John Wolz

Editor�s Note: The following are excerpts from public comments filed on the proposed regulations for the Fastener Quality Act � Public Law 101-592, as amended by Public Law 106-34. The National Institute of Standards & Technology is responsible for writing the regulations.
Excerpts from the Procedures for Implementation of the FQA were published in the December 15, 1999, issue of FIN. The proposed regulations can be accessed at www.NIST.gov/fqa
The Industrial Fasteners Institute submitted comments in a letter signed by chairman John O�Brien and managing director Rob Harris. Excerpts were published in the January 31, 2000, issue of FIN.

Joe McIlhon, president, National Fastener Distributors Association: �NFDA strongly supports the purpose of the fastener hotline and is very disappointed that announcement of the opening of the hotline was not contained [in proposed regulations]. Accordingly, NFDA urges the Department to move quickly in establishing the hotline. NFDA also recommends that the Bureau of Export Enforcement [BXA] operate the hotline, since BXA is an experienced enforcement agency and has responsibility under sections 280.203 through 280.222 of the proposed regulations for administrative enforcement proceedings.�
On a proposal to remove all references to private label distributors pertaining to recordal of insignia: �The rationale for such is the Department�s finding that section 5 of the FQA as amended pertains only to manufacturers of fasteners and not to private label distributors of fasteners. The Department proposes to further revise requirements for recordal of fastener insignia to provide that fasteners whose insignia must be recorded are those fasteners that are required by the applicable consensus standards to bear �an insignia� rather than a �raised or depressed insignia,� and that these fasteners are not subject to recordal requirements if the specifications provide otherwise. NFDA believes that the PTO should continue to voluntarily register insignia for private label distributors and for OEMs that wish to have their insignia appear on a fastener.
�Our reasons are as follows: There is a long-standing practice in the fastener industry whereby a private label distributor or an OEM purchases fasteners from a manufacturer with only the insignia of the private label distributor on the fasteners. This practice was recognized and provided for in the original FQA, and has never been identified as a source of problems in the industry. Under the amended FQA, if a fastener is produced to a consensus standard which requires the manufacturer�s insignia on the fastener then � [it] must be registered with PTO prior to the sale � Our understanding is that a private label distributor�s or OEM�s insignia may also appear on the fastener, but it must be in addition to that of the manufacturer�s, and there is no requirement in the Act that the private label distributor or OEM�s insignia be registered with PTO.
� �NFDA believes, however, that there are instances where it is legal for a private label distributor or OEM to have their insignia appear on a fastener without the manufacturer�s insignia also appearing. The Department explains � that fasteners are not subject to recordal requirements if the specifications provide otherwise. NFDA interprets this as meaning that a private label distributor can by �specification� ask for and receive fasteners with only the insignia of the private label distributor on the head of the fasteners. Under this example, the fastener could be sold with only the insignia of the private label distributor and there would be no traceability to the private label distributor, because he or she is not able to register their headmark with PTO. NFDA believes that a fundamental tenet of the Act is traceability to the manufacturer or to the person responsible for the fastener [the private label distributor in the example cited above]. Therefore, NFDA urges the Department to consider allowing voluntary registration of insignia on the part of private label distributors and OEMs to promote the concept of fastener traceability as envisioned by Congress. Most private label distributors and OEMs that purchase fasteners this way have already registered with PTO as part of preparing for the original FQA, and it makes little sense not to continue this practice.
NFDA also recommends that section 280.300 of the proposed regulations be amended to make it clear per section 5(a) of the Act that recordal of insignia is mandatory only when required by a consensus standard, and that it is not required if �specifications� provide otherwise.
� As now proposed in section 280.320 of the draft regulations, private label distributors and OEMs that have already registered insignia would be identified when such insignia come up for renewal, and they would be prohibited from renewing their registrations because they are not �manufacturers� within the meaning of the Act. This seems counterproductive and not at all in line with the spirit of fastener traceability as envisioned by Congress. NFDA recommends that this section be changed to allow for renewal of insignia by private label distributors and by OEMs.�
Editor�s Note: In a letter signed by president Steve Dunham, the Western Association of Fastener Distributors concurred with the NFDA position.

