[Federal Register Volume 61, Number 188 (Thursday, September 26, 1996)]
[Rules and Regulations]
[Pages 50538-50581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24105]
[[Page 50537]]
_______________________________________________________________________
Part II
Department of Commerce
_______________________________________________________________________
National Institute of Standards and Technology
_______________________________________________________________________
15 CFR Part 280
Fastener Quality Act Implementation Procedures; Final Rule;
Accreditation Body Evaluation and NIST Fastener Laboratory
Accreditation Programs and Consensus Standards Organization Under the
Fastener Quality Act; Notices
Federal Register / Vol. 61, No. 188 / Thursday, September 26, 1996 /
Rules and Regulations
[[Page 50538]]
DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
15 CFR Part 280
[Docket No: 960726209-6209-01]
RIN 0693-AA90
Procedures for Implementation of the Fastener Quality Act
AGENCY: National Institute of Standards and Technology, Commerce.
ACTION: Final rule.
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SUMMARY: The National Institute of Standards and Technology (NIST) is
today issuing a final rule to implement the Fastener Quality Act (the
Act). The Act protects the public safety by: Requiring that certain
fasteners which are sold in commerce conform to the specifications to
which they are represented to be manufactured, providing for
accreditation of laboratories engaged in fastener testing; and
requiring inspection, testing and certification, in accordance with
standardized methods, of fasteners covered by the Act.
The Secretary of Commerce, acting through the Director of the
National Institute of Standards and Technology (NIST), is implementing
the Act by establishing these procedures, under which: Laboratories in
compliance with the Act may be listed; laboratories may apply to NIST
for accreditation; private laboratory accreditation entities (bodies)
may apply to NIST for approval to accredit laboratories; and foreign
laboratories accredited by their governments or by organizations
recognized by the NIST Director under section 6(a)(1)(C) of the Act can
be deemed to satisfy the laboratory accreditation requirements of the
Act. The regulation also establishes, within the Patent and Trademark
Office (PTO), a recordation system to identify the manufacturers or
distributors of covered fasteners to ensure that the fasteners may be
traced to their manufacturers or private label distributors. In
addition, the regulations contain provisions on enforcement, civil
penalties, and hearing and appeal procedures.
DATES: This rule is effective November 25, 1996.
FOR FURTHER INFORMATION CONTACT: For subpart A: Dr. Subhas Malghan, FQA
Program Manager, Technology Services, National Institute of Standards
and Technology, Building 820, Room 311, Gaithersburg, MD 20899,
telephone number (301) 975-4510; for subparts B and C: James L. Cigler,
Chief, National Voluntary Laboratory Accreditation Program, NIST, (301)
975-4171; for subparts D, E, and F: Robert L. Gladhill, Global
Standards Policy Program, NIST, (301) 975-4273; for subpart G: William
H. Arvin, Special Assistant to the Assistant Secretary for Export
Enforcement, (202) 482-1564; and for subpart H: Lizbeth Kulick,
Trademark Legal Administrator, Patent and Trademark Office, (703) 308-
8900.
SUPPLEMENTARY INFORMATION:
As required by section 13 of the Fastener Quality Act (the Act),
the National Institute of Standards and Technology (NIST) is today
issuing a final rule to implement that Act. The Act protects the public
safety by: (1) Requiring that certain fasteners which are sold in
commerce conform to the specifications to which they are represented to
be manufactured, (2) providing for accreditation of laboratories
engaged in fastener testing; and (3) requiring inspection, testing and
certification, in accordance with standardized methods, of fasteners
covered by the Act.
The Secretary of Commerce, acting through NIST, is implementing the
Act by establishing these procedures, under which: (1) Laboratories in
compliance with the Act may be listed; (2) laboratories may apply to
NIST for accreditation; (3) private laboratory accreditation entities
(bodies) may apply to NIST for approval to accredit laboratories; and
(4) foreign laboratories accredited by their governments or by
organizations recognized by the NIST Director under section 6(a)(1)(C)
of the Act can be deemed to satisfy the laboratory accreditation
requirements of the Act. The regulation also establishes, within the
Patent and Trademark Office (PTO), a recordation system to identify the
manufacturers or distributors of covered fasteners to ensure that the
fasteners may be traced to their manufacturers or private label
distributors. In addition, the regulations contain provisions on
enforcement, civil penalties, and hearing and appeal procedures which
are administered by the Bureau of Export Administration.
Subpart A--``General'' sets out the purpose of the rule, and
presents a general description of the rule. It also contains
definitions that apply throughout the rule and establishes specific
requirements with respect to applicable provisions of the Act.
Subpart B--``Laboratory Accreditation'' provides that all
laboratories that desire to engage in fastener testing covered by the
Act and its implementing regulations must be listed by NIST in the
``Accredited Laboratory List'' established by this subpart. NIST will
prepare and maintain the List, which shall be composed of all
laboratories currently accredited under subparts C, D, and E of these
regulations. Only laboratory test reports prepared by an accredited
laboratory currently listed in the Accredited Laboratory List shall be
deemed to meet the requirements of the Act. Procedures for removing a
fastener testing laboratory from listing and for appeals of listing
decisions are also included.
Subpart C--``NIST Fastener Laboratory Accreditation Procedures,''
sets out the procedures and technical requirements of the National
Voluntary Laboratory Accreditation Program (NVLAP) Fasteners Testing
Program. These procedures are in conformance with ISO/IEC Guide 25-
1990, ``General Requirements for the Competence of Calibration and
Testing Laboratories.''
Subpart D--``NIST Approval of Private Accreditation Programs''
governs NIST approval of accreditation programs operated by private
entities. All private accreditation entities that seek to accredit
fastener testing laboratories must receive recognition under this
subpart. Revocation procedures of such approval are also covered in
subpart D.
Subpart E--``Recognition of Accreditation Programs,'' in accordance
with section 6(a)(1)(C) of the Act, sets forth the conditions under
which the accreditation of foreign laboratories by their governments or
by organizations recognized by the Director shall be deemed to meet the
requirements of section 7 of the Act.
Subpart F--``Requirements for Fastener Laboratory Accreditation
Bodies'' sets out requirements that must be met by all accreditation
bodies approved by NIST under subpart D and recognized under subpart E.
These requirements, based on ISO/IEC Guide 58, are intended to assure
that the approved laboratory accreditation body has the administrative
and technical capability to conduct a fastener accreditation program
which meets all the requirements of the Act. Subpart F also sets out
the requirements against which an approved accreditation body assesses
the technical competence of an applicant's testing laboratory. These
requirements are consistent with those contained in subpart C of the
regulations and all technical requirements established under that
subpart.
Subpart G--``Enforcement'' sets forth the procedures governing the
Commerce Department's administrative procedures for assessment of civil
penalties and remedies.
[[Page 50539]]
Subpart H--``Recordal of Insignia'' contains the conditions and
procedures for manufacturers'' insignias to be recorded by the Patent
and Trademark Office (PTO). The purpose of Section 8 of the Act is to
ensure that fasteners may be traced. The Act effects this purpose by
requiring manufacturers, private label distributors, and persons who
significantly alter fasteners, as defined by the Act, to inscribe any
fastener, required by the standards and specifications to which it was
manufactured to bear a raised or depressed insignia identifying its
manufacturer, private label distributor, or alterer, with insignias
that can be used to trace the fastener to its original manufacturer,
private label distributor, or person who significantly altered the
fastener. However, the Act does not establish any particular
recordation system to effect that purpose. The PTO was charged with
establishing such a system.
Background--Part 1: Summary of the Comment Process from August 1992
Issuance of the Draft Rule and Discussion of the Subsequent Actions
That Lead to the Amendment of the Fastener Quality Act (Pub. L. 101-
592)
On August 17, 1992, NIST published a proposed rule to implement the
Fastener Quality Act in the Federal Register (57 FR 37032). In response
to its request for public comments on the proposed regulation, NIST
received 308 letters. An even 50 percent of the comments, 154, were
submitted by representatives of businesses that distribute fasteners,
and another 69 comments, or 22.4 percent, were submitted by fastener
manufacturers. The remainder of the comments were distributed among
representatives of trade associations: 22 comments received, or 7.1
percent of the total; commenters who identified themselves as users of
fasteners covered by the Act: 16 comments received, or 5.1 percent of
the total; members of the NIST Fastener Advisory Committee: 8 comments
received, or 2.5 percent of the total; representatives of fastener
testing laboratories: 7 comments received, or 2.2 percent of the total;
and 8 letters, or 2.5 percent, were from governmental officials,
including one United States Senator, four agencies of the United States
Government, one state government, and two foreign governments. The
remaining 24 letters, or 8.2 percent, were from individuals or were not
otherwise identifiable as belonging to any group.
The subjects raised by the comments touched on a number of topics,
including some 225 letters that supported legislative changes to the
Fastener Quality Act that had been recommended by a NIST advisory
committee to reduce the cost to the fastener industry of implementing
the Act. In addition, NIST received letters on many topics directly
involving the language of the regulation, such as the need to refine
certain definitions, suggested changes to the procedures governing the
NIST Fastener Laboratory Accreditation Program, suggested changes to
sections of the regulation pertaining to the approval and recognition
by NIST of third parties for the purpose of accrediting fastener
testing laboratories, and other matters. Finally, NIST received a
number of comments on the draft Regulatory Impact Analysis.
The legislative changes recommended by the advisory committee and
supported by the public comments included the following five changes to
the Fastener Quality Act:
* To permit tests of either chemical composition of fasteners to be
carried out upon raw materials or finished fasteners. The effect of
this proposed change would be to greatly reduce the number of tests
needed to verify the chemical composition of fasteners, since many lots
of fasteners are usually manufactured from one ``mill heat.''
* To permit the sale of fasteners which, upon testing under the
Act, are found to have ``minor'' flaws resulting in the fastener not
conforming to the tolerances stated in the standards and specifications
to which they were manufactured. Section 5(a) of the Act expressly
prohibited the sale of fasteners which (1) do not conform to the
standards and specifications to which they were manufactured, and (2)
have not been inspected, tested and certified as provided under the
Act. The Committee felt that many lots of fasteners that could not be
sold under the Act as presently written could be sold, were this
amendment enacted, thus reducing manufacturer costs.
* To permit distributors to commingle fasteners from more than one
lot in the same container, thus reducing warehouse costs for the
distributors, despite the provisions of section 7(e) of the Act.
* To require that any person who significantly alters a fastener be
responsible for retesting that fastener, despite the provisions of
section 7(d) of the Act. And,
* To restrict the availability of test reports to the original
purchaser despite the requirements of section 10 of the Act that such
reports be made available to all subsequent purchasers.
A Hearing before the Subcommittee on Science, Technology, and Space
of the Committee on Commerce, Science, and Transportation, United
States Senate, was held in July 1993 to receive testimony from NIST and
from the fastener industry on the need for amendments to the 1990 Act.
Amendments addressing the issues raised by NIST and the Committee were
introduced in the 102nd Congress and were passed by the U.S. House of
Representatives as part of the National Competitiveness Act of 1994
(H.R. 820). The U.S. Senate passed a slightly different version of the
same bill (S.4). However, the bills did not emerge from the House/
Senate Conference before the 102nd Congress adjourned.
In October 1994 the Industrial Fasteners Institute (IFI), the
National Fastener Distributors Association (NFDA), and the Fastener
Industry Coalition (FIC) formed a bipartisan task force composed of
nine members, nominated from the three organizations, to forge an
industry strategy regarding amendments to the Fastener Quality Act. In
January 1995, the Public Law Task Force (PLTF) submitted its report and
recommendations to Senator Conrad Burns, Chairman, Subcommittee on
Science, Technology and Space, U.S. Senate, and to Congressman Robert
Walker, Chairman, Science Committee, U.S. House of Representatives. At
the request of Senator Burns and Congressman Walker, the Advisory
Committee reviewed the Task Force's report and recommendations and
found them to be consistent with the Committee's recommendations for
amending the Act that were transmitted to NIST and to Congress in 1993.
The Task Force submitted recommendations to Congress for further
simplification and clarification of the Act in early June 1995. Joint
recommendations for amendments from the Fastener Advisory Committee and
the Public Law Task Force were included in legislation introduced as HR
2196 in the U.S. House of Representatives and as S.1164 in the U.S.
Senate. A compromise version was passed in February 1996 as the
National Technology Transfer and Advancement Act, and signed into law
by President Clinton in March 1996 as Pub L. 104-113.
Background--Part 2: Summary of the Fastener Quality Act and Amendments
to the Act as Part of Pub L. 104-113
The Fastener Quality Act requires that certain fasteners sold in
commerce conform to the specifications to which they are represented to
be manufactured; provides for accreditation of laboratories engaged in
[[Page 50540]]
fastener testing; and requires the inspection, testing and
certification (in accordance with standardized methods) of fasteners
covered by the Act.
Section 2 of the Act sets out the findings of Congress with respect
to the Act. Section (a)(4) was deleted, and in section(b) the
references to fasteners used in ``critical applications'' were deleted.
These changes are consistent with the deletion of section 4 of the Act,
assigning the Secretary of Commerce responsibility to determine
categories of fasteners used in ``critical applications'' for purposes
of adding or deleting them from coverage under the Act. The term ``by
lot number'' was deleted from (a)(7) to be consistent with proposed
changes in section 7(e), which allow distributors to voluntarily
commingle two or more certified lots of like fasteners.
Section 3 of the Act provides definitions of terms used in the Act
and in the proposed rule. The following definitions were amended in the
Act:
Definition (1) ``alter'' was amended by deleting the
reference to a minimum tensile strength of 150,000 pounds per square
inch (psi). It was felt that this type of technical requirement did not
belong in the Act and should be covered in implementing regulations.
Accordingly, the issue is dealt with under Sec. 280.2 of this proposed
rule.
Definition (2) ``consensus standards organization'' was
amended by adding the word ``consensus'' in the third line to emphasize
the reliance upon ``consensus standards'' for fasteners covered by the
Act.
Definition (5) ``fastener'' was amended by deleting item
(D) to be consistent with the deletion of section 4 which assigns the
Secretary of Commerce responsibility to add or delete fasteners from
coverage under the Act based upon their use in ``critical
applications.'' In addition, fasteners produced in accordance with ASTM
F432 are exempt from coverage under the Act. ASTM F432 covers rock and
roof bolts and accessories used in the mining industry. This action was
the result of a petition by the American Mining Congress that such
products do not meet the intent of the Act and that they are strictly
regulated by the Mine Safety and Health Administration.
Definition (6) ``grade identification marking'' was
amended by deleting the term ``other person'' and replacing it with
``government agency.'' This change was necessary to be consistent with
the revision of the definition of ``standards and specifications.''
Definition (8) ``Institute'' was amended to correct the
spelling of ``Standards'' in NIST' name.
Definition (11) ``original equipment manufacturer'' was
deleted from the Act to be consistent with the change to section 7(f)
which deletes any reference to OEMs.
Definition (13) ``standards and specifications'' was
amended to resolve two major problems. First, the wording in the
original definition was interpreted by NIST and Commerce attorneys as
prohibiting the sale of any fastener not fully meeting the requirements
of the standards or specifications to which it was manufactured. Such
interpretation does not recognize long-standing industry practice of
disposing of non-conforming fasteners in accordance with defined
procedures contained in consensus standards. The objectionable language
was removed from the definition. Second, the definition as now
constructed makes it clear that for the purposes of the Act only
fasteners which are covered by standards and specifications published
by a consensus standards organization or by a government agency are
subject to the Act.
Definition (14) ``through-harden'' was amended by adding
``* * * for the purpose of achieving a uniform hardness'' to improve
its meaning.
Section 4 of the Act was completely deleted. NIST, with the
assistance of the Fastener Advisory Committee, attempted but was
unsuccessful in establishing guidelines under which the Secretary of
Commerce would add or exempt categories of fasteners from coverage
under the Act. Originally, Congressional intent was that the Act would
cover only ``high strength'' fasteners used in ``critical
applications.'' A figure of 1% of fasteners meeting these categories
was used throughout early Congressional discussions of the Act.
However, upon passage of the Act and further study and interpretation
of its requirements by the Department of Commerce, the Fastener
Advisory Committee, and various industry groups, it became apparent
that the Act applied to a majority of fasteners in the industry.
Further, while it was possible to come to an agreement that a
``critical application'' of a fastener was any application for which it
was reasonably foreseeable that a failure of the fastener would result
in serious personal injury or death, significant property damage, or
significant repair costs, it was not possible to come to agreement a
priori as to which fasteners were used in critical applications. The
problem is that a single type or category of fasteners might be used in
many different applications, some may be critical in terms of having
the potential for causing death or injury if the fastener(s) fails, and
others not. The ultimate user of the fastener determines how fasteners
will be used, and there were many instances cited where ``low
strength'' fasteners were being used in critical applications. Thus,
NIST and the Fastener Advisory Committee concluded that there was no
systematic way in which the Secretary of Commerce could add or exempt
whole categories of fasteners from coverage under the Act, and that to
attempt to do so could be costly in terms of potential litigation, with
no resulting benefit to anyone. Such conclusion was based on evidence
that there is no instance within the industry where one can make a
clear-cut case that a particular fastener category, not currently
covered by the Act, is always used in ``critical applications'' or vice
versa.
Section 5 of the Act prohibits selling (or offering for sale) any
fastener unless it is part of a lot which: (1) Conforms to the
standards and specifications to which the manufacturer represents it
has been manufactured; and (2) has been inspected, tested, and
certified as provided by the Act. An exception to this pre-sale
requirement is provided for certain small lots. These small lots must
be tested as soon as practicable after delivery to the purchaser.
Section 5 also provides that fastener inspection and testing be
performed by a laboratory accredited in accordance with procedures and
conditions specified by the Secretary of Commerce. Sections 5(a)(1)(B)
and 5(a)(2)(B) were amended to add reference to the new section (d)
covering alternative procedures for chemical testing. Section 5(c)(2)
was amended to make it clear that the laboratory report of testing must
include a reference to the standards and specifications the
manufacturer claims the fasteners have been manufactured to. Section
5(c)(3) was amended to remove the examples of fastener markings and
characteristics to be tested. The examples are incomplete and could be
misleading. Section 5(c)(4) was amended to allow the manufacturer to
follow section 5(d) regarding alternative procedures for testing
chemical characteristics of fasteners. A new section 5(d) providing for
an alternative procedure for determining the chemical characteristics
of fasteners was added. This new section recognizes a long-standing
industry practice of manufacturers relying on certificates from the raw
material supplier for assuring that the chemical characteristics of a
mill heat of material conform to specified standards. The section
requires that testing be carried
[[Page 50541]]
out in a laboratory accredited in accordance with the Act.
Section 6 requires the Secretary of Commerce, acting through the
Director of NIST, to issue regulations including: (1) Procedures and
conditions for NIST accreditation of fastener testing laboratories; (2)
conditions (consistent to the extent practicable with requirements of
national or international consensus documents) under which private
entities may apply for approval to directly accredit laboratories in
accordance with the requirements of the Act; and (3) conditions under
which the accreditation of foreign laboratories by their governments or
organizations recognized by the NIST Director will be deemed to satisfy
the requirements of the Act. The Act leaves to the discretion of the
Director the procedures NIST will use to determine the competency of
foreign governments'' (or other organizations') laboratory
accreditation programs. Section 6(a)(1) was amended to delete the
reference to the Secretary's issuance of regulations within 180 days of
enactment of the Act, because that time period is no longer relevant.
Section 7 of the Act covers sales of fasteners subsequent to their
manufacture and establishes requirements which manufacturers,
importers, and private label distributors must meet in the sale of
fasteners. It also requires that any person who significantly alters a
fastener so that it no longer conforms to the description in the
relevant certificate of conformance and offers such fastener for
subsequent sale is to be treated as a manufacturer for purposes of the
Act. Section 7 also governs the commingling of fasteners from different
lots in the same container.
There were several significant amendments to section 7 of the Act.
Section 7(a) was amended to delete reference to section 4 of the Act,
which was deleted. Section 7(a) was also amended to remove the
responsibility from the manufacturer of domestically produced fasteners
of supplying to the purchaser, at the time of delivery, a written
certificate attesting that the fasteners have been manufactured
according to applicable standards and specifications and have been
inspected and tested by an accredited laboratory. Instead, the new
requirement is that the manufacturer maintain on file a manufacturer's
certificate of conformance covering fasteners and that the certificate
be available for inspection. The requirement that the original
laboratory report of test be maintained on file by the manufacturer
remains unchanged. Copies of the manufacturers certificate of
conformance and original test report for a given lot of fasteners may
be requested by purchasers of such fasteners, under an amendment to
section 10 of the Act. This change was made to reduce paperwork burdens
under the Act and to reduce the possibility of fraudulent use of
certificates of conformance or laboratory test reports. It is not the
intent of these changes to deny access to such information to any
person who can demonstrate a legitimate need for the information.
Section 7(b) remains unchanged in terms of requiring delivery of
fasteners of foreign origin to be accompanied by a manufacturer's
certificate of conformance and an original laboratory testing report
for each lot of imported fasteners. Exemptions to these requirements
are provided for products manufactured within a nation which is a party
to a congressionally-approved free trade agreement with the United
States or for Canadian-origin products under the United States-Canada
Automobile Pact for use as original equipment in the manufacture of
motor vehicles. Also, importers or private label distributors may take
delivery of imported fasteners without the original copy of the
laboratory test report if the manufacturer provides a certificate of
conformance indicating that the fasteners have been manufactured
according to the requirements of the applicable standards and
specifications and the importer or private label distributor assumes
responsibility in writing for the inspection and testing of the
fasteners in accordance with the Act.
Section 7(c)(2) was amended by adding several words to improve its
meaning. In section 7(d) the word ``certificate'' was replaced with
``test report'' to make it clear that it is the test report and not the
manufacturer's certificate of conformance that should be referred to in
determining whether or not significant alterations have been made to a
fastener. Section 7(e) on Commingling was amended to permit voluntary
commingling of two or more tested and certified lots by fastener
distributors. There is still a restriction on commingling of more than
two tested and certified lots by manufacturers, importers, or private
label distributors. Section 7(f) on subsequent purchaser was amended to
indicate that any person who purchases fasteners for any reason has the
right to request and receive containers of fasteners with the lot
number from which they were taken conspicuously marked on the
container. Section 7(g) was deleted because the Secretary of Commerce
is provided authority to issue regulations pursuant to the Act in
section 13.
Section 8 prohibits offering fasteners for sale that are required
by an applicable standard or specification to bear a raised or
depressed insignia identifying the manufacturer or distributor unless
the manufacturer or distributor has complied with the requirements of a
program to be established by the Secretary of Commerce for the
registration of such insignias to ensure that the fasteners may be
traced to their manufacturers or private label distributors. However,
the Act does not establish any particular recordation system to effect
that purpose. The Patent and Trademark Office (PTO) was charged with
establishing such a system. These requirements are proposed as subpart
H of this rule.
Section 9(a) of the Act authorizes the Attorney General to bring an
action in U.S. district courts for declaratory and injunctive relief
against persons who violate the Act or implementing regulations.
Section 9(b) requires the Secretary of Commerce to establish ``notice
and opportunity for hearing'' procedures for the assessment of civil
penalties not to exceed $25,000 for each violation of the Act or
implementing regulations, authorizes penalty recovery actions by the
Attorney General, and authorizes the Secretary to issue subpoenas of
witnesses or documents. A ``substantial evidence'' standard of judicial
review is provided. Section 9(c) of the Act provides for criminal
penalties, which are enforced by the Department of Justice. A new
section 9(d) dealing with enforcement was added as an amendment to the
Act at the request of the Bureau of Export Administration within the
Department of Commerce. The Bureau of Export Administration has been
delegated responsibility for enforcement of the Act by the Secretary of
Commerce. This new language provides authority for agents and
investigators from the Bureau of Export Administration to also use
authorities conferred upon them by other laws of the U.S., subject to
policies and procedures approved by the Attorney General to enforce
this Act. Proposed regulations implementing section 9 are contained in
subpart G of this rule.
Section 10 of the Act deals with record keeping requirements. This
section was amended to reduce from 10 years to 5 years, the period
during which records must be kept by persons subject to the Act. In
section 10(b) the word ``any'' has been replaced by the word ``the'' to
limit the responsibility of manufacturers, importers, private label
[[Page 50542]]
distributors, and persons who make significant alterations under the
Act, to supply copies of applicable laboratory testing reports or
manufacturers' certificates only to their purchasers of fasteners. The
intent of the change is to reduce paperwork burdens and to protect
against fraudulent use of test reports and certificates of conformance.
Section 13 provides authority to the Secretary of Commerce to issue
regulations pursuant to the Act. The reference to issuance of
regulations within 180 days of enactment of the Act was deleted because
the time frame is no longer relevant.
Section 14 requires the establishment of an advisory committee to
assist in implementation of the Act. This section was deleted. The
requirements of the section have been met by NIST.
Background--Part 3: Summary of Public Comments Received by NIST in
Response to the 1992 Request for Public Comments, and NIST's Response
to the Comments
As was noted above, on August 17, 1992, NIST published a proposed
rule to implement the Fastener Quality Act in the Federal Register (57
FR 37032). A detailed analysis of the comments follows.
Comments Requesting NIST To Issue Another Proposed Rule
Several commenters requested that in light of amendments made to
the Fastener Quality Act under Pub. L. 104-113, NIST should issue
another proposed rule for public comment. NIST asserts that this final
rule is the logical outgrowth of the 1992 proposed rule and the public
comment process. A majority of the public comments received on the 1992
proposed rule suggested the need for particular amendments to the FQA.
The suggested amendments were enacted as part of Pub. L. 104-113. This
rule contains regulations making final the 1992 proposed rule, as well
as regulations to implement expressly the FQA as amended pursuant to
specific public comments received regarding the 1992 proposed rule.
Therefore, under the Administrative Procedures Act, 5 U.S.C. 553, and
relevant case law, see International Harvester Co. v. Ruckelshaus, 478
F.2d 615 (D.C. CIR. 1973), South Terminal Corp. v. Environmental
Protection Agency, 504 F.2d 646 (1st CIR. 1974), and United Steel
Workers v. Marshall, 647 F.2d 1189 (D.C. CIR. 1980), denied, 101 S.Ct.
3148 (1981), NIST has determined that it has the authority to issue
this final rule without the necessity for issuing another proposed
rule.
Comments Urging Changes to the Regulations Requiring Amendments to the
Fastener Quality Act
NIST received 225 letters (146 from fastener distributors, 50 from
fastener manufacturers, 13 from trade associations, and 13 from
fastener users or importers, and other sources) supporting
recommendations of the Fastener Advisory Committee (the ``Committee''),
which proposed that the following amendments be made to the Fastener
Quality Act:
Comment: Permit tests of the chemical composition of
fasteners to be carried out upon raw materials, rather than upon
finished lots of fasteners as required by the Act.
NIST Response: This legislative change was made in Pub. L. 104-113,
which added a new section 5(d) ``Alternative Procedure for Chemical
Characteristics'' to the Act. New section 5(d) of the Act is
implemented in section 280.15 of the regulations being published today.
Comment: Permit the sale of fasteners which, upon testing
under the Act, are found to have ``minor'' flaws resulting in the
fastener not conforming to the tolerances stated in the standards and
specifications to which they were manufactured. Section 5(a) of the Act
expressly prohibits the sale of fasteners which (1) do not conform to
the standards and specifications to which they were manufactured, and
(2) have not been inspected, tested and certified as provided under the
Act.
NIST Response: This legislative change was made in Pub. L. 104-113,
which amended the definition of ``standards and specifications'' found
in subsection 3(13) of the Fastener Quality Act. The legislative change
recognizes the provisions of numerous commercial and military documents
which provide for a cost effective disposition system for nonconforming
products when a minor nonconformance does not adversely affect the
health and safety, performance, interchangeability, reliability,
maintainability or effective use or operation. The changed definition,
which will permit the sale of fasteners with minor nonconformances is
found in Sec. 280.2 of the regulations being published today.
Comment: Permit distributors to commingle fasteners from
more than one lot in the same container, thus reducing warehouse costs
for the distributors, despite the provisions of section 7(e) of the
Act.
NIST Response: This legislative change was made in Pub. L. 104-113,
which amended section 7(e) of the Fastener Quality Act to permit
commingling of no more than two lots of fasteners under specified
circumstances. The change is implemented in Sec. 280.4 of the
regulations being published today.
Comment: Require that any person who significantly alters a
fastener be responsible for retesting that fastener, despite the
provisions of section 7(d) of the Act.
NIST Response: No legislative changes have been made in response to
this comment. Accordingly, no changes have been made to the regulation.
Comment: Restrict the availability of test reports to the
original purchaser despite the requirements of section 10 of the Act
that such reports be made available to all subsequent purchasers.
NIST Response: In section 10(b) of the Act, the word ``any'' has
been replaced by the word ``the'' to limit the responsibility of
manufacturers, importers, private label distributors, and persons who
make significant alterations under the Act, to supply copies of
applicable laboratory testing reports or manufacturers' certificates
only to their purchasers of fasteners. The intent of the change is to
reduce paperwork burdens and to protect against fraudulent use of test
reports and certificates of conformance.
Subpart A--General
Comments received by NIST pertaining to this subpart are addressed
section by section. If no comments were received pertaining to a
particular section, there is no corresponding entry in this analysis.
Section 280.2 Definitions
As a result of changes made to subparts C and E of these
regulations based on comments described in the relevant sections of
this analysis, several changes have been made to definitions. A
definition has been added for the term ``Accreditation Body,'' to refer
to the National Voluntary Laboratory Accreditation Program, and to
those private entities currently approved by NIST under subpart D of
these regulations and those foreign governments or organizations
currently recognized by NIST under subpart E of these regulations. A
definition has also been added for ``Approved signatory'' to mean an
individual employed by a laboratory accredited under the Act and these
regulations who is recognized by an accreditation body as competent to
sign accredited laboratory test reports. Finally, the definition of
``Certificate of Accreditation'' has been expanded so that it now
refers to a document issued by an accreditation body to a laboratory
that has met the criteria and conditions
[[Page 50543]]
of accreditation, that, together with the assigned code number and
scope of accreditation issued by the accreditation body, may be used as
proof of accredited status.
