`[Federal Register Volume 89, Number 248 (Friday, December 27, 2024)]
[Proposed Rules]
[Pages 105490-105504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 730

[Docket No. FDA-2023-N-4225]
RIN 0910-AI82


Testing Methods for Detecting and Identifying Asbestos in Talc-
Containing Cosmetic Products

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to require testing of talc-containing cosmetic products using 
standardized testing methods for detecting and identifying asbestos 
that may be present as a contaminant in talc. We are also proposing 
corresponding adulteration provisions. Asbestos is a potential 
contaminant in talc, which is used in certain cosmetic products, and is 
a known human carcinogen. This proposed rule, if finalized, will help 
protect users of talc-containing cosmetic products from harmful 
exposure to asbestos given the potential for contamination of these 
products.

DATES: Either electronic or written comments on the proposed rule must 
be submitted by March 27, 2025. Submit written comments (including 
recommendations) on information collection issues under the Paperwork 
Reduction Act of 1995 by January 27, 2025.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 27, 2025. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:

[[Page 105491]]

     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-4225 for ``Testing Methods for Detecting and Identifying 
Asbestos in Talc-Containing Cosmetic Products.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents, the 
plain language summary of the proposed rule of not more than 100 words 
as required by the ``Providing Accountability Through Transparency 
Act,'' or the electronic and written/paper comments received, go to 
https://www.regulations.gov and insert the docket number, found in 
brackets in the heading of this document, into the ``Search'' box and 
follow the prompts and/or go to the Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
    Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 (PRA) to the Office of Management and 
Budget (OMB) at https://www.reginfo.gov/public/do/PRAMain. Find this 
particular information collection by selecting ``Currently Under 
Review--Open for Public Comments'' or by using the search function. The 
title of this proposed collection is ``Testing Methods for Detecting 
and Identifying Asbestos in Talc-Containing Cosmetic Products.''

FOR FURTHER INFORMATION CONTACT: 
    With regard to the proposed rule: Jennifer Ross, Office of the 
Chief Scientist, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-4880 
(this is not a toll-free number), [email protected].
    With regard to the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction
    B. Need for the Regulation
    C. History of the Rulemaking
    D. Incorporation by Reference
IV. Legal Authority
V. Description of the Proposed Rule
    A. Who is subject to this section? (Proposed Sec.  730.3(a))
    B. What definitions apply to this section? (Proposed Sec.  
730.3(b))
    C. What test methods must you use? (Proposed Sec.  730.3(c))
    D. How does one determine if a sample has tested positive for 
asbestos? (Proposed Sec.  730.3(d))
    E. Is there an alternative to performing finished product 
testing for detecting and identifying asbestos in a talc-containing 
cosmetic product? (Proposed Sec.  730.3(e))
    F. How frequently must tests be performed? (Proposed Sec.  
730.3(f))
    G. Proposed Records/Record Retention Requirements (Proposed 
Sec.  730.3(g))
    H. Proposed Enforcement Provisions (Proposed Sec.  730.3 (h), 
(i), and (j))
VI. Proposed Effective Date
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    We are issuing this proposed rule pursuant to the Modernization of 
Cosmetics Regulation Act of 2022 (MoCRA), which requires the 
promulgation of proposed and final regulations to establish and require 
standardized testing methods for detecting and identifying asbestos in 
talc-containing cosmetic products. This proposed rule, if finalized, 
will help protect users of talc-containing cosmetic products from 
harmful exposure to asbestos given the potential for asbestos 
contamination of these products.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule describes the test methods that, if finalized, 
manufacturers of talc-containing cosmetic products will be required to 
use to detect and identify asbestos in these products. The proposed 
rule would require manufacturers to test a representative sample of 
each batch or lot of a talc-containing cosmetic product for asbestos 
using both Polarized Light Microscopy (PLM) (with dispersion staining) 
and Transmission Electron Microscopy (TEM)/Energy Dispersive 
Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED).
    The proposed rule also contains provisions that would allow 
manufacturers flexibility to either test each batch or lot of the talc 
cosmetic ingredient, or rely on a certificate of analysis for each 
batch or lot from a qualified talc supplier prior to using the talc to 
manufacture a talc-containing cosmetic, provided that the analytical 
methods used to test the talc include both PLM and TEM/EDS/SAED. It is 
FDA's understanding based on discussions and meetings with industry 
representatives that it is common industry practice to test talc prior 
to adding it during the manufacture of cosmetic products so as to avoid 
manufacturing and distributing talc-containing cosmetic products that 
contain asbestos. We specifically invite comment on existing industry 
practices and the utility of this approach.

