Procedures for Implementation of the Fastener Quality Act

SUMMARY: The Director of the National Institute of Standards and

Technology (NIST), United States Department of Commerce, and the Under

Secretary of the Bureau of Export Administration (BXA), United States

Department of Commerce (collectively referred to as the Department),

are today issuing a final rule based on comments received in response

to the notice of proposed rulemaking published in the Federal Register

on September 8, 1997 (62 FR 47240-47260) (1997)) amending regulations

found at 15 CFR part 280 implementing the Fastener Quality Act (the

Act). This final rule establishes the procedures for registration of

in-process inspection activities of qualifying manufacturing facilities

that use Quality Assurance Systems (QAS), revises definitions and

related sections for clarity, and corrects editorial errors. These

changes will facilitate the implementation of the Act and will better

accommodate modern industry practices by incorporating these practices

into the certification process of fasteners covered by the Act. This

rule also extends the implementation date of the Fastener Quality Act

by sixty days to July 26, 1998.

DATES: This rule is effective May 14, 1998. The date of implementation

of the Act is July 26, 1998.

FOR FURTHER INFORMATION CONTACT: Dr. Subhas G. Malghan, FQA Program

Manager, Technology Services, National Institute of Standards and

Technology, Building 820, Room 306, Gaithersburg, MD 20899, telephone

number (301) 975-5120.

SUPPLEMENTARY INFORMATION:

Extension of Implementation Date

The final rule implementing the Fastener Quality Act became

effective on November 25, 1996, and was to apply to fasteners

manufactured on or after May 27, 1997, the ``implementation date''. On

April 18, 1997, as permitted by section 15 of the Act, NIST announced a

one year delay of the implementation date of the regulations because

there were an insufficient number of accredited laboratories to conduct

the volume of inspection and testing required by the Act and

regulations (62 FR 19041 (1997)). Currently, NVLAP and the NIST-

recognized private accreditation bodies have received applications from

approximately 430 testing laboratories, a sufficient number for

implementation of the Act. Of these, approximately 130 testing

laboratories have been accredited and are listed on the NIST Accredited

Laboratory List. Although NVLAP and the private accreditation bodies

have been working diligently to complete accreditation of these

laboratories, it seems unlikely that the necessary 425 laboratories

will be accredited by May 26, 1998. Therefore, to ensure that there are

a sufficient number of accredited laboratories to conduct the

inspection and testing required by the Act, pursuant to section 15 of

the Act, NIST is extending the implementation date of the Act by sixty

days to July 26, 1998.

Background--Final Rule

The Fastener Quality 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 and registration of

manufacturing facilities 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 the Director of NIST,

published final regulations implementing the Act on September 26, 1996.

Those regulations established procedures under which: (1) Laboratories

in compliance with the Act may be listed; (20 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 established, 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 contained provisions on

testing and certification of fasteners, sale of fasteners subsequent to

manufacture, recordkeeping, applicability of the Act, enforcement,

civil penalties, and hearing and appeal procedures.

Those regulations became effective on November 25, 1996, and were

to apply to fasteners manufactured on or after May 27, 1997, the

``implementation date''. On April 18, 1997, as permitted by section 15

of the Act, NIST announced a one year delay of the implementation date

of the regulations because there were an insufficient number of

accredited laboratories to conduct the volume of inspection and testing

required by the Act and regulations (62 FR 19041 (1997)).

Following issuance of the final regulations on September 26, 1996,

the automobile industry approached the Department and expressed its

concern that the Act and the implementing regulations did not recognize

the use of modern manufacturing methods using prevention-based quality

assurance systems employing statistical process controls (SPC). On

February 4, 1997, a Public Workshop was held at NIST to solicit

information from all interested parties, including the automobile,

aerospace, construction, and fastener industries on the use of

prevention-based quality assurance systems employing SPC in the

manufacture of fasteners. The Department published a notice of proposed

rule making in the Federal Register on September 8, 1997, seeking

public comments on proposed amendments to the regulations that

recognize the use of prevention-based quality assurance systems under

the Act.

To incorporate Quality Assurance Systems/Statistical Process

Control (QAS/SPC) into the regulations, the Department proposed adding

Sec. 280.104, Accreditation of Certain Manufacturing Facilities as

Laboratories; subpart I, Special Rule for the Accreditation of Certain

Fastener Manufacturing Facilities, Whose Implemented Fastener Quality

Assurance Systems Meet Defined Requirements, as Laboratories; subpart

J, Recognition of Foreign Registrar Accreditation Bodies; subpart K,

Requirements for Registrar Accreditation Bodies (Accreditors); and

subpart L, Requirements for Registrars. In addition, the Department

proposed adding a definition of Fastener Quality Assurance System

(FQAS) and defining the terms Accreditor, Registrar, and Facility. The

Department also proposed amendments to section 280.6, Laboratory Test

Reports and Sec. 280.10, Sampling, to specify requirements for

facilities.

[[Page 18261]]

Summary of Public Comments Received by the Department in Response

to the September 8, 1997 Request for Public Comments, and the

Department's Response to the Comments

As noted above, on September 8, 1997, the Department published in

the Federal Register (62 FR 47240-47260) (1997) (Sept. 8, 1997) a

proposed rule to amend 15 CFR part 280. The Department received 125

responses to the request for comments. Twenty-five comments were

received from fastener manufacturers, twenty domestic and five foreign;

twenty-five were from associations, twenty domestic and five foreign;

thirteen were from consultants; ten were from fastener distributors;

eight were from entities involved in laboratory accreditation/facility

registration, three laboratory assessors, two fastener testing

laboratories, one laboratory accreditor, one foreign QAS registrar, and

one foreign registration accreditation body; eight were manufacturers

of products that incorporate fasteners, five from the aerospace

industry, two from the automobile industry (one domestic and one

foreign), and one foreign equipment manufacturer; eight were from

government agencies; six were from importers of fasteners; one was from

a foreign exporter of fasteners; one was from a raw material

manufacturer; and twenty were from other interested parties, fifteen

domestic and five foreign. Of the some 125 commenters, 69 commented on

the issue of incorporating SPC/QAS into the FQA regulations. A detailed

analysis of the comments follow.

As explained in detail below, based on the comments received, the

Department has included all the proposed changes, with some editorial

corrections and clarifications, in the final rule. For further

clarification, the Department also has included definitions for

recognized accreditor, accredited registrar, registered facility, and

authorized representative, and has amended the definition of consensus

standards organization to clarify that it is NIST that will identify

such organizations.

Comments on the Overall Effectiveness of the Proposed QAS

Regulation

Of the 125 commenters, 69 commented on the issue of incorporating

SPC/QAS into the FQA regulations; 44 favored the incorporation of SPC/

QAS into the FQA regulations, and 25 were opposed.

Of the 44 commenters who favored the incorporation of SPC/QAS into

the FQA regulations, thirteen were fastener manufacturers, ten domestic

and three foreign; thirteen were trade associations, ten domestic and

three foreign; six were manufacturers of products that incorporate

fasteners, three aerospace manufacturers, two automobile manufacturers

(one domestic and one foreign), and one foreign equipment manufacturer;

three were fastener distributors; three were consultants; one was a

government agency; one was a foreign QAS registrar; and four were other

interested parties, two domestic and two foreign.

Of the 25 commenters opposed to the incorporation of SPC/QAS into

the FQA regulations, four were consultants; four were laboratory

accreditors/accessors; three were domestic fastener manufacturers; two

were fastener distributors; three were government agencies; one was a

raw material manufacturer; and seven were other interested parties.

Comment: Support for the proposed incorporation of QAS/SPC into the

regulation was widespread, although many raised questions on details of

the regulation, as is explained more fully elsewhere in this document.

However, a substantial minority of the commenters, twenty-five,

expressed the concern that without final testing, the QAS/SPC scheme

proposed by NIST would not ensure the quality of fasteners covered by

the regulations, and would fail to protect the public safety.

Response: The decision by the Department to include QAS/SPC into

the regulations as an alternative to end-of-line sampling and testing

is based upon strong evidence that QAS/SPC reduces the defect rate in

the fastener manufacturing process. A lower defect rate means that

fewer fasteners are manufactured that fail to comply with relevant

standards and specifications, and thus that fewer defective fasteners

will enter into commerce. Public safety is preserved and enhanced.

Furthermore, the Department has structured the regulation to provide

checks and balances to ensure that this is the case.

The administrative record for this rule-making contains strong

evidence that QAS/SPC systems utilizing continuous monitoring and

control in the manufacturing process yields a substantially lower

defect rate than do traditional manufacturing techniques that rely

solely upon end-of-line sampling and testing. Testimony at the Public

Workshop of February 7, 1997 indicates that the use of QAS/SPC may

reduce the defect rate from the range of thousands or tens of thousands

parts-per-million experienced by traditional manufacturing techniques

to approximately 100 parts-per-million. The improved manufacturing

techniques embedded in QAS/SPC thus improve the quality of fasteners by

reducing the portion of each lot that fails to meet standards and

specifications. The regulations being issued today offer the benefits

of QAS/SPC manufacturing to consumers in this country. But consistent

with the FQA, these regulations also mandate in-process inspection and

testing of fasteners manufactured under QAS/SPC systems, to verify that

the promise of QAS/SPC is the reality.

As a means of providing checks and balances to the process controls

that underlie the QAS/SPC methodology, the regulations mandate in-

process inspection and testing of fasteners to assure the quality of

fasteners, and thus the protection of public safety. Process controls

in QAS/SPC facilities are required by the regulation to be augmented by

all testing required by the standards and specifications that the

manufacturer holds out that a given lot meets. The general rule is set

out in Sec. 280.104(a), which states that registration of a fastener

manufacturing facility employing a fastener quality assurance system

(FQAS) shall be deemed to meet the requirements of accreditation of a

laboratory under the FQA. This general rule is amplified in Sec. 280.2,

which defines the term FQAS, and Sec. 280.10, which sets out

requirements for sampling methods to be followed by QAS/SPC facilities.

These sections of the regulation address three issues in the regime

required of QAS/SPC facilities:

What is the sampling methodology required of QAS/SPC

facilities as part of their responsibility to conduct in-process

testing and inspection?

What specific tests and testing techniques must QAS/SPC

facilities apply to the samples that are to be tested?

Where must these tests be performed?

Sampling is a concept that will not always be relevant in the QAS/

SPC environment. The definition of FQAS speaks about ``process

inspection embodied in a comprehensive and written control plan for

product/process characteristics, process controls (including

statistical process control), tests, and measurement systems that will

occur during mass production.'' The Department recognizes that under

QAS/SPC, some tests and inspections will be conducted on every fastener

in the lot. That is, the test sample will be one hundred percent of the

fastener lot. Section 280.10(c), as it has been revised as a result of

the public comment

[[Page 18262]]

process, makes this point clear by stating, as one alternative, that

``a manufacturer operating a Registered Facility may elect to conduct

inspections and tests upon all of the fasteners within a specified lot,

provided that this election is documented in the control plan of its

Fastener Quality Assurance System.'' Otherwise, the sample size is

governed by the general rule in Sec. 280.10(a), which states that

``[f]or tests conducted either in a laboratory on the Accredited

Laboratory List or in a Registered Facility, if a manufacturer

represents that the fasteners in a particular sample have been

manufactured to a standard or specification which provides for the

size, selection or integrity of the sample to be inspected and tested,

the sample shall be determined in accordance with that standard or

specification''; or the first alternative in Sec. 280.10(c) ``For tests

conducted in a Registered Facility, and not in a laboratory on the

Accredited Laboratory List, if a manufacturer represents that the

fasteners in a particular sample have been manufactured to a standard

or specification which does not provide for the size, selection or

integrity of the sample to be inspected and tested, the sample for

inspections and tests by the Facility shall be determined by the

sampling plan provided by its Fastener Quality Assurance System or by

standards and specifications intended for use with a Fastener Quality

Assurance System, as appropriate.''

Tests are as required in the relevant standards and guidelines.

Where testing occurs in the QAS/SPC regime is governed by

Sec. 280.104(b) of the regulations, which requires that all in-process

laboratory inspection and testing must be performed in laboratories

accredited under the FQA; and Sec. 280.104(d), which requires that the

chemical composition of all fastener lots manufactured under QAS/SPC

must be conducted in laboratories accredited under the FQA. In-process

testing and inspection may occur within Registered Facilities.

In the view of the Department, these requirements meet the

statutory mandates of the FQA, and protect the public safety.

280.2 Definitions

Comment: Eight commenters addressed the issue of whether

subcontracted processes required final testing by an accredited

laboratory or whether they could be performed by another Facility.

Response: In Sec. 280.2, the definition of Facility has been

expanded to include a facility performing subcontracted processes such

as electroplating and heat treating, provided that they too are listed

on NIST's Facilities list. In addition, Sec. 280.807 allows

subcontracting to other Facilities listed on the Facilities list.

Comment: Eight commenters suggested that Quality Assurance Systems

are not equivalent, and that they do not define which characteristics

to measure and how to measure them.

Response: No changes have been made to the regulations based on

these comments because the QAS facilities must meet equally rigorous

standards to maintain their registration by an accredited Registrar.

Comment: Two commenters requested that the regulations be amended

to allow QAS in lieu of metal testing by a metal manufacturer.

Response: No changes were made to the regulations because to the

Department's knowledge, chemistry of metal is obtained by testing it in

a laboratory. Therefore, chemical analysis by QAS is not an acceptable

testing method.

Comment: Ten commenters suggested deleting references to ISO-9000

in the definition of Fastener Quality Assurance System because it lacks

quality details and does not contain the details of ISO-25. In

addition, three of these commenters stated that the proposed rule does

not satisfy the intent of the Congress and will have a serious effect

on the laboratory accreditation, and that a final inspection should be

still required.

Response: No changes were made to the regulations based on these

comments. The regulations are clear on laboratory accreditation and

registration of fastener manufacturing facilities. The laboratory

accreditation is performed in accordance with ISO Guides 58 and 25, and

specific requirements of the Act and the regulations. Registration of

fastener manufacturing facilities is carried out in accordance with the

ISO Guides 61, 62 and the specific requirements of the Act and the

regulations. The revised rule accommodating QAS facilities is fully

within the intent of the Act because under QAS, fasteners are produced

to stringent standards that yield fasteners of at least as good quality

as end-of-line laboratory testing can assure. Since the two programs,

accreditation and registration, are treated separately, the Department

does not believe that laboratory accreditation will be seriously

affected.

