Systematic Review Protocol for the Perfluorobutanoic Acid (PFBA) and Related Compound Ammonium Perfluorobutanoic Acid IRIS Assessment (Preliminary Assessment Materials, 2019)

Abstract

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.
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).

Impact/Purpose

This document presents a draft assessment plan for the PFAB assessment 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

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

Citation

U.S. EPA. Systematic Review Protocol for the Perfluorobutanoic Acid (PFBA) and Related Compound Ammonium Perfluorobutanoic Acid IRIS Assessment (Preliminary Assessment Materials, 2019). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-19/050, 2019.

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]
02- Jul 2020	EPA released an update to the Systematic Review Protocol for the PFBA, PFHxA, PFHxS, PFNA, and PFDA IRIS Assessments in response to public comments.

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, 3.3 MB, about PDF)

Related Link(s)

• An Update to the Systematic Review Protocol for the PFBA, PFHxA, PFHxS, PFNA, and PFDA IRIS Assessments (Oct 2020) (PDF)  (203  pp, 3.2 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, 105.5 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, 2.9 MB, about PDF)
• Systematic Review Protocol for the PFBA, PFHxA, PFHxS, PFNA, and PFDA IRIS Assessments (Oct 2019) (PDF)  (197  pp, 2.9 MB, about PDF)
• Systematic Review Protocol for the PFAS IRIS Assessments (2021)
• Toxicological Review of Perfluorobutanoic Acid and Related Compound Ammonium Perfluorobutanoic Acid (PFBA) (Interagency Science Consultation Draft, 2020)
• IRIS Toxicological Review of Perfluorobutanoic Acid (PFBA) and Related Salts (Public Comment and External Review Draft, 2021)

HERO Project

• Primary Literature Search References Sorted By Author (PFBA)

Docket

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