Notice2023-16455
Letter Peer Review; White Paper: Quantitative Human Health Approach To Be Applied in the Risk Evaluation for Asbestos Part 2; Notice of Availability and Request for Comment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 3, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on the document entitled: "White Paper: Quantitative Human Health Approach to be Applied in the Risk Evaluation for Asbestos Part 2--Supplemental Evaluation including Legacy Uses and Associated Disposals of Asbestos" and related charge questions. EPA will be soliciting comments from expert ad hoc reviewers on the quantitative approach described in this white paper. The white paper describes the systematic review considerations and criteria for identifying studies for dose-response analysis; includes an evaluation and comparison of existing cancer IURs and the non-cancer point of departure (POD) with the results of the new systematic review; and a proposal for a cancer IUR and non-cancer POD for use in the Part 2 risk evaluation for asbestos. In addition to the final charge questions and white paper, public comments received by the date specified in this document will be provided to the peer reviewers for consideration. The letter peer review is expected to begin October 25, 2023, and end November 24, 2023. Feedback from the letter peer review will be considered by EPA in the development of the Part 2 risk evaluation for asbestos, a draft of which will be released subsequently, along with a separate response document.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 148 (Thursday, August 3, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51309-51310]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16455]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2023-0309; FRL-9347-05-OCSPP]
Letter Peer Review; White Paper: Quantitative Human Health
Approach To Be Applied in the Risk Evaluation for Asbestos Part 2;
Notice of Availability and Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comment on the document entitled:
``White Paper: Quantitative Human Health Approach to be Applied in the
Risk Evaluation for Asbestos Part 2--Supplemental Evaluation including
Legacy Uses and Associated Disposals of Asbestos'' and related charge
questions. EPA will be soliciting comments from expert ad hoc reviewers
on the quantitative approach described in this white paper. The white
paper describes the systematic review considerations and criteria for
identifying studies for dose-response analysis; includes an evaluation
and comparison of existing cancer IURs and the non-cancer point of
departure (POD) with the results of the new systematic review; and a
proposal for a cancer IUR and non-cancer POD for use in the Part 2 risk
evaluation for asbestos. In addition to the final charge questions and
white paper, public comments received by the date specified in this
document will be provided to the peer reviewers for consideration. The
letter peer review is expected to begin October 25, 2023, and end
November 24, 2023. Feedback from the letter peer review will be
considered by EPA in the development of the Part 2 risk evaluation for
asbestos, a draft of which will be released subsequently, along with a
separate response document.
DATES: Comments must be received on or before October 2, 2023.
ADDRESSES: Submit written comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2023-0309, through <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Additional information on commenting or visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Contact the Peer Review Leader (PRL),
Tamue Gibson, Mission Support Division, Office of Program Support,
Office of Chemical Safety and Pollution Prevention, Environmental
Protection Agency; telephone number: (202) 564-7642 or call the main
office number:(202) 564-8450; email address: <a href="/cdn-cgi/l/email-protection#b6d1dfd4c5d9d898c2d7dbc3d3f6d3c6d798d1d9c0"><span class="__cf_email__" data-cfemail="7e19171c0d1110500a1f130b1b3e1b0e1f50191108">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. What action is the Agency taking?
EPA is announcing the availability of and soliciting public comment
on the document entitled: ``Quantitative Approach to the Human Health
Assessment for the Risk Evaluation for Asbestos Part 2: Supplemental
Evaluation including Legacy Uses and Associated Disposals of
Asbestos.''
B. What is the Agency's authority for taking this action?
Section 6(b) of the Toxic Substances Control Act (TSCA) (15 U.S.C.
2605(b)), requires that EPA conduct risk evaluations on existing
chemical substances and identifies the minimum components EPA must
include in all chemical substance risk evaluations. The risk evaluation
must not consider costs or other non-risk factors (15 U.S.C.
2605(b)(4)(F)(iii)). The specific risk evaluation process is set out in
40 CFR part 702 and summarized on EPA's website at <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca</a>.
C. Does this action apply to me?
This action is directed to the public in general. This action may,
however, be of interest to those involved in the manufacture,
processing, distribution, and disposal of chemical substances and
mixtures, and/or those interested in the assessment of risks involving
chemical substances regulated under TSCA. Since other entities may also
be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action.
D. What should I consider as I submit my comments to EPA?
1. Submitting Confidential Business Information (CBI).
Do not submit CBI or other sensitive information to EPA through
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If your comments contain any
information that you consider to be CBI or otherwise protected, please
contact the PRL listed under FOR FURTHER INFORMATION CONTACT to obtain
special instructions before submitting that information.
2. Tips for preparing comments.
When preparing and submitting your comments, see Tips for Effective
Comments at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
III. Request for Comment
EPA is seeking public comment on both the white paper and the draft
charge questions for the letter peer review. Both documents are
available in EPA Docket ID No. EPA-HQ-OPPT-2023-0309 at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and may also be accessed through EPA's website at
<a href="https://www.epa.gov/tsca-peer-review">https://www.epa.gov/tsca-peer-review</a>. As additional background
materials become available, EPA will include those additional
background documents (e.g., reviewers participating in this letter peer
review) in the docket and on the website.
III. Letter Peer Review
A. What is the purpose of this Letter Peer Review?
The focus of this Letter Peer Review is to review the quantitative
approach to assessing cancer and non-cancer human health hazards.
Feedback from this review will be considered in the development of Part
2 of the risk evaluation for asbestos.
