ENVIRONMENTAL REPORT 2012 · acceptable from a global perspective. Each of us must not only strictly adherence to rules and legislation but ... also fulfill our societal mission as

ENVIRONMENTAL REPORT2012

Japan Pharmaceutical Manufacturers Association

Message

1

Since its foundation in 1968, the Japan Pharmaceutical Manufacturers Association (JPMA) has made many contributions to the improvement of the health and welfare of people throughout the world including Japan through member companies’ commitment to our motto, “Realization of patient-oriented healthcare,” and their efforts in research and development of therapeutic pharmaceutical products that have delivered more beneficial new drugs.

The Great East Japan Earthquake of March 11 2011 and the unprecedented devastation caused by the tsunami and the catastrophic nuclear accident that followed took away so many precious lives in a matter of hours, and destroyed large areas of our land. In the aftermath, the JPMA and member companies were made aware of our mission of stable supplies of high quality drugs. The JPMA has learned from this experience, and, now endeavors to become as prepared for future various crises as possible.

The Japanese government published the Comprehensive Strategy for the Rebirth of Japan in July 2012. One of its focus tasks was Life Innovation. The JPMA, as a

member of the industry responsible for improving World Health and leading the Japanese economy, must endeavor to attain the following three goals and continue its contributions to society.

1.Contributions to building a healthy and concern-free society through creating innovative new drugs that 　overcome diseases.2.Contributions to the development of science and technology through the facilitation and support of cutting 　edge R&D efforts for creating innovative new drugs, with expected ripple effects in related industries, and 　the development of specialized human resources that will carry out the most advanced research in future.3.Contributions to economic growth through stable and high-level tax-paying potential and employment of 　specialist professions in multiple fields, such as medicine and pharmacology.

Meanwhile, increasing globalization has required us to fulfill our roles in society as corporations that are acceptable from a global perspective. Each of us must not only strictly adherence to rules and legislation but also fulfill our societal mission as trusted business entities committed to meeting high ethical standards. The JPMA has taken the following actions to support member companies in advancing their efforts for compliance: formulation of the Transparency Guideline, implemented since April 2012, to promote more transparent corporate activities for healthcare professionals and other stakeholders; revision of the JPMA Charter for Good Corporate Conduct and Compliance Program Guidelines, and, planning of a full revision of the JPMA Promotion Code for Prescription Drugs to meet the provisions of the revised international rules.

Furthermore, the JPMA identifies the efforts in tackling global environmental issues and making our workplaces safe & worker friendly as one of the most significant challenges of Corporate Social Responsibility (CSR). We have paid specific focus on the following challenges for continuing the JPMA's organization-wide voluntary efforts:

1.Energy Saving and Prevention of Global Warming 2.Resource conservation and Waste Management 3.Chemical Substances Management, and 4.Occupational Safety and Health Management

In particular, we have formulated voluntary action plans to turn our society into a low carbon society to help control global warming and stabilize the climate, as well as a society with sound material cycle based on the 3Rs (Reduce, Reuse & Recycle), and promoted these plans towards attainment of our goals.

The JPMA will continue to work for our industry’s contributions towards improved health and welfare of people worldwide and Japan’s economic growth, and actively promote environment and safety related actions. We will facilitate bilateral communication between us and the various stakeholders, especially our patients, so that we can meet the expectations society has for our industry.

Message from the President, Japan Pharmaceutical Manufacturers Association

Isao Teshirogi, Ph.D. President, Japan Pharmaceutical Manufacturers Association

Japan Pharmaceutical Manufacturers Association Environmental Report 2012

2

The 2008 Fukuda Vision presented us with the target of over 50% of electricity supplied to be generated by nuclear technology and from renewable energy sources (such as photovoltaic, wind powered, geothermal, and biomass fuel) by 2030. The Energy Basic Plan formulated in June 2010 included the plan to dramatically increase the proportion of nuclear energy from the then 26 % to 45 % by 2030. However the Great East Japan Earthquake in March 2011 and the ensuing nuclear accident at Tokyo Electric Power Company (TEPCO) Fukushima Daiichi Plant triggered a major paradigm shift in our approach to power generation from a nuclear-energy-centered option to the building of a society without reliance on nuclear energy. To achieve that goal we will need to introduce more renewable energy-based power options on a mass scale. However, some point out possible environmental issues that would be created by building such types of power plants and the need to act while taking the impact on biodiversity into consideration. Although it is impossible to eliminate every single risk to the environment, we are still required to be aware of the risks to the overall environment and balance them with our actions.

The JPMA established the Environment Committee in 1996 and revised its name in 2002 to the Environment & Safety Committee to extend the committee’s scope to include occupational safety

and health issues. The committee’s actions are focused on Energy Saving and Global Warming Prevention, Resource Conservation and Waste Management, Chemical Substances Management, and Occupational Safety and Health Management implemented by three expert subcommittees, Environment Expert Subcommittee, Occupational Safety & Health Expert Subcommittee and Global Warming Prevention Expert Subcommittee. In 2012, some 70 employees from our member companies voluntarily took part in the committee actions, including monitoring the status of member companies through questionnaire surveys, information gathering at lectures and technology training courses and facilitating training & motivational actions including providing information about model cases that achieved excellent results. The outcomes of those activities are made available to the membership in forms of various study reports and the quarterly publication, ‘Environment News’, and also delivered to our stakeholders via the JPMA Newsletter.

The JPMA has committed itself to meeting the challenges posed by global warming. We have implemented collaborative energy-saving actions with the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) towards attaining of our target “to maintain the mean total CO2 emissions from pharmaceutical manufacturers over the first five-year period pledged under the Kyoto Protocol below that of the FY 1990 baseline”. Although we attained the target in FY 2009 and 2010 against the 1990 benchmark, the Great East Japan Earthquake and following catastrophe impacted our performance in the electricity related CO2 emission indicators, whose negative effects caused us to fail to meet our targets in FY 2012. Nonetheless, we will continue our efforts in energy saving and global warming prevention actions, while keeping Nippon Keidanren's Commitment to a Low Carbon Society (FY2013 – 2020) firmly in our vision.

For resource conservation and waste management, there are ongoing 3R (Reduce Reuse Recycle) efforts towards the target of “Reduction of final disposal amount of industrial wastes in 2015 by almost 65 percent of the quantity in FY 2000”. Our motivational and promotional actions in this endeavor are focused on bottom-up reduction efforts.

Adequate control of the risks chemical substances pose to the environment is another important challenge for us. The current approach of creating per-chemical level regulations is unable to keep up with the speed of new substance registration. We have placed our focus on a comprehensive management of plant effluent pollutant levels including un-regulated substances and hosted workshops and courses. We believe the effluent management technique learned through this experience will contribute to progress our efforts on the reducing chemical substance risks to the environment, in the Fundamental Philosophy and Guideline for Conduct Concerning Biodiversity, formulated last year.

Although occupational health and safety actions should aim to achieve zero damage-causing incidents, it is difficult to guarantee safety as long as a human action is involved. However, it is possible to reduce the frequency and severity of occupational injuries. Our questionnaire survey to the JPMA membership showed that the implementation of a risk assessment has the effect of reducing occupational incidents and injuries. We believe actions to facilitate the implementation of risk assessments will become important in the future.

The JPMA publishes the annual Environment Report, delivered to the many stakeholders. We hope the Environment Report 2012 helps in our membership’s actions for the environment and safety, and our stakeholders’ understanding of our actions.

Message from the Chairman, Environment & Safety Committee

Teruyuki Tosaka, Ph.D. Chairman, Environment & Safety Committee, JPMA

ENVIRONMENTALREPORT

2012


The purpose for publishing this Environmental Report is the dissemination of information about actions taken by the Environment & Safety Committee of the Japan Pharmaceutical Manufacturers Association, to the respective member companies, and society in general. The Environmental Report contains articles about the progress of and relevant activities conducted towards the Action Plan adopted by the Environment & Safety Committee General Assembly. The information used in these articles is collated from reports submitted by respective member companies or provided by those supported committee’s actions. Information collection and analyses are conducted by the respective Expert Subcommittee and collated and/or summarized at the Steering Committee. The editor hopes this Environmental Report will be positively reviewed by our respective member companies and by society, and used effectively as a communication tool.

JPMA has a membership of 70 companies (as of October 1, 2012). The membership list can be found on page 30. Please note that the performance data collected mainly from 69 member companies in 2011, but some data include data from companies belong to other associations under FPMAJ.

Editorial Policy

December 2012 (Planned Publication of Next Issue: December 2013)

This report is also available at our website.

(JPMA Website; “About Activities of JPMA; JPMA Publication; free Publications)

http://www.jpma.or.jp/about/issue/gratis/eco/eco2012.html (Japanese version)

http://www.jpma.or.jp/english/Library/Environmental /2012.html (English version)

Date of Publication

Scope of this Report

Performance data were collected and collated for the entire FY 2011 (from April 2011 to March 2012). Information on each group’s activities up to as late as October 2012 may also be included.

Period of this Report

3 Japan Pharmaceutical Manufacturers Association Environmental Report 2012

Period / Scope of this Report, Editorial Policy, Table of Contents

C o n t e n t s

Organizational Structure

Planning/Progress

Global Warming Prevention

Resource Conservation & Waste Management

Chemical Substances Management

Occupational Safety & Health Management

Stakeholder Engagement

Training & Motivation

History of Environmental and Safety Initiative

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5

8

12

14

17

23

26

28

Environment & Safety Committee

The Japan Pharmaceutical Manufacturers Association (JPMA) is a voluntary association comprising 70 research-oriented pharmaceutical companies.JPMA, established in 1968, has been contributing to advancing global healthcare through the development of innovative ethical

drugs, facilitating sound development of the pharmaceutical industry through proactively establishing policies and recommendations in response to globalization and enhancing public understanding of pharmaceuticals.

Organization


4

ENVIRONMENTALREPORT

2012


Organizational Structure

The Environment & Safety Committee, established in 1996, sets targets for global environmental conservation and occupational safety and health, and supports member companies pursuing environmental, health and safety policies.

The Committee prepares an annual plan to clarify the targets with numerical values and support to attain them through facilitating the exchange of information between member companies and hosting the technical training courses and

seminars. Through these activities, we try to assist to attain targets, and follow-up the situation annually.

It is also recognized as an important role of the Committee to collaborate with various stakeholders in the effort to tackle the environment and occupational safety and health issues, which are common tasks for the pharmaceutical industry. Thus, the Committee endeavors to strengthen communication with outside parties.

The Environment & Safety Committee consists of committee members and technical committee members who participate in the following: the “General Assembly”, “Planning Conference”, “Steering Committee” and “Expert Subcommittees”. The General Assembly is held annually in April to govern basic policies, establishing the business plan for each fiscal year, and other businesses. The Planning Conference, consisting of a chairperson, deputy chairpersons, and a secretariat, assigns and coordinates Expert Subcommittee tasks, handles government administration-related matters, and reports to and communicates with the Board of Directors. The Steering Committee consists of a chairperson and vice chairperson of each Expert Subcommittee, Planning Conference members, and others, and is responsible for implementing the business/project plan and coordinating other matters of general business. Within each Expert Subcommittee, the technical committee members are assigned to working groups, each of


(General Assembly)

Steering committee

Secretariat

Planning Conference


Environment Expert Subcommittee

Occupational Safety & Health Expert Subcommittee

Global Warming Prevention Expert Subcommittee

Expert Subcommittees

which engages in a particular task described in the business/project plan, and these groups conduct investigations, plan training courses, prepare various reports, and/or other relevant tasks.

Expert Subcommittees consist of Environment Expert Subcommittee, Occupational Safety & Health Expert Subcommittee and Global Warming Prevention Expert Subcommittee. They are grappling with environment and occupational safety & health themes.

JPMA Organization

Vice PresidentsPresident

General Assembly

Board Directors [Standing B/D]

Auditors

Council on Planning & Policy

Compliance Committee

Promotion Code Committee

Review Board of Ethical Drug Product Information Brochure

Distribution Improvement Committee

Pharmaceutical Industrial Policy Committee

Drug Evaluation Committee

ICH Project

Quality & Technology Committee

Biopharmaceutical Committee

Regulatory Affairs Committee

Intellectual Property Committee

R&D Committee

Center for Pharmaceutical Publication

International Affairs Committee


Public Affairs Committee

Patient Cooperration Committee

Consumer Consultation Review Committee

Japan Pharmacetical Industry Legal Affairs Association

Office of Pharmaceutical Industry Research(OPIR)



The Environment & Safety Committee General Assembly is held annually in April to discuss and decide the annual and midterm action plans, taking into account progress made in the previous fiscal year and current trends in society. In FY 2011, Expert Subcommittees were set to work in four project areas consisting of Global Warming Prevention, Resource Conservation & Waste Management, Chemical Substance Management, and Occupa-tional Safety and Health. These subcommittees promoted each activity according to the plans. Some issues were difficult for a single company to resolve. To help those member companies facing the challenges, the Environment & Safety Committee gathered pertinent information from external parties and experts, so that the necessary tasks could be clarified and solutions found. The Environment & Safety Committee also periodically publishes

information bulletins, investigational reports, technical information dossier, etc., to make findings accessible and to assist our member companies’ actions on the environment, occupational safety and health.

Followings are numerical targets set by the Environment & Safety Committee for each respective area.

