Notice2024-24558
Final Revisions to the National Lead Laboratory Accreditation Program (NLLAP); Notice of Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 23, 2024
Effective
October 23, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is announcing the availability of the document titled "Laboratory Quality Standards for Recognition (LQSR 4.0)" under the National Lead Laboratory Accreditation Program (NLLAP), which is a revision to the EPA document titled "Laboratory Quality System Requirements (LQSR) Revision 3.0," dated November 5, 2007. The revised LQSR 4.0 updates and streamlines the guidance by referencing existing laboratory standards already in practice by NLLAP participating laboratories and directly related to laboratory lead analysis; and includes updates to the test and sampling method standards to better complement EPA's lead- based paint program activities.
Full Text
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<title>Federal Register, Volume 89 Issue 205 (Wednesday, October 23, 2024)</title>
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[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84576-84578]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-24558]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0456; FRL-11424-02-OCSPP]
Final Revisions to the National Lead Laboratory Accreditation
Program (NLLAP); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
announcing the availability of the document titled ``Laboratory Quality
Standards for Recognition (LQSR 4.0)'' under the National Lead
Laboratory Accreditation Program (NLLAP), which is a revision to the
EPA document titled ``Laboratory Quality System Requirements (LQSR)
Revision 3.0,'' dated November 5, 2007. The revised LQSR 4.0 updates
and streamlines the guidance by referencing existing laboratory
standards already in practice by NLLAP participating laboratories and
directly related to laboratory lead analysis; and includes updates to
the test and sampling method standards to better complement EPA's lead-
based paint program activities.
DATES: LQSR 4.0 is effective October 23, 2024. However, in order to be
recognized by the NLLAP, laboratories and accreditation organizations
that currently administer the NLLAP can comply with the standards of
LQSR 3.0 or LQSR 4.0 until December 22, 2025. After December 22, 2025,
all NLLAP-recognized organizations must implement and comply with the
standards of LQSR 4.0 in order to maintain participation in NLLAP.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2023-0456, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kathleen Ferry, Existing
Chemicals Risk Management Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460-0001; telephone number: (202) 564-2214; email
address: <a href="/cdn-cgi/l/email-protection#dfb9baadada6f1b4beabb7b3babab19fbaafbef1b8b0a9"><span class="__cf_email__" data-cfemail="5137342323287f3a3025393d34343f113421307f363e27">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#792d2a3a385431160d1510171c391c0918571e160f"><span class="__cf_email__" data-cfemail="47131404066a0f28332b2e29220722372669202831">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you perform or
may perform testing under the Agency's regulations regarding lead or
otherwise interact with such testing programs. Specifically, entities
potentially affected by these revisions are Fixed-Site, Mobile, and
Field Sampling and Measurement Organizations (FSMOs) that perform lead
testing. Analytical testing laboratories currently recognized by the
NLLAP and accreditation organizations that currently administer the
NLLAP or other organizations that might seek a Memorandum of
Understanding (MOU) with the Agency to become an accreditation
organization could be affected by these revisions. In addition,
certified inspectors, certified risk assessors, developers,
manufacturers, distributors of equipment and supplies used by FSMOs
testing lead might also be affected by these revisions; and EPA-
authorized state and tribal lead-based paint training and certification
programs may also be affected by these revisions.
Other entities potentially affected by changes to the NLLAP for
lead testing are the owners and managers of target housing and child-
occupied facilities, as well as realtors, lessees, and residents, who
ultimately pay for the testing services and stand to benefit by
obtaining lead test results quicker.
Since other entities may also be interested, the Agency has not
attempted to describe all of the specific entities that may be affected
by this notice. If you have any questions regarding the applicability
of this notice to a particular entity, consult the technical person
listed under FOR FURTHER INFORMATION CONTACT.
B. What action is the Agency taking?
EPA is finalizing the proposed revisions to the LQSR, now named
``Laboratory Quality Standards for Recognition'' (LQSR 4.0), with
certain changes prompted by public comments.
C. Reasonable Availability to the Public.
You may access the International Organization for Standardization
and International Electrochemical Commission (ISO/IEC) Standard 17025:
2017 (E) ``General requirements for the competence of testing and
calibration laboratories'' through the American National Standards
Institute (ANSI) Incorporation by Reference (IBR) reading room at
<a href="https://ibr.ansi.org/">https://ibr.ansi.org/</a>, as well as the American Society for Testing and
Materials (ASTM) standard E1583-21a ``Standard Practice for Evaluating
Laboratories Engaged in Determination of Lead in Paint, Dust, Airborne
Particulates, and Soil Taken from and Around Buildings and Related
Structures'' at <a href="http://astm.org">astm.org</a>. These standards were incorporated into the
LQSR 4.0 and referenced in this document.