Various comments suggested that three interrelated definitions, for
``alter,'' ``critical application,'' and ``significantly alter'' should
be revised. These comments came from the Fastener Advisory Committee,
four trade associations, two users, three manufacturers, and one
foreign government. The Fastener Advisory Committee recommended that
the definition of ``alter'' be slightly amended to make clear that
alter pertains to electroplating of fasteners that are ``specified'' as
having a minimum tensile strength of 150,000 psi or greater, otherwise
the requirement could be misinterpreted to mean that electroplated
fasteners that are ``tested'' and found to be greater than 150,000 psi
would have been considered significantly altered even though they were
specified with a minimum tensile strength lower than 150,000 psi.
Definition of Significantly Alter
The Fastener Advisory Committee devoted a great deal of study to
the term ``Significantly Alter'' through its Alteration Working Group.
Public comments stressed the need to be clear about what is or is not a
significant alteration; who is responsible as the alterer of the
fastener; and what tests and markings are required. Consistent with
language found in the Act, the Committee felt it is important to define
a significant alteration as an action which could weaken or otherwise
materially affect the performance or capabilities of the fastener as it
was originally manufactured, grade or property class marked, and
tested. Alterations not considered significant include the application
of adhesives or sealants, locking elements, cutting off, provisions for
lock wires, or coatings and platings of parts below a certain hardness
level to be discussed later in this part. The practice of cutting
threads off a finished fastener is not defined as a significant
alteration. Similarly, the cutting of finished threaded studs, rods,
and bars to produce individual smaller length threaded studs for resale
is not considered a significant alteration. However, the individual
fasteners cut from threaded studs, rods, and bars and offered for
resale shall be individually marked with the grade or property class
identification marking appearing on or accompanying the original
threaded studs, rods, and bars from which the fasteners were cut.
Commenters also asked for clarification on who is responsible as the
alterer of a fastener. NIST and the Committee agree that the person who
owned the fastener at the time the alterations were carried out is
responsible for assuring adherence to the regulations. Accordingly, a
definition of ``Alterer'' has been added to Sec. 280.2, per the
Committee's wishes.
With respect to questions concerning marking and testing of
significantly altered fasteners, the significant alterer will be
responsible for applying a registered insignia to the altered fastener
if so required by the original standards and specifications, and for
assigning a new lot number. A new Sec. 280.11 has been added to the
regulations to spell out these requirements. The significant alterer
will also be responsible for causing the altered fasteners to be
inspected and tested as required under section 5 of the Act, unless the
fastener is delivered to a purchaser accompanied by a written statement
noting the original lot number and the new lot number assigned by the
alterer, disclosing the subsequent alteration, and warning that such
alteration may affect the dimensional or physical characteristics of
the fastener.
If the alteration is not a significant alteration, a new headmark
and new lot number are not required and the only testing requirements
which apply are those required by the specification to which the minor
alteration was performed, such as prevailing torque or salt spray. If
the significant alteration is only electroplating of fasteners above a
certain hardness level or strength level, the requirement for a new
headmark is waived, but a new lot number must be assigned and testing
for hydrogen embrittlement must be performed in addition to those tests
required by the plating specification.
Based upon subsequent input from the Public Law Task Force on the
issue of alteration and significant alteration of fasteners, the Task
Force recommended to Congress that the definition of ``alter'' should
be amended by deleting the reference to a minimum tensile strength of
150,000 pounds per square inch (psi). It was felt that this type of
technical requirement did not belong in the Act and should be covered
in implementing regulations. Pub. L. 104-113 amended section 3(1)(B) of
the Act to remove this requirement.
The Public Law Task Force recommended to the Department that the
Rockwell C Hardness Scale be used in the regulations in lieu of tensile
strength for purposes of determining which fasteners have been
significantly altered through electroplating. It is widely held within
the fastener industry that the process of electroplating fasteners,
particularly high strength fasteners, increases their susceptibility to
hydrogen embrittlement. The intent of the Act and the regulations is to
require that electroplating of high strength fasteners be considered a
significant alteration, and to further require that the manufacturer or
person responsible for the alteration assign a new lot number to the
fasteners and test them in accordance with the plating specification. A
specified Rockwell C value of 32 has been selected as the threshold
hardness for determining when electroplating is a significant
alteration of fasteners. This value has been selected for the following
reasons: (1) It is roughly equivalent to the original threshold of
150,000 psi contained in the 1990 Act (ASTM A370, which provides
approximate hardness conversion numbers for nonaustenitic steels,
indicates that Rockwell C 32 is approximately equivalent to a tensile
strength of 146,000 psi and Rockwell C 33 is approximately equivalent
to a tensile strength of 149,000 psi), thereby covering the same types
and grades of fasteners; and (2) setting the threshold Rockwell C
hardness value at 32 rather than 33 would treat Grade 8 fasteners and
metric 10.9 fasteners (which are substantially equivalent) equally for
purposes of determining when electroplating is a significant
alteration.
Definition of Critical Application
A large number of comments were received on the definition of
``critical application.'' Some of the commenters felt that the
definition did not offer guidance in determining what is meant by
``significant property damage'' or ``significant repair costs.'' Other
commenters felt that the definition should be changed to indicate that
fasteners having minimum tensile strengths of 150,000 psi or greater
should be considered as critical and those below 150,000 psi should be
exempt from coverage under the Act because they are not generally used
in critical applications. The Fastener Advisory Committee and the
Public Law Task Force devoted much time and effort to studying this
issue and recommended to Congress that section 4 of the Act be deleted
in its entirety which would also mean deleting the definition of
``critical application'' as it applies only to section 4. Section 4 of
the Act was repealed by Pub. L. 104-113, and accordingly, the
definition of ``critical application'' has been removed from the
regulations being published today.
NIST, with the assistance of the Fastener Advisory Committee,
attempted but was unsuccessful in
[[Page 50544]]
establishing guidelines under which the Secretary of Commerce would add
or exempt categories of fasteners from coverage under the Act under the
now-repealed section 4 of the Act. Originally, Congressional intent was
that the Act would cover only ``high strength'' fasteners used in
``critical applications.'' A figure of 1% of fasteners meeting these
categories was used throughout early Congressional discussions of the
Act. However, upon passage of the Act and further study and
interpretation of its requirements by the Department of Commerce, the
Fastener Advisory Committee, and various industry groups, it became
apparent that the Act applied to a majority of fasteners in the
industry. Further, while it was possible to come to agreement that a
``critical application'' of a fastener was any application for which it
was reasonably foreseeable that a failure of the fastener would result
in serious personal injury or death, significant property damage, or
significant repair costs, it was not possible to come to agreement a
priori as to which fasteners were used in critical applications. The
problem is that a single type or category of fasteners might be used in
many different applications, some may be critical in terms of having
the potential for causing death or injury if the fastener(s) fails,
others not. The ultimate user of the fastener determines how fasteners
will be used, and there were many instances cited where ``low
strength'' fasteners were being used in critical applications. Thus,
NIST and the Fastener Advisory Committee concluded that there was no
systematic way in which the Secretary of Commerce could add or exempt
whole categories of fasteners from coverage under the Act, and that to
attempt to do so could be costly in terms of potential litigation, with
no resulting benefit to anyone. Such conclusion was based on evidence
that there is no instance within the industry where one can make a
clear-cut case that a particular fastener category, not currently
covered by the Act, is always used in ``critical applications'' or vice
versa.
Definition of Commingling
The Fastener Advisory Committee felt it was important to define
commingling because it is used in the Act. Accordingly, the regulation
has been revised to define ``Commingling'' as meaning the mixing of
fasteners from different lots in the same container.
Definition of Fastener--Washers Subject to the Act
During the joint meeting of the Fastener Advisory Committee and the
Public Law Task Force, held May 15-16, 1996 at the National Institute
of Standards and Technology (NIST), washer manufacturers present at the
meeting commented that there was confusion about which washers were
``fasteners'' under the Act. In particular, they pointed to confusion
among their customers, many of whom were interpreting the Act as
covering any washer that was to be used with a bolt or screw that
itself was covered by the Act.
Congressional intent on this issue is clearly stated in page 10 of
Senate Report 101-388, dated July 23, 1990, which accompanied the
original H.R. 3000 (Fastener Bill). It states as follows:
``Subparagraph (C) of section 3(5), which defines `fastener,' is
intended to cover those washers which standards indicate are associated
with particular fasteners and must be used in order for those fasteners
to conform to those standards. A washer whose use with a particular
fastener is permitted but not required is not covered by this
definition.''
The Advisory Committee and the Task Force concluded that there were
only two U.S. standards and specifications which specifically call out
requirements for washers used in association with covered fasteners
under the Act, and that the regulations should identify such standards
and specifications to make it clear what washers were fasteners within
the meaning of the Act. The standards and specifications are ASTM F959
or F959M pertaining to load indicating washers, and ASTM F436 or F436M
which pertain to washers specified for use with structural bolts or
equivalent high strength bolts. The Advisory Committee and the Task
Force also pointed out that there may be foreign or international
equivalents to these standards and specifications.
The Department believes that the conclusion of the Advisory
Committee and the Task Force, as stated above, is consistent with the
stated Congressional intent of the Act, but feels that it would be
inappropriate to include a specific determination within the
regulations that only washers manufactured to or held out as being
manufactured to the above-mentioned standards and specifications are
fasteners within the meaning of the Act. To do so would unnecessarily
restrict the freedom of consensus standards bodies to significantly
change these standards and specifications in the future, or to propose
new standards and specifications which would have the effect of
including additional washers as ``fasteners'' within the meaning of the
Act. In addition, doing so could exclude washers held out as meeting a
foreign or international standard or specification that requires
certain washers to be used with particular fasteners in order to
conform to that standard or specification.
Definition of ``Fastener''--Referencing of Consensus Standards
During the joint meeting of the Fastener Advisory Committee and the
Public Law Task Force, held May 15-16, 1996 at the National Institute
of Standards and Technology (NIST), comments were received from a
member of the Advisory Committee on that part of the definition of
``fastener'' in Sec. 280.2 of the regulations, which includes the
requirement that: ``A screw, nut, bolt, stud, or washer held out as
being produced according to the requirements of a document other than a
document published by a consensus standards organization is a fastener
within the meaning of the Act and this part if that document
incorporates or references (directly or indirectly) standards and
specifications published by a consensus standards organization or
government agency for purposes of delineating performance or materials
characteristics of the fastener.''
In the view of this Committee member the Congressional intent was
to amend the definition of ``standards and specifications'' in section
3(14) of the Act to remove from coverage under the Act fasteners
produced to standards and specifications published by ``major end-
users,'' and therefore the language proposed in Sec. 280.2 of the
regulations as noted above was not consistent with Congressional
intent. The Committee member proposed an amendment to the definition of
``standards and specifications'' which would have the effect of
exempting from coverage under the Act and regulations fasteners
produced to standards and specifications published by ``major end-
users'' who then purchase such fasteners and install them into a
structure or assembly. The Department agreed to study this matter and
no action was taken on the proposal by the Advisory Committee and the
Task Force.
The Department has studied this issue and concludes that the
definition of fastener as provided in Sec. 280.2 of the regulations
meets Congressional intent. Therefore, the proposal to exempt fasteners
produced to standards and specifications published by ``major end-
users'' is rejected. The reasons are as follows. In the 1990 version of
the Fastener Quality Act, ``standards and specifications'' were defined
as
[[Page 50545]]
documents published by ``consensus standards organizations,''
``government agencies,'' and ``major end-users.'' The Act further
defined ``consensus standards organization'' but did not define ``major
end-user'' of fasteners. NIST, with the assistance of the Fastener
Advisory Committee, defined ``major end-user'' in the draft
implementing regulations issued for public comment in 1992 as ``a
recognized developer and publisher of standards bearing such user's
identification which have characteristics similar to national consensus
standards and which have been developed or modified to fit the specific
needs of such user.''
During the 1992 public comment period, comments were received from
the Fastener Advisory Committee that there are manufacturers and
private label distributors who modify existing standards and
specifications to produce unique fasteners either for marketing
purposes or to satisfy a particular market niche, and that such
manufacturers or private label distributors might not be considered
``major end-users'' for purposes of this definition. The result could
be that fasteners produced this way might be considered ``blueprint
specials'' and, therefore, not subject to the Act. Based upon such
comments, the Department proposed a change to the definition of
``standards and specifications'' to have it read: ``* * * the
provisions of a document published by a consensus standards
organization, a government agency, a manufacturer, a private label
distributor, or a major end-user of fasteners.'' The net effect of the
proposed change would have been to include a much broader population of
fasteners under the Act. For example, fasteners produced to a company's
proprietary standard would have been included under the Act provided
the fastener met all other requirements pertaining to the definition of
a ``fastener.''
In 1995 industry formed the Public Law Task Force to forge a
unified industry position on needed amendments to the Act. The Task
Force was invited by Congress to propose clarifying and substantive
amendments to the Act. NIST was asked to cooperate with the Task Force
in developing such recommendations. The definition of ``standards and
specifications'' was an issue raised by the Task Force, who felt that
the definition was confusing and needed to be simplified. In reviewing
the definition, NIST concluded that the 1992 proposed change had the
effect of including within the meaning of the Act fasteners produced to
standards and specifications published by manufacturers and private
label distributors, and that such extension of the Act was not
supportable after a review of Congressional history of the Act.
Additionally, the definition of ``major end user'' as proposed in the
1992 draft of the regulations was confusing in terms of deciding which
standards of which organizations would apply.
A review of legislative history indicates that the intent was to
cover fasteners produced for use by original equipment manufacturers
(OEMs) in ``aircraft, the space shuttle, motor vehicles of all kinds,
military equipment, highway bridges, and buildings'' (page 2, Senate
Report 101-388, dated July 23, 1990). Additional evidence is contained
in the Act itself by virtue of the definition of OEMs contained in
section 3(11) of the 1990 Act and in examples cited in pp 18-19, of the
Senate Report cited above. Further, in discussions within the Task
Force it was clear that industry practice among companies like General
Motors, Ford, and Chrysler was to reference standards from ASTM, SAE,
and other consensus standards bodies in their standards.
Accordingly, the Task Force proposed an amendment to the definition
of ``standards and specifications'' in section 3(14), which was adopted
by Congress and which bases the Act's coverage of fasteners on those
produced to standards and specifications of consensus standards bodies
and government agencies. Such amendment was proposed with the
understanding that NIST would further specify by regulation that
fasteners produced to documents other than those of consensus standards
organizations or government agencies would be fasteners within the
meaning of the Act if those documents incorporate or reference
(directly or indirectly) standards and specifications published by a
consensus standards organization or a government agency for purposes of
delineating performance or materials characteristics of the fastener.
Therefore, fasteners produced to standards and specifications published
by major end-users are covered by the Act and Regulations, if those
standards and specifications incorporate or reference, directly or
indirectly, standards and specifications published by a consensus
standards organization or a government agency.
Definition of Grade or Property Class Identification Marking
Several comments were received that the definition of ``Grade or
Property Class Identification Marking'' should be clarified to
distinguish between grade or property class marks and ``raw material
marks.'' A grade mark is placed on a fastener to indicate that the
material, strength properties, or performance capabilities of the
fastener conform to a specific standard. A raw material mark indicates
the base material used and is not considered a grade identification
mark for purposes of the Act and Regulations, unless the mark is
required by the fastener standards and specifications to identify
specific conformance.
Definition of Lot Traceability
The Fastener Advisory Committee recommended that ``lot
traceability'' be defined as it is an important term used in the Act
and regulations. A definition has been provided in the regulations. As
part of the definition, it is necessary to make it clear that the
fastener part number, manufacturer's identity, and lot number are
critical elements of information needed to assure lot traceability.
Accordingly, a definition has also been added for ``lot-specific
identification information,'' as meaning information applicable to a
fastener consisting of, at a minimum, (i) the part number (or a part
description if there is no applicable part number), (ii) the identity
of the manufacturer, and (iii) the lot number. A definition has also
been provided for ``Lot number'' as meaning a number assigned by a
manufacturer to the lot.
Definitions Related to ``OEMS''
Eight commenters, five manufacturers and users of fasteners, and
three trade associations suggested that changes should be made in the
definitions contained in the regulations to clarify the meaning of the
terms ``original equipment manufacturer'' (OEM) and ``authorized
dealer.'' Some of the commenters suggested that a definition should be
provided for the term ``authorized dealer'' in order to clarify that
the term ``original equipment manufacturer'' is not limited to the
automobile industry. Other commenters expressed confusion about the
application of the regulation in the context of original equipment
manufacturers who are also importers. Two amendments to the Act have
taken care of this issue. First, section 7(e), commingling was amended
to permit voluntary commingling of fasteners by distributors and the
reference to original equipment manufacturer was removed. Second, the
definition of ``original equipment manufacturer'' in section 3(11) was
deleted.
[[Page 50546]]
Definition of Original Laboratory Testing Report
During the May 1996 joint meeting of the Fastener Advisory
Committee and the Public Law Task Force there was discussion about the
requirement in Sec. 280.5 of the regulations that an ``original
laboratory testing report'' was required to be maintained on file with
the manufacturer, importer, or private label distributor. Questions
arose as to what constituted an original test report. In order to
clarify the intent of the regulations a definition of ``original
laboratory testing report'' has been added which states that it is ``a
laboratory testing report which is originally-signed by an approved
signatory or a copy thereof, certified by the laboratory that conducted
the test''.
Definition of Standards and Specifications
Comments were received from the Fastener Advisory Committee
concerning the definition of ``Standards and Specifications.'' The
Committee noted that there are manufacturers and private label
distributors who modify existing standards and specifications to
produce unique fasteners either for marketing purposes or to satisfy a
particular market niche, and that such manufacturers or private label
distributors might not be considered ``major end-users'' for purposes
of this definition. The definition of ``standards and specifications''
has been amended in the Act to make it clear that for purposes of the
Act only fasteners covered by standards and specifications published by
a consensus standards organization or by a government agency are
subject to the Act.
Definition of Traceability
Four commenters, three manufacturers and one trade association,
suggested that the term ``traceability'' should be revised to
distinguish between traceability of fasteners and traceability as
defined in the context of the standards arena. In response to this
comment, the definition of ``traceability'' contained in the draft
regulations has been replaced by two definitions. The first, ``Lot
traceability,'' defines traceability in the context of fasteners as
meaning the recording and maintenance of lot-specific identification
information sufficient to trace fasteners from a single lot throughout
(i) the manufacturer's fabrication or alteration process, (ii) all
inspection and testing operations, and (iii) the subsequent chain of
distribution in commerce. The second, ``Traceability of Measurements,''
defines measurement traceability as meaning a documented chain of
comparisons connecting the accuracy of a measuring instrument to other
measuring instruments of higher accuracy and, ultimately, to a primary
standard.
In response to a series of comments on laboratory test reports
which are described below in the narrative relevant to that section, a
definition of ``Tamper-resistant system'' has been added to Sec. 280.2.
The phrase is defined to mean the use of special paper, embossing
stamps, or other controls which discourage, prevent, or minimize
alteration of test reports subsequent to manufacturing, inspection, and
testing.
Old Sec. 280.4: Waiver Requirement and Old Sec. 280.5: Inclusion of New
Fasteners
Pub. L. 104-113 repealed section 4 of the Act, rendering these
sections obsolete. Accordingly, they have been removed from the
regulation being published today.
New Sec. 280.4: Commingling
Pub. L. 104-113 amended section 7(e) of the Fastener Quality Act to
permit voluntary commingling of no more than two tested and certified
lots by fastener distributors. There is still a restriction on
commingling of more than two tested and certified lots by
manufacturers, importers, or private label distributors. The change is
implemented in Sec. 280.4 of the regulations being published today.
New Sec. 280.5: Certification of Fasteners
One commenter asked whether the regulation requires distributors to
furnish to their customers a manufacturer's certificate when they make
their sale. NIST notes that distributors are not required to provide
copies of the certificates. A new Sec. 280.5 of the regulation has been
added which specifies information that must appear in the ``certificate
of conformance'' and the responsibility of the manufacturer to maintain
the certificate on file available for inspection. The sale of fasteners
by parties other than the manufacturer without an accompanying
certification is not prohibited.
Section 280.6: Laboratory Test Reports
A wide range of comments were received by NIST on the general topic
of the requirements for laboratory test reports set out in Sec. 280.6
of the regulations. For ease of analysis, those comments are discussed
under the following general categories:
* General Observations and Comments;
* Authorized Signatories;
* Tamper Proof Paper; and
* Test Report Contents.
Each of these topics is discussed below.
General Observations and Comments
NIST received eight general comments on the requirements set out in
Sec. 280.6 for the content of laboratory test reports. Four commenters
(three manufacturers and one importer) stated that the reports were
either burdensome, clumsy, irrelevant or otherwise unpleasant, and
suggested that revisions be made to ``clean up'' Sec. 280.6. NIST's
response to these comments is contained in the following paragraphs.
Another commenter suggested that NIST require that all test reports
include the words ``Certified Fastener Test Report'' in a clear and
prominent position. No change to the regulation has been made based
upon this comment. Three manufacturers and a trade association
suggested that NIST delete the requirement to report on ``test
conditions, test set up'' found in Sec. 280.6(a). This deletion has
been made.
NIST has made a number of changes to the regulation in an effort to
simplify and clarify the required contents of laboratory test reports.
In addition, some of the required elements of laboratory test reports
have been grouped into logical units that NIST hopes will make the test
reports more logical and orderly in presentation. Old Secs. 280.6(a)
(6), (7) and (8) from the proposed regulation have been grouped under
the category ``Sampling Information'' in a renumbered Sec. 280.6(a)(5),
and have been assigned the numbers 280.6(a)(5) (i), (ii) and (iii). In
addition, old Secs. 280.6(a) (9), (10), (12), (14) and (15) from the
proposed regulation have been grouped under the category ``Test
Results'' in a renumbered Sec. 280.6(a)(6), and have been assigned the
numbers 280.6(a)(6) (i), (ii), (iii), (iv), (v) and (vi).
Approved Signatories
NIST received three comments on the requirement contained in
Sec. 280.6(a)of the regulation that all laboratory test reports be
signed by an approved signatory. All three comments were from
manufacturers, and suggested either that the requirement for a
signature be removed completely, or that copies of signatures be
permitted. No changes have been made by NIST to the regulation. An
original test report containing an ``original signature of an approved
signatory'' of the laboratory must be provided to the manufacturer, and
under section 7(a)(2) of the Act the original test report must be
maintained on file with the manufacturer and be available for
inspection. However, copies of such report provided by the manufacturer
on a request basis to
[[Page 50547]]
customers do not have to bear original signatures. A definition of
``approved signatory,'' has been added to Sec. 280.2 of the regulation
to clarify which individuals are empowered to sign test reports on
behalf of accredited laboratories.
Tamper Proof Paper
NIST received twelve comments pertaining to the requirement found
in Sec. 280.6(a) that all laboratory test reports use tamper proof
paper. Seven of the comments urged that the requirement for tamper
proof paper be deleted; these comments came from three manufacturers,
two trade associations and two users of fasteners.
The remaining five comments urged that the requirement for tamper-
proof paper be replaced by a requirement for a system which discourages
tampering, perhaps embossing, because tamper-proof paper is not
generally available. These comments came from four manufacturers and
one trade association. As a result of these comments, NIST has revised
Sec. 280.6(a) of the regulations to provide for the use of a ``tamper-
resistant system'' in the preparation of laboratory test reports. In
addition, a definition has been added to Sec. 280.2 as follows
``Tamper-resistant system'' means the use of special paper or embossing
stamps or other controls which discourage, prevent or minimize
alteration of test reports subsequent to manufacturing, inspection and
testing.
Test Report Contents
NIST received numerous comments pertaining to the specific contents
of laboratory test reports required by Sec. 280.6 of the regulations.
In the following paragraphs these comments are described along with
NIST's response to them.
One comment from an importer stated that Sec. 280.6(a)(3) should be
revised so that ``Name of client'' should apply only to independent
laboratories, and not to in-house laboratories. In order to avoid
creating confusion for parties that may review the laboratory test
report at a later date the regulation has not been changed.
NIST received eleven comments on the provisions of old
Sec. 280.6(a)(5) (now Sec. 280.6(a)(4)), which pertains to the
description of the fastener required in laboratory test reports.
Comments from a manufacturer and an importer raised concern about the
requirement for describing head markings found in old
Sec. 280.6(a)(4)(iii) (now Sec. 280.6(a)(4)(iv)). One commenter
suggested that the requirement should be deleted, and another suggested
that the requirement was too burdensome. NIST has determined that the
requirements of this section are essential to the report, and have
clarified its wording that both the manufacturer's recorded insignia
and grade markings must be reported. Three comments were received about
old Sec. 280.6(a)(4)(iv) (now Sec. 280.6(a)(4)(v)), an importer
observing that the requirement for a listing of thread tolerance on
laboratory test reports was not needed because this information was
specified by a standard; a distributor stated that the section should
refer to ``Nominal Diameter'' instead of ``Diameter''; and an agency of
the United States Government suggested that ``class of fit'' be
replaced with ``dimensional tolerance class'' and add ``thread
application category (safety critical thread, other thread etc.), or
conformance requirements, and the dimensional standard under which the
threads were manufactured.'' The section has been revised to refer to
``nominal dimensions'' as suggested.
Continuing the discussion on old Sec. 280.6(a)(5) (now
Sec. 280.6(a)(4)), one manufacturer suggested that the section be
revised to require inclusion in the test report of information on the
revision level of applicable drawing or standard at the time of
manufacture. Also, a trade association suggested that the same section
be revised to add part numbers. No changes have been made to the
regulation based upon these comments since NIST believes that adequate
information on these matters is already required. Another manufacturer
suggested that old Sec. 280.6(a)(5)(viii) (now Sec. 280.6(a)(4)(viii))
be revised by changing ``specification and grade of material'' to
``grade of material.'' No change was made to the regulation based upon
this comment. A user and a manufacturer each suggested that old
Sec. 280.6(a)(4)(ix) be revised to eliminate ``heat treated to the
requirements of the following specification'' and this change has been
made. The last comment on old Sec. 280.6(a)(5)(now Sec. 280.6(a)(4))
was a suggestion by a user who suggested that it be revised not to
require thickness, baking, and so on. The coating material must be
specified, but the regulation has been changed in the now
Sec. 280.6(a)(4)(ix) to drop any reference to thickness of coating or
baking of fasteners.
Three manufacturers and a trade association suggested that original
Sec. 280.6(a)(8) (now Sec. 280.6(a)(5)(iii)) be revised to delete the
name and affiliation of the person performing lot sampling, and two
manufacturers, a user and an importer suggested that Sec. 280.6(a)(9)
was redundant. NIST has determined that these elements are essential to
the report; accordingly no changes have been made. Five comments were
received pertaining to original Sec. 280.6(a)(10) (now
Sec. 280.6(a)(6)(ii)) of the regulations, divided among two
manufacturers, a user, an importer, and a trade association. The
commenters noted that a clarification was needed of the meaning of
``test results''; that is, whether the results should be given as pass/
fail, as maximum and minimum results, or within the context of actual
specification limits. The ``test results'' to be recorded in the test
report are those specified in the applicable standard, specification,
or test method cited by the manufacturer and/or used by the laboratory.
Hence, no change to the regulation was made based upon these comments.
Three comments from manufacturers questioned the provisions of
original Sec. 280.6(a)(12) (now Sec. 280.6(a)(6)(iii)) pertaining to
reporting on all deviations from the test method, asking whether
deviations from the test method would result in flawed testing/
erroneous test results. Two commenters, a manufacturer and an importer,
suggested that original Sec. 280.6(a)(14) (now Sec. 280.6(a)(6)(iv))
should be revised by deleting ``all other items required by the test
method'' as ambiguous or expanding the section to define that which is
required. No changes have been made to the regulation based upon this
comment. One manufacturer commented that the wording of original
Sec. 280.6(a)(15) (now Sec. 280.6(a)(6)(vi)) appears to suggest
nonconforming products can be sold.
Two manufacturers recommended that old Sec. 280.6(a)(17) (now
Sec. 280.6(a)(8)) be deleted, thus removing the requirement that the
test report relate only to the item(s) tested, and two manufacturers
suggested deleting the requirement found in Sec. 280.6(a)(18) (now
Sec. 280.6(a)(10)) for reporting the name of the body which accredited
the laboratory for the specific tests performed which are the subject
of the report and the current period of accreditation. NIST has
determined that this information is essential to the report, and the
requirements of these two sections have not been removed.
One user commented that current Sec. 280.6(c) should be revised to
require numbering for supplemental reports amending previously issued
reports. No change has been made to the regulation based upon this
comment because the regulation already provides that supplementary
information must be reported on a ``suitably marked'' document.
[[Page 50548]]
Section 280.7: Recordkeeping Requirements
The Department received comments on a variety of issues raised by
Sec. 280.7 of the regulations. A paragraph is devoted below to each of
these issues.
NIST received four comments, two from manufacturers and two from
trade associations, stating that test reports should only be available
to the original purchaser. An amendment to section 10 of the Act
provides for this.
NIST received ten comments suggesting that Sec. 280.7(a) be revised
to permit electronic record storage, five from manufacturers, three
from trade associations, one from a university professor and one from a
consultant. This final rule provides that records may be kept in the
form (whether paper, photographic, electronic or some other form) in
which they are created or received by the regulated person. In
addition, Sec. 280.7 of this final rule permits reproductions
(including paper, photographic, magnetic, or some other form) to be
kept in lieu of originals for all records except for test reports (for
which the Act requires originals). However, it establishes specific
requirements of retrievability and legibility that must be met if the
person required to keep records elects to destroy originals and keep
reproductions in lieu thereof. It also makes clear that the regulated
person must make the records available to NIST or BXA upon request.
A testing laboratory and a government agency noted that the law has
no provisions for the protection of records should a manufacturer or
test laboratory file bankruptcy, be dissolved, or be destroyed by fire
and/or by an act of God. The commenters recommended that this problem
be addressed, and that it be documented as either a waiver to the law
or a requirement to the law as how to protect records for ten years in
the event of a misfortune to the manufacturer and/or test facility. In
response, NIST notes that the Act contains no provision for waiving the
record retention requirement under any circumstance and that 1996
amendments to the Act reduced the record retention requirement to five
years.
Three commenters, two manufacturers and a trade association,
suggested that the wording in Sec. 280.7(a) requiring that the records
be sufficiently detailed to permit duplication of the ``exact test
conditions'' at a later date be relaxed, perhaps to simply require
sufficient information to ``allow the test results to be verified by a
retest if necessary.'' Section 280.7 of this final rule adopts this
change.