Our actions towards occupational safety and health mainly involve investigation of the member companies’ efforts regarding the state of work-related accidents and incidents, the manage-ment of emplpyees’ health, mental health management, measures to prevent business vehicle accidents, etc. Findings are then disclosed to the member companies.

Control CO2 emissions in FY 2010 (mean level of the first commitment period (FY 2008-2012 under the Kyoto Protocol) to below FY 1990 level.

Chemical Substance Management

* Since FY 1997, we have continued our efforts in this area, encouraging the main organization and companies under the umbrella to take part in the Follow-up to the Keidanren Voluntary Action Plan on the Environment. In accordance with the provision made under the Kyoto Protocol in which the stipulated target was reduced emissions, our target has been set to reduce CO2 emissions below FY 1990 level.

Reduction of final disposal amount of industrial wastes in 2015 by almost 65 percent of the quantity in FY 2000

* Since FY 1998 to date, we have set numerical targets for the final output of waste and quantity recycled into resource as part of our waste reduction efforts. The third-period action

plan, formulated in FY 2006, was completed in FY 2010 with the targets attained through our efforts. The fourth-period action plan towards its final year of FY 2015 was formulated

and started in FY 2011. Our efforts have continued towards attainment of the new target.

We have endeavored to reduce atmospheric emissions of harmful atmospheric pollutants such as dichloromethane, 1,2-dichloroethane, and chloroform since FY1997. FY2007 was the final year of the third term action plan and, as the result of analyses of the data for the year, it was deemed that these actions achieved the primary objective, therefore, no new numerical targets shall be set but existing efforts shall be continued.

Planning/Progress

5

Environment & Safety Action Plan


FY 2011 CO2 emissions exceeded the baseline year figure by 11.8 % (195,000 tons), which was an increase of 14.1 % (228,000 tons) from the previous business year. What caused the major increase in FY 2011 CO2 emissions was the closing of the nuclear power plants following the Great East Japan Earthquake on March 11, 2011, which markedly worsened the electricity carbon emissions coefficient (a coefficient representing the quantity of CO2 emissions from electricity use). As the carbon emissions coefficient for FY 2012 is not expected to improve, attainment of

the numerical target for the first pledged period, the mean value between FY 2008 and FY 2012, will prove difficult.Meanwhile, a projection using an alternative carbon emissions coefficient had the earthquake not struck (published by the Federation of Electric Power Companies of Japan) shows that CO2 emissions would have been 4.6% (76,000 tons) below of the baseline year, indicating we would have attained the targets in three consecutive years from 2009.

Our actions so far saw us setting numerical targets for the period ended FY 2010 in regard to the volume of waste for final disposal, the final disposal rate and the waste generation output, and attaining them all. Building upon these achievements, we developed a new action plan during FY 2010, for a period from FY 2011 to FY 2015. So far, we have seen the volume of waste

for final disposal in FY 2011 being reduced by 78% of the baseline year (FY 2000). We will continue our effort towards attaining the numerical targets and facilitating technical information sharing among the member companies that participate in the voluntary action plan.

With regard to the third-term action plan, aiming to reduce atmospheric emissions of dichloromethane, 1,2-dichloroethane, and chloroform, the numerical targets were already attained in FY 2007. Based on these achievements, the JPMA deemed that our primary objective for our voluntary control plan of

harmful atmospheric pollutants had been sufficiently achieved. We will continue to promote our member companies’ commitment to further voluntary actions for reductions, as well as to continue our investigations and reviews for new actions.

The JPMA action plans for resource conservation, waste management and chemical substance management have progressed smoothly. Conversely, with regard to global warming prevention, our performance has fallen short of the numerical target due to factors such as production increases. Although the excess trend hit its peak in FY2004, the CO2 emissions reduction in the ensuing years was back on track. However, the CO2 emissions in FY 2011 bore the effect of the markedly worse

carbon emissions coefficient than projected owing to the impact from the Great East Japan Earthquake, making the attainment of the numerical target for the first pledged period very difficult. We still intend to give full commitment to attaining the numerical targets for the pharmaceutical industry in an alternative projection of CO2 emission levels, assuming an alternative carbon emissions coefficient that eliminates the impact of the earthquake.

The Environment & Safety Committee implements its activities following action plans developed annually and for the medium-term by each expert subcommittee in their respective areas such as measures to prevent global warming, measures to reduce waste, measures to reduce atmospheric emissions of harmful atmospheric pollutants, and promoting occupational health and safety activities. Meanwhile, for matters related to

reinforcing partnerships with major industrial bodies, the national government and society, the Planning Conference liaises with the relevant expert subcommittee to facilitate information sharing and exchanges of opinions. The following summarizes the state of progress of the Environment & Safety Committee activities in FY2011.

◆ Global Warming Prevention

◆ Resource Conservation and Waste Management

◆ Chemical Substances Management

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Action Plans: State of Progress

ENVIRONMENTALREPORT

2012


FY2011 Action Plan: Summary of Progress and Achievement

Planning/Progress

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ENVIRONMENTALREPORT

2012


Topics FY2011 Working Plan FY2011 Activities and Achievement

Energy Saving & Global

Warming Prevention

Resource Conservation &

Waste Management

Chemical

Substance Management

Occupational

Safety & Health

Numerical targets

Other Issues

●●●●●

●

●

Action plan

Reduce CO2 emissions in FY2010 (mean level of the first commitment period under the Kyoto Protocol) to below FY1990 level.

Follow-up for the Keidanren Voluntary Action PlanHost a technical training course on energy savingCompile information on global warming prevention Develop a post-Kyoto CO2 emissions reduction planPromotion of effective use of business vehicles used by MRsRequest top managements of member companies to attain the target of CO2 emission

●●

●

●

Conduct PRTR and VOC surveyStudy technologies for reduction of atmospheric emissions of chemical substances and their feed-back to the member companiesStudy environmental risk assessment of pharmaceutical productsStudy on chemical process safety

●

●

●

Conducted PRTR and VOC survey for the member companies, and fed them back to the member companies　PRTR substances emitted to the atmosphere in FY2011 were reduced by 72% against the level of FY2002　The total air emissions of VOCs in FY 2011 were 3,107 tonsConducted information gathering about environmental impact of pharmaceutical products and hosted a technical training courseConducted process safety studies and hosted lectures and a study tour for risk assessment of chemical processes

●

●

●

●

Conduct survey on activities for occupational safety and health, and feed them back to the member companiesStudy actions for maintaining and improving employees’ healthHost a technical training course on occupational safety and health , and feed them back to the member companiesStudy and develop measures to prevent business vehicle accidents , and feed them back to the member companies

●

●

●

Conducted survey on the state of the occupational incident, and fed it back them to the member companiesHosted a technical training cource about occupational safety and healthConducted a study and survey on the state of accident prevention and vehicle accidents involving business vehicles

●

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●

●

Dispatch timely an appropriate information on environment, safety and health such as Environmental Report and Environment News Collaboration and communication with stakefolders as well as among the industryStudy on biodiversity and feed it back to the member companiesHost environmental & safety lectures, and environmental & safety seminars and so on

●●●

●

●

●

Published Environmental Report 2011Published 4 Issues of Environment NewsDistributed Achievement Reports 2011 to the member companiesInformation sharing and collaboration with other JPMA committees and participation in FPMAJ Environmental CommitteeDeveloped fundamental philosophy and guideline for biodiversityHosted an environmental & safety lecture and an environmental & safety seminar

Numerical targets

●

●●

●

●

●

Action plan

The CO2 emissions exceeded 11.8% above the target figure in FY1990

Conducted the follow-up survey in collaboration with FPMAJ and reported this to the KeidanrenHosted the 15th technical training courseFacilitated information gathering /exchange and study tours on global warming preventionCondacted the survey on the fuel consumption of business vehicles and introducing rate of hybrid cars and electric carsConducted briefing to management layer and start-up preimplementation activity about new action plan incollaboration with FPMAJ

Numerical targets

●●●

●

●

Action plan

Almost 65% reduction of final disposal amount of wastes in FY2015 against that in FY 2000

Follow-up for the Keidanren Voluntary Action PlanHost the technical training course to promote 3R activityStudy on municipal solid medical wastes and feed them back to the member companiesSupport member companies to improve the packaging for pharmaceutical products

Numerical targets

●

●

●

Action plan

Final disposal amount of waste : reduced by 78% compared to the FY2000 performance

Conducted a follow-up survey in collaboration with FPMAJ and reported this to the KeidanrenConducted information gathering about municipal solid medical wastes in collaboration with the FPMAJ

--

1. Voluntary Action Plan on the Environment (Global Warming Prevention Edition)

Scope of the Survey and Methodology for Follow-up Action

Scope of the Survey The scope of the survey is energy use and CO2 emission levels at manufacturing facilities and laboratories in three associations, JPMA, JGPMA and JSMI.

A questionnaire survey was conducted and the data returned by each company was then compiled for each fiscal year. The calculation of the quantity of energy used and the CO2 emissions level was conducted using the formula provided in the Keidanren Voluntary Action Plan for the Environment Follow-Up Action survey form. The CO2 emissions level from electricity use was calculated using an adjusted electricity carbon emissions coefficient.

Methodology

JPMA carries out Follow-Up Action according to the Keidanren (Japan Business Federation) Voluntary Action Plan for the Environment every year in partnership with FPMAJ since FY1997. As an effort to expand voluntary

action plan participation, we requested the Japan Generic Medicines Association (JGA) and Japan Self-Medication Industry (JSMI) to ask their members to take part in a survey on the Follow-Up Action since FY2008.

The Great East Japan Earthquake of March 11 is thought to have largely impacted energy consumption in FY 2011. The closure of all nuclear power plants in Japan following the nuclear accident at Fukushima Daiichi nuclear power plant dramatically worsened the electricity carbon emissions

coefficient (36% worse than the previous year and 40% worse than the FY 2011 emissions coefficient aimed for by the Federation of Electric Power Companies of Japan). The Environment & Safety Committee addressed these issues and investigated their impact on the pharmaceutical industry’s action plan.

If global warming progresses at the current rate, it is highly likely to impact the natural environment, human lives and health, as well as the economy and society. It has been noted that global warming is a security concern with a potential to uproot the very foundations of human existence. Approaches to climate change mitigation and adaptation were said to be one of the biggest challenges to the 21st century for the human race. In addition, the Great East Japan Earthquake of March 2011 left a major impact on future energy policy and global warming prevention measures. For the pharmaceutical industry, it was the

event that made us reflect and strongly affirm our mission of maintaining stable drug supplies and renewed our awareness of the importance of energy management, taking into consideration energy-saving and global-warming-prevention measures, as well as risk manage-ment and service continuity.Meanwhile, threat of the global warming still grows steadily, forcing us to reaffirm the importance of our prevention measures and continuing commitments towards energy saving.

Control CO2 emissions in FY 2010 (mean level of the first commitment

period (2008-2012) under the Kyoto Protocol) to below the FY 1990 level

1

Responcled Companies

Responses from a total of 101 companies including 64 JPMA members and 37 JGA or JSMI members were received. The validity of the data submitted from these companies was assessed and 66 companies were deemed fit to be compiled in the Follow-Up Action Survey. The companies who responded were deemed unfit to be part of

2

the survey since they did not have energy profile data of the base year, FY1990. The 66 companies that were subject to the Follow-Up Action Survey Analysis account for 17.8% of the pharmaceutical manufacturers in Japan. However, their sales performance of the 66 companies covers 75.9% .

JPMA’s Actions

Target


* Power supplier’s carbon emissions coefficient with taking domestic verified emissions reduction of Kyoto mechanism credit info consideration.

*

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ENVIRONMENTALREPORT

2012


The JPMA takes part in the Follow-Up Action for the Japan Business Federation’s (Nippon Keidanren) Voluntary Action Plan on the Environment through collaboration with the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ), JPMA monitors, reports and publishes the levels of CO2 emissions and efforts by members in the prevention of global warming.

The JPMA hosts an annual Energy Saving / Global Warming Prevention Technical Training Course to facilitate information sharing and opinion exchanges on energy management policies and measures against global warming in the future.

The JPMA works for a smooth launch of the newly formulated Action Plan toward a Low Carbon Society (towards Year 2020) in the pharmaceutical industry and continues to support lasting actions by JPMA member companies

1

2

3

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Figure 1.CO2 Emissions

Figure 2.CO2 Emissions Per Sales Unit

The quantity of CO2 emissions that was discharged in FY2011 was 1,848,000 tons, which was an increase of 14.1% (228,000 tons) against the level of the previous year, and, when compared with FY 1990, it was 11.8% (195,000 tons) over the baseline. The causes of any increase or reduction in emissions levels were as follows: an increase of 1,040,000 tons was due to production growth, which was the principle cause, while reduction of 963,000 tons was due to energy-saving measures and actions. A further 117,000 tons of increase was attributed to the changes in the fuel situation and electricity CO2 emission index.The CO2 emissions (per sales unit) have improved over the years. The index number of CO2 emissions per sales unit in FY 2011 was somewhat worse compared to the previous year, owing to the worse CO2 emission index. However it is still an improvement of 0.624 (or 0.564 against the previous year) against the 1 in the baseline year.