Comment: Two commenters suggested that the Department specify a

level of revision of ISO Guides referred to in the QAS regulations that

will assure the Department that the QAS approved today will remain

compliant in the future.

Response: No changes were made to the regulations based on these

comments. As they currently exist, the ISO Guides referenced in the QAS

regulations fulfill the needs of the Act and the regulations. The

regulations are sufficiently flexible to accommodate moderate change in

these standards.

Comment: One commenter remarked that the parameters of a control

plan are not discussed in the proposed rule.

Response: No changes were made to the regulations based on this

comment because the Department has decided that the broad parameters

described in Sec. 280.2 are sufficient.

Comment: One commenter suggested clarifying the meaning of

``documented criteria of a QAS.''

Response: No changes were made to the regulations based on this

comment because the definition of QAS describes specific criteria to be

met by the QAS facility.

Comment: One commenter suggested adding a requirement that

personnel who collect data pursuant to the operation of a QAS be held

to the same standards of training, experience and competency as

laboratory personnel.

Response: No changes were made to the regulations based on this

comment. The processes involved in laboratory testing differ from those

in a QAS facility. Requirements for personnel performing tasks involved

in these processes differ. The requirements for laboratory personnel

are described in ISO Guide 25. The requirements for QAS facility

personnel are described, in general, in the fastener QAS followed by

that QAS facility.

Comment: One commenter remarked that QAS plans should be required

to measure all characteristics called for in the standard and

specification, rather than just those that the manufacturer finds

appropriate for product functionality.

Response: The Department agrees. Changes were made to the

regulations in Sec. 280.2 under the definition of Fastener Quality

Assurance System in (2)(v). To improve clarity, this section is amended

to read as follows: ``a requirement that the in-process control plan

include those characteristics specified by the QAS standard,

characteristics specifically indicated by the applicable fastener

standards and specifications, and those characteristics as designated

by the end user for evaluating product functionality.''

Comment: One commenter asked if a fastener standard does not accept

SPC as an alternative to the final testing, then can the SPC be used.

[[Page 18263]]

Response: No changes were made to the regulations based on this

comment. If a fastener standard does not accept SPC, SPC may not be

used to meet the requirements of that standard.

Comment: One commenter requested amending Sec. 280.5 to confer upon

the major end user the responsibility of specifying how a lot of

fasteners is to be tested, including in accordance with major end users

in-house publication or in accordance with QAS, rather than in

accordance with the embedded standards and specifications.

Response: No changes were made to the rule based on this comment

because section 5(b)(1) of the Act requires that a manufacturer have

lot samples tested to determine whether the lot conforms to the

standards and specifications to which the manufacturer represents it

has been manufactured. The Act does not offer the flexibility of

delegating this responsibility to the end user.

Comment: One commenter suggested adding a definition of major end

user to the rule.

Response: The Department has not made any changes to the

regulations based on this comment. A definition of major end user is

not necessary because the term major end user does not appear in the

regulations.

Comment: One commenter remarked that NIST overlooked the basis of

its Malcolm Baldrige award, and NIST should practice its quality

outreach program by reissuing regulations to encompass ISO-9002 and QS-

9000 and state of the art quality programs.

Response: No changes were made to the regulations based on this

comment. ISO-9002 and QS-9000 are used worldwide while the Malcolm

Baldrige criteria are familiar only to United States firms. Since

fasteners to which the Act and the regulations apply are produced

worldwide, international standards are more appropriate.

280.5 Certification of Fasteners

Comment: One commenter proposed an amendment to Sec. 280.5 of the

rule to clarify that a manufacturer that follows QAS is in compliance

with the Act.

Response: No changes were made based on this comment because

Sec. 280.5(a) states the rule for inspecting, testing, and

certification of covered fasteners, and Sec. 280.104(a) brings

registered QAS facilities under this general rule, and therefore, in

compliance with the Act.

280.6 Laboratory Test Reports

Comment: Nine commenters stated that manufacturers registered to

QAS should not have to prepare test reports as proposed in Sec. 280.6

(b) and that requirement would make the QAS program unworkable. These

commenters stated that amendments to proposed Sec. 280.6(b) would be

necessary. In addition, two additional commenters requested that the

Department reduce the contents of the test reports for QAS facilities

since it is unnecessary and burdensome, limit requirements to those of

the Act and require just a statement that fasteners conform to the QAS

plan on the report.

Response: The requirement for a test report is mandated by sections

5 and 7 of the Act. However, based on these comments, amendments have

been made to Sec. 280.6(b) of the regulations by deleting certain

reporting requirements. Also, similar amendments were made in

Sec. 280.6(a) to simplify laboratory test report requirements for both

laboratories and Facilities. Further, Sec. 280.7 was amended to

accommodate amendments made to Sec. 280.6.

Comment: Two commenters asked whether imported fasteners produced

under QAS must be accompanied by a certificate and laboratory testing

report.

Response: No changes were made to the regulations because there is

no exception that states that imported fasteners produced under QAS

need not be accompanied by a certificate and laboratory test report.

Section 280.13 describes the requirements for imported fasteners, which

include a manufacturer's certificate of conformance and an original

laboratory test report.

Comment: One commenter suggested that a ``synopsis'' of the test

report would not provide assurances for end user.

Response: In response to this comment, the word, ``synopsis'' has

been deleted from Sec. 280.6(b) to clarify that registered facilities

must include test results in their reports rather than a synopsis of

their test results. The reporting of actual test results will provide

assurances for the end user.

Comment: Two commenters asked that QAS reports include basic and

unique identification information to tie a particular fastener lot with

the report and control plan.

Response: In response to this comment, the Department has amended

Sec. 280.6(b)(2) to require that test reports include: ``Unique

identification of the test report, including date of issue and serial

number, or other appropriate means, including reference to the control

plan identification.''

Comment: Three commenters suggested allowing facilities to make a

certified statement that fasteners with a specific lot number are

fulfilling the requirements of stated standards and specifications, in

place of a detailed test report as required by Sec. 280.6(b).

Response: No changes were made to the regulations based on this

comment because a certified statement will not satisfy the requirements

of sections 5 and 7 of the Act. An original laboratory testing report

and a manufacturer's conformance certificate are required.

Comment: One commenter asked how he should report QAS test results

in accordance with the regulations.

Response: No changes were made to the regulations based on this

comment because Sec. 280.6 describes procedures for reporting QAS test

results.

280.10 Sampling

Comment: Two commenters addressed a conflict between Sec. 280.10,

which pertains to sampling, and one of the goals of QAS. According to

these commenters, Sec. 280.10 appears to permit a plan provided by a

Fastener QAS only when the standards and specifications do not provide

for size, selection and integrity of the sample. However, one of the

goals of QAS is to have a control plan which describes a sampling plan.

Therefore, these commenters requested guidance on which sampling plan

should they follow. Another commenter requested allowing sampling plans

specified by the customer in a QAS control plan.

Response: Section 280.10 has been rewritten in response to these

concerns to clarify sampling requirements under the FQA and these

regulations. Section 5(b)(2) of the Act restricts the authority of the

Department to prescribe sampling procedures for fastener testing to

those instances where the standards and specifications relevant to a

fastener lot are silent on sampling. This is why revised Sec. 280.10(a)

states ``For tests conducted either in a laboratory on the Accredited

Laboratory List or in a Registered Facility, if a manufacturer

represents that the fasteners in a particular sample have been

manufactured to a standard or specification which provides for the

size, selection or integrity of the sample to be inspected and tested,

the sample shall be determined in accordance with that standard or

specification''.

However, in response to these comments, the Department has included

Sec. 280.10(c) to clarify sampling procedures in the QAS/SPC setting.

Section 280.10(c) sets out procedures to be followed when

Sec. 280.10(a) does not apply: ``For tests conducted in a Registered

Facility, and not in a laboratory on the Accredited Laboratory List, if

a manufacturer represents that the fasteners in a particular sample

have been manufactured to a standard or

[[Page 18264]]

specification which does not provide for the size, selection or

integrity of the sample to be inspected and tested, the sample for

inspections and tests by the Facility shall be determined by the

sampling plan provided by its Fastener Quality Assurance System or by

standards and specifications intended for use with a Fastener Quality

Assurance system, as appropriate. Or, a manufacturer operating a

Registered Facility may elect to conduct inspections and tests upon all

of the fasteners within a specified lot, provided that this election is

documented in the control plan of its Fastener Quality Assurance

System.''

The last sentence in Sec. 280.10(c) has been added because sampling

is a concept that will not always be relevant in the QAS/SPC

environment. The definition of FQAS speaks about ``process inspection

embodied in a comprehensive and written control plan for product/

process characteristics, process controls (including statistical

process control), tests, and measurement systems that will occur during

mass production.'' The Department recognizes that under QAS/SPC, some

tests and inspections will be conducted upon every fastener in the lot.

That is, the test sample will be one hundred percent of the fastener

lot. The last sentence in Sec. 280.10(c), as it has been revised as a

result of the public comment process, makes this point clear by stating

that ``[A] manufacturer operating a Registered Facility may elect to

conduct inspections and tests upon all of the fasteners within a

specified lot, provided that this election is documented in the control

plan of its Fastener Quality Assurance System''.

Comment: Three commenters remarked that the default sampling plans

prescribed in the regulations are overly restrictive. One commenter

cited the example of sampling plans restricting lot size to 250,000

pieces while manufacturing lots may be larger.

Response: No changes were made to the regulations based on this

comment. Section 5(b)(2)(B) of the Act provides that default sampling

plans prescribed by the Secretary must, to the extent practicable, use

consensus testing standards and related materials. Sampling plans are

prescribed by these standards and specifications. NIST does not have

the authority to change those standards.

280.12 Applicability

Comment: Eighteen commenters stated that the planned implementation

date of May 26, 1998 will not allow enough time for NIST to approve

Accreditors, for Accreditors to accredit Registrars, and for the

Registrars to register fastener manufacturing facilities. Suggested

approaches were: (1) To delay implementation date of the Act until a

sufficient number of facilities are registered, (2) to grant

provisional approval of current QAS-registered facilities and begin

audit in six months, (3) to convene a meeting of all interested parties

to establish a reasonable time line for industry compliance.

Response: The Department has studied these comments and assessed

the registration requirements of the fastener industry. To accommodate

the industry needs, the Department has developed the following plan,

codified in Sec. 280.810(c)(3), to provisionally approve current QAS-

registered facilities so that commerce in fasteners is unaffected as a

result of the July 26, 1998 implementation date.

If a Facility intends to be listed in accordance with

Sec. 280.810(c)(1) but the registration process will not be completed

by July 26, 1998, the Facility may be provisionally listed on the

Facilities List by providing the following to NIST on or before

September 30, 1998:

1. Certification that: (a) The Facility is registered to QS-9000 or

an equivalent by a quality systems registrar; (b) the Facility conforms

to all other requirements of the Act and the regulations at the time of

certification; (c) if the Facility ceases to be registered to QS-9000

or an equivalent by an accredited Registrar and/or ceases to conform to

any other requirement of the Act and the regulations at any time during

the provisional listing period, it will notify NIST of that fact within

three working days; and (d) if the Facility fails to apply to an

accredited Registrar for registration under the FQA within 30 days of

the time the Registrar is accredited by a NIST-approved Accreditor, an

authorized representative of the Facility will immediately notify NIST.

(If the Facility's current Registrar decides not to seek accreditation

under the FQA, it is the Facility's responsibility to apply to another

Registrar that has been approved by NIST-ABEP.);

2. A list of fasteners produced or processed by the Facility,

identified by either a part number or a specification number;

3. A list of standards included in the Facility's registration;

4. A copy of the Facility's registration certificate; and

5. The listing fee established by NIST.

The Facility must meet all the requirements of the Act and the

regulations by May 25, 1999. If the Facility fails to receive FQA

registration by May 25, 1999, it will be removed from the Facilities

List.

Comment: Six commenters requested delaying the implementation date

(for example, one more year) so that outstanding questions can be

interpreted and lead time provided to get ready for implementation of

the Act.

Response: Changes were made to the regulations based on these

comments. As described earlier, the Department has developed a

procedure, based on industry input, by which manufacturing Facilities

in the QS-9000 system may ``self-certify'' for one year. The Department

is also delaying the implementation date from May 26, 1998 to July 26,

1998, following the Department's determination that there will be an

insufficient number of accredited laboratories to perform the volume of

inspections and testing required on May 26, 1998.

Comment: Three commenters, including a U.S. government agency,

requested delaying the implementation date until a detailed regulatory

flexibility analysis is conducted and published for public comment.

They claim the proposed regulations will have a significant negative

impact on fastener distributors and manufacturers because of the cost

of inventory scrapped, the cost of accrediting laboratories, the loss

of potential market share because of exemption of fasteners in free

trade zones, the disruption in supply and resulting loss of business to

OEM customers, the disproportionate cost of laboratory accreditation on

QAS registered facilities, and the disproportionate cost to certify raw

materials.

Response: A detailed regulatory flexibility analysis was conducted

and published as part of the final regulations on September 26, 1996,

which considered almost all issues raised by these commenters. The

remaining issues related to QAS regulations were addressed as part of

the proposed rule on September 8, 1997. As noted above, the Department

has delayed the implementation date until July 26, 1998.

Comment: An agency of the U.S. Government commented that the

proposed rule does not provide a meaningful regulatory alternative to

small businesses because of the short deadline of May 26, 1998, and

does not address economic impact on affected sectors.

Response: The Department has addressed the issue of the short

deadline for registering a sufficient number of facilities before the

July 26, 1998 implementation date by adding Sec. 280.810(c)(3), which

allows

[[Page 18265]]

provisional approval of current QAS-registered facilities if they meet

certain requirements.

The Department certified, under 5 U.S.C. 605(b), that the proposed

rule would not have a significant economic impact on a substantial

number of small entities. The factual basis for this certification was

published with the proposed rule. The Department does not agree with

the commenter's conclusion that the proposed rule does not afford a

meaningful alternative to small businesses as no preference is given to

large manufacturers and registrars over small industry participants.

This methodology would be available to any business, large or small,

that employs QAS of manufacturing. Moreover, whether small or large,

businesses are not forced to adopt QAS. The amended rule would

establish a second option for those manufacturers interested and

qualified to use the QAS of manufacturing.