Matthew McGrath, attorney for the American Association of Fastener Importers: �While manufacturers and importers will now be exempt from much of the Act if they are producing or selling fasteners made pursuant to ISO 9000 or equivalent quality assurance systems, there will continue to be situations in which testing and certification by an accredited laboratory are necessary. Proposed Section 280.103 provides that: �A laboratory may be accredited by any voluntary laboratory accreditation program that may be established by private sector person(s) or by the National Voluntary Laboratory Accreditation Program for fasteners, established by the director ��
�This language technically omits foreign government laboratory accreditation programs, although apparently covering foreign private sector accreditation. Based on conversations with your office, we understand that this provision is not intended to make such a distinction. As NIST is aware, there are many high-quality foreign government accreditation bodies and programs which are available to manufacturers and exporters, and which will continue to fully serve the intent of the Act. Some of these are recognized formally by NIST under Mutual Recognition Agreements, such as the Asia Pacific Laboratory Accreditation Cooperation and the Standards Council of Canada. Any failure to recognize these MRA programs under the modified FQA would potentially be a U.S. violation of the WTO Agreement on Technical Barriers to Trade. Of course, there are also a number of foreign laboratories accredited by NIST (NVLAP Directory of Foreign Accredited Laboratories), but the number of fully accredited laboratories available to foreign producers and importers would be greatly limited if competent foreign accrediting bodies are not recognized.
�Therefore, we request that the language of the draft regulation be modified to clarify that a laboratory may be accredited by any voluntary laboratory accreditation program that may be established �by a foreign government,� as well as by the private sector or NVLAP.�

Peter Unger, president, American Association for Laboratory Accreditation: A2LA suggests allowing a �person publishing a document setting forth guidance or requirements for the accreditation of laboratories may petition the director to approve such document for use as described � the director shall approve such petition if the document provides equal or greater rigor and reliability as compared to ISO/IEC Guide 25, including revisions from time to time. A petition shall contain sufficient information to allow the director to make this determination.
�Revisions to ISO/IEC Guide 25 are due to be issued in the next month or two as ISO/IEC 17025. Since the revisions are significant, it may be worth mentioning the new standard in the changes to the regulations.�
Approval of accreditation bodies: A person �publishing a document setting forth guidance or requirements for the approval of accreditation bodies to accredit laboratories may petition the director to approve such document for use as described � The director shall approve such petition if the document provides equal or greater rigor and reliability as compared to ISO/IEC Guide 58, including revisions from time to time. A petition shall contain sufficient information to allow the director to make this determination.
�We find it unfortunate that the FQA does not directly consider recognition of existing approvals between accreditation bodies which have undergone rigorous international peer evaluations to determine accreditation body competence. Since ISO/IEC Guide 58 serves as the criteria for these peer evaluations, we suggest that the director also take into account such existing approvals.�

Charles Lockwood II, general counsel, and Vann Wilber, director of vehicle safety and harmonization, of the Alliance of Automobile Manufacturers: �In general, AIAM (Association of International Automobile Manufacturers) and the Alliance support the proposed regulations � we have concerns regarding two matters relating to the fastener insignia provisions � (1) Insignia requirement � The process by which motor vehicle manufacturers establish some of those requirements, but specify other requirements, different from consensus standards, to obtain the characteristics required for a specific application. One example of such a difference involves fastener insignias. Consensus standards frequently require that fasteners produced to such standards must bear an insignia. However, in certain cases, vehicle manufacturers have found it necessary or desirable to have fasteners produced without an insignia. Vehicle manufacturers have found that the fastener insignia could, in some cases, impair the function of the fastener, or the insignia could be undesirable for aesthetic reasons.
�The FQA amendments of 1999 explicitly permitted the elimination of insignias from consensus standard fasteners, by adding to the law a definition of �specifications.� Specifications are the required characteristics of fasteners, as determined by contractual agreement between the fastener manufacturer and the end-user. Section 5 of the Amendments specifically exempts from the requirements for affixing the insignia to the fastener and recording the insignia with the Patent & Trademark Office those fasteners that are produced to a specification that provides for no insignia.
�The proposed regulations do not fully reflect the �specifications� exemption � it neglects to include the key exemption language of section 5 � This discrepancy in the proposal inappropriately impairs the ability of vehicle manufacturers to obtain fasteners that do not have affixed insignia. We request that the final rule reflect the �specifications� exemption in a manner consistent with section 5 �
�(2) Private label distributors � Section 280.310 of the proposal provides that only fastener manufacturers may record fastener insignias under the FQA. Under the previous version of the law and regulations, �private label distributors� were also permitted to record their insignia. The proposal�s more restricted authorization for recordation is apparently based upon the deletion from the law of the definition of �private label distributors� and the elimination of the use of that term in various provisions. �Private label distributors� were defined under the previous statute as distributors that contract for the fabrication of fasteners bearing the distributor�s (rather than the fabricator�s) insignia. It is our understanding that the �private label distributor� definition was deleted from the law in order to clarify that fastener end-users would not generally be brought under the various administrative requirements of the previous statute, including recordkeeping and other requirements. We are unaware of any indication that Congress intended to prohibit the recordation of the insignias of private label distributors or end- users.
�Moreover, some consensus standards explicitly permit the affixing of the private label distributor�s identification on fasteners. An example of such a standard is ASTM 563-94, �Standard Specification for Carbon and Alloy Steel Nuts� � which states: �In addition, nuts of Grades C, C3, D, DH, and DH3 and hex nuts made to the requirements of DH3, shall be marked with a symbol to identify the manufacturer or private label distributor, as appropriate.�
�Consistent with this understanding of the legislative purpose and industry practice, we see no statutory necessity or public policy benefit to prohibiting private label distributors and end-users from voluntarily recording their insignia. Voluntary recordation would promote increased traceability of fasteners in actual use. Therefore, we request that the final rule permit voluntary recordation of fastener insignias by any party that manufactures fasteners or that contracts for the production of fasteners bearing its insignia.
�It is our understanding that fastener end-users may continue to arrange through contractual specifications for their suppliers to produce fasteners having the end-user�s insignia. The �specifications� exception in section 5 of the FQA amendments exempts from the prohibition against the sale of fasteners that lack the manufacturer�s insignia those end-users that contract for the affixing of their own insignia. However, such end-users might wish to voluntarily record their insignia, and good public policy would justify inclusion of such insignia in the insignia registry maintained by the Patent & Trademark Office.�

Richard Stump, management consultant, Consultants in Quality Inc.: Recommendations: Delay lab accreditation implementation and approval of accrediting bodies for three years. �Keep the original, well-established NIST Technology Services operations, based on ISO/IEC Guide 25 (soon to be ISO 17025), NIST Handbooks 150 and 150-18, Fasteners & metals, and ISO/IEC Guide 58 in place, as they have been and currently are being practiced.
�Prepare a quantitative study of the initial accreditation results and renewal accreditation results of fastener testing laboratories, to study the kinds and amounts of lab assessment findings, and establish a base line for later decision making.�
A team led by NIST and �composed of major, fastener industry, representative organizations and user-organization representatives that have showed significant interest in FQA laboratory accreditation� and ABEP approval bodies, �to function for at least the next three years, with one or more of the following objectives in mind:� (A) Monitor assessment results of labs to ensure significant improvements in documentation and performance; (B) Determine if a review every three years should be continued or �be replaced by another style of industry-based formal oversight�; or �folded into another established accreditation program; or follow guidelines of 1999 FQA and team disbanded. (C) �Level the playing field in the cost area of laboratory testing for FQA covered fasteners. All manufacturers can compete with less concern over the cost of meeting the minimum expected level of commitment to the NIST Handbooks � knowing that all competitors are obligated to do likewise.�
�Empirical observations, based upon personal assessments and review of assessments performed by other assessors of fastener testing laboratories, in the U.S., Japan, Taiwan and India, present a case that the typical laboratory is not ready to function in the newly prescribed environment provided by the FQA� as amended in 1999. �While there are a few satisfactorily structured and well-performing fastener-testing laboratories, the majority can be described as significantly poor performers with the quality system they have implemented and/or in their compliance to customer requested consensus test standards methodologies.�
Stump noted the following �major categories where typical poor-performing FQA test laboratories fall short include: poorly and/or inadequately documented quality systems; not performing to the documented quality systems; change in lab management resulting in the quality system falling through the cracks; lab test technicians not following the prescribed test method in the company and/or the applicable consensus standard; improper interpretation of the specific requirement being addressed; not having the proper issue of a consensus standard at hand or being practiced; now, with accreditation renewals, commitments made to gain initial accreditation, but not completed within the two-year period until the next assessment.�
Stump predicted labs �will progressively deteriorate in the new, less-demanding atmosphere� of the amended FQA.
�The promulgation of [the FQA] set off a torrent of emotions across the U.S., and probably with our international trading partners as well. Those wanting to right the ills described in the seminal document �The Threat From Substandard Fasteners: Is America Losing Its Grip?� were thrilled to have such a strong response to their efforts. Others were aghast, with the prediction that the cure was worse than the disease. Still others were confused as to why there are so many new activities to be done to comply with this maze of requirements.�
Stump wrote that there is a perception that testing is �end-of-the-line,� but �in-process testing is the norm� for many FQA labs, �providing a critical feedback to fastener manufacturing that can significantly affect end-product performance. Therefore, a big question surrounds how each specific company makes use of its own testing laboratory.�
Stump cited �loosening the rigor of federal monitoring� of food industry labs allowing �a laxness� to grow at a Sara Lee Corporation plant. Stump wrote that it resulted in �killing 21 people and costing Sara Lee a $76 million write-off against profit to recover from the catastrophe.�

Samuel Bleicher, attorney, Miles & Stockbridge of Washington, D.C., writing for Black & Decker Corporation: �NIST should remove the paraphrases of what constitutes a violation of the Act and replace them with either verbatim quotations from the Act or references to the relevant provisions of the Act.�
The Secretary of Commerce �has no authority under the Act to adopt regulations defining what constitutes a violation of the Act � it would be inappropriate for the Secretary to seek to alter or expand the scope of violations ��
�NIST has offered no reasoned explanation to support its attempt to adopt regulations that broaden the scope of violations under the Act, which alone is a sufficient ground to invalidate them under applicable principles of administrative law.
�The language of 280.201(b) and (c) clearly goes beyond 4(a) of the Act. Section 280.201(b), aside from changing the introductory language in a manner that has no apparent reason or basis, substitutes the word �connection� for the word �conjunction� in the statutory phrase �in conjunction with the sale or offer for sale or fasteners from a single lot� � No justification whatever has been offered or exists for changing the word chosen by Congress.
�NIST should include the statutory language that eliminates the insignia requirement if �the specifications provide otherwise� in the introductory sentence, not in subparagraph (a) � Section 280.300 alters the language of section 5 of the Act by moving the crucial introductory phrase, �Unless the specifications provide otherwise,� so that it appears to apply only to the obligation to record the insignia, rather than to the entire insignia requirement. Again, the preamble contains no mention of the change or explanation of its significance. The Act is expressly structured to allow specification to override otherwise applicable consensus standards, contrary to NIST�s interpretation of the prior version of the Act. The Act now allows specifications to do away entirely with the �manufacturer�s insignia� requirement, whether or not otherwise applicable consensus standards call for marking.
�NIST should eliminate all reference to a �raised or depressed� insignia, in light of the removal of that language from the Act, and all other requirements for the insignia. Section 280.300(b) seeks to impose three requirements about the nature of the manufacturer�s insignia, none of which are grounded in the Act or justified in the Preamble to the Proposed Rule. The manufacturer must (a) �apply the insignia through a raised or depressed impression (s) to the head� (or to another surface if the fastener has no head) (3) �readable with no greater than 10x magnification.
�None of these requirements find any support or justification in the Act. Indeed all references to �raised or depressed� insignia were carefully removed from the Act by Congress, as NIST implicitly acknowledges in its discussion in the Preamble � Since the Secretary�s general rule-making authority under the old law has been repealed, the fact that earlier versions of the regulations included such provisions is not a sufficient basis for the Proposed Rule. On the contrary, the Act�s long title announces that one primary purpose of the amendments is to �eliminate unnecessary requirements,� � Yet the Proposed Rule would lock industry into a specific kind of manufacturer�s insignia, in a particular location, and of a particular size. It gives no consideration to the possibilities of different marking or identification techniques that manufacturers might develop �
�NIST should implement the mandate in Section 6(D)(2) of the Act to �establish and maintain a hotline system to facilitate the reporting of alleged violations � If NIST is serious about addressing the concerns that Congress feels need attention, it will forgo efforts to re-regulate the industry�s quality assurance systems and move swiftly to establish an efficient system for facilitating consumer reporting and dealing with any fraud or misrepresentation that consumers report.�

Shin Suzuki, senior manager, quality system planning department, Nippon Steel Corporation: �As you know, the use of accredited laboratories will not take effect until June 2001 � Manufacturers and importers shall, however, retain the record of conformance which contains the chemistry of fastener material. This means in our understanding that they still have to get certifications or reports on chemistry. The following questions then arise: (1) Until June 2001, would the �mill test report� issued by steel melter be permitted as the record of conformances on chemistry retained by manufacturers? (2) What if the �mill test report� above contains the statement that the chemistry was tested and certified by its entrusted subsidiary lab? (3) After June 2001, would the �mill test report� issued by steel melter be permitted as the record of conformance on chemistry, if it contains the statement that the chemistry was tested and certified by its entrusted subsidiary lab which is accredited?
�We are afraid that the final implementation rules still contain difficulty to make the matter above clear.
�We understand that test certificates issued by labs may be accepted, but are wondering if the �mill test reports� containing steel chemistry issued by a steel melter may be also accepted.
�In the steel industry, most labs for chemistry are subsidiaries of steel melters. That is, the steel melters entrust chemical analysis to their subsidiary labs and issue [certify] mill test reports on their own, adopting the data from labs. These reports are also called �mill sheets� or �inspection certificates.��
��we would be grateful if the final rules would touch upon the matter above, make it clear, and could give us some interpretation��

