US EPA

In November 2019, EPA released the Systematic Review Protocol for the PFBA, PFHxA, PFHxS, PFNA, and PFDA IRIS Assessments for a 45-day public comment period. As part of developing a draft IRIS assessment, EPA presents a methods document, referred to as the protocol, for conducting a chemical-specific systematic review of the available scientific literature. Protocols include strategies for literature searches, criteria for study inclusion or exclusion, considerations for evaluating study methods, information management for extracting data, approaches for synthesis within and across lines of evidence, and methods for derivation of toxicity values.

U.S. EPA. Systematic Review Protocol for the Perfluorononanoic Acid (PFNA) IRIS Assessment (Preliminary Assessment Materials). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-19/050, 2019.

This protocol includes strategies for literature searches, criteria for study inclusion or exclusion, considerations for evaluating study methods, information management for extracting data, approaches for synthesis within and across lines of evidence, and methods for derivation of toxicity values.

The IRIS Program posts assessment protocols and protocol updates publicly on a chemical’s HERO project page, the IRIS website, and in systematic review repositories such as Zenodo (https://zenodo.org/record/2654896#.XMsScOhKjcs).

Date	Description
01-Nov 2019	EPA released the Systematic Review Protocol for the PFAS IRIS Assessment (Preliminary Assessment Materials). [Federal Register Notice Nov 8, 2019]

The IRIS Program will use the methods for conducting the systematic review as described in the protocol to develop the draft assessment.

This download(s) is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy.

• An Update to the Systematic Review Protocol for the Pfba, Pfhxa, Pfhxs, PFNA, and Pfda IRIS Assessments (Jan 2021) (PDF)  (208 pp, 3 MB, about PDF)

If you have a disability and the format of any material on our web pages interferes with your ability to access the information, please reach out to us using the Contact us about IRIS form for assistance. To enable us to respond in a manner most helpful to you, please indicate the nature of the accessibility problem, the web address of the requested material, your preferred format in which you want to receive the material (electronic format (ASCII, etc.), standard print, large print, etc.), and your contact information.

• An Update to the Systematic Review Protocol for the Pfba, Pfhxa, Pfhxs, PFNA, and Pfda IRIS Assessments (Oct 2020) (PDF)  (203 pp, 3 MB, about PDF)
• Errata Sheet Pertaining to the July 2020 Update to the Systematic Review Protocol for the Pfba, Pfhxa, Pfhxs, PFNA, and Pfda IRIS Assessments (Sep 2020) (PDF)  (1 pp, 108 KB, about PDF)
• An Update to the Systematic Review Protocol for the Pfba, Pfhxa, Pfhxs, PFNA, and Pfda IRIS Assessments (July 2020) (PDF)  (203 pp, 3 MB, about PDF)
• Systematic Review Protocol for the Pfba, Pfhxa, Pfhxs, PFNA, and Pfda IRIS Assessments (Oct 2019) (PDF)  (197 pp, 3 MB, about PDF)
• EPA-HQ-ORD-2019-0275
• Systematic Review Protocol for the PFAS IRIS Assessments (2021)

• Primary Literature Search References Sorted By Author (PFNA)

• FR Notice: Nov 8, 2019