Significant Federal Laws and Policies
In recent years, Congress has responded to a growing need to strengthen
OMB Circular A-119
and has passed several laws making it clear that federal agencies rely upon
private voluntary standards whenever feasible.
Foremost among these laws is the
National Technology Transfer and Advancement Act (Public Law 104-113).
Signed into law in early 1996, this landmark legislation contains the following
key provisions pertaining to standards and conformity assessment:
All Federal agencies and departments shall use technical standards that are
developed or adopted by voluntary consensus standards bodies, using such
technical standards as a means to carry out policy objectives or activities
determined by the agencies and departments;
Federal agencies and departments shall consult with voluntary, private sector,
consensus standards bodies and shall, when such participation is in the public
interest and is compatible with agency and departmental missions, authorities,
priorities, and budget resources, participate with such bodies in the
development of technical standards;
Exception - If compliance is
inconsistent with applicable law or otherwise impractical, a Federal agency or
department may elect to use technical standards that are not developed or
adopted by voluntary consensus standards bodies if the head of each such agency
or department transmits to the Office of Management and Budget an explanation
of the reasons for using such standards. Each year, beginning with fiscal year
1997, the Office of Management and Budget shall transmit to Congress and its
committees a report summarizing all explanations received in the preceding year
under this paragraph.
This legislation is having a dramatic impact upon the way federal agencies do business in the
standardization area. NIST has its
available on the NIST website.
Other laws and policies that reinforce the strong public-private partnership
approach to standards and conformity assessment in specific sectors or areas of
interest include the following:
Standards Development Organization Advancement Act of 2004 (H.R. 1086)
HR 1086 provides qualified standards developers with an opportunity to file
for, and obtain, a limited exclusion from antitrust liability for treble
damages. This protection is identical to the protection which has been
available to joint venturers under the National Cooperative Research and
Production Act since 1993, which also remains available to those utilizing a
consortium, or other informal process to develop standards.
As a large number of ANSI-accredited SDOs were raising questions about the
impact of H.R. 1086 on their standardization activities, a list of FAQs were
developed by ANSI staff following conversations with House and Senate staff,
and with some of those people working with the Department of Justice on
a .pdf version of the FAQ document here.
The Consumer Product Safety Act.
Under the Consumer Product Safety Act, the Consumer Product Safety Commission
is specifically to rely upon voluntary consensus consumer product safety
standards rather than promulgate its own standards. The relevant portion of the
law is set forth below:
"…The Commission shall rely upon voluntary consumer product safety standards
rather than promulgate a consumer product safety standard prescribing
requirements described in Subsection (a) whenever compliance with such
voluntary standards would eliminate or adequately reduce the risk of injury
addressed and it is likely that there will be substantial compliance with such
voluntary standards." (Source: Section 7(b)(1) of the Consumer Product Safety
Act (15 USC 2056; PL 92-573; 86 Stat. 1207, Oct. 27, 1972, as amended in 1981.)
The Health Insurance Portability and Accountability Act of 1995.
This Act requires the Secretary of Health and Human Services to adopt standards
developed by ANSI-accredited standards developers whenever possible.
The Telecommunications Act of 1996.
The first major overhaul of U.S. telecommunications law in almost 62 years, the
act contains several provisions that propel the Federal Communications
Commission (FCC) toward reliance upon private sector standards. In particular,
the FCC is seeking to ensure that the standards development process in the
telecommunications area is open and consensus-based - the very things provided
for by ANSI accreditation requirements.
The Food and Drug Administration (FDA) Modernization Act of 1997.
This act contains provisions which allow the FDA in some instances to accept
manufacturers’ declarations of compliance to certain standards during the
evaluation of premarket submissions for electrical medical devices. This is
expected to result in a substantial reduction of time-to-market for some
medical devices, while still ensuring that fundamental regulatory health and
safety responsibilities are met.
In 1994, Secretary of Defense William Perry announced that one of the Department
of Defense’s (DoD’s) top priorities would be to move away from military-unique
specifications and standards (milspecs) and toward reliance upon private sector
standards. "Moving to greater use of performance and commercial specifications
and standards is one of the most important actions that DoD must take to ensure
we are able to meet our military, economic, and policy objectives in the
future," Perry said. The so-called "Perry initiative" is transforming the way
the Defense Department does business.
Federal, state and local governments and agencies have formally adopted
thousands of voluntary standards produced by the ANSI Federation, and the
process appears to be accelerating. As an example, the Occupational Safety and
Health Administration (OSHA) works closely with ANSI and its accredited
standards developers, referencing over 200 of the 800 existing American
National Standards for safety and health.
In addition, there are several examples of federal laws that specifically cite
the American National Standards Institute (ANSI):
The Higher Education Programs Authorization Extension Bill (P.L. 105-244)
This bill, signed in 1998, extended for an additional five years the
authorization of programs under the Higher Education Act of 1965, which is the
basic framework for federal policies in higher education including massive
federal programs of student financial assistance. The bill also retained other
current programs, providing some modest new initiatives, lowering borrowing
costs to students and authorizing small improvements in program funding.
The Compactors and
Balers Safety Standard Modernization Act of 1996 (P.L. 104-174)
This act amended section 13(c) of the Fair Labor Standards Act of 1938,
modifying Hazardous Occupations Order (HO) No. 12. The amendment changes HO 12
to authorize minors 16 years of age and older, under the child labor
provisions, to load materials into balers and compacters that meet appropriate
American National Standards Institute design safety standards.
The Safe Water Drinking Act Amendment (P.L. 104-182)
This amendment, signed in 1996, revised title XIV of the Public Health Service
Act of 1974, and focused on establishing a new groundwater protection program,
abolishing unnecessary testing and monitoring requirements , and establishing a
new procedure for identifying contaminants for regulation. The reauthorization
process also provided Congress a vehicle to examine drinking water treatment
and supply infrastructure needs.