Nationally Recognized Testing Laboratories; Clarification of the Types of Programs and Procedures

DEPARTMENT OF LABOR

[Docket No. NRTL-1-95]

Nationally Recognized Testing Laboratories; Clarification of the

Types of Programs and Procedures

AGENCY: Occupational Safety and Health Administration, Department of

Labor.

ACTION: Notice of interpretation.

-----------------------------------------------------------------------

SUMMARY: This notice announces the Occupational Safety and Health

Administration's (OSHA) clarification of the types of programs and

procedures [[Page 12981]] that Nationally Recognized Testing

Laboratories (NRTL) may engage in under the OSHA/NRTL recognition

program, 29 CFR 1910.7. This notice addresses in particular those

programs under which the NRTL controls and audits, but does not itself

generate, the data relied upon for product certification. OSHA invites

currently recognized NRTLs as well as new applicants to request

approval for any of these acceptable procedures.

EFFECTIVE DATE: March 9, 1995.

FOR FURTHER INFORMATION CONTACT:

Office of Variance Determination, NRTL Recognition Program,

Occupational Safety and Health Administration, U.S. Department of

Labor, 200 Constitution Avenue, NW., Room N3653, Washington, DC 20210.

SUPPLEMENTARY INFORMATION:

Background

On March 6, 1984, (49 FR 8326), the Occupational Safety and Health

Administration proposed a comprehensive overhaul of its regulatory

procedures related to OSHA's requirements for safety testing or

certification of certain workplace equipment and materials. The goals

of the proposal were:

(1) To assure that products required to be tested and certified

would be reliably tested and certified;

(2) To implement testing and certification requirements and

procedures which would be administratively workable; and

(3) To take advantage of developments by others in organizing and

evaluating product certification systems and in accrediting

laboratories for testing.

In the proposal, OSHA stated that it was attempting to build upon

the self regulatory efforts of the private sector, particularly in the

fields of electrical and fire safety. OSHA intended to take full

advantage of the mechanisms which existed in the private sector or in

government, and to keep its long-term involvement in these activities

to a minimum (see 53 FR 12103 second column, first paragraph). A three

day informal public hearing was held on September 25, 26, and October

1, 1984. Based on the comments received and a review of the testimony

in the record, the Agency modified its original proposal and, on April

12, 1988, (53 FR 12102), promulgated a new section, 1910.7--Definition

and requirements for a nationally recognized testing laboratory, and a

new Appendix A to section 1910.7--OSHA Recognition Process for

Nationally Recognized Testing Laboratories.

The cornerstone of this regulation is the definition of the

regulatory term ``NRTL'', with respect to specific elements. There are

four elements that are identified as NRTL requirements: capability to

test and evaluate equipment; control of certified products;

independence; and procedures to produce creditable findings. These four

elements that define an NRTL are incorporated into the criteria for the

various types of procedures which OSHA approves and, when followed,

provide OSHA with a reasonable degree of assurance that the products

may be used safely in the workplace.

As noted above, capability to test and evaluate equipment, and

independence are two of the elements required of an NRTL. These

elements are discussed in the preamble to the final rule.

Capability to test does not mean that all testing will be done by

the NRTL. OSHA stated in the preamble that while it expected generally

that most applicants would do the testing in-house this was not a

requirement of the standard. OSHA recognized that, in some cases,

laboratories would subcontract out the testing of a certain product or

aspect thereof due to unique or special testing needs. Anticipating

this occurrence, OSHA stated that the laboratory actually doing the

work must have the necessary capability to conduct the tests, and the

laboratory applying for recognition would retain primary responsibility

for fulfilling the requirements of the standard and complying with the

procedures set out in Appendix A.

Independence also does not mean that an NRTL has to carry out all

of its functions totally separate from other entities, including the

manufacturer. Simply put, the independence requirement means that the

analytical and decision making processes, which are the critical

functions that must be performed, are accomplished by an organization

which is financially independent of manufacturers, vendors, and users

of certified products. As long as the NRTL retains these functions, the

credibility of the testing and approval process will be maintained.

OSHA believes that this understanding of the concept of

independence was implicit in the rule from the time of its adoption.