Section 280.8: Ownership of Laboratories by Manufacturers
NIST received three comments concerning Sec. 280.8 of the
regulations, one from a user, one from a trade association, and one
from the category ``other.'' One commenter suggested that NIST ban all
ownership of testing laboratories by manufacturers; another commenter
urged that NIST impose no ban on the ownership of testing laboratories
by manufacturers; and the third stated that it was unclear what
conditions might be imposed on accredited laboratories affiliated with
a manufacturer.
Section 280.8 of the regulations repeats the provisions of section
5(b) of the Act, essentially verbatim. As written, Sec. 280.8 creates a
procedural mechanism under which decisions may be made by the Director
of NIST as to whether the public health and safety would be increased
by a ban on the ownership of testing laboratories by manufacturers for
specific types of fasteners and tests. Specifically, any ban would be
the subject of a notice and comment process before taking effect. NIST
believes that its discretion in proposing a particular ban intended to
protect the public health and safety should not be limited in advance
by regulation. Accordingly, no change has been made to this section of
the regulations.
Section 280.9: Subcontracting of Testing
Several commenters appeared to be confused as to whether tests
carried out by subcontractor laboratories under the provisions of
Sec. 280.9 of the regulations would meet the requirements of the Act.
Some expressed confusion as to what entities qualified as
subcontractors. One manufacturer, for example, suggested that suppliers
and manufacturers be permitted to be subcontractors. Two other
manufacturers expressed similar confusion. One distributor suggested
revising Sec. 280.9(b)(2) to eliminate confusion by adding the word
``accredited'' to references to the subcontractor.
NIST believes the regulation is clear as written and no changes are
made to it based upon these comments. However, in order to avoid any
possibility of further confusion, NIST wishes to stress that any and
all subcontracting of testing under the Fastener Quality Act must be to
a laboratory that is accredited under the Act and these regulations.
Any party that meets the conditions set out in this regulation may
apply for such accreditation, regardless of their affiliation with a
manufacturer, distributor or other entity.
In addition to the comments described above, NIST received six
comments, three from trade associations, two from manufacturers and one
from a distributor, urging that the regulations be revised to delete
the requirement found in Sec. 280.9(b)(2) for notification of the
client before the fact that the tests will be subcontracted by the
accredited laboratory to another laboratory. NIST does not agree with
these comments, and takes the view that notification of the client
before the fact is important to allow them to decide if they wish for
all testing to be done in-house.
Section 280.10: Sampling
NIST received six comments, from four manufacturers and two trade
associations, suggesting that the emphasis of the regulations on final
inspection is misplaced and that the industry practice is statistical
process control. These commenters suggested the use of statistical
process control rather than lot sampling in the regulation. They
further suggested that the regulation be revised to include the use of
ANSI/ASME B18.18.3M, and ANSI/ASME B18.18.4M, in addition to ANSI/ASME
B18.18.2M already referenced in Sec. 280.10, for purposes of sample
selection when the standard being used by the fastener manufacturer
does not include a sampling plan. In addition to the above comments,
submitted in response to the August 1992 comment period on the proposed
regulations, the automobile industry submitted comments in August 1996
on the same issue of statistical process control. As part of their
comments, the automobile industry projected costs of between $140
million and $209 million annually if its suppliers of automotive
fasteners are required by the Act and regulations to conduct final
inspection of finished fasteners. The costs projected by the industry
were apparently predicated on two assumptions: (1) That the Act and
regulations require final inspection of finished fasteners in lieu of
in-process inspection and controls; and (2) that the Act and
regulations require the use of ASME B.18 quality assurance standards
for inspection and testing of fasteners in lieu of QS9000 quality
assurance standards, which are currently in-use within the automobile
industry. NIST has concluded that neither of these assumptions are
valid for the following reasons. First, there is nothing in the Act or
implementing regulations that prohibits the in-process inspection and
[[Page 50549]]
testing of a given lot of fasteners based upon quality assurance
programs such as QS9000, so long as the requirements of sections 5 (a),
(b), and (c) of the Act are met. That is: (1) The tests called out by
the applicable fastener standards and specifications have been carried
out; (2) the tests have been carried out by a laboratory accredited in
accordance with section 6 of the Act; and (3) the data are reported on
a test report in accordance with Sec. 280.6 of the implementing
regulations. NIST recognizes that some product standards from the
Society of Automotive Engineers (SAE) and from the American Society of
Testing and Materials (ASTM) used in the automotive industry require
final inspection of fasteners, and that under statistical control
procedures, fastener manufacturers may control influence factors (e.g.,
temperature, pressure, etc. in heating treating operations) as a means
of assuring that a particular physical property such as hardness is
within the stated values of the standard rather than conduct final
inspection. Under these circumstances, supporting data for a test that
may be required by the SAE or ASTM standard, indicating that the
fastener lot had been tested for hardness and providing the test
results would not be available. Hence, the manufacturer may not be able
to meet the requirements of sections 5 (a), (b), and (c) of the Act
because there would be no specific evidence that a hardness test had
been conducted if it is required by the standard. Under the Act this
problem can be easily resolved by having the automobile industry
request that SAE or ASTM change the affected fastener standards so that
the manufacturer has the choice in satisfying the standard, and thus
the Act and regulations, by either providing data that the influence
factors affecting hardness are in control for that lot of fasteners, or
providing data that a discreet hardness test has been conducted. The
Act, in relying on standards and specifications from consensus
standards organizations and from government agencies as the basis for
technical requirements to be met by manufacturers, provides significant
flexibility to these standards developers to determine the inspection
and testing requirements for certification of fasteners under the Act
and regulations. Second, as to the automobile industry's assumption
that the Act requires the use of ASME B18 quality assurance standards,
the Act does not mandate the use of any standard or specification.
Under authority provided by section 5(b)(2)(B) of the Act, and at the
request of the Fastener Advisory Committee, NIST has included
references to ANSI/ASME B18.18.2M, B18.18.3M and B18.18.4M, for sample
selection in the event the standard or specification used by the
manufacturer does not provide for the size, selection, or integrity of
the sample to be selected. NIST does not have the authority to mandate
the use of the ANSI/ASME B18.18.2M, 3M, or 4M standards for all
inspection and testing carried out under section 5 of the Act.
Old Section 280.11: Surplus Fasteners
This section was deleted.
New Section 280.11: Significant Alteration of Fasteners
With respect to questions concerning marking and testing of
significantly altered fasteners, the significant alteror will be
responsible for applying a registered insignia to the altered fastener
if so required by the original standards and specifications, and for
assigning a new lot number. A new Sec. 280.11 has been added to the
regulations to spell out these requirements. The significant alteror
will also be responsible for causing the altered fasteners to be
inspected and tested as required under section 5 of the Act, unless the
fastener is delivered to a purchaser accompanied by a written statement
noting the original lot number and the new lot number assigned by the
alteror, disclosing the subsequent alteration, and warning that such
alteration may affect the dimensional or physical characteristics of
the fastener.
If the alteration is not a significant alteration, a new headmark
and new lot number are not required and the only testing requirements
which apply are those required by the specification to which the minor
alteration was performed, such as prevailing torque or salt spray. If
the significant alteration is only electroplating of fasteners above a
certain hardness level or strength level, the requirement for a new
headmark is waived, but a new lot number must be assigned and testing
for hydrogen embrittlement must be performed in addition to those tests
required by the plating specification. If the alteration involves
cutting of threaded studs, rods, or bars into studs, these cut
fasteners must be marked with the grade or property class
identification marking appearing on the original threaded studs, rods,
and bars.
New Section 280.12: Applicability
Seven commenters expressed concern during the 1992 comment process
that the requirement for the use of accredited laboratories not take
effect until a sufficient number of foreign accreditation bodies and
laboratories have been recognized and accredited. The commenters also
expressed concern as to how NIST would know when the number of
accredited laboratories is sufficient. These comments were received
from two trade associations, two importers, one distributor, one
representative of a foreign government, and one individual.
Except as provided in this section, the regulation will become
effective on November 25, 1996. However, NIST notes that section 15 of
the Act makes the regulation applicable only to fasteners manufactured
180 days after the regulation becomes effective, i.e., May 27, 1997 and
also provides that the Director of NIST may delay the applicability of
the regulations to fasteners manufactured beyond that date if at that
time an insufficient number of laboratories have been accredited to
perform the volume of inspection and testing required. A new
Sec. 280.12 of the regulations has been added in order to clarify this
point.
NIST intends to closely monitor the accreditation of laboratories
under these regulations, and will defer the applicability of the
regulations should circumstances warrant.
Status of Inventory
One commenter during the 1992 comment process asked whether
existing inventories of fasteners will be covered when the regulations
take effect.
NIST notes that section 15 of the Act requires only that the
regulations be applicable to fasteners manufactured 180 days or more
after the regulations become effective (herein after referred to as
implementation date). This issue of applicability of fasteners has been
discussed several times since the 1992 comment process. In its January
10, 1995, report and recommendations for amending the Act, the Public
Law Task Force recommended that fasteners manufactured before the
implementation date not be allowed to be certified as conforming
fasteners under the Act. This recommendation was endorsed by the
Fastener Advisory Committee in letters to Congress dated February 9,
1995. During the joint meeting of the Fastener Advisory Committee and
the Public Law Task Force, held May 15-16, 1996, at the National
Institute of Standards and Technology (NIST), this issue was raised
again. In addition, the Advisory Committee and the Task Force
recommended that language be added to the regulations which would
permit the use of metal manufactured before the implementation date to
be used to manufacture fasteners after that date.
[[Page 50550]]
In order to clarify these points, a new Sec. 280.12 has been added
to the regulations, stating that the requirements of the Fastener
Quality Act and these regulations shall be applicable only to fasteners
fabricated 180 days or more after the effective date of the
regulations. This Act and these regulations do not restrict the sale of
fasteners manufactured prior to the implementation date. Fasteners
manufactured prior to the implementation date may be sold in U.S.
commerce for an indefinite period of time, provided such fasteners are
not offered for sale or sold as being in conformance with the Act and
these regulations. The section also specifies that metal manufactured
prior to the implementation date may not be used to manufacture
fasteners covered by the Act and these regulations after such date,
unless the metal has been tested for chemistry pursuant to Sec. 280.15
of these regulations by a laboratory accredited under the Act and these
regulations.
The Director of NIST may delay the applicability of the regulations
beyond the 180-day time period upon making a determination that an
insufficient number of laboratories have been accredited to perform the
volume of inspection and testing required.
New Section 280.13: Imports of Fasteners and New Section 280.14: Option
for Importers and Private Label Distributors
One commenter questioned whether the draft regulation was
consistent with the Act's treatment of importers. After reviewing the
regulations, NIST has decided to add a new Sec. 280.13 of the
regulations dealing with imports of fasteners, and also a new
Sec. 280.14 dealing with options for importers and private label
distributors. New Sec. 280.13 sets out the rule contained in section
7(b) of the Act that it shall be unlawful for any person to sell to an
importer, and for any importer to purchase any shipment of fasteners or
fastener sets manufactured outside the United States unless such
shipment to an importer is accompanied by a manufacturer's certificate,
an original laboratory testing report with respect to each lot from
which the fasteners are taken, and any other relevant lot
identification information. It then sets out the statutory exceptions
to the general rule, which require that delivery of fasteners to any
importer must be accompanied by an original laboratory testing report
shall not apply:
(1) In the case of fasteners imported into the United States as
products manufactured within a nation which is party to a
congressionally approved free trade agreement with the United States
that is in effect, provided that the Director has published in the
Federal Register a certification that satisfactory arrangements have
been reached by which purchasers within the United States can
readily gain access to an original laboratory test report for such
fasteners. Or,
(2) In the case of fasteners imported into the United States as
Canadian-origin products under the United States-Canada Automobile
Pact for use as original equipment in the manufacture of motor
vehicles.
At the present time, no Federal Register notice is planned by NIST
under exemption (1); accordingly, this exemption is not now available.
New Sec. 280.14 sets out the statutory provisions of section 7(c)
of the Act. Entitled ``Option for Importers and Private Label
Distributors,'' Sec. 280.14 states that notwithstanding the provisions
of Sec. 280.13, delivery of a lot, or portion of a lot, of fasteners
may be made by a manufacturer to an importer or private label
distributor without the required original copy of the laboratory
testing report if the manufacturer provides to the importer or private
label distributor a manufacturer's certificate certifying that the
fasteners have been manufactured according to the requirements of the
applicable standards and specifications; and the importer or private
label distributor assumes responsibility in writing for the inspection
and testing of such lot or portion by an accredited laboratory. The
section also provides that the provisions of section 5(a) and sections
7(a) and 7(b) of the Act shall apply to the importer or private label
distributor in the same manner and extent as to a manufacturer.
New Section 280.15: Alternative Procedure for Chemical Characteristics
Pub. L. 104-113 enacted a new subsection 5(d) of the Fastener
Quality Act entitled ``Alternative Procedure for Chemical
Characteristics.'' The new procedure is implemented in Sec. 280.15 of
the regulations being published today.
New Section 280.16: Subsequent Purchaser
This section reflects changes made to section 7(f) of the Act by
Pub. L. 104-113.
Subpart B--Laboratory Accreditation
NIST received no specific comments on subpart B of the regulations.
Subpart C--NIST Fastener Laboratory Accreditation Procedures
To meet the requests of many commenters that the criteria for
accreditation follow ISO/IEC Guide 25 ``General Requirements for the
Competence of Calibration and Testing Laboratories,'' section 280.201
establishes that the criteria for accrediting laboratories under the
Act will be part 285, title 15, Code of Federal Regulations, which are
NVLAP procedures that conform with the requirements of ISO/IEC Guide
25. Furthermore, since ISO/IEC Guide 25 is the document used
internationally by accreditation bodies to assess the competence of
laboratories, the revised procedures should facilitate interpretation
of the NVLAP criteria at the international level.
Section 280.200--Introduction
One commenter, an agency of the United States Government, requested
that a requirement be added stating ``Standards with similar scopes,
but with different requirements shall not have the same: (a) Title, (b)
standard designation number, (c) product labeling system, or (d)
conformance requirements labeling system.'' The standards organizations
are responsible for controlling these concerns. The regulation has not
been changed. However, the Director of NIST will work with the
standards organizations to resolve any problems of this nature.
A representative for foreign manufacturers requested that
laboratories should be allowed to perform the same kind of test to
comply with standards from different countries. Since the Act provides
that the manufacturer of fasteners certify that the fasteners meet the
requirements of the standards and specifications, the regulation was
not changed.
A laboratory requested the addition of a ``Code of Ethics.'' Many
specific requirements and conditions are mandated for accredited
laboratories and no change was made to this section.
A laboratory accreditation body asked for a clarification as to
whether a laboratory's quality assurance program must assure a required
degree of accuracy and precision beyond that required by standard test
methods used. NVLAP procedures cited in Sec. 280.201 address
measurement traceability and calibration requirements.
A trade association requested a retest be required for foreign
sources at the receiving end. Since this is contrary to the Act's
treatment of foreign products this section was not changed. The trade
association also requested that the regulation ``should include
requirements and methods for notifying customers/users of lots with
latent defects discovered after delivery.'' Existing mechanisms for
notification of users of fasteners with latent defects are
[[Page 50551]]
not preempted by the requirements in this regulation. However,
procedures cited in Sec. 280.201 do require laboratories to notify
clients promptly, in writing, of any event, such as the identification
of defective measuring or test equipment, that casts doubt on the
validity of results.
New Section 280.203--Adding to or modifying the Program
A new Sec. 280.203 was added to reflect the Act's intent that the
program reflect the changing requirements placed upon laboratories by
the industry. This section allows the program to be added to, modified,
or realigned based on either a written request or a need identified by
NIST. Subsequent sections in this subpart have been renumbered
accordingly.
Old Section 280.203 New Section 280.204--NVLAP Program Handbook
A domestic manufacturer, a distributor and a consultant requested
that the handbook follow ISO/IEC Guide 25-1990. This did not require a
change to the regulation, however, the draft handbook is compatible
with the ISO/IEC Guide 25 and contains a general operations checklist
which follows the ISO/IEC Guide 25 technical requirements. The NVLAP
Handbook will supplement this Subpart.
A consultant, an accreditation body, a foreign manufacturer and two
foreign aerospace associations requested distribution of the NVLAP
handbook. This did not require a change to the regulation. However, in
preparation for the February 1993 workshop, over 600 copies of the
draft NVLAP handbook were distributed for public comment.
A foreign manufacturer commented that there were too many test
methods with not enough details, and no instructions for testing core
hardness of \1/4\'' diameter bolts. Since the standards and
specifications determine how fasteners are to be tested, no change in
the regulation was made to address this comment. The commenter should
contact relevant standards organizations with specific concerns.
Old Section 280.204 New Section 280.205--Applying for Accreditation
Additional requirements were added to this section for foreign
laboratories. These requirements were necessary to enable NVLAP to
assess properly foreign laboratories and establish fees to maintain
self-sufficiency. The following language was added. Foreign
laboratories may require:
(1) Translation of laboratory documentation into English; and
(2) Payment of additional traveling expenses for on-site
assessments and proficiency testing.
Old Section 208.206 New Section 280.207--Granting and Renewing
Accreditation
On-site Assessment Interval
A fastener manufacturer and a college professor commented that the
on-site assessment interval was not specified. No change to the
regulation was made. This information is provided in the NVLAP
handbook.
Accreditation by Discipline Rather than by Test Method
Two laboratories suggested that accreditation be offered by
discipline rather than by test method. No change in the regulation was
made. The handbook explains the approach which NVLAP will use to group
together like test methods and accredit laboratories for the entire
group.
Accreditation Period
Six technical societies/trade associations, 7 fastener
manufacturers and 2 consultants requested that accreditation be changed
from 1 year to 3 years. Comments received from an agency of the United
States Government and 3 manufacturers requested a 2-year accreditation.
One automotive manufacturer requested the period be extended beyond one
year. The reference to a one-year accreditation period has been deleted
from this section. However, the NVLAP handbook will provide for a
three-year accreditation period. If experience proves positive, the 3-
year accreditation period will be maintained, otherwise, it will be
reduced to a shorter period. The on-site assessment will be conducted
on a 2-year cycle with additional monitoring visits at random or to
address specific problems called to NVLAP's attention.
Old Section 280.207 New Section 280.214--Conditions for Accreditation
A fastener manufacturer, an automobile manufacturer, and a
consultant requested the accreditation period be extended beyond one
year. The accreditation period will be the same as for all other NVLAP
accreditation programs.
A fastener manufacturer requested removal of the requirement that a
laboratory demonstrate, upon request by NVLAP, that it is able to
perform tests representative of those for which it is seeking
accreditation. This requirement has been maintained.
A laboratory requested a limitation to the cost of accreditation.
No change in the regulation was made. The Act specifies that sufficient
fees be collected to cover the cost of the accreditation process.
A fastener company requested that a laboratory must ``be capable of
performing all tests for which it is accredited according to the latest
version of the test method'' and delete an allowance of up to one year
after publication, or another time limit specified by NVLAP. No change
was made to the regulation.
A laboratory requested that accredited laboratories be permitted to
add tests without additional inspections and audits. No change in the
regulation was made. The handbook describes the process for changing a
laboratory's scope of accreditation. Specific circumstances will
dictate the need for an additional on-site visit.
A fastener manufacturer requested removal of the requirement to
keep ``records of all actions taken in response to testing
complaints,'' because Sec. 280.6 requires 5-year retention of all
records. No change was made to this requirement.
Old Section 280.208 New Section 280.215--Criteria for Accreditation
Eight commenters (an agency of the United States Government, an
automobile manufacturer, a distributor, a consultant, 2 fastener
manufacturers, a laboratory accreditation body and a law firm
representing foreign manufacturers) requested that the criteria for
accreditation follow ISO/IEC Guide 25 ``General Requirements for the
Competence of Calibration and Testing Laboratories.'' NVLAP procedures
cited in Sec. 280.201 are in full accordance with ISO/IEC Guide 25.
A law firm representing foreign companies suggested this section
conform to ISO/IEC Guides 54 and 55. These ISO/IEC documents pertain to
accreditation bodies, not laboratories. Since this section provides
criteria for laboratories and not accreditation bodies, no changes were
made to the regulation.
Several comments dealt with the requirements for a laboratory
quality manual. A fastener manufacturer suggested that old
Sec. 280.208(a)(1)(now Sec. 280.215(c)(1)) be changed to ``the Quality
Manual in conjunction with other approved procedures must include as
appropriate.'' This suggestion is taken care of in the existing NVLAP
procedures.
A laboratory accreditation body requested deletion in old
Sec. 280.208(a) (now Sec. 280.215(c)) of the requirements that the
quality manual contain provisions for meeting NVLAP
[[Page 50552]]
conditions for accreditation, provisions of the Fastener Quality Act,
and quality assurance practices for test methods. This suggestion is
taken care of in the existing NVLAP procedures.
A laboratory accreditation organization requested that old
Sec. 280.208(d)'s requirement (now Sec. 280.215(h)) for a calibration
manual be replaced with section 9 of ISO/IEC Guide 25 and 280.208(e)'s
requirement for a test plan be replaced with section 10 of ISO/IEC
Guide 25. This suggestion is taken care of in the existing NVLAP
procedures.
A trade association requested that old Sec. 280.208(b)(6)(i)'s
statement (now Sec. 280.215(b)(2)(ii)) that staff members are not to be
subjected to undue pressure be deleted. The existing NVLAP procedures
which follow ISO/IEC Guide 25 contain this requirement. ISO/IEC Guide
25 also provides that the laboratory shall have policies to ensure that
its personnel are free from any commercial, financial and other
pressures which might adversely affect the quality and integrity of
their work.
A commenter from an agency of the United States Government
requested that old Sec. 280.208(c) (now Sec. 280.215(f)) on facilities
and equipment be modified to add a statement that: ``Equipment shall be
of contemporary design and capability. The equipment shall be modern
enough to require the minimum amount of operator interpretation or
skill in determining the difference between a pass and fail condition
of the product being tested.'' Existing NVLAP procedures require that
the laboratory shall be furnished with all items of equipment
(including reference materials) required for the correct performance of
tests.
A college professor requested that old Sec. 280.208(c) (3)(vi)'s
requirements (now Sec. 280.215(f)(4)) for equipment records report
variation between working and traceable instruments, and also report
differences due to adjustments of working instrument. Existing NVLAP
procedures require that equipment records be maintained to include
dates and results of calibrations and/or verifications.
A fastener manufacturer requested that old Sec. 280.208(d)(2) (now
Sec. 280.215(h)) be changed to ``have a Calibration Manual, or
equivalent.'' Existing NVLAP procedures require that the quality manual
and related documentation shall contain reference to procedures for
calibration, verification and maintenance of equipment.
A fastener manufacturer requested deletion of provision in old
Sec. 280.208(e) (1) and (2) (now Sec. 280.215(h)) to allow departure
from test methods and procedures when necessary for technical reasons.
This change has not been accepted.
A consultant requested removal of the requirement to retain all
original observations, calculations and derived data. Stating that it
``is an unnecessary burden and serves no useful purpose. The final test
report should stand on its own. If a laboratory has demonstrated
proficiency in its various test procedures, there is no need for the
above requirement.'' Existing NVLAP procedures follow the ISO/IEC Guide
25 requirements on records which requires retention of original data.
A trade association requested old Sec. 280.208(f)(2)'s reference
(now Sec. 280.215(j)) to a ten-year record retention requirement for
all records pertaining to tests, inspections and certifications be
deleted, since it is already specified. This is covered in existing
NVLAP procedures.
A consultant requested that old Sec. 280.208(g)(3) (now
Sec. 280.215(j)) pertaining to retention of supplemental information
collected by a laboratory be deleted. This language has been removed
from the regulation.
Old Section 280.209 New Section 280.208--Denying, Suspending and
Revoking Accreditation
A trade association requested that a specific provision be added to
permit users to notify NVLAP of complaints, failures, etc. Users can
report problems with a laboratory directly to NVLAP.
NVLAP will follow-up with the laboratory to resolve such
complaints.
Section 280.212--Approved Signatory
Two fastener manufacturers and a trade association requested that
authorized reproductions of the original signature of an Approved
Signatory be permitted. The NVLAP handbook will provide guidance in use
of an ``authorized'' signature of an Approved Signatory.
Subpart D--NIST Approval of Private Accreditation Programs
NIST received nine comments stating that the proposed approval
period for accreditation bodies of one year was too short, with
suggested periods ranging from between two to six years or indefinite.
The commenters included four manufacturers, one distributor, one
testing laboratory, and two trade associations, and one individual.
NIST agrees with this recommendation and the Program Handbook on
Private Accreditation Programs now reflects this change. Accordingly,
approvals will now be indefinite and old Sec. 280.305 has been deleted
since renewals are no longer required. Subsequent sections in this
subpart have been renumbered accordingly.
NIST received a comment from a laboratory accreditation body that
the requirement contained in Sec. 280.301(c)(17) was not in accordance
with language contained in ISO/IEC Guide 58 with respect to assuring
that accreditation bodies have formal rules and structures that will
assure that senior executives, staff, and committees are free from any
financial and other pressures which might influence the results of the
accreditation process. NIST has changed the language to be in
accordance with applicable provisions of ISO/IEC Guide 58. The new
language is contained in Secs. 280.501(b)(1)(I) and (J).
In addition, one government agency suggested that other Federal
government agencies should be authorized to accredit laboratories for
the purposes of the act. NIST notes that the Act does not provide for
that authorization.
Subpart E--Recognition of Accreditation Programs
NIST received thirteen comments on the procedures for the
recognition of foreign accreditation bodies for testing under the
Fastener Quality Act. The commenters consisted of five manufacturers,
one user, three trade associations, two testing laboratories, one
importer and one government agency. The common thread throughout the
comments was the concern that foreign entities recognized by NIST
should be held to the same standards demanded of U.S. laboratories and
accreditors, and should not be subsidized by fees paid by domestic
organizations. The suggestion was also made that international
recognition agreements should be published in the Federal Register for
public comment.
In response to these comments, revisions have been made to subpart
E to make clear that the principle of national treatment will apply;
that is, all parties, regardless of country of origin will satisfy the
same requirements and pay equivalent fees. NIST has, however,
determined that publication of proposed international recognition
agreements for comment is neither required by law nor appropriate.
Subpart F--Requirements for Fastener Laboratory Accreditation Bodies
NIST received seven comments, one from a manufacturer, two from
testing laboratories, one from a government agency, one from a foreign
government, one from a trade association and one from an individual,
stating that the
[[Page 50553]]
procedures and criteria contained in this subpart should be based on
the most currently available international guides. In part, the
regulations are based on ISO/IEC guides 54 and 55 which have been
superseded by ISO/IEC Guide 58. In response to these comments, subpart
F has been rewritten and is now based upon ISO/IEC Guide 25 and 58.
Subpart G--Enforcement
This final rule consolidates the provisions of the proposed rule,
subparts G, H and I, into a subpart G. As in the proposed rule, this
final rule defines the conduct that constitutes violations of the Act
and the regulations. However, instead of enumerating an exclusive list
of acts prohibited by the Act and the regulations (as in subpart G of
the proposed rule), this final rule provides that any conduct
prohibited by the Act and regulations would be a violation of the Act
and the regulations. Subpart G of this final rule also sets forth
certain specific and general actions by persons subject to the Act and
the regulations that can give rise to a charge that a violation has
been committed.
As in the proposed rule, this final rule provides an administrative
process by which a person charged with violating the Act and the
regulations is given notice and opportunity for a hearing before a
civil penalty may be imposed. This final rule provides that the Office
of Export Enforcement will initiate administrative enforcement
proceedings and the Office of Chief Counsel for Export Administration
will represent the Department in such proceedings before an
administrative law judge.
In response to the publication of the proposed rule, one commenter
pointed out possible inconsistencies between the Act and the list of
prohibited acts set out in Sec. 280.602 of the proposed rule.
This commenter stated that language in Sec. 280.602(a), (b), (c),
(g), (i) & (m) of the proposed rule would prohibit conduct beyond that
intended by the Act. Language in those paragraphs would have prohibited
the ``introduction (into commerce), delivery for introduction (into
commerce), transportation or causing to be transported in commerce for
the purpose of sale or delivery'' of fasteners that did not meet the
requirements of Sections 5 or 7 of the Act. The commenter pointed out
that, by such language, the regulations could apply to fasteners that a
manufacturer of an end product produced in-house and shipped to a
contractor for fabrication into a subassembly which the contractor then
returned to the manufacturer for incorporation into a finished end
product.
We agree that the Act was not intended to cover such transactions.
Subpart A of the final rule is consistent with sections 5 and 7 of the
Act by making it a violation to do anything prohibited by the Act and
this final rule. (See Sec. 280.602 of the final rule.) However, this
does not mean, that, in all instances, the ``delivery * * *
transportation or causing to be transported in commerce for the purpose
of sale or delivery'' would be permissible. If any of these actions
caused, aided, abetted a violation of the Act or regulations, or
constituted solicitation, attempt or conspiracy to violate the Act or
regulations, such conduct would be prohibited. (See Sec. 280.602(b),
(c) and (d) of the final rule.)
The same commenter pointed out that the language of Sec. 280.602(i)
of the proposed rule omitted a condition required by section 7(b) of
the Act. Section 280.602(i) of the proposed rule excepted imports from
countries with which the United States has a free trade agreement from
the requirement that imports be accompanied by a laboratory test
report. However, Sec. 280.602(i) of the proposed rule failed to include
the following condition contained in section 7(b) of the Act, namely:
(That) the Secretary certif[y] that satisfactory arrangements
have been reached by which purchasers within the United States can
readily gain access to an original laboratory test report * * *.
Section 280.13 of the final rule has corrected this omission by
including the following requirement in paragraph (b)(1):
(That) the Director has published in the Federal Register a
certification that satisfactory arrangements have been reached by
which purchasers within the United States can readily gain access to
an original laboratory test report for such fasteners.
Moreover, Sec. 280.602 of the final rule prohibits conduct that
refrains from doing anything required by the Act and regulations.
Therefore, a failure to provide the proper certificate of conformance
to accompany imports, as required by section 7(b) of the Act and
Sec. 280.13 and 280.602 of the regulations, would be a violation of the
Act and regulations.