Note the reason for the large excess of CO2 emissions against the baseline year was the major setback in the electricity carbon emissions coefficient as a result of the closure of all nuclear power plants in Japan caused by the Great East Japan Earthquake of March 11, 2011, and the nuclear power plant accident that followed.Taking into account the issue of the major negative confounding factor of a jump in the CO2 emissions level in FY 2011, as a result of the Great East Japan Earthquake, the pharmaceutical industry has made an alternative calculation of CO2 emissions based on “the alternative electricity carbon emissions coefficient had the Great Quake not happened” presented by Keidanren. The alterna-tive emissions level in that scenario was 1,577,000 tons, 4.6 % (76,000 tons) below the baseline year level, a figure which meets the numerical target.

State of Progress in FY 20113

Altogether, 41 companies have a manufacturing plant and/or R&D facility in the areas supplied by Tohoku Electric Power Company or Tokyo Electric Power Company. Among them, 31 companies suffered a direct impact on their FY 2011 CO2 emissions. Our survey of those impacted companies revealed closure or

reduced operation caused altogether 28,585 tons of CO2 emissions. The following table shows the specific events that impacted the companies that responded to our survey, and the events’ impact on their energy usage.

Impacts of the Great East Japan Earthquake

Impact on manufacturing plants and R&D facilities

4

100

131.8 130.0 125.3 127.6

108.6 98.5 98.0

95.4

111.8

27.1

165.3

217.9 214.9

207.1 211.1

179.6

162.8 162.0 157.7

20

40

60

80

100

120

140

0

50

100

150

200

250

300

1990 2004 2005 2006 2007 2008 2009 2010 2011

Percentage against the baseline FY (%)CO2 /10,000 tons

(FY)

CO2 emissions

Portion attributed to the worsened electricity emission coefficient

Percentage against FY 1990 data (%)

CO2 emissions per sales unit

Portion attributed to the worsened electricity emission coefficient

Index number

36.7 32.3 31.0 29.6 29.4

24.6 21.2 20.7 19.5

3.4

1.000 0.880

0.844 0.807 0.800

0.669

0.578 0.564

0.531

0.624

0.000

0.200

0.400

0.600

0.800

1.000

0

5

10

15

20

25

30

35

40

45

50

1990 2004 2005 2006 2007 2008 2009 2010 2011

Index numberCO2 emissions per sales unit(ton/ ¥100 million)

(FY)



CO2 Emissions

10

Measures implemented in FY2011

Installation of highly efficient machinery

Cases CO2 reduction (tons)

35 8,445

Review of facility or machinery operational procedures and control method 19 6,998

Modification of operational standard values 16 4,647

Energy source switch 8 3,288

Making employees more energy-saving conscious through actions within the company

11 2,884Reduction of radiation heat loss by insulation of machinery and pipes

14 2,175

Recovery of lost heat 3 1,373

Installation of inverters 14 726

Implementation of measures to prevent water and other leakages 4 519

Review of manufacturing process 3 506

The pharmaceutical industry needs to meet strict international control standards in research and development, manufacturing and distribution. Consequently, there are ever-increasing energy expenditures for air conditioning facilities, etc. We take efforts to reduce energy through measures to switch energy sources (convert fuel) and introduce highly efficient appliances. Measures implemented in FY 2011 for energy saving and global warming prevention cost a total of ¥3,771,000,000 in capital and expendi-ture. A summary of the principle measures implemented and their CO2 emissions-reduction effects are presented in Table 2.

The projection of CO2 emissions in FY 2012 using the same electricity carbon emissions coefficient as FY 2011 would be 1,906,000 tons, expected to exceed the baseline of FY 1990 by 253,000 tons. Consequently, the mean annual CO2 emission over the five year period from FY 2008 to FY 2012 would be 1,759,000 tons, exceeding the FY 1990 baseline by 106,000 tons (533,000 tons over the five years) or 6.4 %. This projection means attainment of the target is difficult.

On the other hand, an alternative calculation using the alterna-tive electricity carbon emissions coefficient had the Great Quake not happened makes FY 2012 CO2 emission projection at 1,626,000 tons, 27,000 tons lower than the baseline, which puts the mean level over the five year period from FY 2008 to FY 2012 at 1,649,000, which clears the baseline value.

2. FY 2011 Global Warming Prevention Actions

3. CO2 Emissions for the First Pledge Period (projection)

Direct impactFirms and sites directly impacted

Firms Plants

Total

R&D facilities

Operation closed (including temporary closure) owing to the earthquake, tsunami and/or other related disastersEvacuation owing to radiation pollution from the nuclear power plantHad to use own electricity generator owing to powersupply shortageHad to switch fuel/ energy source owing to power supply shortage (electricity → other fuel)Had to alter operations owing to the electricity use restriction orders

Reduced production owing to production shift

Level of impact on CO2 emissions

17 28,543 tons less

1 Cannot calculate

14 1,729 tons more

5 639 tons less

12 166 tons more

1

17

1

15

4

13

1

3

0

5

3

5

0 1,297 tons less

28,585 tons less

Table 1 The Quake’s impact on plants and laboratories

Figure 3. Impact of the Earthquake on Offices

FY 2011 saw a 15.2 % reduction of energy consumption per office floor from the previous FY (38.5 → 32.6 L/m2). Because the range of this survey included regions other than those supplied by Tokyo and Tohoku Electric Power Companies, we believe the nationwide office energy campaign following the Great East Japan Earthquake and the nuclear accident has led to this major reduction in office consumption. On the other hand, CO2 emissions per floor area were on an increase, owing to the worse carbon emissions coefficient of electricity, as in the case with plants and laboratories.

Impact at offices

38.6 36.8 37.9 38.5 32.6

69.8 65.5 63.3 64.6 65.6

0.954 0.984 0.998

0.845

1.000

0.937 0.907

0.940

0.600

0.700

0.800

0.900

1.000

0

10

20

30

40

50

60

70

80

2007 2008 2009 2010 2011

Index number

Base unitThermal output equivalent of crude oil (L/ m2)

CO2 emissions (kg/ m2)

(FY)

Base unit of crude oil = L/ m2 Base unit of CO2 = kg/ m2

0.925

ENVIRONMENTALREPORT

2012


Table 2. Cases of implemented actions in FY 2011 and their CO2 reduction effects

T O P I C ST O P I C ST O P I C ST O P I C ST O P I C S

11

Technical Training Course of Energy Saving & Global Warming Prevention

The 16th Technical Training Course of Energy Saving & Global Warming Prevention was held on October 19, 2012 at Toranomon Hills New Wing (Toranomon, Minato-ku Tokyo), attended by some 120 participants.The 16th Technical Training Course has been held annually since FY 1997 by the Environment & Safety Committee for the purpose of assisting member companies’ advancements in energy saving and global warming prevention actions.The course was held on the theme of Energy Policies and Actions of Pharmaceutical Industry Towards a Low Carbon Society – Towards Attainment of the FY 2020 Target –, in the context of the ongoing national energy & environment strate-gies following the Great East Japan Earthquake and nuclear power plant accident.The speaker from the Ministry of Economy, Trade and Industry spoke on “Movement & Direction of Japanese Energy Saving Policies”, the speaker from the Ministry of Environment spoke on “Movement & Direction of the Global Warming Prevention Measures in Japan” and the speaker from a private company (Daikin Industries, Ltd.) spoke on “The Latest Air Conditioning Systems and Energy Saving Measures”. We also had three member companies (Bayer Yakuhin, Ltd., Takeda Pharmaceutical Co., Ltd. & Shionogi & Co., Ltd.) share their experiences of summer-time power saving, actions to meet the challenge of the electricity shortage and energy-saving measures implemented at laboratories.The Environment & Safety Committee intends to continue assisting the efforts by JPMA member companies in their energy saving and global-warming-prevention actions, which are anticipated to increase its severity, by creating opportuni-ties to share information about international movements, domestic trend sand experiences at other companies.

Reduce CO2 emissions by the pharmaceutical industry by 23% from the FY 2005 level by FY 2020

As the current voluntary action plan based on the Kyoto Protocol will be concluded this year (in FY 2012), the pharmaceutical industry has developed a new action plan (Action Plan toward a Low Carbon Society), aimed at “Reducing CO2 emissions by the pharmaceutical industry by 23% from the FY 2005 level by FY 2020.” Demand on medicines is expected to increase further owing to an increasingly

aging society. Consequently, we think it will require considerable effort to absorb the expected energy demand for increasing drug production and attain the new numerical targets by FY 2020. We believe we will need to do as much as we can to achieve the current voluntary action plan, as well as promote more effort aimed at fulfilling the newly developed action plan toward a Low Carbon Society.

The JPMA has a history of strategically encouraging member companies to switch from liquid fuels to other sources with fewer CO2 emissions such as the city gas and electricity, on the assumption that the electricity carbon emissions coefficient would improve. Because of this, while we calculate the CO2 emissions based on the electricity carbon emissions coefficient worsened by the Great Quake, we consider the pharmaceutical industry’s responsibility to be that of meeting the alternative CO2 emissions level based on the pre-Great Quake electricity carbon emissions coefficient published by the Federation of Electric Power Companies of Japan (the alternative electricity carbon emissions coefficient had the Great Quake not happened), and achieving the target.

CO2 from energy use, emitted by manufacturing plants and R&D facilities

Summary of the Action Plan toward a Low Carbon Society in Pharmaceutical Industry

Reduction target

Scope covered by the action plan

11

4. JPMA New Action Plan (Action Plan toward a Low Carbon Society)

Figure 4. Total CO2 Emissions During the First Pledge Period (projection)

165.3179.6

162.8 162157.7

162.6

27.1 28.0

164.9

11.0

0

40

80

120

160

200

1990 2008 2009 2010 2011 2012(Projection)

2008-2012Mean (projection)

CO2 (10,000 tons)

(FY)

Emissions Portion attributed to the worsened electricity emission coefficient

Global Warming PreventionENVIRONMENTAL

REPORT

2012


T O P I C ST O P I C S

101212

　 Final Disposal Amount of Waste (Figure 1)

Due to our member companies’ efforts in reducing their

generation and recycling waste, the final disposal amount

has been steadily reduced and achieved the target of

around 35% (= approx. 65 % reduction) by FY 2006. It has

since fluctuated at around the 20% level. The final disposal

amount of waste in FY 2011 was as low as 4,300 tons

(21.6 % of FY 2000)

　 Wastes Generation (Figure 2)

In spite of increasing sales of pharmaceuticals owing to the

rapidly aging society, waste generation has gradually

decreased in recent years. Waste generation in FY 2011

was 183,600 tons, a 28% reduction compared to the FY

2000 figure.

1

2

Quantity generated

Percentage against the baseline FY (%)

Figure 2. Quantity of Waste Generated

Figure 1. Final Waste Disposal Level

Since promulgation of the Basic Act on Establishing a Sound Material-Cycle Society in 2001, the JPMA has developed its own voluntary action plan for the environment (setting waste disposal reduction targets) for our actions, as well as conducting studies into generation and disposal of our waste. Since FY 2000, various educational and motivational actions and member companies’ efforts towards reducing the final output for disposal saw a steady reduction of the final amount disposed. The Great East Japan Earthquake of March 2011 and the nuclear power plant accident that followed had major

impacts on our waste management actions. Disposal of the massive quantity of debris from the earthquake, pollution exposure suffered by the waste management business workers, concentration of radioactive materials into the ash generated by interim disposal processes, and other unprecedented challenges now face us.This is a kind of situation in which continuous efforts to reduce waste are essential. We have set a new target for the fourth period plan, started in FY 2011, to progress our waste management actions.

The following is a summary of the state of progress of our membership’s waste management measures in FY 2011. The data were obtained through a questionnaire survey of 70 JPMA member companies (as of the time of the survey). The data

from the 58 companies that responded were adjusted for the sales cover rate. The sales cover rate for the FY 2011 actual figure was 95.1%

Reduction of final disposal amount of industrial waste in 2015 by almost 65 percent of the quantity in FY 2000

The JPMA has developed voluntary targets to save resources and reduce waste, and has been implementing various 3R activities to achieve them.

1. Voluntary Action Plan for the Environment (Sound Material-Cycle Society): State of Progress

19.9

11.2

6.44.5 4.7 3.9 3.1 4.3

7.0

100

56.3

32.2

22.6 23.619.4

15.621.6

35.2

0

20

40

60

80

100

0

5

10

15

20

25

2000

(Baseline)

2005 2006 2007 2008 2009 2010 2011 2015

(Target)

Percentage against the baseline FY (%)Final disposal (1,000 tons)

(FY)

254.8 246.4 249.0 246.1 252.0202.2

169.7 183.6

10096.7 97.7 96.6

98.9

79.4

66.672.1

30

40

50

60

70

80

90

100

0

50

100

150

200

250

300

350

2000 2005 2006 2007 2008 2009 2010 2011

Percentage against the baseline FY (%)Quantity generated (1,000 tons)

(FY)

ENVIRONMENTALREPORT

2012



JPMA’s Actions

Target

Meiji Seika Pharma has a flagship environmental policy: “We shall promote better productivity and resource & energy saving in every aspect of our business activities and the entire product life cycle from design to disposal, so that the burden to the environment from our business can be reduced,” which demonstrates our approach to reducing the burden on the environment. The Gifu Plant followed this environmental policy of ours to promote the 3R actions continuously towards our action goal of “Achieving zero-emissions through continuous promotion of the 3Rs”. We achieved zero emissions in FY 2010 and continued our achievement in FY 2011.