On the issue of cost of inventory produced before the

implementation date, the industry has long recognized this problem and

has had adequate time to react appropriately. This issue 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, the fastener industry coalition, 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. Other cost elements were addressed in the

September 26, 1996 notice of final rulemaking.

280.104 Accreditation of Certain Manufacturing Facilities as

Laboratories

Comment: Four commenters stated that the requirement that in-

process testing be done by a laboratory on the Accredited Laboratory

List would require a costly additional evaluation of the laboratory by

an accreditation body. In addition, one suggested that the QS-9000

registration process should include accreditation of the Facility's

laboratory.

Response; No changes were made to the regulations based on this

comment. The requirement that in-process testing be performed by a

laboratory on the Accredited Laboratory List is included in the

regulations because registration of a QAS facility under ISO Guide 9001

or 9002 or QS-9000 does not include evaluation of technical credibility

and validity of test results from an accredited laboratory.

Comment: One commenter stated that having to be assessed by a body

approved by NIST is just as onerous a burden as getting laboratory

accreditation.

Response: No changes were made to the regulations because section 6

of the Act mandates that laboratory accreditation be performed by

accreditation bodies recognized by NIST. Facilities are brought into

the FQA regime under Sec. 280.104(a) of the regulations, which deems

registration of Facilities to meet the requirements of laboratory

accreditation. Therefore, the Act's requirements for laboratory

accreditation apply to the registration of Facilities, as well.

Comment: One commenter suggested clarifying the phrase ``any in-

process inspection and testing,'' because it does not include all in-

process testing at a QAS facility.

Response: Based on this comment, the Department revised

Sec. 280.104(d) of the regulations to clarify which tests must be

performed by a laboratory on the Accredited Laboratory List.

Comment: Three commenters suggested making laboratories used by QAS

registered facilities meet ISO Guide 25 and proficiency testing

requirements so that QAS registered facilities provide consistency in

accreditation of laboratories.

Response: Since these requirements are already present in the

revised regulations, no changes were made.

Comment: One commenter suggested that since laboratories must

comply with stricter standards (ISO-25, EN-45001, etc) than

manufacturers, the Department should allow laboratories owned by

distributors to use the same standards as manufacturers.

Response: No changes have been made to the regulations because

manufacturers follow QAS standards defined under Sec. 280.2 of the

regulations to qualify as a QAS facility. Distributors are not

manufacturers manufacturing, hence they cannot follow the same

standards as the manufacturers. However, irrespective of the ownership

of the laboratory, the laboratory has to meet the same requirements.

Comment: One commenter stated that recognizing SPC as an

alternative to final testing inspection is unlikely to benefit the

aerospace industry because aerospace industry specifications

specifically do not allow SPC.

Response: No changes were made to the regulations based on this

comment because the incorporation of fastener specific QAS standards is

an essential element of the QAS requirements. If the aerospace industry

requires final testing and inspection, it will not be affected by the

addition of the QAS option.

Comment: One commenter suggested that if a chemical laboratory is

included in the registration of a QAS registered facility, there is no

need to go to an accredited laboratory for testing.

Response: No changes were made based on this comment. Section

280.104(d) requires that chemical testing be performed by a laboratory

on the Accredited Laboratory List. Section 280.104(b) allows that such

a laboratory may be located on the same premises as a fastener

manufacturing facility if the laboratory is separately accredited

pursuant to a provision of the regulations other than Sec. 280.104(a).

Therefore, a chemical laboratory cannot be accredited through

registration process.

Comment: One commenter requested providing clarification as to when

a QAS Facility does testing and when an accredited laboratory does

testing.

Response: In response to this comment, Sec. 280.104(d) has been

amended to clarify the requirements for laboratory tests.

Subparts I-L: Accreditation of Manufacturing Facilities; Foreign

Accreditors; Accreditors; Registrars

Comment: Two commenters requested amending Sec. 280.800 to allow

the use of QAS facilities registration by another agency, in addition

to NIST.

Response: No changes were made to the regulations based on this

comment. NIST is the only government agency allowed to carry out

laboratory accreditation under section 6 of the Act.

Comment: Three commenters suggested recognizing accreditation

bodies that have been recognized by organizations other than NIST. Two

commenters mentioned recognizing accreditation bodies accessed under

the International Accreditation Forum. One commenter suggested that if

one accreditation body is recognized in Europe under the Act and the

regulations, NIST should recognize all other bodies that are part of

multilateral agreements to which the recognized accreditation body is a

party.

Response: No changes were made to the rule based on this comment.

Section 6 of the Act allows FQA accreditation only by bodies recognized

by NIST. Under this regulatory program, each accreditation body must

apply to NIST directly and be individually evaluated to obtain

recognition. Blanket accreditation under a multilateral agreement or

under an international forum would not allow NIST to ensure that each

accreditation body meets all

[[Page 18266]]

requirements of the Act and the regulations.

Comment: One commenter asked if the Registrars will be required to

evaluate the substantive content of control plan.

Response: Under the definition of a Fastener QAS in Sec. 280.2, one

of the elements of a QAS is a requirement that a fastener manufacturer

fully document a detailed control plan. Therefore, it is the

responsibility of the manufacturer to develop and maintain a detailed

control plan. However, as part of the registration process, a Registrar

is required to evaluate the contents of the control plan.

Comment: One commenter stated that in Japan, a government body

approves QAS registered fastener manufacturing facilities as JIS

Marking factories. In this situation, the commenter asked, how will the

proposed system of registration work.

Response: No changes were made to the regulations based on this

comment because the system of registration in the current regulations

is based on internationally accepted procedures. The system proposed by

the commenter is different from the internationally accepted standards

procedures. The commenter has two options to comply with the

regulations: 1. Separation of registration and accreditation

activities; or 2. Use of a private registrar to register facilities.

Comment: One commenter asked if the United Kingdom Accreditation

Service (UKAS) can accredit Registrars for QAS assessments.

Response: No changes were made to the regulations based on this

comment because the procedures for seeking recognition by NIST-ABEP are

described in the ABEP handbook. If interested in engaging in the

acceditation of Registrars, UKAS must apply to NIST-ABEP for

recognition.

Comment: One commenter inquired whether approving Registrars will

require additional resources for NIST. According to the commenter, if

NIST approves registrars, it will be perceived as expansion of

government into a role previously performed by the private sector. If

that is the case, the commenter asked, why not rely on the private

sector.

Response: No changes were made to the regulations based on this

comment because the revised regulations clarify that NIST will not

directly accredit Registrars. NIST will rely on NIST-approved private

sector Registrar Accreditation Bodies to perform Registrar

accreditation. There will be no additional resources required for NIST

because section 6(d)(2) of the Act specifies that accreditation

activities performed by NIST will be on a reimbursable basis.

Comment: One commenter asked how NIST-ABEP will assure that a

manufacturer is competent to conduct fastener testing if the criteria

is based on ISO-9000 series.

Response: No changes were made to the regulations based on this

comment. Registering a fastener manufacturing facility to ISO-9000 does

not indicate that the facility is competent to perform laboratory

tests. Any laboratory tests performed during in-process inspection and

testing must be performed by a laboratory on the Accredited Laboratory

List.

Comment: One commenter commented that elements (ii), (iv), and (v)

in proposed Sec. 280.1010(d)(5) are not related to quality elements.

Response: No changes have been made to the regulations as a result

of this comment. Section 280.1010(d)(5) details the requirements for a

quality manual, which necessarily must contain administrative

information as well as quality elements. The same information is

required by ISO Guide 61, so these requirements are familiar to the

industry.

Comment: One commenter asked for clarification of terms used in

Secs. 280.1010 and 280.1011: ``appropriate international

documentation'' in Sec. 280.1010(d)(5)(xiv); ``informed'', ``corrective

action'', and ``timely and appropriate'' in Sec. 280.1010(f);

``appropriate international documentation'', ``technical experts'',

``assessment of familiarity'' and others in Sec. 280.1011. Similarly,

this commenter suggested that subparts K and L need to be reworked to

eliminate vague terms.

Response: No change was made to the regulations. The ABEP handbook

will provide guidance for interpreting these terms.

Comment: One commenter mentioned that Sec. 280.1010(i)(2), the

prohibition on disclosure of information about an accreditation body

without its written consent, could interfere with the responsibilities

of end-users to control the quality of their suppliers in quality

management.

Response: No changes were made to the regulations based on this

comment. Section 280.1010(i)(2) refers to confidentiality of

information obtained by the Accreditor concerning the applicant

Registrars. The Department feels that this provision is required to

safeguard confidentiality of the information provided by the Registrar

to its Accreditor. The regulations do not prevent the end user from

getting the quality management-related information of its Registrar

from the Registrar itself or from the Accreditor with the Registrar's

written permission.

Comment: One commenter stated that there is a high probability of

inconsistent requirements under various registration systems. This

commenter specifically asked how NIST will assure that NIST and

Registrar Accreditation Body recognition requirements are equivalent.

Response: No changes have been made to the regulations in response

to this comment. Subparts I through L describe the criteria by which

Registrar Accreditation Bodies will be approved and by which Registrars

will be accredited by the approved bodies. NIST plans to closely adhere

to these requirements to maintain uniformity among the Registrars

accredited by various bodies.

Comment: One commenter asked if auditors will be approved for

appropriate standard industrial codes. The commenter also asked if

auditors will be required to be experts in both QAS and fastener

technology.

Response: No changes were made to the regulations based on this

comment. Approval of auditors will be the responsibility of accredited

Registrars under subpart L, which is based on ISO Guide 62. Auditors

will be required to be competent in both QAS and fastener technology.

Additional requirements specific to the fastener technology will be

described in the ABEP Handbook.

Comment: One commenter requested that NIST function as a Registrar

Accreditation Body if no accreditation body seeks NIST's approval.

Response: No changes were made to regulations based on this comment

because NIST does not foresee such a problem. The industry has

indicated that accreditation bodies are ready to apply once the

regulations take effect.

Comment: One commenter suggested that all Registrars currently

approved by Registrar Accreditation Bodies should be automatically

approved by NIST and all companies with QAS systems accredited by those

Registrars should be deemed to have approved QAS.

Response: No changes were made to the regulations based on this

comment. Recognition of Accreditation Bodies, accreditation of

Registrars, and registration of Facilities under the Act and the

regulations include meeting requirements specific to the Act and

regulations. Therefore, prior recognition, accreditation, or

registration, based on different requirements, are insufficient to meet

the requirements of the Act and the regulations.

[[Page 18267]]

Comment: One commenter suggested appointing the major users of QS-

9000 as registrars.

Response: The requirements for an organization to qualify as a

registrar are outlined in subpart L. If a major user wants to become a

registrar, it must meet those requirements and must apply to a

recognized registrar accreditation body to become an accredited

registrar.

Comment: One commenter requested that the Act should merely require

that certification (recognition of accreditation bodies and

accreditation of registrars) be made in accordance with applicable

standards because existing certification practices are sufficient to

meet the purposes of the Act.

Response: No changes were made to the regulations based on this

comment because existing practices do not require that accreditation

bodies and registrars meet the specific requirements of the Act and its

implementing regulations and, therefore, are insufficient for these

purposes.

Comment: One commenter suggested modifying Sec. 280.1010(e)(1) by

replacing ``partially or in total, for all or part of the accreditation

body's scope of accreditation'' with ``for FQA.''

Response: No changes were made to the regulations based on this

comment. The regulations apply only to FQA accreditations, not all

accreditations. Therefore, the current language of Sec. 280.1010(e)

refers only to partial or total suspension or withdrawal of

accreditation under the FQA.

Comment: One commenter suggested modifying Sec. 280.1012(c)(2)(iii)

by replacing ``product categories'' with ``Fasteners.''

Response: The Department has accepted the suggestion and modified

Sec. 280.1012(c)(2)(iii) by replacing ``product categories'' with

``fasteners covered by the Act.''

Comment: One commenter requested deleting the requirement for

accreditors in Sec. 280.1010(b)(17) that they must have a structure

where members are chosen to provide a balance of interest, where no

single interest predominates.

Response: The Department has not made any changes to

Sec. 280.1010(b)(17) based on this comment because a balance of

interest is required to maintain objectivity in making decisions

related to accreditation.

Comment: One commenter requested deleting Sec. 280.1010(b)(18),

which is a requirement for accreditors that offer other products,

processes or services not to compromise confidentiality or the

objectivity or impartiality of its accreditation process and decisions.

Response: No changes were made to the regulations based on this

comment because, according to ISO Guide 61, this is a necessary

condition that assures a fair decision making process in granting

accreditations.

Comment: One commenter suggested the following changes to the

proposed regulations: replace ``international documentation'' in

Sec. 280.1010(d)(5)(xiv), Sec. 280.1010(b)(2), and Sec. 280.1010(b)(3)

with ``ISO Guide 10011-1.''

Response: No changes were made to the proposed regulations based on

this comment. The Department deliberately used the term ``international

documentation'' rather than referring to an existing document so as not

to restrict the interpretation of that term. The Department notes that

Secs. 280.1010(b)(2), and 280.1010(b)(3) do not include the words

``international documentation.''

Comment: Two commenters requested changing the reassessment period

for accreditors, registrars, and QAS manufacturing facilities from two

years to three years to be consistent with the policies of the

International Accreditation Forum.

Response: No changes were made to the regulations based on this

comment. The Department has decided to retain the two year reassessment

period in order to be consistent with the laboratory accreditation

reassessment period under the Act and the regulations.

Comment: Three commenters requested that NIST should have an

oversight role on the Registrar activities to assure uniformity.

Response: No changes were made to the regulations based on this

comment. Detailed descriptions of oversight roles will appear in the

ABEP Handbook.

Part 2: Summary of Comments Received on Six Proposed Amendments

Six issues were addressed in the proposed amendments with a request

for public comment. A discussion of the comments received, and the

actions taken by the Department as a result of these comments follows:

1. Significant Alterations of Fasteners

Of the 125 commenters, 15 commented on the issue of significant

alteration of fasteners; eight favored the proposed changes to the FQA

regulations, and seven others offered different issues in the area of

significant alteration. Of the eight commenters who favored the

proposed changes regarding the significant alteration of fasteners,

four were trade associations, three domestic and one foreign; two were

fastener manufacturers, one domestic and one foreign; one was a

fastener distributor; and one was an other interested party. Of the

seven commenters who proposed changes regarding the significant

alteration of fasteners, three were government agencies; two were

aerospace manufacturers; and two were consultants.

