EHS Management & Compliance

Protecting our people, our communities and the environment is fundamentally important to the way our company operates.

Highlights
  • Performed 55 corporate Environment, Health and Safety (EHS) audits of our facilities, covering 76 percent of our manufacturing, and research locations and involving 693 auditor days of onsite review activities
  • An internal Quality Assurance Review of the EHS Auditing program was conducted in 2018/2019 by Corporate Audit and Assurance Services. As a result of this internal review, the EHS auditing program was rated “Effective,” with controls and practices deemed to be in line with company requirements and expectations.

Our approach

Our company strives every day to conduct business in a safe and environmentally responsible manner. We are committed to providing a safe and healthy workplace for our employees and to reducing the environmental impact of our operations around the world. Our core values are focused around promoting the health and safety of our employees and respect for the environment. This is reflected in our Corporate Policy: Respect for Environmental, Health and Safety.

In addition to complying with all applicable country, regional, state, provincial and local safety and environmental laws, we strive for EHS performance that is among the best in the pharmaceutical industry.

We also adhere to the following key operating principles:

  • Maintain a safe and healthy working environment for all employees, contractors and guests
  • Foster a culture of EHS excellence that is built on science, integrity, accountability, personal responsibility, collaboration and active employee participation
  • Seek to continuously improve our EHS systems, processes and standards
  • Minimize our impact on the environment by identifying and implementing approaches to reduce the resources we use during the design, development and manufacture of our products
  • Understand the potential hazards associated with our products and take action to minimize any potential risks or adverse impacts
  • Promote EHS excellence in our supply chain by entering into business relationships with partners that share our commitment to responsible EHS stewardship

The Global Safety and Environment (GSE) department is responsible for the global EHS Management System which is based on the “Plan, Do, Check, Act” model. This enables us to assess and continually improve our practices over time. The model is implemented globally through a set of interwoven business processes that span the corporation:

  • Our planning process includes developing goals, objectives and metrics based on a review of our company’s performance, EHS programs, applicable regulations and external factors that may impact our business (PLAN)
  • Activities are performed by using standards, guidelines and tools that 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-based compliance committees, review business unit performance and progress against objectives throughout the year. EHS audits are also performed throughout the year. (CHECK)
  • Corrective actions and continuous-improvement initiatives are established to resolve EHS concerns that have surfaced during periodic assessments, audits and routine surveillance of the regulatory landscape. We track our corrective actions centrally to ensure proper oversight. (ACT)

Programs and initiatives

We have robust programs and initiatives to address global challenges and opportunities related to achievement of our short and long-term environmental management and compliance objectives.

Training

Training is critical to building worldwide employee competencies that will improve compliance, reduce risks and drive continuous performance improvement.

We have a global standard that defines the EHS training expectations for employees in three categories:

  • Manager training covers specific management responsibilities with regard to safety and environmental compliance and promoting a “safety-first” culture
  • EHS professional training is designed to expand technical expertise and improve our EHS capabilities around the world
  • Employee training covers the specific information our employees need to perform their jobs in a safe and environmentally compliant manner, focusing on hazards they encounter on the job and the corresponding control measures

Site EHS professionals complete an assessment of the activities performed at their sites and ensure that relevant topics are included in their site training plans. They develop employee training curricula to comply with internal and regulatory training requirements specific to their country. These training programs are reviewed periodically to ensure that they remain current. Our EHS training program materials are available in both instructor-led and e-learning formats. We also conduct periodic web-based seminars to inform EHS professionals of changes in regulations, standards and company practices.

EHS governance

Our commitment to the environment and employee health and safety begins with the company’s Executive Committee, which has established the corporate EHS Council.

The EHS Council is composed of senior-level executives representing all business units, and is responsible for overall EHS governance, as well as for leading and driving enterprise-wide excellence in EHS management and performance. In 2019, the EHS Council formally met four times, with additional off-cycle communications as needed.