[[Page 105492]]

    Additionally, the proposed rule contains provisions that would 
require manufacturers to keep records to demonstrate compliance with 
the rule.
    Finally, the proposed rule contains enforcement provisions. Failure 
of a manufacturer to operate in compliance with both the testing and 
recordkeeping requirements would render the product adulterated under 
the Federal Food, Drug, and Cosmetic Act (FD&C Act.) Further, because 
there is no established safe level below which asbestos could not cause 
adverse health effects, FDA has determined that asbestos at any level 
in talc-containing cosmetic products may render these products 
injurious to users. As such, the proposed rule would codify in 
regulations that if asbestos is present in a talc-containing cosmetic 
product, or in talc used in a cosmetic product, that cosmetic is 
adulterated under the FD&C Act. Likewise, if asbestos is present in 
talc intended for use in a cosmetic, the talc is adulterated under the 
FD&C Act.
    We seek comments on all aspects of this proposed rule.

C. Legal Authority

    On December 29, 2022, the President signed the Consolidated 
Appropriations Act, 2023 into law, which included MoCRA. Among other 
provisions, MoCRA mandated the establishment and requirement of 
standardized testing methods for detecting and identifying asbestos in 
talc-containing cosmetic products. We are also issuing these 
regulations pursuant to section 601(c), section 601(a), and section 
701(a) of the FD&C Act.

D. Costs and Benefits

    This proposed rule, if finalized, would require testing of talc-
containing cosmetic products using standardized testing method(s) for 
detecting and identifying asbestos that may be present as a contaminant 
in talc. Benefits include potential public health benefits to consumers 
from fewer asbestos exposures. To the extent the proposed rule would 
reduce exposures, the health benefits would include fewer illnesses, 
such as mesothelioma, lung cancer, larynx cancer, and ovarian cancer. 
We lack data to quantify these public health benefits, so we instead 
discuss qualitatively. Additionally, we quantify benefits to 
manufacturers of talc-containing cosmetics from fewer recalls. We 
quantify costs to talc suppliers and to cosmetics manufacturers to read 
and understand the rule and to test talc for asbestos. We estimate that 
the annualized monetized benefits over 10 years would range from $0.00 
million to $1.39 million at a 7 percent discount rate, with a primary 
estimate of $0.06 million, and from $0.00 million to $1.39 million at a 
3 percent discount rate, with a primary estimate of $0.06 million. The 
annualized costs would range from $1.29 million to $6.78 million at a 7 
percent discount rate, with a primary estimate of $3.54 million, and 
from $1.30 million to $6.78 million at a 3 percent discount rate, with 
a primary estimate of $3.55 million.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

------------------------------------------------------------------------
          Abbreviation/acronym                    What it means
------------------------------------------------------------------------
APA....................................  Administrative Procedure Act.
CTFA...................................  Cosmetic, Toiletry, and
                                          Fragrance Association.
EDS....................................  Energy Dispersive Spectroscopy.
EO.....................................  Executive Order.
EPA....................................  Environmental Protection
                                          Agency.
FD&C Act...............................  Federal Food, Drug, and
                                          Cosmetic Act.
IEC....................................  International Electrotechnical
                                          Commission.
IR.....................................  Infrared Spectroscopy.
ISO....................................  International Organization for
                                          Standardization.
IWGACP.................................  Interagency Working Group on
                                          Asbestos in Consumer Products.
MoCRA..................................  Modernization of Cosmetics
                                          Regulation Act of 2022.
OIRA...................................  Office of Information and
                                          Regulatory Affairs.
OMB....................................  Office of Management and
                                          Budget.
PLM....................................  Polarized Light Microscopy.
SAED...................................  Selected Area Electron
                                          Diffraction.
SEM....................................  Scanning Electron Microscope.
TEM....................................  Transmission Electron
                                          Microscope.
USP....................................  U.S. Pharmacopeia.
XRD....................................  X-Ray Diffraction.
------------------------------------------------------------------------

III. Background

A. Introduction

    MoCRA, enacted on December 29, 2022, requires the promulgation of 
proposed and final regulations to establish and require standardized 
testing methods for detecting and identifying asbestos in talc-
containing cosmetic products.

