We are working to better understand the qualitative and quantitative impacts of our products and recognize that employees across Bristol-Myers Squibb have a role to play. Our management system requires business functional areas to identify, evaluate and minimize the direct and indirect EHS impacts of existing and newly developed product lines.
Polyvinyl Chloride Use
Stakeholders have been urging companies to eliminate polyvinyl chloride (PVC) from plastic products and in packaging because of potential health concerns. As part of Bristol-Myers Squibb’s commitment to developing and manufacturing more sustainable products, we have made significant progress to reduce PVC from our packaging components. We are continuing to explore opportunities to eliminate PVC as technical alternatives become available.
To date, we have eliminated PVC from our rigid packaging containers (bottles), reduced the use of PVC in blister packaging for medicines and have eliminated the use of PVC packaging trays. For all new products requiring a blister package, Bristol-Myers Squibb is committed to evaluating alternative materials that will not only replace PVC, but be environmentally friendly.
We have also found vendors who do not use PVC in the standard plastic bottles to package pills and have moved away from PVC secondary packaging in physician samples.
Product Life Cycle Responsibility
For many years, Bristol-Myers Squibb has reviewed and worked to reduce the EHS impacts of our products throughout their life cycle from design and development through manufacturing, distribution, sales, use and ultimate fate. Our product life cycle (PLC) reviews of products continue to produce EHS and economic benefits at our operations around the world. Company initiatives that support PLC responsibility include sharing technical expertise with others.
Our packaging group is developing metrics for environmental improvements, engaging with customers to identify potential packaging improvements and setting goals each year for specific sustainability-related packaging projects.
Bristol-Myers Squibb engineers incorporate sustainable packaging design principles into their day-to-day responsibilities. For example, engineers redesigned cold chain shippers to improve efficiency and reduce packaging weight. As a result of these improvements, implemented in September 2008, we reduced the weight of the general overnight shipper used for the ORENCIA® (abatacept) overnight shipper by 20 percent; the ERBITUX® (cetuximab) weekend shipper by 41 percent; and the general overnight shipper used for ERBITUX and other oncological products by 62 percent.
To further reduce the impacts of ORENCIA packaging we developed stability data to support eliminating the exterior paperboard carton. With the U.S. FDA approval in 2009, the new design will now be saving over 33 tons of paperboard annually.
As part of our PLC responsibility, our Green Chemistry program provides scientists and engineers with a tool—the Process Greenness Scorecard—to identify the environmental, health and safety implications of new and existing products and processes. By implementing Bristol-Myers Squibb’s green chemistry principles in the manufacturing process, we are reducing energy consumption, hazardous materials use and waste generation.
Through eco-efficiency, we are improving productivity while reducing negative environmental impacts. For example, innovation teams working at Swords, Ireland, have successfully achieved yield improvements, ranging from 1.5 to 4 percent, in seven products or intermediates, resulting in increased efficiency and reduced waste. The solvent recovery plant at the Swords facility allows the on-site recovery of nearly all the solvents rather than off-site removal. The recovered solvents can then be reused on site, leading to reductions in fresh solvent purchasing requirements. In 2008 and 2009, Swords recovered 1,075,000 and 830,000 tonnes of solvents, respectively.
Biotechnology and Biosafety
Bristol-Myers Squibb has established requirements for biological safety and biosecurity at its facilities worldwide. The company's biological safety requirements follow the World Health Organization (WHO) Laboratory Biosafety Manual. In addition, where appropriate, the U.S. National Institutes of Health Guidelines, and the U.S. Centers for Disease Control and Prevention Biosafety in Microbiological and Biomedical Laboratories Guidance supplement our core biosafety requirements.
As part of our environment, health and safety management system, Bristol-Myers Squibb maintains a corporate directive on Biological Safety. This directive addresses the biosafety, biosecurity, and bioethical issues associated with our Research & Development and manufacturing work with biological agents and other biological materials. State of the art engineering controls, work practices and procedures, and personal protective equipment are used when working with biological agents and materials. Bristol-Myers Squibb has established a robust evaluation process that regularly monitors and seeks to continuously improve our biosafety program and work practices.
At each facility that uses biological agents and other biological materials, a Biosafety Officer ensures that appropriate systems are in place for biological safety and biosecurity. Where appropriate, Bristol-Myers Squibb also has established facility Biosafety Committees, some with community representation, that meet on a regular basis to review projects involving biological agents, genetically modified organisms and biological materials. These committees also advise research staff on any specific biosafety concerns.
