[Federal Register Volume 88, Number 219 (Wednesday, November 15, 2023)]
[Notices]
[Pages 78355-78357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25141]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2023-0456; FRL-11424-01-OCSPP]


Proposed Revisions to the National Lead Laboratory Accreditation 
Program (NLLAP); Notice of Availability and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and soliciting comment on proposed revisions to EPA's 
document titled ``Laboratory Quality System Requirements (LQSR) 
Revision 3.0'' dated November 5, 2007, under the National Lead 
Laboratory Accreditation Program (NLLAP). Proposed revisions reflected 
in the draft document titled, ``Laboratory Quality Standards for 
Recognition'' (LQSR 4.0),'' are intended to update and streamline the 
guidance by referencing existing laboratory standards already in 
practice by NLLAP participating laboratories and directly related to 
laboratory lead analysis, and to update the test and sampling method 
standards to better complement EPA's lead-based paint program 
activities.

DATES: Comments must be received on or before December 15, 2023.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2023-0456, through the Federal eRulemaking 
Portal at https://www.regulations.gov. Follow the online instructions 
for submitting comments. Do not submit electronically any information 
you consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Additional 
instructions on commenting and visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Scott Drewes, Existing Chemicals 
Risk Management Division, Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200

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Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-8833; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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 today's 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. 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 ANSI IBR reading room at 
https://ibr/ansi.org as well as the American Society for Testing and 
Materials (ASTM) standard E1583-17 ``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 https://astm-y.sharepoint.com/:w:/g/personal/mpezzella_astm_org/EVDPKoFENotKmA_Cx20yyZoB8A2L-Uh8ou1nfIEGZoHfgA?rtime=sxRRGVaB20g. These standards were incorporated 
into the LQSR 4.0 and referenced in this document.

C. What should I consider as I prepare my comments for EPA?

1. Submitting CBI
    Do not submit CBI to EPA through https://www.regulations.gov or 
email. If you wish to include CBI in your comment, please follow the 
applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that 
you claim to be CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2.
2. Tips for Preparing Your Comments
    When preparing and submitting your comments, see the commenting 
tips at https://www.epa.gov/dockets/comments.html.

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 and control program. In 
response to this federal mandate, the Office of Pollution Prevention 
and Toxics (OPPT) established the NLLAP which recognizes laboratories 
which 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 systems 
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. Currently, an 
organization must meet the requirements listed in the third version of 
the LSQR, also referred to as LQSR 3.0, to attain recognition under the 
NLLAP as a lead-testing laboratory. The last revision of the LQSR was 
published in 2007 and EPA is now proposing to revise and rename it to 
``Laboratory Quality Standards for Recognition'' (LQSR 4.0).

III. Proposed Revisions

    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, 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 is 
proposing to

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streamline the LQSR by conforming and referencing the updated ISO 
17025: 2017 (E) and ASTM E1583-17. 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 
E1583-17 and the proposed LQSR 4.0. These additional clarifications or 
criteria are included throughout the proposed draft.
    EPA is also proposing updates in LQSR 4.0 which are needed to 
support EPA's implementation of EPA's lead-based paint program, 
specifically the activities under 40 CFR part 745 which are being 
reconsidered in a separate action 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). For 
example, EPA is proposing in this action to clarify that the laboratory 
must demonstrate that the test and/or sampling methods used can achieve 
a quantitation limit equal to or less than 50% of the lowest action 
level for dust wipe samples for the relevant surface area (e.g., 
windowsills, floors). EPA is requesting comment on the impact of the 
proposed revision as it relates to laboratory capabilities to meet the 
proposed lower regulatory limits. 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.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: November 8, 2023.
Denise Keehner,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2023-25141 Filed 11-14-23; 8:45 am]
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