Protecting our people, our communities and the environment is fundamentally important to the way our company operates.
Our mission and values are articulated by our company Code of Conduct, Our Values and Standards, which serves as a vehicle to communicate them to all of our employees. We also communicate Environmental Health and Safety (EHS) expectations to our suppliers through our Business Partner Code of Conduct, which outlines the EHS requirements for the firms with which we do business. Our EHS values and commitments are further detailed in our corporate policy, Respect for Environmental, Health and Safety. In addition to compliance with all applicable country, regional and local safety and environmental laws, we strive for EHS performance that is among the best in the pharmaceutical industry.
As our EHS Policy states, we:
- Maintain a safe and healthy working environment for all employees, contractors and guests
- Foster a culture of EHS excellence that is built on integrity, accountability, collaboration and active employee participation, and seek to continuously improve our systems, processes and standards in further support of that culture
- Investigate and implement approaches to reduce the resources we use during the design, development and manufacturing of our products and delivery of commercial services, so as to minimize our impact on the environment
- Understand the potential hazards associated with our products and take action to reduce any potential risks or adverse impacts
- Promote EHS excellence in our supply chain and expect third parties doing work on our behalf to do the same. We enter into business relationships with partners that share our commitment to responsible EHS stewardship
Our EHS Management System is based on the “Plan, Do, Check, Act” model, which allows us to assess and continually improve our practices over time. The model is implemented through a set of interwoven business processes that span the corporation:
- The planning process includes development of goals, objectives and metrics based on a review of company performance, EHS programs, applicable regulations and other external factors [PLAN]
- Activities are informed by Standards, Guidelines and Tools, which are integrated into the EHS Management System, and include specific expectations for sites and operating organizations [DO]
- Governance committees, from the executive-level EHS Council through site-compliance committees, review performance and progress against objectives. Central audits and self-assessments raise issues, and our monthly and annual performance metrics reflect our progress [CHECK]
- Corrective actions and continuous-improvement initiatives are established to resolve EHS concerns that are surfaced during performance reviews, assessments, audits and routine surveillance of the regulatory landscape [ACT]
Training is critical to building worldwide employee competencies that will improve compliance, reduce risks and drive continuous improvement.
We have a global standard that defines the Environmental Health & Safety (EHS) training expectations for employees in of three categories:
- Managers—covers specific management responsibilities with regard to safety and environmental compliance and promoting a “safety first” culture
- EHS professionals—designed to drive and expand technical expertise and improved EHS capabilities around the world
- Overall employee population—covers the specific information our employees need to perform their jobs in a safe and environmentally compliant manner, focusing on hazards and control measures employees encounter on the job
These training programs are reviewed periodically to ensure they remain current. Our EHS training program materials are available in both instructor-led as well as e-learning formats. A mandatory course for all senior company leaders highlights the importance of EHS to the business, the critical role senior leaders play in EHS performance, and the specific actions our leaders can take to drive their areas of accountability toward EHS excellence.
Our commitment to the environment and employee health and safety begins with the company’s Executive Committee, which has established the corporate Environmental, Health & Safety (EHS) Council.
This council, composed of senior-level executives from all business units, is responsible for overall EHS governance as well as leading and driving enterprise-wide excellence in EHS management and performance.
The Council’s responsibilities include:
- Establishing EHS strategy, policy and standards
- Providing company-wide oversight of environmental and employee safety issues, risk mitigation and control strategies
- Monitoring performance, establishing continuous-improvement targets, and recognizing and promoting excellence
- Allocating resources and/or sponsoring projects to address specific concerns
An EHS Standards Committee chartered by the Council provides stewardship over the Standards and enables business engagement in the development of new or revised Standards. Each area of the business is responsible for executing against the Standards, contributing to development of programs, supporting internal audits and communicating significant EHS events. Divisional compliance committees have been established to provide governance on the implementation of the Standards and for other EHS matters. The vice president (VP) of Global Safety and the Environment (GSE) is responsible for communicating to the Board of Directors, the Executive Committee and EHS Council regarding progress on goals, objectives and metrics, as well as other material issues. The VP of GSE partners with business leaders to establish long- and short-term goals and performance metrics to drive EHS excellence.