The same commenter noted that the proposed rule provided specific
time-periods within which responses to discovery requests must be made.
That commenter recommended adopting the time-periods established in the
Federal Rules of Civil Procedure, rather than the shorter time-periods
set forth in the proposed rule.
This final rule generally does not establish time periods for
responses to discovery requests; rather, this final rule encourages the
parties to engage in voluntary discovery and provides discretion to the
administrative law judge in setting a time-period for responses to
discovery, if formal discovery is requested. This final rule does
require that the service of discovery requests be made at least 20 days
prior to the scheduled date of the hearing, unless the administrative
law judge specifies a shorter time period. This final rule also
provides a minimum of 10 days for responses to requests for admissions
of fact or law, although the administrative law judge may provide
additional time for such responses. The Department believes that the
flexibility for dealing with discovery provided by the final rule is
preferable to the rigid response dates set forth in the Federal Rules
of Civil Procedure.
Old Subpart H--Civil Penalties
This subpart has been revised and consolidated into the new subpart
G. NIST received no specific comments on subpart H of the regulations.
Old Subpart I--Hearing and Appeals Procedures
This subpart has been revised and consolidated into the new subpart
G. NIST received no specific comments on subpart I of the regulations.
Old Subpart J--Recordal of Insignia
Subpart J has been redesignated as subpart H.
New Subpart H--Recordal of Insignia
Two manufacturers suggested that any type of permanent marking,
rather than just a raised or depressed insignia, as required by
Sec. 280.900, be permitted for applying the recorded insignia on the
fastener. Section 8 of the Act applies only to fasteners which by their
standards and specifications must bear the manufacturer's or private
label distributor's mark as a raised or depressed insignia. In those
cases, the Act itself requires use of a raised or depressed insignia.
Six comments were received on Sec. 280.700(b) of the proposed
regulation. Two of these comments were from large end users of
fasteners, one was from a manufacturer's association, one was from a
government agency, and two were from manufacturers. These comments
suggested that there is a conflict between Secs. 280.700(a) and
280.700(b). Subsection 280.700(a) states that ``any fastener which is
required by
[[Page 50554]]
the standards and specifications which it is manufactured to bear a
raised or depressed insignia'' must bear a raised or depressed insignia
identifying its manufacturer. Subsection 280.700(b) states that ``The
manufacturer's, or private label distributor's, insignia must be
applied to * * * any fastener which is sold or offered for sale.'' Thus
the language in Sec. 280.700(b) encompasses a broader class of
fasteners. In response to this comment, the language in
Sec. 280.700(a), which tracks the statutory language, was added to
Sec. 280.700(b).
One professional organization suggested that Sec. 280.700(c) be
amended to state that all insignia required by the Act be readable
without magnification. In response, inasmuch as the Act covers
fasteners which are \1/4\ inch in diameter, the PTO felt it was
necessary to permit markings small enough to require magnification.
One fastener organization, one manufacturer and one distributor
suggested that the time periods for filing the maintenance document for
the certificate of recordal set out in Sec. 280.720(a) be harmonized
with the period for filing the renewal of the registration. In the view
of the Patent and Trademark Office (PTO), a regulation which ensures
that the renewal of the certificate of recordal and the trademark
registration occur at the same time would be unduly complex. PTO would
need to set out three renewal periods for fastener recordals, one for
renewals of recordals based on trademark applications, one for renewals
based on trademark registrations, and one for alphanumeric
designations. In addition, the PTO would need to update its recordals
to show the registration date of applications which mature into
registrations. Accordingly, no change has been made to the regulation
based upon these comments.
The members of the Fastener Advisory Committee suggested that
Sec. 280.723(d) be amended to permit the assignment of alphanumeric
designations. In response, the section was rewritten to permit the
assignment of alphanumeric designations upon notification to the
Commissioner and re-application for the alphanumeric designation. The
inability to assign alphanumeric designation would have created serious
problems with unusable inventory if an ongoing business was purchased.
The requirement that the Commissioner be notified of the assignment of
the alphanumeric designation, and that a new application be filed in
the name of the entity which purchases rights in the alphanumeric
designation, will ensure that the traceability requirement of section 8
of the Act is met.
Two manufacturers and one professional organization suggested that
the PTO recognize the fastener markings in MIL Handbook 57, NATO or
CAGE codes, or the fastener markings listed with ASME, DISC or IFI. In
response, PTO notes that the suggested listings contain identical marks
used by different manufacturers. Therefore these listings do not meet
the traceability requirements of section 8(b) of the Act.
One government agency suggested that recordal of fastener insignia
be permitted only to manufacturers not to private label distributors.
Since the Act requires recordal of insignia both for manufacturers and
private label distributors, no change to the regulation was made based
upon this comment.
One manufacturer suggested that the regulations be amended to
permit sale of nonconforming fasteners, manufactured before the Act
becomes effective, for a period of 5-10 years, to reduce the burden of
imprinting a raised or depressed insignia on the fastener. Section 15
of the Act makes the provisions of the Act applicable only to fasteners
manufactured 180 days after final regulations are issued.
One government agency suggested that the PTO add language to its
regulations to clarify that a manufacturer may have an unlimited number
of insignia recorded with the PTO. Another government department
suggested that the regulations be amended to limit the number of
insignia any private label distributor be allowed to have. The
regulations, as presently written, do not limit the number of recorded
insignia or alphanumeric designations a manufacturer or private label
distributor may have. The PTO felt that each business should make its
own determination as to how many recorded insignias it needed. The PTO
did not feel it had sufficient expertise to determine a limit on the
number of recorded insignias each business should be permitted.
One writer suggested that, when a transfer or assignment includes
the liabilities from previously manufactured products, the regulations
permit the assignee to use the unaltered insignia of the assignor. In
response, PTO notes that the regulations as presently written would
permit the assignee to use the mark of the previous manufacturer or
private label distributor, although the assignee would need a new
certificate of recordal.
Comments on the Regulatory Impact Analysis
NIST received comments on a wide array of issues concerning the
draft Regulatory Impact Analysis (RIA) prepared in 1992, including
comments on the percentage of fasteners that might be covered by the
law, observations on the costs of laboratory testing, recordkeeping
costs, nonconforming product costs, distributor costs, and so on. Each
of these topics is treated in a separate section below. Additionally,
NIST has prepared a final Regulatory Impact Analysis/Regulatory
Flexibility Analysis that takes into account the 1996 amendments to the
Act. Comments received as a result of the 1992 public comment process
on the draft implementing regulations and as a result of subsequent
Fastener Advisory Committee meetings have been taken into account in
the preparation of the final Regulatory Impact Analysis.
Percentage of Fasteners Covered by the Law
All comments received on the percentage of fasteners covered by the
law indicated that coverage would exceed the congressional estimate of
1 percent. One United States Senator, six distributors, three
manufacturers, and two trade associations provided estimates ranging
from 15 to 60 percent coverage with aerospace fastener industry
estimates at the upper end of the range. Results from the Fastener
Industry Coalition (FIC) Survey of distributors estimated the range of
coverage from 5 percent to 100 percent, with an average of 54 percent.
Laboratory Accreditation/Testing Costs
Several commenters suggested that some costs of testing have been
omitted from the analysis. Four manufacturers noted that the economic
impact analysis did not include the purchase cost or continued
calibration cost of spectrographs ($100,000 to $200,000 per unit) or
other equipment needed by many manufacturers who operate their own
laboratories. Two manufacturers indicated that the cost of not allowing
mill heat certifications had to be increased to include increased
inventory costs and delivery/pickup costs to the nearest accredited
lab. One distributor and one manufacturer noted that the cost of
providing original copies of certifications (estimated at $15 to $35
per certificate) should be included in the analysis. One distributor
noted that foreign manufacturers may find it impossible to provide full
certification for small lots of unusual items rushed into the U.S. by
air, forcing companies
[[Page 50555]]
to set up testing laboratories in the United States to certify items.
While two manufacturers agreed with the $35 per lot estimated
spectrochemical testing cost, three manufacturers, one distributor, and
one academician noted that the cost impact for spectrochemical analysis
reflected the cost of only one element. Industry practice is to provide
5 to 13 elements in a chemical analysis to more accurately reflect the
material composition. Cost may therefore be 5 to 13 times higher than
estimated. One distributor, while agreeing with the $35 estimate, noted
that with very large lots, several tests may be required. One
manufacturer estimated that testing costs (excluding spectrochemical
testing) would be ten times the NIST estimate. Section 5 of the Act has
been amended to permit fastener manufacturers to use mill heat
certifications of chemistry supplied by metal producers instead of
testing samples of finished fasteners for chemistry. Before the
amendment to section 5, NIST estimated that it would cost the fastener
industry $100.6 million annually in additional costs to conduct
chemical tests of finished fasteners assuming 25% fastener coverage
under the Act. The Fastener Advisory Committee, through its Cost
Effectiveness Task Group, estimated a maximum range of between $28
million to $1.9 billion in additional annual costs, with a more
probable range of between $100 million to $286 million. With the
amendment to section 5 of the Act, NIST projects that the increased
tests costs to industry under the Act will remain at the $6 million
level as indicated in the Summary of Adjusted Industry Costs provided
below.
One manufacturer estimated that the number of laboratories at the
lower bound of the RIA estimate was too low. An estimate of 298-300
manufacturers laboratories plus an additional 152-200 independent
laboratories for offshore production and to cover manufacturers without
laboratories would result in the need for a minimum of 450-500
accredited laboratories. One manufacturer noted that most modern
processing techniques, such as Just-in-Time, KanBan, etc., heavily
influence the lot size downward, and the number of lots may be
understated.
Production Delay Costs
Four distributors/manufacturers and one auto maker indicated that
because each lot must be tested and some tests are lengthy, ``just-in-
time'' production practices will have to be altered and very costly
lot-by-lot product storage will be required which would increase the
basic production cycle. Under a just-in-time inventory management
policy, assembly operations may have to shutdown pending completion of
testing. NIST has discussed this issue with the fastener industry. It
relates to certain types of testing such as salt spray tests where the
amount of time to conduct the test involves days or weeks. These types
of tests are generally not required by the standards and specifications
to be carried out on every lot of fasteners. Moreover, NIST feels that
prudent inventory control and efficient scheduling of tests by
manufacturers and distributors will alleviate shutdowns in assembly
operations.
Recordkeeping Costs
One manufacturer indicated that the recordkeeping requirements of
the proposed regulations may go beyond what laboratories presently
keep. If records of each inspection, calculations made in the
laboratory, etc., must be maintained in addition to the test
certificate there will be a major increase in costs. The Fastener
Advisory Committee has indicated to NIST that laboratories currently
involved in testing fasteners keep records that are very close to those
required by the regulations.
One manufacturer, one distributor, and one foreign trade
association noted that the time required for signing a test report
should include time for report review. Estimated time ranged from 2-20
minutes. Additional review time will be required if test reports are
reviewed more thoroughly after the regulation is implemented.
Training/Education Costs
Two distributors noted that increased training and supervision of
personnel will be required to insure compliance and that training/
information on the requirements of the Act would also have to be
provided to foreign suppliers. NIST has been working with the fastener
industry to organize a series of public workshops both in the U.S. and
abroad to provide training on the Act and regulations, once the
regulations are issued. Eight such workshops have been planned, and
most will coincide with already planned meetings and conferences within
the fastener industry so as to minimize costs. NIST does not feel that
the cost of training and education needed to assure compliance with the
Act and regulations will be significant.
Imported Assemblies Containing Fasteners
Two manufacturers and one manufacturer/distributor noted the Act
allows foreign competitors to produce fasteners without additional
costs imposed by the Act and put them into automotive and other
products which are then imported by U.S. based firms as final products
or subassemblies. This will put U.S. firms producing similar items at a
competitive disadvantage. NIST accepts the comments that imported
assemblies or final products containing fasteners might have a slight
competitive advantage over U.S. assemblies or final products containing
fasteners manufactured in compliance with the Act and regulations.
However, NIST feels that there are many other influence factors such as
cost of materials, labor, and currency fluctuations that could mitigate
any competitive advantage and that it is not realistic to claim that
the cost of fasteners alone will result in a competitive disadvantage
to U.S. firms.
Nonconforming Product Costs
Eleven manufacturers, four distributors, and one importer commented
on the major economic impact of not allowing minor nonconformances that
do not affect the form, fit or function of a fastener. While no cost
estimates were provided, comments indicated that total manufacturing
cost will be significantly affected and may result in shutdown of a
substantial number of firms. ``Just-in-time'' production practices and
worldwide parts sourcing will also be affected and could cause
temporary plant shutdowns.
The Fastener Advisory Committee at its meeting of December 2, 1992
requested its Subcommittee on Cost Effectiveness to prepare a ``white
paper'' projecting the probable economic consequence of implementing
final regulations without amending the Act per the Committee's
recommendations. The report focused on three issues: (1) Permitting the
sale of fasteners tested and found to contain minor nonconformances
from standards which do not affect form, fit, or function; (2)
permitting the acceptance of mill heat certificates from raw material
suppliers rather than post manufacturing testing of finished fasteners;
and (3) permitting the commingling of like fasteners by distributors. A
report was produced by the Subcommittee and adopted by the full
Committee at its meeting March 3-4, 1993. On the issue of nonconforming
product costs, the Report estimates that fastener lot rejection costs
will range
[[Page 50556]]
from $89 million to $285 million annually unless nonconformances now
recognized in existing standards prevail. The Report further noted that
such rejection costs will double when parts are plated because of the
wide swings in coating thickness present in the existing process.
Section 3 of the Act was amended to permit the sale of fasteners
with minor non-conformances following guidelines established in
applicable standards and specifications. The amendment resolves the
non-conforming fasteners issue and will eliminate the $285 million
worst case projected costs to industry, as estimated above.
Distributor Costs
One distributor noted that there can be no standard cost of impact
developed that would safely apply to each and every distributor.
Factors affecting impact include the size of the distributorship and
whether it's mostly a bulk operation, a prepackaged operation, a
repackaging operation or a combination of the above. Smaller
distributors would probably be harder hit because they tend to be more
combination operations with a lesser quantity but wider variety of
products and with much smaller unit sales, which includes broken kegs,
carton or package sales. Cost impact estimates provided by individual
distributors on their operations ranged from no or minimal additional
cost to increases of several hundred thousand dollars the first year.
The Fastener Industry Coalition (FIC) Cost Survey indicated wide
variations in costs likely to be incurred by specific companies. The
survey noted that 50 percent of respondents will require additional
warehouse space and that first year costs would range from $1,500 to
$500,000 and average=$50,966 with subsequent annual costs ranging from
$1,000 to $78,000 and averaging $16,604. The survey noted that 85
percent of respondents would require additional personnel. Estimated
cost ranged from $4,000 to $170,000 and averaged $36,444. Eighty-one
percent of respondents would require additional computer hardware/
software. Estimated first year cost ranged from $500 to $175,000 and
averaged $24,821. Seventy four percent would require additional
machinery, equipment, pallet racking, shelving, or supplies. Estimated
first year cost ranged from $500 to $150,000 and averaged $15,326. The
FIC Survey also noted other costs including: Labels for boxes; probable
loss of old uncertified stock or certification costs to recertify it;
maintenance and certification of quality control equipment and purchase
of additional equipment and quality control personnel; additional
recordkeeping and storage requiring cabinets and personnel; reduced
efficiency in receiving, shipping, materials handling, etc.; cost of
providing test reports to customers; increased inventory costs;
transportation cost to test lab; test costs; changing vendors because
some will drop out; cost of goods that must be scrapped; loss of stock
due to non-commingling; cost of test reports from vendor ($5-$100 per
lot); and additional attorney fees/insurance premiums.
Section 7(e) of the Act was amended to permit voluntary commingling
of fasteners by distributors only. NIST estimates that approximately
10% of distributors will continue to provide lot traceability at an
estimated annual cost to the industry of $6.5 million instead of the
projected $373.3 million annual cost if all distributors were required
to maintain lot traceability for 25% of their inventory. Note that the
$6.5 million does not necessarily represent new costs since some
distributors had been providing this service prior to the passage of
the Fastener Quality Act.
Reduced Competition
Six distributors, seven manufacturers and two laboratories noted
that compliance/accreditation costs and liability issues are likely to
drive firms out of the market thus reducing competition. NIST's
assessment of economic impact has shown no evidence of burdensome
compliance/accreditation, and liability issue-related costs.
Loss of Good Will
Five distributors and one manufacturer noted that one of the most
important costs will be loss of customer goodwill resulting from firms
not being able to accept customer returns and from customers having to
purchase more product than they actually need because breaking packages
will not be cost effective. This problem can be minimized using normal
industry practice of inventory control. The Act does not prevent the
current practice of return of unused, unbroken boxes of fasteners.
Lack of Enforcement
Three distributors, three manufacturers, and one trade association
indicated that those producing/distributing poor quality fasteners will
continue to do so to the extent that lack of enforcement makes that
risk attractive. Several noted that there were already laws in effect
to deal with the mismarked or counterfeit fasteners, but that they were
not being sufficiently enforced. The Bureau of Export Administration
(BXA) of the Commerce Department has 140 experienced field
investigators who will actively enforce this Act.
Miscellaneous Comments
One distributor noted that the regulatory impact is a non-issue
since costs of product failures are so large. Primarily, this Act
addresses the issue of improving the quality and traceability of
fasteners, thereby decreasing fastener-related failures.
One manufacturer stated that if commingling is allowed what is to
stop someone from mixing good certified product with bogus, uncertified
product in the same container? The Act specifically addresses who can
commingle fasteners and how to label commingled fasteners. See subpart
A, Sec. 280.4 of the regulations.
One distributor noted that if a manufacturer can create bogus
fasteners, creating bogus test reports will not be a problem either.
The Act imposes severe criminal penalties for creating either bogus
fasteners or bogus test reports. See Subpart G, Sec. 280.603 of the
regulations.
One manufacturer noted that expected potential benefit resulting
from decreased buyer inspection and testing cost is not anticipated in
the aerospace industry. The Act is not intended to change the current
practice of buyer inspection and testing in the aerospace industry.
Classification
Administrative Procedure Act
This final rule is the logical outgrowth of the proposed rule and
the public comment process. A majority of the public comment received
on the 1992 proposed rule suggested the need for particular amendments
to the FQA. The suggested amendments were enacted as part of Pub.L.
104-113. This rule contains regulations making final the 1992 proposed
rule, as well as regulations to implement expressly the FQA as amended
pursuant to specific public comment received regarding the 1992
proposed rule.
Executive Order 12866
This rule has been determined to be significant under section 3(f)
of Executive Order 12866. However, it has been determined that this
rule is not an economically significant rule within the meaning of
section 3(f)(1) of Executive Order 12866, or a major rule as defined by
section 804 of Pub.L. 104-121, based upon the adjusted costs to
industry of
[[Page 50557]]
complying with the Fastener Quality Act as amended by Pub.L. 104-113
(Technology Transfer and Advancement Act of 1995). The projected $18.9
million annual costs to industry summarized below are based upon NIST's
estimate that 25% of currently produced fasteners would be covered
under the Act. Assuming that 55% of currently produced fasteners would
be covered under the Act, as is projected in industry studies, the
estimated annual industry costs adjusted by amendments to the Act would
be approximately $38.7 million. NIST has prepared a final Regulatory
Impact Analysis on the expected costs that will be incurred by both
government and industry to implement these regulations, as well as on
the expected benefits to be derived from the rule's implementation.
NIST has transmitted this Analysis to the Office of Management and
Budget.
Summary of Adjusted Industry Costs
The following table summarizes the annual costs to industry for
complying with the Fastener Quality Act, as originally estimated in the
1993 NIST Impact Analysis, and as adjusted based upon the recent
amendments to the Act that were contained in Pub.L. 104-113 (Technology
Transfer and Advancement Act of 1995).
Estimated Industry Costs
[In millions]
------------------------------------------------------------------------
Adjusted
With no by
Activity amendments amendments
to act to act
------------------------------------------------------------------------
Lab Accreditation Costs......................... $6.4 $6.4
Increased Test Costs............................ 6.0 6.0
Nonconforming Fastener Costs*................... N/A 0.0
Spectrochemical Test Costs...................... 100.6 0.0
Distributor Costs............................... 373.7 ** 6.5
-----------------------
Total Annual Industry Cost.................. 486.7 18.9
------------------------------------------------------------------------
* NIST was not able to estimate these costs. However, a task force of
the Fastener Advisory Committee estimated lot rejection costs based
upon not being able to sell fasteners with minor nonconformances as
permitted by standards and specifications at $285 million annually,
worst case.
** The $6.5 million does not necessarily represent all new costs since
some distributors had been providing this service prior to the passage
of the Fastener Quality Act.
Summary of Benefits of the Regulation
The economic costs associated with faulty or substandard fasteners
entering the marketplace are difficult to measure. In the legislative
history of the Act, numerous examples were cited of faulty or
substandard fasteners. The one example that was quantified--the NASA
space shuttle equipment example--included an estimated $11 million
price tag associated with the discovery and removal of substandard
fasteners. It is also clear from the other examples included in the
legislative history, that many (if not most) of them resulted in
economic losses well into the millions of dollars--losses that will be
substantially reduced through implementation of this Act. In addition
to economic losses, the injuries and deaths associated with product
failures resulting from the use of faulty or counterfeit fasteners will
be reduced. Another benefit will be a potential reduction in the
inspection and testing costs incurred by purchasers associated with the
quality control of incoming critical fastener procurements. Similarly,
another benefit, although not quantifiable, is associated with customer
perception of improved product quality for U.S. made fasteners
resulting from the Act. Because the Act applies equally to all
enterprises in the United States, be they domestic or foreign,
implementation of the Act will also help to ``level the playing field''
in domestic sales by making it more difficult for unethical
manufacturers and distributors to substitute substandard or counterfeit
fasteners at ``reduced prices'' thereby being able to undercut the
prices of their competitors. Finally, the Act uses voluntary standards
developed by the private sector to set appropriate fastener
specifications and test methods. This approach, which complies with the
requirements of the Technology Transfer and Advancement Act of 1995,
reduces the degree of regulatory involvement in and control over the
marketplace and leaves the determination of fastener requirements to
those most familiar with fastener technology and use.
Regulatory Flexibility Act
The Department has conducted a final Regulatory Flexibility
Analysis for this final rule. Laboratories, most of which are small
entities, desiring to test fasteners in accordance with the provisions
of the Act will incur costs related to accreditation and recordkeeping.
These costs have been discussed in Section IV of the Regulatory Impact
Analysis under LABORATORY COSTS. Based on estimates provided by the
Fastener Advisory Committee, between 328 and 457 laboratories will
require accreditation to implement Pub. L. 101-592, as amended. Using
the 1 to 25 percent range, between 26 and 639 laboratories will require
accreditation. Accreditation cost per laboratory will vary with the
scope of accreditation sought (the number of test methods for which the
laboratory seeks accreditation); however, the annual accreditation cost
(based on NVLAP's experience) is expected to average $10,000 per
laboratory.
Manufacturers who sell grade-marked fasteners covered by the Act
will incur additional testing and recordkeeping costs. Most of the
approximately 350 U.S. fastener manufacturers are not small entities.
No data is available on how many (if any) small U.S. fastener
manufacturers produce fasteners covered by the Act. Manufacturer costs
for all manufacturers are discussed in Section IV of the Regulatory
Impact Analysis under MANUFACTURER COSTS and in the June 1996 update to
the Analysis.
Distributors that sell grade-marked fasteners covered by the Act
will also incur additional costs in supplying lot traceable fasteners
to those purchasers who request them. These costs are discussed in the
June 1996 update to the original 1993 Regulatory Impact Analysis.
As noted above, to the extent that the Act permitted some
flexibility in the development of the implementing regulations, the
Department has sought and incorporated advice from its Fastener
Advisory Committee, chartered pursuant to the Act, to maximize the cost
effectiveness of the regulations.
Responses to comments are contained elsewhere in this rule and this
is thought to minimize the significant impact of this rulemaking
through enactment of amendments to the Act, as described above.
Paperwork Reduction Act
This rule contains three information collection requirements
subject to the Paperwork Reduction Act. Two collections of information
have been approved by the Office of Management and Budget under Control
Numbers 0693-0003, and 0693-0015. The public reporting burden for
collecting information dealing with the accreditation of fastener
testing laboratories (0651-0003) is estimated to average 1 hour per
response, and an estimated total annual burden of 2400 hours. The
public reporting burden for collecting information dealing with
approving laboratory accreditation bodies (0651-0015) is estimated to
average 4 hours per response, with an estimated total annual burden of
20 hours.
[[Page 50558]]
The final rule contains one information collection provision that
is subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
requirements are shown below with the estimate of the annual reporting
and recordkeeping burden. Included in the estimate is the time for
reviewing instruction, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Title: Fastener Quality Act Insignia Recordal Process.
Description: This collection of information is required by section
8 of the Fastener Quality Act. Under section 8, each manufacturer or
private label distributor must apply to PTO for recordal of an insignia
on the Fastener Insignia Register. The PTO has drafted a suggested
application form for use by the public.
Description of Respondents: Fastener manufacturers and private
label distributors.
Estimate of Annual Reporting and Recordkeeping Burden: The
estimated total annual burden of hours is calculated at 100 hours. PTO
estimates that there will be between 300 and 900 respondents, or an
average of 600 respondents per year. The Office estimates that it will
take the applicant 10 minutes to collect the data and complete the
application/renewal form.
Notwithstanding any other provisions of law, no person is required
to respond to nor shall a person be subject to a penalty for failure to
comply with a collection of information subject to the requirements of
the Paperwork Reduction Act unless that collection of information
displays a currently valid OMB Control Number.
List of Subjects in 15 CFR Part 280
Business and industry, Fastener industry, Imports.
Dated: September 13, 1996.
Samuel Kramer,
Associate Director.
For reasons set forth in the preamble, title 15 of the Code of
Federal Regulations is amended by adding part 280 to read as follows:
PART 280--FASTENER QUALITY
Subpart A--General
Sec.
280.1 Purpose/description of rule.
280.2 Definitions.
280.3 Relationship to State laws.
280.4 Commingling of fasteners.
280.5 Certification of fasteners.
280.6 Laboratory test reports.
280.7 Recordkeeping requirements.
280.8 Ownership of laboratories by manufacturers.
280.9 Subcontracting of testing.
280.10 Sampling.
280.11 Significant alterations of fasteners.
280.12 Applicability.
280.13 Imports of fasteners.
280.14 Option for importers and private label distributors.
280.15 Alternative procedure for chemical characteristics.
280.16 Subsequent purchaser.
Subpart B--Laboratory Accreditation
280.100 Introduction.
280.101 Accredited laboratory list.
280.102 Procedures for inclusion in the accredited laboratory list.
280.103 Removal from the accredited laboratory list.
Subpart C--NIST Fastener Laboratory Accreditation Procedures
280.200 Introduction.
280.201 Applicability of part 285, title 15, Code of Federal
Regulations.
280.202 Establishment of the program.
280.203 Adding to or modifying the program.
280.204 NVLAP Program Handbook.
280.205 Applying for accreditation.
280.206 Assessing and evaluating a laboratory.
280.207 Granting and renewing accreditation.
280.208 Denying, suspending and revoking accreditation.
280.209 Voluntary termination of accreditation.
280.210 Change in status of laboratory.
280.211 Authorized representative.
280.212 Approved signatory.
280.213 Application of accreditation conditions and criteria.
280.214 Conditions for accreditation.
280.215 Criteria for accreditation.
Subpart D--NIST Approval of Private Accreditation Programs
280.300 Introduction.
280.301 Application.
280.302 Review and decision process.
280.303 Criteria for approval.
280.304 Maintaining approved status.
280.305 Voluntary termination of approval.
280.306 Involuntary termination of approval by NIST.
Subpart E--Recognition of Foreign Laboratories
280.400 Introduction.
280.401 Recognition of foreign laboratories.
Subpart F--Requirements for Fastener Laboratory Accreditation Bodies
280.500 Introduction.
280.501 Accreditation body.
280.502 Laboratory assessors.
280.503 Accreditation process.
280.504 Relationship between approved/recognized accreditation body
and laboratory.
Subpart G--Enforcement
280.600 Scope.
280.601 Definitions used in this subpart.
280.602 Violations.
280.603 Penalties, remedies and sanctions.
280.604 Administrative enforcement proceedings.
280.605 Institution of administrative enforcement proceedings.
280.606 Representation.
280.607 Filing and service of papers other than charging letter.
280.608 Answer and demand for hearing.
280.609 Default.
280.610 Summary decision.
280.611 Discovery.
280.612 Subpoenas.
280.613 Matter protected against disclosure.
280.614 Prehearing conference.
280.615 Hearings.
280.616 Interlocutory review of rulings.
280.617 Proceeding without a hearing.
280.618 Procedural stipulations; extension of time.
280.619 Decision of the administrative law judge.
280.620 Settlement.
280.621 Reopening.
280.622 Record for decision and availability of documents.
280.623 Appeals.
Subpart H--Recordal of Insignia
280.700 Recorded insignia required prior to offer for sale.
The Written Application
280.710 Applications for insignia.
280.711 Review of the application.
280.712 Certificate of recordal.
280.713 Recordal of additional insignia.
Post-recordal Mainenance
280.720 Maintenance of the certificate of recordal.
280.721 Notification of changes of address.
280.722 Transfer or amendment of the certificate of recordal.
280.723 Transfer or assignment of trademark registration or
recorded insignia.
280.724 Change in status of trademark registration or amendment of
the trademark.
280.725 Cumulative listing of recordal information.
280.726 Records and files of the Patent and Trademark Office.
Authority: Sec. 13 of the Fastener Quality Act (Pub.L. 101-592,
as amended by Pub. L. 104-113).
Subpart A--General
Sec. 280.1 Purpose/description of rule.
The Fastener Quality Act (the Act) (Pub.L. 101-592, as amended by
Pub. L. 104-113) is intended to protect the public safety, to deter the
introduction of nonconforming fasteners into commerce, to improve the
ability to trace fasteners covered by the Act, and generate greater
assurance that fasteners meet stated specifications. The Act:
(a) Requires that certain fasteners which are sold in commerce
conform to the specifications to which they are represented to be
manufactured,
[[Page 50559]]
(b) Provides for accreditation of laboratories engaged in fastener
testing; and
(c) Requires inspection, testing and certification, in accordance
with standardized methods, of fasteners covered by the Act.
