Notice & Comment

Health, Development, and the International Standardization Process

With Engineering Rules, JoAnne Yates and Craig Murphy have contributed an important volume analyzing the history of standardization generally, and with tailored historical insights for individual standard-setting bodies, consortia, and entrepreneurs.  The compilation, identification, and preservation of new primary materials will no doubt be of enormous aid to future scholars. They are to be congratulated for a masterful work.

As part of this symposium, I write both as a health law scholar and a scholar of global development, emphasizing episodes in the history of standard setting that have particularly impacted individual and public health not only in the wealthier countries where standardization has had its most significant impact, but in those countries that participated, at least independently, after the most important turning points described in the book. This emphasis is important, I think, as Engineering Rules is focused on the origins of standardization with heavy industry, its evolution through radio and electronics, and finally with standards relevant to web interoperability (the end of the volume is dedicated to environmental and social responsibility standards). The book is not focused on products directly relevant to health. Scholars of international standards relevant to health (outside of labor standards which are, as the authors note, largely ignored) tend not to situate their analyses within the broader literature of standard-setting nor even economics, or perhaps organizational behavior, where the authors at least appear to situate their text.

Thus, an essay that highlights the overlap between standards related to health, development, and the broader literature might catalyze more scholarship devoted to that nexus.  Since this essay will emphasize standards as they have adversely affected health, it may also shed light on concerns and externalities that exist beyond the anticompetitive and sector monopoly concerns that pervade Engineering Rules.

As a preliminary note, it is worth bringing to the attention of a lawyer audience like that of Notice & Comment that many of the standards Yates and Murphy analyze are not, strictly speaking, binding rules of law.  They become law, at least in the U.S., through various channels.  In 2005, the U.S. Forest Service adopted a final rule requiring affected forests and grasslands to develop and implement an environmental management system compliant with ISO 14001. International standards may also be introduced in environmental tort claims or product liability lawsuits as evidence of an applicable standard of care. Compliance with ISO standards may also serve as mitigating considerations when the Department of Justice or the Environmental Protection Agency investigate industrial accidents. In these contexts, compliance with ISO standards affects decisions to prosecute and/or reduces fines imposed for violations. In Australia, by contrast, the adoption of ISO 9000 has much more significant legal effect, closer to that of legislation. The European Union has incorporated ISO 9000 into many of their product safety laws regulating products such as medical devices.

Although some standards, such as screw threads or credit cards, have little impact on the health of consumers, many of these standards directly impact consumer health and safety. One of the most significant, and deadly, frauds committed upon the consuming public was the development of “mild”, “light”, “ultra-light” and similar descriptors to lead consumers to believe that there was a safe, or at least safer, cigarette. The ISO standard (the history of the ISO is detailed in pages 143-52 of Engineering Rules) based on machine generated measures of nicotine yield was an essential part of this fraud. In many countries, those claims could not be made without the submission of some sort of supporting evidence as to the claim.  The use of ISO to fabricate that evidence was not only part of a grand strategy deployed by tobacco companies, it was an episode showing that standardization processes may be manipulated, especially under the conditions that in many circumstances Yates and Murphy generally regard as positive aspects of the process: representatives from competing firms, suppliers, customers, and others, coordinating on the formation and implementation of standards.

The relevant standard, “tobacco and tobacco products—determination of vapour-phase nicotine in air-gas chromatography method,” ISO 11454, was drafted largely according to tobacco industry interests. The standard was submitted as an effort to measure the tar and nicotine yield of cigarettes across brands and brand families to determine the health consequences for smokers. Drafted by TC 126, the majority of individuals involved in the development process were tobacco industry representatives. Of the fifty-two individuals present at the 1995 plenary meeting, only seven identified themselves as representatives of their national standards body. The scientific evidence used in drafting the standard came from the Cooperation Center for Scientific Research Relative to Tobacco, an organization of tobacco industry chemists. The resulting standards for measuring the release of nicotine allowed tobacco companies to “cheat” the testing procedures for cigarettes, allowing them to significantly underrepresent the amount of tar and nicotine being delivered to human smokers (the tobacco companies had known since the 1970s that smokers took deeper and more frequent puffs of cigarettes assessed by machines to yield less nicotine).

With respect to global development, Yates and Murphy acknowledge the significance that the majority of the standardization entrepreneurs they identify were white, male, and from the industrialized countries that both shaped and benefited from now international standards.  The authors do not delve into the details of membership in the ISO, but those are hierarchical: “full” members adopt or sell standards while “correspondent” and “subscriber” members generally do not.  Almost all of the correspondent and subscriber members are from developing countries, which have no voting power and only have the limited ability to observe meetings, or, in the case of subscriber members, be informed of standards that may be of interest to them.

While it is left somewhat ambiguous in the manuscript, there are concrete impacts to this homogeneity.  Take, for example, the process leading to ISO’s 14000 series of environmental standards. Technical Committee 207 handled the development of these standards beginning in 1993. Of the participating members in TC 207, only twenty-six percent were from developing countries, with only seventeen percent having voting privileges. In contrast, over ninety percent of the standards-setting institutions of the twenty-four developed countries were voting members in TC 207. Attendance at meetings of TC 207 and its numerous working groups and subcommittees also proved difficult for developing countries. For example, only seventeen percent of developing countries were present at the June 1995 meeting in Oslo in which the vote to move ISO 14001 to a draft international standard occurred while ninety-two percent of developed nations were present and voting. ISO 14001 thus reflects environmental concerns of the constituencies who could attend with meaningful voice. While problems such as loss of habitat, loss of biodiversity and desertification disproportionately affect developing countries, their relevance is not reflected in the standard.

Yates and Murphy have written a thorough, important history, emphasizing the extraordinary “standardization entrepreneurs” who have facilitated much of the globalized economy. Acknowledging those achievements, this post has endeavored to highlight some of the vulnerabilities in that process, some of which the authors address, and others that will hopefully energize further research at the nexus of health and international standard setting.

This post is part of a symposium reviewing JoAnne Yates and Craig N. Murphy‘s Engineering Rules: Global Standard Setting since 1880 (John Hopkins University Press). Previous posts in the symposium can be viewed here.