DoD Environmental Laboratory Accreditation Program (ELAP), 80996-81003 [2016-27645]
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Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Rules and Regulations
and consistent with regulatory
objectives. E.O. 13563 further
emphasizes that regulations must be
based on the best available science and
that the rulemaking process must allow
for public participation and an open
exchange of ideas. We have developed
this rule in a manner consistent with
these requirements.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
requires an agency to prepare a
regulatory flexibility analysis for all
rules unless the agency certifies that the
rule will not have a significant
economic impact on a substantial
number of small entities. The RFA
applies only to rules for which an
agency is required to first publish a
proposed rule. (See 5 U.S.C. 603(a) and
604(a)). Because the FCPIA of 2015
requires agencies to adjust penalties for
the catch-up adjustment through an
interim final rulemaking, agencies are
not required to complete a notice and
comment process prior to promulgation.
Thus, the RFA does not apply to this
rulemaking.
C. Small Business Regulatory
Enforcement Fairness Act
This rule is not a major rule under 5
U.S.C. 804(2), the Small Business
Regulatory Enforcement Fairness Act.
This rule:
(1) Does not have an annual effect on
the economy of $100 million or more.
(2) Will not cause a major increase in
costs or prices for consumers,
individual industries, Federal, State, or
local government agencies, or
geographic regions.
(3) Does not have significant adverse
effects on competition, employment,
investment, productivity, innovation, or
the ability of U.S.-based enterprises to
compete with foreign-based enterprises.
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D. Unfunded Mandates Reform Act
This rule does not impose an
unfunded mandate on State, local, or
tribal governments, or the private sector
of more than $100 million per year. The
rule does not have a significant or
unique effect on State, local, or tribal
governments or the private sector.
Therefore, a statement containing the
information required by the Unfunded
Mandates Reform Act (2 U.S.C. 1531 et
seq.) is not required.
E. Takings (E.O. 12630)
This rule does not effect a taking of
private property or otherwise have
takings implications under E.O. 12630.
Therefore, a takings implication
assessment is not required.
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F. Federalism (E.O. 13132)
Under the criteria in section 1 of E.O.
13132, this rule does not have sufficient
federalism implications to warrant the
preparation of a federalism summary
impact statement. Therefore, a
federalism summary impact statement is
not required.
G. Civil Justice Reform (E.O. 12988)
This rule complies with the
requirements of E.O. 12988.
Specifically, this rule:
(1) Meets the criteria of section 3(a)
requiring that all regulations be
reviewed to eliminate errors and
ambiguity and be written to minimize
litigation; and
(2) Meets the criteria of section 3(b)(2)
requiring that all regulations be written
in clear language and contain clear legal
standards.
extraordinary circumstances listed in 43
CFR 46.215 that would require further
analysis under NEPA.
K. Effects on the Energy Supply (E.O.
13211)
This rule is not a significant energy
action under the definition in E.O.
13211. Therefore, a Statement of Energy
Effects is not required.
List of Subjects in 30 CFR Part 250
Administrative practice and
procedure, Continental shelf,
Environmental impact statements,
Environmental protection, Government
contracts, Incorporation by reference,
Investigations, Oil and gas exploration,
Penalties, Pipelines, Continental Shelf—
mineral resources, Continental Shelf—
rights-of-way, Reporting and
recordkeeping requirements, Sulfur.
H. Consultation With Indian Tribes
(E.O. 13175 and Departmental Policy)
The Department of the Interior strives
to strengthen its government-togovernment relationship with Indian
tribes through a commitment to
consultation with Indian tribes and
recognition of their right to selfgovernance and tribal sovereignty. We
have evaluated this rule under the
Department of the Interior’s
consultation policy, under Departmental
Manual Part 512 Chapters 4 and 5, and
under the criteria in E.O. 13175. We
have determined that it has no
substantial direct effects on federally
recognized Indian tribes and that
consultation under the Department of
the Interior’s tribal consultation policy
is not required.
Amanda C. Leiter,
Acting Assistant Secretary, Land and
Minerals Management.
I. Paperwork Reduction Act
This rule does not contain
information collection requirements,
and a submission to the OMB under the
Paperwork Reduction Act (44 U.S.C.
3501 et seq.) is not required. We may
not conduct or sponsor, and you are not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
32 CFR Part 188
J. National Environmental Policy Act
This rule does not constitute a major
Federal action significantly affecting the
quality of the human environment. A
detailed statement under the National
Environmental Policy Act of 1969
(NEPA) is not required because the rule
is covered by a categorical exclusion
(see 43 CFR 46.210(i)). This rule is
excluded from the requirement to
prepare a detailed statement because it
is a regulation of an administrative
nature. We have also determined that
the rule does not involve any of the
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PART 250—OIL AND GAS AND
SULPHUR OPERATIONS IN THE
OUTER CONTINENTAL SHELF
Accordingly, the interim rule
amending 30 CFR part 250 which was
published at 81 FR 41801 on June 28,
2016, is adopted as a final rule without
change.
■
[FR Doc. 2016–27503 Filed 11–16–16; 8:45 am]
BILLING CODE 4310–MR–P
DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DOD–2013–OS–0230]
RIN 0790–AJ16
DoD Environmental Laboratory
Accreditation Program (ELAP)
Under Secretary of Defense for
Acquisition, Technology, and Logistics,
DoD.
ACTION: Final rule.
AGENCY:
This final rule establishes
policy, assigns responsibilities, and
provides procedures to be used by DoD
personnel for the operation and
management of the DoD ELAP. The DoD
ELAP provides a unified DoD program
through which commercial
environmental laboratories can
voluntarily demonstrate competency
and document conformance to the
international quality systems standards
as they are implemented by DoD.
SUMMARY:
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This rule is effective on
December 19, 2016.
DATES:
FOR FURTHER INFORMATION CONTACT:
Edmund Miller, 571–372–6904.
On
October 15, 2015 (80 FR 61997–62003),
the Department of Defense published a
proposed rule in the Federal Register
titled ‘‘DoD Environmental Laboratory
Accreditation Program (ELAP)’’ for a 60day public comment period. After the
60-day public comment period had
completed, no public comments were
received. As a result, no changes were
made to the rule text.
SUPPLEMENTARY INFORMATION:
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Executive Summary
The purpose of this regulatory action
is to document the procedures for the
operation and management of the DoD
Environmental Laboratory Accreditation
Program (ELAP). The legal authority for
the regulatory action is Section 515,
Treasury and General Government
Appropriations Act for Fiscal Year 2001
(Public Law 106–554), which directed
the Office of Management and Budget
(OMB) to issue government-wide
guidelines that ‘‘provide policy and
procedural guidance to Federal
Agencies for ensuring and maximizing
the quality, objectivity, utility, and
integrity of information (including
statistical information) disseminated by
Federal Agencies.’’ OMB guidelines,
provided by FR Volume 67, Number 36,
page 8452 (February 22, 2002) required
federal agencies to maintain a basic
standard of quality and take appropriate
steps to incorporate information quality
criteria into DoD public information
dissemination practices. The guidance
further provided that DoD Components
shall adopt standards of quality that are
appropriate to the nature and timeliness
of the information they disseminate.
The DoD ELAP provides the standards
for ensuring the quality, objectivity,
utility, and integrity of definitive
environmental testing data disseminated
by DoD for the Defense Environmental
Restoration Program (DERP).
This rule includes a general overview
of DoD ELAP and establishment of
standard operating procedures. It
utilizes the baseline quality systems
requirements of The NELAC Institute
(TNI) and ISO/IEC 17025 standards, but
alone neither of these standards meet
the testing and analysis needs for DERP.
Therefore the DoD Quality Systems
Manual (QSM) for environmental
laboratories serves as the standard for
DoD ELAP accreditation. The QSM
contains the minimum requirements
DoD considers essential to ensure the
generation of definitive environmental
data of know quality, appropriate for
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their intended uses. These minimal
needs are not met by TNI or ISO 17025
standards alone. The DoD ELAP
includes procedures on how to evaluate
and recognize 3rd party accreditation
bodies; perform and document
government oversight of the DoD ELAP
to ensure ongoing compliance with
program requirements and to identify
opportunities for continual
improvement; conduct project-specific
laboratory approvals for specific tests
not addressed in the DoD ELAP; and
handle specific complaints concerning
the processes established by the DoD
ELAP or the QSM.
Past DoD laboratory assessment
programs were specific to each DoD
Component and limited to available
resources. This created an overlap in
assessments and fewer opportunities for
laboratories to participate on DoD
contracts. This rule proposes to
establish a program to allow qualified
laboratories to received third-party
accreditation and become eligible to
provide environmental sampling and
testing services for DoD. It will be a
voluntary program open to any qualified
laboratories wishing to participate,
thereby promoting fair and open
competition among commercial
laboratories.
Since laboratories fund their own
participation in the accreditation
process, it will allow DoD to focus its
resources on providing oversight of
laboratory contracts. By proposing to
replace separate DoD Componentspecific laboratory approval programs,
the DoD ELAP will eliminate redundant
assessments, promote interoperability
across the Department, streamline the
process for DoD to identify and procure
competent providers of environmental
laboratory services, and provide more
opportunities for commercial
laboratories to participate in DoD
environmental sampling and testing
contracts.
The scope of accreditation under
ELAP includes specific laboratory
services such as the test methods used,
type of material tested (soil, water, etc.),
and type of contaminants measured.
The evaluation of a test method also
includes the use of internal laboratory
standard operating procedures.
Statement of Legal Authority: 15
U.S.C. 3701 promotes transfer and
utilization of science and technology
resources of the Federal government.
Public Law 106–554 requires the
Federal government to ensure the
quality and integrity of information
disseminated by Federal agencies. In
response, the DoD ELAP sets forth
requirements on environmental
laboratories conducting analytical
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testing for DoD to generate documented
quality data capable of being
reproduced in accordance with
commonly accepted scientific standards
and practices.
Regulatory Procedures
Executive Order 12866, ‘‘Regulatory
Planning and Review’’ and Executive
Order 13563, ‘‘Improving Regulation
and Regulatory Review’’
Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distribute impacts, and equity).
Executive Order 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This rule has not been
designated a ‘‘significant regulatory
action,’’ because it does not: (1) Have an
annual effect on the economy of $100
million or more or adversely affect in a
material way the economy; a section of
the economy; productivity; competition;
jobs; the environment; public health or
safety; or State, local, or tribal
governments or communities; (2) create
a serious inconsistency or otherwise
interfere with an action taken or
planned by another Agency; (3)
materially alter the budgetary impact of
entitlements, grants, user fees, or loan
programs, or the rights and obligations
of recipients thereof; or (4) raise novel
legal or policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in these
Executive Orders.
