posal to deny accreditation, the testing laboratory shall have thirty (30) days from the date of receipt of such notification to request a hearing under the provisions of 5 U.S.C. 556. The Secretary's proposed denial shail become final through the issuance of a written decision to the applicant in the event that the applicant does not appeal such notification by the end of that thirty (30) day period. In the event, however, that the applicant testing laboratory requests a hearing within that thirty (30) day period, the Secretary's proposed denial shall be stayed until the hearing held pursuant to 5 U.S.C. 556.

§ 7b.13 Revocation or termination of accreditation of a testing laboratory.

(a) If the Secretary finds that a testing laboratory which has previously been accredited violated the terms of its accreditation or the provisions of these Part 7b procedures, after consultation with such testing laboratory, the Secretary shall notify that testing laboratory of the proposed revocation of its accreditation.

(b) Upon receipt of a notice from the Secretary of the proposed revocation, which notice shall set forth the reasons for such proposed revocation, the accredited testing laboratory shall have thirty (30) days from the date of receipt of such notification to request a hearing under the provisions of 5 U.S.C. 556. The Secretary's proposed revocation shall become final through the issuance of a written decision to the testing laboratory in the event that such testing laboratory does not appeal the proposed revocation within that thirty (30) day period. In the event, however, that the accredited testing laboratory requests a hearing

within that thirty (30) day period, the Secretary's proposed revocation shall be stayed until the hearing is held pursuant to 5 U.S.C. 556.

(c) A testing laboratory may at any time terminate its participation and responsibilities under this NVLAP Part 7b program or withdraw its application for accreditation by giving written notice to the Secretary. Upon receipt by the Secretary of such notice, the Secretary shall terminate further processing of the testing laboratory's application for accreditation. If such testing laboratory has been accredited, the Secretary shall terminate that testing laboratory's accreditation. The Secretary shall notify the testing laboratory that its accreditation has been terminated pursuant to its request.

(d) A testing laboratory whose application has been rejected or whose accreditation has been denied, revoked or terminated or which has withdrawn its application price to being accredited may reapply for and be accredited if it meets the applicable general and specific criteria promulgated by the Secretary under § 7h.8(c)(1) and agrees also to meet the conditions set out under § 7b.7(c) and the provisions of § 7b.12.

§ 7b.14 Cessation of accreditations.

(a) The Secretary shall cease the accreditation of testing laboratories that serve a specific product if requested to do so by the Federal agency which requested the program if such agency makes a determination that the program is no longer needed. Such request, however, may not be made if the program has been in existence for less than one year after publication of the final accreditation criteria. The determination that the program is no longer needed shall be submitted to the Secretary in writing and shall set forth the requesting agency's reasons for causing the Secretary to cease accreditation through this NVLAP. Termination of the program will occur 60 days after the Secretary has published in the FEDERAL REGISTER a notice of such determination. If the program is being used for a purpose in addition to the purpose specified by the requesting Federal agency, the accreditation program may be continued in its own

right under the original or other optional NVLAP procedures.

(b) If the Secretary ceases the accreditation of testing laboratories that serve a specific product as provided in this section, accreditation issued to all those testing laboratories serving the same specific product before termination of the program has occurred shall continue for the remainder of the period for which accreditation has been granted.

§ 7b.15 Refund of fees and charges.

(a) If a testing laboratory withdraws its application for accreditation after it has submitted the required examination fees and provides written notice to the Secretary of such withdrawal prior to the issuance of an accreditation of the denial thereof, the testing laboratory will be refunded such fees except for the application fee, if any, and for any other costs that have been incurred relative to its application.

(b) If a testing laboratory terminates its participation and responsibilities under this Part 7b program at any time after it has been accredited or after it has been notified by the Secretary that it is not being accredited, no part of the fees and charges paid by the testing laboratory will be refunded.

(c) If the accreditation of a testing laboratory is revoked by the Secretary under § 7b.13, no part of the fees and charges paid by the testing laboratory will be refunded.

(d) If the Secretary ceases the accreditation of testing laboratories that serve a specific product under § 7b.14 and withdraws the accreditation of a testing laboratory to test a specific product under that section, such testing laboratory will be refunded the unexpended part of the examination fees or charges paid by such testing laboratory to maintain its accredited status under this program: Provided, however, That no such testing laboratory will be refunded its original application fee, if any, to be accredited to serve a specific product.

§ 7b.16 Amendment or revision of criteria.

The Secretary, the requesting Federal agency in those cases where it recommended general and specific crite

ria to the Secretary, or a Criteria Committee acting at the request of the Secretary, may undertake the development of amendments or revisions of any applicable general or specific criteria previously promulgated by the Secretary by following the same procedures pertaining to the original development of such criteria.

§ 7b.17 User information and reports.

(a) For each specific product for which a NVLAP Part 7b accreditation exists, the Secretary will publish a quarterly report noting all actions regarding such matters as accreditations, revocations, the establishment of fees and charges, the promulgation of general and specific criteria and any amendments or revisions to such criteria. Such publications shall clearly state that testing laboratories accredited by the Secretary under these procedures are in no manner immune from the necessity of being in compliance with all legal obligations and responsibilities imposed by existing Federal, State, and local laws, ordinances, and regulations, including those related to consumer protection and antitrust prohibitions.