Our final landfill disposal rate and recycling rate in FY 2003 were 1.2% and 86.1%, respectively. As the result of our active promo-tion of the 3R actions towards the goal of achieving zero emissions, as in 0% final landfill disposal rate and 100% recycling rate by the target year of FY 2011, we achieved our goal one year earlier in FY 2010 and maintained this goal in FY 2011.Our plant will continue efforts such as the 3Rs, in our production of mainly bulk drugs, for reducing the environmental burden following the Meiji Group’s philosophy, to maintain our status as a factory that is trusted by society.We hope to receive your continuing guidance and support for our efforts in the future.

Gifu Plant, Meiji Seika Pharma followed the company’s environmental policy and set the achievement target, “To achieve the zero emissions by FY 2011, to keep the final landfill output rate under 1% and the recycle rate at over 99%”.

The 3R Efforts at Gifu Plant, Meiji Seika Pharma, the Recipient of the Minister of Health, Labour and Welfare Award for Contribution to Promotion of Reduce,

Reuse & Recycle in FY 2012


Osamu Yamashita Gifu Plant Meiji Seika Pharma Co., Ltd.

13

1. Target

2. Main 3R efforts

3. Our actual achievement through the 3R actions

* Zero emissions as defined at our company: Final landfill disposal rate= volume of final disposal to landfill / waste volume = under 1% Recycle rate = recycled volume / waste volume = over 99%


Graph showing changes of waste output and final disposal quantity

1

10

100

1,000

10,000

2003 2004 2005 2006 2007 2008 2009 2010 2011

7,867 7,9663,521 3,889 4,055 5,241 6,440 5,263 5,116

9664 51 43 41

9124

0 0

Waste output (tons) Final disposal (tons)

Reviewed and improved manufacturing technologies to reduce use and discharge of organic solvents

Reduction of sludge disposal volume through better sludge dehydration and dry weight rate

Reusing the containers for raw material transportation

Reusing used solvent when it is recoverable by the specialized contractors

Unrecoverable solvent re-used as a boiler fuel for waste solvent burning boilers at our plant

When the foundation and oil retaining wall were removed, the concrete was crushed to be re-used as the aggregates for plant ground

Sludge was turned into fertilizer, compost or raw material for cement

Molten Glass waste was added to iron ore or road foundation material

Plastic waste was turned into RFP solid fuel

1

2

1

2

1

2

3

4

5

Reduce

Reuse

Recycle

ENVIRONMENTALREPORT

2012


(FY)


14

Various kinds of chemical substances are used in the pharmaceutical industry for the research, development, and manufacturing of pharmaceuticals contributing to people’s health. Some of those chemicals may have a harmful impact on human health and/or the ecosystem if discharged into the environment. Consequently, we recognize that reducing the quantity of such harmful chemical substances discharged into the environment is

one of major issues in the pharmaceutical industry, and voluntary programs on chemical substance management have been implemented.

We also promote the research activities on process safety in order to prevent environmental pollution and fire caused by chemical substances used for manufacturing pharmaceuticals.

The amendment of the Air Pollution Control Act brought in a provision to control the atmospheric releases of volatile organic compounds (VOCs). Although the member companies hardly have facilities applied by this regulation, JPMA conducted an

survey on the annual usage of VOCs among the member companies. The VOCs in the survey included the 100 main VOCs stipulated by the Ministry of Environment, plus n-propyl alcohol, which is widely used in the pharmaceutical industry.

0

400

800

1200

1600

50

1693

1361 1240

851 734 701 696 668 441 474

5043

3230 21 18 15

15 8

2000

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

(tons)

(FY)

Atmosphere Water

JPMA member companies have continuously reduced the emissions of PRTR substances to the environment. They have been steadily reduced since FY 2002. We succeeded in a 72% reduction of emissions by FY 2011 against the level in FY 2002.

JPMA’s Actions

1. PRTR Survey

2. VOC Survey

Dichloromethane266ｔ

Acetonitrile 40ｔ

Chloroform 25ｔ

N,N-dimethylacetamide19ｔ

Others

49ｔ

Toluene 75ｔ

ENVIRONMENTALREPORT

2012



JPMA has conducted a voluntary PRTR survey actions in FY 1997 to monitor the quantity of emissions to the environment and transfers of the designated chemical substances handled in the pharmaceutical industry, and the survey results have been disclosed. Since FY 2007 we have also investigated the use of volatile organic compounds (VOCs, Note 1).

68 JPMA member companies handled 13,759 tons (a 23% reduction compared to the amount in FY 2010) of 462 class 1 substances (PRTR substances, Note 2), of which 474 tons (8% increase) were released into the atmosphere, 8 tons (47% reduction) into public water, and nil into the soil. We also promote the research activities on safety.In terms of the annual usages, toluene (4,115 tons), acetonitrile (2,360 tons), dichlcromethane(2,048 tons) and

N,N-dimethyfformamide (1,225 tons) were the four biggest substances in this order. Regarding the air emissions, the two biggest sabstances were dichoromethane and toluene, both amounting to 341 tons These were followed by acetonitrile, chloroform and N,N-dimethylacetamide in this order. Total of the air emissions of these five substances comprised 90% of the total air emissions.

Figure 1　Air emissions of PRTR substances in FY 2011(Note 3)

Figure 2　Changes in environmental emission of PRTR substances

Note 1)

Note 2)

Note 3)

Volatile organic compounds (VOCs) are one of the causes of suspended particulate matters and photochemical oxidantsChemical substances stipulated in the “Act on the Confirmation, etc. of the Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof” (PRTR Act)Survey covered a total of 217 business establishments belonging to JPMA member companies, their affiliated or related companies

In FY 2011, 39 substances were handled in quantities of one ton or more anuualy, and in total 39,950 tons (a 2% increase compared to the amount in FY 2010) were handled. The four biggest substances were methanol, ethanol, acetone, and toluene, listed in decreasing order (see figure 3). The total air

emissions of VOCs were 3,107 tons. The biggest six substances were ethanol, ethyl acetate, dichloromethane, isopropyl alcohol, methanol, acetone in decreasing order (see figure 4). These six substances comprised 92% of the total emissions of VOCs.

15

Methanol 8,345t

Acetonitrile2,360t

Dichloromethane2,048t

Isopropyl alcohol 1,704t Others

5,136t

Ethanol6,559t

Acetone5,818t

Toluene4,115t

Ethyl acetate3,864t

Ethyl acetate285t

Dichloromethane266t

Isopropyl alcohol253t

Methanol231t

Acetone103t

Acetonitrile40t

Ethanol1,728t

Toluene75t

Others125t

Efforts Towards Biodiversity Conservation


Since the formation of the earth, 4.6 billion years have passed, and now some 30 million species of organisms live in support of each other. According to information provided by the United Nations, the human race has accelerated the rate of species extinction by about one thousand times in the last several hundred years. Also, it claimed that 10 – 30 % of mammalian, bird and amphibian species are now facing the risk of extinction. If biodiversity continues to

decline, it has been claimed that the human race will face various problems, such as a water shortage and food crisis. Under these circumstances, the United Nations Conference on Environment and Development held in Rio de Janeiro in 1992 adopted the Convention on Biological Diversity. The convention has the three following objectives:

For those objectives, the Basic Act on Biodiversity came into force in June 2008 in Japan, and in March 2009, the Declaration of Biodiver-sity by Nippon Keidanren (Japan Business Federation) was developed and published. Those moves were followed by the Tenth Meeting of the Conference of the Parties to the Convention on Biodiversity in the City of Nagoya in October 2010, where the Nagoya Protocol concerning access to genetic resources and the fair and equitable sharing of benefits generated by their utilization and a new ten-year Strategic Plan for 2011 onwards (the Aichi Target) were adopted. In the future, we are required to have more awareness of biodiversity in conducting our business activities. We will need to take wide-ranging measures, including the procurement of raw materials, waste water discharge, chemical substance management, and the prevention of global warming. Depending on the type of industry and company, efforts to protect biodiversity will vary. Against this backdrop, the JPMA developed the JPMA Guideline of Conduct Concerning Biodiversity during FY 2011, to promote the member companies’ biodiversity conservation efforts. The guideline states the fundamental philosophy and a four point guideline for conduct.

Fundamental Philosophy and Guideline for Conduct Concerning BiodiversityFundamental PhilosophyConsideration to conserving the global environment, gratitude for the bounties of nature and harmonization of business activities with the natural environment, are included in the declaration

Guideline for Conduct Promoting actions for the prevention of global warming Sustainable use of resources Reducing chemical substance risks to the environment Building a foundation for conserving biodiversity

The JPMA has hosted the annual environmental technology training course in January every year since FY 2009 on the topic of chemical substances being discharged into environment, which is also closely related to the protection of our ecosystems and conservation of biodiversity. The FY 2009 program was titled The Current Status of Chemical Substance Management and the Future – the Challenge of Zero-Emissions, aiming to reduce atmospheric emissions of chemical substances, while the title for FY 2010, Environmental Impact of Drugs and its Risk Assessment” indicates its focus on the issue of the environmen-tal discharge of drugs into aquatic ecosystems. And, in FY 2011, we directed our focus to environmental toxicity of the discharged effluent and shared information about specific technologies such as the WET tests (Total Effluent Toxicity tests), under the title of New Effluent Management Utilizing Biological Responses”. The course for this year is planned to be on specific actions relating to the conservation of biodiversity.

123

4



Figure 3　Annual usage of VOCs (in FY2011: Note 3) Figure 4　Air emission of VOCs (in FY2011: Note 3)

(1)The conservation of biological diversity (2)The sustainable use of its components (3)The fair and equitable sharing of the benefits

generated by utilization of genetic resources

16


Group Activities Process Safety Study Group

Summary of acitivities of Process Safety Study Group from December 2011 to October 2012

The Process Safety Study Group started its activities in April 2007. The group is now in its sixth year and has 21 members from 14 companies. The original objectives of the group are to acquire knowledge and improve skills concerning safety assessment in developing the manufacturing processes of active pharmaceutical ingredients (API), scale-up, and production reviews. In addition, in response to the recent spate of chemical plant accidents and encouraged by the recent opening of the Safety Improvement Center by the Japan Society for Safety Engineering, a non-specified not-for-profit action corporation, we have focused on the tripartite efforts by the industry, officials and academia towards improving the ability to maintain safety, in an effort to prevent accidents and promote risk assessment. In addition, in December 2011, we visited The National Institute of Advanced Industrial Science and Technology (AIST) in Tsukuba for a study tour of their explosion testing facility and listened to lectures. In October 2012, we visited the National Institute of Occupa-tional Safety and Health, Japan (JNIOSH, in Kiyose), for a facility tour and lecture. Other activities include information sharing by the group member companies, such as case studies and responses to process safety issues. We will continue our group activities to help members acquire practical knowledge and share information.

Title Speakers and organizations

Study tours and lectures(Venue: AIST Tsukuba Central & Tsukuba West) 1. Introduction to AIST2. Lecture: “JPMA Process Safety Study Group”3. Study tour of the explosion testing facility4. Lecture: “Combustion of chemical substances and risks of explosion”5. Lecture: “Influence of container material in DSC assay”6. Lecture: “Specific cases of recent explosion events and their elucidation”

Study tour and lectures (venue: National Institute of Occupational Safety and Health, Japan (JNIOSH, in Kiyose))1. An overview of JNIOSH2. Lecture: “An even view of chemical substances: with a focus on calorimeter data”3. Lecture: “Static charge safety at a chemical plant: how to choose and use static charge control products4. Tour of JNIOSH facilities

1. Utilizing explosions: introduction of the industrial safety group2. Lecture: “Introduction of the relational database of chemical damage and accident analysis technique PFA”3. Facility tour for utilizing explosions: introduction of the industrial safety group

2. Process Safety Study Group3. Satoshi Okada, Miyako Akiyoshi4. Group leader, Takehiro Matsunaga5. Miyako Akiyoshi6. Yoshihiko Sato

The 20th(December)Two day session

Group leaderYuji Wada

1. Lecture: “An overview of safety measures against chemical reactions”

Kikuchi TakeshiOffice of Responsible Care (Audit), Sumitomo Chemical Co., LTD.

The 21st(February)

The 22nd(June)

The 23rd(October)Two day session

2. Lecture: “Controlling static charges made easy: part 3 (analysis of accidents caused by a static charge)

Kunio MatsukuraTechnical staff, AIST

1. Case study by one of the group member companies (Chugai Pharmaceuticals Co.,Ltd.)

2. Lecture: “Ability to maintain safety: On voluntary safety improvements in the chemical industry”

3. Lecture: “Towards prevention of accidents and incidents in the chemical industry”

Terushige Ogawa,Senior managing director, Research Institute for Safe Engineering (public interest foundation)Honorary professor, Yokohama National University

Masahide Wakakura,Leader, Safety Improvement Center Preparation Office, Japan Society for Safety Engineering (NPO), Director, Disaster Information Center (NPO), Research advisor, AIST

1. Satoshi Tamate: Construction safety study group2. Teruhito Otsuka: Chemical safety study group3. Mizuki Yamaguma: Electrical safety study group

4. Masaaki Yashima, Dr. Choi Kwangseok, Shinta Kimura

1. Lecture: “How to approach industrial safety”

2. Case study by one of the group member companies (Shionogi)

3. Lecture: “An overview of safety measures against chemical reactions (continued)

Yoshikazu Taketomi, Industrial security research officer, Commerce Distribution Safety Group, Ministry of Economy, Trade and Industry

Kikuchi Takeshi Office of Responsible Care (Audit), Sumitomo Chemical Co., LTD.