Sec. 202, Public Law 104–4, ‘‘Unfunded
Mandates Reform Act’’
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Pub. L. 104–4) requires agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2014, that
threshold is approximately $141
million. This rule will not mandate any
requirements for State, local, or tribal
governments, nor will it affect private
sector costs.
Public Law 96–354, ‘‘Regulatory
Flexibility Act’’ (5 U.S.C. 601)
The Department of Defense does not
expect this final rule would have a
significant economic impact on a
substantial number of small entities
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within the meaning of the Regulatory
Flexibility Act (5 U.S.C. 601, et. seq.).
The rule establishes a policy to provide
a unified DoD program for commercial
environmental laboratories to
voluntarily demonstrate competency
and document conformance to the
international quality system standards
already implemented by DoD. The
Department’s experience with these
laboratories indicates that the
professional skill and technical
requirements of the accreditation
program limits the numbers of entities
that are likely to be impacted by this
rule to approximately 100 entities.
Therefore, the Regulatory Flexibility
Act, as amended, does not require that
DoD prepare a regulatory flexibility
analysis.
Public Law 96–511, ‘‘Paperwork
Reduction Act’’ (44 U.S.C. Chapter 35)
It has been certified that 32 CFR part
188 does not impose reporting or
recordkeeping requirements under the
Paperwork Reduction Act of 1995. The
requirements in this rule do not require
OMB approval under the Paperwork
Reduction Act as the information is
collected by the four accreditation
bodies and not the Department. These
accreditation bodies accredit the
laboratories to meet DoD standards for
environmental sampling and testing.
Executive Order 13132, ‘‘Federalism’’
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
This rule will not have a substantial
effect on State and local governments.
List of Subjects in 32 CFR Part 188
Laboratories, Oversight.
■ Accordingly, 32 CFR part 188 is
added to read as follows:
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PART 188—DOD ENVIRONMENTAL
LABORATORY ACCREDITATION
PROGRAM (ELAP)
Sec.
188.1
188.2
188.3
188.4
188.5
188.6
Purpose.
Applicability.
Definitions.
Policy.
Responsibilities.
Procedures.
Authority: 15 U.S.C. 3701; Pub. L. 106–
554, 114 Stat. 2763.
§ 188.1
Purpose.
This part implements policy, assigns
responsibilities, and provides
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procedures to be used by DoD personnel
for the operation and management of the
DoD ELAP.
§ 188.2
Applicability.
This part applies to Office of the
Secretary of Defense, the Military
Departments, the Office of the Chairman
of the Joint Chiefs of Staff and the Joint
Staff, the Combatant Commands, the
Office of the Inspector General of the
Department of Defense, the Defense
Agencies, the DoD Field Activities, and
all other organizational entities within
the DoD (referred to collectively in this
part as the ‘‘DoD Components’’).
§ 188.3
Definitions.
Unless otherwise noted, these terms
and their definitions are for the
purposes of this part.
Accreditation. Third-party attestation
conveying formal demonstration of a
laboratory’s competence to carry out
specific tasks.
Accreditation body (AB).
Authoritative organization that performs
accreditation.
Assessment. Process undertaken by an
AB to evaluate the competence of a
laboratory, based on requirements
contained in the DoD Quality Systems
Manual for Environmental Laboratories
(QSM), for a defined scope of
accreditation.
Change. A reissuance of the DoD QSM
containing minor changes to
requirements or clarifications of existing
requirements necessary to ensure
consistent implementation.
Complaint. Defined in International
Organization for Standardization/
International Electrotechnical
Commission (ISO/IEC) 17025:2005,
‘‘General Requirements for the
Competence of Testing and Calibration
Laboratories’’ (available for purchase at
https://www.iso.org/iso/store.htm).
Contractor project chemist. Defined in
Under Secretary of Defense for
Acquisition, Technology, and Logistics
Memorandum, ‘‘Acquisitions Involving
Environmental Sampling or Testing
Services’’ (available at https://
www.acq.osd.mil/dpap/dars/dfars/
changenotice/2008/20080303/
223.7.pdf).
Corrective action response.
Description, prepared by the laboratory,
of specific actions to be taken to correct
a deficiency and prevent its
reoccurrence.
Deficiency. An unauthorized
deviation from requirements.
Definitive data. Defined in DoD
Instruction 4715.15, ‘‘Environmental
Quality Systems’’ (available at https://
www.dtic.mil/whs/directives/corres/pdf/
471515p.pdf).
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Environmental Data Quality
Workgroup (EDQW) component
principal. A voting member of the DoD
EDQW.
Errata sheet. A document prepared by
the EDQW and issued by the EDQW
chair, defining minor ‘‘pen and ink’’
changes that apply to the most recently
issued version of the DoD QSM. Errata
will be corrected in the next change or
revision of the DoD QSM.
Government chemist. Defined in
USD(AT&L) Memorandum,
‘‘Acquisitions Involving Environmental
Sampling or Testing Services.’’
Government oversight. The set of
activities performed by or on behalf of
the DoD EDQW to provide assurance
that ABs and assessors are providing
thorough, consistent, objective, and
impartial assessments within the
specified scopes of accreditation and to
identify opportunities for continual
improvement of the DoD QSM and DoD
ELAP.
International Laboratory
Accreditation Cooperation (ILAC)
mutual recognition arrangement (MRA).
An arrangement through which ABs are
evaluated and accepted by their peers
for conformance to ILAC rules and
procedures. To be accepted into the
ILAC MRA, the AB must become a
signatory to its requirements;
specifically, it must commit to maintain
conformance with the current version of
Deputy Secretary of Defense
Memorandum, ‘‘Ensuring Quality of
Information Disseminated to the Public
by the Department of Defense’’) and
ensure that the laboratories it accredits
comply with ISO/IEC 17025:2005.
ILAC MRA peer evaluation. The
process through which ABs are assessed
by other ABs and receive or maintain
acceptance into the ILAC MRA.
Project-specific laboratory approval.
The set of activities undertaken by the
DoD EDQW to assess whether a
laboratory is competent to perform
specific tests, in the case where no
DoD–ELAP accredited laboratory is able
to perform the required tests.
Quality system. Defined in ISO/IEC
17025:2005.
Recognition. The acceptance of an AB
by the EDQW based on its demonstrated
commitment to maintain signatory
status in the ILAC MRA and accept the
DoD ELAP conditions and criteria for
recognition.
Revision. A reissuance of the DoD
QSM containing significant changes in
requirements or scope. A significant
change is one that could reasonably be
expected to affect a laboratory’s ability
to comply with the requirement (i.e., the
laboratory is likely to have to make a
change in its quality system or technical
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procedures in order to maintain
compliance).
Scope of accreditation. Specific
laboratory services, stated in terms of
test method, matrix, and analyte, for
which accreditation is sought or has
been granted.
§ 188.4
Policy.
It is DoD policy, in accordance with
DoD Instruction 4715.15, to implement
the DoD ELAP for the collection of
definitive data in support of the Defense
Environmental Restoration Program
(DERP) at all DoD operations, activities,
and installations, including
government-owned, contractor-operated
facilities and formerly used defense
sites.
§ 188.5
Responsibilities.
(a) Secretaries of the Military
Departments and Director, Defense
Logistics Agency (DLA). The Director,
DLA, is under the authority, direction,
and control of the USD(AT&L), through
the Assistant Secretary of Defense for
Logistics and Materiel Readiness. The
Secretaries of the Military Departments
and Director, DLA:
(1) Provide resources to support
project-specific government oversight
for the collection of definitive data in
support of the DERP.
(2) Provide resources to support
project-specific laboratory approvals, if
required.
(b) Secretary of the Navy. In addition
to the responsibilities in paragraph (a) of
this section, the Secretary of the Navy
plans, programs, and budgets for DoD
EDQW activities necessary to support
government oversight of the DoD ELAP.
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§ 188.6
Procedures.
(a) DoD ELAP Overview—(1)
Introduction. (i) DoD ELAP provides a
unified DoD program through which
commercial environmental laboratories
can voluntarily demonstrate
competency and document conformance
to the international standard established
in ISO/IEC 17025:2005 as implemented
by the Deputy Under Secretary of
Defense for Environmental Security
Memorandum, ‘‘DoD Quality Systems
Manual for Environmental Laboratories’’
(available at https://www.denix.osd.mil/
edqw/upload/QSM-V4-2-Final102510.pdf) (referred to in this part as
the ‘‘DoD Quality Systems Manual for
Environmental Laboratories (QSM)’’).
The DoD QSM provides minimum
quality systems requirements, based on
ISO/IEC 17025:2005, for environmental
laboratories performing testing for DoD.
(ii) DoD ELAP was developed in
compliance with 15 U.S.C. 3701 (also
known as the ‘‘National Technology
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Transfer and Advancement Act’’).
Support and guidance was provided by
the National Institute of Standards and
Technology, following procedures used
to establish similar programs for other
areas of testing. The DoD ELAP supports
implementation of section 515 of Public
Law 106–554, ‘‘Treasury and General
Government Appropriations Act, 2001’’
and Office of Management and Budget
Guidance, ‘‘Guidelines for Ensuring and
Maximizing the Quality, Objectivity,
Utility, and Integrity of Information
Disseminated by Federal Agencies’’ (67
FR 8452) as implemented by Deputy
Secretary of Defense Memorandum,
‘‘Ensuring Quality of Information
Disseminated to the Public by the
Department of Defense.’’
(iii) Using third party ABs operating
in accordance with the international
standard ISO/IEC 17011:2004(E),
‘‘Conformity Assessment—General
Requirements for Accreditation Bodies
Accrediting Conformity Assessment
Bodies’’ (available for purchase at
https://www.iso.org/iso/store.htm), the
DoD ELAP:
(A) Promotes interoperability among
the DoD Components.
(B) Promotes fair and open
competition among commercial
laboratories.
(C) Streamlines the process for
identifying and procuring competent
providers of environmental laboratory
services.
(D) Promotes the collection of data of
known and documented quality.
(2) Authority. Operation of the DoD
ELAP is authorized by DoD Instruction
4715.15.
(3) Program requirements. (i) Pursuant
to DoD Instruction 4715.15, laboratories
seeking to perform testing in support of
the DERP must be accredited in
accordance with DoD ELAP.
(ii) The DoD ELAP applies to:
(A) Environmental programs at DoD
operations, activities, and installations,
including government-owned,
contractor-operated facilities and
formerly used defense sites.
(B) Permanent, temporary, and mobile
laboratories regardless of their size,
volume of business, or field of
accreditation that generate definitive
data.