A comprehensive Biological Assessment of Risk (BAR) process has been implemented to facilitate the risk assessment, management, and communication of our use of biological agents and materials. Through the BAR management system, we comprehensively review projects involving biological agents and materials and assign a risk category to each biological project. The risk categories we use are consistent with those used by the U.S. Centers for Disease Control and Prevention, the U.S. National Institutes of Health, and the WHO. The BAR system also provides detailed information to Biosafety Officers, company medical personnel, and R&D and manufacturing staff who work with biological agents and materials.
Through these programs, Bristol-Myers Squibb R&D and manufacturing facilities maintain comprehensive biosafety programs to protect our workers, our site visitors, our communities and the environment.
Commitment to the Ethical Use of Animals in Research
At Bristol-Myers Squibb our mission is to discover, develop and deliver innovative medicines to patients with serious diseases such as cancer, genetically defined diseases, hepatitis, HIV/AIDS, cardiovascular disease, and immune-system disorders like rheumatoid arthritis. We have both a legal and an ethical obligation to ensure the safety and efficacy of investigational new medicines prior to their use in humans.
Regulatory agencies around the world require that investigational medicines be thoroughly evaluated before approving them for use in human clinical trials. To fulfill these obligations, research or testing methods that include the use of animals are sometimes required, and will continue to be a component of our efforts to help patients prevail over serious diseases. At the same time, providing high-quality humane animal care and developing alternatives to animal use are moral, scientific and legal necessities. We are committed to reducing our reliance on animal testing methods, and promoting the development, validation and use of non-animal testing models. The Company requires that where animals have been or may be used for research or testing, that we abide by the principles of the 3Rs of animal research. Before using animals, our scientists must give serious consideration to finding innovative, scientific ways to:
- Replace animal research and testing with other methods;
- Reduce the number of animals used; and
- Refine procedures to enhance animal welfare.
The company confers an annual Animal Welfare 3Rs Innovation Award to scientists who have implemented innovative scientific methods or procedures that reduce the number of animals required in research while still obtaining valid results, refine research methods to eliminate or minimize impact to animals, or replace animal use in testing. Over the past two decades Bristol-Myers Squibb has consistently advanced our research methodologies and moved to a research system that relies on a combination of in silico, in vitro and in vivo approaches.
For example, Bristol-Myers Squibb has created a world-class imaging department that has allowed scientists to view the impact of experimental drugs on disease and assess the long-term effectiveness of a potential new treatment in a non-invasive manner. In addition, we have consistently provided funding to external organizations to support the development of alternatives to animal research.
When the use of animals is necessary, Bristol-Myers Squibb is committed to providing the highest level of care. We ensure that the care and use of all laboratory animals meets or exceeds relevant local, national and international regulations, as well as our own internal standards of animal care.
- The Bristol-Myers Squibb Animal Welfare Oversight Committee, which reports to our senior leadership team overseeing research, provides guidance on animal welfare policies and standards, clarifies the Company’s expectations for implementation of new regulations and guidelines related to animal care and use, and assures that the appropriate resources are available to support our animal care and use programs.
- Bristol-Myers Squibb’s research sites voluntarily seek and secure review and accreditation by an independent organization called the Association for the Assessment and Accreditation of Laboratory Care International (AAALAC), a private, nonprofit organization that promotes humane treatment of animals in science and is internationally recognized as the gold standard for research programs.
- The Company’s Animal Care and Use Committees / Animal Ethics Committees review, approve and monitor all animal use, and perform monitoring audits, as well as semiannual facility animal care and use inspections and program reviews, to ensure the animals are healthy and cared for appropriately.
- Our investigators and our Animal Care and Use Committees take great care in assuring animal welfare when designing a study or when conducting research. We provide our animals with environmental enrichment to enhance their welfare. We ensure quality veterinary care is available at all times.
- We provide special training and development to all employees who work in any aspect of our animal research programs to ensure they demonstrate ethical and humane care and respect for all research animals. Safe and compassionate procedures for handling and caring for animals are in place at our facilities and disciplinary actions, up to and including termination, can be taken against employees who do not comply with our standards and procedures.
- Contractors who carry out research for Bristol-Myers Squibb are also expected to apply the same care and ethical standards and accreditation requirements. We conduct an Animal Welfare Risk Assessment of contractors and regular inspections to ensure compliance with these standards.
- We routinely conduct internal Animal Welfare Practice audits at each of our animal facilities.