ENVIRONMENTALREPORT

2012


Pharmaceutical companies are involved in people’s lives and health. It is a part of our missions to create and maintain a work place environment for our employees that is safe, healthy and comfortable to work in. In order to achieve this, JPMA has conducted studies on and promotional activities for

occupational safety and health. Especially in recent years, we have been engaged in proactive actions to detect and handle risks that threaten occupational safety and health before an incident happens.

Sixty-three out of 70 JPMA member companies responded to our 2011 questionnaire about the rate of occupational incidents occured in FY 2011 (excluding incidents occurred during commuting). In FY 2010 we added a section for incidents that did not require a day off work as a result of the incident in addition to the existing questions about the incidents that required a day off work. For the current year, we also investigated a new item: Accident Type.

The 63 companies altogether recorded 621 cases of occupational incidents that did not require a day off work in FY 2011. Among those, sales offices had the highest number of such incidents with 320 cases (51%), followed by manufacturing plants with 173 cases (28%), R&D facilities with 59 cases (10%), head offices with 50 cases (8%) and others with 19 cases (3%). Sales offices and manufacturing plants accounted for 79% of the total number of incidents. The pattern of incidents that did not require day off work over the past three years shows an increase of about 1.5 times for the number of incidents in sales offices, from 219 cases in FY 2009 to 320 cases in FY 2011 (number of staff surveyed was increased by 13% from 52,690 to 59,626) The main contributing factor was occupational incidents consisting of motor accidents involving business vehicles.In response to this situation, the Environment & Safety Committee has created the Business Vehicle Accident Prevention Study Group to investigate & analyze the current state, and promote information sharing and educational and/or motivational actions, including sharing of new technologies for accident prevention and actions by respective companies.

The number of recorded occupational incidents in FY 2011 that resulted in an injury which required at least one day off work (excluding those occurred during commuting), was 106 cases (63 companies). When reviewing the per workplace type numbers, manufacturing plants had the highest number of incidents that required a day(s) off work, with 42 cases (40%). This was followed by sales offices with 38 cases (36%), R&D facilities with 14 cases (13%), head offices with 11 cases (10%) and others with 1 case (1%). Manufacturing plants and sales offices accounted for 76% of the total number of incidents that required a day(s) off work. The percentages of incidents that required a day(s) off work against all occupational incidents, when looked at in terms of the type of workplace, were as follows: manufacturing plants (20% = 42/215 cases), R&D facilities (19% = 14/73 cases), head offices (18% = 11/61 cases) and sales offices (11% = 38/358 cases), showing a trend of sales offices having a smaller percentage of incidents that required a day(s) off work than other types of workplace.As stated before, the total number of incidents that did not require a day off work was 621, about six times higher than the number of incidents that required a day(s) off work (106).

Figure 1. Occupational incidents that did not requirea day off work in FY 2011 indicated by the number & percentage of injuries by type of workplace

Figure 2. Occupational incidents that required at least a day off work in FY 2011 indicated by the number & percentage of injuries & deaths by type of workplace

17

JPMA’s Actions

JPMA aims to create a safe environment, in which every employees, not limited to those at manufacturing or R&D facilities, can work in a physically and mentally healthy condition. JPMA has conducted studies in occupational safety and business vehicle accidents. In addition, JPMA has held a seminor regarding mental health issues of employees and prevention of traffic accidents by business vehicles.

Occupational incidents that did not require a day off work in FY 2011

1 Occupational incidents that required a day(s) off work in FY 2011

2

R&D facilities 59 cases (10%)

Head offices50 cases (8%)

Sales offices320 cases (51%)Manufacturing plants

173 cases (28%)

Others19 cases (3%)

Total621 cases

Manufacturing plants42 cases (40%)

Sales offices38 cases (36%)

Head offices11 cases (10%)

Others1 cases (1%)


1. Status of Occupational Incidents



Total106 cases

18

The total number of work days lost owing to occupational incidents in FY 2011 reported by the 63 companies was 1,535 daysThe type of workplace with the highest number was the same as the previous year: manufacturing plants, losing 667 days (43%). This was followed by 482 days (31%) lost at sales offices. Those two types of workplace accounted for 74% of the total. Manufactur-ing plants and sales offices were also responsible for 76% of the total number of incidents that required a day(s) off work, which shows the same trend as seen in the total number of work days lost owing to occupational incidents (number of days off work).

Figure 4. Frequency of incidents requiring a day off work in FY 2011 by type of workplace

Figure 5. Severity by type of workplace in FY 2011

Figure 3. Total number of work days lost & percentage owing to occupational incidents in FY 2011 by type of workplace

0.41

0.19

0.33

0.13

0.38

0.00

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

Manufacturingplants

R&D facilities

Head offices

Sales offices

Others Total

Manufacturingplants

R&D facilities

Head offices

Sales offices

Others Total

Freq

uenc

y of

inci

dent

s re

quiri

ng a

day

off

wor

k Entire manufacturing sector：1.05Entire chemical industry：0.88

0.011

0.005

0.003

0.004

0.002

0.005

0

0.002

0.004

0.006

0.008

0.01

0.012

0.014

Sev

erity

Note) Frequency＝

Number of injured persons or deaths in occupational incidents

Accumulative work hours1,000,000×

Note) Severity＝Number of work days lost

Accumulative work hours1,000×

Entire manufacturing sector：0.08Entire chemical industry：0.04

Total number of work days lost owing to occupational incidents in FY 2011(Number of days off work)

In FY 2011 the overall frequency (in the 63 companies) of incidents that required at least one day off work was 0.38. According to the MHLW, the FY 2011 occupational incident figure representing the per-sector frequency of incidents requiring a day off work was 1.05 for the entire manufacturing sector and 0.88 for the entire chemical industry. Our survey results were even lower compared to those figures. In terms of per-workplace, manufacturing plants had the highest figure at 0.67, with R&D facilities at 0.41, sales offices at 0.33, head offices at 0.19 and others at 0.13.The number of incidents requiring a day off work at R&D facilities, 14 cases (13% of the total, see Figure 2), translated as a high frequency of incidents requiring a day off work when total working hours were taken into account, the second highest following that for manufacturing plants

Frequency of incidents requiring a day off work in FY 2011

The overall severity data (of the 63 companies that responded) indicating the seriousness of an occupational incident was 0.005. Compared to the per-sector severity data from the MHLW’s occupational incident statistics for FY 2011, 0.08 for the entire manufacturing sector and 0.04 for the entire chemical industry, our figure was low.Per-workplace scores were, 0.011, the highest, for the manufactur-ing plants, followed by 0.005 at the R&D facilities, 0.004 at the sales offices, 0.003 at the head offices and 0.002 for others. These data suggest the manufacturing plants are more prone to severe occupational incidents when compared with other types of workplace.

FY 2011 occupational incident severity

3

4

5

Manufacturing plants667 days (43%)

Sales offices482 days (31%)


Others13 days (1%)

Total1,535 days

Head offices195 days (13%)

0.67

ENVIRONMENTALREPORT

2012


Figure 6. Classification of types of occupational incidents that did not require a day off work

Figure 7. Classification of types of occupationalincidents that required at least a day off work


19

Our FY 2011 survey included questions about types of accident for incidents that did not require a day off work and incidents that did require a day(s) off work. Accident types were based on the 21 accident types published by the MHLW in 1972, and, with an additional type, “laboratory animal bite”, it has been 22 categories. The following is the data from the 57 companies that responded to these questions.

Most common accident type that related to incidents that did not require a day off work in FY 2011 (616 cases in 57 companies) was “motor accident (on road)” accounting for the 40% of all 246 cases of incidents that did not require a day off work. This was followed by “being caught between objects or in a machine” (9%/55 cases), “falling over” (8%/ 52 cases), “cut or abrasion” (8%/52 cases), “falling off/ down” (6%/38 cases) and “contact with harmful object/substance” (5%/28 cases).

Among those types of occupational incidents (170 cases),“being caught between objects or in a machine” was the most prominent out of incidents at manufacturing plants that did not require a day off work: 37 cases accounting for 22% of the total. This was followed by “cut or abrasion” (16%/27 cases), “contact with harmful object/substance” (9%/16 cases), collision (9%/16 cases), “falling off/down” (8%/13 cases) and “falling over” (8%/13 cases). For cases at R&D facilities (58 cases), the figures were “cut or abrasion” (22%/13 cases), “contact with harmful object/substance” (16%/9 cases) and “being caught between objects or in a machine” (12%/7 cases). “Laboratory animal bite” also registered 6 cases (10%). In cases at sales offices (319 cases), the figures were “motor accident (on road)” (75%/238 cases) and “falling over” (8%/27 cases). This is thought to be due to the large number of incidents that did not require a day off work caused by motor accidents involving business vehicles.

The most common accident type that related to incidents that required a day(s) off work in FY 2011 (total of 103 cases) was “falling over” representing 29% of all 30 cases of incidents that required a day(s) off work, followed by “motor accident (on road)” (20%/21 cases), “Recoil of movement or forced operation (lower back pain, etc.)” (17%/18 cases).Among these types, “falling over” (27%/11 cases) was the most prominent out of incidents at manufacturing plants (41 cases) that required a day(s) off work, followed by “Recoil of movement or forced operation (lower back pain, etc.)” (20%/8 cases) and “being caught between objects or in a machine” (12%/5 cases). For cases at R&D facilities (13 cases), the figures were “Recoil of movement

or forced operation (lower back pain, etc.)” (46%/6 cases), “contact with harmful object/substance” (23%/3 cases) and “falling over” (15%/2 cases). Meanwhile, for cases at sales offices (37 cases), the figures were “motor accident (on road)” (54%/20 cases) and “falling over” (32%/12 cases). In terms of the accident types for incidents that required a day(s) off work, “falling over”, “motor accident (on road) and “Recoil of movement or forced operation (lower back pain, etc.) accounted for 66% of all incidents. As an effort to achieve zero occupational incidents, we need to direct our resources at actions to prevent falls, lower back pain and business vehicle accidents.

Types of occupational incidents and accidents6

0

10

20

30

40

50

60

70

80

Fallin

g off o

r fallin

g dow

n

Fallin

g ove

r

Being c

augh

t betw

een o

bjects

or in a

mac

hine

Cuts & ab

rasion

s

Contac

t with

hot o

r cold

objec

t

Contac

t with

harm

ful ob

ject

Traffic

accid

ents (

on ro

ad)

Traffic

accid

ents (

others

)

Labo

ratory

anim

al bites

Electro

cution

Explos

ion

Bursting Fir

e

Collisio

n

Collisio

n cau

sed b

y othe

r

party

or ob

ject

Hit by fl

ying o

r fallin

g obje

ct

Floor

break

age w

hen s

teppe

d on

Drownin

g

Avalan

che o

r colla

pse

Recoil

of mov

emen

t or

force

d ope

ration Othe

rs

Canno

t be c

atego

rized

Fallin

g off o

r fallin

g dow

n

Fallin

g ove

r

Being c

augh

t betw

een o

bjects

or in a

mac

hine

Cuts & ab

rasion

s

Contac

t with

hot o

r cold

objec

t

Contac

t with

harm

ful ob

ject

Traffic

accid

ents (

on ro

ad)

Traffic

accid

ents (

others

)

Labo

ratory

anim

al bites

Electro

cution

Explos

ion

Bursting Fir

e

Collisio

n

Collisio

n cau

sed b

y othe

r

party

or ob

ject

Hit by fl

ying o

r fallin

g obje

ct

Floor

break

age w

hen s

teppe

d on

Drownin

g

Avalan

che o

r colla

pse

Recoil

of mov

emen

t or

force

d ope

ration Othe

rs

Canno

t be c

atego

rized

Accident types (22 categories)

Accident type (22 categories)

Num

ber o

f occ

upat

iona

l incid

ents

that

did

not

requ

ire a

day

off

wor

k (c

ases

)N

umbe

r of o

ccup

atio

nal in

ciden

ts

that

requ

ired

at le

ast a

day

off

wor

k (c

ases

)

Manufacturing plants R&D facilities Head offices Sales offices Others

246

Manufacturing plants R&D facilities Head offices Sales offices Others

0

5

10

15

20

25

30

Total: 616 cases

Total: 103 cases


20

Figure 8. Rate of Liable Accidents

Figure 10. Trend in Accidents

0.0％

5.0％

10.0％

15.0％

20.0％

25.0％

30.0％

All vehicles Leased Vehicles Vehicles owned by MRs

FY 2009

FY 2010

FY 2011

Figure 9. Rate of Injury Causing Accidents

0

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

All vehicles Leased Vehicles Vehicles owned by MRs

With regard to leased vehicles, the liable accident rate in FY 2011was 25.4%, a slight decrease compared to the FY 2010 level. The rate of injury-causing accidents also decreased for two consecutive year, standing at 2.6%.

For the question of whether there was an increase or decrease in the rate of accidents over the past three years, more compa-nies than in the previous year answered “Considerably increased” or “Increased,” while fewer companies said “No change”. The number of companies that answered “Decreased” or “Considerably decreased” remained almost unchanged. Overall, an increasing trend in accident numbers was observed.

Many companies said there was “an increase in accidents caused by younger MRs, including new recruits” “an increase of younger MRs and/or MRs joined after having worked at another company”, suggesting they think unskilled driving and/or lack of experience was the reason for the increase.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

FY 2009 FY 2010 FY 2011

Largely reduced

Reduced

No change

Increased

Largely increased

FY 2009

FY 2010

FY 2011

In 2011, the mean liable accident rate (the number of accidents divided by the total number of vehicles) was high at 22.1%, a slight increase compared to the level in FY 2010. The rate of accidents

resulting in an injury or death was 2.3% for all kinds of vehicles, remaining unchanged for the past three years.