(iii) Participation in the program is
voluntary and open to all laboratories
that operate under a quality system
conforming to ISO/IEC 17025:2005 and
Deputy Under Secretary of Defense for
Environmental Security Memorandum,
‘‘DoD Quality Systems Manual for
Environmental Laboratories.’’
Laboratories may seek accreditation for
any method they perform in accordance
with documented procedures, including
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non-standard methods. Laboratories are
free to select any participating AB for
accreditation services.
(iv) To participate in DoD ELAP, ABs
must be U.S.-based signatories to the
ILAC MRA and must operate in
accordance with ISO/IEC 17011:2004(E).
(4) Program oversight. In accordance
with Assistant Deputy Under Secretary
of Defense for Installations and
Environment Memorandum, ‘‘DoD
Environmental Data Quality Workgroup
Charter’’ (available at https://
www.denix.osd.mil/edqw/upload/
USA004743-10-Signed-Memo-to-DASsDLA-DoD-Envir-Data-QualityWorkgroup-Charter-1Oct10-1.pdf), the
DoD EDQW:
(i) Provides coordinated responses to
legislative and regulatory initiatives.
(ii) Responds to requests for DoD
Component information.
(iii) Develops and recommends
department-wide policy related to
sampling, testing, and quality assurance
for environmental programs.
(iv) Implements and provides
oversight for the DoD ELAP.
(v) Includes technical experts from
the Military Services and DLA as well
as an EDQW component principal
(voting) member from each of the
Military Services.
(vi) Specifies the EDQW Navy
principal, Director of Naval Sea Systems
Command (NAVSEASYSCOM)
04XQ(LABS), serve as EDQW chair.
(b) Maintaining the DoD QSM—(1)
General. The DoD EDQW will maintain
and improve the DoD QSM to ensure
that:
(i) The DoD QSM remains current in
accordance with ISO/IEC 17025:2005.
(ii) Minimum essential requirements
are met.
(iii) Requirements are clear, concise,
and auditable.
(iv) The DoD QSM will efficiently and
effectively support the DoD ELAP.
(2) Procedures.— (i) Annual review.
At a minimum, the DoD EDQW will
perform an annual review of the DoD
QSM, based on feedback received from
participants in DoD ELAP (e.g., DoD
Components, commercial laboratories,
and ABs). The review will also address
any revisions to ISO/IEC 17025:2005.
(ii) Ongoing review. As received, the
DoD EDQW will respond to questions
submitted through the Defense
Environmental Network Information
Exchange (DENIX) concerning the
interpretation of DoD QSM
requirements. DoD EDQW participants
will forward all questions through their
EDQW component principal to the DoD
EDQW chair.
(iii) Issuances. The DoD EDQW chair
will prepare DoD QSM updates:
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(A) Correspondence. The DoD EDQW
chair, in consultation with the EDQW
component principals, will prepare
correspondence (email or
memorandum) providing responses to
all written requests for clarification and
interpretation of the DoD QSM.
Depending on the significance of the
issue, as determined by the EDQW
chair, the response may also result in a
posting to the frequently asked question
(FAQ) section of the appropriate Web
sites.
(B) Errata sheets. Minor corrections to
the DoD QSM, such as typographical
errors, may be made by the issuance of
an errata sheet defining ‘‘pen and ink’’
changes that apply to the current
version of the DoD QSM. Following
concurrence by all EDQW component
principals, errata sheets will be issued
as needed by the DoD EDQW chair.
Errata will be corrected in the next
change or revision to the DoD QSM.
(C) Changes. Changes to the DoD QSM
will be issued as necessary to reflect
minor changes to requirements or
clarifications of existing requirements
that are necessary to ensure consistent
implementation. Following concurrence
by the EDQW component principals,
changes will be issued by the DoD
EDQW chair in the form of a complete
DoD QSM.
(1) The first change to DoD QSM
Version 4 will be numbered Version 4.1,
the second change will be Version 4.2,
etc.
(2) Changes to the DoD QSM will be
posted on DENIX in place of the
previous version or change of the DoD
QSM.
(D) Revisions. A revision will be
issued if one or more of the proposed
changes could reasonably be expected to
affect a laboratory’s ability to comply
with the requirement (i.e., the laboratory
is likely to have to make a change in its
quality system or technical procedures).
(1) Once EDQW component principals
have reached consensus on the
proposed revision, the DoD EDQW chair
will forward the proposed revision to all
participating DoD ELAP-accredited
laboratories and ABs for review.
(2) The DoD EDQW will review and
respond to comments received from the
DoD ELAP-accredited laboratories and
ABs within the designated comment
period.
(3) Following concurrence by the
EDQW component principals, revisions
will be issued by the DoD EDQW chair
in the form of a complete DoD QSM.
(4) A revision of Version 4 will be
issued as Version 5, a revision of
Version 5 will be issued as Version 6,
etc.
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(5) The final revised version of the
DoD QSM will be posted on DENIX in
place of the previous version including
any DoD QSM updates.
(3) Continual improvement. The DoD
EDQW will meet with the ABs on an
annual basis to review lessons learned
and identify additional opportunities for
continual improvement of the DoD
ELAP and the DoD QSM.
(4) Data and records management.
Through NAVSEASYSCOM, the DoD
EDQW will maintain all DoD QSM
updates in accordance with Secretary of
the Navy Manual M–5210.1,
‘‘Department of the Navy Records
Management Program: Records
Management Manual’’ (available at
https://doni.daps.dla.mil/
SECNAV%20Manuals1/5210.1.pdf).
(c) Recognizing ABs.—(1) General. (i)
The DoD EDQW will:
(A) Use the procedures in this
paragraph to evaluate and recognize
third-party ABs in support of the DoD
ELAP.
(B) Develop and maintain the
application for recognition, the
conditions and criteria for recognition
and related forms, and review submitted
AB applications for completeness and
compliance with DoD ELAP
requirements.
(ii) The DoD EDQW chair, following
consultation with and concurrence by
the EDQW component principals, grants
or revokes AB recognition in accordance
with this paragraph.
(2) Limitations. Candidate ABs must
be U.S.-based signatories in good
standing to the ILAC MRA. ABs must
maintain ILAC recognition to maintain
DoD ELAP recognition. Because the
EDQW continually monitors AB
performance, no pre-defined limits are
placed on the duration of recognition;
however, the EDQW may revoke
recognition at any time, for cause, in
accordance with paragraph (c)(3)(vii) of
this section.
(3) Procedures. (i) Upon receipt of an
application for recognition, the DoD
EDQW will review the application
package for completeness. A complete
application package must include:
(A) Application for recognition.
(B) Signed acceptance of the
conditions and criteria for DoD ELAP
recognition.
(C) Electronic copy of the AB’s quality
systems documentation.
(D) Copy of the most recent ILAC
MRA peer evaluation documentation.
(ii) If necessary to complete the
review, the DoD EDQW will request
additional documentation from the
applicant.
(iii) The EDQW component principals
will review the application package for
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compliance with requirements. Prior to
granting recognition, the EDQW
component principals must
unanimously concur that all application
requirements have been met.
(iv) Once the EDQW component
principals have completed review of the
application package, the DoD EDQW
chair will notify the AB, either granting
recognition or citing specific reasons for
not doing so (i.e., indicating which areas
of the application package are deficient).
(v) Once recognition has been granted,
the DoD EDQW chair will post the name
and contact information of the AB on
DENIX.
(vi) With unanimous concurrence, the
EDQW component principals may
revoke recognition if the AB:
(A) Violates any of the conditions or
criteria for recognition.
(B) Fails to operate in accordance
with its documented quality system.
(vii) Should it become necessary to
revoke an AB’s recognition, the DoD
EDQW chair will notify the AB stating
specific reasons for the revocation and
remove the AB’s name from the list of
DoD ELAP-recognized ABs.
(viii) If recognition is revoked, the AB
must immediately cease to perform all
DoD ELAP assessments.
(ix) ABs who have been denied
recognition, or ABs whose recognition
has been revoked, may appeal that
decision.
(A) Within 15 calendar days of its
receipt of a notice denying or revoking
recognition, the AB must submit to the
DoD EDQW chair a written statement
with supporting documentation
contesting the denial or revocation.
(B) The submission must demonstrate
that:
(1) Clear, factual errors were made by
the DoD EDQW during the review of the
AB’s application for recognition; or
(2) The decision to revoke recognition
was based on clear, factual errors, and
that the AB would have been
determined to meet all requirements for
recognition if those errors had been
corrected.
(x) The DoD EDQW will have up to
30 calendar days to review the appeal
and provide written notice to the AB
either accepting the appeal and
granting, or restoring, recognition, or
explaining the basis for denying the
appeal.
(4) Continual improvement. The DoD
EDQW will meet with ABs on an annual
basis to review lessons learned and
identify additional opportunities for
continual improvement of the DoD
ELAP. On a 5-year cycle, at minimum,
the DoD EDQW will evaluate whether
the process for evaluating and
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recognizing ABs is continuing to meet
DoD needs.
(5) Data and records management.
Through NAVSEASYSCOM, the DoD
EDQW, will maintain copies of all
application packages and associated
documentation in accordance with
Secretary of the Navy Manual M–
5210.1.
(d) Performing government
oversight—(1) General. DoD personnel
will use the procedures in this
paragraph to perform and document
government oversight of the DoD ELAP.
Government oversight will include
monitoring the performance of AB
assessors during laboratory assessments,
reviewing laboratory assessment reports,
observing ILAC MRA peer evaluations,
and evaluating AB Web sites for content
on accredited laboratories.
(2) Limitations. (i) DoD personnel
performing oversight must observe, but
must not participate in, laboratory
assessments or ILAC MRA peer
evaluations. Specifically, DoD personnel
must not:
(A) Offer specific advice to the
laboratory regarding the development or
implementation of quality systems or
technical procedures;
(B) Offer specific advice or direction
to assessors or peer evaluators regarding
accreditation processes, assessment
procedures, or documentation of
findings; or
(C) Impede assessors, peer reviewers,
or laboratory personnel in any way
during the performance of their work,
including technical procedures,
document reviews, observations,
interviews, and meetings.
(ii) If, during the course of an
assessment, questions by laboratory
personnel or assessors are directed to
DoD personnel, personnel must limit
responses to specific text from the DoD
QSM or published FAQs. DoD
personnel must not render opinions
regarding interpretation of the DoD
QSM. If there are questions about the
DoD QSM that require interpretation,
DoD personnel must advise the assessor
to contact the AB who may, if necessary,
contact the DoD EDQW chair for a
coordinated response.
(iii) If DoD personnel observe any
evidence of inappropriate practices on
the part of assessors or laboratory
personnel during the course of the
assessment, they must record the
observations and notify the DoD EDQW
chair immediately (inappropriate
practices are identified in the DoD
QSM). DoD personnel must not call
either the laboratory’s or the assessor’s
attention to the specific practice in
question.