Sec. 280.2 Definitions.
Unless the context requires otherwise or unless specifically stated
the terms in this part have the meanings prescribed in the statute. In
addition the following definitions apply.
Accreditation means laboratory accreditation.
Accreditation Body refers to the National Voluntary Laboratory
Accreditation Program and those private entities currently approved by
NIST under subpart D of this part and those foreign governments or
organizations currently recognized by NIST under subpart E of this
part.
Accreditation criteria means a set of requirements used by an
accreditation body which a laboratory must meet to be accredited.
The Act means the Fastener Quality Act (Pub.L. 101-592, as amended
by Pub.L. 104-113).
Alter means to alter by through hardening; by electroplating of
fasteners; or by machining.
Alteror means a person who owns a fastener and causes it to be
altered.
Approved signatory is an individual employed by a laboratory
accredited under the Act and these regulations who is recognized by an
accreditation body as competent to sign accredited laboratory test
reports.
Bureau of Export Administration or (BXA) means the Bureau of Export
Administration of the United States Department of Commerce, including
the Office of Export Enforcement.
Certificate of Accreditation is a document issued by an
accreditation body to a laboratory that has met the criteria and
conditions of accreditation. The certificate, together with the
assigned code number, and scope of accreditation issued by the
accreditation body may be used as proof of accredited status.
Commingling means the mixing of fasteners from different lots in
the same container.
Commissioner means the Commissioner of Patents and Trademarks.
Consensus standards organization means the American Society for
Testing and Materials (ASTM), American National Standards Institute
(ANSI), American Society of Mechanical Engineers (ASME), Society of
Automotive Engineers (SAE), or any other consensus standards setting
organization (domestic or foreign) determined by the Secretary to have
comparable knowledge, expertise, and concern for the health and safety
in the field for which such organization purports to set standards.
Container means any package of fasteners traded in commerce.
Date of manufacture means that date upon which the initial
conversion of material into a fastener takes place.
Director means the Director of the National Institute of Standards
and Technology (NIST).
Fastener means any screw, nut, bolt or stud, washer or other item
included within the definition for fastener contained in section 3(5)
of the Fastener Quality Act. The term ``fastener'' does not include a
screw, nut, bolt, or stud:
(1) That is produced and marked as ASTM A307 Grade A;
(2) That is produced in accordance with ASTM F432; or
(3) That is held out as being produced to other than the provisions
of standards and specifications published by a consensus standards
organization, or a government agency.
A screw, nut, bolt, stud or washer held out as being produced
according to requirements of a document other than a document published
by a consensus standards organization is a fastener within the meaning
of the Act and this part if that document incorporates or references
(directly or indirectly) standards and specifications published by a
consensus standards organization or government agency for purposes of
delineating performance or materials characteristics of the fastener.
Fastener insignia register means the register established at the
U.S. Patent and Trademark Office for the recordal of fastener insignia
to identify the manufacturer or private label distributor.
Fastener set means a collection of small quantities of products,
including fasteners, of varying sizes, collected together and sold as a
package.
Grade or property class identification marking means any symbol
appearing on a fastener purporting to indicate that the fastener's base
material, strength properties, or performance capabilities conform to a
specific standard of a consensus standards organization or government
agency. A raw material mark is not considered as a grade identification
mark for purposes of these regulations unless this mark is required by
the fastener standards and specifications to identify specific
conformance.
Importer means a person located within the United States who
contracts for the initial purchase of fasteners manufactured outside
the United States for resale or such person's use within the United
States.
Laboratory accreditation is the formal recognition that a testing
laboratory is competent to carry out specific test(s) or specific
type(s) of tests.
Laboratory accreditation body means a legal or administrative
entity that accredits laboratories.
Laboratory assessment means the on-site examination of a testing
laboratory to evaluate its compliance with specified criteria.
Laboratory test report means a report prepared by an accredited
laboratory in accord with Sec. 280.6.
Lot means a quantity of fasteners of one part number fabricated by
the same production process from the same coil or heat number of metal
as provided by the metal manufacturer and submitted for inspection and
testing at one time.
Lot number means a number assigned by a manufacturer to the lot.
Lot-specific identification information means information
applicable to a fastener consisting of, at a minimum:
(1) The part number (or a part description if there is no
applicable part number),
(2) The identity of the manufacturer, and
(3) The lot number.
Lot traceability means the recording and maintenance of lot-
specific identification information sufficient to trace fasteners from
a single lot throughout:
(1) The manufacturer's fabrication or alteration process,
(2) All inspection and testing operations, and
(3) The subsequent chain of distribution in commerce.
Manufacturer means a person who fabricates fasteners, who
significantly alters fasteners, or who alters any item so that it
becomes a fastener.
NIST means the National Institute of Standards and Technology, U.S.
Department of Commerce.
NVLAP means the National Voluntary Laboratory Accreditation Program
operated by the National Institute of Standards and Technology.
Original laboratory testing report means a laboratory testing
report which is originally signed by an approved signatory or is a copy
thereof, certified by the laboratory that conducted the test.
Person means any individual, partnership, limited partnership or
corporate entity and/or a representative, agent or designee.
Private label distributor means a person who contracts with a
[[Page 50560]]
manufacturer for the fabrication of fasteners bearing the distributor's
distinguishing insignia.
Product includes any type or category of manufactured goods,
constructions, installations, or natural or processed materials.
Proficiency testing means the determination of laboratory testing
performance by means of comparing and evaluating tests on the same or
similar items or materials in accordance with predetermined conditions.
Scope of Accreditation is a document issued by an accreditation
body to an accredited laboratory which lists the test methods,
standards or specifications for which the laboratory is accredited.
Secretary means the Secretary of Commerce.
Significantly Alter means to alter in a manner which could weaken
or otherwise materially affect the performance or capabilities of the
fastener as it was originally manufactured, grade or property class
marked, tested, or represented. The term does not include the
application of adhesives or sealants, locking elements, provisions for
lock wires, coatings and platings of parts having a specified Rockwell
C hardness of less than 32, or cutting off of fasteners. The cutting of
finished threaded rods, bars or studs to produce individual smaller
length threaded studs for resale is not a significant alteration.
However, cut threaded studs, rods, and bars offered for sale shall be
individually marked with the grade or property class identification
marking appearing on or accompanying the original threaded studs, rods,
and bars from which the fasteners were cut.
Standards and specifications means the provisions of a document
published by a consensus standards organization, or a government
agency.
Tamper-resistant system means the use of special paper or embossing
stamps or other controls which discourage, prevent or minimize
alteration of test reports subsequent to manufacturing, inspection and
testing.
Testing laboratory is a laboratory which measures, examines, tests,
calibrates or otherwise determines the characteristics or performance
of products.
Through-harden means heating above the transformation temperature
followed by quenching and tempering for the purpose of achieving a
uniform hardness.
Traceability of Measurements means a documented chain of
comparisons connecting the accuracy of a measuring instrument to other
measuring instruments of higher accuracy and, ultimately, to a primary
standard.
Sec. 280.3 Relationship to State laws.
Nothing in the Act or these regulations shall be construed to
preempt any rights or causes of action that any buyer may have with
respect to any seller of fasteners under the law of any State, except
to the extent that the provisions of the Act or these regulations are
in conflict with such State law.
Sec. 280.4 Commingling of fasteners.
(a) No manufacturer, importer, or private label distributor may
commingle fasteners of the same type, grade, and dimension from
different lots in the same container; except that such manufacturer,
importer, or private label distributor may commingle fasteners of the
same type, grade, and dimension from not more than two tested and
certified lots in the same container during repackaging and plating
operations: Provided, that any container which contains the fasteners
from two lots shall be conspicuously marked with the lot identification
numbers of both lots.
(b) Fastener distributors, and persons who purchase fasteners for
sale at wholesale or retail, may commingle fasteners of the same type,
grade, and dimension from different lots in the same container.
Sec. 280.5 Certification of fasteners.
(a) No fastener shall be offered for sale or sold in commerce
unless it is part of a lot which has been inspected, tested, and
certified in accordance with Section 5 of the Act and this part, and
found to conform to the standards and specifications to which the
manufacturer represents it has been manufactured.
(b) (1) the requirements of paragraph (a) of this section shall not
apply to fasteners which are part of a lot of 50 fasteners or less if
within 10 working days after delivery of such fasteners, or as soon as
practicable thereafter--
(i) Inspection, testing, and certification as provided in
subsections 5 (b), (c), and (d) of the Act and this part is carried
out; and
(ii) Written notice detailing the results of such inspection,
testing, and certification is sent:
(A) To all purchasers of such fasteners, except retail sellers and
retail consumers, and
(B) To any retail seller or retail consumer who, prior to delivery,
requests such written notice.
(2) If a fastener is sold under paragraph (b) of this section, each
purchaser of such fastener, except for retail sellers and retail
consumers unless such retail sellers and retail consumers request such
notice in advance, shall be provided, contemporaneously with each sale
and delivery, written notice stating that such fastener has not yet
been inspected, tested, and certified as required by the Act and this
part.
(c) Each manufacturer, importer, private label distributor, or
alteror who significantly alters any fastener shall keep on file and
make available for inspection in accordance with the recordkeeping
requirements of Sec. 280.7 an original laboratory testing report
described in section 5(c) of the Act and Sec. 280.6 of this part and a
manufacturer's certificate of conformance for each lot of fasteners
subject to the Act and this part which that manufacturer, importer,
private label distributor, or alteror who significantly alters any
fastener offers for sale or sells in commerce. Such certificate shall,
as a minimum, include: Fastener description information contained in
Sec. 280.6(a)(4) of this part; the date of issue and serial number of
the laboratory testing report; and
A statement certifying that the fasteners have been manufactured
according to the requirements of the applicable standards and
specifications and found to conform with its requirements. The
requirements of this paragraph shall not apply to an alteror who
significantly alters fasteners and who delivers to the purchaser the
written statement provided for by Sec. 280.11(a)(3) of this part.
Sec. 280.6 Laboratory test reports.
(a) When performing tests for which they are accredited under this
part, each laboratory accredited under subparts C, D, or E of this part
and currently listed in the Accredited Laboratory List shall issue test
reports of its work which accurately, clearly, and unambiguously
present the test conditions, test set-up, test results, and all
information required by this section. All reports must be in English or
be translated into English, must be signed by an approved signatory,
must be protected by a tamper resistant system, and contain the
following information:
(1) Name and address of the laboratory;
(2) Unique identification of the test report including date of
issue and serial number, or other appropriate means;
(3) Name and address of client;
(4) Fastener Description, including:
(i) Manufacturer (name and address);
(ii) Product family (screw, nut, bolt, washer, or stud), drive and/
or head configurations as applicable;
[[Page 50561]]
(iii) Date of manufacture;
(iv) Head markings (describe or draw manufacturer's recorded
insignia and grade identification or property class symbols);
(v) Nominal dimensions (diameter; length of bolt, screw or stud;
thickness of load bearing washer); thread form and class of fit;
(vi) Product standards and specifications related to the laboratory
in writing by the manufacturer, importer or distributor;
(vii) Lot number;
(viii) Specification and grade of material;
(ix) Coating material and standard and specification as applicable;
(5) Sampling information:
(i) Standards and specifications or reference for sampling scheme;
(ii) Production lot size and the number sampled and tested;
(iii) Name and affiliation of person performing the lot sampling;
(6) Test results:
(i) Actual tests required by the standard and specification;
(ii) Test results for each sample;
(iii) All deviations from the test method;
(iv) All other items required on test reports according to the test
method;
(v) Where the report contains results of tests performed by sub-
contractors, these results shall be clearly identified along with the
name of the laboratory and accreditation information listed in
paragraph (a)(10) of this section.
(vi) A statement that the samples tested either conform or do not
conform to the fastener standards and specifications or standards and
identification of any nonconformance, except as provided for in
Secs. 280.13 and 280.14;
(7) A statement that the report must not be reproduced except in
full;
(8) A statement to the effect that the test report relates only to
the item(s) tested;
(9) Name, title and signature of approved signatory accepting
technical responsibility for the tests and test report;
(10) The name of the body which accredited the laboratory for the
specific tests performed which are the subject of the report, and code
number assigned to the laboratory by the accreditation body, and the
expiration of accreditation.
(b) For alternative chemical tests carried out under Sec. 280.15 of
this part, each laboratory accredited under subparts C, D, or E of this
part and currently listed in the Accredited Laboratory List shall
provide to the fastener manufacturer, either directly or through the
metal manufacturer, a written inspection and testing report containing
all required information. All reports must be in English or be
translated into English, must be signed by an approved signatory, must
be protected by a tamper resistant system, and contain the following
information:
(1) Name and address of the laboratory;
(2) Unique identification of the test report including date of
issue and serial number or other appropriate means.
(3) Name and address of client;
(4) Coil or heat number of metal being tested;
(5) Test results:
(i) Actual tests required by the standards and specifications;
(ii) Test results for each sample;
(iii) All deviations from the test method;
(iv) All other items required on test reports according to the test
method;
(v) Where the report contains results of tests performed by sub-
contractors, these results shall be clearly identified along with the
name of the laboratory and accreditation information listed in
paragraph (b)(9) of this section.
(vi) A statement that the samples tested either conform or do not
conform to the metal standards and specifications and identification of
any nonconformance;
(6) A statement that the report must not be reproduced except in
full;
(7) A statement to the effect that the test report relates only to
the item(s) tested;
(8) Name, title and signature of approved signatory accepting
technical responsibility for the tests and test report;
(9) The name of the body which accredited the laboratory for the
specific tests performed which are the subject of the report, and code
number assigned to the laboratory by the accreditation body, and the
expiration of accreditation.
(c) The laboratory shall issue corrections or additions to a test
report only by a further document suitably marked, e.g. ``Supplement to
test report serial number * * *'' This document must specify which test
result is in question, the content of the result, the explanation of
the result, and the reason for acceptance of the result.
Sec. 280.7 Recordkeeping requirements.
(a) Each laboratory accredited under subparts C, D, or E of this
part shall retain for 5 years after the performance of a test all
records pertaining to that test concerning the inspection and testing,
and certification, of fasteners under the Act and these regulations.
The final test report or the test records maintained by the laboratory
shall contain sufficient information to permit the test to be repeated
at a later time if a retest is necessary. The laboratory shall maintain
the test report and a record of all original observations,
calculations, and derived data. The records shall include the identity
of personnel involved in sample preparation and testing. Procedures for
storage and retrieval of records must be documented and maintained in
the laboratory's quality manual.
(b) Manufacturers, importers, private label distributors, and
persons who significantly alter fasteners shall retain for 5 years
after the performance of a test all records pertaining to that test
concerning the inspection and testing, and certification, of fasteners
under the Act and these regulations.
(c) Original records required. Persons required to keep records
under this part must maintain the original records in the form in which
that person receives or creates them unless that person meets all of
the conditions of paragraph (d) of this section relating to
reproduction of records. Original laboratory test reports described in
Secs. 280.5, 280.6, 280.13 and 280.15(b) of this part must be kept.
(d) Reproduction of original records. A person required to keep
records under this part may maintain reproductions of documents other
than laboratory test reports instead of the original records using any
photographic, photostatic, miniature photographic, micrographic,
automated archival storage, or other process that completely,
accurately, legibly and durably reproduces the original records
(whether on paper, microfilm, or through electronic digital storage
techniques). The process must meet all of the requirements of
paragraphs (d)(1) through (d)(9) of this section.
(1) The system must be capable of reproducing all records on paper.
(2) The system must record and be able to reproduce all marks,
information, and other characteristics of the original record,
including both obverse and reverse sides of paper documents in legible
form.
(3) When displayed on a viewer, monitor, or reproduced on paper,
the records must exhibit a high degree of legibility and readability.
(For purposes of this section, legible and legibility mean the quality
of a letter or numeral that enable the observer to identify it
positively and quickly to the exclusion of all other letters or
numerals. Readable and readability mean the quality of a group of
letters or numerals being recognized as complete words or numbers.)
(4) The system must preserve the initial image (including both
obverse
[[Page 50562]]
and reverse sides of paper documents) and record all changes, who made
them and when they were made. This information must be stored in such a
manner that none of it may be altered once it is initially recorded.
(5) The regulated person must establish written procedures to
identify the individuals who are responsible for the operation, use and
maintenance of the system.
(6) The regulated person must establish written procedures for
inspection and quality assurance of records in the system and document
the implementation of those procedures.
(7) The system must be complete and contain all records required to
be kept by this part or the regulated person must provide a method for
correlating, identifying and locating records relating to the same
transaction(s) that are kept in other record keeping systems.
(8) The regulated person must keep a record of where, when, by
whom, and on what equipment the records and other information were
entered into the system.
(9) Upon request by the Bureau of Export Administration or NIST,
the regulated person must furnish, at the examination site, the
records, the equipment and, if necessary, knowledgeable personnel for
locating, reading, and reproducing any record in the system.
(e) Destruction or disposal of records. If the Bureau of Export
Administration, NIST or any other government agency makes a formal or
informal request for any record or records, such record or records may
not be destroyed or disposed of without the written authorization of
the agency concerned. This prohibition applies even if such records
have been retained for a period of time exceeding that required by
paragraphs (a) or (b) of this section.
(f) All persons required to keep records by this part must furnish
those records when requested to do so by an employee of the Bureau of
Export Administration or NIST.
Sec. 280.8 Ownership of laboratories by manufacturers.
(a) If the Director finds that, as to a specific type of fastener,
and as to a specific type of inspection or testing, a ban on
manufacturer ownership or affiliation with a laboratory performing
tests under the Act and these regulations would increase the protection
of health and safety of the public or industrial workers, the Director
may impose such a ban.
(b) Before imposing a ban under paragraph (a) of this section, the
Director shall provide advance notice and the opportunity for public
comment.
Sec. 280.9 Subcontracting of testing.
(a) Whenever a laboratory accredited under subparts C, D, or E of
this part issues a test report under the Act and this part, it is
implied that the report reflects work performed, and results obtained,
by the personnel, equipment, and procedures of that laboratory.
However, in some cases a laboratory may require the use of another
facility due to equipment failure, need for specialized equipment, work
overload, or to perform tests outside the laboratory's own scope of
accreditation.
(b) Whenever a laboratory accredited under subparts C, D, or E of
this part subcontracts to another laboratory for the performance of any
test or portion of a test it must:
(1) Place the work with another laboratory accredited under either
subpart C, D, or E of this part;
(2) Inform the client, before the fact, that subcontracting will be
necessary; and
(3) Clearly identify in its records, and in the report to the
client, specifically which test method(s) or portions of a test
method(s) were performed by the accredited laboratory and which were
performed by the subcontractor.
Sec. 280.10 Sampling.
In the event that the standard or specification to which a
manufacturer represents the fasteners in a particular sample to have
been manufactured does not provide for the size, selection or integrity
of the sample to be inspected and tested, the sample shall be
determined in accordance with ASME/ANSI B18.18.2M, Inspection and
Quality Assurance For High-Volume Machine Assembly Fasteners; ASME/ANSI
B18.18.3M, Inspection and Quality Assurance for Special Purpose
Fasteners; or ASME/ANSI B18.18.4M, Inspection and Quality Assurance for
Highly Specialized Engineering Applications--Fasteners, as appropriate.
Sec. 280.11 Significant alterations of fasteners.
(a) Any alteror who significantly alters a fastener so that it no
longer conforms to the description in the relevant test report issued
under section 5(c) of the Act or this part, and who thereafter offers
for sale or sells such significantly altered fastener, shall:
(1) Assign a new lot number;
(2) Apply his or her registered insignia to the significantly
altered fastener if the standards and specifications to which the
fastener was originally manufactured required the fastener to bear a
raised or depressed insignia identifying its manufacturer or private
label distributor; and
(3) Be treated as a manufacturer for the purposes of the Act and
this part, and shall cause the fastener to be inspected and tested as
required by section 5 of the Act and by this part unless the
significantly altered fastener is delivered to a purchaser accompanied
by a written statement noting the original lot number and the new lot
number assigned by the alteror, disclosing the subsequent alteration,
and warning that such alteration may affect the dimensional or physical
characteristics of the fastener.
(b) If the significant alteration is only electroplating of
fasteners having a specified Rockwell C hardness of 32 or above, the
requirements set forth in paragraphs (a)(2) and (a)(3) of this section
shall not apply, but the alteror shall assign a new lot number as set
forth in paragraph (a)(1) of this section and shall test the
electroplated fasteners as required by the plating standards and
specifications.
(c) Any person who knowingly sells a significantly altered fastener
as described in paragraph (a) of this section, and who did not alter
such fastener, shall provide to the purchaser a copy of the statement
required by paragraph (a)(3) of this section; unless the significant
alteration is only electroplating of the fastener, as described in
paragraph (b) of this section.
(d) If the alteration is not a significant alteration, the
requirements set forth in paragraph (a) of this section shall not
apply, and the only testing requirements which apply are those required
by the standards and specifications to which the alteration is
performed. If the alteration involves cutting of threaded studs, rods,
or bars into studs, these cut fasteners must be marked with the grade
or property class identification marking appearing on the original
threaded studs, rods, and bars.
Sec. 280.12 Applicability.
(a) The requirements of the Fastener Quality Act and this part
shall be applicable only to fasteners manufactured on or after May 27,
1997.
(b) Metal manufactured prior to May 27, 1997 may not be used to
manufacture fasteners subject to the Act and this part, unless the
metal has been tested for chemistry pursuant to Sec. 280.15 of this
part by a laboratory accredited under the Act and this part and the
chemical characteristics of the metal conform to those required by the
standards and specifications.
[[Page 50563]]
(c) Nothing in the Act and this part prohibits selling finished
fasteners manufactured prior to May 27, 1997 or representing that such
fasteners meet standards and specifications of a consensus standards
organization or a government agency. Fasteners manufactured prior to
May 27, 1997 may not be represented as being in conformance with the
Act or this part.
Sec. 280.13 Imports of fasteners.
(a) Except as provided in paragraph (b) of this section, it shall
be unlawful for any person to sell to an importer, and for any importer
to purchase any shipment of fasteners or fastener sets manufactured
outside the United States unless such shipment to an importer is
accompanied by a manufacturer's certificate of conformance, an original
laboratory testing report with respect to each lot from which the
fasteners are taken, and any other relevant lot identification
information.
(b) The requirement that delivery of fasteners to any importer must
be accompanied by an original laboratory testing report shall not
apply:
(1) In the case of fasteners imported into the United States as
products manufactured within a nation which is party to a
congressionally approved free trade agreement with the United States
that is in effect, provided that the Director has published in the
Federal Register a certification that satisfactory arrangements have
been reached by which purchasers within the United States can readily
gain access to an original laboratory test report for such fasteners;
or,
(2) In the case of fasteners imported into the United States as
Canadian-origin products under the United States-Canada Automobile Pact
for use as original equipment in the manufacture of motor vehicles.
Sec. 280.14 Option for importers and private label distributors.
(a) Notwithstanding the provisions of Sec. 280.13 of this part,
delivery of a lot, or portion of a lot, of fasteners may be made by a
manufacturer to an importer or private label distributor without the
required original copy of the laboratory testing report if--
(1) The manufacturer provides to the importer or private label
distributor a certificate which, as a minimum, includes fastener
description information contained in Sec. 280.6(a)(4), and a statement
by the manufacturer certifying that the fasteners have been
manufactured according to the requirements of the applicable standard
or specification, but have not been tested by a laboratory accredited
in accordance with section 6 of the Act; and
(2) The importer or private label distributor assumes
responsibility in writing for the inspection and testing of such lot or
portion by a laboratory accredited in accordance with the procedures
set out in this Part.
(b) If the importer or private label distributor assumes the
responsibility in writing for the inspection and testing of such lot or
portion, the provisions of section 5(a), (b) and (c) of the Act shall
apply to the importer or private label distributor in the same manner
and to the same extent as to a manufacturer; except that the importer
or private label distributor shall provide to the testing laboratory
the certificate described under paragraph (a)(1) of this section.
Sec. 280.15 Alternative procedure for chemical characteristics.
Notwithstanding any other provision of this regulation, a
manufacturer shall be deemed to have demonstrated that the chemical
characteristics of a lot conform to the standards and specifications to
which the manufacturer represents such lot has been manufactured if the
following requirements are met:
(a) The coil or heat number of metal from which such lot was
fabricated has been inspected and tested with respect to its chemical
characteristics by a laboratory accredited in accordance with the Act
and these regulations;
(b) Such laboratory has provided to the manufacturer, either
directly or through the metal manufacturer, a written inspection and
testing report, prepared in accordance with Sec. 280.6 of this part,
listing the chemical characteristics of such coil or heat number;
(c) The report described in paragraph (b) of this section indicates
that the chemical characteristics of such coil or heat number conform
to those required by the standards and specifications to which the
manufacturer represents such lot has been manufactured; and,
(d) The manufacturer demonstrates that such lot has been fabricated
from the coil or heat number of metal to which the report described in
paragraphs (b) and (c) of this section relates.
Sec. 280.16 Subsequent purchaser.
(a) If a purchaser of fasteners requests the seller to mark the
container of fasteners with the lot number from which such fasteners
were taken, either prior to the sale or at the time of sale, the seller
shall conspicuously mark the container of fasteners with the lot
number.
(b) The seller shall provide copies of any applicable laboratory
testing report or certification of conformance upon request to the
subsequent purchaser of fasteners taken from the lot to which such
testing report or manufacturer's certificate of conformance relates.
Subpart B--Laboratory Accreditation
Sec. 280.100 Introduction.
The Fastener Quality Act sets out three alternatives by which a
laboratory may become accredited for testing under the Act. This
regulation sets out implementing procedures for each of those
alternatives:
(a) Subpart C of this part contains procedures by which the
National Institute of Standards and Technology's National Voluntary
Laboratory Accreditation Program will accredit laboratories for the
testing of fasteners under the Act;
(b) Subpart D of this part sets out procedures under which private
entities may apply to NIST for approval to engage directly in the
accreditation of laboratories for the testing of fasteners under the
Act; and
(c) Subpart E of this part sets out conditions under which the
accreditation of foreign laboratories by their governments or
organizations recognized by the Director shall be deemed to satisfy the
laboratory accreditation requirements for the testing of fasteners
under the Act.
Sec. 280.101 Accredited laboratory list.
NIST shall prepare and maintain an Accredited Laboratory List of
laboratories accredited under subparts C, D, and E of this part. Only
laboratory test reports covering tests performed by a laboratory listed
in the Accredited Laboratory List at the time the report was issued,
and which are within the scope of the laboratory's accreditation, shall
be deemed to meet the requirements of the Act.
Sec. 280.102 Procedures for inclusion in the accredited laboratory
list.
(a) NVLAP, and all entities approved by NIST under subpart D of
this part or recognized by NIST under subpart E of this part shall
promptly notify NIST of each accreditation action taken under subparts
C, D, or E of this part, respectively. Accreditation actions include
initial accreditation, denials of accreditation, renewals, suspensions,
terminations, revocations and changes in scope. Notifications shall be
filed with: Fastener Quality Act Program Manager, Office of Standards
Services, National Institute of Standards and Technology, Gaithersburg,
Maryland 20899.
[[Page 50564]]
(b) Each notification to NIST shall include the following
information, in English: The name of the laboratory accreditation body
which granted the accreditation; the name and address of the laboratory
affected by the accreditation action; the nature of the accreditation
action; a copy of the laboratory's accreditation certificate and a
scope of accreditation which states the fastener test methods for which
it has been accredited; the name and telephone number of the authorized
representative(s) and approved signatory(s) of the fastener testing
laboratory; information concerning the physical locations of all
organizational units involved in accredited fastener testing, and the
specific scope of fastener testing for each organizational unit for
which accreditation has been granted.
(c) NIST shall revise as appropriate the Accredited Laboratory List
when notified of accreditation actions and shall take appropriate steps
to make information changes promptly available to the public.
Sec. 280.103 Removal from the accredited laboratory list.
(a) NIST may remove from the Accredited Laboratory List any
fastener testing laboratory accredited under subpart C, D or E of this
part if NIST deems such action to be in the public interest. Laboratory
test reports describing tests performed by a laboratory after it has
been removed from the Accredited Laboratory List under this section
shall not be deemed to meet the requirements of the Act.
(b) A laboratory may appeal the removal or proposed removal from
the Accredited Laboratory List to the Director by submitting a
statement of reasons why the laboratory should remain on the list. NIST
may, at its discretion, hold in abeyance a removal action pending a
final decision by the Director. The Director shall inform the
laboratory in writing of the decision within sixty days following
receipt of the appeal.
Subpart C--NIST Fastener Laboratory Accreditation Procedures
Sec. 280.200 Introduction.
This subpart sets out the procedures and technical requirements of
the NVLAP Fasteners Testing Program (``the Program'') for the
accreditation of laboratories that test fasteners. Laboratories which
are granted accreditation under this program for certain tests will be
eligible to provide testing services and test reports required by the
Fastener Quality Act for those tests. Accreditation may be granted to
any laboratory (including: Commercial; manufacturers'; university; and
laboratories located in foreign countries) that demonstrates competence
to provide services according to the criteria specified in this
subpart. It is up to the laboratory to select the areas and specific
tests within each area for its proposed scope of accreditation. A
laboratory may be accredited to test and/or measure fasteners in any
one or more of the areas of chemical, dimensional, nondestructive,
mechanical and physical, or metallography testing. Laboratories located
outside of the U.S. must meet certain additional requirements
including: Additional fees for travel outside the U.S. and provision of
a language translator.
Sec. 280.201 Applicability of part 285, title 15, Code of Federal
Regulations.
As permitted by section 6 of the Act, and for the purposes of that
Act only, the provisions of part 285, title 15 of the Code of Federal
Regulations are superseded by the procedures and requirements set forth
in this Subpart. The provisions of part 285, title 15 of the Code of
Federal Regulations remain in effect except as they pertain to
laboratory accreditation actions required by the Act.
Sec. 280.202 Establishment of the Program.
(a) NVLAP shall develop the technical requirements for the Program
based on expert advice.
(b) As a means of assuring effective and meaningful cooperation,
input, and participation by those federal agencies that may have an
interest in and may be affected by the Program, NVLAP may communicate
and consult with appropriate officials within those agencies.
(c) When NVLAP has completed the development of the technical
requirements of the Program and established a schedule of fees for
accreditation, NVLAP shall publish a notice in the Federal Register
announcing the establishment of the Program.
