Systematic Review Protocol for the PFAS IRIS Assessments (2021)

Notice

EPA released an update to the Systematic Review Protocol for the PFBA, PFHxA, PFHxS, PFNA, and PFDA IRIS Assessments in response to public comments. The IRIS Program is using the updated systematic review protocol to develop five separate PFAS IRIS assessments.

Abstract

The protocol presents the methods for conducting the systematic reviews and dose-response analyses for development of a draft IRIS assessment for five per- and polyfluoroalkyl substances (PFAS) assessments including: perfluorodecanoic acid (PFDA; CASRN 335-76-2), perfluorononanoic acid (PFNA; CASRN 375-24-4), perfluorohexanoic acid (PFHxA, CASRN 307-24-4), perfluorohexanesulfonic acid (PFHxS, CASRN 355-46-4), and perfluorobutanoic acid (PFBA, CASRN 375 22 4), and their related salts which are all members of the group per and polyfluoroalkyl substances (PFAS). These five toxicity assessments are being developed according to the scope and methods outlined in this protocol built upon several other PFAS assessments that have already been developed by the EPA. It includes a summary of why these specific PFAS were prioritized for evaluation, description of the objectives and specific aims of the assessments, draft PECO (Populations, Exposures, Comparators, and Outcomes) criteria, and identification of key areas of scientific complexity.

Impact/Purpose

This document presents a draft assessment plan for 5 PFAS assessments that will be the subject of an SAB/Chemical Assessment Advisory Committee meeting in the Fall of 2019 and that will define the scope and approach of the IRIS assessment for these chemicals.

Status

Concluding the public comment period, the IRIS Program will use the comments received and the methods outlined in the protocol for conducting the systematic review to develop 5 individual PFAS IRIS draft assessments.


Citation

U.S. EPA. Systematic Review Protocol for the PFAS IRIS Assessments (2021). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-19/050, 2019.

History/Chronology

Date Description
03-Nov 2019EPA released the Systematic Review Protocol for the PFAS IRIS Assessments (Preliminary Assessment Materials). [Federal Register Notice Nov 8, 2019]
04-Jul 2020EPA released an update to the Systematic Review Protocol for the PFBA, PFHxA, PFHxS, PFNA, and PFDA IRIS Assessments in response to public comments.
05-Oct 2020EPA released an update to the Systematic Review Protocol for the PFBA, PFHxA, PFHxS, PFNA, and PFDA IRIS Assessments.
06-Jan 2021EPA released an update to the Systematic Review Protocol for the PFBA, PFHxA, PFHxS, PFNA, and PFDA IRIS Assessments.

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.


Docket

Comments on the assessment may be submitted and reviewed using the Docket ID EPA-HQ-ORD-2019-0275