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(3) Personnel qualifications. DoD
personnel or contractors performing
oversight must:
(i) Meet the government chemist or
contractor project chemist requirements
contained in the USD(AT&L)
Memorandum, ‘‘Acquisitions Involving
Environmental Sampling or Testing
Services.’’
(ii) Have a working knowledge of the
DoD QSM requirements and be familiar
with environmental test methods and
instrumentation.
(iii) Obey all laboratory instructions
regarding health and safety precautions
while in the laboratory.
(4) Procedures. (i) The DoD EDQW
will maintain an up-to-date calendar of
scheduled assessments and peer
evaluations based on input from the
ABs, peer evaluators, and assigned
oversight personnel.
(ii) Once an assessment or peer review
has been scheduled, the EDQW
component principals will determine if
DoD oversight of the activity will be
performed. The goal will be to observe
a representative number of activities for
each AB.
(iii) The EDQW component principals
will provide the DoD EDQW chair the
names of personnel from their
respective DoD Components who will
participate in the oversight.
(iv) The DoD EDQW chair will
provide the AB with contact
information for the oversight personnel.
(v) If two or more DoD personnel are
scheduled to monitor the assessment,
the DoD EDQW chair will designate a
lead that will be responsible for
compiling an oversight report.
(vi) The lead for the oversight activity
will request a copy of the assessment
plan from the AB’s lead assessor and
distribute it to other oversight
personnel.
(vii) The lead will review the
assessment plan to determine the scope
of accreditation and ensure that
oversight personnel are assigned to
monitor a cross-section of the
assessment.
(viii) Persons performing oversight
will review previous oversight reports,
if available, for the particular AB and
assessors performing the assessment.
(ix) Observing all health and safety
protective measures, oversight
personnel must accompany the
assessor(s) as they witness procedures
and conduct interviews, taking care not
to interfere with the assessment.
(5) Reporting. Within 15 calendar
days of the onsite assessment, the lead
for the oversight activity will complete
an oversight report and forward the
completed report through the
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81001
appropriate EDQW component principal
to the DoD EDQW chair.
(i) The DoD EDQW chair will provide
copies of the report to the EDQW
component principals for review.
(ii) After review by the EDQW
component principals, the DoD EDQW
chair will provide a summary of the
oversight report to the AB performing
the assessment.
(6) Handling disputes. Laboratories
must follow the AB’s dispute resolution
process for all disputes concerning the
assessment or accreditation of the
laboratory, including disagreements
involving an interpretation of the DoD
QSM arising during the accreditation
process.
(i) In the event the laboratory and the
AB are unable to resolve a disagreement
concerning the interpretation of the DoD
QSM, either the laboratory or the AB
may request the DoD EDQW provide an
interpretation of the DoD QSM. The
DoD EDQW chair will provide a written
response to the laboratory and the AB
providing the DoD authoritative
interpretation of the DoD QSM. No
review of this interpretation will be
available to the laboratory or the AB.
(ii) The DoD EDQW will not consider
or take a position on requests by either
a laboratory or an AB on a dispute
concerning accreditation of the
laboratory.
(7) Continual improvement. The DoD
EDQW will:
(i) Review the ABs’ assessment
reports and the DoD oversight reports to
evaluate the thoroughness, consistency,
objectivity, and impartiality of the DoD
ELAP assessments.
(ii) Compare assessment reports
across laboratories, ABs, and assessors.
(iii) Compare DoD ELAP findings to
findings from previous assessments.
(iv) Identify opportunities for
continual improvement of the DoD
ELAP.
(v) Meet with ABs on an annual basis
to review lessons learned and identify
additional opportunities for continual
improvement of the DoD ELAP.
(8) Data and records management.
Through NAVSEASYSCOM, the DoD
EDQW will maintain copies of all
oversight reports in accordance with
Secretary of the Navy Manual M–
5210.1.
(e) Conducting project-specific
laboratory approvals—(1) General. The
DoD EDQW will use the procedures in
this paragraph to conduct projectspecific laboratory approvals for specific
tests in the rare instances when DoD is
unable to identify a DoD ELAPaccredited laboratory capable of
providing the required services. This
will ensure that competent laboratories
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are used to support DoD environmental
projects. Examples of these rare
instances include:
(i) The required method, matrix, or
analyte is not included in the scope of
accreditation for any existing DoD
ELAP-accredited laboratories.
(ii) The required method, matrix, and
analyte combination is included in the
scope of accreditation for an existing
accredited laboratory; however, the
laboratory is unable to meet one or more
of the project-specific measurement
performance criteria.
(2) Limitations. (i) Project-specific
laboratory approvals are not to be used
as substitutes for the required DoD
ELAP-accreditation.
(ii) The DoD EDQW will not perform
project-specific laboratory approvals in
cases where one or more DoD ELAPaccredited laboratories capable of
meeting project-specific requirements
are available.
(iii) The project-specific laboratory
approval is a one-time approval, the
specific terms of which will be outlined
in the approval notice issued by the
DoD EDQW.
(3) Personnel qualifications. DoD
personnel and contractors assessing
laboratories for the purpose of
performing project-specific laboratory
approvals must meet the government
chemist or contractor project chemist
requirements contained in USD(AT&L)
Memorandum, ‘‘Acquisitions Involving
Environmental Sampling or Testing
Services.’’ Personnel must have a
working knowledge of the DoD QSM
requirements and be familiar with
required environmental test methods
and instrumentation.
(4) Procedures. (i) If a project-specific
laboratory approval is requested, the
DoD EDQW will request and review a
copy of the project’s quality assurance
project plan (QAPP).
(ii) If, after review of the QAPP, the
DoD EDQW determines that an existing
DoD ELAP-accredited laboratory is
available to provide the required
services, the laboratory contact
information will be provided to the
project manager requesting assistance.
(iii) If, after review of the QAPP, the
DoD EDQW determines that no existing
DoD ELAP-accredited laboratory is
available to provide the required
services, the DoD EDQW will:
(A) Work with the project team to
determine whether the use of alternative
procedures by an existing DoD ELAPaccredited laboratory is feasible;
(B) Determine if the required services
can be added to the scope of
accreditation of an existing DoD ELAPaccredited laboratory; or
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(C) Work with the project team to
identify a candidate laboratory for
project-specific laboratory approval.
(iv) If a project-specific approval is
needed, the DoD EDQW will:
(A) Determine the type of assessment
required (on-site, document review,
etc.).
(B) Determine if additional funding is
required to support the assessment. If
additional funding is required, the DoD
EDQW will provide a cost estimate and
work with the project manager to
establish funding.
(v) If the DoD EDQW determines that
a project-specific laboratory approval is
warranted and resources (including
funding and technical expertise) are
available to support the assessment, the
DoD EDQW chair will coordinate with
the EDQW component principals to
appoint an assessment team with
appropriate technical backgrounds.
(vi) The DoD EDQW chair will
designate an assessment team leader.
The assessment team leader will:
(A) Request the documentation
needed to perform the assessment.
(B) Assign responsibilities for
individual members of the assessment
team, if appropriate.
(C) Coordinate the document reviews.
(D) Lead the assessment team in the
performance of the on-site assessment, if
required.
(E) Provide a report to the DoD EDQW
chair. The report will identify whether:
(1) The laboratory is capable of
meeting all project-specific
requirements.
(2) Documentation procedures are in
place to provide data that are
scientifically valid, defensible, and
reproducible.
(3) Any deficiencies must be corrected
prior to granting the project-specific
laboratory approval.
(vii) The DoD EDQW chair, with
concurrence by the EDQW component
principals, will issue a report to the
project manager and laboratory detailing
the results of the assessment and any
deficiencies that must be corrected prior
to granting a project-specific laboratory
approval.
(viii) Upon receipt of the laboratory’s
corrective action response, if required,
the assessment team will:
(A) Review the laboratory’s corrective
action response for resolving the
deficiencies.
(B) Provide the EDQW component
principals with a final report describing
the resolution of findings and
containing recommendations on
whether to grant the project-specific
laboratory approval.
(ix) The DoD EDQW chair, with
concurrence by the EDQW component
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principals, will prepare a report for the
DoD project manager describing the
results of the assessment and the status
and terms of the project-specific
laboratory approval. Information about
project-specific laboratory approvals
will not be posted on Web sites listing
DoD ELAP-accredited laboratories.
(5) Continual improvement. The
EDQW component principals will
review project-specific laboratory
assessment reports to evaluate the
thoroughness, consistency, objectivity,
and impartiality of project-specific
assessments and make
recommendations for continual
improvement of the DoD QSM and the
DoD ELAP.
(6) Data and records management.
Through NAVSEASYSCOM, the DoD
EDQW will maintain copies of all
laboratory records and project-specific
assessment reports in accordance with
Secretary of the Navy Manual M–
5210.1.
(f) Handling complaints—(1) General.
The DoD EDQW will use the procedures
in this paragraph to handle complaints
concerning the processes established in
the DoD ELAP or the DoD QSM. The
DoD EDQW will document and resolve
complaints promptly through the
appropriate channels, consistently and
objectively, and identify and implement
any necessary corrective action arising
from complaints. Complaints generally
fall into one of four categories:
(i) Complaints by any party against an
accredited laboratory.
(ii) Complaints by any party against
an AB.
(iii) Complaints by any party
concerning any assessor acting on behalf
of the AB.
(iv) Complaints by any party against
the DoD ELAP itself.
(2) Limitations. The procedures in this
paragraph:
(i) Do not address appeals by
laboratories regarding accreditation
decisions by ABs. Appeals to decisions
made by ABs regarding the accreditation
status of any laboratory must be filed
directly with the AB in accordance with
agreements in place between the
laboratory and the AB.
(ii) Are not designed to handle
allegations of unethical or illegal actions
as described in paragraph (d)(2)(iii) of
this section.
(iii) Do not address complaints
involving contractual requirements
between a laboratory and its client. All
contracting issues must be resolved with
the contracting officer.
(3) Procedures. (i) All complaints
must be filed in writing to the EDQW
chair. All complaints must provide the
basis for the complaint (i.e., the specific
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process or requirement in the DoD ELAP
or the DoD QSM that has not been
satisfied or is believed to need
changing) and supporting
documentation, including descriptions
of attempts to resolve the complaint by
the laboratory or the AB.
(ii) Upon receipt of the complaint, the
DoD EDQW chair will assign a unique
identifier to the complaint, send a
notice of acknowledgement to the
complainant, and forward a copy of the
complaint to the EDQW component
principals.