Thus the OSHA rule was intended to build upon the system of testing and

certification already in existence, not to supplant it. The existing

system did not require a rigid barrier between NRTL and manufacturer,

for example, which would completely prevent the NRTL from utilizing the

manufacturer's testing or other information sources. As long as the

NRTL, which was not economically affiliated with the manufacturer, had

ultimate authority and responsibility for the approval of the product

and use of the certification mark, the needs of independence would be

satisfied. The current clarification is consistent with and fleshes out

the past practice.

OSHA intended a pragmatic application of the elements of

independence and capability to perform testing, as well as the other

elements that go into defining an NRTL. This can be seen from the

general discussion in the preamble to the final rule, and specifically

from the decision to grandfather the operations of UL and FMRC for a

five-year period.

Thus, in the final rule, OSHA grandfathered some of the procedures

that were in existence at the time of the rule. ``It seems reasonable

that product testing systems already in place should be able to

continue their operations without Agency rulemaking on the testing

standards, methods and procedures they are using now and have

successfully used in the past. The operation of already existing

product testing systems, such as UL and FMRC, could be seriously

disrupted if the Agency attempted to undertake rulemaking on the

testing standards, methods and procedures they are using.'' (See 53 FR

12108, second column, last paragraph). The initial assessment for

renewal of UL and FMRC in 1993 and 1994, identified mature and

functioning procedures, some over thirty years old, which included the

acceptance of test data from other sources and use of contract

organizations for other services.

In addition, OSHA's intent in the 1988 rule was to allow a level of

flexibility in meeting the mandatory requirements. OSHA recognized that

procedures may operationally vary from laboratory to laboratory, and

still be acceptable. For example, the preamble to the final rule stated

that, ``. . . while the record indicates that current safety testing

standards and practices may vary slightly among the third party safety

testing organizations, the testing laboratories themselves indicate

that they have compensating mechanisms and controls built into their

particular systems which are intended to assure that the ultimate

result will fall within an acceptable range'' (TR 534,550). ``The

laboratories claim that they use those testing standards, methods and

procedures which adequately address all necessary safety concerns and

thereby justify their decision to ``pass'' the item in question and to

allow the use of the laboratory's listing or identifying mark'' (Ex 38,

p 3; TR 552, [[Page 12982]] 553). (53 FR 12108, third column, first

paragraph).

Thus, OSHA recognized that there were testing practices that might

vary and differ among laboratories. OSHA also recognized that the

compensating mechanisms and controls for each system and laboratory

depends upon the confidence the laboratory has in the final result

leading to use of the mark.

OSHA's review of the applications for renewal of recognition

submitted by UL and FMRC have lead to the conclusion that it is

appropriate to provide further clarification of acceptable NRTL

procedures. In order for other NRTLs and future applicants to utilize

these types of procedures, OSHA has provided specific criteria that

will identify the critical elements of the various procedures. These

criteria, as discussed earlier, were derived from the four elements

that define an NRTL. By providing such criteria, an NRTL may tailor its

methods and testing techniques to any procedure the NRTL would like to

include.

The identification of criteria discussed in this document will

provide guidance to applicants utilizing the various procedures, while

still allowing the flexibility that was identified in the discussion of

the regulation.

Clarification

The Occupational Safety and Health Administration is clarifying the

types of testing and certification procedures which may meet the

requirements for acceptance under section 1910.7.

The Agency has previously determined that an NRTL may, but is not

obligated to, accept test data, component or product approvals, or

other information or data from another NRTL, as long as it is satisfied

with their appropriateness. The NRTL has the prerogative to retest or

reapprove, as it deems necessary.

OSHA is aware that in addition to the procedures which were

previously clearly understood to be acceptable, NRTLs also utilize

procedures involving entities such as contractors, manufacturers, and

other laboratories, for the performance of many of their functions.

These other procedures are acceptable with certain controls in place.

OSHA recognizes that to maintain credibility of these procedures, a

higher level of expertise and controls by the NRTL will be required.

Therefore, applicants for these will be assessed and audited by OSHA to

more stringent guidelines. Generally, all acceptable procedures fall

within one or more of the following.