In the notice of proposed rulemaking, the Department proposed

changes to the definition of ``significantly alter'' in Sec. 280.2 and

to Sec. 280.11(b) to correct editorial errors in the reference to

Rockwell C hardness in these sections. These changes have been adopted

into the final rule.

Comment: One aerospace manufacturer, one professional organization

and one consulting organization commented that other alterations such

as application of adhesives, locking elements and cutting off of

finished fasteners should be considered significant alterations.

Response: Based upon advice from the Fastener Advisory Committee,

the Department has determined that application of adhesives, locking

elements, and cutting off of finished fasteners are not significant

alterations because they do not weaken or otherwise materially affect

the performance or capabilities of fasteners as they were originally

manufactured, grade or property class marked, tested, or represented.

This language appears in the current definition of ``significantly

alter.'' Therefore, no changes were made based on these comments.

Comment: One distributor commented that clarification is needed as

to whether ``coating'' a fastener with a Rockwell hardness of C32 or

above is a significant alteration.

Response: The definition of ``alter'' as contained in the Act lists

only through-hardening, electroplating, and machining as forms of

alteration. The regulations do not expand upon this definition.

Therefore, ``coating'' other than electroplating is not a significant

alteration under the Act and the regulations.

Comment: The Department received three comments, two from

distributors and one from an equipment manufacturer, requesting that

the regulations be revised to allow alterers who electroplate the

option of either testing or warning rather than requiring them to test

to the plating specifications.

Response: Based upon advice from the Fastener Advisory Committee,

which deliberated this issue at great length during the initial review

of the regulations implementing the Act and recommended the requested

option not

[[Page 18268]]

be offered for electroplating due to concerns about hydrogen

embrittlement as a result of electroplating, the Department has made no

changes to the rule.

Comment: One distributor suggested deleting all references to

adhesives and sealants from the regulations and workshop materials and

requested that the Department issue a clarifying statement that these

issues are not covered by the Act.

Response: No changes have been made to the rule based on this

comment. The definition of ``significantly alter'', as it appears in

the regulations, specifically states that ``[t]he term does not include

the application of adhesives or sealants * * *.'' The Department feels

that retaining this definition clarifies what processes are not

considered significant alterations for purposes of the Act and the

regulations.

2. Removal of Head Markings

Of the 125 commenters, 18 commented on the proposed amendment to

allow the removal of head markings for decorative purposes and to meet

customer needs; eight favored the proposed changes, and 10 were

opposed. Of the eight commenters who favored the proposed changes

regarding the removal of head markings, five were trade associations;

three domestic and two foreign; one was a foreign equipment

manufacturer; one was a foreign fastener manufacturer; and one was a

foreign other interested party. Of the 10 commenters who opposed the

proposed changes regarding the removal of head markings, four were

government agencies; two were fastener distributors; two were fastener

manufacturers, one domestic and one foreign; one was a trade

association; and one was an aerospace manufacturer. In all of these

comments, it was noted that the proposed amendments did not contain the

statement, ``fasteners are to be manufactured according to the OEM or

major end user standard which does not require head marking'' though

the same was found in the preamble. This statement was included in the

preamble in error. Some of these commenters noted that removal of head

markings would not have adverse implications.

The proposed rule included a proposed new Sec. 280.11(c) to allow a

fastener user or purchaser to special order fasteners covered under the

Act and regulations without the required manufacturer or grade

identification markings under certain conditions. Based on comments

received, the Department has excluded this section from the final rule.

Comment: Two commenters suggested that the head marking exclusion

be moved to Sec. 280.700(b).

Response: No changes have been made based on this proposal. Since

the Department has decided not to adopt the proposed change, it will

not appear in either section.

Comment: Several commenters stated that the proposal to remove head

markings is contrary to the intent of the Act, and that markings are

vital for informing the user of strength levels and traceability. These

commenters emphasized that the removal of head markings does not

conform with the purpose of the Act that fasteners conform with

standards to which they were represented to have been manufactured. One

commenter from a trade association stated that removal of markings

promotes unsafe alteration of fasteners. Three commenters (a

manufacturer and two trade associations) noted that allowing the

removal of markings could lead to misapplication, misrepresented

fasteners, entry of substandard fasteners into commerce, and

significant equipment failures. These commenters stated that if the end

users want fasteners without markings, they can contract to have them

made that way. One manufacturer stated that no sales should be allowed

without the markings. Two commenters from U.S. Government agencies

stated that the removal of head markings would hinder investigations

and reduce accountability; therefore, it should not be allowed.

Response: Based on comments, the Department has decided not to

adopt the proposed change but to retain the existing rule.

3. Supplying Originals vs Copies of Test Reports

Of the 125 commenters, 18 commented on the issue of originals vs.

copies of test reports; 13 favored the proposed changes, and five were

opposed. Of the 13 commenters who favored the proposed changes

regarding originals vs. copies of test reports, five were trade

associations, two domestic and three foreign; four were fastener

manufacturers, three domestic and one foreign; three were consultants;

and one was a government agency. Of the five commenters opposed to the

proposed changes, two were government agencies; two were fastener

manufacturers, one domestic and one foreign; and one was a raw material

manufacturer.

The proposed rule included a proposed amendment to the definition

of ``original laboratory testing report'' in Sec. 280.2 to allow metal

manufacturers, as well as laboratories, to certify copies of laboratory

testing reports of chemical characteristics. Based on comments

received, the new definition has been included in the final rule. In

addition, the Department has added a definition of ``certified copy''

to further clarify the issue.

Comment: Two foreign equipment manufacturers commented that the

proposed rule does not allow a fastener manufacturer to test his own

fasteners rather than rely on the metal manufacturer's chemical

analysis of the metal.

Response: The Department has determined that the proposed rule does

not prevent fastener manufacturers who choose to adopt QAS from

obtaining chemical analysis, provided that the fastener manufacturers

obtain such analysis from an accredited laboratory.

Comment: A manufacturer proposed an approach in which the fastener

manufacturer keeps the actual test report of material chemistry and

transfers only the data from the raw material test report.

Response: The Department has determined that this approach is not

consistent with section 5 of the Act, according to which the entire

chemical test report is necessary for traceability purposes.

Comment: One commenter recommended that the term ``certified copy

of test report'' be explained or defined.

Response: The Department concludes that it would be useful to

provide guidance as to what constitutes a certified copy. Therefore,

this final rule amends Sec. 280.2 to add a definition to read as

follows: ``Certified Copy (of a laboratory testing report) means a

complete and accurate copy of the original laboratory testing report,

which contains a statement describing it as an accurate and complete

copy of the original and which is signed by an authorized

representative of the accredited laboratory issuing the report or, in

the case of metal chemistry testing reports, an authorized

representative of the metal manufacturer.''

Comment: One consulting firm recommended that the Department repeal

Sec. 280.15(d) of the regulations because it allows the fastener

manufacturer to use tests performed on the raw materials by the metal

manufacturer; however, the fastener manufacturer cannot prove that

fasteners came from the same coil or heat as required by

Sec. 280.15(d).

Response: The Department has determined that repeal of this section

is not appropriate at this time. Allowing chemical testing of raw

material by the

[[Page 18269]]

metal manufacturer to be sufficient for meeting the requirements of

chemical certification of fasteners was one of several options

recommended by a large segment to the industry as part of the 1996

amendments to the Act. The Fastener Advisory Committee supported this

amendment.

4. Laboratory Test Reports

Of the 125 commenters, seven commented on the issue of laboratory

test reports; all favored the proposed changes. Of the seven

commenters, three were trade associations, two domestic and one

foreign; two were foreign fastener manufacturers; and one was a

consultant.

Based on these comments, the Department has adopted the proposed

amendments dealing with a discrepancy in the language used in reporting

of alternative chemical characteristics. Following the amendments,

Sec. 280.6(b)(5)(ii), which is redesignated as Sec. 280.6(c)(5)(ii),

reads as follows:

Test results for such coil or heat number chemical

characteristics.

5. New Definition of Lot Number

Of the 125 commenters, 18 commented on the new definition of lot

number; four were in favor of the proposed changes, and 14 were

opposed. Of the four commenters who favored the proposed changes, two

were trade associations, one domestic and one foreign; one was a

fastener distributor; and one was a consultant. Of the 14 commenters

who opposed the proposed changes, five were fastener manufacturers,

four domestic and one foreign; three were domestic trade associations;

three were government agencies; one was a fastener distributor; one was

a fastener testing laboratory; and one was an other interested party.

The proposed rule included a proposed amendment to the definition

of ``lot number'' in Sec. 280.2 to include a number assigned by a

manufacturer, importer, distributor, or significant alterer to the lot.

Based on comments received, the Department has excluded the proposed

definition of lot number and retained the original definition of lot

number in the final rule. Based on the comments, for purposes of the

Act and the regulations, there is only one lot number that is assigned

by the manufacturer of fasteners or significant alterers, i.e., the lot

number is unique to the manufacturer or significant alterer.

Distributors and importers may use ``tracking numbers''; however, if

the tracking number is used for lot identification, both lot number and

tracking number must be used. Therefore, the Department has decided not

to adopt the proposed change but to retain the existing rule, under

which the ``Lot number means a number assigned by a manufacturer to the

lot.''

The following issues were highlighted by those that opposed the

adoption of the new definition of lot number:

--Allowing distributors and importers to designate lot numbers will

make it impossible for users to verify that the test report relates to

the fasteners they receive, possibly requiring them to engage in costly

retesting,

--The proposed rule would thwart enforcement efforts by creating gaps

in the paper trail,

--The proposed rule would conflict with published consensus standards,

--The proposed rule would conflict with numerous Federal and State

codes,

--The proposed rule would prevent product recalls,

--The proposed rule would make counterfeiting easier.

These commenters suggested that the original manufacturer's lot

number and any number assigned by an importer or distributor should be

sent to the end user. Otherwise, merely requiring that a subsequent lot

number be traceable to a manufacturer's lot number creates too great a

possibility that traceability will be lost. These comments suggested

that the lot number should be reserved for the number assigned to a lot

by the manufacturer; distributors and importers may assign their own

inventory number or tracking number or traceability number.

Comment: One commenter suggested allowing alterers to deliver only

the new lot number assigned by the alterer so long as it is traceable

to the manufacturer's lot number.

Response: The Department does not consider this to be an

appropriate change because traceability would be questionable.

Comment: A common theme among those who supported this proposed

change in the definition of lot number is that distributors and

importers that use their own lot numbers should be able to prove that

those lot numbers link to manufacturer's lot numbers all the way back

to ladle analysis, and there should be no provision allowing the

fasteners to be sold without the manufacturer's original lot number.

Response: No changes were made to the regulations based on these

comments because importers and distributors can use a trace number to

avoid confusion with the lot number that is assigned by manufacturers.

Comment: One commenter asked how the two numbers should be

identified.

Response: The Department recommends that both numbers, the lot

number assigned by the manufacturer and the trace number assigned by

the distributor or importer, appear on the package and wherever the

trace number appears.

6. Grandfathered Fasteners Issue

In response to the notice of proposed rulemaking, NIST received 28

comments on the issue of grandfathering, i.e., representing that

fasteners produced prior to the implementation date of May 26, 1998 are

in compliance with the Act and the regulations. Of the seven commenters

that opposed any form of grandfathering, three were agencies of the

U.S. Government, two were domestic fastener manufacturers, and one was

a domestic trade association. Of the 21 commenters who suggested that

grandfathering of different degrees should be allowed, 10 were fastener

manufacturers, nine domestic and one foreign; five were domestic trade

associations; three were fastener distributors; one was a foreign

automobile manufacturer; and one was an other interested party.

In the notice of proposed rulemaking, the Department proposed

amending section 280.12(c) of the regulations by moving the last

sentence of that section, which states that fasteners manufactured

prior to the implementation date of the Act may not be represented as

being in conformance with the Act or the regulations, to Sec. 280.602,

Violations. Based on the comments and because as a prohibition on

certain specific conduct, the language more appropriately belongs in

the Violations section, the Department has included this change in the

final rule, with appropriate modification to reflect the changes made

to Sec. 280.12 that are described below.

Although the commenters supported the proposed change, the comments

NIST received offered a wide variety of alternative grandfathering

solutions. The Department considered each of these, as well as other

regulatory alternatives.

The first and most crucial ``regulatory'' alternative for the

disposition of pre-existing inventory is found in section 15 of the Act

itself, which provides that the requirements of the Act apply only to

fasteners manufactured after the implementation date of the regulation,

now set at July 26, 1998. Thus, the sale of pre-existing inventory

after the regulation becomes effective is legal, and the fasteners may

properly be held out as complying with relevant standards and

specifications.

[[Page 18270]]

Five other regulatory alternatives have been considered by the

Department during the current rulemaking. The genesis of the

Department's consideration of the pre-existing inventory or

``grandfathering'' issue, however, predates the promulgation of the

final rule implementing the FQA on September 26, 1996. (See 61 FR

50538.) During that rulemaking, NIST sought the advice of the Fastener

Advisory Committee on the grandfathering issue, noting that the Act

prohibited all parties from holding out fasteners in the pre-existing

inventory as being compliant without the various lots of fasteners

being retested. The Fastener Advisory Committee responded that

fasteners in the pre-existing inventory, if not held out as FQA

compliant, could still be sold after the implementation of the Act,

meaning that the companies would suffer no economic loss on these

fasteners. The Committee, also, however, recommended to NIST that

finished fasteners manufactured prior to the implementation date be

permitted to be retested to be in compliance with the FQA provided that

all the associated requirements of law could be met for the lot of

fasteners in question, such as the presence of the original set of

certifications. The Committee also recommended a one year moratorium on

the retesting of these fasteners to avoid shortages in the pipeline

that could occur if pre-implementation material was put up for

retesting at the same time as new complying material was put up for

initial testing. There also was discussion of placing a time limit,

i.e., three years or five years, on retesting of pre-implementation

fasteners, but no conclusion was reached on this issue. The Fastener

Advisory Committee reemphasized that if the holders of pre-existing

inventory did not wish to incur the cost of the retesting after the

proposed moratorium, the product would still be saleable in commerce

under section 15 of the Act.

