[Federal Register Volume 60, Number 46 (Thursday, March 9, 1995)]
[Notices]
[Pages 12980-12985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5780]
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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.
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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