1. The basic procedure where all product testing and evaluation is

performed in-house by the NRTL that will certify the product

2. Acceptance of testing data from independent organizations, other

than NRTLs

3. Acceptance of product evaluations from independent organizations,

other than NRTLs

4. Acceptance of witnessed testing data

5. Acceptance of testing data from non-independent organizations

6. Acceptance of evaluation data from non-independent organizations

(requiring NRTL review prior to marketing)

7. Acceptance of continued certification following minor product

modifications by the client

8. Acceptance of product evaluations from organizations that function

as part of the International Electrotechnical Commission Certification

Body (IEC-CB) Scheme

9. Acceptance of services other than testing or evaluation performed by

subcontractors or agents

Certain procedures are unacceptable. Included among these are

manufacturer self-declaration, client self-certification, and other

similar procedures that permit non-NRTLs to determine conformance with

the product standard, i.e., certify the product.

A number of procedures encountered during on-site investigations by

OSHA assessors have existed in one form or another prior to the

existence of the NRTL program in 1988. Most of these procedures appear

to have matured to a degree necessary to maintain product safety in the

workplace and included controls necessary for conformity with NRTL

program requirements.

This Notice discussed procedures and criteria to be utilized by

OSHA assessors and auditors in evaluating each of them. OSHA will

continue to closely monitor progress under these criteria and evaluate

the effectiveness of the procedures.

The specific criteria utilized for evaluating the procedures of an

applicant for recognition as a nationally recognized testing laboratory

are based upon ``national consensus standards and international

guides''.

Three basic principles, to assure that product certifications would

provide necessary levels of safety, were derived from the rule.

These principles are as follows:

(1) The NRTL shall be capable of performing all aspects of a

product certification scheme on its own.

The NRTL shall be recognized to perform the tests,

evaluations, and other services before it can accept such services from

other organizations.

(2) Where the services of other organizations are used, the NRTL

shall retain control of, and responsibility for, all aspects of the

product certification scheme.

The NRTL shall have procedures consistent with the

appropriate national standards and international guides for granting,

maintaining, and extending its qualification of an organization or

service.

The NRTL shall use assessors who met the competence

requirements of the appropriate national standards and international

guides to evaluate the organization.

The NRTL shall ensure that all aspects of certification

work performed by others--including participants, locations of testing,

witnessing, and evaluations--are identified in the NRTL and client

records and reports.

(3) The NRTL shall ensure that each organization providing data,

product evaluations, or other services to the NRTL is capable of doing

so, and that the relationship between the NRTL and the organization

does not compromise the NRTL's independence.

The NRTL shall be able to demonstrate that each

organization it employs is capable of providing data, product

evaluations, or other services that meet, or exceed, the quality of

those provided by the NRTL.

The NRTL shall maintain reports of its assessments of such

organizations; these assessments shall conform to appropriate national

standards and international guides.

The NRTL shall have a documented surveillance program to

ensure continued compliance with the NRTL's qualification procedures;

this surveillance program shall be consistent with the appropriate

national standards and international guides.

The NRTL shall not be economically affiliated with any of

these outside organization.

Procedures and specific criteria for each, were then developed from

the basic principles. These principles, wherever they are applicable,

shall be an integral requirement of the following procedures.

1. The Basic Procuredure--All Product Testing and Evaluation is

Performed In-House by NRTL That Will Certify the Product

This is the basic procedure utilized by an NRTL under conditions

where it is feasible. The first and second basic principles are

applicable to this procedure. [[Page 12983]]

2. Acceptance of Testing Data From Independent Organizations, Other

Than NRTLS

As was noted previously in reference to the preamble to the final

rule, OSHA anticipated that most testing by an NRTL would be done in-

house, but did not make this a requirement of the standard.

Subcontracting out of some of the tests was anticipated by OSHA, when

it noted that the laboratory actually doing the work must have the

necessary capability to conduct the tests, and the laboratory applying

for recognition would retain primary responsibility for fulfilling the

requirements of the standard and complying with the procedures set out

in Appendix A.

An NRTL may accept testing conducted by an independent organization

provided the following criteria are complied with:

The NRTL shall retain control of, and responsibility for, all

aspects of the product certification scheme.

The NRTL shall review each test package and complete the

product evaluations required by the test standards.

The NRTL shall ensure that all data in the test data

package originated with an organization that the NRTL qualified.

The NRTL shall ensure that each organization providing testing data

is capable of conducting the test and that the relationship between the

NRTL and the organization does not compromise the NRTL's independence.