(d) The notice will:
(1) Identify the scope of the Program;
(2) Advise how to apply for accreditation.
(e) NVLAP shall establish fees in amounts that will enable the
Program to be self-sufficient. NVLAP shall revise the fees when
necessary to maintain self-sufficiency.
Sec. 280.203 Adding to or modifying the program.
(a) The Program may be added to, modified, or realigned based on
either a written request from any person wishing to add or delete
specific standards, test methods, or types of test methods or a need
identified by NVLAP.
(b) NVLAP may choose to make the additions or modifications
available for accreditation when:
(1) The additional standards, test methods, or types of test
methods requested are directly relevant to the Program;
(2) It is feasible and practical to accredit testing laboratories
for the additional standards, test methods, or types of test methods;
and
(3) It is likely that laboratories will seek accreditation for the
additional standards, test methods, or types of test methods.
Sec. 280.204 NVLAP Program Handbook.
All specific laboratory accreditation requirements and NVLAP
interpretations shall be documented in a program handbook which NVLAP
shall develop and maintain. The handbook shall be made available to all
participating laboratories. NVLAP may prepare a NVLAP Program Handbook
for the Fastener Testing Program for use by applicant and accredited
laboratories. The purpose of the handbook is to provide specific
technical details for fastener testing as they apply to on-site
assessment, proficiency testing, test equipment and facilities, and
scope of accreditation.
Sec. 280.205 Applying for accreditation.
(a) A laboratory may request an application for accreditation in
the Program in accordance with instructions provided in notices
announcing the Program's formal establishment.
(b) Upon receipt of a laboratory's application, NVLAP shall:
(1) Acknowledge receipt of the application;
(2) Request further information, if necessary;
(3) Confirm payment of fees before proceeding with the
accreditation process; and
(4) Specify the next step(s) in the accreditation process.
(c) All laboratory accreditation documents must be in English or
the laboratory seeking accreditation must supply an English translation
of all documents at the time it files its application.
(d) Accreditation of laboratories outside the United States may
require payment of additional traveling expenses for on-site
assessments and proficiency testing.
[[Page 50565]]
Sec. 280.206 Assessing and evaluating a laboratory.
(a) Information used to evaluate a laboratory's compliance with the
conditions for accreditation set out in Sec. 280.214, the criteria for
accreditation set out in Sec. 280.215, and the technical requirements
established will include:
(1) Application and other material submitted by the laboratory
(Sec. 280.214(b)).
(2) On-site assessment reports;
(3) Laboratory performance on proficiency tests;
(4) Laboratory responses to identified deficiencies; and
(5) Technical evaluation.
(b) NVLAP shall arrange the assessment and evaluation of applicant
laboratories in such a way as to minimize potential conflicts of
interest.
(c) NVLAP shall inform each applicant laboratory of any action(s)
that the laboratory must take to qualify for accreditation.
Sec. 280.207 Granting and renewing accreditation.
(a) NVLAP will take action to grant initial accreditation, or
renew, suspend, or propose to deny or revoke accreditation of an
applicant laboratory, based on the degree to which the laboratory
complies with the specific NVLAP requirements. Accreditation shall be
granted for a one year period. Before initial accreditation and every 2
years thereafter, an on-site assessment of each laboratory shall be
conducted to determine compliance with the NVLAP criteria.
(b) If accreditation is granted or renewed, NVLAP shall:
(1) Provide a Certificate of Accreditation and a Scope of
Accreditation to the laboratory;
(2) Provide guidance on referencing the laboratory's accredited
status, and the use of the NVLAP logo by the laboratory and its
clients, as needed; and
(3) Remind the laboratory that accreditation does not relieve it
from complying with applicable federal, state, and local laws and
regulations.
(c) NVLAP shall notify an accredited laboratory at least 30 days
before its accreditation expires advising of the action(s) the
laboratory must take to renew its accreditation.
Sec. 280.208 Denying, suspending, and revoking accreditation.
(a) If NVLAP proposes to deny or revoke accreditation of a
laboratory, NVLAP shall inform the laboratory of the reasons for the
proposed denial or revocation and the procedure for appealing such a
decision.
(b) The laboratory will have 30 days from the date of receipt of
the proposed denial or revocation letter to appeal the decision to the
Director of NIST. If the laboratory appeals the decision to the
Director of NIST, the proposed denial or revocation will be stayed
pending the outcome of the appeal. The proposed denial or revocation
will become final through the issuance of a written decision to the
laboratory in the event that the laboratory does not appeal the
proposed denial or revocation within that 30-day period.
(c) If NVLAP finds that an accredited laboratory has violated the
terms of its accreditation or the provisions of these procedures, NVLAP
may, after consultation with the laboratory, suspend the laboratory's
accreditation, or advise of NVLAP's intent to revoke accreditation. If
accreditation is suspended, NVLAP shall notify the laboratory of that
action stating the reasons for and conditions of the suspension and
specifying the action(s) the laboratory must take to have its
accreditation reinstated.
(d) A laboratory whose accreditation has been denied, revoked,
terminated, or expired, or which has withdrawn its application before
being accredited, may reapply and be accredited if the laboratory:
(1) Completes the assessment and evaluation process; and
(2) Meets the conditions and criteria for accreditation that are
set out in sections 280.214 and 280.215.
(e) Conditions of suspension will include prohibiting the
laboratory from using the NVLAP logo on its test reports during the
suspension period. The determination of NVLAP whether to suspend or to
propose revocation of a laboratory's accreditation will depend on the
nature of the violation(s) of the terms of its accreditation.
Sec. 280.209 Voluntary termination of accreditation.
A laboratory may at any time terminate its participation and
responsibilities as an accredited laboratory by advising NVLAP in
writing of its desire to do so. NVLAP shall terminate the laboratory's
accreditation and shall notify the laboratory stating that its
accreditation has been terminated in response to its request.
Sec. 280.210 Change in status of laboratory.
Accreditation of a laboratory is based on specific conditions and
criteria including the laboratory ownership, location, staffing,
facilities, and configuration. Changes in any of these conditions or
criteria could result in loss of accreditation. NVLAP must be informed
if any of the conditions or criteria for accreditation are changed so
that a determination can be made concerning the status of the
accreditation.
Sec. 280.211 Authorized representative.
The laboratory shall designate an Authorized Representative to sign
the NVLAP application form and commit the laboratory to fulfill the
NVLAP requirements. Only the Authorized Representative can authorize a
change in the scope or nature of the laboratory's application. This
person will receive all correspondence and inquiries from NVLAP. The
Authorized Representative may also be an Approved Signatory. The
laboratory must provide to NVLAP the name and address of the Authorized
Representative and must, within 30 days, notify NVLAP of a change of
Authorized Representative.
Sec. 280.212 Approved signatory.
(a) The laboratory shall designate one or more staff members as
Approved Signatories. Approved Signatories shall be persons with
appropriate responsibility, authority and technical capability within
the organization. The laboratory must maintain a list of Approved
Signatories and make that list available for review during on-site
assessments. The laboratory must provide to NVLAP the name(s) and
address(es) of the Approved Signatory(s) and must, within 30 days,
notify NVLAP of a change of Approved Signatory(s).
(b) The authorized signature of at least one Approved Signatory
must appear on each test reports that is written in compliance with the
Act and endorsed with the NVLAP logo. The approved signatory is
responsible for the technical content of the report and is the person
to be contacted by NVLAP, laboratory clients, or others in case of
questions or problems with the report.
Sec. 280.213 Application of accreditation conditions and criteria.
To become accredited and maintain accreditation, a laboratory must
meet the conditions for accreditation set out in Sec. 280.214, the
criteria set out in Sec. 280.215, and the guidance provided in the
Program Handbook.
Sec. 280.214 Conditions for accreditation.
(a) To become accredited and maintain accreditation, a laboratory
shall agree in writing to:
(1) Be assessed and evaluated initially and on a periodic basis;
(2) Demonstrate, on request that it is able to perform the tests
representative
[[Page 50566]]
of those for which it is seeking accreditation;
(3) Pay all fees;
(4) Participate in proficiency testing as required.
(5) Be capable of performing the tests for which it is accredited
according to the latest version of the test method within one year
after its publication or within another time limit specified by NVLAP;
(6) Limit the representation of the scope of its accreditation to
only those tests or services for which accreditation is granted;
(7) Resolve all deficiencies;
(8) Limit all its work or services for clients to those areas where
competence and capacity are available;
(9) Inform its clients that the laboratory's accreditation or any
of its test reports in no way constitutes or implies product
certification, approval, or endorsement by NIST;
(10) Maintain records of all actions taken in response to testing
complaints for 5 years, as required by Sec. 280.7 of this part;
(11) Maintain an independent decisional relationship between itself
and its clients, affiliates, or other organizations so that the
laboratory's capacity to render test reports objectively and without
bias is not adversely affected;
(12) Report to NVLAP within 30 days any major changes involving the
location, ownership, management structure, authorized representative,
approved signatories, or facilities of the laboratory; and
(13) Return to NVLAP the Certificate of Accreditation and the Scope
of Accreditation for revision or other action should it:
(i) Be requested to do so by NVLAP;
(ii) Voluntarily terminate its accredited status; or
(iii) Become unable to conform to any of these conditions, the
applicable criteria of this Subpart or Sec. 280.215, and related
technical requirements.
(b) To become accredited and maintain accreditation, a laboratory
shall supply, upon request, the following information:
(1) Legal name and full address;
(2) Ownership of the laboratory;
(3) Organization chart defining relationships that are relevant to
performing testing covered in the accreditation request;
(4) General description of the laboratory, including its facilities
and scope of operation;
(5) Name, address, and telephone and FAX number of the authorized
representative of the laboratory;
(6) Names or titles and qualifications of laboratory staff
nominated to serve as approved signatories of test reports that
reference NVLAP accreditation;
(7) The laboratory quality manual; and
(8) Other information as NVLAP may require.
Sec. 280.215 Criteria for accreditation.
(a) Scope. (1) This section sets out the general requirements in
accordance with which a laboratory has to demonstrate that it operates,
if it is to be recognized as competent to carry out specific tests.
(2) Additional requirements and information which have to be
disclosed for assessing competence or for determining compliance with
other criteria may be specified by NVLAP, depending upon the specific
character of the task of the laboratory.
(3) This section is for use by testing laboratories in the
development and implementation of their quality systems. It will also
be used by NVLAP in the determination of the competence of
laboratories.
(b) Organization and management. (1) The laboratory shall be
legally identifiable. It shall be organized and shall operate in such a
way that its permanent, temporary and mobile facilities meet the
requirements of this Subpart.
(2) The laboratory shall:
(i) Have managerial staff with the authority and resources needed
to discharge their duties;
(ii) Have policies to ensure that its personnel are free from any
commercial, financial and other pressures which might adversely affect
the quality of their work;
(iii) Be organized in such a way that confidence in its
independence of judgement and integrity is maintained at all times;
(iv) Specify and document the responsibility, authority and
interrelation of all personnel who manage, perform or verify work
affecting the quality of calibrations and tests;
(v) Provide supervision by persons familiar with the calibration or
test methods and procedures, the objective of the calibration or test
and the assessment of the results. The ratio of supervisory to non-
supervisory personnel shall be such as to ensure adequate supervision;
(vi) Have a technical manager (however named) who has overall
responsibility for the technical operations;
(vii) Have a quality manager (however named) who has responsibility
for the quality system and its implementation. The quality manager
shall have direct access to the highest level of management at which
decisions are taken on laboratory policy or resources, and to the
technical manager. In some laboratories, the quality manager may also
be the technical manager or deputy technical manager;
(viii) Nominate deputies in case of absence of the technical or
quality manager;
(ix) Have documented policy and procedures to ensure the protection
of clients' confidential information and proprietary rights;
(x) Where appropriate, participate in interlaboratory comparisons
and proficiency testing programs.
(c) Quality system, audit and review. (1) The laboratory shall
establish and maintain a quality system appropriate to the type, range
and volume of calibration and testing activities it undertakes. The
elements of this system shall be documented. The quality documentation
shall be available for use by the laboratory personnel. The laboratory
shall define and document its policies and objectives for, and its
commitment to, good laboratory practice and quality of calibration or
testing services. The laboratory management shall ensure that these
policies and objectives are documented in a quality manual and
communicated to, understood, and implemented by all laboratory
personnel concerned. The quality manual shall be maintained current
under the responsibility of the quality manager.
(2) The quality manual, and related quality documentation, shall
state the laboratory's policies and operational procedures established
in order to meet the requirements of this subpart. The quality manual
and related quality documentation shall also contain:
(i) A quality policy statement, including objectives and
commitments, by top management;
(ii) The organization and management structure of the laboratory,
its place in any parent organization and relevant organizational
charts;
(iii) The relations between management, technical operations,
support services and the quality system;
(iv) Procedures for control and maintenance of documentation;
(v) Job descriptions of key staff and reference to the job
descriptions of other staff;
(vi) Identification of the laboratory's approved signatories;
(vii) The laboratory's procedures for achieving traceability of
measurements;
(viii) The laboratory's scope of calibrations and/or tests;
(ix) Arrangements for ensuring that the laboratory reviews all new
work to
[[Page 50567]]
ensure that it has the appropriate facilities and resources before
commencing such work;
(x) Reference to the calibration, verification and/or test
procedures used;
(xi) Procedures for handling calibration and test items;
(xii) Reference to the major equipment and reference measurement
standards used;
(xiii) Reference to procedures for calibration, verification and
maintenance of equipment;
(xiv) Reference to verification practices including interlaboratory
comparisons, proficiency testing programs, use of reference materials
and internal quality control schemes;
(xv) Procedures to be followed for feedback and corrective action
whenever testing discrepancies are detected, or departures from
documented policies and procedures occur;
(xvi) The laboratory management policies for departures from
documented policies and procedures or from standard specifications;
(xvii) Procedures for dealing with complaints;
(xviii) Procedures for protecting confidentiality and proprietary
rights;
(xix) Procedures for audit and review.
(xx) Policies and procedures directly related to compliance with
this Subpart.
(3) The laboratory shall arrange for audits of its activities at
appropriate intervals to verify that its operations continue to comply
with the requirements of the quality system. Such audits shall be
carried out by trained and qualified staff who are, wherever possible,
independent of the activity to be audited. Where the audit findings
cast doubt on the correctness or validity of the laboratory's
calibration or test results, the laboratory shall take immediate
corrective action and shall immediately notify, in writing, any client
whose work may have been affected.
(4) The quality system adopted to satisfy the requirements of this
Section shall be reviewed at least once each year by the management to
ensure its continuing suitability and effectiveness and to introduce
any necessary changes or improvements.
(5) All audit and review findings and any corrective actions that
arise from them shall be documented. The person responsible for quality
shall ensure that these actions are discharged within the agreed
timescale.
(6) In addition to periodic audits the laboratory shall ensure the
quality of results provided to clients by implementing checks. These
checks shall be reviewed and shall include, as appropriate, but not be
limited to:
(i) Internal quality control schemes using whenever possible
statistical techniques;
(ii) Participation in proficiency testing or other interlaboratory
comparisons;
(iii) Regular use of certified reference materials and/or in-house
quality control using secondary reference materials;
(iv) Replicate testings using the same or different methods;
(v) Re-testing of retained items;
(vi) Correlation of results for different characteristics of an
item.
(d) Personnel. (1) The testing laboratory shall have sufficient
personnel, having the necessary education, training, technical
knowledge and experience for their assigned functions.
(2) The testing laboratory shall ensure that the training of its
personnel is kept up-to-date.
(3) Records on the relevant qualifications, training, skills and
experience of the technical personnel shall be maintained by the
laboratory.
(e) Accommodation and environment. (1) Laboratory accommodation,
calibration and test areas, energy sources, lighting, heating and
ventilation shall be such as to facilitate proper performance of
calibrations or tests.
(2) The environment in which these activities are undertaken shall
not invalidate the results or adversely affect the required accuracy of
measurement. Particular care shall be taken when such activities are
undertaken at sites other than the permanent laboratory premises.
(3) The laboratory shall provide facilities for the effective
monitoring, control and recording of environmental conditions as
appropriate. Due attention shall be paid, for example, to biological
sterility, dust, electromagnetic interference, humidity, voltage,
temperature, and sound and vibration levels, as appropriate to the
calibrations or tests concerned.
(4) There shall be effective separation between neighboring areas
when the activities therein are incompatible.
(5) Access to and use of all areas affecting the quality of these
activities shall be defined and controlled.
(6) Adequate measures shall be taken to ensure good housekeeping in
the laboratory.
(f) Equipment and reference materials. (1) The laboratory shall be
furnished with all items of equipment (including reference materials)
required for the correct performance of calibrations and tests. In
those cases where the laboratory needs to use equipment outside its
permanent control it shall ensure that the relevant requirements of
this Section are met.
(2) All equipment shall be properly maintained. Maintenance
procedures shall be documented. Any item of equipment which has been
subjected to overloading or mishandling, or which gives suspect
results, or has been shown by verification or otherwise to be
defective, shall be taken out of service, clearly identified and
wherever possible stored at a specified place until it has been
repaired and shown by calibration, verification or test to perform
satisfactorily. The laboratory shall examine the effect of this defect
on previous calibrations or tests.
(3) Each item of equipment including reference materials shall,
when appropriate, be labeled, marked or otherwise identified to
indicate its calibration status.
(4) Records shall be maintained of each item of equipment and all
reference materials significant to the calibrations or tests performed.
The records shall include:
(i) The name of the item of equipment;
(ii) The manufacturer's name, type identification, and serial
number or other unique identification;
(iii) Date received and date placed in service;
(iv) Current location, where appropriate;
(v) Condition when received (e.g. new, used, reconditioned);
(vi) Copy of the manufacturer's instructions, where available;
(vii) Dates and results of calibrations and/or verifications and
date of next calibration and/or verification;
(viii) Details of maintenance carried out to date and planned for
the future;
(ix) History of any damage, malfunction, modification or repair.
(g) Measurement traceability and calibration. (1) All measuring and
testing equipment having an effect on the accuracy or validity of
calibrations or tests shall be calibrated and/or verified before being
put into service. The laboratory shall have an established program for
the calibration and verification of its measuring and test equipment.
(2) The overall program of calibration and/or verification and
validation of equipment shall be designed and operated so as to ensure
that, wherever applicable, measurements made by the laboratory are
traceable to national standards of measurement where available.
Calibration certificates shall wherever applicable indicate the
traceability to national standards of measurement and shall provide the
[[Page 50568]]
measurement results and associated uncertainty of measurement and/or a
statement of compliance with an identified metrological specification.
(3) Where traceability to national standards of measurement is not
applicable, the laboratory shall provide satisfactory evidence of
correlation of results, for example by participation in a suitable
program of interlaboratory comparisons or proficiency testing.
(4) Reference standards of measurement held by the laboratory shall
be used for calibration only and for no other purpose, unless it can be
demonstrated that their performance as reference standards has not been
invalidated.
(5) Reference standards of measurement shall be calibrated by a
body that can provide traceability to a national standard of
measurement. There shall be a program of calibration and verification
for reference standards.
(6) Where relevant, reference standards and measuring and testing
equipment shall be subjected to in-service checks between calibrations
and verifications.
(7) Reference materials shall, where possible, be traceable to
national or international standards of measurement, or to national or
international standard reference materials.
(h) Calibration and test methods. (1) The laboratory shall have
documented instructions on the use and operation of all relevant
equipment, on the handling and preparation of items and for calibration
and/or testing, where the absence of such instructions could jeopardize
the calibrations or tests. All instructions, standards, manuals and
reference data relevant to the work of the laboratory shall be
maintained up-to-date and be readily available to the staff.
(2) The laboratory shall use appropriate methods and procedures for
all calibrations and tests and related activities within its
responsibility (including sampling, handling, transport and storage,
preparation of items, estimation of uncertainty of measurement and
analysis of calibration and/or test data). They shall be consistent
with the accuracy required, and with any standard specifications
relevant to the calibrations or tests concerned.
(3) Where methods are not specified, the laboratory shall, wherever
possible, select methods that have been published in international or
national standards, those published by reputable technical
organizations or in relevant scientific texts or journals.
(4) Where it is necessary to employ methods that have not been
established as standard, these shall be subject to agreement with the
client, be fully documented and validated, and be available to the
client and other recipients of the relevant reports.
(5) Where sampling is carried out as part of the test method, the
laboratory shall use documented procedures and appropriate statistical
techniques to select samples.
(6) Calculations and data transfers shall be subject to appropriate
checks.
(7) Where computers or automated equipment are used for the
capture, processing, manipulation, recording, reporting, storage or
retrieval of calibration or test data, the laboratory shall ensure
that:
(i) The requirements of this subpart are complied with;
(ii) Computer software is documented and adequate for use;
(iii) Procedures are established and implemented for protecting the
integrity of data; such procedures shall include, but not be limited
to, integrity of data entry or capture, data storage, data transmission
and data processing;
(iv) Computer and automated equipment is maintained to ensure
proper functioning and provided with the environmental and operating
conditions necessary to maintain the integrity of calibration and test
data;
(v) It establishes and implements appropriate procedures for the
maintenance of security of data including the prevention of
unauthorized access to, and the unauthorized amendment of, computer
records.
(8) Documented procedures shall exist for the purchase, reception
and storage of consumable materials used for the technical operations
of the laboratory.
(i) Handling of calibration and test items. (1) The laboratory
shall have a documented system for uniquely identifying the items to be
calibrated or tested, to ensure that there can be no confusion
regarding the identity of such items at any time.
(2) Upon receipt, the condition of the calibration or test item,
including any abnormalities or departures from standard conditions as
prescribed in the relevant calibration or test method, shall be
recorded. Where there is any doubt as to the item's suitability for
calibration or test, where the item does not conform to the description
provided, or where the calibration or test required is not fully
specified, the laboratory shall consult the client for further
instruction before proceeding. The laboratory shall establish whether
the item has received all necessary preparation, or whether the client
requires preparation to be undertaken or arranged by the laboratory.
(3) The laboratory shall have documented procedures and appropriate
facilities to avoid deterioration or damage to the calibration or test
item, during storage, handling, preparation, and calibration or test;
any relevant instructions provided with the item shall be followed.
Where items have to be stored or conditioned under specific
environmental conditions, these conditions shall be maintained,
monitored and recorded where necessary. Where a calibration or test
item or portion of an item is to be held secure (for example, for
reasons of record, safety or value, or to enable check calibrations or
tests to be performed later), the laboratory shall have storage and
security arrangements that protect the condition and integrity of the
secured items or portions concerned.
(4) The laboratory shall have documented procedures for the
receipt, retention or safe disposal of calibration or test items,
including all provisions necessary to protect the integrity of the
laboratory.
(j) Records. (1) The laboratory shall maintain a record system to
suit its particular circumstances and comply with any applicable
regulations. It shall retain on record all original observations,
calculations and derived data, calibration records and a copy of the
calibration certificate, test certificate or test report for an
appropriate period as required in Sec. 280.7. The records for each
calibration and test shall contain sufficient information to permit
their repetition. The records shall include the identity of personnel
involved in sampling, preparation, calibration or testing.
(2) All records (including those listed in Sec. 280.215(f)(4)
pertaining to calibration and test equipment), certificates and reports
shall be safely stored, held secure and in confidence to the client.
(k) Certificates and reports. (1) The results of each calibration,
test, or series of calibrations or tests carried out by the laboratory
shall be reported accurately, clearly, unambiguously and objectively,
in accordance with any instructions in the calibration or test methods.
The results should normally be reported in a calibration certificate,
test report or test certificate and should include all the information
necessary for the interpretation of the calibration or test results and
all information required by the method used.
(2) Where the certificate or report contains results of
calibrations or tests
[[Page 50569]]
performed by sub-contractors, these results shall be clearly
identified.
(3) Particular care and attention shall be paid to the arrangement
of the certificate or report, especially with regard to presentation of
the calibration or test data and ease of assimilation by the reader.
The format shall be carefully and specifically designed for each type
of calibration or test carried out, but the headings shall be
standardized as far as possible.
(4) Material amendments to a calibration certificate, test report
or test certificate after issue shall be made only in the form of a
further document, or data transfer including the statement ``Supplement
to Calibration Certificate for Test Report or Test Certificate, serial
number * * * or as otherwise identified'', or equivalent form of
wording. Such amendments shall meet all the relevant requirements of
Sec. 280.215(j).
(5) The laboratory shall notify clients promptly, in writing, of
any event such as the identification of defective measuring or test
equipment that casts doubt on the validity of results given in any
calibration certificate, test report or test certificate or amendment
to a report or certificate.
(6) The laboratory shall ensure that, where clients require
transmission of calibration or test results by telephone, telex,
facsimile or other electronic or electromagnetic means, staff will
follow documented procedures that ensure that the requirements of this
Subpart are met and that confidentiality is preserved.
(l) Subcontracting of calibration or testing. (1) Where a
laboratory sub-contracts any part of the calibration or testing, this
work shall be placed with a laboratory accredited under either subparts
C, D or E of this part for the specific tests being subcontracted. The
laboratory shall comply with Sec. 280.9, and shall advise the client in
writing of its intention to subcontract any portion of the testing to
another party.
(2) The laboratory shall record and retain details of its
investigation of the accredited status and testing competence of
subcontractors and maintain a register of all subcontracting.
(m) Outside support services and supplies. (1) Where the laboratory
procures outside services and supplies, other than those referred to
this Subpart, in support of calibrations or tests, the laboratory shall
use only those outside support services and supplies that are of
adequate quality to sustain confidence in the laboratory's calibrations
or tests.
(2) Where no independent assurance of the quality of outside
support services or supplies is available, the laboratory shall have
procedures to ensure that purchased equipment, materials and services
comply with specified requirements. The laboratory should, wherever
possible, ensure that purchased equipment and consumable materials are
not used until they have been inspected, calibrated or otherwise
verified as complying with any standard specifications relevant to the
calibrations or tests concerned.
(3) The laboratory shall maintain records of all suppliers from
whom it obtains support services or supplies required for calibrations
or tests.
(n) Complaints. (1) The laboratory shall have documented policy and
procedures for the resolution of complaints received from clients or
other parties about the laboratory's activities. A record shall be
maintained of all complaints and of the actions taken by the
laboratory.
(2) Where a complaint, or any other circumstance, raises doubt
concerning the laboratory's compliance with the laboratory's policies
or procedures, or with the requirements of this section or otherwise
concerning the quality of the laboratory's calibrations or tests, the
laboratory shall ensure that those areas of activity and responsibility
involved are promptly audited in accordance with this section.
Subpart D--NIST Approval of Private Accreditation Programs
Sec. 280.300 Introduction.
In accordance with section 6(a)(1)(B) of the Act (15 U.S.C. 5405
(a)(1)(B)), this subpart sets forth the procedures and conditions under
which private entities may apply for approval by NIST to engage
directly in the accreditation of laboratories for the testing of
fasteners under the Act.
Sec. 280.301 Application.
(a) Application must be made to NIST for approval to accredit
laboratories for fastener testing under the Act. Upon request, NIST
will provide application forms and instructions. The applicant shall
complete the application in English and may provide whatever additional
enclosures, attachments or exhibits the applicant deems appropriate.
(b) Application packages may be obtained from: Manager, FQA
Accreditation Body Evaluation Program, NIST, Bldg. 820, Room 282,
Gaithersburg, Maryland, 20899. Requests may be made by mail or by FAX
to: (301) 963-2871.
(c) The applicant shall reimburse NIST for all costs incurred in
the evaluation of its accreditation program and subsequent costs
incurred in ensuring the continued compliance of its program.
Reimbursement shall be in accordance with the fee schedule established
by NIST for this purpose.
(d) An application may be revised by an applicant at any time prior
to the final decision by NIST. An application may be withdrawn by an
applicant, without prejudice, at any time prior to the final decision
by the Director.
Sec. 280.302 Review and decision process.
(a) Applications submitted by private laboratory accreditation
bodies will be accepted by NIST and their receipt acknowledged in
writing. The applications will be reviewed by NIST against the criteria
specified in this subpart and in subpart F of this part. NIST may
request additional information as needed from the applicant.
(b) NIST shall conduct on-site assessments of the facilities of the
applicant including all of the applicant's organizational units and
locations covered by the application.
(c) If the applicant's program is deemed by NIST to have met the
requirements for approval, the applicant shall be notified by NIST in
writing. The approval notice shall include the dates when the approval
begins and the scope of the approval. The approval period shall be for
as long as the laboratory accreditation body continues to satisfy the
requirements of Sec. 280.303. As part of maintaining its approved
status, each laboratory accreditation body shall agree to be reassessed
by NIST every two years following its initial notice of approval. NIST
will maintain and make available to the public a list of approved
fastener accreditation programs.
(d) If the applicant's program does not meet the requirements for
approval, the applicant shall be notified in writing, listing the
specific requirements from this subpart and subpart F of this part
which the applicant's program has not met. After receipt of such a
notification, and within the response period provided by NIST, the
applicant may:
(1) Submit additional information for further review. Reviewing the
new submission may involve additional on-site visits by NIST personnel.
Additional fees may be required. Or,
(2) Submit a request that the original application be reconsidered,
including a statement of reasons why the application should have been
approved.
Sec. 280.303 Criteria for approval.
An applicant for NIST approval must demonstrate the ability to
operate an accreditation program consistent with the requirements of
this subpart and subparts A, B and F of this part.
[[Page 50570]]
Sec. 280.304 Maintaining approved status.
(a) Approved accreditation bodies shall continue to satisfy all the
requirements of approval during the approval period.
(b) Upon request by NIST, approved accreditation bodies shall make
available to NIST and BXA all records and materials pertaining to the
program.
(c) NIST may elect to have its representative participate as an
observer during on-site visits to testing laboratories seeking
accreditation by an approved accreditation body.
(d) Neither the accreditation body, nor any laboratory it accredits
under the Act and these regulations shall take any action which states
or implies the approval, or endorsement by NIST or any other agency of
the U.S. government of the results of tests carried out by such
laboratories. In addition, neither the accreditation body, nor any
laboratory it accredits under the Act and these regulations shall take
any action which states or implies that the accreditation body or its
accredited laboratories are recognized by NIST in any testing or other
area(s) beyond those for which NIST has approved the accreditation body
under this regulation. Approved accreditation bodies shall not engage
in misrepresentation of the scope or conditions of its approval by
NIST.