B. Need for the Regulation

    Talc is used in various cosmetic products. Talc is mined as a 
naturally occurring hydrous magnesium silicate. Asbestos is found in 
the same rock types that host talc deposits (Refs. 1, 2) and so may be 
found in commercial talc mines and may be inseparable from talc in the 
mining process. As a result, talc used in cosmetic products sometimes 
contains asbestos fibers from serpentine or amphibole minerals present 
in proximity to talc deposits (Refs. 3, 4).
    Asbestos is a known human carcinogen, and its health risks are 
well-documented (Refs. 5 to 10). There is general agreement among U.S. 
Federal Agencies (Refs. 8, 11), and the World Health Organization (Ref. 
12), that there is no established safe threshold for adverse health 
effects from asbestos exposure. Because there is no established safe 
level below which asbestos could not cause adverse health effects, 
asbestos at any level in talc-containing cosmetic products may render 
these products injurious to users. For this reason, we conduct testing 
for asbestos in talc-containing cosmetic products and have issued 
safety alerts when such products have tested positive for asbestos 
(see: https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-stop-using-certain-cosmetic-products). In addition, 
we are concerned about even low levels of asbestos in cosmetics, given 
that such products are applied to the body and used by many people on a 
regular, daily basis, throughout their lives. The risk of harmful 
effects from asbestos is higher with repeated and long-term exposure to 
the carcinogen (Ref. 8).
    Inhalation is the primary pathway of exposure to asbestos in talc-
containing cosmetic products, although ingestion and perineal exposures 
also occur. Exposure to asbestos by inhalation can cause sequelae 
ranging from inflammation to pleural disease and diseases such 
asbestosis, lung cancer, and mesothelioma. These effects rarely occur 
acutely, but they typically occur one or more decades later. Once 
inside the body through inhalation, ingestion, or perineal exposure, 
asbestos can migrate through tissues and organs to secondary sites of 
exposure where progressive cell damage can occur that may lead to 
diseases in other parts of the body that are remote from the sites of 
primary exposure, including cancers of the larynx, gastrointestinal 
tract, and ovaries (Refs. 9, 13, 14, 15, 16). Positive associations 
have been observed between exposure to asbestos and cancer of the 
pharynx, stomach, and colorectum (Ref. 9).
    The presence of asbestos found as a result of independent testing 
of talc-containing cosmetics products indicates any asbestos that may 
be present in the talc ore is difficult to remove during processing to 
manufacture talc for use in cosmetics (Ref. 17). FDA monitors for 
asbestos in talc-containing cosmetic products, including sampling of 
products reported to contain asbestos by various laboratories using PLM 
and TEM/EDS/SAED microscopy methods. For example, in 2010, FDA's 
contract laboratory tested 34 talc-containing cosmetic powder products, 
including body powders, face powders, foundation, eye shadow, and 
blush, and samples of talc as an ingredient used in

[[Page 105493]]

cosmetics from suppliers and found no asbestos contamination using PLM 
and TEM/EDS/SAED (Ref. 18). In 2019, FDA's contract laboratory tested 
52 talc-containing powder cosmetic products, including body powders, 
face powders, eye shadows, blushes, bronzers, and face makeup using PLM 
and TEM/EDS/SAED. In March, June, August, and October 2019, FDA 
confirmed the presence of asbestos in nine talc-containing cosmetic 
products, which were voluntarily recalled by the companies (Ref. 19).
    In considering existing voluntary consensus standards or published 
methods for testing for asbestos in talc, we did not find any 
standardized testing method that laboratories can follow without 
modification to test for asbestos in talc-containing cosmetic products. 
Specifically, we found that the published standards and methods to test 
for asbestos in talc (i.e., Talc USP monograph and CTFA method J4-1) 
have long-recognized shortcomings in specificity and sensitivity 
compared with electron microscopy-based methods (Refs. 17, 20, and 21). 
Furthermore, even when the most sensitive electron microscopy methods 
are used, laboratories testing the same product may reach different 
conclusions about the presence of asbestos. These differences may be 
attributed to a lack of a standardized testing method that provides 
unambiguous guidelines for detecting and identifying asbestos fibers 
and lack of homogeneity of asbestos found in samples. The absence of a 
standardized testing method for the determination of the presence of 
asbestos in talc and talc-containing cosmetic products has led many 
analytical laboratories to combine and/or adapt published test methods 
developed for the determination of the presence of asbestos in air or 
building materials (Refs. 20, 21). This could, at least in part, 
account for discrepancies in laboratory findings that have been 
reported.
    This proposed rule, if finalized, would require testing of talc-
containing cosmetic products, and would require such testing be 
performed for detecting and identifying asbestos that may be present as 
a contaminant in talc using both PLM and TEM/EDS/SAED microscopy 
methods. The proposed rule would also require referring to images in 
standards for identifying asbestos fibers to help ensure that the 
results are accurately and consistently interpreted. Using both of 
these test methods for detecting and identifying asbestos would 
substantially improve a manufacturer's ability to detect the presence 
of asbestos in talc-containing cosmetic products as compared to testing 
using only one of the methods alone, or not testing at all. Such 
testing would in turn improve a manufacturer's ability to take action 
to prevent the distribution of such products if asbestos is detected.