The NRTL shall have a written program for assessing the

qualification of the organization to perform testing for each product

type it may be required to test.

This qualification program shall include procedures for

evaluating the organization's independence, facilities, utilities,

environmental controls, personnel, testing and calibration equipment,

written testing procedures, calibration procedures, quality assurance

program, and other elements as outlined in the appropriate national

concensus standards and international guides.

3. Acceptance of Product Evaluations From Independent Organizations,

Other Than NRTLS

Although no clear distinction between testing and evaluation is

made in the final rule (29 CFR 1910.7), such distinction exists.

Many NRTLs utilize outside organizations for specific or unique

tests. In these instances, the NRTL stipulates the tests and defines

the testing procedures to be utilized and, finally, evaluates the test

results to determine conformance of the product to the product standard

and certifies the product where it does conform.

In this type procedure, the outside organization both tests and

evaluates the results of the tests to determine conformance of a

product to a standard, and them issues a test and evaluation report to

the NRTL. The NRTL, in return, weighs the report for validity and

conformance of the product to the product standard in order to decide

whether the product is certifiable.

Authorization for an NRTL to accept product evaluations

significantly expands the scope of the services which may be provided

to the NRTL from an outside source. Acceptance of product evaluations

will require the NRTL to establish a more formalized, long-term

relationship with the independent organization to acquire confidence in

its evaluation procedures.

An NRTL may accept product evaluations prepared by an independent

organization provided the following criteria, in addition to the

requirements in Procedure 1, are complied with:

The NRTL shall retain control of, and responsibility for, all

aspects of the product certification scheme.

The NRTL shall review each evaluation package, and

complete the product evaluations required by the test standards before

the product certification is issued.

The NRTL shall ensure that evaluations are obtained from

an organization which it has qualified.

The NRTL shall ensure that data relied upon have been

developed under the program established by the NRTL.

The NRTL shall require the organization to establish and

maintain a system to document technical correspondence and test

standard interpretations.

The NRTL shall assure that the organization, in preparing

the evaluation package, follows the written procedures established by

the NRTL.

The NRTL shall ensure that each organization providing product

evaluations is capable of conducting the tests and performing the

evaluations, and that the relationship between the NRTL and the

organization does not compromise the NRTL's independence.

The NRTL's qualification program shall be used to assess

the organization's procedures and personnel to determine its

qualifications relative to each product type it may be asked to

evaluate.

The qualification program shall establish a minimum period

and level of mutual effort between the NRTL and the organization for

confidence-building. During this period the NRTL will witness

evaluations, verify the evaluations through inter-organizational

comparisons, and validate the competence of personnel to perform

product evaluations.

4. Acceptance of Witnessed Testing Data

This procedure involves technical personnel from the NRTL

witnessing product testing generally carried out at a location other

than that of the NRTL. The organization carrying out the tests may or

may not be independent.

The majority of testing witnessed by representatives of the NRTL is

consistent with the statement in the preamble to the final rule that *

* * in some cases, laboratories may wish to subcontract out the testing

of a certain product or aspect thereof due to unique or special testing

needs.

Representatives of an NRTL may witness testing provided the

following criteria are complied with:

The NRTL shall retain control of, and responsibility for, all

aspects of the product certification scheme.

The NRTL shall train its own personnel to take an active

role in witnessing each phase of the tests.

This training shall include specific testing procedures

for each product type the trainees may witness.

The NRTL shall assure that the organization providing the testing

data is capable of conducting the tests and that the relationship

between the NRTL and the organization does not compromise the NRTL's

independence.

The NRTL shall have a written program for assessing the

qualification of the organization to perform testing for each product

type it may be required to test.

This qualification program shall include procedures for

evaluating the outside organization's facilities, utilities, personnel,

testing and calibration equipment, written testing procedures,

calibration procedures, environmental controls, and other elements as

outlined in the appropriate national consensus standards and

international guides.

The NRTL shall qualify the outside organization using the

NRTL's own staff.

5. Acceptance of Testing Data From Non-Independent Organizations

This program involves test data generated by an organization that

has a vested interest in the outcome of the test results.

Data submitted under this program shall not include products

intended for use in hazardous (classified) locations

[[Page 12984]] (see 29 CFR 1910.307). A substantial number of tests of

products intended for use in hazardous locations involves subjective

analysis and have levels of complexity well beyond that required for

tests of products meant for use only in ordinary locations.