David Sharp, vice president of quality & engineering, TurnaSure LLC (formerly J&M Turner Inc.): The amended FQA �will provide miniscule if any support for critical fastener standards, and makes a mockery of concerns over safety and reliability � It is a testament to the bold lobbying campaign of those opposed to fastener quality that it is now downright near impossible to find a �fastener� that is covered by the amended law.�
Sharp recalled a tour of a fastener plant where �we were shown fasteners that were arriving in packages indicating �Manufactured in compliance with the Fastener Quality Act,� an impossibility at the time, and I was told, an illegal misrepresentation � we were in one of the best quality-controlled facilities in the world � yet even portions of their fastener supply base were successfully having misrepresented fasteners installed in the production of the latest, most sophisticated civilian and military aircraft engines.�
Sharp said ISO 9000 or equivalent registration systems are insufficient. �It�s helpful for all of us to try and forget that one of the biggest cases of fastener fraud ever committed was by a supplier to the Alaskan pipeline project. And guess what: That supplier was one of the first ISO 9000 fastener companies in the world. Perhaps, in light of their ISO 9000 status, we should retroactively overturn their convictions, and return the fines.�
The amended FQA �broadly encourages wholesale �Grandfathering� of fasteners which would otherwise be unsuitable and illegal to supply to unknowing purchasers. Some day NIST and others will have to acknowledge how prevalent the practice of selling �outdated� fasteners as meeting the requirements of the latest specification has been. Then they�ll have to live with having been enablers of the practice as well.�
Comments on the Proposed Regulations: �In Subpart CV: Enforcement, it is useless to add regulations to make it a violation of the Act to knowingly falsify or misrepresent fasteners, or to sell fasteners without manufacturers� insignia, when almost all fasteners are exempt from the law in the first place.�
Sharp described the ISO 9000 exemption as �the enforcement comedy of �you�re innocent until you�re proven guilty, and they you�re innocent again.��
�Subpart D: �References to �raised or depressed� insignias must remain. Should fasteners only have to �bear an insignia,� they will inevitably be marked by inadequate means for proper identification or traceability to their sources. It is only by a �raised or depressed� portion of the metal that one can assure some permanence in the marking.�
The Internet site for insignia registry �is inordinately slow, because the list is not alphabetical, nor are there useful serial numbers that can be used to reference a specific entry.
�If historians ever wish to see a good example of a double-entendre, this is it. A good starting place for inquiry would be an evaluation of whether or not the Fastener Quality Act is in direct conflict with existing �truth in labeling� laws. The FQA covers virtually no fasteners, and handles quality in the most unorthodox fashion yet devised by man.�

John Cole, Product Risk Reductions: �The fastener industry has gained the economically advantageous position in having transferred all risks and responsibility to the user and thus the public� with the implementation of the amended FQA. �Now, unless NIST and Commerce issue an edict imposing technical, legal and ethical truths from both a socially responsible and scientific base of data, the country will once again be faced with countless loss of life due to fastener failures. Fasteners being highly engineered component parts comprise less than 1/2 of 1% of the cost of an assembly, 20% of the labor in making the assembly but 100% of the trouble if they do not have minimum known values of standards.�

Tommy Grant, chair, Fastener Quality Association: (Grant submitted comments from a July 1999 presentation to ASME North West Houston Sub Section, Petroleum Technical Chapter, Plant Engineering & Maintenance Technical Chapter) � �The New FQA does not adequately prevent misrepresented, counterfeit, mismarked, untested and nonconforming fasteners from being sold in U.S. Commerce � The amended law protects fastener suppliers � seriously compromises ability of buyer to procure fasateners that meet all fastener standards requirements � fastener coverage is limited and many fasteners are completely excluded or can be easily exempted in a number of ways � The law�s definition of fastener quality assurance system does not adequately assure that fasteners comply with standards to which they may be represented to meet �The FQA �record of conformance� does not require the documented compliance of fasteners to all the requirements of a fastener standard (compliance to one characteristic is enough) � Definitions for key terms permit fasteners to be represented as meeting standards based only on the intention that as few as one characteristic is in conformance ,,,the law defines contractual agreement with the manufacturer as the controlling document, not the fastener standard � there is a role reversal � instead of fastener manufacturer being liable for parts, the buyer assumes majority of responsibility and liability since buyer must not specifically define fastener requirements.�

Editor�s Note: The public comment period on the proposed regulations ended January 28, 2000. Final regulations for the FQA are being prepared. NIST is not required to consider late submissions. However, anyone interested in responding to above comments should write to: Subhas Malghan, Technology Services, National Institute of Standards & Technology, Mail Stop 2000, Gaithersburg, MD 20899-2000. E-mail: malghan@nist.gov