C. History of Rulemaking

    In developing this proposed rule, FDA carefully considered the 
scientific evidence and complex policy issues related to detecting and 
identifying asbestos in talc and talc-containing cosmetic products. 
FDA's activities have included forming an Interagency Working Group on 
Asbestos in Consumer Products (IWGACP) in the fall of 2018 and holding 
a public meeting entitled ``Testing Methods for Asbestos in Talc and 
Cosmetic Products Containing Talc'' in February 2020 where preliminary 
scientific opinions of the IWGACP were presented. Subsequently, FDA 
released the IWGACP's final scientific opinions in a White Paper (Ref. 
22) and related Technical Appendices in January 2022 (Ref. 13), both of 
which were peer-reviewed (Ref. 23). The IWGACP concluded that X-ray 
diffraction (XRD) or infrared (IR) spectroscopy followed by PLM if XRD 
or IR is positive for amphibole or serpentine minerals are not specific 
or sensitive enough to detect the presence of asbestos (Ref. 22). This 
proposed rule is based in part on FDA's consideration of those 
scientific opinions and is also informed by presentations/comments at a 
Public Meeting on Testing Methods for Asbestos in Talc and Cosmetic 
Products Containing Talc (Ref. 24) and comments to the docket from that 
public meeting. Additionally, FDA relied on other studies reported in 
the scientific literature as noted in the reference section (including 
for example Refs. 25 to 30), as well as on FDA's scientific and 
regulatory experience in overseeing the safety of cosmetic products 
containing talc. Further, FDA is promulgating this proposed rule 
pursuant to section 3505 of MoCRA, which requires FDA to promulgate 
proposed regulations to establish and require standardized testing 
methods for detecting and identifying asbestos in talc-containing 
cosmetic products.

D. Incorporation by Reference

    We propose to incorporate by reference the following annexes from 
consensus standards, with the approval of the Director of the Federal 
Register in accordance with the Administrative Procedure Act (APA), 5 
U.S.C. 552(a), and 1 CFR part 51:
     Annex D in ISO 22262-1:2012(E), ``Air quality--Bulk 
materials--Part 1: Sampling and qualitative determination of asbestos 
in commercial bulk materials,'' First edition, July 1, 2012 (Ref. 31).
     Annex C in ISO 10312:2019(E), ``Ambient air--Determination 
of asbestos fibres--Direct-transfer transmission electron microscopy 
method,'' Second edition, October 10, 2019 (Ref. 32). Specifically, we 
would require the use of Figure C.1 in ISO 10312:2019(E), Annex C.
    The International Organization for Standardization (ISO) is an 
independent, nongovernmental international organization with a 
membership of national standards bodies. For an overview of ISO 22262-
1:2012(E) and ISO 10312:2019(E), see section V.C of this document.
    The annexes of the consensus standards proposed to be incorporated 
by reference are available to the public in two different ways. 
Interested parties may: (1) examine these readily available standards 
at Dockets Management Staff, administered by the Federal Dockets 
Management System (FDMS), at (see ADDRESSES), (2) purchase copies of 
these standards from International Organization for Standardization, 
BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, 
Switzerland; phone: +41-22-749-01-11; email: [email protected]; 
website: https://www.iso.org/store.html.
    FDA is proposing to incorporate by reference the specified annexes 
in ISO 22262-1:2012(E) and ISO 10312:2019(E). Any future revisions to 
these standards affecting the specified annexes would need to be 
evaluated to determine the impact of the changes and whether this 
proposed rule, if finalized, should be amended. If deemed necessary and 
appropriate, FDA will update the final regulation in accordance with 
the APA (5 U.S.C. 553) and obtain approval of any changes to the 
incorporation by reference in accordance with 1 CFR part 51.

IV. Legal Authority

    We are issuing this proposed rule pursuant to section 3505 of 
MoCRA, under section 601 of the FD&C Act (21 U.S.C. 361), and under 
section 701 of the FD&C Act (21 U.S.C. 371). Section 3505 of MoCRA 
requires the promulgation of proposed and final regulations to 
establish and require standardized testing methods for detecting and 
identifying asbestos in talc-containing cosmetic products. These 
proposed regulations would require testing of talc-containing cosmetic 
products using PLM and TEM/

[[Page 105494]]