Sec. 280.305 Voluntary termination of approval.
At any time, an accreditation body may voluntarily terminate its
program's approval by giving written notice to NIST and to all
laboratories accredited by that body under its fastener laboratory
accreditation program. The written notice shall state the date on which
the termination will take effect.
Sec. 280.306 Involuntary termination of approval by NIST.
(a) NIST may terminate or suspend its approval of an accreditation
body if such an action is deemed to be in the public interest.
(b) Before terminating the approval of an accreditation body, NIST
will notify the accreditation body in writing, giving it the
opportunity to rebut or correct the stated reasons for the proposed
termination. If the problems are not corrected or reconciled within 30
days, or such longer time as NIST in its sole discretion may grant, the
termination shall become effective.
(c) An accreditation body may appeal a termination to the Director
by submitting a statement of reasons why the approval should not be
terminated. NIST may, at its discretion, hold in abeyance the
termination action pending a final decision by the Director. Within
sixty days following receipt of the appeal, the Director shall inform
the accreditation body in writing of his or her decision.
(d) Fastener testing laboratories which have been listed by NIST in
accordance with subpart B of this part, based on their accreditation by
an accreditation body whose approval has terminated, shall be removed
from the list, unless an exception is granted by NIST.
Subpart E--Recognition of Foreign Laboratories
Sec. 280.400 Introduction.
In accordance with section 6(a)(1)(C) of the Act, this subpart sets
forth the conditions under which the accreditation of foreign
laboratories by their governments, by organizations acting on behalf of
their governments, or by organizations recognized by the Director shall
be deemed to meet the requirements of the Act.
Sec. 280.401 Recognition of foreign laboratories.
Foreign entities wishing to be recognized to accredit fastener
testing laboratories must submit an application for evaluation to NIST.
NIST recognition is limited to bodies that accredit laboratories
performing tests on materials or fasteners covered by the Act. To be
recognized by NIST, accredited foreign laboratories must meet
conditions set out in subpart C of this part, and applicable laboratory
accreditation bodies must meet conditions set out in subparts D and F
of this part.
Subpart F--Requirements for Fastener Laboratory Accreditation
Bodies
Sec. 280.500 Introduction.
This subpart sets out organizational, operational and other
requirements that must be met by all accreditation bodies approved or
recognized (hereafter ``approved/recognized'') by NIST under subpart D
or E of this part. This subpart also sets out the requirements against
which an approved/recognized accreditation body assesses the technical
competence of an applicant testing laboratory. These requirements
include conditions with respect to subpart C of this part.
Sec. 280.501 Accreditation bodies.
(a) General provisions. (1) The procedures under which an approved/
recognized accreditation body operates shall be administered in a non-
discriminatory manner. Access to an accreditation system operated by an
approved/recognized accreditation body shall not be conditional upon
the size of the laboratory or membership in any association or group,
nor shall there be undue financial conditions to restrict
participation.
(2) The competence of an applicant laboratory shall be assessed by
an approved/recognized accreditation body against requirements
consistent with the conditions set out in subpart C of this part.
(3) The requirements of Sec. 280.501(a)(2) may have to be
interpreted for a specific test or type of test by an approved/
recognized accreditation body. These interpretations shall be
formulated by relevant and impartial committees or persons possessing
the necessary technical competence. They shall be published by the
accreditation body.
(4) An approved/recognized accreditation body shall require
accredited laboratories to maintain impartiality and integrity.
(5) An approved/recognized accreditation body shall confine its
requirements, assessment and decision on accreditation to those matters
specifically related to the scope of the accreditation being
considered.
(b) Organization of an approved/recognized accreditation body
(1) An approved/recognized accreditation body shall:
(i) Be a legally identifiable, public or private entity;
(ii) Have rights and responsibilities relevant to its accreditation
activities;
(iii) Have adequate arrangements to cover liabilities arising from
its operations and/or activities;
(iv) Have the financial stability and resources required for the
operation of an accreditation system;
(v) Have and make available on request a description of the means
by which it receives its financial support;
(vi) Employ a sufficient number of personnel having the necessary
education, training, technical knowledge and experience for handling
the type, range and volume of work performed, under a senior executive
who is responsible to the organization, body or board to which it
reports;
(vii) Have a quality system including an organizational structure,
that enables it to give confidence in its ability to operate a
laboratory accreditation system satisfactorily;
(viii) Have documented policies and procedures for the operation of
the quality system that include:
(A) Policies and decision-making procedures that distinguish
between laboratory accreditation and any other activities in which the
body is engaged;
(B) Policies and procedures for the resolution of complaints and
appeals
[[Page 50571]]
received from laboratories about the handling of accreditation matters,
or from users of services about accredited laboratories or any other
matters;
(ix) Together with its senior executive, and staff, be free from
any commercial, financial and other pressures which might influence the
results of the accreditation process;
(x) Have formal rules and structures for the appointment and
operation of committees involved in the accreditation process; such
committees shall be free from any commercial, financial and other
pressures that might influence decisions or shall have a structure
where members are chosen to provide impartiality through a balance of
interest where no single interest predominates;
(xi) Establish one or more technical committees, each responsible,
within its scope, for advising the accreditation body on the technical
matters relating to the operation of its accreditation system;
(xii) Not offer consultancies or other services which may
compromise the objectivity of its accreditation process and decisions;
(xiii) Have arrangements that are consistent with applicable laws,
to safeguard, at all levels of its organization (including committees),
confidentiality of the information obtained relating to applications,
assessment and accreditation of laboratories;
(2) An approved/recognized accreditation body shall have
arrangements for either controlling the ownership, use and display of
the accreditation documents or controlling the manner in which an
accredited laboratory may refer to its accredited status, or both.
(c) Quality system. (1) An approved/recognized accreditation body
shall operate a quality system appropriate to the type, range and
volume of work performed. This system shall be documented and the
documentation shall be available for use by the accreditation body
staff. The accreditation body shall designate a person having direct
access to its highest executive level, to take responsibility for the
quality system and the maintenance of the quality documentation.
(2) The quality system shall be documented in a quality manual and
associated quality procedures, and the quality manual shall contain or
refer to at least the following;
(i) A quality policy statement;
(ii) The organizational structure of the accreditation body;
(iii) The operational and functional duties and services pertaining
to quality, so that each person concerned will know the extent and the
limits of their responsibility;
(iv) Administrative procedures including document control;
(v) Policies and procedures to implement the accreditation process;
(vi) Arrangements for feedback and corrective actions whenever
discrepancies are detected;
(vii) The policy and procedures for dealing with appeals,
complaints and disputes;
(viii) The policy and procedures for conducting internal audits;
(ix) The policy and the procedures for conducting quality system
reviews;
(x) The policy and the procedures for the recruitment and training
of assessors and monitoring their performance.
(3) An approved/recognized accreditation body shall audit its
activities to verify that they comply with the requirements of the
quality system. The quality system shall also be reviewed to ensure its
continued effectiveness. Audits and reviews shall be carried out
systematically and periodically and recorded together with details of
any corrective actions taken.
(4) An approved/recognized accreditation body shall maintain
records to demonstrate that accreditation procedures have been
effectively fulfilled, particularly with respect to application forms,
assessment reports, and reports relating to granting, maintaining,
extending, suspending or withdrawing accreditation. These accreditation
documents shall form part of the record.
(5) An approved/recognized accreditation body shall have a policy
and procedures for retaining records. The records shall be retained for
a period of at least 5 years, and shall be available to NIST personnel
and other persons considered by the accreditation body to have a right
of access to these records.
(d) Granting, maintaining, extending, suspending, and withdrawing
accreditation. (1) An approved/recognized accreditation body shall
specify the conditions for granting, maintaining and extending
accreditation and the conditions under which accreditation may be
suspended or withdrawn, partially or in total for all or part of the
laboratory's scope of accreditation.
(2) An approved/recognized accreditation body shall have
arrangements to grant, maintain, suspend or withdraw accreditation,
increase or reduce the scope of accreditation or require reassessment,
in the event of changes affecting the laboratory's activity and
operation, such as changes in personnel or equipment, or if analysis of
a complaint or any other information indicates that the laboratory no
longer complies with the requirements of the accreditation body.
(3) An approved/recognized accreditation body shall have
arrangements relating to the transfer of accreditation when the legal
status (e.g. ownership) of the accredited laboratory changes.
(e) Documentation. An approved/recognized accreditation body shall
provide (through publications, electronic media or other means), update
at adequate intervals, and make available on request:
(1) Information about the authority under which accreditation
systems operated by the accreditation body were established and
specifying whether they are mandatory or voluntary;
(2) A document containing its requirements for accreditation in
accordance with this document;
(3) A document stating the arrangements for granting, maintaining,
extending, suspending and withdrawing accreditation;
(4) Information about the assessment and accreditation process;
(5) General information on the fees charged to applicant and
accredited laboratories;
(6) A description of the rights and duties of accredited
laboratories as specified in Sec. 280.504 of this part, including
requirements, restrictions or limitations on the use of the accrediting
body's logo and on the ways of referring to the accreditation granted.
Sec. 280.502 Laboratory assessors.
(a) Requirements for assessors. The assessor or assessment team
appointed to assess a laboratory shall:
(1) Be familiar with the relevant legal regulations, accreditation
procedures and accreditation requirements;
(2) Have a thorough knowledge of the relevant assessment method and
assessment documents;
(3) Have appropriate technical knowledge of the specific tests or
types of tests for which accreditation is sought and, where relevant,
with the associated sampling procedures;
(4) Be able to communicate effectively, both in writing and orally;
(5) Be free of any commercial, financial or other pressures or
conflicts of interest that might cause assessor(s) to act in other than
an impartial or non-discriminatory manner;
(6) Not have offered consultancies to laboratories which might
compromise their impartiality in the accreditation process and
decisions.
(b) Qualification procedures for assessors. An approved/recognized
[[Page 50572]]
accreditation body shall have an adequate procedure for:
(1) Qualifying assessors, comprising an assessment of their
competence and training, and attendance at one or more actual
assessments with a qualified assessor, and
(2) Monitoring the performance of assessors.
(c) Contracting of assessors. An approved/recognized accreditation
body shall require the assessors to sign a contract or other document
by which they commit themselves to comply with the rules defined by the
accreditation body, including those relating to confidentiality and
those relating to independence from commercial and other interests, and
any prior association with laboratories to be assessed.
(d) Assessor records. An approved/recognized accreditation body
shall possess and maintain up-to-date records on assessors consisting
of:
(1) Name and address;
(2) Organization affiliation and position held;
(3) Educational qualification and professional status;
(4) Work experience;
(5) Training in quality assurance, assessment and calibration and
testing;
(6) Experience in laboratory assessment, together with field of
competence;
(7) Date of most recent updating of record.
(e) Procedures for assessors. Assessors shall be provided with an
up-to-date set of procedures giving assessment instructions and all
relevant information on accreditation arrangements.
Sec. 280.503 Accreditation process.
(a) Application for accreditation. (1) A detailed description of
the assessment and accreditation procedure, the documents containing
the requirements for accreditation and documents describing the rights
and duties of accredited laboratories (including fees to be paid by
applicant and accredited laboratories) shall be maintained up-to-date
and given to applicant laboratories.
(2) Additional relevant information shall be provided to applicant
laboratories on request.
(3) A duly authorized representative of the applicant laboratory
shall be required to sign an official application form, in which or
attached to which
(i) The scope of the desired accreditation is clearly defined;
(ii) The applicant's representative agrees to fulfill the
accreditation procedure, especially to receive the assessment team, to
pay the fees charged to the applicant laboratory whatever the result of
the assessment may be, and to accept the charges of subsequent
maintenance of the accreditation of the laboratory;
(iii) the applicant agrees to comply with the requirements for
accreditation and to supply any information needed for the evaluation
of the laboratory.
(4)(i) The following minimum information shall be provided by the
applicant laboratory prior to the on-site assessment:
(A) The general features of the applicant laboratory (corporate
entity: Name, address, legal status, human and technical resources);
(B) General information concerning the laboratory covered by the
application, such as primary function, relationship in a larger
corporate entity and, If applicable, physical location of laboratories
involved;
(C) A definition of the materials or products tested, the methods
used and the tests performed;
(D) A copy of the laboratory's quality manual and, where required,
the associated documentation.
(ii) The information gathered shall be used for the preparation of
on-site assessment and shall be treated with appropriate
confidentiality.
(b) Assessment. (1) An approved/recognized accreditation body shall
appoint qualified assessor(s) to evaluate all material collected from
the applicant and to conduct the assessment on its behalf at the
laboratory and any other sites where activities to be covered by the
accreditation are performed.
(2) To ensure that a comprehensive and correct assessment is
carried out, each assessor shall be provided with the appropriate
working documents.
(3) The date of assessment shall be mutually agreed with the
applicant laboratory. The latter shall be informed of the name(s) of
the qualified assessor(s) nominated to carry out the assessment, with
sufficient notice so that the laboratory is given an opportunity to
appeal against the appointment of any particular assessor.
(4) The assessor(s) shall be formally appointed. A lead assessor
shall be appointed, if relevant. The mandate given to the assessor(s)
shall be clearly defined and made known to the applicant laboratory.
(c) Sub-contracting of assessment. (1) If an approved/recognized
accreditation body decides to delegate fully or partially the
assessment of a laboratory to another body, then the accreditation body
shall take full responsibility for such an assessment made on its
behalf.
(2) An approved/recognized accreditation body shall ensure that the
party to which assessment has been delegated is approved/recognized by
NIST.
(d) Assessment report. (1) An approved/recognized accreditation
body may adopt reporting procedures that suit its needs but as a
minimum these procedures shall ensure that:
(i) A meeting takes place between the assessor or assessment team
and the laboratory management prior to leaving the laboratory at which
the assessment team provides a written or oral report on the compliance
of the applicant laboratory with the accreditation requirements;
(ii) The assessor or assessment team provides the accreditation
body with a detailed assessment report containing all relevant
information concerning the ability of the applicant laboratory to
comply with all of the accreditation requirements, including any which
may come about from the results of proficiency testing;
(iii) A report on the outcome of the assessment is promptly brought
to the applicant laboratory's notice by the accreditation body,
identifying any non-compliances that have to be discharged in order to
comply with all of the accreditation requirements. The laboratory shall
be invited to present its comments on this report and to describe the
specific actions taken, or planned to be taken within a defined time,
to remedy any non-compliances with the accreditation requirements
identified during the assessment.
(2) The final report authorized by an approved/recognized
accreditation body and submitted to the laboratory, if it is different,
shall include as a minimum:
(i) Date(s) of assessment(s);
(ii) The names of the person(s) responsible for the report;
(iii) The names and addresses of all the laboratory sites assessed;
(iv) The assessed scope of accreditation or reference thereto;
(v) comments of the assessor(s) or assessment team on the
compliance of the applicant laboratory with the accreditation
requirements.
(3) The reports shall take into consideration:
(i) The technical qualification, experience and authority of the
staff encountered, especially the persons responsible for the technical
validity of test reports or test certificates;
(ii) The adequacy of the internal organization and procedures
adopted by the applicant laboratory to give confidence in the quality
of its services, the physical facilities, i.e., the environment and the
calibration/test equipment of the laboratory including maintenance and
calibration having
[[Page 50573]]
regard to the volume of work undertaken;
(iii) Proficiency testing or other interlaboratory comparison
performed by the applicant laboratory, the results of this proficiency
testing, and the use of these results by the laboratory;
(iv) The actions taken to correct any non-compliances identified at
previous assessments.
(e) Decision on accreditation. (1) The decision whether or not to
accredit a laboratory shall be taken by an approved/recognized
accreditation body on the basis of the information gathered during the
accreditation process.
(2) An approved/recognized accreditation body shall not delegate
its responsibility for granting, maintaining, extending, suspending or
withdrawing accreditation.
(f) Granting accreditation. (1) An approved/recognized
accreditation body shall transmit to each accredited laboratory formal
accreditation documents such as a letter or a certificate signed by an
officer who has been assigned such responsibility. These formal
accreditation documents shall permit identification of--
(i) The name and address of the laboratory that has been
accredited;
(ii) The scope of the accreditation including:
(A) The tests or types of test for which accreditation has been
granted;
(B) For tests, the materials or products tested, the methods used
and the tests performed;
(C) For specific tests for which accreditation has been granted the
methods used defined by written standards or reference documents that
have been accepted by the accreditation body.
(iii) Where appropriate, the persons recognized by the
accreditation body as being responsible for the test certificates or
the test reports;
(iv) The term of accreditation which shall be valid for a period
not to exceed three years;
(v) The accredited laboratory by a unique number.
(2) An approved/recognized accreditation body shall furnish
notification to NIST required by Subpart B of this part.
(g) Surveillance and reassessment of accredited laboratories. (1)
An approved/recognized accreditation body shall have an established
documented program consistent with the accreditation granted for
carrying out periodic surveillance and reassessment at sufficiently
close intervals to ensure that its accredited laboratories continue to
comply with the accreditation requirements.
(2) Surveillance and reassessment procedures shall be consistent
with those concerning the assessment of laboratories as described in
this Subpart.
(h) Proficiency testing. (1) The approved/recognized accreditation
body shall require each fastener testing laboratory it accredits, and
each laboratory which has applied to it for accreditation to
participate in proficiency testing comparable to that conducted under
Subpart C of this part by NVLAP.
(2) Although an accreditation shall not be granted or maintained
only on the basis of the results of proficiency testing, accreditation
shall not be granted or maintained if required proficiency testing
participation is unsatisfactory.
(i) Certificates or reports issued by accredited laboratories. (1)
An approved/recognized accreditation body shall normally allow an
accredited laboratory to refer to its accreditation in test reports and
test certificates that contain only the results of tests or types of
test for which accreditation is held.
(2) An approved/recognized accreditation body shall have a policy
that defines the circumstances in which accredited laboratories are
permitted to include in test reports or test certificates, the results
of tests for which accreditation is not held and the results of sub-
contracted tests.
Sec. 280.504 Relationship between approved/recognized accreditation
body and laboratory.
(a) An approved/recognized accreditation body shall have
arrangements to ensure that the laboratory and its representatives
afford such accommodation and co-operation as is necessary, to enable
the accreditation body to verify compliance with the requirements for
accreditation. These arrangements shall include provision for
examination of documentation and access to all testing areas, records
and personnel for the purposes of assessment, surveillance,
reassessment and resolution of complaints.
(b) An approved/recognized accreditation body shall require that an
accredited laboratory--
(1) At all times complies with the relevant provisions of these
regulations;
(2) Claims that it is accredited only in respect of services for
which it has been granted accreditation and which are carried out in
accordance with these conditions;
(3) Pays such fees as shall be determined by the accreditation
body;
(4) Does not use its accreditation in such a manner as to bring the
accreditation body into disrepute and does not make any statement
relevant to its accreditation which the accreditation body may consider
misleading or unauthorized;
(5) Upon suspension or withdrawal of its accreditation (however
determined) forthwith discontinues its use of all advertising matter
that contains any reference thereto and return any certificates of
accreditation to the accreditation body;
(6) Does not use its accreditation to state or imply any product
approval by the accreditation body or any agency of the United States
Government;
(7) Endeavors to ensure that no certificate or report nor any part
thereof is used in a misleading manner;
(8) In making reference to its accreditation status in
communication media such as advertising, brochures or other documents,
complies with the requirements of the accreditation body.
(c) Notification of change. (1) An approved/recognized
accreditation body shall have arrangements to ensure that an accredited
laboratory informs it without delay of changes in any aspect of the
laboratory's status or operation that affects the laboratory's:
(i) Legal, commercial or organizational status;
(ii) Organization and management, e.g., key managerial staff;
(iii) Policies or procedures, where appropriate;
(iv) Premises;
(v) Personnel, equipment, facilities, working environment or other
resources, where significant;
(vi) Authorized signatories;
(vii) Or other such matters that may affect the laboratory's
capability, or scope of accredited activities, or compliance with the
requirements in this document or any other relevant criteria of
competence specified by the accreditation body.
(2) Upon receipt of due notice of any intended changes relating to
the requirements of this document, the relevant criteria of competence
and any other requirements prescribed by the accreditation body, the
accreditation body shall ensure that the laboratory carries out the
necessary adjustments to its procedures within such time, as in the
opinion of the body is reasonable. The laboratory shall notify the body
when such adjustments have been made.
(d) Directory of accredited laboratories. An approved/recognized
accreditation body shall produce periodically but at least annually a
[[Page 50574]]
directory of accredited laboratories describing the accreditation
granted.
Subpart G--Enforcement
Sec. 280.600 Scope.
Section 280.601 of this part lists definitions used in this part.
Section 280.602 of this part specifies that failure to take any action
required by or taking any action prohibited by this part constitutes a
violation of this part. Section 280.603 describes the penalties that
may be imposed for violations of this part. Sections 280.605 through
280.623 establish the procedures for imposing administrative penalties
for violations of this part.
Sec. 280.601 Definitions used in this subpart.
The definitions in this Sec. 280.601 apply to this part.
Administrative law judge (ALJ). The person authorized to conduct
hearings in administrative enforcement proceedings brought under the
Act.
Assistant Secretary. The Assistant Secretary for Export
Enforcement, Bureau of Export Administration.
Department. The United States Department of Commerce, specifically,
the Bureau of Export Administration, NIST and the Patent and Trademark
Office.
Final decision. A decision or order assessing a civil penalty or
otherwise disposing of or dismissing a case, which is not subject to
further review under this part, but which is subject to collection
proceedings or judicial review in an appropriate Federal district court
as authorized by law.
Initial decision. A decision of the administrative law judge which
is subject to review by the Under Secretary for Export Administration,
but which becomes the final decision of the Department in the absence
of such an appeal.
Party. The Department and any person named as a respondent under
this part.
Respondent. Any person named as the subject of a charging letter,
proposed charging letter, or other order proposed or issued under this
part.
Under Secretary. The Under Secretary for Export Administration,
United States Department of Commerce.
Sec. 280.602 Violations.
(a) Engaging in prohibited conduct. No person may engage in any
conduct prohibited by or contrary to, or refrain from engaging in any
action required by the Act, this part, or any order issued thereunder.
(b) Causing, aiding, or abetting a violation. No person may cause
or aid, abet, counsel, command, induce, procure, or permit the doing of
any act prohibited, or the omission of any act required, by the Act,
this part, or any order issued thereunder.
(c) Solicitation and attempt. No person may solicit or attempt a
violation of the Act, this part, or any order issued thereunder.
(d) Conspiracy. No person may conspire or act in concert with one
or more persons in any manner or for any purpose to bring about or to
do any act that constitutes a violation of the Act, this part, or any
order issued thereunder.
(e) Misrepresentation and concealment of facts. No person may make
any false or misleading representation, statement, or certification, or
falsify or conceal any material fact, either directly to NIST, or the
Bureau of Export Administration, the Patent and Trademark Office, or
any official of any other United States agency, or indirectly through
any other person:
(1) In the course of an investigation or other action subject to
the Act and this part; or
(2) In connection with the preparation, submission, issuance, use,
maintenance of a laboratory test report, certificate of conformance as
described in Secs. 280.5 and 280.6 of this part; or
(3) In connection with any application for laboratory accreditation
as described in Sec. 280.205 of this part; or
(4) In connection with an application to be an accreditation body
as described in Sec. 280.301 of this part.
(f) Falsification of test report. No person shall falsify or make
any false or misleading statement on or in connection with a laboratory
test report required by section 5(c) of the Act or Sec. 280.6 of this
part.
(g) Falsification of certificate of conformance. No person shall
falsify or make any false or misleading statement on or in connection
with a certificate of conformance required by Sec. 280.5 of this part.
(h) Falsification of documents relating to laboratory accreditation
or accreditation bodies. No person shall falsify or make any false or
misleading statement on or in connection with any document relating to
laboratory accreditation or approval or recognition of accreditation
bodies as required by sections 6(a) or 6(b) of the Act or this part.
(i) Use of another person's recorded insignia. No person may apply
an insignia to a fastener if the Commissioner has issued a certificate
of recordal (as described in Sec. 280.712 of this part) for that
insignia to another person without written permission from the person
to whom the certificate was issued.
(j) False claim of laboratory accreditation or accreditation body.
No person shall falsely claim to be an accredited laboratory or
approved or recognized accreditation body as described in section 6 of
the Act or subparts B, C, D, and E of this part.
Sec. 280.603 Penalties, remedies and sanctions.
(a) Civil remedies. The Attorney General may bring an action in an
appropriate United States district court for declaratory and injunctive
relief against any person who violates the Act or any regulation issued
thereunder. Such action may not be brought more than 10 years after the
cause of action accrues.
(b) Civil penalties. Any person who is determined, after notice and
opportunity for a hearing, to have violated the Act or any regulation
issued thereunder shall be liable to the United States for a civil
penalty of not more than $25,000 for each violation.
(c) Criminal penalties. (1) Whoever knowingly certifies, marks,
offers for sale, or sells a fastener in violation of the Act or a
regulation issued thereunder shall be fined under title 18, United
States Code, or imprisoned not more than 5 years, or both.
(2) Whoever intentionally fails to maintain records relating to a
fastener in violation of the Act or a regulation issued thereunder
shall be fined under title 18, United States Code, or imprisoned not
more than five years or both.
(3) Whoever negligently fails to maintain records relating to a
fastener in violation of the Act or a regulation issued thereunder
shall be fined under title 18, United States Code, or imprisoned not
more than two years or both.
Sec. 280.604 Administrative enforcement proceedings.
Sections 280.605 through 280.623 set forth the procedures for
imposing administrative penalties for violations of the Act and
Fastener Quality Regulations (FQR).
Sec. 280.605 Institution of administrative enforcement proceedings.
(a) Charging letters. The Director of the Office of Export
Enforcement (OEE) may begin administrative enforcement proceedings
under this part by issuing a charging letter. The charging letter shall
constitute the formal complaint and will state that there is reason to
believe that a violation of this part has occurred. It will set forth
the essential
[[Page 50575]]
facts about each alleged violation, refer to the specific regulatory or
other provisions involved, and give notice of the sanctions available
under the Act and this part. The charging letter will inform the
respondent that failure to answer the charges as provided in
Sec. 280.608 of this part will be treated as a default under
Sec. 280.609 of this part, that the respondent is entitled to a hearing
if a written demand for one is requested with the answer, and that the
respondent may be represented by counsel, or by other authorized
representative. A copy of the charging letter shall be filed with the
administrative law judge, which filing shall toll the running of the
applicable statute of limitations. Charging letters may be amended or
supplemented at any time before an answer is filed, or, with permission
of the administrative law judge, afterwards. The Department may
unilaterally withdraw charging letters at any time, by notifying the
respondent and the administrative law judge.
(b) Notice of issuance of charging letter instituting
administrative enforcement proceeding. A respondent shall be notified
of the issuance of a charging letter, or any amendment or supplement
thereto:
(1) By mailing a copy by registered or certified mail addressed to
the respondent at the respondent's last known address;
(2) By leaving a copy with the respondent or with an officer, a
managing or general agent, or any other agent authorized by appointment
or by law to receive service of process for the respondent; or
(3) By leaving a copy with a person of suitable age and discretion
who resides at the respondent's last known dwelling.
(4) Delivery of a copy of the charging letter, if made in the
manner described in paragraph (b)(2) or (3) of this section, shall be
evidenced by a certificate of service signed by the person making such
service, stating the method of service and the identity of the person
with whom the charging letter was left. The certificate of service
shall be filed with the administrative law judge.
(c) Date. The date of service of notice of the issuance of a
charging letter instituting an administrative enforcement proceeding,
or service of notice of the issuance of a supplement or amendment to a
charging letter, is the date of its delivery, or of its attempted
delivery if delivery is refused.
Sec. 280.606 Representation.
A respondent individual may appear and participate in person, a
corporation by a duly authorized officer or employee, and a partnership
by a partner. If a respondent is represented by counsel, counsel shall
be a member in good standing of the bar of any State, Commonwealth or
Territory of the United States, or of the District of Columbia, or be
licensed to practice law in the country in which counsel resides if not
the United States. A respondent personally, or through counsel or other
representative who has the power of attorney to represent the
respondent, shall file a notice of appearance with the administrative
law judge. The Department will be represented by the Office of Chief
Counsel for Export Administration, U.S. Department of Commerce.
Sec. 280.607 Filing and service of papers other than charging letter.
(a) Filing. All papers to be filed shall be addressed to ``FQA
Administrative Enforcement Proceedings,'' at the address set forth in
the charging letter, or such other place as the administrative law
judge may designate. Filing by United States mail, first class postage
prepaid, by express or equivalent parcel delivery service, or by hand
delivery, is acceptable. Filing by mail from a foreign country shall be
by airmail. In addition, the administrative law judge may authorize
filing of papers by facsimile or other electronic means, provided that
a hard copy of any such paper is subsequently filed. A copy of each
paper filed shall be simultaneously served on each party.
(b) Service. Service shall be made by personal delivery or by
mailing one copy of each paper to each party in the proceeding. Service
by delivery service or facsimile, in the manner set forth in paragraph
(a) of this section, is acceptable. Service on the Department shall be
addressed to the Chief Counsel for Export Administration, Room H-3839,
U.S. Department of Commerce, 14th Street and Constitution Avenue, NW.,
Washington, DC. 20230. Service on a respondent shall be to the address
to which the charging letter was sent or to such other address as
respondent may provide. When a party has appeared by counsel or other
representative, service on counsel or other representative shall
constitute service on that party.
(c) Date. The date of filing or service is the day when the papers
are deposited in the mail or are delivered in person, by delivery
service, or by facsimile.
(d) Certificate of service. A certificate of service signed by the
party making service, stating the date and manner of service, shall
accompany every paper, other than the charging letter, filed and served
on parties.
(e) Computing period of time. In computing any period of time
prescribed or allowed by this part or by order of the administrative
law judge or the Under Secretary, the day of the act, event, or default
from which the designated period of time begins to run is not to be
included. The last day of the period so computed is to be included
unless it is a Saturday, a Sunday, or a legal holiday (as defined in
Rule 6(a) of the Federal Rules of Civil Procedure), in which case the
period runs until the end of the next day which is neither a Saturday,
a Sunday, nor a legal holiday. Intermediate Saturdays, Sundays, and
legal holidays are excluded from the computation when the period of
time prescribed or allowed is seven days or less.