II. Background
EPA is identified by Congress as the federal agency responsible for
establishing an accreditation program for laboratories participating in
the analysis of lead in paint, soil and dust samples as a part of a
national residential lead-based paint abatement
[[Page 84577]]
and control program. In response to this federal mandate, the Office of
Pollution Prevention and Toxics (OPPT) established the NLLAP which
recognizes laboratories that have demonstrated the ability to
accurately analyze for lead in paint, dust, and soil samples. EPA also
publishes the LQSR which sets the minimum lab standards under Toxic
Substances Control Act (TSCA) section 405(b) for laboratory analysis of
lead in paint films, soil, and dust.
There are two basic components to the NLLAP. The first component is
a laboratory proficiency testing program (the Environmental Laboratory
Proficiency Analytical Testing (ELPAT) Program) administered by the
American Industrial Hygiene Association (AIHA) in conjunction with
EPA's NLLAP. AIHA sends out ELPAT proficiency testing samples on a
quarterly basis (four test rounds per year). AIHA assimilates the test
results for each test round and evaluates the laboratories' performance
on a statistical basis. The second component of the NLLAP is a system
audit to be conducted by a laboratory accrediting organization
recognized by EPA. EPA currently recognizes the organizations as
accrediting organizations through a memorandum of agreement (<a href="https://www.epa.gov/lead/national-lead-laboratory-accreditation-program-nllap">https://www.epa.gov/lead/national-lead-laboratory-accreditation-program-nllap</a>).
Once a laboratory successfully meets the requirements of the ELPAT
Program and passes an NLLAP system audit, the laboratory is recognized
by EPA under the NLLAP.
In 1993, EPA issued its first version of the LQSR, which outlined
minimum requirements for NLLAP recognized laboratories. An organization
requesting NLLAP recognition shall be a laboratory capable of
performing sampling and/or lead testing. A laboratory shall have
distinct staffing, instrumentation, sampling, and test methods, as
appropriate, and depending upon the type, a laboratory may have
multiple physical facilities and may use field test kits. The last
revision of the LQSR was published in 2007, LQSR 3.0, to attain
recognition under the NLLAP as a lead-testing laboratory.
III. EPA Response to Public Comments
EPA requested comment on the revisions to LQSR 3.0 (88 FR 78355,
November 15, 2023 (FRL-11424-01-OCSPP)). A docket was created and used
to receive public comments on EPA's proposed revisions through December
15, 2023 (Docket Number EPA-HQ-OPPT-2023-0456). EPA received a total of
three comments, two from NLLAP accrediting bodies and one from an
individual. The two accrediting bodies commented (EPA-HQ-OPPT-2023-
0456-0006, EPA-HQ-OPPT-2023-0456-0005) in general support of EPA's
updates to the LQSR (i.e., LQSR 4.0), including the alignment to the
current version of ISO/IEC 17025 as well as the ASTM E1583-21a
Standard.
A. Reporting Limit Issue
One commenter (EPA-HQ-OPPT-2023-0456-0005) expressed concern over
the ``reporting limit issue'' created by the proposed dust-lead hazard
standard (88 FR 50444) and encouraged EPA to amend the LQSR to allow
laboratories to have reporting limits above their method detection
limit (MDL) without requiring the MDL multiplier. In addition, the
commenter (EPA-HQ-OPPT-2023-0456-0005) recommended that the amended
LQSR not require that the laboratories have a reporting limit of at
least half of the lowest regulatory level, stating this would be
interpreted to be 50% of zero. EPA disagrees that 50% of zero would
have been the reporting limit under the dust-lead proposal. As EPA
explained in its dust-lead proposed rule (88 FR 50444), if the rule
were to be finalized as proposed, the dust-lead clearance levels would
become the ``action level'' as described in LQSR 4.0, not the dust-lead
hazard standards which EPA had proposed to be ``any reportable level as
analyzed by a laboratory recognized by EPA's NLLAP''. Learn more about
EPA's efforts to lower the dust-lead hazard standards and post-
abatement dust-lead clearance levels under TSCA sections 402 and 403:
<a href="https://www.epa.gov/lead/hazard-standards-and-clearance-levels-lead-paint-dust-and-soil-tsca-sections-402-and-403">https://www.epa.gov/lead/hazard-standards-and-clearance-levels-lead-paint-dust-and-soil-tsca-sections-402-and-403</a>. However, in response to
concerns raised regarding the impacts of lower clearance levels and the
reporting limit on laboratories, EPA has modified LQSR 4.0's Section
5.3 Test and Sampling Methods so that NLLAP-recognized laboratories
that analyze dust wipe samples for lead must show that they can achieve
a quantitation limit ``equal to or less than . . . 80% of the lowest
action level (i.e., regulatory limit) for dust wipe samples''; this is
a shift from the draft LQSR 4.0 where it was 50%. To be clear, under
the current dust-lead regulations for floors (i.e., 10 micrograms per
square foot ([micro]g/ft\2\)), the quantitation limit under the final
LQSR 4.0 would be 8 [micro]g/ft\2\. For the two options for clearance
or action levels proposed in the dust-lead proposal, the corresponding
quantitation limit under the final LQSR 4.0 would be 4 [micro]g/ft\2\
(for an action level of 5 [micro]g/ft\2\ for floors) or 2.4 [micro]g/
ft\2\ (for an action level of 3 [micro]g/ft\2\ for floors) when the
compliance date arrives for any such updated value. EPA expects its
upcoming final dust-lead rule to also clarify this point upon
finalizing its reconsideration of the action levels. In addition, EPA
is finalizing in the LQSR 4.0 that the quantitation limit must be ``at
least 1.6 times but no greater than 10 times the method detection
limit,'' whereas EPA proposed ``at least 2 times but no greater than
10'' in the draft LQSR 4.0.