EDS/SAED testing methods for detecting and identifying asbestos that 
may be present as a contaminant in talc.
    Section 201 (i) of the FD&C Act defines cosmetics as ``articles 
intended to be rubbed, poured, sprinkled, or sprayed on, introduced 
into, or otherwise applied to the human body . . . for cleansing, 
beautifying, promoting attractiveness, or altering the appearance.'' 
This definition includes skin moisturizers, perfumes, lipsticks, 
fingernail polishes, eye and facial makeup, cleansing shampoos, 
permanent waves, hair colors, deodorants, and components of cosmetic 
products, but excludes soap.
    Under section 601(c) of the FD&C Act, a cosmetic is adulterated if 
``it has been prepared, packed, or held under insanitary conditions 
whereby it may have become contaminated with filth, or whereby it may 
have been rendered injurious to health.'' Asbestos is a known human 
carcinogen, and its health risks are well-documented (Refs. 5 to 10). 
Because there is no established safe level below which asbestos could 
not cause adverse health effects (Refs. 8, 11, 12), asbestos at any 
level in talc-containing cosmetic products may render these products 
injurious to users. In addition, we are concerned about even low levels 
of asbestos in cosmetics, given that such products are applied directly 
to the body and used by many people on a regular, daily basis, 
throughout their lives. The risk of harmful effects from asbestos is 
higher with repeated and long-term exposure to the carcinogen (Ref. 8). 
Exposure to asbestos can cause a range of adverse health effects that 
may injure users, including causing sequelae ranging from inflammation 
to pleural diseases and diseases such asbestosis, lung cancer, and 
mesothelioma. Once inside the body through inhalation, ingestion, or 
perineal exposure, asbestos can migrate through tissues and organs to 
secondary sites of exposure where progressive cell damage can occur 
that may lead to diseases in other parts of the body that are remote 
from the sites of primary exposure, including cancers of the larynx, 
gastrointestinal tract, and ovaries (Refs. 9, 13, 14, 15, 16). Positive 
associations have been observed between exposure to asbestos and cancer 
of the pharynx, stomach, and colorectum (Ref. 9).
    There is no established safe exposure threshold for asbestos (Refs. 
8, 11, 12). Asbestos is found in the same rock types that host talc 
deposits from which the talc in talc-containing cosmetic products is 
mined (Refs. 1, 2). As a result of the mining process, talc used in 
cosmetic products may contain asbestos fibers from serpentine or 
amphibole minerals present in proximity to talc deposits (Refs. 3, 4). 
Indeed, FDA has confirmed the presence of asbestos in some talc-
containing cosmetic products. Specifically, in 2019, FDA surveyed 52 
talc-containing cosmetic products and confirmed the presence of 
asbestos in nine of these products (Ref. 19). FDA considers the 
proposed testing techniques to be suitable methods for detecting and 
identifying asbestos in talc or cosmetic products that contain talc. 
FDA is not aware of any other equally suitable methods. Therefore, we 
are proposing this rule to codify in our regulations that a talc-
containing cosmetic product is adulterated under section 601(c) of the 
FD&C Act if the product has been prepared, packed, or held under 
conditions that could allow the product to contain asbestos, including 
by not testing and maintaining records of such testing for asbestos, a 
substance that is injurious to the health of consumers and known to be 
naturally occurring in talc.
    Under section 601(a) of the FD&C Act, a cosmetic is adulterated if 
``it bears or contains any poisonous or deleterious substance which may 
render it injurious to users under the conditions of use prescribed in 
the labeling thereof, or, under such conditions of use as are customary 
or usual . . .''. Individuals can be exposed to asbestos during use of 
cosmetics that contain talc, should the talc used to manufacture the 
product contain asbestos. As such, asbestos may cause injury to users 
under the expressly indicated, customary, or usual conditions of use of 
a cosmetic product. Therefore, FDA currently considers that a cosmetic 
product that is manufactured using talc that contains asbestos contains 
a poisonous or deleterious substance that may be injurious to users 
under expressly indicated, customary, or usual use conditions. To make 
this conclusion explicit in our regulations, we are proposing to codify 
in our regulations that if asbestos is present in a talc-containing 
cosmetic product, or in talc used in a cosmetic product, that cosmetic 
product is adulterated under section 601(a) of the FD&C Act. Likewise, 
as section 201(i)(2) of the FD&C Act (21 U.S.C. 321(i)(2)) states that 
``cosmetic'' includes ``articles intended for use as a component'' of a 
cosmetic, we are also proposing to codify in our regulations that if 
asbestos is present in talc intended for use in a cosmetic, that talc, 
as an article intended for use as a component ingredient of a cosmetic, 
is an adulterated cosmetic under 601(a) of the FD&C Act.
    Under section 701(a) of the FD&C Act, we may promulgate regulations 
for the efficient enforcement of the FD&C Act. A regulation that 
requires testing methods to detect and identify asbestos in talc-
containing cosmetics and that clearly establishes FDA's conclusion that 
a cosmetic containing asbestos is adulterated would help prevent talc-
containing cosmetics from containing asbestos, a substance that may 
injure users. This would allow for the efficient enforcement of the 
FD&C Act.
    Further, we are proposing to use our authority under 701(a) of the 
FD&C Act to promulgate requirements to keep asbestos testing records 
for at least 3 years after the date the record was created. We are 
proposing under 701(a) of the FD&C Act to require that records be made 
available within 1 business day for inspection and copying upon 
request, either at the place of business of the manufacturer during 
inspection or remotely through electronic delivery. We chose 1 business 
day to be largely consistent with other FDA regulations that require 
production within 1 business day. As an example, 21 CFR 1.1455(c) 
regarding food traceability records requires records production within 
24 hours. We seek comment on this proposed timeframe.
    The proposed recordkeeping requirements are necessary for both FDA 
and manufacturers to ensure that manufacturers are complying with the 
testing requirements of the proposed rule. Therefore, these proposed 
recordkeeping requirements are necessary for the efficient enforcement 
of the FD&C Act because they will aid both manufacturers and FDA in 
ensuring that a talc-containing cosmetic is not adulterated.
    In addition, because the underlying testing requirements are 
necessary to minimize the likelihood of adulteration of a talc-
containing cosmetic product, access to records that demonstrate that a 
manufacturer has followed those requirements is essential to the 
efficient enforcement of the FD&C Act as it allows us to confirm 
compliance. Likewise, the ability to copy these records is essential to 
the efficient enforcement of the FD&C Act as this allows FDA to confirm 
compliance. This may be necessary, for example, if our investigator 
needs assistance in reviewing a certain record from relevant experts in 
headquarters. Otherwise, we would have to rely solely on our 
investigator's notes and reports when drawing conclusions. In addition, 
copying records will facilitate followup regulatory actions. Therefore, 
at this