Our corporate EHS organization is responsible for:
- Developing corporate policies, procedures, guidelines, standards, tools and programs to set expectations and to support EHS compliance
- Providing technical and regulatory support to site-based safety and environmental staff and operating organizations
- Managing and implementing an internal audit program targeted at understanding the current state of compliance and identifying potential issues
- Tracking and communicating internal and external trends that should be addressed
- Anticipating, tracking and commenting on new regulations affecting our business and, where appropriate, developing plans to address them
Our site-based safety and environmental professionals around the world support the EHS needs of their business areas, which include manufacturing, research operations, sales and administrative activities, by:
- Ensuring that line management fully understands EHS requirements, including applicable regulations, permit requirements and company EHS Standards
- Establishing, assessing and improving programs
- Providing regulatory and technical support to employees and the operating areas
- Routinely assessing performance against both regulatory and company requirements
- Acting as the primary liaison with local regulators and inspectors
- Investigating incidents and developing corrective action plans to address identified root causes
We have a detailed and rigorous internal corporate safety and environmental audit program.
Our global corporate Environmental Health & Safety (EHS) Audit Program is one way in which we identify and resolve compliance and performance issues.
- Our audit leaders are full-time professional auditors with extensive experience in auditing a broad range of EHS programs applicable to the company. Audit team members consist of EHS professionals with extensive site and subject-matter expertise. In many cases, particularly outside of the United States, our internal auditors work with independent consultants who have regulatory expertise in the laws of the host country.
- All audit findings are addressed through the development of corrective and preventative action plans, which are reviewed, approved by the audit leader and regional GSE leader, and tracked to completion
- Findings from our audit program are communicated to appropriate parts of the organization so that learnings may be shared and actions can be taken
- Audit performance and key program metrics are reviewed as part of our governance process
EHS audits of our facilities covered 55% of our manufacturing and research locations in 2015.
The audit frequency for a given facility is primarily risk based. Manufacturing and research sites are generally audited every one to two years, depending on the type of facility, its size and other factors. Less complex facilities, such as sales and business offices and our warehouses, are typically audited every five years. In 2015, we performed 42 corporate EHS audits of our facilities, covering 55 percent of our manufacturing and research locations, and involving 605 auditor days of on-site review activities.
In addition to our corporate EHS audit program, our sites regularly perform self-inspections, and annually complete self assessments of selected regulatory requirements and company standards, with all programs being self assessed at least once every three years.
Environmental management practices have evolved significantly over the past 30 years.
With research and manufacturing operations dating back more than 100 years, some of our facilities operated at a time when there were few regulations and little understanding of good environmental practices. Because our company has responsibility for remediation of these sites, we have launched investigations, developed science-based remediation plans and implemented cleanup projects to protect the health and safety of our neighbors, communities, employees and the environment, and comply with all applicable requirements.
For remediation and environmental liabilities, including at formerly owned and operated sites, we spent $12 million in 2014 and $8 million in 2015. Our company has an Environmental Liability reserve of approximately $100 million to fund the continued remediation of these sites now and into the future. In addition, we are a potentially responsible party at 19 multiparty Superfund sites in the United States.
Our centralized environmental, health & safety (EHS) information system allows us to collect, manage, learn from and share our safety and environmental performance data more efficiently.
We collect and analyze data reflecting both leading and lagging metrics to look for potential trends and identify opportunities that could help drive performance improvement. We continuously explore new ways to learn from and report on our performance.
|Global Environmental & Safety Compliance Summary1|
|Notices of Violations (NOV) / Citations||2011||2012||2013||2014||2015|
|Environmental fines paid||$1,531,765||$12,100||$1,167||$81,600||$157,270|
|Number of environmental fines||14||1||1||4||7|
|Safety fines paid||$7,500||$121,827||$3,827||$1,000||$0|
|Number of safety fines||2||2||2||1||0|
|1 Previously reported data have been restated for consistency with Global Reporting Initiative (GRI) guidelines.|
Notices of Violations, Fines & Settlements
We report all forms of EHS compliance notices using the term Notices of Violations (NOVs), which includes citations, letters of warning and notices of noncompliance from environmental and safety-focused regulatory agencies.
In 2015, we had 183 EHS-related inspections of our facilities around the world. We received two safety NOVs and no safety-related fines in 2015. We received 16 environmental NOVs and paid $157,270 in fines associated with seven environmental incidents in 2015. Over the last five years, the number of NOVs and fines received by our company has been trending downward, and in 2015, we saw a significant decrease in the number of safety-related NOVs over the prior year.
Significant Environmental Events
A “significant environmental event” is defined as an environmental release that results in environmental harm to humans, aquatic organisms or wildlife, or any environmental release that requires reporting to the U.S. Securities and Exchange Commission. We experienced no significant environmental events in 2015.