I INTRODUCTION 55 II STANDARDS, STANDARDIZATION AND STANDARDS DEVELOPMENT 56 ORGANIZATIONS: AN OVERVIEW A Standards 57 B Standardization 59 C Standards Development Organizations 60 1 Voluntary Consensus Standards 61 2 How 61 3 Who 62 III STANDARDS-BASED REGULATION: LAW AND MECHANISMS 63 IV PUBLIC POLICY CONTEXT OF PRIVATE STANDARDS-BASED " 63 QUASIREGULATION" A How Do Private Standards Regulate Products? 67 B How Do Private Standards Regulate Athletic Headgear? 68 1 Hockey 70 2 Football, Baseball and Lacrosse 71 V EFFECTIVENESS OF STANDARDS-BASED REGULATION FOR ATHLETIC 74 PROTECTIVE HEADGEAR A Criticism 75 B Context, Considerations and Recent Developments 76 C Effectiveness 79 VI RECOMMENDATIONS 81 A Develop the Integrity of Conformity Assessment Systems 81 for Helmets B Continue Private Standards-Based Regulation with CPSC 82 Support C Coverage of New Equipment Technology by Private 83 Regulation Structure VII CONCLUSION 84 I. INTRODUCTION
Sports-related brain injury has recently been at the forefront of discussion in countless fields. It continues to receive increasing media coverage. In the wake of high profile player-deaths and legal settlements, the issue of concussion and related traumatic brain injury in sports is a topic of interest for a variety of professional disciplines as well as the common sports enthusiast or news consumer. Conversation about brain injury in sports has permeated the national awareness and has captured the attention of contemporary legal curiosity.
Considerations of the legal aspects of brain injury in sports are often concerned primarily with topics in the realm of traditional litigation, like personal injury and class action lawsuits. However, the issues that arise at the intersection of law and sportsrelated brain injuries are nearly limitless. Lately, there has been no shortage of symposia held by the academic world or conferences that see participation from Sto proliferate and there are always new theories or novel new angles at which to analyze this issue. (1)
This paper considers the regulatory reality of sports equipment that is at the center of this brain trauma in sports issue. It reveals that not all regulation concerning athletic head injuries occurs in the public sector. It goes on to explain that in the case of sports helmets, very little is performed by the government and explains how the private sector executes this regulation instead.
Protective equipment (helmets, by and large) are regulated, or more precisely, "quasi-regulated" (2) by a structure defined largely by private technical standards. This paper offers an introduction to these standards and explains the key elements and differences between the private regulatory models for helmets. It also evaluates the effectiveness of standards-based regulation of athletic headgear and concludes with recommendations for adjustments to the existing conformity assessment systems and undertakings by the helmet standards community that would serve the end of providing excellent private regulation for equipment that faces the serious challenge of reducing brain injury in sports.
STANDARDS, STANDARDIZATION AND STANDARDS DEVELOPMENT ORGANIZATIONS: AN OVERVIEW
A discussion of how standards define the private world that "quasi-regulates" (3) sports equipment designed to mitigate head injury first requires an understanding of standards themselves. What exactly are standards? How are they developed and implemented? Who are the participating individuals and groups in a private standards-based regulatory system? This section of the article will provide an introduction to standards and the concept of "standardization." A discussion of the entities that are responsible for standards--SDOs, (4) will illustrate how their structure, membership and procedural guidelines demonstrate characteristics which, although based in the private sector, are essentially "governmental" and "legislative." (5)
Merriam-Webster's dictionary defines a standard as "a level of quality, achievement, etc. that is considered acceptable or desirable." (6) In the sense that I will be using the term, a standard is a "technical standard", meaning a set of characteristics or qualities that describes features and/or performance of a product, process or service. At the conceptual level, "standards", technical and otherwise, are not easily distinguished from law. (7) They both have the same essential tendencies: to require, to order or provide for order, to establish a "level" or "common denominator" for the given subject of the standard. (8) The National Technology Transfer and Advancement Act (9) provides the following official definition of a technical standard, "the definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, performance, designs, or operations; measurement of quality/quantity in describing materials, processes, products, systems, services or practices; test methods and sampling procedures." (10) The International Organization for Standardization offers this slightly more concise definition: "A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose." (11)
Standards are best understood by way of how they function. They help to ensure the quality and safety of production processes, products and services and to prevent negative impacts on health and the environment. (12) From an economic perspective, standards aid producers and consumers by promoting quality, compatibility, uniformity and other desirable characteristics in any marketplace. For example, a standard describing the geometry of hypodermic needles helps the health care profession be more safe and efficient. It provides different medical equipment manufacturers with the assurance that their devices will integrate with needles as intended. It also gives practitioners the confidence that the materials they use will have characteristics fit for the purpose that they were selected for. Some good historical examples of standards include the necessity of standardizing railroad track widths and rail gauges as well as the thickness and thread of hardware (screws, bolts, hose connectors, etc.). There are standards for the ways that computer networks communicate with one another, standards for the components of fluorescent lamps, and standards describing how to run a business's management system so that it promotes quality. (13)
In the current global economy, there are technical standards for almost anything and everything. Some technical standards are developed in the public sector. They are often encountered as mandatory regulations, although an increasing number of regulations that are assumed to be public are private developed standards that have been incorporated by reference into a government regulation. (14) Privately developed standards, which offer comparative efficiency and are favored over mandatory standards by public policy, now outnumber public regulations. (15) They offer wider, more detailed and more specialized topical coverage, which would be unrealistic to expect from governmental agencies given their resources and knowledge base.
The theme that underlies standards themselves is, unsurprisingly, "standardization". Standardization is an activity that has long been central to human societies. Without standardized monetary systems or a standard system for weights and measures, both trade and science as we know them would be impossible. Standardization is a phenomenon with tremendous positive externalities for society. It facilitates safety, reliability, and generally helps people interact with both the physical world they inhabit and other. As noted, when very broadly defined, standardization is sometimes performed by Congress when it makes laws or when local governments make ordinances. These efforts "standardize" behavior. When more narrowly defined as the process of developing and implementing technical standards, some standardization is still performed in the public sector, by executive agencies within the government, like the FDA or NHSTA. However, in the United States the majority of standardization is performed in the private sector by standards development organizations (hereinafter "SDOs"). (16)
SDO's are non-governmental bodies that create voluntary private standards. (17) They exist all over the world. Private technical standards in Japan are curated by JIS (Japanese Industrial Standards); (18) technical Standards in Europe are maintained by CEN (European Committee for Standardization); (19) and finally, the International Organization for Standardization (ISO) represents the "pinnacle" SDO. (20) It coordinates the resources and participation of national standards bodies and their personnel to create unified international technical standards. (21) ISO documents truly encompass the spirit of "standardization". However, given its relatively brief existence (since 1947) and the complexity of creating standards that represent global input, ISO does not have standards for all areas and topics. This is the case for athletic protective equipment. Standards for helmets, goggles, padding, and the like are most sophisticated and recognized at the national level, and in the case of Europe, regional level.
While private standardization at the international level is overseen by ISO, domestic standardization is coordinated by a cooperative effort between two entities: "ANSI" and "NIST." (22) "ANSI" is the American National Standards Institute. (23) It is a private non-profit organization that oversees the creation, promulgation and use of standards in the U.S. (24) Founded in 1918, ANSI's mission is "enhance the global competitiveness of US business and the US quality of life by promoting and facilitating voluntary consensus...