Committee on Technical Barriers to Trade - Notification - United States - Laboratory quality system requirements

NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.

Notifying Member: UNITED STATES OF AMERICA

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible:

Environmental Protection Agency (EPA) [2097]

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov

3.

Notified under Article 2.9.2 [ ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], other [X]: The current LQSR guidance (LQSR 3.0), refers to a now outdated 2005 version of a laboratory quality standard, ISO/IEC Standard 17025: 2005 (E) "General requirements for the competence of testing and calibration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.

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Test and sampling method standards for lead-based paint program activities; Services (ICS code(s): 03.080); Quality (ICS code(s): 03.120); Test conditions and procedures in general (ICS code(s): 19.020); Paint ingredients (ICS code(s): 87.060)

5.

Title, number of pages and language(s) of the notified document: Proposed Revisions to the National Lead Laboratory Accreditation Program (NLLAP); Notice of Availability and Request for Comment; (3 page(s), in English)

6.

Description of content: Notice of Availability and Request for Comment by 15 December 2023 - 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 5 November 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.

7.

Objective and rationale, including the nature of urgent problems where applicable: Quality requirements

8.

Relevant documents:

88 Federal Register (FR) 78355, 15 November 2023:

https://www.govinfo.gov/content/pkg/FR-2023-11-15/html/2023-25141.htm

https://www.govinfo.gov/content/pkg/FR-2023-11-15/pdf/2023-25141.pdf

This notice is identified by Docket Number EPA-HQ-OPPT-2023-0456. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/EPA-HQ-OPPT-2023-0456/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders by 4pm Eastern Time on 15 December 2023 will be shared with the EPA and will also be submitted to the Docket on Regulations.gov if received within the comment period.

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Final date for comments: 15 December 2023

11.

Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:

https://members.wto.org/crnattachments/2023/TBT/USA/23_13494_00_e.pdf