(b) The Secretary will also prepare an annual report summarizing all activities carried out under these procedures which shall include a listing of all testing laboratories accredited by the Secretary during the year to which the annual report relates.

(c) As a means of giving prompt notice to the public of accreditation action taken, the Secretary shall, in addition to the reports called for under this section, publish in the FEDERAL REGISTER all actions taken during the preceding month which grant, revoke, terminate, or result in the withdrawal of the accreditation of a testing laboratory. Such notice shall include the name and address of the testing laboratory concerned, and a brief explanation of the action taken by the Secretary with respect to that laboratory.

§ 7b.18 Support function.

The Secretary is authorized to make provisions for administrative and technical support and staff services as may be needed to carry out this program.

The Secretary is also authorized to negotiate for and use funds and personnel of the requesting Federal agency as such funds and personnel are authorized for use by the requesting agency.

PART 7c-NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM: PRIVATE SECTOR ORGANIZATIONS

Sec.

7c.1 Purpose.

7c.2 Description and goal of program. 7c.3 Definitions.

7c.4 Request to accredit testing laboratories.

7c.5 Establishment of criteria with which to accredit laboratories.

7c.6 Establishment and functions of a National Laboratory Accreditation Criteria Committee.

7c.7 Development and recommendation of criteria for accrediting testing laboratories.

7c.8 Publication of proposed criteria. 7c.9 Coordination with Federal agencies. 7c.10 Establishment of fees and charges. 7c.11 Participation of testing laboratories. 7c 12 Reference to accredited status. 7c.13 Revocation or termination of accreditation of a testing laboratory.

7c.14 Cessation of accreditations. 7c.15 Refund of fees and charges. 7c.16

Amendment or revision of criteria. 7c.17 User information and reports. 7c.18 Support function.

AUTHORITY: Sec. 2, 31 Stat. 1449, as amended; sec. 1, 64 Stat. 371 (15 U.S.C. 272); Reorganization Plan No. 3 of 1946, part VI. SOURCE: 44 FR 24277, Apr. 25, 1979, unless otherwise noted.

§ 7c.1 Purpose.

The purpose of this part is to establish procedures under which a National Voluntary Laboratory Accreditation Program (NVLAP) will operate at the request of certain organizations in the private sector which employ decision making conditions assuring fair representation of all interests.

§ 7c.2 Description and goal of program.

(a) This program extends the opportunity to use the general approach of NVLAP (Title 15 CFR Part 7a) in examining the professional and technical competence of testing laboratories that serve the public interest. The pro

gram will operate in conjunction with the NVLAP Part 7a program ("Part 7a-National Voluntary Laboratory Accreditation Program: General" is the redesignation of the original Title 15 CFR "Part 7-Procedures for a National Voluntary Laboratory Accreditation Program,' as published in the FEDERAL REGISTER, Volume 41, No. 38, Wednesday, February 25, 1976 (pp. 8163-8168)). After criteria established pursuant to the Part 7c procedures set out below have been established, testing laboratories that meet them will be accredited just as under the Part 7a procedures. The Part 7c program will also require testing laboratories that want to maintain accredited status to undergo periodic checks and examinations.

The Part 7c program will seek, through coordination and consultation, to maximize benefits derived from other testing laboratory examination and accreditation activities including those conducted under Part 7a. In this way, it is intended that the program will avoid wasteful duplication of the Part 7a program or other testing laboratory examination or accreditation programs conducted by the public and private sectors.

(b) The intended goal of this Part 7c program is to simplify and shorten the NVLAP procedures for private sector organizations which meet the conditions of § 7c.3(b). It will serve the needs of industry and consumers in an even more timely basis by accrediting this Nation's testing laboratories when requested to do so by qualified organizations in the private sector without first proposing and then making a finding of need before work on criteria is even initiated. Achievement of this goal will further promote attaining a uniformly acceptable base of clearly defined professional and technical competence in testing laboratories. It will establish a background of experience necessary to the orderly evolution of a laboratory accreditation system designed to serve national needs as they develop which is the intent of NVLAP.

§ 7c.3 Definitions.

(a) The term "Secretary" means the Secretary of Commerce or the Secretary's designee.

(b) The term "private sector organization" refers to any permanent group of persons or standing subgroup thereof, an ad hoc group which is part of a permanent organization, or a group which otherwise meets in its own right: Provided, That each such group is of nongovernmental character and meets conditions (1) through (6) set out below as follows:

(1) Public notice of meetings and other activities including requests for LAPS is provided in a fashion which is timely and likely to reach the attention of most interested persons;

(2) Meetings are open and participation in activities is available to interested persons;

(3) Decisions reached by the private sector organization in the development of a request for a LAP represent substantial agreement of the interested persons;

(4) Prompt consideration is given to the expressed views and concerns of all interested parties;

(5) Adequate and impartial mechanisms for handling substantive and procedural complaints and appeals are in force; and

(6) Appropriate records of any meeting are maintained and the official procedures used by the private sector organization to make a formal request for a LAP are made available upon request by any interested person.

