Final Revisions to the National Lead Laboratory Accreditation Program (NLLAP); Notice of Availability

<NOTICE> ENVIRONMENTAL PROTECTION AGENCY <DEPDOC>[EPA-HQ-OPPT-2023-0456; FRL-11424-02-OCSPP]</DEPDOC> <SUBJECT>Final Revisions to the National Lead Laboratory Accreditation Program (NLLAP); Notice of Availability</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> 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. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2023-0456, is available online at <E T="03">https://www.regulations.gov.</E> Additional information about dockets generally, along with instructions for visiting the docket in-person, is available at <E T="03">https://www.epa.gov/</E> dockets. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">For technical information contact:</E> 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: <E T="03">ferry.kathleen@epa.gov.</E> <E T="03">For general information contact:</E> The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: <E T="03">TSCA-Hotline@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. General Information</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> 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 <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <HD SOURCE="HD2">B. What action is the Agency taking?</HD> 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. <HD SOURCE="HD2">C. Reasonable Availability to the Public.</HD> 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 <E T="03">https://ibr.ansi.org/,</E> 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. <HD SOURCE="HD1">II. Background</HD> 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 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 ( <E T="03">https://www.epa.gov/lead/national-lead-laboratory-accreditation-program-nllap</E> ). 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. <HD SOURCE="HD1">III. EPA Response to Public Comments</HD> 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 ( <E T="03">i.e.,</E> LQSR 4.0), including the alignment to the current version of ISO/IEC 17025 as well as the ASTM E1583-21a Standard. <HD SOURCE="HD2">A. Reporting Limit Issue</HD> 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: <E T="03">https://www.epa.gov/lead/hazard-standards-and-clearance-levels-lead-paint-dust-and-soil-tsca-sections-402-and-403.</E> 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 Metho ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 20k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━