Proper Management of Pollutant Release and Transfer Register (PRTR) Substances
Chemical substances that are used in the research and development and production of pharmaceutical products include some substances subject to the PRTR system that could have an impact on the environment. The amounts of these substances handled, released into the environment and transferred as waste need to be understood and properly managed. Therefore, in addition to using our unique reagent management system to monitor the usage of reagents by the Eisai Group in Japan, we are also striving to reduce our usage of PRTR substances and to control their release into the environment. With regard to the usage of these substances exceeding the amount of the designated limit, we surely report this matter to the relevant prefectural governments without delay.
The amount of chemical substances used in the manufacturing processes depends largely on the volume of pharmaceutical products produced. However, to maintain the quality of active pharmaceutical ingredients, it is not easy to change manufacturing conditions after entering the commercial production phase. Therefore, we try to reduce the amount of chemical substances used by utilizing alternative solvents from the research and development stage and by developing synthesis processes that reduce the usage. At the same time, we actively promote the reuse of organic solvents and incorporate various means into the manufacturing processes to minimize their release into the atmosphere.
The total amount of PRTR substances handled by the Eisai Group in Japan during fiscal 2019 remained almost the same as the previous fiscal year’s level, coming to 264 tons. Also the same as previous year, we notified authorities of seven substances.
Volatile Organic Compounds (VOCs) Release Control
VOCs, such as ethyl acetate, acetone and methanol, are highly volatile and turn into gas in the atmosphere, and as is the case with NOx discharged from production plants, cause the generation of photochemical oxidants. In view of preventing air pollution, these substances need to be controlled to reduce their release into the atmosphere. In response, main production plants and research facilities of the Eisai Group in Japan implement the same level of efforts as for PRTR substances to reduce the usage of VOCs and stipulate equipment operating procedures to minimize their release from production or research processes.
The graph below shows chronological changes of the amount handled and released into the atmosphere of 55 substances (taken from the Ministry of the Environment’s list of major 100 VOCs, excluding PRTR substances) that are handled and released by plants and research laboratories of the Eisai Group in Japan. In fiscal 2019, total amount of VOCs used by the domestic Eisai Group was 1,127 tons, up 17% compared with the previous fiscal year, due to an increase of production at the Kashima Plant. Thanks to countermeasures taken at plants and research laboratories, amount released into the atmosphere was minimized to 24 tons, 2.2% of the amount of VOCs handled.
Proper Management of Polychlorinated Biphenyl (PCB) Waste
We store PCB waste properly in enclosures with locks and warning signs and with measures to prevent vaporization, dispersion and leakage. In fiscal 2018, the disposal of the waste stored at the Tsukuba Research Laboratories was completed. In fiscal 2019, only the Kawashima Plant stored PCB waste. We disposed of much of the PCB waste stored at the Kawashima Plant, including fluorescent light Proper Management of Polychlorinated Biphenyl (PCB) Waste Management of Fluorocarbons stabilizers. As a result, only a transformer and a set of PCB-containing paints＊ are the only PCB waste currently stored.
We will proactively and systematically dispose of PCB waste and report the status of its treatment and storage to the relevant prefectural governments without delay.
＊ We identified new waste target based on the fiscal 2019 investigation
Management of Fluorocarbons
The Eisai Group in Japan is systematically getting rid of and renewing equipment that contains fluorocarbons and changing to equipment that uses hydrofluorocarbons (HFC) and non-fluorocarbons (NON), which do not have an ozone layer depletion effect. Fluorocarbons have a strong greenhouse gas effect and therefore we conduct regular inspections to prevent leakage incidents. In the event of a leakage, we make efforts to immediately share information and prevent the recurrence.
According to the result of a survey on fluorocarbons conducted in fiscal 2019, hydrofluorocarbons (HFC) and hydrochlorofluorocarbons (HCFC) are 91.8% and 8.1%, respectively, of the fluorocarbons used at the major production plants and research laboratories in Japan. These two types are the majority of the fluorocarbons used. Chlorofluorocarbons (CFC), characterized by their powerful effect to deplete the ozone layer, account for 0.1% of all fluorocarbons used. If converted into a CO2 equivalent, the amount of fluorocarbons used at the major production plants and research laboratories of the Eisai Group in Japan was equal to 48,530 t-CO2.
Whenever a piece of equipment is removed, we ensure that all fluorocarbons are collected, destroyed and disposed of, and ensure that process certificate is received from fluorocarbon recovery firm. The leakage volume of fluorocarbons of Eisai Co., Ltd. in fiscal 2019 that we calculated under the Act on Controlling Emissions of Fluorocarbons was equivalent to 621 tons of CO2, which fell below the threshold for notification to the Ministry of Health, Labour and Welfare.