An NRTL may accept testing conducted by a non-independent

organization provided the following criteria are complied with, in

addition to the requirements in Procedure 1, with the exception for the

need to document the independence of the organization:

The NRTL shall establish procedures and maintain records which will

demonstrate that the test data are unbiased.

The NRTL shall ensure that the organization providing the data is

capable of conducting the tests and that the relationship between the

NRTL and the organization does not compromise the NRTL's independence.

The NRTL's qualification procedures shall establish a

minimum time period for confidence-building. During this period the

NRTL will witness tests and verify them by duplicate testing at the

NRTL's facility.

The NRTL's surveillance program shall include annual site

evaluations, review of test packages, random samples and retests by the

NRTL, and other controls outlined in the appropriate national standards

and international guides.

6. Acceptance of Evaluation Data From Non-Independent Organizations

(Requiring NRTL Review Prior To Marketing)

This type of procedure enables an organization to evaluate a

product in which it has a vested interest. However, the product shall

not be released to the market until the NRTL has reviewed and concurred

with the evaluation.

An NRTL may accept product evaluations prepared by a nonindependent

organization provided the following criteria are complied with:

Except for the requirement for independence, the specific program

criteria in Procedures 1, 2, and 4 shall apply to product evaluations

by non-independent organizations. The following additional program

criteria shall also be required:

The NRTL shall retain control of, and responsibility for, all

aspects of the product certification scheme.

The NRTL shall establish and maintain records of procedure

and product deficiencies identified, and the corrective actions taken

by it and the organization.

The NRTL shall establish and maintain a program to monitor

and confirm the organization's evaluations.

The NRTL shall assure that no product is released to the

market until it has verified the organization's testing data and

concurred with its evaluation of the product.

The NRTL shall assure that each organization providing data and

evaluations is capable of performing these functions and that the

relationship between the NRTL and the organization does not compromise

the NRTL's independence.

The NRTL shall establish and maintain records that

demonstrate that the organization continues to be proficient in testing

and evaluation.

The NRTL shall demonstrate that the organization's

laboratory has sustained the quality of its performance in testing

before being considered for this program.

7. Acceptance of Continued Certification After Minor Product

Modifications by the Manufacturer

This type of procedure would allow a manufacturer to make minor

changes to a certified product, test and evaluate the change or

changes, and continue to use the certification mark on the modified

product.

With all the controls in place and a clear understanding of what a

``minor'' product modification encompasses, there should be no reason

to consider this procedure as not falling within the scope of the NRTL

program. A minor product modification is one which involves the use of

an interchangeable component in a previously accepted product. Examples

are the substitution of an equivalent switch from a different

manufacturer, or the replacement of a motor with a comparable one of

different horsepower.

An NRTL may accept minor product modifications from a manufacturer

without requiring recertification provided the following criteria, as

well as the criteria in Procedures 1, 2, 4, and 5 (except for the

requirements for independence), are complied with:

The NRTL shall retain control of, and responsibility for, all

aspects of the product certification scheme.

The NRTL shall clearly define what is meant by ``minor''

modifications.

The NRTL shall review each test and evaluation report for

each product modification.

The NRTL shall assure that each manufacturer providing the test

data and evaluation is capable of conducting the tests and making the

product evaluations, and that the relationship between the NRTL and the

organization does not compromise the NRTL's independence.

The NRTL shall demonstrate that the client has sustained

the quality of its performance in both testing and product evaluation

before being considered for this program.

8. Acceptance of Product Evaluations From Organizations That Function

As Part of the International Electrotechnical Commission Certification

Body (IEC-CB) Scheme

The IEC-CB scheme authorizes organizations accredited as certified

bodies to exchange product test data and evaluation reports with each

other.

An NRTL may accept product evaluations from organizations that are

part of the IEC-CB scheme provided the following criteria are complied

with:

The NRTL shall retain control of, and responsibility for, all

aspects of the product certification scheme.

The NRTL shall physically evaluate each product.

The NRTL shall review each test and evaluation report and

certificate of certification to determine that the correct nationally

recognized standards has been used to test the product and, where

applicable, that the US deviations have been properly applied.

The NRTL shall have written procedures for the evaluation

of products, and for the interpretation of any results.

