[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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