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

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 564–8833; email address: drewes.scott@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; email address: TSCA-Hotline@epa.gov.

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 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.