Due to concerns about lot integrity and falsification of

certification documents for pre-implementation fasteners, and the

``bottle-necking'' concerns raised by the Fastener Advisory Committee,

in the final regulations of September 26, 1996, NIST made no provision

for the retesting of the pre-existing inventory. This effectively meant

that the fasteners in the pre-existing inventory, when sold after the

effective date of the regulations, could not be held out as FQA

compliant.

Following the September 8, 1997 notice of proposed rulemaking, the

Department has considered the following alternative solutions to the

grandfathering issue, each of which was supported by one or more

comments:

(1) Seven of the comments opposed any regulatory change that would

permit fasteners manufactured before the effective date of the

regulation to be held out as complying with the FQA. The Department

views this as essentially a reaffirmation of the proposed change. Among

the reasons stated for this position were: The inability of a procurer

of fasteners to determine whether the fasteners were manufactured pre-

or post-FQA; possible hindrance of the Government's ability to

prosecute defective or counterfeit fastener cases currently being

investigated; enforcement problems; the additional cost and demand on

laboratories that retesting would cause; and the inability to

``upgrade'' lots of fasteners produced to previous revisions of

consensus standards to certify that they conform to the requirements of

the current revisions.

(2) One comment suggested that NIST permit new fasteners tested in

a duly accredited FQA laboratory prior to the effective date of the

regulation be permitted to be held out as FQA compliant. NIST deemed

this alternative to be permissible under the FQA since the requirement

of testing in a FQA accredited laboratory has been met.

(3) Two comments suggested that the regulation be amended to permit

fasteners to be held out as FQA compliant if they are included in lots

of fasteners manufactured before the effective date of the regulation

but subsequently tested or retested after the effective date of the

regulation in FQA accredited laboratories. NIST deemed this alternative

to be permissible under the FQA since the FQA requirement of testing in

an FQA accredited laboratory has been met.

(4) Eight comments suggested that since fasteners are manufactured

to high standards, NIST should permit all fasteners manufactured prior

to the effective date of the regulation to be held out as FQA

compliant, regardless of whether the fasteners were ever tested in a

laboratory, accredited or otherwise. NIST has rejected this alternative

because the FQA requires that fasteners must be tested by an accredited

laboratory to be deemed FQA compliant. Hence, this alternative is not

permissible by law, since it does not require testing.

(5) Six comments suggested that fasteners manufactured prior to the

effective date be deemed to be FQA compliant after a ``paperwork''

review of laboratory records. NIST has rejected this alternative

because the FQA requires that fasteners must be tested by an FQA

accredited laboratory to be deemed FQA compliant. Hence, this

alternative is not permissible by law, since the tests being reviewed

were not conducted by FQA accredited laboratories.

(6) The recommendation of the Fastener Advisory Committee received

no comment, but is the sixth alternative considered by NIST.

Thus, NIST was left with four lawful alternatives, options (1),

(2), (3), and (6) above. Based upon the public comments, NIST believes

that the weight of the evidence supports the view that some form of

grandfathering beyond option (1) is appropriate. Accordingly, NIST has

decided to proceed immediately with option (2) and has included this

option in the final rule in Secs. 280.12 (d) and (e). Section 280.12(d)

allows that ``fasteners manufactured on or after May 14, 1998 may be

represented, sold, or offered for sale as complying with the Act and

these regulations if they are tested and certified by a laboratory

appearing on the Accredited Laboratory List * * * and meet all other

requirements of the Act and this part.'' Section 280.12(e) allows that

``fasteners manufactured on or after May 14, 1998 by a Facility listed

on the Facilities List may be represented, sold, or offered for sale as

complying with the Act and regulations'' if the Facility meets the

requirements of Sec. 280.810(c)(3).

NIST does not believe that the existing record permits it to

endorse either option (3) or (6).

7. Paperwork Reduction Act and Regulatory Flexibility Act

Various commenters questioned the statements made in the preamble

to the proposed rule regarding the Paperwork Reduction Act or the

Regulatory Flexibility Act or both. In general, these commenters stated

that the Department understated the cost to industry to comply with the

Act and regulations and the impact that those costs would have on small

businesses. The costs cited in these comments included the costs of

scrapping inventories and disruptions to supply because customers would

not accept preimplementation fasteners on or after the implementation

date, the costs of obtaining laboratory accreditation or using an

accredited laboratory, the costs of testing small lots, the costs of

added paperwork and storage of records. Two specific proposals were

made in regard to this issue. One proposal was to form a joint

government-industry task force to measure the costs of compliance. The

other proposal was to conduct an in-

[[Page 18271]]

depth analysis of the negative impact on distributors and manufacturers

under the Regulatory Flexibility Act and publish it for public comment.

Several commenters recommended delaying implementation of regulations

because of the costs to industry. The Department notes that all of the

concerns cited above relate to the cost of complying with the existing

rule. The final rule creates an option for fastener manufacturers to

use, in certain instances, instead of the existing rule. Any costs

associated with developing a registered fastener QAS would not be

affected by the costs of complying with the existing rule. Therefore,

the Department is not delaying the implementation of the regulations

due to this issue.

Comment: Two trade organizations commented that the cost of raw

material analysis obtained by coil analysis is disproportionately high

for small producers.

Response: No change is made based on this comment. The requirements

for raw material analysis and reports under the Act are the same for

large producers and small producers. Under the revised regulations,

small firms may obtain raw material analysis reports from either the

laboratory that conducted the tests or from the metal manufacturer.

Part 3: Comments Received Regarding Issues Not Presented for Public

Comment in the Notice of Proposed Rulemaking

The Department received many comments on issues that were not

presented for public comment in the notice of proposed rulemaking.

These issues included: Repeal the Fastener Quality Act, amend the

Fastener Quality Act, deem compliance with other regulations to be

compliance with the Fastener Quality Act, create exemptions to the

coverage of the Act and regulations, and define more terms. The

Department will not respond to these comments at this time because they

were not presented for public comment in the notice of proposed

rulemaking but will retain these comments for possible action at a

later date.

Additional Information

Executive Order 12866

This rule has been determined not to be significant under section

3(f) of Executive Order 12866.

Executive Order 12612

This rule does not contain policies with Federalism implications

sufficient to warrant preparation of a Federalism assessment under

Executive Order 12612.

Regulatory Flexibility Act

The Assistant General Counsel for Legislation and Regulation of the

Department of Commerce certified to the Chief Counsel for Advocacy of

the Small Business Administration that this rule will not have a

significant economic impact on a substantial number of small entities.

NIST received one comment, addressed above, regarding this

certification. This comment did not cause a change in the determination

regarding the certification. As a result, no final regulatory

flexibility analysis was prepared.

Paperwork Reduction Act

Notwithstanding any other provision of the Act, no person is

required to respond to, nor shall any person be subject to a penalty

for failure to comply with a collection-of-information, subject to the

requirements of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.,

unless that collection of information displays a currently valid Office

of Management and Budget (OMB) control number.

This rule contains collections of information subject to the

requirements of the Paperwork Reduction Act that have been cleared

under OMB Control Nos. 0693-0015 and 0693-0026. The public reporting

burden for the self-certification of QAS fastener manufacturing

facilities is approximately four hours: The provisional registration is

estimated at three hours, and one hour for the associated recordkeeping

requirements. Send comments regarding these burden estimates or any

other aspect of the data requirements, including suggestions for

reducing the burden to the Office of Information and Regulatory

Affairs, Office of Management and Budget, Washington, DC 20230

(Attention: NIST Desk Officer) and to NIST (Attention: FQA Program

Manager, NIST, Building 820, Room 306, National Institute of Standards

and Technology, Gaithersburg, MD 20899).

National Environmental Policy Act

This rule will not significantly affect the quality of the human

environment. Therefore, an environmental assessment or Environmental

Impact Statement is not required to be prepared under the National

Environmental Policy Act of 1969.

List of Subjects in 15 CFR Part 280

Business and industry, Fastener industry, Imports.

Dated: April 3, 1998.

Robert E. Hebner,

Acting Deputy Director, National Institute of Standards and Technology.

Dated: April 3, 1998.

William A. Reinsch,

Under Secretary for Export Administration.

For reasons set forth in the preamble, Title 15 of the Code of

Federal Regulations part 280 is amended as follows:

PART 280--FASTENER QUALITY

1. The authority for part 280 continues to read as follows:

Authority: Sec. 13 of the Fastener Quality Act (Pub. L. 101-592,

as amended by Pub. L. 104-113).

2. Section 280.1 is amended by adding paragraph (d) to read as

follows:

Sec. 280.1 Purpose/description of rule.

* * * * *

(d) Delegations of authority. The Secretary of Commerce has

delegated authority to the Director, National Institute of Standards

and Technology to promulgate regulations in this part under sections 5

through 8 of the Fastener Quality Act (15 U.S.C. 5404-5407). In

addition, the Secretary of Commerce has delegated concurrent authority

to the Under Secretary for Export Administration to amend the

regulations issued under sections 5 through 7 of the Act, regarding

enforcement. The Secretary of Commerce has also delegated concurrent

authority to amend the regulations issued under section 8 of the Act,

regarding recordal of insignias, to the Assistant Secretary and

Commissioner of Patents and Trademarks.

3. Section 280.2 is amended by revising the definitions for

accreditation, consensus standards organization, and original

laboratory testing report, and adding the remaining definitions as set

forth below:

Sec. 280.2 Definitions.

* * * * *

Accreditation for purposes of the Act and this part means

accreditation of a testing laboratory or the registration of a fastener

manufacturing facility employing a quality assurance system (a

Facility).

* * * * *

Accredited registrar means a registrar, as defined in this part,

that is accredited by a recognized accreditor and appears on the

Registrars List described in section 280.810(b).

* * * * *

[[Page 18272]]

Accreditor means a Registrar accreditation body that meets the

requirements of subpart K of this part.

* * * * *

Authorized representative means an employee of an organization who

is authorized by that organization to speak on its behalf for purposes

of the Act and this part.

* * * * *

Certified Copy (of a laboratory testing report) means a complete

and accurate copy of the original laboratory testing report, which

contains a statement describing it as an accurate and complete copy of

the original and which is signed by an authorized representative of the

accredited laboratory issuing the report or, in the case of metal

chemistry testing reports, an authorized representative of the metal

manufacturer.

* * * * *

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) publicly identified by NIST as

having comparable knowledge, expertise, and concern for the health and

safety in the field for which such organization purports to set

standards.

* * * * *

Facility means a fastener manufacturing facility, or a facility

performing subcontracted processes for a fastener manufacturing

facility, implementing a fastener quality assurance system as defined

in this part.

* * * * *

Fastener Quality Assurance System (QAS). (1) Fastener Quality

Assurance System (QAS) means a fastener manufacturing system that has

as a stated goal the prevention of defects through continuous

improvement, and which seeks to attain that goal by incorporating:

(i) Advanced quality planning;

(ii) Monitoring and control of the manufacturing process;

(iii) Process inspection embodied in a comprehensive and written

control plan for product/process characteristics, process controls

(including statistical process control), tests, and measurement systems

that will occur during mass production; and

(iv) The creation, maintenance, and retention of electronic,

photographic, or paper records, available for inspection during the

periods required by section 10 of the Act and Sec. 280.7 of this part,

regarding the inspections, tests, and measurements required by or

performed pursuant to the control plan.

(2) A Fastener Quality Assurance System contains the following

elements at a minimum:

(i) A documented quality management system that satisfies the

requirements of ISO-9001 ``Quality Systems--Model for quality assurance

in design, development, production, installation and servicing,'' ISO-

9002 ``Quality Systems--Model for quality assurance in production,

installation and servicing,'' or other quality system standards that

incorporate ISO-9001 or ISO-9002 (e.g. QS-9000, AS-9000, etc.);

(ii) A requirement that raw material certification supplied to the

fastener manufacturer shall be traceable to that of a mill heat of

material that has been tested by a laboratory on the Accredited

Laboratory List;

(iii) A requirement that subcontracted processes, including plating

and heat treating, are controlled by the manufacturer, to avoid product

lot contamination, and that finished lots of fasteners shall be

traceable to subcontracted processes performed by a registered Facility

on the Facilities List described in Sec. 280.810 of tested by a

Laboratory on the Laboratories List described in Sec. 280.101;

(iv) A requirement that the fastener manufacturer fully document

fastener sampling and inspection points and an in-process control plan

that emphasizes defect prevention, relates frequency of inspection,

corrective action for nonconforming characteristics, and sampling

frequency and sample size; a requirement that the control plan be made

available to the customer upon request and shall identify those

standards and specifications upon which the plan is based; and

(v) A requirement that the in-process control plan include those

characteristics specified by the QAS standard, characteristics

specifically indicated by applicable fastener standards and

specifications, and those characteristics as designated by the end user

for evaluating product functionality.

* * * * *

Original laboratory testing report means: (1) In general, 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; or

(2) For purposes of the alternative procedures for chemical

characteristics described in section 5(d) of the Act and Sec. 280.15 of

this part only, 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 or by the metal manufacturer.

* * * * *

Recognized accreditor means an accreditor, as defined in this part,

that is recognized by NIST and appears on the Accreditors List

described in Sec. 280.810(a).

* * * * *

Registered facility means a facility, as defined in this part, that

is registered by an accredited registrar and appears on the Facilities

List described in Sec. 280.810(c).

* * * * *

Registrar means a quality systems Registrar that meets the

requirements of subpart L of this part.

* * * * *

Registration means evaluation and certification of a manufacturing

facility as competent to carry out and conforming to the applicable

requirements of a Fastener Quality Assurance System when such

evaluation and certification is performed by a Registrar as defined in

this part.

* * * * *

Significantly alter means to alter or take any other 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, 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

minimum 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.

* * * * *

4. Section 280.6 is revised to read as follows:

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,

[[Page 18273]]

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;

(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 indicating 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) Final manufacturing lot size;

(6) Test Results:

(i) Test results for each sample;

(ii) All deviations from the test method;

(iii) All other items required on test reports according to the

test method;

(iv) 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.

