
[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51309-51310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16455]


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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.

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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 https://www.regulations.gov. 
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 https://www.epa.gov/dockets.

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: [email protected].

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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.

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 
https://www.regulations.gov 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 https://www.epa.gov/dockets.

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 https://www.regulations.gov and may also be accessed through EPA's website at 
https://www.epa.gov/tsca-peer-review. 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]
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