B. Why did EPA develop these documents?
Asbestos was identified as one of the first 10 chemicals for risk
evaluation
[[Page 51310]]
under TSCA in December 2016. For the purposes of the risk evaluation
for asbestos under TSCA section 6(a), EPA initially adopted the TSCA
Title II (added to TSCA in 1986), section 202 definition; which is
``asbestiform varieties of six fiber types--chrysotile (serpentine),
crocidolite (riebeckite), amosite (cummingtonite-grunerite),
anthophyllite, tremolite or actinolite.'' The latter five fiber types
are amphibole varieties. EPA initially focused its risk evaluation on
chrysotile asbestos, as described in the Problem Formulation for the
Risk Evaluation for Asbestos, as this is the only fiber type with
ongoing use, meaning current manufacture, processing, or distribution
in commerce. Following release of the decision to exclude legacy uses
from the risk evaluation, EPA was legally challenged by Safer
Chemicals, Healthy Families, and in late 2019, the court in Safer
Chemicals, Healthy Families v. EPA, 943 F.3d 397 (9th Cir. 2019) held
that EPA's Risk Evaluation Rule (82 FR 33726, July 20, 2017 (FRL-9964-
38)), should not have excluded ``legacy uses'' (i.e., uses without
ongoing or prospective manufacturing, processing, or distribution) or
``associated disposals'' (i.e., future disposal of legacy uses) from
the definition of conditions of use, although the court upheld EPA's
exclusion of ``legacy disposals'' (i.e., past disposal). Due to the
court ruling, in the March 2020 Draft Risk Evaluation for Asbestos, EPA
had signaled the inclusion of other fiber types, in addition to
chrysotile, as well as consideration of legacy uses and associated
disposal for the asbestos risk evaluation in a supplemental scope
document and supplemental risk evaluation when these activities are
known, intended, or reasonably foreseen. This was supported by both
public comment and the Science Advisory Committee on Chemicals (SACC)
during the SACC Peer Review meeting on June 8-11, 2020. The Risk
Evaluation for Asbestos Part 1: Chrysotile Asbestos was finalized in
December 2020 and specified a Part 2 scope document and risk evaluation
would be forthcoming. The Final Scope of the Risk Evaluation for
Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and
Associated Disposals of Asbestos took into consideration public comment
and was released in June 2022.
In the final scope document for the Part 2 Risk Evaluation, EPA
articulated the plan for the human health analysis to continue to focus
on epidemiologic studies, given the robust evidence base and decades
worth of evidence examining the relationship between exposure to
asbestos and health effects. However, unlike the analysis in Part 1
that was focused on inhalation exposures and cancer, the analysis for
human health in Part 2 also considers non-cancer effects and other
routes of exposure. EPA has applied systematic review approach methods,
as described in the Final Scope of the Risk Evaluation for Asbestos
Part 2: Supplemental Evaluation Including Legacy Uses and Associated
Disposals of Asbestos and the Draft Systematic Review Protocol
Supporting TSCA Risk Evaluations for Chemical Substances to identify
the reasonably available information to be considered in the Part 2
Risk Evaluation. EPA has continued to screen and evaluate the
epidemiologic evidence following the finalization of the final scope
document in order to determine the specific technical and quantitative
analyses that may be warranted.
As anticipated, numerous epidemiology studies were identified,
particularly for inhalation exposures with more limited information for
oral and dermal exposure routes, examining asbestos and cancer and non-
cancer effects. Because the human health hazards are well-established,
it was recognized that streamlined identification of epidemiology
studies that could inform dose-response would be both efficient and
scientifically appropriate. Thus, EPA employed a fit-for-purpose
objective and transparent approach to efficiently identify and evaluate
the relevant information. In addition, EPA considered the reasonably
available information in the context of the existing EPA assessments
and the quantitative risk values those assessments established.
Specifically, EPA considered the Risk Evaluation for Asbestos Part 1:
Chrysotile Asbestos (2020) and a chrysotile-specific inhalation unit
risk (IUR) of 0.16 per fiber/cubic centimeter (cc), the Integrated Risk
information System (IRIS) Libby Amphibole Assessment (2017) and a Libby
amphibole-specific IUR of 0.17 per fiber/cc and (Reference
Concentration (RfC) for Inhalation Exposure of 9x10-5 milligram per
cubic meter (mg/m3), and the IRIS Asbestos Assessment (1988) and a
mixed-fiber IUR of 0.23 per fiber/milliliter (mL)). Based on evaluation
and consideration of the totality of the information, EPA has developed
a quantitative approach to assessing cancer and non-cancer human health
hazards for Part 2 of the Risk Evaluation for Asbestos.
EPA is soliciting comments through letter peer review on the
quantitative approach employed to identify the dose-response relevant
information, the evaluation of the epidemiologic cohorts and data for
dose-response assessment, analysis of the existing IURs and RfC and
their potential suitability for application in the Part 2 Risk
Evaluation, and the selection of an IUR and point of departure. EPA has
prepared these technical details in the document entitled: ``White
Paper: Quantitative Human Health Approach to be Applied in the Risk
Evaluation for Asbestos Part 2--Supplemental Evaluation including
Legacy Uses and Associated Disposals of Asbestos, which will be
distributed for a letter peer-review that is expected to begin October
25, 2023, and end November 24, 2023. Feedback from the letter peer
review will be considered by EPA in the development of the Part 2 risk
evaluation for asbestos, a draft of which will be released
subsequently, along with a separate response document.
Authority: 15 U.S.C. 2601 et seq.
Dated: July 27, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-16455 Filed 8-2-23; 8:45 am]
BILLING CODE P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 3, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.