The research, development and manufacturing of pharmaceutical products involve the use of numerous types of chemical substances. Some of them can adversely impact human health, ecosystems, and the global environment. The handling of chemical substances is governed by the Pollutant Release and Transfer Register (PRTR) Act and various other laws and regulations. It goes without saying that Shionogi strictly adheres to these rules. We also make sure to appropriately manage chemical substances by regulating their release into the atmosphere, sewers and public waters in accordance with our voluntary criteria, which are stricter than those imposed by related laws and regulations. We consider these actions to be extremely important in terms of compliance and reputation.

[Risks and opportunities]

Shionogi has always strictly controlled the release of antimicrobials into the environment over the many years it has engaged in the development, manufacture and sale of antimicrobials. Since antimicrobial resistance (AMR) is believed to be caused not only by the inappropriate or excessive administration of antimicrobials but also by their release into the environment from pharmaceutical manufacturing plants, it is essential to devise and implement countermeasures from various aspects. As a pharmaceutical company that manufactures antimicrobials, we believe it is imperative to regulate the emergence of AMR, which is now a global challenge, working in collaboration with our suppliers.

PPTR

In compliance with the Pollutant Release and Transfer Register (PRTR) Act, under which it is mandatory to record, calculate and publish the status of release of chemical substances into the environment, Shionogi submits relevant data to the authorities and manages the handle, release and transfer of volatile organic compounds (VOCs). We intend to continue the appropriate management of such handle, release and transfer to reduce the impact that our operations may have on the environment.
Under the PRTR, the release into the air and rivers, disposal, and recycling of chemical substances used are recorded and reported to the authorities under the headings indicated in the table below. The “amount transferred” to “outside operating sites” refers to the amount handled as waste.
Class 1 designated chemical substances under the PRTR Act (tons) [FY2014] Amount handled: 279, Amount released: 50, Amount transferred: 170 [FY2015] Amount handled: 377, Amount released: 61, Amount transferred: 235 [FY2016] Amount handled: 289, Amount released: 63, Amount transferred: 148 [FY2017] Amount handled: 251, Amount released: 35, Amount transferred: 177 [FY2018] Amount handled: 274, Amount released: 43, Amount transferred: 156
Chemical substances to be registered under the PRTR Act (Unit: kg)
Substance name Amount handled Amount released Amount transferred
Air Public waters Soil Outside operating sites Sewers
N,N-dimethylacetamide 6,609 0 0 0 6,609 0
N,N-dimethylformamide 3,336 10 0 0 3,326 0
Acetonitrile 99,276 1,498 0 0 58,556 0
Chloroform 7,523 284 0 0 7,238 0
Dichloromethane (methylene chloride)
121,033 40,621 1 0 60,918 0
Triethylamine 1,217 12 0 0 1,205 0
Tributylamine 7,885 0 0 0 0 0
Toluene 1,174 6 0 0 1,168 0
N-hexane 7,274 417 0 0 6,857 0
Pyridine 17,955 0 0 0 9,687 0
Benzene 711 0 0 0 133 0
VOC handled and released into the air (tons) [FY2014] Amount of VOCs handled: 755, Release into the air: 88 [FY2015] Amount of VOCs handled: 987, Release into the air: 116 [FY2016] Amount of VOCs handled: 1,196, Release into the air: 77 [FY2017] Amount of VOCs handled: 780, Release into the air: 42 [FY2018] Amount of VOCs handled: 491, Release into the air: 46

PCB

Polychlorinated biphenyls (PCBs) are a cause of great concern in terms of global-scale contamination because they do not easily biodegrade in the environment but easily accumulate in the bodies of living organisms through the food chain. Since PCBs were used in numerous items such as condensers, transformers and fluorescent light ballasts in the past, it is imperative that all materials containing PCBs, whether they are being replaced or are still in use, be appropriately managed to contain their impact. At Shionogi, personnel are appointed to appropriately manage PCB-containing materials, while their treatment and disposal are continued according to a medium-term plan. In FY 2018, the disposal of all materials containing PCBs was completed at the Aburahi Facilities. The remaining disposal is scheduled for completion by 2021.

Environmental and safety assessment of chemical processes

Shionogi performs preliminary assessment of the safety of chemical substances and the danger of reaction and incompatibility in the development stage of manufacturing and testing methods for pharmaceutical compounds and candidate compounds, and in the designing stage of related equipment. We also continue to explore production processes that lead to greater efficiency in terms of waste reduction, energy conservation, and the like in the manufacturing stage. In FY 2018, we conducted environmental and safety assessment and education concerning a total of 61 processes of 22 articles. Shionogi representatives regularly attend the process safety study group events organized by JPMA, such as lectures on hazards in chemical processes and safety assessment, reports on cases, and factory visits. These events enable Shionogi to collect useful information, allowing us to continue to improve the safety of our chemical processes.