# Presentation: 866178

##     Welcome  

- Using Standards in Regulation
*Tom O’Toole*
*Manager, Committee E05 **on Fire Standards*
- ASTM International

**Notes:**
Welcome to ASTM International. This training module will take you inside the dynamic world of ASTM - the preeminent international standards development organization. You'll learn how ASTM standards are developed and used; how they impact both our global economy and environment, as well as our day-to-day lives; who develops ASTM standards; and how you can get involved in the ASTM standards development process.

## Objectives for this Presentation

- Introduction to ASTM International
- Explain why and how standards are used in regulation in the United States
- How to obtain information
- Domestic and international examples
- Final thoughts

## About ASTM International

- Established 1898
- Provides an open forum for developing voluntary consensus standards used globally
- Non-profit, non-government organization funded primarily through the sale of its publications

## About ASTM International

- Currently 135 technical committees serve 90 industry sectors
- Publishes over 12,000 standards and various technical publications
- Approximately 170 staff provide support
- Over 32,000 members participating from over 115 nations

## About ASTM International

- Approximately 350 ASTM International standards are cited in the model codes, referenced cumulatively over 1300 times
- Over 2000 ASTM International standards are used as the basis of or cited in the legislation of over 50 nations

## Using Standards in Regulation

## How are Standards Used in Legislation?

- There is no single U.S. government agency that has control over standards
- Standards may be cited in the legislation or may be cited by the agency charged with implementing the legislation.

## How Are Standards Used in Legislation? 

- Used for regulation
- Typically set health, safety or environmental criteria, for example
- U.S. Food and Drug Administration
- U.S. Environmental Protection Agency

- Used for procurement
- Sets the requirements that must be met by those supplying to the government, for example
- U.S. Department of Housing and Urban Development
- U.S. Department of Defense

## Who Makes the Decision to Use a Private Sector Standard?

- Decentralized system of selecting standards by federal agencies.  Each agency asks:
- Does a standard that might meet the agency’s needs currently exist in the private sector?
- If such standards exist, which private sector standard meets the agency’s needs best?
- How will the agency ensure compliance with and/or enforcement of the standard?

## Why Use Private Sector Standards?

- National Technology Transfer and Advancement Act (Public Law 104-113)
- Minimizes cost to the government
- In standards development
- Procurement of goods and services
- Eliminates duplication of effort and of standards
- Increases private sector acceptance of regulation
- Furthers the policy of the Government’s reliance on the private sector to supply goods and services

## About the NTTAA

- Encourages federal agencies to use public sector standards, where appropriate.
- Encourages federal agencies to participate in the development of the private sector standards
- Federal agencies must explain why they write their own standards rather than use a private sector standard

## Additional Supporting Legislation

- Defense Authorization Bill of 2003 – ANSI Amendment (Public Law 107-107)
- Permits the use of public funds to pay for membership and participation on private sector activities such as standards development

## Agency Specific Directives

- Some federal agencies have additional legislation or directives urging the use of private sector standards.  For example
- Food and Drug Modernization Act
- Department of Defense

## Regulatory Agency

- U.S. Food and Drug Administration
- Food and Drug Administration Modernization Act indicates that the product manufacturer “may declare conformity” to “recognized” standards to meet some or all regulatory requirements
- FDA publishes an annual list of “Recognized Medical Device Standards”
- Includes deviations from the standard contained in a Supplementary Data Sheet

## Procurement Agency

- U.S. Department of Defense
- MILSPEC and MILSTD reform policy
**Use of Non-Government Standards:** I encourage the Under Secretary of Defense (Acquisition and Technology) to form partnerships with industry associations to develop non-government standards for replacement of military standards where practicable.
*	**	**--Defense Secretary William J. Perry (6/94)*

## Are Private Sector Standards Being Used?

- According to the National Institute of Standards and Technology
- 7985 citations of standards  incorporated by reference for regulation; 6600(~83%) are private sector standards
- 10,559 citations of standards incorporated by reference for procurement

## Federal Government’s Role...

- ...in private sector standardization
- Government is a standards user
- In product purchases and by incorporating standards by reference
- Government representatives contribute knowledge to  standards development as an equal partner
- Govern laboratories participate in testing and contribute data to the content of private sector standards

## Benefits of Private Sector Standardization

- Economical forum for all stakeholders
- Open, neutral and balanced forum
- Private sector provides all administration
- Reflects the needs of the marketplace

- Ensures regular review and revision
- Facilitates discussion of new technologies
- Encourages round-robin testing
- Manages editing, marketing and distribution of codes and standards

## This Practice Is Not Unique

- Other nations report using private sector standards in regulation and legislation.  An example (specific to ASTM International)
- 50 nations use ASTM standards as the basis of a national standard or by reference in that nation’s regulations
- Over 2000 ASTM standards from 85 technical committees are used for this purpose.

