and we organize training sessions to minimize environmental impacts. In addition, we conduct drills every year in preparation for accidents and emergencies that may lead to water pollution and soil contamination. In preparation for an emergency event when wastewater containing hazardous substances flows into the drainage system, we have installed a storage tank to store wastewater, and for the wastewater containing highly-active API, we have separated them from the drainage system by setting up a dedicated collection tank.
At Yamaguchi Plant, pharmaceutical products including injectable drugs are manufactured using water from the Fushino River water system (city water) as a raw material. At the Fushino River Water System Clean Campaign held in July 2023 (co-sponsored by Yamaguchi City government, Fushino River Fishermen's Cooperative, and Yamaguchi City Kaiteki Kankyo Zukuri Suishin Kyogikai [Yamaguchi City Comfortable Environment Promotion Council]), employees working at Yamaguchi Plant participated in the campaign and helped to clean the Fushino River.
At the Minase Research Institute, we are a member of the “Rikyu no Mizu” Conservation Society to protect a famous water source, which has been selected as one of the 100 best springs in Japan. In FY2022, we took part in the joint cleanup activities that are organized twice a year.
In FY2022, in addition to the aforementioned activities, we held opportunities for discussion with local governments and NPOs and exchanged opinions on what we can all do for nature conservation.