(v) A statement that the samples tested either conform or do not

conform to the fastener standards and specifications 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) When performing tests for which they are registered under this

part, each facility registered under subpart I or J of this part and

currently listed in the Facilities List shall issue test reports of its

work which accurately, clearly, and unambiguously present test results,

and all information required by this section. In addition, the

facilities shall attach reports of chemical characteristics and any

report of the tests conducted in a laboratory under the accredited

laboratories list. All reports must be in English or be translated into

English, must be signed by an approved signatory, must be protected by

a temper resistant system, and contain the following information:

(1) Name and address of the facility;

(2) Unique identification of the test report, including date of

issue and serial number, or other appropriate means including

references to control plan identification;

(3) Name and address of client, if applicable;

(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;

(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 facility

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) Final manufacturing lot size;

(iii) Identification of control plan governing production of the

lot to which the test report is applicable;

(6) Test Results:

(i) Test results of actual tests required by applicable fastener

standards and specifications, and characteristics designated by the end

user;

(ii) All deviations from the test method;

(iii) All other items required on test reports according to the

applicable fastener standards and specifications, and characteristics

designated by the end user;

(iv) Where the report contains results of tests performed by sub-

contractors, these results shall be clearly identified along with the

name of the laboratory/facility and accreditation/registration

information listed in paragraph (b)(9) of this section.

(v) Where all processes under the applicable QAS were found to be

in accordance with the inspections, tests and measurements required by

the standards and specifications and the QAS and characteristics

designated by the end user, a statement that the samples tested conform

to the applicable fastener standards and specifications;

(vi) Where any process under the applicable QAS was found not to be

in accordance with the inspections, tests, or measurements required by

such QAS, a statement that the samples tested do not conform to the

applicable fastener standards and specifications and identification of

any nonconformance;

(7) A statement that the report must not be reproduced except in

full;

(8) Name, title and signature of approved signatory accepting

technical responsibility for the tests and test report;

(9) The name of the registrar which registered the facility, and

code number assigned to the facility by the registrar, and the

expiration of registration.

(c) 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 such coil or heat number chemical

characteristics;

(iii) All deviations from the test method;

(iv) All other items required on test reports according to the test

method;

[[Page 18274]]

(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 (c)(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.

(d) 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.

(e) For tests carried out by a Facility registered pursuant to

subpart I or J of this part, the Facility shall maintain laboratory

test reports in the forms of electronic, photographic, or paper

records, available for inspection during the periods required by

section 10 of the Act and Sec. 280.7 of this part, regarding the

inspections, tests, and measurements required or performed pursuant to

the QAS control plan.

5. Section 280.7 is amended by revising paragraph (a) to read as

follows:

Sec. 280.7 Recordkeeping requirements.

(a) Each laboratory accredited under subparts C, D, or E or

Sec. 280.104 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 this part. 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 performing the testing. Procedures for

storage and retrieval of records must be documented and maintained in

the laboratory's quality manual.

* * * * *

6. Section 280.10 is revised to read as follows:

Sec. 280.10 Sampling.

(a) For tests conducted either in a laboratory on the Accredited

Laboratory List or in a Registered Facility, if a manufacturer

represents that the fasteners in a particular sample have been

manufactured to a standard or specification which provides for the

size, selection or integrity of the sample to be inspected and tested,

the sample shall be determined in accordance with that standard or

specification.

(b) For tests conducted in a laboratory on the Accredited

Laboratory List, if a manufacturer represents that the fasteners in a

particular sample have been manufactured to a standard or specification

which 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 the sampling plan provided by 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.

(c) For tests conducted in a Registered Facility, and not in a

laboratory on the Accredited Laboratory List, if a manufacturer

represents that the fasteners in a particular sample have been

manufactured to a standard or specification which does not provide for

the size, selection or integrity of the sample to be inspected and

tested, the sample for inspections and tests by the Facility shall be

determined by the sampling plan provided by its Fastener Quality

Assurance System or by standards and specifications intended for use

with a Fastener Quality Assurance System, as appropriate. Or, a

manufacturer operating a Registered Facility may elect to conduct

inspections and tests upon all of the fasteners within a specified lot,

provided that this election is documented in the control plan of its

Fastener Quality Assurance System.

7. Section 280.11 is amended by revising paragraph (b) to read as

follows:

Sec. 280.11 Significant alterations of fasteners.

* * * * *

(b) If the significant alteration is only electroplating of

fasteners having a minimum 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 alterer 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.

* * * * *

8. Section 280.12 is revised to read as follows:

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 July 26,

1998.

(b) Metal manufactured prior to July 26, 1998 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.

(c) Nothing in the Act and this part prohibits selling finished

fasteners manufactured prior to July 26, 1998 or representing that such

fasteners meet standards and specifications of a consensus standards

organization or a government agency.

(d) Fasteners manufactured on or after May 14, 1998, may be

represented, sold, or offered for sale as complying with the Act and

these regulations if they are tested and certified by a laboratory

appearing on the Accredited Laboratory List described in Sec. 280.101,

and meet all other requirements of the Act and this part.

(e) Fasteners manufactured on or after May 14, 1998, by a Facility

listed on the Facilities List may be represented, sold, or offered for

sale as complying with the Act and these regulations upon NIST's

acknowledgment of receipt of the items required in Sec. 280.810(c)(3).

9. Section 280.104 is added to subpart B to read as follows:

Sec. 280.104 Accreditation of certain manufacturing facilities as

laboratories.

(a) Subject to the limitations contained in paragraphs (b), (c),

and (d) of this section, registration of a fastener manufacturing

facility employing a fastener quality assurance system shall be deemed

to meet the requirements of accreditation of a laboratory for purposes

of the Act and this part. The independent third-party Registrar

registering such facility under this section shall comply with all

procedures set forth in subparts I through L of this part. Records

[[Page 18275]]

documenting the inspection and testing of a lot of fasteners performed

by such an accredited laboratory shall be maintained by the facility in

accordance with the requirements of Secs. 280.6, 280.808, and 280.809

of this part.

(b) In any instance where a Facility accomplishes any in-process

inspection and testing by performing laboratory tests on a sample of

fasteners at any stage in the manufacturing process, those tests must

be conducted by a laboratory on the Accredited Laboratory List. Such a

laboratory may be located on the same premises as a fastener

manufacturing facility if the laboratory is separately accredited

pursuant to a provision of this part other than Sec. 280.104(a).

(c) Any laboratory tests performed outside the Facility's in-

process inspection and testing must be conducted by a laboratory on the

Accredited Laboratory List.

(d) Chemical and raw material testing must be performed by a

laboratory on the Accredited Laboratory List.

10. Section 280.602 is amended by revising paragraphs (e)(2), (h),

and (j) and adding paragraphs (k), (l), (m), (n), and (o) to read as

follows:

Sec. 280.602 Violations.

* * * * *

(e) Misrepresentation and concealment of facts. * * *

(2) In connection with the preparation, submission, use, or

maintenance of a laboratory test report, certificate of conformance as

described in Secs. 280.5 and 280.6 of this part, or any quality

assurance system document required by this part or;

* * * * *

(h) Falsification of documents relating to accreditation of

laboratories or registrars or approval or recognition of accreditors 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, Accreditors or Registrars as required by section 6(a) or 6(b)

of the Act or this part.

* * * * *

(j) Falsification of laboratory accreditation, accreditation body

or accreditor. No person shall falsely claim to be an accredited

laboratory or approved or recognized accreditation body or Accreditor

as described in section 6 of the Act or subparts B, C, D, E, I and J of

this part.

(k) Sale of fasteners manufactured prior to the implementation date

as compliant with the Act. No person shall represent, sell, or offer

for sale fasteners manufactured prior to July 26, 1998 as being in

conformance with the Act or this part except as provided for in

Sec. 280.12(d) or (e) of this part.

(l) Failure to assign lot number traceable to manufacturer's

single, unique lot number. No importer, distributor, or significant

alterer shall assign a lot number unless the assigned lot number is

traceable to a manufacturer's single, unique lot number.

(m) Falsification of documents relating to the registration of

fastener manufacturing facilities as accredited laboratories,

accreditation of registrars or recognition of accreditors. No person

shall falsify or make any false or misleading statement on or in

connection with any document relating to the registration of Fastener

Manufacturing Facilities as accredited laboratories, accreditation of

Registrars or recognition of Accreditors as required by subparts I, J,

K, and L of this part.

(n) False claim of registration of fastener manufacturing

facilities as accredited laboratories, accreditation of registrars, and

recognition of accreditors. No person shall falsely claim to be a

registered Fastener Manufacturing Facility, an accredited Registrar, or

a recognized Accreditor as described by subparts I, J, K, and L of this

part.

(o) Falsification of documents relating to the certification of FOA

compliance required for provisional listing on the Facilities List. No

person shall falsify or make any false or misleading statement on or in

connection with any document relating to the certification of FQA

compliance required for provisional listing on the Facilities List

pursuant to Sec. 280.810(c)(3).

11. Subparts I through L are added to read as follows:

Subpart I--Special Rule for the Accreditation of Certain Fastener

Manufacturing Facilities, Whose Implemented Fastener Quality Assurance

Systems Meet Defined Requirements, as Laboratories

Sec.

280.800 Introduction.

280.801 Application.

280.802 Review and decision process.

280.803 Criteria for recognition.

280.804 Maintaining recognized status.

280.805 Voluntary termination of recognition.

280.806 Involuntary termination of recognition by NIST.

280.807 Subcontracting.

280.808 Reports.

280.809 Record keeping.

280.810 Listing of recognized accreditors, accredited Registrars,

and registered facilities.

280.811 Removal from a list.

280.812 Appeal.

Subpart I--Special Rule for the Accreditation of Certain Fastener

Manufacturing Facilities, Whose Implemented Fastener Quality

Assurance Systems Meet Defined Requirements, as Laboratories

Sec. 280.800 Introduction.

(a) This special rule applies to those fastener manufacturers,

employing a fastener quality assurance system (QAS) as defined in this

part, who wish to seek accreditation of the particular manufacturing

facility employing the QAS as a laboratory within the meaning of the

Act. This rule consists of this subpart, and subparts J, K and L of

this part. The rule adopts the view that a fastener manufacturing

facility is deemed to be an accredited laboratory for purposes of the

Act and this part if such facility employs a fastener quality assurance

system (QAS) that has been formally registered by a NIST-recognized

quality systems Registrar. The rule applies only to facilities

manufacturing fasteners; raw materials for fastener manufacture must be

tested and certified by a laboratory listed on the Accredited

Laboratory List. This Subpart sets out the full process that NIST

requires for the accreditation of a fastener manufacturing facility

employing a QAS in the United States: A fastener manufacturing facility

employing a QAS (a ``Facility'') will be deemed to be an accredited

laboratory if it is registered by a Quality Systems Registrar (a

``Registrar'') that in turn has been accredited by a Registrar

Accreditation Body (an ``Accreditor'') that has been recognized by

NIST. Subpart J provides for foreign Accreditors to be recognized and

to recognize Registrars under the same procedures.

(b) A chain is thus established to assure the proper regulation of

Facilities: NIST recognizes Accreditors that meet the requirements of

subpart K of this part, which is based upon ISO Guide 61; the NIST-

recognized Accreditors may in turn accredit Registrars that meet the

requirements of subpart L of this part, which is based upon ISO Guide

62. The Registrars, in turn, may register Facilities that satisfy the

elements of a fastener quality assurance system (QAS), as defined in

this part.

(c) Within this subpart, Secs. 280.801 through 280.809 contain the

procedures that NIST uses to process requests from Accreditors for

recognition by NIST.

[[Page 18276]]

Section 280.810 establishes three lists that NIST will maintain:

Section 280.810(a) provides for a list of Accreditors that have been

recognized by NIST; Sec. 280.810(b) provides for a list of Registrars

that have been accredited by Accreditors listed according to

Sec. 280.810(a); and Sec. 280.810(c) provides for a list of Facilities

that have been registered by Registrars listed according to

Sec. 280.810(b). The remainder of this subpart, Secs. 280.811 and

280.812, contain procedural provisions related to the lists established

by Sec. 280.810.

Sec. 280.801 Application.

(a) Application must be made by Accreditors to NIST for recognition

to accredit Registrars 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 NIST.

Sec. 280.802 Review and decision process.

(a) Applications submitted by Accreditors 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 K 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 recognition, the applicant shall be notified by NIST

in writing. The recognition notice shall include the date when the

recognition begins and the scope of the recognition. The recognition

period shall be for as long as the Accreditor continues to satisfy the

requirements of Sec. 280.803. As part of maintaining its approved

status, each Accreditor shall agree to be reassessed by NIST every two

years following its initial notice of recognition. NIST will maintain

and make available to the public a list of recognized Accreditors.

(d) If the applicant does not meet the requirements for

recognition, the applicant shall be notified in writing, listing the

specific requirements from this subpart and subpart K 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 applicant should have been

recognized.

Sec. 280.803 Criteria for recognition.

An applicant for NIST recognition must demonstrate the ability to

operate a registrar accreditation program consistent with the

requirements of this subpart and subparts A and K of this part, and

accredit registrars of Facilities to requirements set out in subpart L

of this part.

Sec. 280.804 Maintaining recognized status.

(a) Accreditors shall continue to satisfy all the requirements of

recognition during the recognition period.

(b) Upon request, recognized Accreditors shall make available to

NIST and/or BXA all records and materials pertaining to the program.

(c) NIST has the right to participate as an observer during any on-

site visit to a Registrar being audited by a NIST-recognized

Accreditor, or a Facility being audited by an accredited Registrar, or

it may perform its own surveillance visit of such bodies at its

discretion.

(d) Neither the Accreditor, nor any Registrar it accredits, nor any

Facility registered under the Act and this part shall take any action

which states or implies the approval, or endorsement by NIST or any

other agency of the U.S. Federal Government of any product or report

pertaining to a product associated with any activities carried out

under the recognition. None of these entities may take any action which

states or implies that they are recognized or authorized by NIST to act

or perform in any area(s) beyond that which was specified in their

recognition under this part.

Sec. 280.805 Voluntary termination of recognition.

An Accreditor may voluntarily terminate its recognition by giving

written notice to NIST and to all Registrars accredited by that body

under its accreditation program. The written notice shall state the

date on which the termination will take effect.

Sec. 280.806 Involuntary termination of recognition by NIST.

(a) NIST may terminate or suspend its recognition of an Accreditor

if such an action is deemed to be in the public interest.

(b) Before terminating the recognition of an Accreditor, NIST will

notify the Accreditor 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 Accreditor may appeal a termination to the Director by

submitting a statement of reasons why the recognition should not be

terminated. NIST may, at its discretion, hold in abeyance the

termination action pending a final decision by the Director. Within 60

days following receipt of the appeal, the Director shall inform the

Accreditor in writing of his or her decision.

