Protocol for the Naphthalene IRIS Assessment (Preliminary Assessment Materials)
On this page:
Alert
Notice
EPA announced the release of the Protocol for the Naphthalene IRIS Assessment for a 30-day public comment period as announced in a March 17, 2023 Federal Register Notice. The deadline for comments is April 17, 2023.
Abstract
In March 2023, EPA released the Protocol for the Naphthalene IRIS Assessment (Preliminary Assessment Materials) for a 30-day public review and comment period. As part of developing a draft IRIS assessment, EPA presents a protocol that describes the methodology for how the assessment will be conducted, including systematic review and dose-response. These could 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.Naphthalene is a white crystalline solid with an aromatic odor. Naphthalene is naturally occurring and is most abundantly found in coal, tar, and petroleum. Naphthalene is mainly used in the manufacture of dyes, surfactants, leather tanning reagents, dispersants, pesticides, resins, solvents, and chemical intermediates. Major consumer products containing naphthalene include moth repellents, in the form of mothballs or crystals, and toilet deodorant blocks. Naphthalene is used as a fragrance in non-food use pesticide products, while naphthalene derivatives are also used as inert ingredients in non-food use pesticide products regulated by EPA. Lastly, naphthalene is a constituent of tobacco smoke.
Impact/Purpose
Not provided.Status
The IRIS Program will use the protocol to develop the draft assessment.Citation
U.S. EPA. Protocol for the Naphthalene IRIS Assessment (Preliminary Assessment Materials). U.S. Environmental Protection Agency, Washington, DC, EPA/635/R-23/030, 2023.History/Chronology
| Date | Description |
|---|---|
| 01- Aug 1998 | EPA revised the IRIS Summary and Toxicological Review of Naphthalene and released an external review draft for public comment. |
| 02- Jul 2004 | EPA released a revised IRIS Summary and Toxicological Review of Naphthalene (External Review Draft) for public comment and hosted an peer review panel meeting. |
| 03- Apr 2005 | EPA hosted a Peer Consultation Workshop on research needs related to the mode of action of inhalation carcinogenicity on April 7, 2005. |
| 04- Aug 2005 | EPA released the document Research Needs Related to Naphthalene Assessment summary report from the workshop. |
| 05- Jul 2014 | EPA released the IRIS Toxicological Review of Naphthalene (Scoping and Problem Formulation Materials) for discussion at a public science meeting held on September 3-4, 2014 to provide the opportunity for the public to give input on the developing draft assessment. |
| 06- Jul 2018 | EPA released the IRIS Assessment Plan of Naphthalene (Scoping and Problem Formulation) for a 30-day public comment period. An August 23, 2018 IRIS Public Science Webinar to discuss the document was also announced. [Federal Register Notice Jul 5, 2018] |
| 07- Aug 2018 | EPA has announced that the August 23, 2018 IRIS Public Science Meeting was postponed until the IRIS Program identified suitable public science meeting dates in the near future. Stakeholders wishing to provide written comments to the IRIS Program were invited to continue to do so through the docket on Regulations.gov until September 5, 2018. |
| 08- Apr 2019 | EPA suspended the assessment in fiscal year 2019. It may be restarted as Agency priorities change. |
| 09- Mar 2021 | The IRIS assessment of naphthalene was released from suspension and announced in the June 2021 IRIS Program Outlook. |
| 10- Sep 2021 | EPA updated the IAP and posted an errata sheet outlining the changes that were made to the draft assessment and posted on this site on Sep 30, 2021. |
| 11- Sep 2021 | EPA announced the rescheduling of the IRIS Public Science Meeting for Naphthalene to be held on November 9, 2021 to discuss the key science issues identified in the 2018 IRIS Assessment Plan (IAP). |
| 12- Nov 2021 | EPA held the IRIS Public Science Meeting for Naphthalene on November 9, 2021 to discuss the key science issues identified in the 2018 IRIS Assessment Plan (IAP). |
| 13- Mar 2023 | EPA released the Protocol for the Naphthalene IRIS Assessment (Preliminary Assessment Materials). [Federal Register Notice March 17, 2023] |
Download(s)
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.
Related Link(s)
Notices
Docket
Comments on the assessment may be submitted and reviewed using the Docket ID EPA-HQ-ORD-2014-0527