## China’s Use of Private Sector Standards

- Determined from the WTO enquiry point for the United States
- China uses 490 standards from 69 ASTM International technical committees as the basis of its national standards

## Where to Find Information

- About U.S. regulations
- Code of Federal Regulations
- Lists the codification of the general and permanent rules published in the Federal Register by executive departments and agencies of the U.S. federal government
- http://www.gpo.gov/nara/cfr.index.html

## Where to Find Information

- About U.S. legislation and ongoing modifications, new rulemaking, etc.
- Federal Register
- The official daily federal publication for rules, proposed rules, and notices of federal agencies and organizations
- http://www.gpo.gov/su_doc/aces/aces140.html

## Where to Find Information

- National enquiry point
- Each member must establish an enquiry point which is able to answer all reasonable enquiries from other members and interested parties as well as to provide, relevant documents.
- Peoples Republic of China Enquiry Point Research Center, State General Administration of the People’s Republic of China for Quality, Supervision and Quarantine (AQSIQ)

## Where to Obtain Information

- About standards
- Standards.gov (_[http://www.standards.gov](http://www.standards.gov/)__)_
- One stop location for information related to use of voluntary consensus standards
- Each federal agency has information on standards (Standards.gov provides links to agency sites)
- NSSN (_[http://www.nssn.org](http://www.nssn.org/)__)_
- A central pint to search standards information from multiple sources

## Where to Obtain Information

- About standards...
- Websites of individual standards developers
- For example, _[www.astm.org](http://www.astm.org/)_
- Use the “Tracker Service” to receive free weekly email alerts about new standards or new work items
- You choose the information you wish to view and identify the relevant sectors

## Applying the practice in a local jurisdiction

- Construction Codes and Standards

## Description of Codes

- Codes state when and where something must be done in construction
- For example, ICC Building Code states...
**1507.15 Liquid-applied coatings**.  The installation of liquid-applied coatings shall comply with the provision of this section
**1507.15.1 Slope**.  Liquid-applied roofs shall have a design slope of a minimum of one-fourth unit vertical in 12 units horizontal (2-percent slope)

## Description of Standards

- Standards are referenced by the codes and provide the specifications for materials, products and systems, or provide instruction on application or installation.
- For example, ICC Building Code states
**1507.15.2 Material standards**.  Liquid-applied  roof coatings shall comply with ASTM C836, ASTM C957, ASTM D6083, ASTM D1227 or ASTM D3468.

## Why do Codes Cite Standards?

- Clarify specific requirements
-  Reflect the latest technology in materials and procedures
- Provide a common reference to facilitate the flow of goods and services
- Gain the benefit of the technical research contained with the standard without having specific expertise on the topic of the standard

## Why do Codes Cite Standards?

- For convenience
- To incorporate technological advances
- For efficiency and economic advantages
- To incorporate safety aspects contained in the standards

## A Few Final Thoughts

- In the past...
- ASTM joined the China Association for Standards in publishing a Chinese language version of *Standardization News* and the 9th edition of *ASTM Dictionary of Science and Engineering*

## Moving Forward

- ASTM and SAC recently signed a Memorandum of Understanding
- ASTM has also signed agreements of cooperation with the China National Institute for Standardization and the Shanghai Institute of Standardization.

- The agreements will serve as brides between global and Chinese enterprises.  The agreements provide
- Membership
- Access to ASTM Standards
- Cooperation in training
- Hosting of interns at ASTM International

## Thank you for your participation!

- We look forward to increased
- Cooperation with China

- Questions?

- _[www.astm.org](http://www.astm.org/)_
- Mr. Thomas O’Toole
- +610 832 9739
- _[Totoole@astm.org](mailto:Totoole@astm.org)_
- Mrs. Kitty Kono (*Vice President for Global Cooperation*)
- +610 832 9687
- Kkono@astm.org