The NRTL shall establish records that demonstrate that the

organizations furnishing test and evaluation reports continue to be

competent. These records will include documentation to demonstrate that

the organization understands the US deviations and has correctly

applied them.

The NRTL shall determine that the components used in the

product are tested to a standard comparable to the appropriate

nationally recognized standard.

The NRTL shall determine that components used in the

product have been certified through an appropriate regulatory

authority's scheme, and that the scheme includes routine evaluation of

the manufacturer's process.

9. Acceptance of Services (Other Than Testing or Evaluation) Performed

by Subcontractors or Agents

Services under this heading include follow-up activities,

calibration activities, and equipment maintenance accomplished by

subcontractors or agents.

Athough there do not appear to be any references in 29 CFR 1910.7

or in the preamble to the final rule that specifically address this

issue, testing [[Page 12985]] laboratories, including the larger

organizations, have historically contracted for certain activities.

Most common are activities such as repair and calibration of test and

measurement instrumentation, security services, and quality system

accreditation. Assuming proper controls for such activities by the

NRTL, they should not affect the ability of the NTRL to produce

credible findings. It was never OSHA's intent to discourage or limit

activities such as the use of national or international standards for

quality assurance qualification and registration of a manufacturer by

organizations other than the NRTL. Such accreditation and services can

be useful tools for an NRTL as long as the NRTL retains ultimate

control and responsibility.

The NRTL shall retain control of, and responsibility for, all

aspects of the product certification scheme.

The NRTL shall assure that subcontractors or agents

performing service which may affect the certification of a product have

been assessed and qualified by the NRTL.

The NRTL shall assure that subcontractors agents use the

follow-up procedures established by the NRTL.

The NRTL shall maintain records of the results of the

follow-up visits.

The NRTL shall assure that each agent or subcontractor providing a

service is capable of performing that service and that the relationship

between the agent or subcontractor does not compromise the NRTL's

independence.

The NRTL shall be able to demonstrate that all

subcontractors and agents are capable of providing services equivalent

to that provided by the NRTL.

The NRTL shall have written procedures to qualify

subcontractors or agents, to monitor their performance, to communicate

effectively with them, and to maintain manufacturer confidentiality.

The NRTL's qualification rpocedures shall include:

qualification requirements; the subcontractor's or agent's quality

assurance and self-auditing programs; the NRTL's monitoring program;

and the documentation requirements for both the NRTL and the

subcontractor or agent.

The NRTL's records shall include documentation to

demonstrate that the subcontractor or agent complies with the NRTL's

program.

The NRTL shall use its own staff to qualify the

subcontractor or agent.

The NRTL shall have the means to ensure that only follow-

up inspectors who are qualified for the task are utilized.

The NRTL's surveillance program shall include routine

audits of the facilities, staff, and procedures involved in its follow-

up program.

The follow-up procedures in foreign countries shall be as

stringent as those required in the US.

The follow-up program shall include an initial assessment

of the manufacturers' procedures, the quality control system,

maintenance procedures, recordkeeping and other elements from the

appropriate national standards and international guides.

The follow-up program shall have the capability to

identify variations in the manufacturers' ability to control the

quality of production.

The NRTL shall periodically inspect samples of products

for compliance.

The Use of An ``NRTL'' Certification Mark for Products Tested and

Certified In Accordance With OSHA's Requirements

OSHA has received requests from several NRTL participants to

initiate action that would implement a requirement for the use of a

unique mark for the NRTL certified products. As a result of these

requests, OSHA will publish a separate document in the Federal Register

explaining how such a program may be implemented, as well as describing

the requirements which are considered to be part of such a program.

In this separate document, OSHA will request comments on the

advantages and disadvantages of implementing such a program and invite

suggestions as to the proper approach OSHA should take. The document

will include the concerns of the Agency and will seek public

information that will enable it to determine the appropriate action.

Authority

Section 6(b) of the Occupational Safety and Health Act of 1970, (84

Stat. 1593, 29 U.S.C. 655), Secretary of Labor's Order No. 1-90 (55 FR

9033).

Signed at Washington, DC, this 3rd day of March 1995.

Joseph A. Dear,

Assistant Secretary.

[FR Doc. 95-5780 Filed 3-8-95; 8:45 am]

BILLING CODE 4510-26-M