The Council’s responsibilities include:

  • Establishing EHS strategy, policy and business risk mitigation controls
  • Ensuring cross-divisional engagement in the design and implementation of EHS business processes
  • Sponsoring and implementing a sustainability strategy
  • Monitoring the EHS performance of the Company and establish continuous improvement targets
  • Enhancing visibility and transparency of EHS risks, processes and issues

An EHS Standards Committee has been chartered by the Council to provide stewardship over the standards and enable business engagement in the development of new or revised standards. Each area of the business is responsible for executing against the standards, contributing to the development of programs, supporting internal audits and communicating significant EHS events. Divisional EHS compliance committees have also been established to manage, execute and resolve EHS issues as they arise.

The vice president (VP) of GSE is responsible for communicating to the company’s Board of Directors, Executive Committee and the EHS Council regarding progress on goals, objectives and metrics, as well as other material issues. In addition, the VP of GSE partners with business leaders to establish long- and short-term goals and performance metrics to drive EHS excellence.

Safety and environmental performance targets are included in divisional management objectives.

Learn more about corporate governance at our company.

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 EHS staff and operating organizations
  • Managing and implementing an internal audit program charged with 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
  • Tracking EHS performance of sites, divisions and the company as a whole, and communicating performance versus targets

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 our company standards, regulatory requirements and performance targets
  • Acting as the primary liaison with local regulators and inspectors
  • Investigating incidents and near-miss events to identify root causes and developing corrective and preventive actions to prevent recurrence

Internal auditing

We have a detailed and rigorous EHS audit program.

Our global corporate EHS audit program is one way in which we identify and resolve compliance and performance issues within the company.

  • Our audit leaders are full-time professional EHS auditors with extensive experience in auditing a broad range of EHS programs applicable to the company. The individual audit teams 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 preventive action plans (CAPA), which are reviewed, approved by the audit leader and regional EHS leader, and tracked to completion. This process includes senior management oversight.
  • 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.

We use multiple factors to determine the audit frequency for our facilities, including facility size, operational complexity, compliance status and performance history. Our most complex operations are audited every year, and all manufacturing and research operations are audited at least every two years. Less complex facilities, such as sales and business offices are audited less frequently. In 2019, we performed 55 corporate EHS audits of our facilities, covering 76 percent of our manufacturing and research locations and involving 693 auditor days of onsite review activities.

An internal Quality Assurance Review of the EHS Auditing program was conducted in 2018/2019 by Corporate Audit and Assurance Services. As a result of this internal review, the EHS auditing program was rated “Effective,” with controls and practices deemed to be in line with company requirements and expectations. These results were consistent with the third-party review of our program in 2017.

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 evaluated at least once every three years.

Certification

Our company is certified in the Responsible Care® Management System Technical Specification RC101.04.2013. The RCMS® recertification occurred on December 4, 2019.

Additionally, our corporate EHS management system is generally aligned with the requirements of the International Standards Organization (ISO), but we do not pursue certification under the Environmental (ISO 14001) or Safety (ISO 45001) frameworks at the global level. Some of our facilities have individually achieved ISO 14001 certification to meet customer requirements.

Remediation

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.

Over time, we have acquired properties and manufacturing facilities that may not have been subject to the same EHS management standards that we have in place today. We are also investigating and remediating those properties where necessary.

We spent $19.5 million in 2019 for remediation and environmental liabilities, including those at formerly owned and operated sites. Our company has an environmental liability reserve of approximately $62.5 million to fund the continued remediation of these sites into the future. In addition, we are a potentially responsible party at 15 multi-party Superfund sites in the U.S.

Performance data

Notices of violations (NOVs) and citations20152016201720182019
Environmental1612569
Safety22314
Fines20152016201720182019
Environmental fines paid$92,270 $33,906 $0 $0 $17,690
Number of environmental fines6 2 0 0 3
Safety fines paid$0 $0 $0 $0 $0
Number of safety fines0 0 0 0 0

Our centralized 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 in both leading and lagging metrics to look for potential trends and identify opportunities that can help drive performance improvement. We continuously explore new ways to learn from and report on our performance.

Notices of violations, fines and settlements

We report all forms of EHS compliance notices using the term Notices of Violation (NOVs), which includes citations, letters of warning and notices of noncompliance from environmental and safety-focused regulatory agencies.

In 2019, we had 163 EHS-related regulatory agency inspections of our facilities around the world. We received four safety-related and nine environmental-related NOVs and paid $17,690 in fines in 2019.

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 USEPA or equivalent entities globally. We experienced no significant environmental events in 2019.