[[Page 105495]]

time, we have concluded that the ability to access and copy records is 
necessary to efficiently enforce the rule and thereby help prevent the 
introduction into interstate commerce of adulterated talc-containing 
cosmetics. We also conclude at this time that requiring delivery within 
1 business day through electronic means rather than solely during in-
person inspections will enable us to efficiently and effectively 
monitor compliance with the testing requirements to help prevent 
adulteration of talc-containing cosmetics and is therefore also 
authorized by section 701(a) of the FD&C Act. We seek comment on the 
proposed timeframes.

V. Description of the Proposed Rule

    We propose to amend chapter I of title 21 of the Code of Federal 
Regulations by adding part 730 to subchapter G entitled ``Requirements 
for Talc-Containing Cosmetic Products.'' If finalized, proposed Sec.  
730.3 entitled ``Testing Methods for Detecting and Identifying Asbestos 
in Talc-Containing Cosmetic Products'' would require testing of talc-
containing cosmetic products using standardized testing methods for 
detecting and identifying asbestos that may be present as a contaminant 
in talc, pursuant to section 3505 of MoCRA and sections 601 and 701 of 
the FD&C Act.

A. Who is subject to this section? (Proposed Sec.  730.3(a))

    We propose that the requirements under this rule would apply to all 
manufacturers of a talc-containing cosmetic product. We note that 
section 3505 of MoCRA is not included in the exemptions provided under 
section 613(a) of the FD&C Act for certain cosmetic products and 
facilities that are subject to the requirements of chapter V of the 
FD&C Act (Drugs and Devices). Therefore, cosmetic products that are 
subject to the requirements of chapter V of the FD&C Act, such as 
cosmetic products that are also drugs, are subject to this proposed 
rule.

B. What definitions apply to this section? (Proposed Sec.  730.3(b))

    For the purpose of this regulation, we propose to define two terms 
in this rule: ``asbestos'' and ``representative sample.'' Asbestos 
refers to a unique asbestiform morphology that occurs when certain 
minerals crystallize. We define ``asbestos'' to mean amosite, 
chrysotile, crocidolite, asbestiform tremolite, actinolite, 
anthophyllite, winchite, and richterite, and other amphibole minerals 
in the asbestiform habit (Ref. 26, 27). We consider an asbestiform 
habit to be a habit of growth that ultimately leads to formation of 
respirable narrow fibers that are hazardous.
    Many published definitions of asbestos, including certain 
definitions in other Federal Agencies' regulations, were considered in 
defining asbestos in this proposed rule (Refs. 26, 27). Generally 
speaking, published definitions of asbestos can be categorized as 
either commercial or mineralogical. For commercial uses, the term 
asbestos encompasses six minerals that are valued both because of their 
unique properties and because their abundance in certain regions makes 
it commercially feasible to mine them. The six commercial minerals 
targeted for detection and identification in other Federal asbestos 
regulations are the serpentine mineral chrysotile and the following 
five amphibole minerals: ``amosite'' (cummingtonite-grunerite 
asbestos), crocidolite (riebeckite asbestos), tremolite asbestos, 
actinolite asbestos, and anthophyllite asbestos. In a strictly 
mineralogical sense, asbestos also refers to minerals identifiable as 
being among the amphibole or serpentine group and having a unique 
fibrous morphology resulting from an asbestiform habit of growth (Ref. 
27). Therefore, we propose applying a mineralogical definition of 
asbestos in talc and talc-containing cosmetic products because the 
commercial definitions of asbestos in other federal regulations do not 
include all hazardous asbestiform amphibole minerals that might be 
detected and identified using the proposed testing methods.
    In applying the mineralogical approach to identifying asbestos in 
talc and talc-containing cosmetic products, we propose to add winchite 
and richterite to the six commercial minerals in our definition of 
asbestos. Winchite and richterite have been identified in samples of 
talc taken from certain regions (Refs. 13, 17, 28), and asbestiform 
winchite and richterite as impurities in other minerals have been 
associated with the same diseases associated with commercial asbestos 
types (Refs. 6, 7).
    We also propose to include ``other asbestiform amphibole minerals'' 
in our definition of asbestos. Inclusion of all asbestiform amphibole 
minerals is based on the cumulative understanding developed over the 
past five decades indicating association of the particle morphology of 
asbestiform amphiboles with adverse health effects (Refs. 29, 30). Our 
proposal is also in recognition that amphiboles are extremely diverse 
in chemical composition (Ref. 33) and subtle differences in chemical 
composition have been observed in amphibole asbestos minerals found in 
association with talc (Ref. 28).
    Because all types of amphibole minerals in cosmetic products have 
potential to release fibers exhibiting size and shape consistent with 
asbestiform morphology, the inclusion of ``other asbestiform amphibole 
minerals'' in our definition of asbestos would help ensure that testing 
for asbestos in talc-containing cosmetic products would detect and 
identify these fibers as asbestos even if mineral nomenclature (Ref. 
33) changes over time.
    We propose to define ``representative sample'' to mean a sample 
that consists of a number of units that are drawn based on rational 
criteria, such as random sampling, and intended to ensure that the 
sample accurately portrays the material being sampled. Rather than 
specify an exact number of units necessary to comprise a 
``representative sample'', this definition provides firms with the 
flexibility to determine the appropriate sample amount-for any given 
testing situation, that would ensure the sample represents the 
material. This definition is also near- identical with FDA's existing 
regulations defining ``representative sample'' in other product areas 
(See 21 CFR 210.3(b)(21) and 106.3).
    We request comment on the proposed definitions and if they provide 
sufficient clarity for manufacturers.

