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

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 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 (µg/ft² )), the quantitation limit under the final LQSR 4.0 would be 8 µg/ft² . 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 µg/ft² (for an action level of 5 µg/ft² for floors) or 2.4 µg/ft² (for an action level of 3 µg/ft² 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.

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.

[FR Doc. 2024-24558 Filed 10-22-24; 8:45 am]

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