(iii) In consultation with the EDQW
component principals, the DoD EDQW
chair will make a preliminary
determination of the validity of the
complaint. Following preliminary
review, the actions available to the DoD
EDQW chair include:
(A) If the DoD EDQW chair
determines the complaint should be
handled directly between the
complainant and the subject of the
complaint, the DoD EDQW will refer the
complaint to the laboratory, or AB, as
appropriate. The DoD EDQW will notify
the complainant of the referral, but will
take no further action with respect to
investigation of the complaint. The
subject of the complaint will be
expected to respond to the complainant
in accordance with their established
procedures and timelines. A copy of the
response will be provided to the DoD
EDQW.
(B) If insufficient information has
been provided to determine whether the
complaint has merit, the DoD EDQW
will return the complaint to the
complainant with a request for
additional supporting documentation.
(C) If the complaint appears to have
merit and the parties to the complaint
have been unable to resolve it, the DoD
EDQW will investigate the complaint
and recommend actions for its
resolution.
(D) If available information does not
support the complaint, the DoD EDQW
may reject the complaint.
(E) If the complaint alleges
inappropriate laboratory practices or
other misconduct, the DoD EDQW chair
will consult legal counsel to determine
the recommended course of action.
(iv) In all cases, the DoD EDQW will
notify the complainant and any other
entity involved in the complaint and
explain the response of the EDQW to the
complaint.
(4) Continual improvement. The DoD
EDQW will look into root causes and
trends in complaints to help identify
actions that should be taken by the DoD
EDQW, or any parties involved with
DoD ELAP, to prevent recurrence of
problems that led to the complaints.
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(5) Data and records management.
Through NAVSEASYSCOM, the DoD
EDQW will maintain copies of all
complaint documentation in accordance
with Secretary of the Navy Manual M–
5210.1.
Dated: November 14, 2016.
Aaron Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2016–27645 Filed 11–16–16; 8:45 am]
BILLING CODE 5001–06–P
DEPARTMENT OF HOMELAND
SECURITY
33 CFR Part 165
[Docket Number USCG–2016–0675]
RIN 1625–AA87
Security Zone; Potomac River and
Anacostia River, and Adjacent Waters;
Washington, DC
Coast Guard, DHS.
Final rule.
AGENCY:
The Coast Guard is
establishing a series of security zones in
the National Capital Region (NCR) on
specified waters of the Potomac River
and Anacostia River, and adjacent
waters during increased security events.
This action is necessary to prevent
terrorist acts and incidents immediately
before, during, and after events held
within the NCR, whenever such an
event exists, as determined by the
Captain of the Port Maryland-National
Capital Region. This rule prohibits
vessels and persons from entering the
security zone and requires vessels and
persons in the security zone to depart
the security zone, unless specifically
exempt under the provisions in this rule
or granted specific permission from the
Coast Guard Captain of the Port
Maryland-National Capital Region. The
regulations will enhance the safety and
security of persons and property within
the Nation’s Capital, while minimizing,
to the extent possible, the impact on
commerce and legitimate waterway use.
DATES: This rule is effective December
19, 2016.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2016–
0675 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
SUMMARY:
PO 00000
Frm 00015
If
you have questions on this rule, call or
email Mr. Ronald L. Houck, at Sector
Maryland-National Capital Region
Waterways Management Division, U.S.
Coast Guard; telephone 410–576–2674,
email Ronald.L.Houck@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background Information and
Regulatory History
Coast Guard
ACTION:
81003
Fmt 4700
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On September 2, 2016, the Coast
Guard published a notice of proposed
rulemaking (NPRM) titled ‘‘Security
Zone; Potomac River and Anacostia
River, and adjacent waters; Washington,
DC’’ in the Federal Register (81 FR
60663). There we stated why we issued
the NPRM, and invited comments on
our proposed regulatory action related
to this security zone. During the
comment period that ended November
1, 2016, we received no comments.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 33 U.S.C. 1231. The
COTP determined that it is necessary to
establish a series of security zones
within the NCR. The purpose of these
security zones is to ensure the safety of
vessels and the relevant navigable
waters before, during, and after the
event.
IV. Discussion of Comments, Changes,
and the Rule
As noted above, we received no
comments on our NPRM published on
September 2, 2016. There are no
changes in the regulatory text of this
rule from the proposed rule in the
NPRM.
This rule establishes a series of
security zones on specified waters of the
Potomac River, Anacostia River and
adjacent waters. The security zones
cover specified navigable waters within
the NCR whenever an event that
requires increased security is taking
place. The duration of the zone is
intended to ensure the safety of vessels
and these navigable waters before,
during, and after the event. No vessel or
person would be permitted to enter the
security zone without obtaining
permission from the COTP or a
designated representative. The COTP
Maryland-National Capital Region will
notify the maritime community, via
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[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Rules and Regulations]
[Pages 80996-81003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27645]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 188
[Docket ID: DOD-2013-OS-0230]
RIN 0790-AJ16
DoD Environmental Laboratory Accreditation Program (ELAP)
AGENCY: Under Secretary of Defense for Acquisition, Technology, and
Logistics, DoD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule establishes policy, assigns responsibilities,
and provides procedures to be used by DoD personnel for the operation
and management of the DoD ELAP. The DoD ELAP provides a unified DoD
program through which commercial environmental laboratories can
voluntarily demonstrate competency and document conformance to the
international quality systems standards as they are implemented by DoD.
[[Page 80997]]
DATES: This rule is effective on December 19, 2016.
FOR FURTHER INFORMATION CONTACT: Edmund Miller, 571-372-6904.
SUPPLEMENTARY INFORMATION: On October 15, 2015 (80 FR 61997-62003), the
Department of Defense published a proposed rule in the Federal Register
titled ``DoD Environmental Laboratory Accreditation Program (ELAP)''
for a 60-day public comment period. After the 60-day public comment
period had completed, no public comments were received. As a result, no
changes were made to the rule text.
Executive Summary
The purpose of this regulatory action is to document the procedures
for the operation and management of the DoD Environmental Laboratory
Accreditation Program (ELAP). The legal authority for the regulatory
action is Section 515, Treasury and General Government Appropriations
Act for Fiscal Year 2001 (Public Law 106-554), which directed the
Office of Management and Budget (OMB) to issue government-wide
guidelines that ``provide policy and procedural guidance to Federal
Agencies for ensuring and maximizing the quality, objectivity, utility,
and integrity of information (including statistical information)
disseminated by Federal Agencies.'' OMB guidelines, provided by FR
Volume 67, Number 36, page 8452 (February 22, 2002) required federal
agencies to maintain a basic standard of quality and take appropriate
steps to incorporate information quality criteria into DoD public
information dissemination practices. The guidance further provided that
DoD Components shall adopt standards of quality that are appropriate to
the nature and timeliness of the information they disseminate. The DoD
ELAP provides the standards for ensuring the quality, objectivity,
utility, and integrity of definitive environmental testing data
disseminated by DoD for the Defense Environmental Restoration Program
(DERP).
This rule includes a general overview of DoD ELAP and establishment
of standard operating procedures. It utilizes the baseline quality
systems requirements of The NELAC Institute (TNI) and ISO/IEC 17025
standards, but alone neither of these standards meet the testing and
analysis needs for DERP. Therefore the DoD Quality Systems Manual (QSM)
for environmental laboratories serves as the standard for DoD ELAP
accreditation. The QSM contains the minimum requirements DoD considers
essential to ensure the generation of definitive environmental data of
know quality, appropriate for their intended uses. These minimal needs
are not met by TNI or ISO 17025 standards alone. The DoD ELAP includes
procedures on how to evaluate and recognize 3rd party accreditation
bodies; perform and document government oversight of the DoD ELAP to
ensure ongoing compliance with program requirements and to identify
opportunities for continual improvement; conduct project-specific
laboratory approvals for specific tests not addressed in the DoD ELAP;
and handle specific complaints concerning the processes established by
the DoD ELAP or the QSM.
Past DoD laboratory assessment programs were specific to each DoD
Component and limited to available resources. This created an overlap
in assessments and fewer opportunities for laboratories to participate
on DoD contracts. This rule proposes to establish a program to allow
qualified laboratories to received third-party accreditation and become
eligible to provide environmental sampling and testing services for
DoD. It will be a voluntary program open to any qualified laboratories
wishing to participate, thereby promoting fair and open competition
among commercial laboratories.
Since laboratories fund their own participation in the
accreditation process, it will allow DoD to focus its resources on
providing oversight of laboratory contracts. By proposing to replace
separate DoD Component-specific laboratory approval programs, the DoD
ELAP will eliminate redundant assessments, promote interoperability
across the Department, streamline the process for DoD to identify and
procure competent providers of environmental laboratory services, and
provide more opportunities for commercial laboratories to participate
in DoD environmental sampling and testing contracts.
The scope of accreditation under ELAP includes specific laboratory
services such as the test methods used, type of material tested (soil,
water, etc.), and type of contaminants measured. The evaluation of a
test method also includes the use of internal laboratory standard
operating procedures.
Statement of Legal Authority: 15 U.S.C. 3701 promotes transfer and
utilization of science and technology resources of the Federal
government. Public Law 106-554 requires the Federal government to
ensure the quality and integrity of information disseminated by Federal
agencies. In response, the DoD ELAP sets forth requirements on
environmental laboratories conducting analytical testing for DoD to
generate documented quality data capable of being reproduced in
accordance with commonly accepted scientific standards and practices.
Regulatory Procedures
Executive Order 12866, ``Regulatory Planning and Review'' and Executive
Order 13563, ``Improving Regulation and Regulatory Review''
Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distribute impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action,'' because it does not: (1) Have an annual effect on
the economy of $100 million or more or adversely affect in a material
way the economy; a section of the economy; productivity; competition;
jobs; the environment; public health or safety; or State, local, or
tribal governments or communities; (2) create a serious inconsistency
or otherwise interfere with an action taken or planned by another
Agency; (3) materially alter the budgetary impact of entitlements,
grants, user fees, or loan programs, or the rights and obligations of
recipients thereof; or (4) raise novel legal or policy issues arising
out of legal mandates, the President's priorities, or the principles
set forth in these Executive Orders.
Sec. 202, Public Law 104-4, ``Unfunded Mandates Reform Act''
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Pub. L. 104-4) requires agencies assess anticipated costs and benefits
before issuing any rule whose mandates require spending in any 1 year
of $100 million in 1995 dollars, updated annually for inflation. In
2014, that threshold is approximately $141 million. This rule will not
mandate any requirements for State, local, or tribal governments, nor
will it affect private sector costs.
