[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84576-84578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov. 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 
https://ibr.ansi.org/, 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 astm.org. 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 (https://www.epa.gov/lead/national-lead-laboratory-accreditation-program-nllap). 
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: 
https://www.epa.gov/lead/hazard-standards-and-clearance-levels-lead-paint-dust-and-soil-tsca-sections-402-and-403. 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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