C. What test methods must you use? (Proposed Sec.  730.3(c))

    We propose to require manufacturers of talc-containing cosmetic 
products to test for asbestos using PLM (with dispersion staining) and 
TEM/EDS/SAED. The requirement for the use of PLM and TEM/EDS/SAED in 
tandem is consistent with established scientific opinions recognizing 
the limitations of PLM in the realm of analysis for asbestos in talc 
and talc-containing cosmetic products, which may result in false 
negative test results. Such limitations are mentioned and discussed in, 
e.g., Cosmetic, Toiletry, and Fragrance Association (CTFA) Method J4-1 
``Asbestiform Amphibole Minerals in Cosmetic Talc'' (Ref. 34), a Notice 
of Intent to Revise the Talc U.S. Pharmacopeia monograph (Talc USP) 
test for asbestos (Ref. 35), and ``IWGACP Scientific Opinions on 
Testing Methods for Asbestos in Cosmetic Products Containing Talc'' 
(Refs. 13, 22). For the reasons described below, we have determined the 
additional use of TEM/EDS/SAED will ensure sensitivity and specificity 
not afforded by PLM alone.
    We propose that manufacturers must use an analytical approach that 
includes PLM and TEM/EDS/SAED. TEM/EDS/

[[Page 105496]]

SAED and PLM are complementary methods, giving different information 
about the different particles (size ranges). Although PLM has much 
lower magnification than TEM/EDS/SAED by about two orders of magnitude, 
PLM provides for a larger amount of sample to be analyzed in comparison 
to when a sample is prepared for TEM/EDS/SAED analysis. Therefore, 
combining TEM, which enables detection of smaller fibers, with PLM, 
which enables testing of larger samples, gives the best chance of 
detecting asbestos. Thus, we are proposing that both methods must be 
used.
    For PLM testing, detecting and identifying asbestos would be 
required to be based on comparison of optical crystallographic 
properties (i.e., color and pleochroism, refractive indices, 
birefringence, extinction characteristics, and sign of elongation) and 
particle morphology with data for and images of asbestos in indicated 
references. Specifically, we would require reference to PLM images of 
asbestos from ISO 22262-1:2012(E) (Annex D) as visual aids to assist 
the analyst for identifying asbestos particles (Ref. 31). For TEM/EDS/
SAED, detecting and identifying asbestos would be required to be based 
on comparison of elemental composition, crystal structure of particles, 
and particle morphology with data for and images of asbestos in 
indicated references. Specifically, we would require reference to 
images of asbestos ISO 10312:2019(E) (Figure C.1 in Annex C) (Ref. 32) 
for TEM/EDS/SAED analysis of asbestos as visual aids to assist the 
analyst for classifying various types of asbestos structures (i.e., 
particles).
    In developing the proposed rule, we considered whether existing 
voluntary consensus standards for testing talc for asbestos were 
suitable for inclusion in the proposed rule as the standardized testing 
method for detection and identification of asbestos in talc-containing 
cosmetic products. For the purposes of this proposed rule, in line with 
the ISO/International Electrotechnical Commission (IEC)'s Guide 2:2004, 
``Standardization and related activities--General vocabulary,'' we 
consider a standard to be a document, established by consensus and 
approved by a recognized body, that provides, for common and repeated 
use, rules, guidelines, or characteristics for activities or their 
results, aimed at the achievement of the optimum degree of order in a 
given context (Ref. 36). Among standards, we consider a voluntary 
consensus standard to be one that is developed or adopted by standards 
development organizations according to strict consensus principles. 
Taken together as such, we evaluated existing voluntary consensus 
standards by reviewing published asbestos testing methods established 
by nationally or internationally recognized standard development 
organizations and that generally only apply to the context of very 
narrow or specific situations in which asbestos is known to be present.
    In addition to these standards, we also evaluated other existing 
published methods, such as those that had not been developed or adopted 
by consensus, for testing talc for asbestos. As discussed below, among 
such published standards and methods reviewed by FDA at the time of 
writing this proposed rule, including those applicable to ``talc'' as 
an ingredient in consumer products, we did not find any that can be 
recognized in its entirety as an appropriate standardized testing 
method to test for asbestos in talc or talc-containing cosmetics.