Business vehicles are an essential tool for our medical information staff (medical representatives or MR). The JPMA conducted the survey on the management and system of business vehicle operation and status of accidents for the seventh time. Responses were received from 57 companies (with approximately 54,000 vehicles). And their actions

were analyzed. The Business Vehicle Accident Prevention Study Group, has been active for four years. Their actions include a presen-tation of case studies on accident prevention measures by our membership and the introduction of safe-driving support devices by an invited speaker.

2. Business Vehicles in Traffic Accidents and Accident Prevention

Status of accidents1

This year’s survey also included the number of new graduate MRs that had an accident within 12 months of their first assignment. The result showed about 56% of the new gradu-ate MRs recruited at the beginning of FY 2010 had a liable accident within 12 months of their first assignment.Also, their liable accident rate (number of liable accidents by FY 2010 new recruit MRs divided by the number of vehicles driven by FY 2010 new recruit MRs) was 82.4%, about the same as the figure for the FY 2009 survey. Given that the overall liable accident rate was around 20%, this figure must be considered to be very high.

Liable accident rate by new graduates or newly recruited MRs within 12 months of their first assignment

2

20.1%21.5% 22.1%

24.5%25.7% 25.4%

8.4% 7.8% 8.6%

2.4% 2.4% 2.3%

Number of firms

43

Number of new graduate MRs

Number of new graduate MRs involved in accidents

1,902

Percentage of new graduate MRs involved in liable accidents

1,065 56.0％

Table 1. Number of FY 2010 new graduate MRs involved in liable accidents

Table 2. Numbers of liable accidents and accidentscausing injury or death involving FY 2010 new graduate MRs

FY 2009 new graduate MRs (reference)

Note) Number of companies responded = 43, number of vehicles used by new graduate MRs = 1,928

1,589

136

82.4

7.1

81.8

8.7

Number of accidents

Liable accidents

Accidents causing injury or death

FY 2010 new graduate MRs

Percentage of accidents involving new graduate MRs within 12 months of assignment

2.9%

1.3%1.1%

2.7%

1.0%

2.6%

ENVIRONMENTALREPORT

2012


Note)

Fifty-seven companies responded to our questions about their efforts in and effects of vehicle accident prevention and safety promotion actions. Many companies introduced measures such as special training for new graduate MRs, special training at the time of recruitment and special training for those who had multiple

accidents and had tangible outcomes. In terms of handling employees that were involved in an accident, an individual face to face guidance program conducted by an immediate superior and a penalty system according to the severity of a liable accident was introduced by many companies, and were found to be effective.

Figure 11. Percentage & Number of Liable Accidents and Number of Persons Involved

Figure 12. Introduction of safety promotion actions and effects

11


21

Efforts in and effects of vehicle accident prevention and safety promotion actions3

Furthermore, since the previous year, we have conducted a year-long survey tracking all vehicles and new graduate MRs and compared the data for the percentage of persons that were involved in liable accidents over the two years.The all-vehicle data showed that about 15% experienced multiple liable accidents for two years in a row, with no change. However, the new graduate MR tracking study found those involved in multiple accidents were represented by a higher percentage than the all-vehicle data. Note that the percentage of FY 2010 new graduate MRs that were involved in multiple accidents within 12 months of their first assignment was 35%, a 5% reduction compared to that for FY 2009 (40%)Working with the persons that were involved in multiple accidents is also a factor in accident prevention. Not only the hardware oriented actions, such as the introduction of drive recorders, but also the

0% 20% 40% 60% 80% 100%

MRsFY 2010

New graduate MRs

FY 2009

All vehiclesFY 2010

All vehiclesFY 2010

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Driving ability assessment and course for prospectivenew graduate MRs before officially joining company

Driving ability assessment and course for new graduate MRs duringthe orientation period after joining company

Practical driving training in actual car and/or theory course for new graduate MRs at the new post

Special course for those with multiple accidents

Specific course, e.g. driving on snow at time of assignment to anew post or when moved to another area

Periodically providing self-directed theory learning coursematerials (e-training) and/or video

Face to face guidance by the immediate supervisor

Face to face guidance by someone other than the immediate supervisor

Mental health care service available after accident (counseling, etc.)

Punitive measure depending of severity of liable accident

Reflected in work performance assessment

Commendation of those without accident history or breach of highway code

Divisional commendation (branch, marketing, department)

Periodic vehicle inspection by the supervisor or other such person (at least annually)

Periodic driver license inspection by the supervisor or other such person (at least annually)

Monitoring of number of cases of highway code breach and managing the breach details

Obtaining safe driving record certificate

Head office management division providing guidance to those who have breached the code

Drive recorder (video camera to record driving)

Safety recorder (to monitor driving characteristics)

Corner sensor (prevention of accidents in a car park)

GPS navigation device (to assist driving in unfamiliar areas)

Reverse monitor (prevention of accidents in a car park while reversing)

T O P I C ST O P I C Ssoftware oriented actions for better safety consciousness need to be improved.

*

*

* 12 months after new graduate MR’s first assignment


Once Twice Three times Four times or more

Good effects of the measure (%)

Some effects from the measure (%)

None (%)

101222

Study Group

Activities Business Vehicle Accident Prevention Study Group

In the interest of ensuring the occupational safety of MRs, corporate social responsibility and compliance, the prevention of business vehicle accidents is identified as a perennial issue within pharmaceutical industry. The Business Vehicle Accident Prevention Study Group investigates member company’s regarding accidents and efforts for accident prevention, and offers opportunities for members to obtain information on accident prevention from various external sources, with the expectation that such actions will lead to an overall reduction in the number of vehicle accidents in the industry.

Activities

Detailed review of the FY2011 questionnaire survey outcomes FY 2012 questionnaire survey and analyses of the data

Case study presentations by member companies Introduction and suggestion of management measures for accident prevention

Introduction of devices and equipment for accident prevention Experience on Safety Driving Skills (Driving course at Toyota Mobilitas)

Actions for the Prevention of Business Vehicle Accidents


The Business Vehicle Accident Prevention Study Group has continued its reviews of effective accident-reduction measures and promoted the sharing of information about accident-prevention measures implemented by respective companies, based on the outcome of their ongoing business vehicle accident status survey. The data from the questionnaire survey to date have shown the challenge facing the pharmaceutical industry, of the large number of vehicle accidents involving new graduate MRs and its marked increase.Those situations motivated us to investigate the ideal timing for implementing accident-prevention measures for the new graduate MRs. The companies that have a representative in this study group cooperated in the investigation and review. (The results are shown in the graphs below.) The period studied was the three years between FY 2008 and 2010. The cases involving new graduate MRs that started driving business vehicles were divided into “cases of liable accident within six months of starting” and “cases of liable accident after six months of starting” and the status of the timing of accidents was investi-gated. The data showed a higher percentage of new graduate MRs that were involved in an accident within six months of starting to drive a business vehicle than in any previous year (FY), suggesting the importance of implementing accident prevention measures for the new graduate MRs within six

months of them starting to drive a business vehicle at their assigned location.These data and the outcomes of our business vehicle accident questionnaire survey in the past were taken into consideration by some companies, which then introduced new accident-reduction measures such as a driving ability assessment and course for new employees and the installation of a drive recorder in new graduate MR vehicles.The Environment & Safety Committee continued their educa-tional motivational actions for accident reduction in FY 2012, and, in addition to the aforementioned, hosted the Safety and Health Technical Training Course, with the focus on a lecture seminar about MR vehicle accident prevention. Mr. Kitamura from Tokio Marine & Nichido Risk Consulting Co., Ltd. was invited to the seminar to give a talk, titled “Essentials and blind spots in vehicle accident prevention of med-pharma MRs,” on the patterns of accidents involving med-pharma MRs, causes of accidents and countermeasures. In his talk, Mr. Kitamura pointed out factors such as the lower level of driving skills among the younger generation of med-pharma MRs owing to their lack of driving experience and the importance of building a mechanism to integrate safe driving education within the company. We were given good hints for future accident-prevention measures.

Timing of vehicle accidents involving new graduate MRs

67%

33%

FY 2008

Less than 6 months 6-12 months

62%

38%

FY 2009

64%

36%

FY 2010

ENVIRONMENTALREPORT

2012


The FPMAJ was founded in 1948 with the mission of contributing to the healthy development of the pharmaceutical industry and improving the lives of the people throughout the world. The FPMAJ currently consists of 14 product-type based organizations and 19 prefecture-based regional organizations. The FPMAJ Board of Directors presides over various committees and councils, each of which conducts investigations and studies in its respective special-ties and develops proposals as required.

The Environment Committee is one of those committees, whose role is to work in partnership with the MHLW and external industrial organizations and councils and tackle such issues as the preven-tion of global warming, resource conservation & waste manage-ment and other pharmaceutical-industry-specific environmental issues to meet legal requirements and society’s demands.

According to the survey conducted in FY 2012 (on actual FY 2011 data), the level of CO2 emissions from the pharmaceu-tical industry increased by 14.1% (228,000 tons) compared to the previous year, and, 11.8% (195,000 tons) more than the level of the baseline (in FY 1990). This was despite FY 2010 emissions falling below the baseline level by 2.0% (33,000 tons), and having attained the numerical target. The reason for this large excess of CO2 emissions in FY 2011 was the considerably worse electricity carbon emissions coefficient due to the closure of all nuclear power plants in Japan as a result of impact from the Great East Japan Earthquake of March 11 of the same year and the nuclear power plant accident that followed.The worsened electricity carbon emissions coefficient accounted for an additional 271,000 tons of CO2. When this

was subtracted from the total CO2 emissions in FY 2011, the alternative CO2 emission level in FY 2011 would have been 76,000 tons (4.6%) lower than the baseline.In response to the aforementioned situation, concerning our voluntary action plans for global warming prevention, the FPMAJ intends to fulfill our future duty to inform through more detailed monitoring and analyses of CO2 level movements from our business activities (including CO2 reduction measures) while distinguishing it from the level fluctuations caused by external factors such as the electricity carbon emissions coefficient change, etc., and presenting the information in an easy to understand fashion.

Among the environmental issues, the FPMAJ Environment Commit-tee has tackled global warming prevention, resource conservation & waste management by taking part in the Keidanren Voluntary Action Plan with targets for FY 2010 right from the outset and monitored our progress annually to report back to Keidanren. In addition, concerning the prevention of global warming,

the MHLW has separately conducted a strict annual review and indicated that proactive efforts to attain the action plan are required. Furthermore, as these environmental issues were not the kind of challenge one could achieve through short term action, when the Keidanren Voluntary Action Plan entered its final year in FY 2010, Keidanren developed a new voluntary action plan and requested participation by the industrial organization under its umbrella. In response to this request, the FPMAJ has formulated its own new action plan for preventing global warming, resource saving and waste management. The new action plan for resource

saving and waste management started in FY 2011. With regard to actions to tackle global warming, because the current action plan will conclude at the end of FY 2012, the FPMAJ has requested the participation and cooperation of 14 organizations governing separate product types in the FPMAJ Action Plan toward a Low Carbon Society.We intend to make the maximum effort to reach the numeri-cal targets posted by the current ongoing voluntary action plan, in accordance with the Kyoto Protocol. At the same time, we will work to ensure a smooth launch of the Action Plan toward a Low Carbon Society that will start in FY 2013, through actions such as enlisting participating companies and restructuring our follow-up regimen.Aside from the aforementioned challenges, the issues unique to the pharmaceutical industry such as medical waste disposal and other environmental issues such as actions for the biodiversity are becoming more important.

Naohiro Yoshigi Chairman, FPMAJ Environment Committee

23

Partnership with the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ)

Actions of the FPMAJ Environment Committee

State of Progress of FY 2011 Business Plan

■Global Warming Prevention



24

An overview of the FPMAJ Action Plan towards a Low Carbon Society starting in FY 2013

With regard to the actions for waste management, we have participated in the Keidanren Voluntary Action Plan on the Environment (Sound Material Cycle Society) since 1998 and endeavored to reduce the level of final output of indus-trial waste, etc. Our efforts reached a successful conclusion in FY 2010, having attained the numerical targets. Thereaf-ter, the FPMAJ refocused its efforts towards the final output

of industrial waste in FY 2011. It was a continuation of previous efforts, with a set numerical target to attain. The new voluntary action plan was in its first year in FY 2011 when the final output of total industrial waste from the entire pharmaceutical industry cleared the numerical target; although it did increase by about 12% (900 tons) from the previous year’s level.

■Resource Conservation and Waste Management

This action plan was developed in FY 2010, using the pre-earthquake electricity carbon emissions coefficient for calculations. Although the electricity carbon emissions coefficient has many uncertain factors, as there has not been a new emissions coefficient published, the FPMAJ still aims for the reduction target in this action plan. If the electricity emissions coefficient is changed in the future, we believe a review of the numerical target will become neces-sary. Please refer to Figure 1 below for the relationship between the FY 2020 numerical target in the FPMAJ Action Plan towards a Low Carbon Society and BAU.