Public Law 96-354, ``Regulatory Flexibility Act'' (5 U.S.C. 601)
The Department of Defense does not expect this final rule would
have a significant economic impact on a substantial number of small
entities
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within the meaning of the Regulatory Flexibility Act (5 U.S.C. 601, et.
seq.). The rule establishes a policy to provide a unified DoD program
for commercial environmental laboratories to voluntarily demonstrate
competency and document conformance to the international quality system
standards already implemented by DoD. The Department's experience with
these laboratories indicates that the professional skill and technical
requirements of the accreditation program limits the numbers of
entities that are likely to be impacted by this rule to approximately
100 entities. Therefore, the Regulatory Flexibility Act, as amended,
does not require that DoD prepare a regulatory flexibility analysis.
Public Law 96-511, ``Paperwork Reduction Act'' (44 U.S.C. Chapter 35)
It has been certified that 32 CFR part 188 does not impose
reporting or recordkeeping requirements under the Paperwork Reduction
Act of 1995. The requirements in this rule do not require OMB approval
under the Paperwork Reduction Act as the information is collected by
the four accreditation bodies and not the Department. These
accreditation bodies accredit the laboratories to meet DoD standards
for environmental sampling and testing.
Executive Order 13132, ``Federalism''
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This rule will not have a substantial effect on State and
local governments.
List of Subjects in 32 CFR Part 188
Laboratories, Oversight.
0
Accordingly, 32 CFR part 188 is added to read as follows:
PART 188--DOD ENVIRONMENTAL LABORATORY ACCREDITATION PROGRAM (ELAP)
Sec.
188.1 Purpose.
188.2 Applicability.
188.3 Definitions.
188.4 Policy.
188.5 Responsibilities.
188.6 Procedures.
Authority: 15 U.S.C. 3701; Pub. L. 106-554, 114 Stat. 2763.
Sec. 188.1 Purpose.
This part implements policy, assigns responsibilities, and provides
procedures to be used by DoD personnel for the operation and management
of the DoD ELAP.
Sec. 188.2 Applicability.
This part applies to Office of the Secretary of Defense, the
Military Departments, the Office of the Chairman of the Joint Chiefs of
Staff and the Joint Staff, the Combatant Commands, the Office of the
Inspector General of the Department of Defense, the Defense Agencies,
the DoD Field Activities, and all other organizational entities within
the DoD (referred to collectively in this part as the ``DoD
Components'').
Sec. 188.3 Definitions.
Unless otherwise noted, these terms and their definitions are for
the purposes of this part.
Accreditation. Third-party attestation conveying formal
demonstration of a laboratory's competence to carry out specific tasks.
Accreditation body (AB). Authoritative organization that performs
accreditation.
Assessment. Process undertaken by an AB to evaluate the competence
of a laboratory, based on requirements contained in the DoD Quality
Systems Manual for Environmental Laboratories (QSM), for a defined
scope of accreditation.
Change. A reissuance of the DoD QSM containing minor changes to
requirements or clarifications of existing requirements necessary to
ensure consistent implementation.
Complaint. Defined in International Organization for
Standardization/International Electrotechnical Commission (ISO/IEC)
17025:2005, ``General Requirements for the Competence of Testing and
Calibration Laboratories'' (available for purchase at https://www.iso.org/iso/store.htm).
Contractor project chemist. Defined in Under Secretary of Defense
for Acquisition, Technology, and Logistics Memorandum, ``Acquisitions
Involving Environmental Sampling or Testing Services'' (available at
https://www.acq.osd.mil/dpap/dars/dfars/changenotice/2008/20080303/223.7.pdf).
Corrective action response. Description, prepared by the
laboratory, of specific actions to be taken to correct a deficiency and
prevent its reoccurrence.
Deficiency. An unauthorized deviation from requirements.
Definitive data. Defined in DoD Instruction 4715.15,
``Environmental Quality Systems'' (available at https://www.dtic.mil/whs/directives/corres/pdf/471515p.pdf).
Environmental Data Quality Workgroup (EDQW) component principal. A
voting member of the DoD EDQW.
Errata sheet. A document prepared by the EDQW and issued by the
EDQW chair, defining minor ``pen and ink'' changes that apply to the
most recently issued version of the DoD QSM. Errata will be corrected
in the next change or revision of the DoD QSM.
Government chemist. Defined in USD(AT&L) Memorandum, ``Acquisitions
Involving Environmental Sampling or Testing Services.''
Government oversight. The set of activities performed by or on
behalf of the DoD EDQW to provide assurance that ABs and assessors are
providing thorough, consistent, objective, and impartial assessments
within the specified scopes of accreditation and to identify
opportunities for continual improvement of the DoD QSM and DoD ELAP.
International Laboratory Accreditation Cooperation (ILAC) mutual
recognition arrangement (MRA). An arrangement through which ABs are
evaluated and accepted by their peers for conformance to ILAC rules and
procedures. To be accepted into the ILAC MRA, the AB must become a
signatory to its requirements; specifically, it must commit to maintain
conformance with the current version of Deputy Secretary of Defense
Memorandum, ``Ensuring Quality of Information Disseminated to the
Public by the Department of Defense'') and ensure that the laboratories
it accredits comply with ISO/IEC 17025:2005.
ILAC MRA peer evaluation. The process through which ABs are
assessed by other ABs and receive or maintain acceptance into the ILAC
MRA.
Project-specific laboratory approval. The set of activities
undertaken by the DoD EDQW to assess whether a laboratory is competent
to perform specific tests, in the case where no DoD-ELAP accredited
laboratory is able to perform the required tests.
Quality system. Defined in ISO/IEC 17025:2005.
Recognition. The acceptance of an AB by the EDQW based on its
demonstrated commitment to maintain signatory status in the ILAC MRA
and accept the DoD ELAP conditions and criteria for recognition.
Revision. A reissuance of the DoD QSM containing significant
changes in requirements or scope. A significant change is one that
could reasonably be expected to affect a laboratory's ability to comply
with the requirement (i.e., the laboratory is likely to have to make a
change in its quality system or technical
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procedures in order to maintain compliance).
Scope of accreditation. Specific laboratory services, stated in
terms of test method, matrix, and analyte, for which accreditation is
sought or has been granted.
Sec. 188.4 Policy.
It is DoD policy, in accordance with DoD Instruction 4715.15, to
implement the DoD ELAP for the collection of definitive data in support
of the Defense Environmental Restoration Program (DERP) at all DoD
operations, activities, and installations, including government-owned,
contractor-operated facilities and formerly used defense sites.
Sec. 188.5 Responsibilities.
(a) Secretaries of the Military Departments and Director, Defense
Logistics Agency (DLA). The Director, DLA, is under the authority,
direction, and control of the USD(AT&L), through the Assistant
Secretary of Defense for Logistics and Materiel Readiness. The
Secretaries of the Military Departments and Director, DLA:
(1) Provide resources to support project-specific government
oversight for the collection of definitive data in support of the DERP.
(2) Provide resources to support project-specific laboratory
approvals, if required.
(b) Secretary of the Navy. In addition to the responsibilities in
paragraph (a) of this section, the Secretary of the Navy plans,
programs, and budgets for DoD EDQW activities necessary to support
government oversight of the DoD ELAP.
Sec. 188.6 Procedures.
(a) DoD ELAP Overview--(1) Introduction. (i) DoD ELAP provides a
unified DoD program through which commercial environmental laboratories
can voluntarily demonstrate competency and document conformance to the
international standard established in ISO/IEC 17025:2005 as implemented
by the Deputy Under Secretary of Defense for Environmental Security
Memorandum, ``DoD Quality Systems Manual for Environmental
Laboratories'' (available at https://www.denix.osd.mil/edqw/upload/QSM-V4-2-Final-102510.pdf) (referred to in this part as the ``DoD Quality
Systems Manual for Environmental Laboratories (QSM)''). The DoD QSM
provides minimum quality systems requirements, based on ISO/IEC
17025:2005, for environmental laboratories performing testing for DoD.
(ii) DoD ELAP was developed in compliance with 15 U.S.C. 3701 (also
known as the ``National Technology Transfer and Advancement Act'').
Support and guidance was provided by the National Institute of
Standards and Technology, following procedures used to establish
similar programs for other areas of testing. The DoD ELAP supports
implementation of section 515 of Public Law 106-554, ``Treasury and
General Government Appropriations Act, 2001'' and Office of Management
and Budget Guidance, ``Guidelines for Ensuring and Maximizing the
Quality, Objectivity, Utility, and Integrity of Information
Disseminated by Federal Agencies'' (67 FR 8452) as implemented by
Deputy Secretary of Defense Memorandum, ``Ensuring Quality of
Information Disseminated to the Public by the Department of Defense.''
(iii) Using third party ABs operating in accordance with the
international standard ISO/IEC 17011:2004(E), ``Conformity Assessment--
General Requirements for Accreditation Bodies Accrediting Conformity
Assessment Bodies'' (available for purchase at https://www.iso.org/iso/store.htm), the DoD ELAP:
(A) Promotes interoperability among the DoD Components.
(B) Promotes fair and open competition among commercial
laboratories.
(C) Streamlines the process for identifying and procuring competent
providers of environmental laboratory services.
(D) Promotes the collection of data of known and documented
quality.
(2) Authority. Operation of the DoD ELAP is authorized by DoD
Instruction 4715.15.
(3) Program requirements. (i) Pursuant to DoD Instruction 4715.15,
laboratories seeking to perform testing in support of the DERP must be
accredited in accordance with DoD ELAP.
(ii) The DoD ELAP applies to:
(A) Environmental programs at DoD operations, activities, and
installations, including government-owned, contractor-operated
facilities and formerly used defense sites.
(B) Permanent, temporary, and mobile laboratories regardless of
their size, volume of business, or field of accreditation that generate
definitive data.
(iii) Participation in the program is voluntary and open to all
laboratories that operate under a quality system conforming to ISO/IEC
17025:2005 and Deputy Under Secretary of Defense for Environmental
Security Memorandum, ``DoD Quality Systems Manual for Environmental
Laboratories.'' Laboratories may seek accreditation for any method they
perform in accordance with documented procedures, including non-
standard methods. Laboratories are free to select any participating AB
for accreditation services.
(iv) To participate in DoD ELAP, ABs must be U.S.-based signatories
to the ILAC MRA and must operate in accordance with ISO/IEC
17011:2004(E).
(4) Program oversight. In accordance with Assistant Deputy Under
Secretary of Defense for Installations and Environment Memorandum,
``DoD Environmental Data Quality Workgroup Charter'' (available at
https://www.denix.osd.mil/edqw/upload/USA004743-10-Signed-Memo-to-DASs-DLA-DoD-Envir-Data-Quality-Workgroup-Charter-1Oct10-1.pdf), the DoD
EDQW:
(i) Provides coordinated responses to legislative and regulatory
initiatives.