B. Effective Date
One commenter (EPA-HQ-OPPT-2023-0456-0005) disagreed with the
proposed effective date (i.e., one year after the publication of the
Federal Register notice) and stated that more time would be needed to
update Environmental Lead Laboratory Accreditation Program (ELLAP)
accreditation policies and train its site assessors on to how to
conduct assessments, especially using the new ASTM Standard. This
commenter (EPA-HQ-OPPT-2023-0456-0005) also cited resource concerns and
the need for adequate time to update technologies. First, EPA would
like to clarify that the one-year compliance date extension was
proposed for EPA's rulemaking titled, ``Reconsideration of the Dust-
Lead Hazard Standards and Dust-Lead Post-Abatement Clearance Levels''
(88 FR 50444, August 1, 2023 (FRL-8524-01-OCSPP)). Interested parties
should review EPA's docket for that rulemaking to learn more about the
compliance deadlines associated with that rulemaking (EPA-HQ-OPPT-2023-
0231).
EPA has considered the comments on both the draft LQSR 4.0 and the
proposed dust-lead rulemaking in impacting NLLAP laboratories, as well
as conducted outreach to obtain a better understanding of laboratories'
capability and capacity for dust wipe testing. For the final LQSR 4.0,
EPA is finalizing an effective date of 425 days after the date of
publication of the document announcing the final LQSR 4.0 in the
Federal Register. This effective date is intended to provide a
reasonable amount of time for NLLAP-recognized laboratories to take
actions to meet the standards in the final LQSR 4 so they can continue
providing dust wipe testing services to the regulated community without
any significant disruption in service. In the meantime, in order to be
recognized by the NLLAP, laboratories and accreditation organizations
that currently administer the NLLAP may comply with the standards of
LQSR 3.0 or LQSR 4.0.
[[Page 84578]]
C. Sampling Criteria
One accrediting body (EPA-HQ-OPPT-2023-0456-0006) suggested that
the EPA consider adopting the criteria for Field Sampling and
Measurement Organizations (FSMOs) and the oversight of FSMOs from the
NELAC Institute (TNI) Field Sampling and Measurement Organization
Sector ``Volume 1 General Requirements for Field Sampling and
Measurement Organizations'' and ``Volume 2 General Requirements for
Accreditation Bodies Accrediting Field Sampling and Measurement
Organizations'' as a way to reduce uncertainty of results due to the
quality of the samples. EPA accepted this suggestion by adding a
recommended reference to NELAC Institute (TNI) Field Sampling and
Measurement Organization Standards ``Volume 1: General Requirements for
Field Sampling and Measurement Organizations''. EPA did not include
reference to ``Volume 2: General Requirements for Accreditation Bodies
Accrediting Field Sampling and Measurement Organizations'' because EPA
determined that volume was out of scope for the LQSR 4.0 due to its
focus on accreditation bodies instead of laboratories.
In reference to clearance testing on floors (as discussed in 40 CFR
745.227(e)), one commenter (EPA-HQ-OPPT-2023-0456-0003) recommended
compositing of four wipe samples from each floor to assure that
clearance failure, if present, is determined. The commenter stated that
clearance should be performed in conformance with Practices E2271/
E2271M and E3074/E3074M with method quantitation limits (MQLs)
determined for the resulting composited wipe samples. While HUD and EPA
regulations allow composite sampling, HUD's ``Guidelines for the
Evaluation and Control of Lead-Based Paint Hazards in Housing''
generally do not encourage composite sampling and most laboratories
discourage their clients from submitting composite dust-wipe samples.
