How do you know that your water is safe to drink, your food safe to eat, and the medical tests performed by your doctor are giving accurate results? What standards do we use? Are they applied across the United States? What will we find when we travel abroad?
To find out, I talked recently with Dr. Leonard Freedman, founding president of the Global Biological Standards Institute. He has more than 30 years of research, management and program development experience in molecular and cell biology, biomedical research and drug discovery in both the private sector and academia. Before starting the institute, Dr. Freedman was vice dean for research and a professor of biochemistry and molecular biology at Jefferson Medical College in Philadelphia.
Following the World Health Organization's recent release of its report “Water Quality and Health Strategy, 2013-2020,” I was particularly interested in what standards mean for public health in the area of water and food safety.
Janet Golden: Why do we need global standards in science?
Leonard Freedman: Standards are an agreed-upon way of doing something, and can be quantitative or qualitative. Standards promote progress and innovation across myriad fields and technologies, including life science research and development. For example, standards are essential for ensuring process and product quality and safety in biological research, preclinical and clinical testing, and the manufacture and the delivery of countless diagnostics, medical devices, and therapeutics. Without life science standards, biological research can result in irreproducible experiments (and retracted publications and reputational impacts), wasted resources, and delayed or missed opportunities to enhance global health. For more information see our FAQ page on standards.
How are standards developed?
Standards (also called guidelines, criteria, or norms) are context-dependent, including whether they are enforceable. Standards development processes range from international activities, such as those prepared by the World Health Organization and the European Commission, to institutional establishment of standards for use in a narrow discipline/industry. Product and process “quality” is often defined as conformance to voluntary standards, which typically arise (spontaneously) to fulfill a need, and evolve into an established norm or set of requirements. Such de facto standards are often formally adopted by regulatory bodies and become mandatory standards. Many international organizations and government agencies support the development, adoption, and adherence to standards, often through participation in an accredited standards development organizations (SDOs) like Codex Alimentarius. Despite their importance, there are few broadly-implemented standards in life science research.
Water safety is a key area of interest in public health worldwide. What is the current situation regarding standards?
The provision of safe drinking water throughout much of the world—from treated water from the tap, untreated water from a well, and bottled water—has been a core responsibility of national, regional, and local governments for decades. Access to adequate amounts (water quantity) of safe drinking water (water quality) is essential to life, the supply of which continues to be a cornerstone of effective legislation, regulations, and policies for public health protection.
Water quality and/or water quantity issues vary widely within both developed and developing nations. For example, in the United States, the safety of treated drinking (tap) water in public water systems is regulated by the Environmental Protection Agency, whereas bottled water is regulated as a food by the Food and Drug Administration. In addition to the general obligation that drinking water must be wholesome and clean, the 1998 Drinking Water Directive that applies to the European Union established standards (microbiological, chemical, and taste and related parameters) for drinking water quality at the tap. In 2011, the World Health Organization published their most recent international guidelines for drinking water quality (excluding bottled water) that serve as the basis for regulations and standard setting in developed and developing nations worldwide.
Is your institute concerned about food safety as well?
Yes. Today, international commerce is a reality of modern food production and supply chains reach every corner of the globe. Moreover, food products are often mixtures of dozens of ingredients from multiple countries, prepared and repackaged by intermediaries around the world before reaching their final destination. As a result, product safety failures in one country can have public health ramifications around the world. Globalization of the food supply has also created conditions favorable for the emergence, reemergence, and spread of foodborne pathogens. At the same time, plant and animal diseases continue to pose a serious and ongoing threat to food security and safety. You can follow our work in this area here.
Janet Golden, a Rutgers University history professor, specializes in the histories of medicine, childhood and women.
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