(c) The term "product" includes the plural thereof and means a type or a category of manufactured goods, constructions, installations and natural and processed materials or those associated services whose characterization, classification, or functional performance determination is specified by standards.

(d) The term "Criteria Committee" means a National Laboratory Accreditation Criteria Committee appointed by the Secretary under §§ 7a.6 and 7c.6 of these NVLAP procedures.

(e) The term "person" means associations, companies, corporations, educational institutions, firms, government agencies at the Federal, State, and local level, partnerships, and soci

eties, as well as divisions thereof, and individuals.

(f) The term "testing laboratory” means any "person" as defined above whose functions include testing, analyzing or inspecting “products," as defined above, and/or evaluating the designs or specifications of such "products" according to the requirements of applicable standards.

(g) The term "general criteria" means those characteristics of a testing laboratory commonly found in, and generally expected of, such a laboratory serving the product under consideration. See in this connection § 7c.7(a)(1).

(h) The term "specific criteria" means those detailed requirements deemed essential to assuring an acceptable examination and evaluation of the testing function performed by a testing laboratory in performing specific tests related to identified standards for the product under consideration. See in this connection § 7c.7(a)(2).

§ 7c.4 Request to establish a laboratory accreditation program (LAP).

(a) Any private sector organization employing procedures which meet conditions (1) through (6) under § 7c.3(b) of this notice and which has concluded under those procedures that there is a need to accredit testing laboratories that test products may request the Secretary to establish a NVLAP based on these Part 7c procedures.

(b) Such a request shall be in writing and shall include the following:

(1) Identification of the product; (2) Text of applicable rules or product standards;

(3) Text of test methods, if not included in the applicable rule or standard identified in paragraph (b)(2) of this section;

(4) Outline of recommended general and specific criteria compatible with criteria developed under the NVLAP Parts 7a and 7b procedures which are to be used in accreditation of testing laboratories, or a request for the establishment of a National Laboratory Accreditation Criteria Committee to develop and recommend such criteria to the Secretary;

(5) A statement of the need to accredit testing laboratories that serve the product identified in paragraph (b)(1) of this section and a list of users who would likely make use of the program;

(6) A statement of the extent to which the private sector organization is willing to support any necessary developmental aspects of the program with funding and personnel by agreement with the Secretary; and

(7) A description of the way in which the organization has met the conditions for a private sector organization,

as

specified in the definition in § 7c.3(b), in developing the request.

(c) Upon receipt of such a request, the Secretary shall promptly file a copy of it in the Department's Central reference and records Inspection Facility, Room 5317, Department of Commerce Building, and shall place in the FEDERAL REGISTER a notice of receipt of such request and its availability for public inspection.

(d) If, on the basis of the information provided or because of the lack of funding and personnel from the requesting private sector organization, the Secretary is unable to justify the establishment of a LAP under these Part 7c procedures, the Secretary will decline to act further on the request. The Secretary shall in that event notify the requesting organization in writing within ten (10) working days after making a decision and shall state the reasons for so declining.

(e) If a request received under this section is believed to affect an existing or developing testing laboratory examination or accreditation program of a Federal regulatory agency, the Secretary shall seek from the head of such agency its views relative to the Secretary's further development of a LAP. If within thirty (30) days after receipt of the Secretary's solicitation of views, or such extension of time as may be agreed to by the Secretary, the head of the affected Federal regulatory agency states in writing that the agency objects to further action on the request and explains the agency's reasons for objecting, the Secretary shall cease to act further on the request. In that event, the Secretary shall notify the private sector organi

zation of the objections in writing within ten (10) working days after receipt of the agency's objections, including a copy of the objections.

with

§ 7c.5 Establishment of criteria which to accredit laboratories. (a) Laboratories will be accredited on the basis of their conformance to general and specific accreditation criteria issued by the Secretary under these procedures. The general criteria will deal with those qualities which make for an effective testing laboratory. The specific criteria will be based on the requirements of the relevant standards and test methods for which accreditation is sought.

(b) Laboratory accreditation criteria may be recommended to the Secretary by the requesting private sector organization or may be developed by a National Laboratory Accreditation Criteria Committee as set forth in § 7a.6 of the NVLAP procedures. The choice of which approach to use will lie with the private sector organization requesting the program.

(c) In cases where the criteria are submitted by the requesting private sector organization, the Secretary will decide, after consultation with the requesting organization, on the precise language of the proposed general and specific criteria to be published by the Secretary in the FEDERAL REGISTER. In making the decision, the Secretary will consider:

(1) The needs and scope of the program of the requesting private sector organization;

(2) Compatibility with other criteria already established and being used in other LAPS; and

(3) The nature and content of other relevant public and private sector laboratory accreditation programs.

§ 7c.6 Establishment and functions of a National Laboratory Accreditation Criteria Committee.

(a) In those instances where a private sector organization decides not to recommend laboratory accreditation criteria, the Secretary will establish a National Laboratory Accreditation Criteria Committee in order to develop and recommend general and specific