(ii) Responds to requests for DoD Component information.
(iii) Develops and recommends department-wide policy related to
sampling, testing, and quality assurance for environmental programs.
(iv) Implements and provides oversight for the DoD ELAP.
(v) Includes technical experts from the Military Services and DLA
as well as an EDQW component principal (voting) member from each of the
Military Services.
(vi) Specifies the EDQW Navy principal, Director of Naval Sea
Systems Command (NAVSEASYSCOM) 04XQ(LABS), serve as EDQW chair.
(b) Maintaining the DoD QSM--(1) General. The DoD EDQW will
maintain and improve the DoD QSM to ensure that:
(i) The DoD QSM remains current in accordance with ISO/IEC
17025:2005.
(ii) Minimum essential requirements are met.
(iii) Requirements are clear, concise, and auditable.
(iv) The DoD QSM will efficiently and effectively support the DoD
ELAP.
(2) Procedures.-- (i) Annual review. At a minimum, the DoD EDQW
will perform an annual review of the DoD QSM, based on feedback
received from participants in DoD ELAP (e.g., DoD Components,
commercial laboratories, and ABs). The review will also address any
revisions to ISO/IEC 17025:2005.
(ii) Ongoing review. As received, the DoD EDQW will respond to
questions submitted through the Defense Environmental Network
Information Exchange (DENIX) concerning the interpretation of DoD QSM
requirements. DoD EDQW participants will forward all questions through
their EDQW component principal to the DoD EDQW chair.
(iii) Issuances. The DoD EDQW chair will prepare DoD QSM updates:
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(A) Correspondence. The DoD EDQW chair, in consultation with the
EDQW component principals, will prepare correspondence (email or
memorandum) providing responses to all written requests for
clarification and interpretation of the DoD QSM. Depending on the
significance of the issue, as determined by the EDQW chair, the
response may also result in a posting to the frequently asked question
(FAQ) section of the appropriate Web sites.
(B) Errata sheets. Minor corrections to the DoD QSM, such as
typographical errors, may be made by the issuance of an errata sheet
defining ``pen and ink'' changes that apply to the current version of
the DoD QSM. Following concurrence by all EDQW component principals,
errata sheets will be issued as needed by the DoD EDQW chair. Errata
will be corrected in the next change or revision to the DoD QSM.
(C) Changes. Changes to the DoD QSM will be issued as necessary to
reflect minor changes to requirements or clarifications of existing
requirements that are necessary to ensure consistent implementation.
Following concurrence by the EDQW component principals, changes will be
issued by the DoD EDQW chair in the form of a complete DoD QSM.
(1) The first change to DoD QSM Version 4 will be numbered Version
4.1, the second change will be Version 4.2, etc.
(2) Changes to the DoD QSM will be posted on DENIX in place of the
previous version or change of the DoD QSM.
(D) Revisions. A revision will be issued if one or more of the
proposed changes could reasonably be expected to affect a laboratory's
ability to comply with the requirement (i.e., the laboratory is likely
to have to make a change in its quality system or technical
procedures).
(1) Once EDQW component principals have reached consensus on the
proposed revision, the DoD EDQW chair will forward the proposed
revision to all participating DoD ELAP-accredited laboratories and ABs
for review.
(2) The DoD EDQW will review and respond to comments received from
the DoD ELAP-accredited laboratories and ABs within the designated
comment period.
(3) Following concurrence by the EDQW component principals,
revisions will be issued by the DoD EDQW chair in the form of a
complete DoD QSM.
(4) A revision of Version 4 will be issued as Version 5, a revision
of Version 5 will be issued as Version 6, etc.
(5) The final revised version of the DoD QSM will be posted on
DENIX in place of the previous version including any DoD QSM updates.
(3) Continual improvement. The DoD EDQW will meet with the ABs on
an annual basis to review lessons learned and identify additional
opportunities for continual improvement of the DoD ELAP and the DoD
QSM.
(4) Data and records management. Through NAVSEASYSCOM, the DoD EDQW
will maintain all DoD QSM updates in accordance with Secretary of the
Navy Manual M-5210.1, ``Department of the Navy Records Management
Program: Records Management Manual'' (available at https://doni.daps.dla.mil/SECNAV%20Manuals1/5210.1.pdf).
(c) Recognizing ABs.--(1) General. (i) The DoD EDQW will:
(A) Use the procedures in this paragraph to evaluate and recognize
third-party ABs in support of the DoD ELAP.
(B) Develop and maintain the application for recognition, the
conditions and criteria for recognition and related forms, and review
submitted AB applications for completeness and compliance with DoD ELAP
requirements.
(ii) The DoD EDQW chair, following consultation with and
concurrence by the EDQW component principals, grants or revokes AB
recognition in accordance with this paragraph.
(2) Limitations. Candidate ABs must be U.S.-based signatories in
good standing to the ILAC MRA. ABs must maintain ILAC recognition to
maintain DoD ELAP recognition. Because the EDQW continually monitors AB
performance, no pre-defined limits are placed on the duration of
recognition; however, the EDQW may revoke recognition at any time, for
cause, in accordance with paragraph (c)(3)(vii) of this section.
(3) Procedures. (i) Upon receipt of an application for recognition,
the DoD EDQW will review the application package for completeness. A
complete application package must include:
(A) Application for recognition.
(B) Signed acceptance of the conditions and criteria for DoD ELAP
recognition.
(C) Electronic copy of the AB's quality systems documentation.
(D) Copy of the most recent ILAC MRA peer evaluation documentation.
(ii) If necessary to complete the review, the DoD EDQW will request
additional documentation from the applicant.
(iii) The EDQW component principals will review the application
package for compliance with requirements. Prior to granting
recognition, the EDQW component principals must unanimously concur that
all application requirements have been met.
(iv) Once the EDQW component principals have completed review of
the application package, the DoD EDQW chair will notify the AB, either
granting recognition or citing specific reasons for not doing so (i.e.,
indicating which areas of the application package are deficient).
(v) Once recognition has been granted, the DoD EDQW chair will post
the name and contact information of the AB on DENIX.
(vi) With unanimous concurrence, the EDQW component principals may
revoke recognition if the AB:
(A) Violates any of the conditions or criteria for recognition.
(B) Fails to operate in accordance with its documented quality
system.
(vii) Should it become necessary to revoke an AB's recognition, the
DoD EDQW chair will notify the AB stating specific reasons for the
revocation and remove the AB's name from the list of DoD ELAP-
recognized ABs.
(viii) If recognition is revoked, the AB must immediately cease to
perform all DoD ELAP assessments.
(ix) ABs who have been denied recognition, or ABs whose recognition
has been revoked, may appeal that decision.
(A) Within 15 calendar days of its receipt of a notice denying or
revoking recognition, the AB must submit to the DoD EDQW chair a
written statement with supporting documentation contesting the denial
or revocation.
(B) The submission must demonstrate that:
(1) Clear, factual errors were made by the DoD EDQW during the
review of the AB's application for recognition; or
(2) The decision to revoke recognition was based on clear, factual
errors, and that the AB would have been determined to meet all
requirements for recognition if those errors had been corrected.
(x) The DoD EDQW will have up to 30 calendar days to review the
appeal and provide written notice to the AB either accepting the appeal
and granting, or restoring, recognition, or explaining the basis for
denying the appeal.
(4) Continual improvement. The DoD EDQW will meet with ABs on an
annual basis to review lessons learned and identify additional
opportunities for continual improvement of the DoD ELAP. On a 5-year
cycle, at minimum, the DoD EDQW will evaluate whether the process for
evaluating and
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recognizing ABs is continuing to meet DoD needs.
(5) Data and records management. Through NAVSEASYSCOM, the DoD
EDQW, will maintain copies of all application packages and associated
documentation in accordance with Secretary of the Navy Manual M-5210.1.
(d) Performing government oversight--(1) General. DoD personnel
will use the procedures in this paragraph to perform and document
government oversight of the DoD ELAP. Government oversight will include
monitoring the performance of AB assessors during laboratory
assessments, reviewing laboratory assessment reports, observing ILAC
MRA peer evaluations, and evaluating AB Web sites for content on
accredited laboratories.
(2) Limitations. (i) DoD personnel performing oversight must
observe, but must not participate in, laboratory assessments or ILAC
MRA peer evaluations. Specifically, DoD personnel must not:
(A) Offer specific advice to the laboratory regarding the
development or implementation of quality systems or technical
procedures;
(B) Offer specific advice or direction to assessors or peer
evaluators regarding accreditation processes, assessment procedures, or
documentation of findings; or
(C) Impede assessors, peer reviewers, or laboratory personnel in
any way during the performance of their work, including technical
procedures, document reviews, observations, interviews, and meetings.
(ii) If, during the course of an assessment, questions by
laboratory personnel or assessors are directed to DoD personnel,
personnel must limit responses to specific text from the DoD QSM or
published FAQs. DoD personnel must not render opinions regarding
interpretation of the DoD QSM. If there are questions about the DoD QSM
that require interpretation, DoD personnel must advise the assessor to
contact the AB who may, if necessary, contact the DoD EDQW chair for a
coordinated response.
(iii) If DoD personnel observe any evidence of inappropriate
practices on the part of assessors or laboratory personnel during the
course of the assessment, they must record the observations and notify
the DoD EDQW chair immediately (inappropriate practices are identified
in the DoD QSM). DoD personnel must not call either the laboratory's or
the assessor's attention to the specific practice in question.
(3) Personnel qualifications. DoD personnel or contractors
performing oversight must:
(i) Meet the government chemist or contractor project chemist
requirements contained in the USD(AT&L) Memorandum, ``Acquisitions
Involving Environmental Sampling or Testing Services.''
(ii) Have a working knowledge of the DoD QSM requirements and be
familiar with environmental test methods and instrumentation.
(iii) Obey all laboratory instructions regarding health and safety
precautions while in the laboratory.
(4) Procedures. (i) The DoD EDQW will maintain an up-to-date
calendar of scheduled assessments and peer evaluations based on input
from the ABs, peer evaluators, and assigned oversight personnel.
(ii) Once an assessment or peer review has been scheduled, the EDQW
component principals will determine if DoD oversight of the activity
will be performed. The goal will be to observe a representative number
of activities for each AB.
(iii) The EDQW component principals will provide the DoD EDQW chair
the names of personnel from their respective DoD Components who will
participate in the oversight.
(iv) The DoD EDQW chair will provide the AB with contact
information for the oversight personnel.
(v) If two or more DoD personnel are scheduled to monitor the
assessment, the DoD EDQW chair will designate a lead that will be
responsible for compiling an oversight report.
(vi) The lead for the oversight activity will request a copy of the
assessment plan from the AB's lead assessor and distribute it to other
oversight personnel.