(d) Registrars and registered organizations which have been listed

by NIST in accordance with this Subpart, based on their accreditation

by an Accreditor whose recognition has been terminated, shall be

removed from the list, unless an exception is granted by NIST.

Sec. 280.807 Subcontracting.

If a recognized Accreditor, an accredited Registrar, or a

registered Facility subcontracts any of its functions to another entity

it must place the work with another recognized Accreditor, accredited

Registrar, or registered Facility; inform the client, before the fact,

that subcontracting will be necessary, and clearly indicate in all

appropriate records, and reports to the client, specifically what

functions were subcontracted.

280.808 Reports.

Reports and records shall be maintained in such a manner to

preserve original data, and be collected as required into a final form,

sufficient to satisfy customer and legal

[[Page 18277]]

requirements. Such reports shall be provided upon request to the Bureau

of Export Administration, to the National Institute of Standards and

Technology, or to any other agency of the federal government authorized

to obtain such records under this part.

Sec. 280.809 Recordkeeping.

Each recognized Accreditor, accredited Registrar, or fastener

manufacturer whose Facility has been registered shall retain all

applicable records required under the Act and this part for 5 years.

All records are subject to the requirements in Sec. 280.7 of this part.

Sec. 280.810 Listing of recognized accreditors, accredited registrars,

and registered facilities.

(a) List of Accreditors. NIST shall prepare and maintain a list of

Accreditors recognized under this subpart and subpart J of this part.

(b) List of Registrars. NIST shall prepare and maintain a list of

Registrars accredited by Accreditors listed in accordance with

Sec. 280.810(a).

(1) Names and information regarding accredited Registrars may only

be included on the list from information submitted to NIST by an

Accreditor listed in accordance with Sec. 280.810(a) that submits the

listing fee established by NIST and the following information, in

English:

(i) The name of the Accreditor which granted the accreditation;

(ii) The name and address of the Registrar affected by the

accreditation action;

(iii) The nature of the accreditation action (e.g., initial

accreditation, renewal of accreditation, etc.);

(iv) A copy of the Registrar's accreditation certificate and a

scope of accreditation which states the quality system standard(s) for

which the Registrar has been accredited for purposes of assessing and

registering a fastener manufacturer's Facility; and

(v) The name and telephone number of the accredited Registrar's

authorized representative(s), and information concerning the physical

locations of all organizational units involved in the accreditation

activities.

(2) All Accreditors listed by NIST in accordance with

Sec. 280.810(a) shall promptly notify NIST of each accreditation action

taken. Accreditation actions include initial accreditations, denials of

accreditation, renewals, suspensions, terminations, 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.

(c) List of Facilities. NIST shall prepare and maintain a list of

Facilities registered by Registrars listed in accordance with

Sec. 280.810(b).

(1) Names and information regarding registered Facilities may only

be included on the list from information submitted to NIST by

accredited Registrars listed in accordance with Sec. 280.810(b) that

submit the listing fee established by NIST, through their Accreditors,

and the following information:

(i) The name of the fastener manufacturer and the address of the

registered Facility;

(ii) The name of the authorized representative of the fastener

manufacturer whose Facility is registered;

(iii) The scope of the registration, stating the quality system

standard(s) to which the Facility has been registered; and

(iv) The effective dates of the registration.

(2) All Registrars listed by NIST in accordance with

Sec. 280.810(b) shall promptly notify NIST of each registration action.

Registration actions include initial registrations, denials of

registration, renewals, suspensions, terminations, 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.

(3)(i) If a Facility intends to be listed in accordance with

Sec. 280.810(c)(1) but the registration process will not be completed

by July 26, 1998, the Facility may be provisionally listed on the

Facilities List by providing the following to NIST on or before

September 30, 1998:

(A) Certification that:

(1) The Facility is registered to QS-9000 or an equivalent by a

quality systems registrar;

(2) The Facility conforms to all other requirements of the Act and

these regulations at the time of certification;

(3) If the Facility ceases to be registered to QS-9000 or an

equivalent by an accredited Registrar and/or ceases to conform to any

other requirement of the Act and these regulations at any time during

the provisional listing period, it will notify NIST of that fact within

three working days; and

(4) If the Facility fails to apply to an accredited Registrar for

registration under the FQA within 30 days of the time the Registrar is

accredited by a NIST-approved Accreditor, an authorized representative

of the Facility will immediately notify NIST. (If the Facility's

current Registrar decides not to seek accreditation under the FQA, it

is the Facility's responsibility to apply to another Registrar that has

been approved by NIST-ABEP.);

(B) A list of fasteners produced or processed by the Facility,

identified by either a part number or a specification number;

(C) A list of standards included in the Facility's registration;

(D) A copy of the Facility's registration certificate; and

(E) The listing fee established by NIST.

(ii) The Facility must meet all the requirements of the Act and

these regulations by May 25, 1999. If the Facility fails to receive FQA

registration by May 25, 1999, it will be removed from the Facilities

List.

(d) These lists will be readily accessible to the public. Only

entities listed by NIST are authorized to offer services which comply

with the Act and this part. NIST shall revise as appropriate all

listings when notified of applicable actions and shall take appropriate

steps to make changes promptly available to the public.

Sec. 280.811 Removal from a list.

NIST may remove from a list any listed entity if NIST deems such

action to be in the public interest. An entity may appeal the removal

or proposed removal from a list to the Director by submitting a

statement of reasons why it 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 entity in writing of the

decision within sixty days following receipt of the appeal.

Sec. 280.812 Appeal.

An applicant Accreditor, Registrar, or fastener manufacturer whose

Facility has been registered may appeal the removal or proposed removal

from the Accreditors list, the Registrars list, or the Facilities list,

to the Director.

Subpart J--Recognition of Foreign Registrar Accreditation Bodies

Sec.

280.900 Introduction.

280.901 Recognition of foreign entities.

Subpart J--Recognition of Foreign Registrar Accreditation Bodies

Sec. 280.900 Introduction.

In accordance with section 6(a)(1)(C) of the Act, this subpart sets

forth the conditions under which the recognition of foreign entities by

their governments,

[[Page 18278]]

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. 280.901 Recognition of foreign entities.

Foreign Accreditors wishing to be recognized to accredit Registrars

must submit an application for evaluation to NIST according to subpart

I of this part. NIST recognition is limited to bodies that accredit

Registrars which register Facilities producing fasteners covered by the

Act. To be recognized by NIST, Accreditors must meet conditions set out

in subparts I and K of this part and accredit Registrars of Facilities

to conditions set out in subpart L of this part.

Subpart K--Requirements for Registrar Accreditation Bodies

(Accreditors)

General

280.1000 Introduction.

280.1001 Scope.

Requirements for Accreditors

280.1010 Accreditors.

280.1011 Accreditor personnel.

280.1012 Decision on accreditation.

280.1013 References to accredited status.

280.1014 Change in the accreditation.

280.1015 Appeals, complaints and disputes.

280.1016 Access to records of appeals, complaints and disputes.

Requirements for Assessment

280.1020 Application for accreditation.

280.1021 Preparation for assessment.

280.1022 Assessment.

280.1023 Assessment report.

280.1024 Surveillance and reassessment procedures.

Subpart K--Requirements for Registrar Accreditation Bodies

(Accreditors)

General

Sec. 280.1000 Introduction.

This subpart sets out organizational, operational and other

requirements that must be met by all Accreditors recognized by NIST

under subpart I or J of this part. This subpart also sets out the

requirements against which an Accreditor assesses the competence of an

applicant Registrar.

Sec. 280.1001 Scope.

These are general requirements for an Accreditor to follow if it is

to be recognized as competent and reliable in assessing and

subsequently accrediting Registrars.

Requirements for Accreditors

Sec. 280.1010 Accreditors.

(a) General provisions. (1) The policies and procedures under which

the Accreditor operates shall be non-discriminatory, and they shall be

administered in a non-discriminatory manner. Procedures shall not be

used to impede or inhibit access by applicant bodies other than as

specified in this part.

(2) The Accreditor shall make its services accessible to all

applicants whose activities fall within its declared field of

operation. There shall not be undue financial or other conditions.

Access shall not be conditional upon the size of the applicant body or

membership of any association or group, nor shall accreditation be

conditional upon the number of bodies already accredited.

(3) The accreditation criteria against which the competence of a

Registrar is assessed shall be those outlined in subpart L of this

part. If an explanation is required as to the application of these

documents to a specific accreditation program, it shall be formulated

by relevant and impartial committees or persons possessing the

necessary technical competence, and published by the Accreditor.

(4) The Accreditor shall confine its requirements, assessment and

decisions on accreditation to those matters specifically related to the

scope of the accreditation being considered.

(b) Organization of a recognized Accreditor. The structure of the

Accreditor shall be such as to give confidence in its accreditations.

In particular, the Accreditor shall:

(1) Be impartial;

(2) Be responsible for its decisions relating to the granting,

maintaining; extending, reducing, suspending and withdrawing of

accreditation;

(3) Identify the management (committee, group or person) which will

have overall responsibility for all of the following:

(i) Performance of assessment and accreditation as defined in this

part;

(ii) Formulation of policy matters relating to the operation of the

Accreditor;

(iii) Decisions on accreditation;

(iv) Supervision of the implementation of its policies;

(v) Supervision of the finance of the Accreditor; and

(vi) Delegation of authority of committees or individuals, as

required, to undertake defined activities on its behalf;

(4) Have documents which demonstrate that it is a legal entity;

(5) Have a documented structure which safeguards impartiality,

including provisions to assure the impartiality of the operations of

the Accreditor; this structure shall enable the participation of all

parties significantly concerned in the development of policies and

principles regarding the content and functioning of the accreditation

system;

(6) Ensure that each decision on accreditation is taken by a person

or persons different from those who carried out the assessment;

(7) Have rights and responsibilities relevant to its accreditation

activities;

(8) Have adequate arrangements to cover liabilities arising from

its operations and/or activities;

(9) Have financial stability and resources required for the

operation of an accreditation system;

(10) Employ a sufficient number of personnel having the necessary

education, training, technical knowledge and experience for performing

accreditation functions relating to the type, range and volume of work

performed, under a responsible senior executive;

(11) Have a quality system, as outlined in paragraph (d) of this

section, giving confidence in its ability to operate an accreditation

system for registration bodies;

(12) Have policies and procedures that distinguish between

accreditation and any other activities in which the Accreditor is

engaged;

(13) 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;

(14) Have formal rules and structure for the appointment and

operation of any committees which are involved in the accreditation

process; such committees shall be free from any commercial, financial

and other pressures that might influence decisions;

(15) Ensure that activities of related bodies do not affect the

confidentiality, objectivity or impartiality of its accreditations and

shall not offer or provide, directly or indirectly, those services that

accredit others to perform, consulting services to obtain or maintain

accreditation, or services to design, implement or maintain a

certification scheme;

(16) Have policies and procedures for the resolution of complaints,

appeals and disputes received from bodies or other parties about the

handling of accreditation of any related matters;

(17) Have a structure where members are chosen to provide a balance

of

[[Page 18279]]

interest, where no single interest predominates; and

(18) Assure that other products, processes or services that may be

offered, directly or indirectly, do not compromise confidentiality or

the objectivity or impartiality of its accreditation process and

decisions.

(c) Subcontracting. (1) When an Accreditor decides to subcontract

work related to accreditation (e.g. audits) to an external body or

person, a properly documented agreement covering the arrangements,

including confidentiality and conflict of interest, shall be drawn up.

The Accreditor shall:

(i) Take full responsibility for such subcontracted work and

maintain its responsibility for granting, maintaining, extending,

reducing, suspending or withdrawing accreditation;

(ii) Ensure that the subcontracted body or person is competent and

complies with the applicable provisions of this part, including section

280.807, and is not involved, either directly or through its employer,

with the design, implementation or maintenance of a registration scheme

in such a way that impartiality could be compromised; and

(iii) obtain the consent of the applicant or accredited body.

(2) Requirements in paragraphs (c)(1) (i) and (ii) of this section

are also relevant, by extension, when an Accreditor uses, for granting

its own accreditation, work provided by another Accreditor with which

it has signed an agreement.

(d) Quality system. (1) The management of the Accreditor with

executive responsibility for quality shall define and document its

policy for quality, including objectives for quality and its commitment

to quality. The management shall ensure that this policy is understood,

implemented and maintained at all levels of the organization.

(2) The Accreditor shall operate a quality system in accordance

with the relevant elements of this part and appropriate to the type,

range and volume of work performed. This quality system shall be

documented, and the documentation shall be available for use by the

staff of the Accreditor.

(3) The Accreditor shall ensure effective implementation of the

documented quality system procedures and instructions.

(4) The Accreditor shall designate a person with direct access to

its highest executive level who, irrespective of other

responsibilities, shall have defined authority to ensure that a quality

system is established, implemented and maintained in accordance with

this part, and report on the performance of the quality system to the

management of the Accreditor for review and as a basis for improvement

of the quality system.

(5) 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) A brief description of the legal status of the Accreditor,

including the names of its owners, if applicable, and, if different,

the names of the persons who control it;

(iii) The names, qualifications, experience and terms of reference

of the senior executive and other accreditation personnel influencing

the quality of the accreditation functions;

(iv) An organization chart showing lines of authority,

responsibility and allocation of functions stemming from the senior

executive and, in particular, the relationship between those

responsible for the assessment and those making decisions regarding

accreditation;

(v) A description of the organization of the Accreditor, including

details of the management (committee, group or person), its

constitution, terms of reference and rules of procedure;

(vi) The policy and procedures for conducting management reviews;

(vii) Administrative procedures including document control;

(viii) The operational and functional duties and service pertaining

to quality, so that the extent and limits of each person's

responsibility are known to all concerned;

(ix) The policy and procedures for the recruitment and training of

Accreditor personnel (including auditors) and monitoring their

performance;

(x) A list of its subcontractors and details of the procedures for

assessing, recording and monitoring their competence;

(xi) Its procedures for handling nonconformities and for assuring

the effectiveness of any corrective actions taken;

(xii) The policy and procedures for implementing the accreditation

process, including:

(A) The conditions for issue, retention and withdrawal of

accreditation documents;

(B) Checks of the use and application of documents used in the

accreditation;

(C) The procedures for assessing and accrediting applicants; and

(D) The procedures for surveillance and reassessment of accredited

bodies.

(xiii) The policy and procedures for dealing with appeals,

complaints and disputes; and

(xiv) The procedures for conducting internal audits based on

appropriate international documentation.

