The Benefits of Using Voluntary Standards
in the Regulatory Process
Governments are involved in the formulation and enforcement of standards for two major reasons – for the procurement of goods and services for governmental use, and to protect public health and safety. The latter is usually accomplished through legislative means. In many countries, government regulations are based on standards developed by private organizations.
“Incorporation by reference” is a method of drafting a regulation in such a way that a detailed statement of the technical requirements is replaced in the text of the regulation by a reference to one or more standards, or parts of standards, produced by private or governmental organizations. The standards may be of national, regional, or international origin and from nongovernmental or governmental sources. Referencing a standard obviates the need to reproduce lengthy requirements, testing procedures, or definitions in the body of a regulation.
How Standards are used in the Regulatory Process
Externally developed standards are used in the regulatory process in a variety of ways. The requirements contained in specific standards may be used as the mandatory requirements. Standards may be used as the starting point for writing a regulation. Legislators may also use standards as purely advisory guidelines or may even refrain from regulation in a given area because the voluntary standards are adequate.
In 1996, the United States Congress signed the National Technology Transfer and Advancement Act (Public Law 104-113), which requires all US Federal agencies to use voluntary consensus standards to the extent possible. Office of Management and Budget Circular A-119, Federal Participation in the Development and Use of Voluntary Standards, provides guidance to agencies in implementing this requirement. Title 1 of the US Code of Federal Regulations Part 51 - Incorporation by Reference, provides guidelines for regulatory agencies when referencing a voluntary standard in a regulation.
When standards are used in the regulatory processes, the reference is usually to either a specific standard or to a particular edition of a standard, including its number, date of issue, and amendments. A standard referenced in a regulation in this manner ensures that compliance with the law requires adherence to the detailed provisions of the standard. Adherence to a revised version would involve contravention of the regulations, unless they were amended to refer to the new revision of the standard. This method of using standards in regulations is inflexible but it does ensure exclusive conformity.
Regulations may also refer to a standard by reference number but not by date. In this case, the regulation requires compliance with the latest edition of the reference standard; that is, the edition in effect at any given time. As use of the current version ensures compliance with the regulation in which it is specified, this technique in effect permits the standards-writing body to modify the details of compliance when it revises the standard to accommodate advancing technologies, the development of new materials, or the use of new testing procedures.
Conformance to the referenced standards may be subject to testing by independent or accredited testing organizations or laboratories. The results of these tests form the quantitative basis for certifying conformance within an acceptable range of values. This method of testing and certifying provides a wide range of choices to organizations requiring assurance that the standards are being appropriately applied.
Role of the Standards-Writing Organizations
Close cooperation between government bodies and standards-writing organizations is necessary at the policy level to define standards needed for technical regulations and to set priorities. The development of standards that may be referred to in legislation requires particular attention in order that standards-writers produce documents that may be readily incorporated by reference in regulations by legislative authorities. A good consensus standard will be acceptable to all parties, feasible to implement, representative of good practice, readily accessible, and enforceable.
National standards committees should be fully representative of all interests, including governments, public authorities, producers, distributors, and users, if they are to develop standards to be used in the regulatory process. The requirements of such documents must be clearly stated and test methods must be provided to determine compliance with the established requirements.
Advantages of Referencing Standards in Regulations
The concept of referencing standards in regulations has been gaining acceptance as a result of its many advantages to legislators. Following are some of these advantages:
1. Relieves regulatory authorities of the need to devise new, detailed, or complex requirements relating to materials, processes, design considerations and criteria, technical procedures, test methods, etc.
2. Permits detailed technical requirements to be embodied into the text of a regulation simply by referencing a standard or the relevant parts of a standard
3. Simplifies and accelerates legislative work and lowers cost to government in developing and enforcing regulations
4. Reduces the number of pages of regulations and makes them more manageable
5. Promotes uniformity of technical requirements – as standards provide the basis for certification, technical requirements can be equitably applied
6. Improves responsiveness of regulators to public concerns
7. Encourages participation in the development of standards
8. Avoids duplication of efforts and optimizes the use of scarce standards resources by taking into consideration the results of international standardization work
9. Facilitates elimination of barriers to trade by referring to recognized national standards which have been harmonized internationally
10. Improves public acceptance of regulations when there is endorsement of existing voluntary standards.
Externally developed standards can help legislators establish a regulatory program quickly, tap the expertise of the private sector, and save time and money that would otherwise be spent writing a regulation from scratch. Referencing standards in regulatory programs is an effective means of using the consensus standards system to benefit government, industry, and consumers.