EPA is not finalizing amendments to the LQSR 4.0 which would compel
risk assessors to take composite samples, including how either single
surface or composite samples are collected, analyzed, or interpreted.
This same commenter (EPA-HQ-OPPT-2023-0456-0003) requested EPA modify
the Glossary term for ``Composite sample'' from ``A sample composed as
a result of collection of more than one sample of the same medium
(e.g., dust) from the same type of surface (e.g., floor, interior
window sill, or window trough) so that multiple samples can be analyzed
as a single sample'' to ``the single sample resulting from the
combination of individual samples collected from different sections of
the same area.'' For reasons previously mentioned, EPA is not
finalizing this recommended change.
This same commenter (EPA-HQ-OPPT-2023-0456-0003) provided edits to
section 5.6.1.4 Sample Custody Procedures of the draft LQSR 4.0, which
would change the chain of custody protocols from ``strongly
recommended'' to ``must conform to ASTM D4840,'' stating handling needs
to be ``beyond doubt.'' EPA reviewed ASTM D4840 and has adapted
language from it to modify this section to state that chain of custody
protocols shall ``provide sufficient assurances, both legal and
technical, that assertions made about a sample and its measurable
characteristics can be supported to an acceptable level of certainty.''
Lastly, two commenters (EPA-HQ-OPPT-2023-0456-0003, EPA-HQ-OPPT-
2023-0456-0005) suggested EPA define ELPAT as ``ELPAT: Environmental
Lead Proficiency Analytical Testing (ELPAT) Program operated by AIHA
Proficiency Analytical Testing Programs (AIHA PATP).'' Successful
participation in this proficiency testing program on a quarterly basis
is required for all laboratories recognized by EPA in the NLLAP.'' EPA
accepted this suggested edit.
D. Referencing Standards
The National Technology Transfer and Advancement Act (NTTAA)
requires federal agencies to use technical standards already developed
or adopted by voluntary consensus standards bodies if compliance would
not be inconsistent with applicable law or otherwise impracticable. The
current LQSR guidance (LQSR 3.0), refers to a now outdated 2005 version
of a laboratory quality standard, International Organization for
Standardization and International Electrochemical Commission (ISO/IEC)
Standard 17025: 2005 (E) ''General requirements for the competence of
testing and calibration laboratories''. In addition, there are other
laboratory standards in LQSR 3.0 that are already in practice by NLLAP
participating laboratories and directly related to laboratory lead
analysis, making parts of the elements in LQSR 3.0 duplicative.
Therefore, EPA proposed to streamline the LQSR by conforming and
referencing the updated ISO 17025: 2017 (E) and ASTM E1583-21a. OPPT
has reviewed the updated laboratory standards and identified any gaps
or areas where additional clarification or criteria are needed between
ISO 17025: 2017 and ASTM E1583-21a and the proposed LQSR 4.0. These
additional clarifications or criteria are included throughout the
proposed draft.
One commenter (EPA-HQ-OPPT-2023-0456-0003) suggested that LQSR 4.0
simply state the requirement that the laboratory be accredited as
conforming to ISO/IEC 17025 and ASTM E1583 as the main prerequisite to
recognition. The commenter notes that EPA refers to the standards as
``ISO/IEC 17025:2017(E)'' and recommends instead ``ISO/IEC 17025'' for
simplicity's sake. Similarly, the reference to the current ASTM
Standard may show the fact that it is an ASTM Standard (i.e., ASTM
E1583) or, if previously discussed, show as the alpha-numeric
designator of the Standard (i.e., E1583). EPA thanks the commenter for
their suggestions and has made these edits in the final LQSR 4.0.
This commenter (EPA-HQ-OPPT-2023-0456-0003) also provided a number
of editorial comments to alleviate confusion over which sections of the
standards do not or may not apply. The commenter (EPA-HQ-OPPT-2023-
0456-0003) recommended that EPA remove references to specific sections
of ISO/IEC 17025 or ASTM E1583 stating that both ISO/IEC 17025 and
E1583 are normative references, and both require conformance, and that
further citation to specific sections could falsely seem to suggest
that other sections of the standards do not or may not apply. EPA
accepted those edits throughout the final LQSR 4.0. The commenter (EPA-
HQ-OPPT-2023-0456-0003) also provided a number of other relevant
standards for EPA to consider for future actions. EPA appreciates the
references and will consider these in future actions affecting NLLAP
laboratories.
Authority: 15 U.S.C. 2601 et seq.
Dated: October 18, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-24558 Filed 10-22-24; 8:45 am]
BILLING CODE 6560-50-P
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