(e) Conditions for granting, maintaining, extending, reducing,

suspending and withdrawing accreditation. (1) The Accreditor shall

specify the conditions for granting, maintaining, extending and

reducing accreditation, and the conditions under which accreditation

may be suspended or withdrawn, partially or in total, for all or part

of the accredited body's scope of accreditation. In particular, the

Accreditor shall require the accredited body to notify it promptly of

any intended changes to the quality system or other changes which may

affect conformity.

(2) The Accreditor shall have procedures to grant, maintain,

withdraw and suspend accreditation; to extend or reduce the scope of

accreditation; and to conduct reassessment in the event of changes

significantly affecting the activity and operation of the accredited

body (such as change of ownership, changes in personnel or equipment),

or if analysis of a complaint or any other information indicates that

the accredited body no longer complies with the requirements of the

Accreditor.

(f) Internal audits and management reviews. (1) The Accreditor

shall conduct periodic internal audits covering all procedures in a

planned and systematic manner, to verify that the quality system is

being implemented and is effective. The Accreditor shall ensure that

personnel responsible for the area audited are informed of the outcome

of the audit; corrective action is taken in a timely and appropriate

manner; and the results of the audit are documented.

(2) The top management of the Accreditor shall review its quality

system at defined intervals sufficient to ensure its continuing

suitability and effectiveness in satisfying the requirements of this

part and the stated quality policy and objectives. Records of such

reviews shall be maintained.

(g) Documentation. (1) The Accreditor shall document, update at

regular intervals, and make available (through publications, electronic

media or other means), on request:

(i) Information about the authority under which the Accreditor

operates;

(ii) A documented statement of its accreditation system, including

its rules and procedures for granting, maintaining, extending,

reducing, suspending and withdrawing accreditation;

(iii) Information about the assessment and accreditation process;

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(iv) A description of the means by which the Accreditor obtains

financial support, and general information on the fees charged to

applicants and accredited bodies;

(v) A description of the rights and duties of applicants and

accredited bodies, as specified, including requirements, restrictions

or limitations on the use of the Accreditor's logo and on the ways of

referring to the accreditation granted, in conformance with

Sec. 280.804(d); and

(vi) Information on procedures for handling complaints, describing

the scope of accreditation granted to each.

(2) The Accreditor shall establish and maintain procedures to

control all documents and data that relate to its accreditation

functions. These documents shall be reviewed and approved for adequacy

by appropriately authorized and competent personnel prior to issuing

any documents following initial development or any subsequent amendment

or change being made. A listing of all appropriate documents with the

respective issue and/or amendment status identified shall be

maintained. The distribution of all such documents shall be controlled

to ensure that the appropriate documentation is made available to

personnel of the Accreditor, or applicants and accredited bodies, when

required to perform any function relating to the activities of

applicants and accredited bodies.

(h) Records. (1) The Accreditor shall maintain a record system to

suit its particular circumstances and to comply with this part. The

records shall demonstrate that accreditation procedures have been

effectively fulfilled, particularly with respect to application forms,

assessment reports, and other documents relating to granting,

maintaining, extending, reducing, suspending or withdrawing

accreditation. The records shall be identified, managed and disposed of

in such a way as to ensure the integrity of the process and

confidentiality of the information. The records shall be kept for a

period of five years.

(2) The Accreditor shall have a policy and procedures for retaining

records for a period of five years. The Accreditor shall have a policy

and procedures concerning access to these records consistent with

paragraph (h)(1) of this section.

(i) Confidentiality. (1) The Accreditor shall have adequate

arrangements, consistent with applicable laws, to safeguard

confidentiality of the information obtained in the course of its

accreditation activities at all levels of its organization, including

committees and external bodies or individuals acting on its behalf.

(2) Except as required in this part, information about a particular

body shall not be disclosed to a third party without the written

consent of the body.

Sec. 280.1011 Accreditor personnel.

(a) General provisions. (1) The personnel of the Accreditor

involved in accreditation shall be competent for the functions they

perform.

(2) Information on the relevant qualifications, training and

experience of each member of the personnel involved in the

accreditation process shall be maintained by the Accreditor. Records of

training and experience shall be kept up to date.

(3) Clearly documented instructions shall be available to the

personnel describing their duties and responsibilities. These

instructions shall be maintained up to date.

(b) Qualification criteria for auditors and technical experts. (1)

In order to ensure that assessments are carried out effectively and

uniformly, the minimum relevant criteria for competence shall be

defined by the Accreditor.

(2) Auditors shall meet the requirements of the appropriate

international documentation.

(3) Technical experts are not required to comply with the

requirements for auditors, and guidance on their personal attributes

may be obtained from appropriate international documentation.

(c) Selection procedure. (1) The Accreditor shall have a procedure

for selecting auditors and, if applicable, technical experts on the

basis of their competence, training, qualifications and experience, and

for initially assessing the conduct of auditors and technical experts

during assessments, and subsequently monitoring the performance of

auditors and technical experts.

(2) When selecting the audit team to be appointed for a specific

assessment, the Accreditor shall ensure that the skills brought to each

assignment are appropriate. The team shall:

(i) Be familiar with the Act and this part, accreditation

procedures and accreditation requirements;

(ii) Have a thorough knowledge of the relevant assessment method

and assessment documents;

(iii) Have appropriate technical knowledge of the fastener

technology for which accreditation is sought and, where relevant with

associated procedures and their potential for failure (technical

experts who are not auditors may fulfill this function);

(iv) Have a degree of understanding sufficient to make a reliable

assessment of the competence of the accredited body to operate within

its scope;

(vi) Be free from any interest that might cause team members to act

in other than an impartial or non-discriminatory manner, for example,

(A) Audit team members or their organization shall not have

provided consulting services to the applicant or accredited body which

compromise the accreditation process and decision; and

(B) In accordance with the directives of the Accreditor, the audit

team members shall inform the Accreditor, prior to the assessment,

about any existing, former or envisaged link between themselves or

their organization and the body to be assessed.

(d) Contracting of assessment personnel. The Accreditor shall

require the personnel involved in the assessment to sign a contract or

other document by which they commit themselves to comply with the rules

defined by the Accreditor, including those relating to confidentiality

and those relating to independence from commercial and other interest,

and any prior and/or present link with the bodies to be assessed. The

Accreditor shall ensure that, and document how, any subcontracted

assessment personnel satisfy all the requirements for personnel

outlined in this subpart.

(e) Assessment personnel records. (1) The Accreditor shall possess

and maintain up-to-date records on personnel conducting assessments,

consisting of:

(i) Name and address;

(ii) Affiliation and position held in the organization;

(iii) Educational qualifications and professional status;

(iv) Experience and training in each field of competence of the

Accreditor;

(v) Date of most recent updating of record; and

(vi) Performance appraisal.

(2) The Accreditor shall ensure, and verify, that any subcontracted

body maintains records, which satisfy the requirements of this part, of

assessment personnel who are subcontracted to the Accreditor.

(f) Procedures for assessment teams. Assessment teams shall be

provided with up-to-date assessment instructions and all relevant

information on accreditation arrangements and procedures.

Sec. 280.1012 Decision on accreditation.

(a) The decision whether or not to accredit a body shall be made on

the basis of the information gathered during the accreditation process

and any other relevant information. Those who make

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the accreditation decision shall not have participated in the audit.

(b) The Accreditor shall not delegate authority for granting,

maintaining, extending, reducing, suspending or withdrawing

accreditation to an outside person or body.

(c) The Accreditor shall provide to each of its accredited bodies

accreditation documents such as a letter outlining the scope of

accreditation and a certificate signed by an officer who has been

assigned such responsibility. These accreditation documents shall

identify, for the body and each of its sites covered by the

accreditation:

(1) The name and address;

(2) The scope of the accreditation granted, including as

appropriate:

(i) The type of registration scheme;

(ii) The standards and/or other normative documents and regulatory

requirements against which products, services or systems are

registered; and

(iii) Fasteners covered by the Act.

(3) The effective date of accreditation and, as applicable, the

term for which the accreditation is valid.

(d) In response to an application for an amendment to the scope of

an accreditation already granted, the Accreditor shall decide what, if

any, assessment procedure is appropriate to determine whether or not

the amendment should be granted and shall act accordingly.

Sec. 280.1013 References to accredited status.

(a) An Accreditor which is proprietor or licensee of a symbol or

logo, intended for use under its accreditation program, shall have a

policy governing its use. It shall normally allow an accredited body to

refer to its accreditation in certificates, reports, and stationery and

publicity material relating to accredited activities.

(b) The Accreditor shall not allow use of its mark or logo in any

way which implies that the Accreditor itself approved a product,

service or system registered by an accredited body. Where a Facility is

registered only with respect to its quality assurance system, the

symbol or logo shall not be used on a product or in any other way that

may be interpreted as denoting product conformance, as required by

Sec. 280.804(d).

(c) The Accreditor shall take suitable action to deal with

incorrect reference to the accreditation system, or misleading use of

accreditation logos found in advertisements, catalogues, etc. Such

action could include corrective action, withdrawal of certificate,

publication of the transgression and, if necessary, other legal action.

Sec. 280.1014 Change in the accreditation.

The Accreditor shall give due notice of any changes it intends to

make in its requirements for accreditation. It shall take account of

views expressed by interested parties before deciding on the precise

form and effective date of the changes. Following a decision on, and

publication of, the changed requirements, it shall verify that each

accredited Registrar carries out any necessary adjustments to its

procedures within such time as, in the opinion of the Accreditor, is

reasonable.

Sec. 280.1015 Appeals, complaints and disputes.

The Accreditor shall keep a record of all appeals, complaints and

disputes, and remedial actions relative to accreditation; take

appropriate corrective and preventive action; and document the actions

taken and assess their effectiveness.

Sec. 280.1016 Access to records of appeals, complaints and disputes.

The Accreditor shall require each applicant and accredited

Registrar to make available to it, when requested, the records of all

complaints, appeals and disputes, and subsequent actions.

Requirements for Assessment

Sec. 280.1020 Application for accreditation.

(a)(1) As specified in Sec. 280.1010(g)(1) of this part, the

Accreditor shall maintain up-to-date detailed descriptions of the

assessment and accreditation procedure, the documents containing the

requirements for accreditation, and documents describing the rights and

duties of accredited Registrars, and shall provide them to applicants

and accredited Registrars. The Accreditor shall require that an

accredited Registrar.

(i) Always complies with the relevant provisions of this part;

(ii) Makes all necessary arrangements for the conduct of the

assessment, including provision for examining documentation and the

access to all areas, records (including internal audit reports) and

personnel for the purposes of assessment, surveillance, reassessment

and resolution of complaints;

(iii) Only claims that it is accredited with respect to those

activities for which it has been granted accreditation;

(iv) Does not use its accreditation in such a manner as to bring

the Accreditor into disrepute, and does not make any statement

regarding its accreditation which the Accreditor may consider

misleading or unauthorized;

(v) Upon suspension or withdrawal of its accreditation,

discontinues use of all advertising matter that contains any reference

thereto and returns any accreditation documents as required by the

Accreditor;

(vi) Does not allow the fact of its accreditation to be used to

imply that a product, process, system, or person is approved by the

Accreditor, as required by Sec. 280.804(d);

(vii) Ensures that no accreditation document, mark or report, or

any part thereof, is used in a misleading manner; and

(viii) In making reference to its accreditation status in

communication media such as documents, brochures or advertising,

complies with the requirements of the Accreditor.

(2) When the desired scope of accreditation is related to a

specific program any necessary explanation shall be provided to the

applicant. If requested, additional application information shall be

provided to the body.

(b) The Accreditor shall require an official application form, duly

completed and signed by a duly authorized representative of the

applicant, in which or attached to which:

(1) The scope of the desired accreditation is defined; and

(2) The applicant agrees to comply with the requirements for

accreditation and to supply any information needed for its evaluation.

(c) At least the following shall be provided by the applicant prior

to the on-site assessment:

(1) The general features of the applicant body, such as corporate

entity, name, address, legal status and, where relevant, human and

technical resources;

(2) General information concerning the body covered by the

application, such as its functions, and its relationship in a larger

corporate entity, and its physical locations;

(3) A description of the systems or products it registers and the

standards or other normative documents applicable to each; and

(4) A copy of its quality manual and, where required, the

associated documentation.

Sec. 280.1021 Preparation for assessment.

(a) Before proceeding with the assessment, the Accreditor shall

conduct, and maintain records of, a review of the request for

accreditation to ensure that:

(1) The requirements for accreditation are clearly defined and

documented;

(2) Any difference in understanding between the Accreditor and the

applicant is resolved; and

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(3) The Accreditor has the capability to perform the accreditation

service with respect to the scope of the accreditation sought, the

location of the applicant's operations, and any special requirements

such as the language used by the applicant.

(b) The Accreditor shall prepare a plan for its assessment

activities to allow for the necessary arrangements to be made.

(c) The Accreditor shall nominate a qualified audit team to

evaluate all material collected from the applicant and to conduct the

audit on its behalf. Experts in the areas to be assessed may be

attached to the Accreditor's team as advisers.

(d) The applicant shall be informed of the names of the members of

the audit team who will carry out the assessment, with sufficient

notice to appeal against the appointment of any particular auditors or

experts.

(e) The audit team shall be formally appointed and provided with

the appropriate working documents. The plan for and the date of the

audit shall be agreed upon with the applicant. The mandate given to the

audit team shall be clearly defined and made known to the applicant,

and shall require the audit team to examine the structure, policies and

procedures of the applicant, and confirm that these meet all the

requirements relevant to the scope of accreditation, and that the

procedures are implemented and are such as to give confidence in the

registrations of the applicant.

Sec. 280.1022 Assessment.

(a) The audit team shall assess all services of the applicant

covered by the defined scope against all applicable accreditation

requirements.

(b) The Accreditor shall witness fully the on-site activities of

one or more assessments or audits conducted by an applicant before an

initial accreditation is granted for any function requiring on-site

activity by the applicant.

Sec. 280.1023 Assessment report.

(a) The Accreditor may adopt reporting procedures that suit its

needs but, as a minimum, these procedures shall ensure that:

(1) A meeting takes place between the audit team and the

applicant's management prior to leaving the premises, at which the

audit team provides a written or oral indication on the conformity of

the applicant with the particular accreditation requirements and

provides an opportunity for the applicant to ask questions about the

findings and their basis;

(2)

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