An increasingly aging society is expected to increase the demand for drugs in the future, and, an annual growth of at least 2.0% is projected. Consequently, energy demand is expected to increase along with the increased demand for drugs. In order to continue the control and reduction of energy consumption and CO2 emissions, we will continue our endeavors towards preventing global warming, such as further promoting the introduction of the most advanced technology when installing new units, etc. Please refer to Figure 2 below for projected CO2 emissions.

Numerical target

Reduce CO2 emissions by the pharmaceutical industry by 23% from the

FY 2005 level by FY 2020

* CO2 emissions in FY 2005 were 2,230,000 tons, and the target level is 1,720,000 tons by FY 2020

* FY 2020 BAU = 2,870,000 tons will be reduced by 1,150,000 tons (including an improved electricity coefficient equivalent of 240,000 tons)

Note) BAU: CO2 emissions level in a case when no actions were taken and the baseline year conditions had been retained.

CO2 Emissions Base unit index

Note) Projected demands for drugs in the period between FY 2015 and 2025 were based on the “New Vision of the Drug Industry” from the MHLW (published on August 30, 2007)

172.6 192.3 210.4 223.4

248287

172

120.5 116.5

109.3

100 98.8

85.6

51.3

0

20

40

60

80

100

120

140

0

50

100

150

200

250

300

350

1990 1997 2000 2005 2015（BAU）

2020(BAU)

2020(Target)

Against base unitCO2 /10,000 tons

(FY)

CO2 /10,000 tons

173210

223248

287

325

51

83

130

150

170

77

94

100111

128

145

20

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0

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1990 2000 2005 2015(projection)

2020(projection)

2025(projection)

Relative percentage (%)

(FY)

CO2 Emissions Against FY 2005 data (demands for drugs)

Against FY 2005 data (CO2)

1,150,000 tons

ENVIRONMENTALREPORT

2012


Figure 1. FPMAJ Action Plan Towards a Low Carbon Society Figure 2. Future Demands for Drugs & CO2 Emissions (projection)

FY 2012 Plan for the FPMAJ Environment Committee (Focus issues)

25


○ Conduct the follow-up survey on the Keidanren Voluntary Action Plan on the Environment and submit a report○ Respond appropriately to the MHLW follow up actions to the FPMAJ Voluntary Action Plan for Environment○ Review the issues and prepare a follow up regimen towards the launch of the Action Plan Towards a Low Carbon Society in FY 2013

■ Prevention of Global Warming

Discussions with Kumamoto University Students ‒ hosting a corporate internship program ‒

An initiative by the Faculty of Pharmacology, Kumamoto University, titled Pharmacological Development Program to Nurture the Bearer of the Eco-Pharma, Aiming to Create Active Pharmacists & Pharmacology Researchers that Protect Lives and the Environment was nominated by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) for its FY 2008 Quality University Education Promotion Program. Since then, the Faculty of Pharmacology, Kumamoto University has endeavored to enrich their environmental educa-tion program. As a part of their efforts, the university facilitated a program in which their pharmacology students and graduate school scholars visit a pharmaceutical corporation and receive information related to environmental issues directly from the person working in the field that is in charge of the matter.On this occasion, the JPMA received a request to provide information about the development of the pharmaceutical industry, our involve-ment in protecting the environment and general information about JPMA actions, leading to the JPMA hosting a session in the afternoon on Monday, August 27th. Altogether, the ten participants from Kumamoto University were the Dean of the Faculty of Pharmacology, an associate professor of Environmental molecular health, two fourth-year faculty students in Pharmacology, three third-year faculty and three fourth-year students in drug creation and life pharmacology, while the JPMA had the senior managing director, director of publicity, director of quality, environment and safety promotion, and the chairman of Environ-ment & Safety Committee in attendance.The senior managing director gave a talk on “The Current State of the Pharmaceutical Industry, Proposals by the JPMA and the JPMA’s Initiative in Offering Drugs in Aid for the Great East Japan Earthquake” and the chairman of the Environment & Safety Committee gave a talk on “Our Efforts to Tackle the Environmental Issues as an Industry Organization and Our Future Actions”. These were followed by very vigorous Q&A discus-sions, which largely exceeded the scheduled time.Later, we received their feedback on the session. Below are excerpts from some of the points they made:

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

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● I believe the session helped me understand the economic and societal roles of the drug industry within the entire industrial sector. It seems the drug industry has the future potential to dynamically grow in Japan as well as expand into overseas markets. The session made me think about the importance of the development of new drugs as well as the importance of launching into overseas markets, including one in a developing country.

● The session helped me understand actions to address unmet needs and the drug-lag issue. In particular, the industry-wide passion and the desire to develop a groundbreaking new drug in an area with a low level of satisfaction for treatments was very impressive, especially in the current situation in which new drug development seems increasingly difficult.

● The talk about corporate efforts for the environment and their pursuit of profitability gave me mixed feelings. However, this session helped me understand that patient benefits and the efforts for the environment as the foundation of human living were both important and related factors, and, what is important is a balanced progress in both.

● The session helped me understand the relationship between the drug industry and the environment, including specific special factors, especially the often trade-off relation between prevention of global warming and the measures to ensure trust in drugs (such as adherence to GMP, GLP and such standards) and unused drug and metabolites from administered drugs can both leave an impact on the environment.

● I felt the passion of the speakers, not only for their economic activities, but also in fulfilling their corporate responsibilities for society, including addressing environmental issues and their efforts for compliance.

○ Conduct the follow-up monitoring of the Keidanren Voluntary Action Plan & submit a report○ Share information and prepare a follow up regimen towards attainment of new numerical targets ○ Gather and provide information for reduction and proper disposal of medical waste and maintain a good relationship 　with related organizations○ Gather information on the environmental challenges that pose a major impact on business activities, such as the biodi　versity issue

■ Resource Conservation and Waste Management

ENVIRONMENTALREPORT

2012


The JPMA Environment & Safety Committee intends to raise awareness and find efficient solutions to the issues through the facilitation of information sharing among the JPMA members, by hosting seminars and technical training courses with invited outside speakers, as well as through the presentation at courses and workshops of case studies of the members’

actions in protecting the environment. The Committee also issues a periodical publication, “Environment News”, conducts various studies on JPMA members’ action for the environment and occupational safety and health and compiles these into booklets, etc, and distributes the information collected from the member companies.

Publication of Study Reports

Publication of Environmental Reports

Publication of “Environment News”

The Environment & Safety Committee organizes the information obtained through various research activities conducted by the respective technical groups, or at lectures, seminars and technical training courses, and collates it into a CD-ROM for distribution to the member companies. This arrangement enables the members to access a wide range of information about the seminars, technical training courses, or other occasions that their personnel were not

Publication of Achievement Report

Training & Motivation

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Study Group Activities

The respective JPMA expert subcommittees have study groups, in which the member companies that do not participate in the expert subcommittees can still participate in areas requir-ing technical expertise. Currently, three study groups are

working actively: “Kyoto Protocol Comprehensive Action Study Group”, “Process Safety Study Group” and “Business Vehicle Accident Prevention Study Group”.

ENVIRONMENTALREPORT

2012


The Environment & Safety Committee General Assembly is held annually in April to discuss and determine an annual action plan concerning Environment and Occupational Safety and Health related matters for the streamlined implementation of these actions. The respective Technical Subcommittees conduct questionnaire surveys, etc., to monitor progress in attaining the targets and to identify issues and tasks, and also

prepare reports of the outcomes as a form of feedback to the member companies. The committee also takes part in the Keidanren Voluntary Action Plan (both the Global Warming Prevention Edition and Sound Material Cycle Society Edition), through follow-up studies on the state of progress and action by the members; compiling the data and information obtained into a report and periodically reporting this to Keidanren.

The Environment & Safety Committee has anually published an Environmental Report from FY1999 to provide a summary of our members’ efforts and actions for the environment and occupational safety and health. The Environmental Report discloses information about the pharmaceutical industry’s efforts for the environment and occupational safety and health as a means to fulfill our responsibility to provide an explanation to stakeholders. The report is also expected to be a tool for commu-nication between the member companies and the society.

The Environment & Safety Committee issues “Environment News”, which includes summaries of Environment and/or Occupational Safety and Health related Seminars and Technical Training Courses for easy access by the member companies. This information is uploaded to PRAISE-NET, the intranet shared between the Federation of Pharmaceuti-cal Manufacturers’ Associations of Japan, the Osaka Pharmaceutical Association and the Tokyo Pharmaceutical Association, so that the information is widely distributed in the pharmaceutical industry.

able to attend. This is a means for the respective member compa-nies to find information about the activities of the Environment & Safety Committee and to apply it effectively in their own activities. It should be noted that this Achievement Report is created through the cooperation and understanding of many lecturers and speak-ers at the seminars, technical training courses, etc.

Environment and Safety Lecture (April 2012)

Energy Saving / Global Warming Prevention Technical Training Course (October 2012)

Japan’s Energy Policies and Ideal Corporate Administration

Testsuyuki MuraiPresident & CEOInstitute of Environmental Administration Strategy, Co.Ltd.

Environment and Safety Seminar (November 2011)

Issues Surrounding Water as a Global Resource

Prof. Taikan OkiInstitute of Industrial Science,University of Tokyo.

Commentaries on the issues that directly affect us, such as global water issues, the reasons for water shortages on the Earth, level of household water used in Japan, an approach to water usage from a view point of “virtual water” including the water used in food production, the impact of a global-warming-induced climate change on water, and the Great East Japan Earthquake and water. Concluded with a proposal: “Drink water & think about the source, drink & eat and think about water – for a sustainable society”

Concept of Water Environment Management Technique Utilizing Biological Responses

Dr. Norihisa TatarazakoSenior ResearcherNational Institute for Environmental Studies

The Minstry of the Environment is reviewing a “Management Technique Utilizing Biological Responses”, as a management technique to monitor and assess the relative impact on the aqua-environment and presence of ecological toxicity from discharged effluent possibly contaminated with chemical substances. The talk provided commentaries on the status of introduction of this approach overseas, the legislative actions if this technique were to be introduced in Japan and how to approach it in terms of the operational aspect, and, an overview and framework for a voluntary management system as a future direction.

WET Tests on Effluent Discharged from Plants within Tokushima Prefecture - from the view point of an academic researcher -

Dr. Hiroshi YamamotoAssociate ProfessorGraduate School of Integrated Arts and Sciences The University of Tokushima

Commentary about the outcomes of the study of several businesses and household effluent treatment plants within Tokushima Prefecture under the regulations of the Water Pollution Control Act, conducted according to a method recognized by the US Environment Protection Agency (Whole Effluent Toxicity or WET method). In addition from an academic researcher’s point of view, the necessity for applied research that would lead to a system design and the development of assessment and management techniques for studying the impact of trace chemical substances on aquatic organisms from multi-angle points of view.

Biological Responses and Toxicity Reduction Evaluation (TRE) or Toxicity Identification Evaluation (TIE)

Tatsuhiro NiinoLeaderEnvironmental Impact TeamMitsubishi Chemical Medience

One characteristic point of the WET based approach is when the level of toxicity in effluent is found to be in excess of the standard, it is necessary to identify the toxic substance and the process of its effluent contamination and to reduce the toxicity within effluent. Specific commentaries were given on the series of procedures termed Toxicity Reduction Evaluation (TRE) to achieve the aforementioned processes, and, the procedures performed when toxicity reduction could not be achieved termed Toxicity Identification Evaluation (TIE)

During a process of risk evaluation, when one focuses on one risk and tries to reduce it, often there is another, different risk surfacing. The important thing is not to try reducing something in a haphazard fashion, but to take a balanced approach aiming to reduce the overall risks for the entire society and to determine the endpoint of what event needs to be avoided at any cost. A warning bell was rung cautioning against our thinking environmental risk evaluation and risk management, where easy options tend to be taken without thorough consideration.

Ever since the Great East Japan Earthquake, a major debate has been heating up in terms of the mid- to long-term energy strategies of Japan and current electricity supply vs. demand. In this situation, in addition to taking all necessary measures to strengthen supply, more than ever it is essential to take action regarding demand, on the side of those with demands. After introducing the previous energy-saving policies from the industrial and service sectors’ view points, a future energy-saving vision was presented based on a change in energy supply and demand structure.

Commentaries about the status of global warming, constructing an international framework for global warming prevention, actions against global warming taken within Japan, and details of such initiative as “Realizing a green growth” and a “Dramatic growth in the introduction of renewable energy”, showing the direction of future global warming prevention action.

Daikin’s experience over the past two years of making efforts to save electricity in the use of air conditioners was shared. Based on the data, energy-saving measures in air conditioning units that lead to real energy saving and information about a new air-conditioning system were presented.

Innovations and Risk Assessment Dr. Junko Nakanishi

FellowNational Institute of Advanced Industrial Science and Technology

Trends & Direction of Japanese Energy Saving Policies

Takeo UharaAssistant ManagerEnergy Efficiency and Conservation DivisionAgency for Natural Resources and EnergyMinister of Economy, Trade and Industry

Trends & Direction of Global Warming Prevention Measures in Japan

Shuichiro NiiharaTeam LeaderOffice for a Low Carbon SocietyPolicy and Coordination DivisionGlobal Environment BureauMinistry of the Environment

The Latest Air Conditioning Units and Energy Saving Measures

Takashi MishinaOffice LeaderCustomer Support CenterAir conditioning Sales DivisionDaikin Industries, Ltd.