Sec. 280.608 Answer and demand for hearing.
(a) When to answer. The respondent must answer the charging letter
within 30 days after being served with notice of the issuance of a
charging letter instituting an administrative enforcement proceeding,
or within 30 days of notice of any supplement or amendment to a
charging letter, unless time is extended under Sec. 280.618 of this
part.
(b) Contents of answer. The answer must be responsive to the
charging letter and must fully set forth the nature of the respondent's
defense or defenses. The answer must admit or deny specifically each
separate allegation of the charging letter; if the respondent is
without knowledge, the answer must so state and will operate as a
denial. Failure to deny or controvert a particular allegation will be
deemed an admission of that allegation. The answer must also set forth
any additional or new matter the respondent believes supports a defense
or claim of mitigation. Any defense or partial defense not specifically
set forth in the answer shall be deemed waived, and evidence thereon
may be refused, except for good cause shown.
(c) Demand for hearing. If the respondent desires a hearing, a
written demand for one must be submitted with the answer. Any demand by
the Department for a hearing must be filed with the administrative law
judge within 30 days after service of the answer. Failure to make a
timely written demand for a hearing shall be deemed a waiver of the
party's right to a hearing, except for good cause shown. If no party
demands a hearing, the matter will go forward in accordance with the
procedures set forth in Sec. 280.617 of this part.
[[Page 50576]]
(d) English language required. The answer, all other papers, and
all documentary evidence must be submitted in English, or translations
into English must be filed and served at the same time.
Sec. 280.609 Default.
(a) General. Failure of the respondent to file an answer within the
time provided constitutes a waiver of the respondent's right to appear
and contest the allegations in the charging letter. In such event, the
administrative law judge, on the Department's motion and without
further notice to the respondent, shall find the facts to be as alleged
in the charging letter and render an initial decision containing
findings of fact and appropriate conclusions of law and issue an
initial decision and order imposing appropriate sanctions. The decision
and order may be appealed to the Under Secretary in accordance with the
applicable procedures set forth in Sec. 280.623 of this part.
(b) Petition to set aside default.--(1) Procedure. Upon petition
filed by a respondent against whom a default order has been issued,
which petition is accompanied by an answer meeting the requirements of
280.608(b) of this part, the Under Secretary may, after giving all
parties an opportunity to comment, and for good cause shown, set aside
the default and vacate the order entered thereon and remand the matter
to the administrative law judge for further proceedings.
(2) Time limits. A petition under this section must be made within
one year of the date of entry of the order which the petition seeks to
have vacated.
Sec. 280.610 Summary decision.
At any time after a proceeding has been initiated, a party may move
for a summary decision disposing of some or all of the issues. The
administrative law judge may render an initial decision and issue an
order if the entire record shows, as to the issue(s) under
consideration:
(a) That there is no genuine issue as to any material fact; and
(b) That the moving party is entitled to a summary decision as a
matter of law.
Sec. 280.611 Discovery.
(a) General. The parties are encouraged to engage in voluntary
discovery regarding any matter, not privileged, which is relevant to
the subject matter of the pending proceeding. The provisions of the
Federal Rules of Civil Procedure relating to discovery apply to the
extent consistent with this part and except as otherwise provided by
the administrative law judge or by waiver or agreement of the parties.
The administrative law judge may make any order which justice requires
to protect a party or person from annoyance, embarrassment, oppression,
or undue burden or expense. These orders may include limitations on the
scope, method, time and place of discovery, and provisions for
protecting the confidentiality of classified or otherwise sensitive
information.
(b) Interrogatories and requests for admission or production of
documents. A party may serve on any party interrogatories, requests for
admission, or requests for production of documents for inspection and
copying, and a party concerned may apply to the administrative law
judge for such enforcement or protective order as that party deems
warranted with respect to such discovery. The service of a discovery
request shall be made at least 20 days before the scheduled date of the
hearing unless the administrative law judge specifies a shorter time
period. Copies of interrogatories, requests for admission and requests
for production of documents and responses thereto shall be served on
all parties, and a copy of the certificate of service shall be filed
with the administrative law judge. Matters of fact or law of which
admission is requested shall be deemed admitted unless, within a period
designated in the request (at least 10 days after service, or within
such additional time as the administrative law judge may allow), the
party to whom the request is directed serves upon the requesting party
a sworn statement either denying specifically the matters of which
admission is requested or setting forth in detail the reasons why the
party to whom the request is directed cannot truthfully either admit or
deny such matters.
(c) Depositions. Upon application of a party and for good cause
shown, the administrative law judge may order the taking of the
testimony of any person by deposition and the production of specified
documents or materials by the person at the deposition. The application
shall state the purpose of the deposition and set forth the facts
sought to be established through the deposition.
(d) Enforcement. The administrative law judge may order a party to
answer designated questions, to produce specified documents or things
or to take any other action in response to a proper discovery request.
If a party does not comply with such an order, the administrative law
judge may make a determination or enter any order in the proceeding as
the ALJ deems reasonable and appropriate. The ALJ may strike related
charges or defenses in whole or in part or may take particular facts
relating to the discovery request to which the party failed or refused
to respond as being established for purposes of the proceeding in
accordance with the contentions of the party seeking discovery. In
addition, enforcement by a district court of the United States may be
sought under section 9(b)(6) of the Act.
Sec. 280.612 Subpoenas.
(a) Issuance. Upon the application of any party, supported by a
satisfactory showing that there is substantial reason to believe that
the evidence would not otherwise be available, the administrative law
judge may issue subpoenas requiring the attendance and testimony of
witnesses and the production of such books, records or other
documentary or physical evidence for the purpose of the hearing, as the
ALJ deems relevant and material to the proceedings, and reasonable in
scope. Witnesses summoned shall be paid the same fees and mileage that
are paid to witnesses in the courts of the United States. In case of
contempt or refusal to obey a subpoena served upon any person pursuant
to this paragraph, the district court of the United States for any
district in which such person is found, resides, or transacts business,
upon application by the United States and after notice to such person,
shall have jurisdiction to issue an order requiring such person to
appear and give testimony before the administrative law judge or to
appear and produce documents before the administrative law judge, or
both, and any failure to obey such order of the court may be punished
by such court as contempt thereof.
(b) Service. Subpoenas issued by the administrative law judge may
be served in any of the methods set forth in Sec. 280.607(b) of this
part.
(c) Timing. Applications for subpoenas must be submitted at least
10 days before the scheduled hearing or deposition, unless the
administrative law judge determines, for good cause shown, that
extraordinary circumstances warrant a shorter time.
Sec. 280.613 Matter protected against disclosure.
(a) Protective measures. The administrative law judge may limit
discovery or introduction of evidence or issue such protective or other
orders as in the ALJ's judgment may be needed to prevent undue
disclosure of classified or sensitive documents or information.
[[Page 50577]]
Where the administrative law judge determines that documents containing
the classified or sensitive matter need to be made available to a party
to avoid prejudice, the ALJ may direct that an unclassified and/or
nonsensitive summary or extract of the documents be prepared. The
administrative law judge may compare the extract or summary with the
original to ensure that it is supported by the source document and that
it omits only so much as must remain undisclosed. The summary or
extract may be admitted as evidence in the record.
(b) Arrangements for access. If the administrative law judge
determines that this procedure is unsatisfactory and that classified or
otherwise sensitive matter must form part of the record in order to
avoid prejudice to a party, the administrative law judge may provide
the parties an opportunity to make arrangements that permit a party or
a representative to have access to such matter without compromising
sensitive information. Such arrangements may include obtaining security
clearances or giving counsel for a party access to sensitive
information and documents subject to assurances against further
disclosure, including a protective order, if necessary.
Sec. 280.614 Prehearing conference.
(a) The administrative law judge, on his or her own motion or on
request of a party, may direct the parties to participate in a
prehearing conference, either in person or by telephone, to consider:
(1) Simplification of issues;
(2) The necessity or desirability of amendments to pleadings;
(3) Obtaining stipulations of fact and of documents to avoid
unnecessary proof; or
(4) Such other matters as may expedite the disposition of the
proceedings.
(b) The administrative law judge may order the conference
proceedings to be recorded electronically or taken by a reporter,
transcribed and filed with the ALJ.
(c) If a prehearing conference is impracticable, the administrative
law judge may direct the parties to correspond with the ALJ to achieve
the purposes of such a conference.
(d) The administrative law judge will prepare a summary of any
actions agreed on or taken pursuant to this section. The summary will
include any written stipulations or agreements made by the parties.
Sec. 280.615 Hearings.
(a) Scheduling. The administrative law judge, by agreement with the
parties or upon notice to all parties of not less than 30 days, will
schedule a hearing. All hearings will be held in Washington, DC.,
unless the administrative law judge determines, for good cause shown,
that another location would better serve the interests of justice.
(b) Hearing procedure. Hearings will be conducted in a fair and
impartial manner by the administrative law judge, who may limit
attendance at any hearing or portion thereof to the parties, their
representatives and witnesses if the administrative law judge deems
this necessary or advisable in order to protect sensitive matter (see
Sec. 280.613 of this part) from improper disclosure. The rules of
evidence prevailing in courts of law do not apply, and all evidentiary
material deemed by the administrative law judge to be relevant and
material to the proceeding and not unduly repetitious will be received
and given appropriate weight.
(c) Testimony and record. Witnesses will testify under oath or
affirmation. A verbatim record of the hearing and of any other oral
proceedings will be taken by reporter or by electronic recording,
transcribed and filed with the administrative law judge. A respondent
may examine the transcript and may obtain a copy by paying any
applicable costs. Upon such terms as the administrative law judge deems
just, the ALJ may direct that the testimony of any person be taken by
deposition and may admit an affidavit or declaration as evidence,
provided that any affidavits or declarations have been filed and served
on the parties sufficiently in advance of the hearing to permit a party
to file and serve an objection thereto on the grounds that it is
necessary that the affiant or declarant testify at the hearing and be
subject to cross-examination.
(d) Failure to appear. If a party fails to appear in person or by
counsel at a scheduled hearing, the hearing may nevertheless proceed,
and that party's failure to appear will not affect the validity of the
hearing or any proceedings or action taken thereafter.
Sec. 280.616 Interlocutory review of rulings.
(a) At the request of a party, or on the administrative law judge's
own initiative, the administrative law judge may certify to the Under
Secretary for review a ruling that does not finally dispose of a
proceeding, if the administrative law judge determines that immediate
review may hasten or facilitate the final disposition of the matter.
(b) Upon certification to the Under Secretary of the interlocutory
ruling for review, the parties will have 10 days to file and serve
briefs stating their positions, and five days to file and serve
replies, following which the Under Secretary will decide the matter
promptly.
Sec. 280.617 Proceeding without a hearing.
If the parties have waived a hearing, the case will be decided on
the record by the administrative law judge. Proceeding without a
hearing does not relieve the parties from the necessity of proving the
facts supporting their charges or defenses. Affidavits or declarations,
depositions, admissions, answers to interrogatories and stipulations
may supplement other documentary evidence in the record. The
administrative law judge will give each party reasonable opportunity to
file rebuttal evidence.
Sec. 280.618 Procedural stipulations; extension of time.
(a) Procedural stipulations. Unless otherwise ordered, a written
stipulation agreed to by all parties and filed with the administrative
law judge will modify any procedures established by this part.
(b) Extension of time. (1) The parties may extend any applicable
time limitation, by stipulation filed with the administrative law judge
before the time limitation expires.
(2) The administrative law judge may, on the judge's own initiative
or upon application by any party, either before or after the expiration
of any applicable time limitation, extend the time within which to file
and serve an answer to a charging letter or do any other act required
by this part.
Sec. 280.619 Decision of the administrative law judge.
(a) Predecisional matters. Except for default proceedings under
Sec. 280.609 of this part, the administrative law judge will give the
parties reasonable opportunity to submit the following, which will be
made a part of the record:
(1) Exceptions to any ruling by the judge or to the admissibility
of evidence proffered at the hearing;
(2) Proposed findings of fact and conclusions of law;
(3) Supporting legal arguments for the exceptions and proposed
findings and conclusions submitted; and
(4) A proposed order.
(b) Decision and order. After considering the entire record in the
proceeding, the administrative law judge will issue a written initial
decision. The decision will include
[[Page 50578]]
findings of fact, conclusions of law, and findings as to whether there
has been a violation of the Act, this part, or any order issued
thereunder. If the administrative law judge finds that the evidence of
record is insufficient to sustain a finding that a violation has
occurred with respect to one or more charges, the ALJ shall order
dismissal of the charges in whole or in part, as appropriate. If the
administrative law judge finds that one or more violations have been
committed, the ALJ may issue an order imposing administrative
sanctions, as provided in this part. The decision and order shall be
served on each party, and shall become effective as the final decision
of the Department 30 days after service, unless an appeal is filed in
accordance with Sec. 280.623 of this part. In determining the amount of
any civil penalty the ALJ shall consider the nature, circumstances and
gravity of the violation and, with respect to the person found to have
committed the violation, the degree of culpability, any history of
prior violations, the effect on ability to continue to do business, any
good faith attempt to achieve compliance, ability to pay the penalty,
and such other matters as justice may require.
(c) Suspension of sanctions. Any order imposing administrative
sanctions may provide for the suspension of the sanction imposed, in
whole or in part and on such terms of probation or other conditions as
the administrative law judge or the Under Secretary may specify. Any
suspension order may be modified or revoked by the signing official
upon application by the Department showing a violation of the
probationary terms or other conditions, after service on the respondent
of notice of the application in accordance with the service provisions
of Sec. 280.607 of this part, and with such opportunity for response as
the responsible signing official in his/her discretion may allow. A
copy of any order modifying or revoking the suspension shall also be
served on the respondent in accordance with the provisions of
Sec. 280.607 of this part.
Sec. 280.620 Settlement.
(a) Cases may be settled before service of a charging letter. In
cases in which settlement is reached before service of a charging
letter, a proposed charging letter will be prepared, and a settlement
proposal consisting of a settlement agreement and order will be
submitted to the Assistant Secretary for approval and signature. If the
Assistant Secretary does not approve the proposal, he/she will notify
the parties and the case will proceed as though no settlement proposal
had been made. If the Assistant Secretary approves the proposal, he/she
will issue an appropriate order, and no action will be required by the
administrative law judge.
(b) Cases may also be settled after service of a charging letter.
(1) If the case is pending before the administrative law judge, the ALJ
shall stay the proceedings for a reasonable period of time, usually not
to exceed 30 days, upon notification by the parties that they have
entered into good faith settlement negotiations. The administrative law
judge may, in his/her discretion, grant additional stays. If settlement
is reached, a proposal will be submitted to the Assistant Secretary for
approval and signature. If the Assistant Secretary approves the
proposal, he/she will issue an appropriate order, and notify the
administrative law judge that the case is withdrawn from adjudication.
If the Assistant Secretary does not approve the proposal, he/she will
notify the parties and the case will proceed to adjudication by the
administrative law judge as though no settlement proposal had been
made.
(2) If the case is pending before the Under Secretary under
Sec. 280.623 of this part, the parties may submit a settlement proposal
to the Under Secretary for approval and signature. If the Under
Secretary approves the proposal, he/she will issue an appropriate
order. If the Under Secretary does not approve the proposal, the case
will proceed to final decision in accordance with Section 280.623 of
this part, as appropriate.
(c) Any order disposing of a case by settlement may suspend the
administrative sanction imposed, in whole or in part, on such terms of
probation or other conditions as the signing official may specify. Any
such suspension may be modified or revoked by the signing official, in
accordance with the procedures set forth in Sec. 280.619(c) of this
part.
(d) Any respondent who agrees to an order imposing any
administrative sanction does so solely for the purpose of resolving the
claims in the administrative enforcement proceeding brought under this
part. This reflects the fact that the Department has neither the
authority nor the responsibility for instituting, conducting, settling,
or otherwise disposing of criminal proceedings. That authority and
responsibility is vested in the Attorney General and the Department of
Justice.
(e) Cases that are settled may not be reopened or appealed.
Sec. 280.621 Reopening.
The respondent may petition the administrative law judge within one
year of the date of the final decision, except where the decision
arises from a default judgment or from a settlement, to reopen an
administrative enforcement proceeding to receive any relevant and
material evidence which was unknown or unobtainable at the time the
proceeding was held. The petition must include a summary of such
evidence, the reasons why it is deemed relevant and material, and the
reasons why it could not have been presented at the time the
proceedings were held. The administrative law judge will grant or deny
the petition after providing other parties reasonable opportunity to
comment. If the proceeding is reopened, the administrative law judge
may make such arrangements as the ALJ deems appropriate for receiving
the new evidence and completing the record. The administrative law
judge will then issue a new initial decision and order, and the case
will proceed to final decision and order in accordance with
Sec. 280.623 of this part.
Sec. 280.622 Record for decision and availability of documents.
(a) General. The transcript of hearings, exhibits, rulings, orders,
all papers and requests filed in the proceedings and, for purposes of
any appeal under Sec. 280.623 of this part, the decision of the
administrative law judge and such submissions as are provided for by
Sec. 280.623 of this part, will constitute the record and the exclusive
basis for decision. When a case is settled after the service of a
charging letter, the record will consist of any and all of the
foregoing, as well as the settlement agreement and the order. When a
case is settled before service of a charging letter, the record will
consist of the proposed charging letter, the settlement agreement and
the order.
(b) Restricted access. On the administrative law judge's own
motion, or on the motion of any party, the administrative law judge may
direct that there be a restricted access portion of the record for any
material in the record to which public access is restricted by law or
by the terms of a protective order entered in the proceedings. A party
seeking to restrict access to any portion of the record is responsible
for submitting, at the time specified in Sec. 280.622(c)(2) of this
part, a version of the document proposed for public availability that
reflects the requested deletion. The restricted access portion of the
record will be placed in a separate file and the file will be clearly
marked to avoid improper disclosure and to
[[Page 50579]]
identify it as a portion of the official record in the proceedings. The
administrative law judge may act at any time to permit material that
becomes declassified or unrestricted through passage of time to be
transferred to the unrestricted access portion of the record.
(c) Availability of documents--(1) Scope. All charging letters,
answers, initial decisions, and orders disposing of a case will be made
available for public inspection in the BXA Freedom of Information
Records Inspection Facility, U.S. Department of Commerce, Room H-6624,
14th Street and Pennsylvania Avenue, NW, Washington, DC 20230. The
complete record for decision, as defined in paragraphs (a) and (b) of
this section will be made available on request.
(2) Timing. Documents are available immediately upon filing, except
for any portion of the record for which a request for segregation is
made. Parties that seek to restrict access to any portion of the record
under paragraph (b) of this section must make such a request, together
with the reasons supporting the claim of confidentiality,
simultaneously with the submission of material for the record.
Sec. 280.623 Appeals.
(a) Grounds. A party may appeal to the Under Secretary from an
order disposing of a proceeding or an order denying a petition to set
aside a default or a petition for reopening, on the grounds:
(1) That a necessary finding of fact is omitted, erroneous or
unsupported by substantial evidence of record;
(2) That a necessary legal conclusion or finding is contrary to
law;
(3) That prejudicial procedural error occurred; or
(4) That the decision or the extent of sanctions is arbitrary,
capricious or an abuse of discretion. The appeal must specify the
grounds on which the appeal is based and the provisions of the order
from which the appeal is taken.
(b) Filing of appeal. An appeal from an order must be filed with
the Office of the Under Secretary for Export Administration, Bureau of
Export Administration, U.S. Department of Commerce, Room H-3898, 14th
Street and Constitution Avenue, NW., Washington, DC 20230, within 30
days after service of the order appealed from. If the Under Secretary
cannot act on an appeal for any reason, the Under Secretary will
designate another Department of Commerce official to receive and act on
the appeal.
(c) Effect of appeal. The filing of an appeal shall not stay the
operation of any order, unless the order by its express terms so
provides or unless the Under Secretary, upon application by a party and
with opportunity for response, grants a stay.
(d) Appeal procedure. The Under Secretary normally will not hold
hearings or entertain oral argument on appeals. A full written
statement in support of the appeal must be filed with the appeal and be
simultaneously served on all parties, who shall have 30 days from
service to file a reply. At his/her discretion, the Under Secretary may
accept new submissions, but will not ordinarily accept those
submissions filed more than 30 days after the filing of the reply to
the appellant's first submission.
(e) Decisions. The decision will be in writing and will be
accompanied by an order signed by the Under Secretary giving effect to
the decision. The order may either dispose of the case by affirming,
modifying or reversing the order of the administrative law judge or may
refer the case back to the administrative law judge for further
proceedings.
(f) Delivery. The final decision and implementing order shall be
served on the parties and will be publicly available in accordance with
Sec. 280.622 of this part.
(g) Judicial Review. The charged party may appeal the Under
Secretary's written order within 30 days to the appropriate United
States District Court pursuant to section 9(b)(3) of the Act (15 U.S.C.
5408(b)(3)) by filing a notice of appeal in such court within 30 days
from the date of such order and by simultaneously sending a copy of
such notice by certified mail to the Chief Counsel for Export
Administration, Room H-3839, U.S. Department of Commerce, 14th Street
and Constitution Avenue, NW., Washington, DC 20230. The findings and
order of the Under Secretary shall be set aside by such court if they
are found to be unsupported by substantial evidence, as provided in
section 706(2) of title 5 United States Code.
Subpart H--Recordal of Insignia
Sec. 280.700 Recorded insignia required prior to offer for sale.
(a) Any manufacturer or private label distributor of a fastener
must, prior to any sale or offer for sale of any fastener which is
required by the standards and specifications by which it is
manufactured to bear a raised or depressed insignia identifying its
manufacturer or private label distributor, apply for and record an
insignia to be applied to any fastener which is to be sold or offered
for sale to ensure that each fastener may be traced to its manufacturer
or private label distributor.
(b) The manufacturer's or private label distributor's insignia must
be applied to any fastener which is sold or offered for sale if such
fastener is required by the standards and specification by which it is
manufactured to bear a raised or depressed insignia identifying its
manufacturer or private label distributor. If the fastener has no head,
the insignia must be applied to another surface area in a legible
manner.
(c) The insignia must be applied through a raised or depressed
impression. The insignia must be readable with no greater than 10x
magnification.
The Written Application
Sec. 280.710 Applications for insignia.
(a) Each manufacturer or private label distributor must submit a
written application for recordal of an insignia on the Fastener
Insignia Register along with the prescribed fee. The application must
be in a form prescribed by the Commissioner.
(b) The written application must be in the English language and
must include the following:
(1) The name of the applicant;
(2) The address of the applicant;
(3) The entity, domicile, and state of incorporation, if
applicable, of the applicant;
(4) either:
(i) A request for recordal and issuance of a unique alphanumeric
designation by the Commissioner, or
(ii) A request for recordal of a trademark, which is the subject of
either a duly filed application or a registration for fasteners in the
name of the applicant in the U.S. Patent and Trademark Office on the
Principal Register, indicating the application serial number or
registration number and accompanied by a copy of the drawing page of
the application or a copy of the registration;
(5) A statement that the applicant will comply with the applicable
provisions of the Fastener Quality Act;
(6) A statement that the person signing the application on behalf
of the applicant has personal knowledge of the facts relevant to the
application and that the person possesses the authority to act on
behalf of the applicant;
(7) A verification stating that the person signing declares under
penalty of perjury under the laws of the United States of America that
the information and statements included in the application are true and
correct; and
[[Page 50580]]
(8) The application fee.
(c) An applicant may designate only one registered trademark for
recordal on the Fastener Insignia Register in a single application. The
trademark application or registration which forms the basis for the
fastener recordal must be in active status, that is a pending
application or a registration which is not expired, abandoned or
canceled, at the time of the application for recordal.
(d) Applications and other documents should be addressed to: Box
Fastener, Commissioner of Patents and Trademarks, Washington DC 20231.
Sec. 280.711 Review of the application.
The Commissioner will review the application for compliance with
Sec. 280.710. If the application does not contain one or more of the
elements required by Sec. 280.710, the Commissioner will not issue a
certificate of recordal, and will return the papers and fees. The
Commissioner will notify the applicant of any defect in the
application. Applications for recordal of an insignia may be re-
submitted to the Commissioner at any time.
Sec. 280.712 Certificate of recordal.
If the application complies with the requirements of Sec. 280.710,
the Commissioner shall accept the application and issue a certificate
of recordal. Such certificate shall be issued in the name of the United
States of America, under the seal of the Patent and Trademark Office,
and a record shall be kept in the Patent and Trademark Office. The
certificate of recordal shall display the recorded insignia of the
applicant, and state the name, address, legal entity and domicile of
the applicant, as well as the date of issuance of such certificate.
Sec. 280.713 Recordal of additional insignia.
(a) A manufacturer or private label distributor to whom the
Commissioner has issued an alphanumeric designation may apply for
recordal of its trademark for fasteners if the trademark is the subject
of a duly filed application or is registered in the U.S. Patent and
Trademark Office on the Principal Register. Upon recordal, either the
alphanumeric designation or the registered mark, or both, may be used
as recorded insignias.
(b) A manufacturer or private label distributor for whom the
Commissioner has recorded a trademark as its fastener insignia, may
apply for issuance and recordal of an alphanumeric designation as a
fastener insignia. Upon recordal, either the alphanumeric designation
or the trademark, or both, may be used as recorded insignias.
Post-Recordal Maintenance
Sec. 280.720 Maintenance of the certificate of recordal.
(a) Certificates of recordal remain in an active status for five
years and may be maintained in an active status for five-year periods
running consecutively from the date of issuance of the certificate of
recordal upon compliance with the requirements of Sec. 280.720(c).
(b) Maintenance applications shall be required only if the holder
of the certificate of recordal is a manufacturer or private label
distributor at the time the maintenance application is required.
(c) Certificates of recordal will be designated as inactive unless,
within six months prior to the expiration of each five-year period
running consecutively from the date of issuance, the certificate holder
files the prescribed maintenance fee and the maintenance application.
The maintenance application must be in the English language and must
include the following:
(1) The name of the applicant;
(2) The address of the applicant;
(3) The entity, domicile, and state of incorporation, if
applicable, of the applicant;
(4) A copy of applicant's certificate of recordal;
(5) A statement that the applicant will comply with the applicable
provisions of the Fastener Quality Act;
(6) A statement that the person signing the application on behalf
of the applicant has knowledge of the facts relevant to the application
and that the person possesses the authority to act on behalf of the
applicant;
(7) A verification stating that the person signing declares under
penalty of perjury under the laws of the United States of America that
the information and statements included in the application are true and
correct; and
(8) The maintenance application fee.
(d) Where no maintenance application is timely filed, a certificate
of recordal will be designated inactive. However, such certificate may
be designated active if the certificate holder files the prescribed
maintenance fee and application and the additional surcharge within six
months following the expiration of the certificate of recordal.
(e) After the six-month period following the expiration of the
certificate of recordal, the certificate of recordal shall be deemed
active only if the certificate holder files a new application for
recordal with the prescribed fee for obtaining a fastener insignia and
attaches a copy of the expired certificate of recordal.
(f) A separate maintenance application and fee must be filed and
paid for each recorded insignia.
Sec. 280.721 Notification of changes of address.
The applicant or the holder of a certificate of recordal shall
notify the Commissioner of any change of address or change of name no
later than six months after the change. The holder must do so whether
the certificate of recordal is in an active or inactive status.
Sec. 280.722 Transfer or amendment of the certificate of recordal.
(a) The certificate of recordal cannot be transferred or assigned.
(b) The certificate of recordal may be amended only to show a
change of name or change of address.
Sec. 280.723 Transfer or assignment of the trademark registration or
recorded insignia.
(a) A trademark application or registration which forms the basis
of a fastener recordal may be transferred or assigned. Any transfer or
assignment of such an application or registration shall be recorded in
the Patent and Trademark Office within three months of the transfer or
assignment. A copy of such transfer or assignment must also be sent to:
Box Fastener, Commissioner of Patents and Trademarks, Washington, DC
20231.
(b) Upon transfer or assignment of a trademark application or
registration which forms the basis of a certificate of recordal, the
Commissioner shall designate the certificate of recordal as inactive.
The certificate of recordal shall be deemed inactive as of the
effective date of the transfer or assignment. Certificates of recordal
designated inactive due to transfer or assignment of a trademark
application or registration cannot be reactivated.
(c) An assigned trademark application or registration may form the
basis for a new application for recordal of a fastener insignia.
(d) A fastener insignia consisting of an alphanumeric designation
issued by the Commissioner can be transferred or assigned.
(e) Upon transfer or assignment of an alphanumeric designation, the
Commissioner shall designate such alphanumeric designation as inactive.
The alphanumeric designation shall be deemed inactive as of the
effective date of the transfer or assignment. Alphanumeric designations
which are designated inactive due to transfer or assignment may be
reactivated upon application by the assignee of such alphanumeric
designation. Such application must meet all the
[[Page 50581]]
requirements of Sec. 280.710 and must include a copy of the pertinent
portions of the document assigning rights in the alphanumeric
designation. Such application must be filed within six months of the
date of assignment.
Sec. 280.724 Change in status of trademark registration or amendment
of the trademark.
(a) The Commissioner shall designate the certificate of recordal as
inactive, upon:
(1) Issuance of a final decision on appeal which refuses
registration of the application which formed the basis for the
certificate of recordal; or
(2) Abandonment of the application which formed the basis for the
certificate of recordal; or
(3) Cancellation or expiration of the trademark registration which
formed the basis of the certificate of recordal.
(b) Any amendment of the mark in a trademark application or
registration which forms the basis for a certificate of recordal will
result in such certificate of recordal being designated inactive. The
certificate of recordal shall become inactive as of the date of the
amendment of the trademark. A new application for recordal of the
amended trademark application or registration may be submitted to the
Commissioner at any time.
(c) Certificates of recordal designated inactive due to
cancellation, expiration, abandonment or amendment of the trademark
application or registration cannot be reactivated.
Sec. 280.725 Cumulative listing of recordal information.
The Commissioner shall maintain a record of the names, current
addresses, and legal entities of all recorded manufacturers and private
label distributors and their recorded insignia.
Sec. 280.726 Records and files of the Patent and Trademark Office.
The records relating to fastener insignia shall be open to public
inspection. Copies of any such records may be obtained upon request and
payment of the fee set by the Commissioner.
[FR Doc. 96-24105 Filed 9-25-96; 8:45 am]
BILLING CODE 3510-13-P