(vii) The lead will review the assessment plan to determine the
scope of accreditation and ensure that oversight personnel are assigned
to monitor a cross-section of the assessment.
(viii) Persons performing oversight will review previous oversight
reports, if available, for the particular AB and assessors performing
the assessment.
(ix) Observing all health and safety protective measures, oversight
personnel must accompany the assessor(s) as they witness procedures and
conduct interviews, taking care not to interfere with the assessment.
(5) Reporting. Within 15 calendar days of the onsite assessment,
the lead for the oversight activity will complete an oversight report
and forward the completed report through the appropriate EDQW component
principal to the DoD EDQW chair.
(i) The DoD EDQW chair will provide copies of the report to the
EDQW component principals for review.
(ii) After review by the EDQW component principals, the DoD EDQW
chair will provide a summary of the oversight report to the AB
performing the assessment.
(6) Handling disputes. Laboratories must follow the AB's dispute
resolution process for all disputes concerning the assessment or
accreditation of the laboratory, including disagreements involving an
interpretation of the DoD QSM arising during the accreditation process.
(i) In the event the laboratory and the AB are unable to resolve a
disagreement concerning the interpretation of the DoD QSM, either the
laboratory or the AB may request the DoD EDQW provide an interpretation
of the DoD QSM. The DoD EDQW chair will provide a written response to
the laboratory and the AB providing the DoD authoritative
interpretation of the DoD QSM. No review of this interpretation will be
available to the laboratory or the AB.
(ii) The DoD EDQW will not consider or take a position on requests
by either a laboratory or an AB on a dispute concerning accreditation
of the laboratory.
(7) Continual improvement. The DoD EDQW will:
(i) Review the ABs' assessment reports and the DoD oversight
reports to evaluate the thoroughness, consistency, objectivity, and
impartiality of the DoD ELAP assessments.
(ii) Compare assessment reports across laboratories, ABs, and
assessors.
(iii) Compare DoD ELAP findings to findings from previous
assessments.
(iv) Identify opportunities for continual improvement of the DoD
ELAP.
(v) Meet with ABs on an annual basis to review lessons learned and
identify additional opportunities for continual improvement of the DoD
ELAP.
(8) Data and records management. Through NAVSEASYSCOM, the DoD EDQW
will maintain copies of all oversight reports in accordance with
Secretary of the Navy Manual M-5210.1.
(e) Conducting project-specific laboratory approvals--(1) General.
The DoD EDQW will use the procedures in this paragraph to conduct
project-specific laboratory approvals for specific tests in the rare
instances when DoD is unable to identify a DoD ELAP-accredited
laboratory capable of providing the required services. This will ensure
that competent laboratories
[[Page 81002]]
are used to support DoD environmental projects. Examples of these rare
instances include:
(i) The required method, matrix, or analyte is not included in the
scope of accreditation for any existing DoD ELAP-accredited
laboratories.
(ii) The required method, matrix, and analyte combination is
included in the scope of accreditation for an existing accredited
laboratory; however, the laboratory is unable to meet one or more of
the project-specific measurement performance criteria.
(2) Limitations. (i) Project-specific laboratory approvals are not
to be used as substitutes for the required DoD ELAP-accreditation.
(ii) The DoD EDQW will not perform project-specific laboratory
approvals in cases where one or more DoD ELAP-accredited laboratories
capable of meeting project-specific requirements are available.
(iii) The project-specific laboratory approval is a one-time
approval, the specific terms of which will be outlined in the approval
notice issued by the DoD EDQW.
(3) Personnel qualifications. DoD personnel and contractors
assessing laboratories for the purpose of performing project-specific
laboratory approvals must meet the government chemist or contractor
project chemist requirements contained in USD(AT&L) Memorandum,
``Acquisitions Involving Environmental Sampling or Testing Services.''
Personnel must have a working knowledge of the DoD QSM requirements and
be familiar with required environmental test methods and
instrumentation.
(4) Procedures. (i) If a project-specific laboratory approval is
requested, the DoD EDQW will request and review a copy of the project's
quality assurance project plan (QAPP).
(ii) If, after review of the QAPP, the DoD EDQW determines that an
existing DoD ELAP-accredited laboratory is available to provide the
required services, the laboratory contact information will be provided
to the project manager requesting assistance.
(iii) If, after review of the QAPP, the DoD EDQW determines that no
existing DoD ELAP-accredited laboratory is available to provide the
required services, the DoD EDQW will:
(A) Work with the project team to determine whether the use of
alternative procedures by an existing DoD ELAP-accredited laboratory is
feasible;
(B) Determine if the required services can be added to the scope of
accreditation of an existing DoD ELAP-accredited laboratory; or
(C) Work with the project team to identify a candidate laboratory
for project-specific laboratory approval.
(iv) If a project-specific approval is needed, the DoD EDQW will:
(A) Determine the type of assessment required (on-site, document
review, etc.).
(B) Determine if additional funding is required to support the
assessment. If additional funding is required, the DoD EDQW will
provide a cost estimate and work with the project manager to establish
funding.
(v) If the DoD EDQW determines that a project-specific laboratory
approval is warranted and resources (including funding and technical
expertise) are available to support the assessment, the DoD EDQW chair
will coordinate with the EDQW component principals to appoint an
assessment team with appropriate technical backgrounds.
(vi) The DoD EDQW chair will designate an assessment team leader.
The assessment team leader will:
(A) Request the documentation needed to perform the assessment.
(B) Assign responsibilities for individual members of the
assessment team, if appropriate.
(C) Coordinate the document reviews.
(D) Lead the assessment team in the performance of the on-site
assessment, if required.
(E) Provide a report to the DoD EDQW chair. The report will
identify whether:
(1) The laboratory is capable of meeting all project-specific
requirements.
(2) Documentation procedures are in place to provide data that are
scientifically valid, defensible, and reproducible.
(3) Any deficiencies must be corrected prior to granting the
project-specific laboratory approval.
(vii) The DoD EDQW chair, with concurrence by the EDQW component
principals, will issue a report to the project manager and laboratory
detailing the results of the assessment and any deficiencies that must
be corrected prior to granting a project-specific laboratory approval.
(viii) Upon receipt of the laboratory's corrective action response,
if required, the assessment team will:
(A) Review the laboratory's corrective action response for
resolving the deficiencies.
(B) Provide the EDQW component principals with a final report
describing the resolution of findings and containing recommendations on
whether to grant the project-specific laboratory approval.
(ix) The DoD EDQW chair, with concurrence by the EDQW component
principals, will prepare a report for the DoD project manager
describing the results of the assessment and the status and terms of
the project-specific laboratory approval. Information about project-
specific laboratory approvals will not be posted on Web sites listing
DoD ELAP-accredited laboratories.
(5) Continual improvement. The EDQW component principals will
review project-specific laboratory assessment reports to evaluate the
thoroughness, consistency, objectivity, and impartiality of project-
specific assessments and make recommendations for continual improvement
of the DoD QSM and the DoD ELAP.
(6) Data and records management. Through NAVSEASYSCOM, the DoD EDQW
will maintain copies of all laboratory records and project-specific
assessment reports in accordance with Secretary of the Navy Manual M-
5210.1.
(f) Handling complaints--(1) General. The DoD EDQW will use the
procedures in this paragraph to handle complaints concerning the
processes established in the DoD ELAP or the DoD QSM. The DoD EDQW will
document and resolve complaints promptly through the appropriate
channels, consistently and objectively, and identify and implement any
necessary corrective action arising from complaints. Complaints
generally fall into one of four categories:
(i) Complaints by any party against an accredited laboratory.
(ii) Complaints by any party against an AB.
(iii) Complaints by any party concerning any assessor acting on
behalf of the AB.
(iv) Complaints by any party against the DoD ELAP itself.
(2) Limitations. The procedures in this paragraph:
(i) Do not address appeals by laboratories regarding accreditation
decisions by ABs. Appeals to decisions made by ABs regarding the
accreditation status of any laboratory must be filed directly with the
AB in accordance with agreements in place between the laboratory and
the AB.
(ii) Are not designed to handle allegations of unethical or illegal
actions as described in paragraph (d)(2)(iii) of this section.
(iii) Do not address complaints involving contractual requirements
between a laboratory and its client. All contracting issues must be
resolved with the contracting officer.
(3) Procedures. (i) All complaints must be filed in writing to the
EDQW chair. All complaints must provide the basis for the complaint
(i.e., the specific
[[Page 81003]]
process or requirement in the DoD ELAP or the DoD QSM that has not been
satisfied or is believed to need changing) and supporting
documentation, including descriptions of attempts to resolve the
complaint by the laboratory or the AB.
(ii) Upon receipt of the complaint, the DoD EDQW chair will assign
a unique identifier to the complaint, send a notice of acknowledgement
to the complainant, and forward a copy of the complaint to the EDQW
component principals.
(iii) In consultation with the EDQW component principals, the DoD
EDQW chair will make a preliminary determination of the validity of the
complaint. Following preliminary review, the actions available to the
DoD EDQW chair include:
(A) If the DoD EDQW chair determines the complaint should be
handled directly between the complainant and the subject of the
complaint, the DoD EDQW will refer the complaint to the laboratory, or
AB, as appropriate. The DoD EDQW will notify the complainant of the
referral, but will take no further action with respect to investigation
of the complaint. The subject of the complaint will be expected to
respond to the complainant in accordance with their established
procedures and timelines. A copy of the response will be provided to
the DoD EDQW.
(B) If insufficient information has been provided to determine
whether the complaint has merit, the DoD EDQW will return the complaint
to the complainant with a request for additional supporting
documentation.
(C) If the complaint appears to have merit and the parties to the
complaint have been unable to resolve it, the DoD EDQW will investigate
the complaint and recommend actions for its resolution.
(D) If available information does not support the complaint, the
DoD EDQW may reject the complaint.
(E) If the complaint alleges inappropriate laboratory practices or
other misconduct, the DoD EDQW chair will consult legal counsel to
determine the recommended course of action.
(iv) In all cases, the DoD EDQW will notify the complainant and any
other entity involved in the complaint and explain the response of the
EDQW to the complaint.
(4) Continual improvement. The DoD EDQW will look into root causes
and trends in complaints to help identify actions that should be taken
by the DoD EDQW, or any parties involved with DoD ELAP, to prevent
recurrence of problems that led to the complaints.
(5) Data and records management. Through NAVSEASYSCOM, the DoD EDQW
will maintain copies of all complaint documentation in accordance with
Secretary of the Navy Manual M-5210.1.
Dated: November 14, 2016.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2016-27645 Filed 11-16-16; 8:45 am]
BILLING CODE 5001-06-P