Environment and Safety Lectures and Technical Training Courses (November 2011 – October 2012)

Environmental Technical Training Course (January 2012)

Listed the three challenges in rebuilding Japanese energy policies: the balance in the energy supply system and energy demand; conversion to electricity and other energy-saving-oriented economic structures; and rebuilding of the framework for nuclear safety and regulation. With regard to corporate responses to these challenges, three proposals were made: changing the structure of society to an electricity-saving-oriented one; switching of ideals from corporate social responsibility (CSR) to the creation of corporate shared values (CSV); and the importance of better corporate competitiveness towards resolving social issues.

Occupational Health and Safety Technical Training Course (July 2012)

Despite actions being taken to avoid business vehicle accidents, many companies are thought to have trouble achieving a reduction in the number of accidents and have difficulty devising countermeasures. The lecture proposed how to understand the risks involved in med-pharma MRs’ accident countermeasures, and how to go about choosing the right actions to address the issue.

Product safety and quality tend to depend on individual judgment. The speaker described the introduction of a management system as a way to remove this dependency and emphasized the importance of the 5S activities. Special commentaries about the 5S activities and its correct definition and expected effects were given. Benefits of the 5S activities were listed as nurturing personnel, generating unity, and developing a good environment. Especially the effect of nurturing personnel is believed to lead not only to improved safety and quality, but also to improved productivity and competitiveness.

Recent years have seen an increase in the number of cases in which workers who were on leave owing to a mental health issue found it difficult to return to the workplace. Firstly, a commentary was given on the reason for the increase in such cases. Then a specific commentary was given about actions to facilitate a smooth return to work and points to note at respective stages from leave to return. The importance of the series of actions, coordination and collaboration between personnel and duty managers, the immediate supervisor and work place physicians was stated.

Essentials and blind spots in vehicle accident prevention of med-pharma MRs

Noriyasu KitamuraLeaderDevelopment GroupAutomobile Risk Business DivisionTokio Marine & Nichido Risk Consulting Co.,Ltd.

Towards an Impressively Safe and Secure Work Place Correct 5S Activities to Nurture Personnel

Hideaki TakemotoGeneral Manager, Nishinomiya PlantManaging officerAsahi Breweries, Ltd.

Leave and Returning to WorkHow to Handle Those with Mental Health Issues

Dr. Takahiro Ohno

Occupational physicianDirectorOhno-Takahiro Occupational Health Consultant Office

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The Environmental and Safety Committee holds an annual environment and safety seminar, for the directors and management staff who are involved in environment, safety and health issues. External speakers are invited to give talks at the seminar, providing us with a wide range of up-to-date information on environment protection and occupational safety

and health. We also run environment and safety lectures and various technical training courses, in which information is given about technology and management in environmental protetion and occupational safety and health. Respective companies’ efforts are presented, so that member companies can improve their levels in their respective areas.

Environment and Safety Lecture, Environment and Safety Seminar and Technical Training Courses



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ENVIRONMENTALREPORT

2012


Participated in Nippon Keidanren’s commitment to a Low Carbon Society, targeted in FY2020, and settled a reduction target of total CO2 emissions. The target for the period from FY2011 to FY2015 as the final year for the Keidanren’s Voluntary Action Plan on the environment (Sound Material-cycle Society) was settled.

The Japan Pharmaceutical Manufacturers Association was founded. “Related Technology Liaison Group” was established to undertake technological reviews on pollution issues around factories (in principle, waste water issues)　

2010

A new voluntary action plan for waste reduction towards the final year of FY 2015 was started.Fundamental Philosophy and Guideline for Conduct Concerning Biodiversity was formulated to present the JPMA’s stance on biodiversity.2011

2010

2008

1968

1978

1979

1996

2001

1997

1998

1999

2003

2005

2006

2002

“Related Technology Liaison Group” was reorganized to the “Factory Waste Water Regulatory Measures Review Group”　

In collaboration with the concerned authorities and agencies, an “Environment Action Review Group” was established for adopting the government administration’s intentions, communicating the industry’s ideas, exchanging information within the industry and the confirmation of a common direction for the environmental action among the members

An “Environment Committee” was established. Five Subcommittees (Planning Subcommittee, Chemical Substances Subcommittee, Environment Management Subcommittee,　Resources Conservation & Waste Management Subcommittee and Energy Saving & Global Warming Prevention Subcommittee) were internally organized and systematic action on global environmental issues was initiated. The first period atmospheric emissions reduction plan for harmful atmospheric pollutants such as dichloromethane, 1,2-dichloroethane and chloroform was settled on.

Participated in the Keidanren Voluntary Action Plan for the Environment implemented the Follow-Up Action and settled a CO2 emissions reduction target. Initiated an energy use survey among the member companies.

Settled “Guidelines for the Voluntary Action Plan for the Environment by Pharmaceutical Manufacturers”, which clearly stated JPMA’s efforts on environmental issues. Published an Environment Report.

Committee activities expanded to occupational safety and health. Renamed the “Environment & Safety Committee”. “Study Groups” were organized as places for activities beyond the subcommittees.

Restructuring of the Committee organization from a five to a four subcommittee regime (Chemical Substances Subcommittee, Environment Management Subcommittee, Resources Conservation & Waste Management Subcommittee and Energy Saving ＆ Global Warming Prevention Subcommittee) alongside the newly created Steering Committee. The second period atmospheric emissions reduction plan for harmful atmospheric pollutants (dichloromethane, 1,2-dichloroethane and chloroform) was settled on.

Settled Action Plans on wastes generation and final disposal amount of waste.

Review the target of final disposal amount of wastes (tighten the rate of reduction from 70% to 80%)

The third period reduction plan for air emissions of harmful atmospheric pollutants (dichloromethane, 1,2-dichloroethane and chloroform) was settled on.

New numerical targets for the final disposal rate and waste generation were introduced　to a Waste Reduction Action Plan, in addition to the final disposal amount of wastes.

Subcommittees reorganized from a four-subcommittee regime (Chemical Substances Subcommittee, Environment Management Subcommittee, Resources Conservation & Waste Management Subcommittee and Energy Saving & Global Warming Prevention Subcommittee) to a three-subcommittee regime (Environment Subcommittee, Occupational Safety & Health Subcommittee and Global Warming Prevention Subcommittee)

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Progress of Our Voluntary Action Plans

Area of Action

Resource Conservation and Waste Management


Action to control Air Emissions


Year AttainedYear of Planning

FY1997(First Period Plan)

Dichloromethane: 20% reduction compared to the amount in FY20031,2-dichloroethane: 20% reduction compared to the amount in FY2003Chloroform: 20% reduction compared to the amount in FY2003

Dichloromethane: 60% reduction compared to the amount in FY19951,2-dichloroethane: 50% reduction compared to the amount in FY1996Chloroform: 30% reduction compared to the amount in FY1996Formaldehyde: reduction effortsBenzene: reduction effortsTetrachloroethylene: reduction effortsAcetonitrile: reduction efforts

Control the average CO2 emissions from FY 2008 to FY 2012 to below in FY1990 level

FY1996(First Period Plan)

Dichloromethane: 30% reduction compared to the amount in FY19951,2-dichloroethane: 30% reduction compared to the amount in FY1996Chloroform: 30% reduction compared to the amount in FY1996

Final disposal amount: 80% reduction in FY2010 against that in FY1990Final disposal rate: 5% or less in FY2010Waste generation: 10% reduction in FY2010 against that in FY1990

Final disposal amount: 80% reduction against that in FY1990

FY2002

FY2005

FY2007

FY2000

FY2004

FY2007

Ongoing

FY2010(Second Period Plan)

Reduce CO2 emissions by 23% from FY 2005 level by FY 2020 Established plan　


Final disposal amount: 70% reduction against that in FY1990FY2001

(First Period Plan)


FY2006(Third Period Plan)

Final disposal amount : almost 65% reduction in FY2015 against that in FY2000 OngoingFY2010(Fourth Period Plan)

FY2005(Third Period Plan)

Action Plan Contents

Members of Planning Conference and Steering Committee of Environment & Safety Committee

Chairperson

Akihiko Tasaka

Seishi Takenawa

Teruyuki Tosaka

Satoru Kobayashi

Akihiro Hara

Junichi Taniguchi

Takeshi Oigawa

Akira Kusai

TAKEDA PHARAMACEUTICAL CO., LTD.

Akihiko Tasaka TAKEDA PHARAMACEUTICAL CO., LTD.

ASTELLAS PHARMA INC.　

CHUGAI PHARMACEUTICAL CO., LTD.

OTSUKA PHARMACEUTICAL CO., Ltd.

Jun Yamamoto

Akinori Hoshitani

DAIICHI SANKYO CO., LTD.

TERUMO CORPORATION

Meiji Seika Pharma Co., Ltd.

TAISHO PHARMACEUTICAL CO., LTD.Naohiro Yoshigi

JPMA

DAIICHI SANKYO CO., LTD.

Satoru Kobayashi DAIICHI SANKYO CO., LTD.

Deputy Chairperson

Environmental

Chairperson

Deputy Chairperson Masayuki Takagishi SHIONOGI & CO., LTD

DAINIPPON SUMITOMO PHARMA CO., LTD. Deputy Chairperson

Deputy Chairperson

Chairperson

Deputy Chairperson

Deputy Chairperson

Chairperson

Occupational Safety & Health

Member nominated by Chairperson

Secretariat

Global WarmingPrevention

Hirotsugu Yokoi

Shinichi Endo

ASAHI KASEI PHARMA CORPORATION

EISAI CO., LTD.Deputy Chairperson

Steering Committee

Planning Conference

Expert Subcommittees

30

JPMA Member Companies (listed in alphabetical order): 70 Companies as of October 2012

ENVIRONMENTALREPORT

2012


ABBOTT JAPAN CO., LTD.

AJINOMOTO PHARMACEUTICALS CO., INC.

ASAHI KASEI PHARMA CORPORATION

ASKA PHARMACEUTICAL CO., LTD.

ASTELLAS PHARMA INC.

AstraZeneca K.K.

BAXTER LTD.

BAYER YAKUHIN, LTD.

BRISTOL-MYERS K.K.

Celgene K.K.

The CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE

CHUGAI PHARMACEUTICAL CO., LTD.

DAIICHI SANKYO CO., LTD

DAINIPPON SUMITOMO PHARMA CO., LTD.

EISAI CO., LTD.

ELI LILLY JAPAN K.K.

FUJIMOTO PHARMACEUTICAL CORP.

FUSO PHARMACEUTICAL INDUSTRIES, LTD.

Genzyme Japan K.K.

GlaxoSmithKline K.K.

HISAMITSU PHARMACEUTICAL CO., INC.

JANSSEN PHARMACEUTICAL K.K.

JAPAN TOBACCO INC.

KAKEN PHARMACEUTICAL CO., LTD.

KISSEI PHARMACEUTICAL CO., LTD.

KOWA Company, Ltd.

KRACIE PHARMA, LTD.

KYORIN PHARMACEUTICAL CO., LTD.

KYOTO PHARMACEUTICAL INDUSTRIES, LTD.

KYOWA HAKKO KIRIN CO., LTD.

MARUHO CO., LTD.

MARUISHI PHARMACEUTICAL CO., LTD.

Meiji Seika Pharma Co., Ltd.

MINOPHAGEN PHARMACEUTICAL CO. LTD.

MITSUBISHI TANABE PHARMA CORPORATION

MOCHIDA PHARMACEUTICAL CO., LTD.

MSD K.K.

MYLAN SEIYAKU LTD.

NIHON PHARMACEUTICAL CO., LTD.

NIPPON BOEHRINGER INGELHEIM CO., LTD.

NIPPON CHEMIPHAR CO., LTD

NIPPON KAYAKU CO, LTD.

NIPPON SHINYAKU Co., Ltd.

NIPPON ZOKI PHARMACEUTICAL CO., LTD.

NOVARTIS PHARMA K.K.

NOVO NORDISK PHARMA LTD.

ONO PHARMACEUTICAL CO., LTD.

OTSUKA PHARMACEUTICAL Co., Ltd.

PFIZER JAPAN INC.

POLA PHARMA INC.

Sanofi K.K.

SANTEN PHARMACEUTICAL CO., LTD.

SANWA KAGAKU KENKYUSHO CO., LTD.

SEIKAGAKU CORPORATION

SENJU PHARMACEUTICAL CO., LTD.

SHIONOGI & CO., LTD.

TAIHO PHARMACEUTICAL CO., LTD.

TAISHO PHARMACEUTICAL CO., LTD.

TAKEDA PHARMACEUTICAL CO., LTD.

TEIJIN PHARMA Limited

TEIKOKU SEIYAKU CO., LTD.

TERUMO CORPORATION

TOA EIYO LTD.

Toray Industries, Inc.

TORII PHARMACEUTICAL CO., LTD.

TOYAMA CHEMICAL CO, LTD.

UCB JAPAN CO., LTD

WAKAMOTO PHARMACEUTICAL CO., LTD.

YAKULT HONSHA CO., LTD.

ZERIA PHARMACEUTICAL CO., LTD.

Ｒ

Planned and Complied by


Torii Nihonbashi Building, 3-4-1, Nihonbashi-honcho,

Chuo-ku, Tokyo 103-0023, Japan

TEL +81-3-3241-0326 FAX +81-3-3242-1767

URL: http://www.jpma.or.jp/


Documents

ENVIRONMENTAL REPORT 2012 · acceptable from a global perspective. Each of us must not only strictly adherence to rules and legislation but ... also fulfill our societal mission as