    The CTFA method entitled ``Asbestiform Amphibole Minerals in 
Cosmetic Talc'' (J4-1) and the Talc USP test for asbestos are the only 
published methods to test for asbestos in talc used in cosmetics and 
pharmaceuticals, respectively. As described below, we concluded these 
methods are not suitable for the purpose of this proposed rule.
    The J4-1 method was developed as a PLM test method for asbestos in 
talc used as a cosmetic ingredient and was not intended to be used to 
test cosmetic products containing talc. As a result, J4-1 does not 
include a method of sample preparation intended to remove ingredients 
in cosmetic products that may interfere with the detection and 
identification of asbestos.
    Additionally, J4-1 has significant shortcomings with respect to 
testing for asbestos in talc to be used as an ingredient in a cosmetic 
product. First, as its title notes, it is intended only to test for 
asbestiform amphibole minerals and not for chrysotile asbestos. On 
review of the protocol, we did not find it to have any utility to test 
for chrysotile or detect chrysotile with adequate sensitivity. Second, 
the J4-1 protocol requires that talc first be screened for amphibole by 
X-Ray Diffraction Analysis (XRD). J4-1 only requires the talc to be 
subsequently tested by PLM for asbestiform amphibole if the sample is 
found to first contain amphibole by the XRD screening. As stated in the 
J4-1 protocol, the XRD screening method has a nominal limit of 
detection of amphibole of 0.5 percent by weight. Thus, if the talc 
contains less than 0.5 percent asbestos by weight, potentially 
representing billions of asbestos fibers per gram of talc, the asbestos 
would not be detected (Ref. 37). In summary, reliance on XRD, absent 
any additional microscopic analysis, can lead to false-negative results 
for talc containing chrysotile asbestos at any level or amphibole 
asbestos at levels below 0.5 percent.
    If XRD testing of talc comes up positive, the talc then has to be 
tested by PLM to determine if the amphibole is asbestiform. FDA is 
concerned that a PLM method alone does not provide sufficient 
sensitivity to enable detection of chrysotile and asbestiform amphibole 
minerals at the levels that might be present in talc intended for use 
in cosmetics and talc-containing cosmetics. Asbestos mineral particles 
in talc and talc-containing cosmetics can be too small to be detected 
and identified by PLM alone. Use of TEM/EDS/SAED in tandem with PLM is 
intended to improve detection of chrysotile and asbestiform amphibole 
should any of these minerals be present in talc intended for use in 
cosmetics or cosmetics manufactured using that talc raw material.
    We also evaluated a test entitled ``Absence of Asbestos'' in the 
current Talc USP monograph (Talc USP test for asbestos) that includes 
three procedures, including a pair of optional procedures to screen for 
amphibole and serpentine. In the current Talc USP test for asbestos 
(Ref. 38), analysts are given the option to perform either Procedure 
1--infrared spectroscopy (IR) (Identification Tests--General Chapter 
USP <191>)--or Procedure 2--XRD [Characterization of Crystalline and 
Partially Crystalline Solids by X-Ray Powder Diffraction (XRPD)--
General Chapter USP <941>]. If the procedure chosen gives a positive 
result, then optical microscopy (Optical Microscopy--General Chapter 
USP <776>) must be performed to confirm whether the sample is to be 
regarded as meeting the requirement for Absence of Asbestos. It appears 
that the XRD method has a nominal limit of detection of no less than 
0.5 percent and that the IR method might have a limit of detection of 
nominally 1 percent. Like explained above regarding the J4-1 method, 
reliance on screening using XRD, or IR as in the USP method, absent any 
additional microscopic analysis, can lead to false-negative results. 
Moreover, the optical microscopy method specified in USP <776> does not 
require the use of polarized light. Use of optical microscopy without 
polarized light lacks specificity, so could lead to misidentification 
of the mineral particles present in talc or a talc-containing cosmetic 
product.

[[Page 105497]]

    Amid concerns pertaining to lack of sensitivity and specificity in 
the test for Absence of Asbestos, USP has formed two successive expert 
panels to develop improvements to the Talc USP test for asbestos. Each 
expert panel has highlighted concerns with the IR, XRD, and optical 
microscopy methods in the Talc USP test (Refs. 21, 35). Culminating the 
efforts of these two expert panels, in March 2022 USP published a 
proposal in Pharmacopeial Forum (Ref. 39), which aims to change the 
name of the ``Absence of Asbestos'' test to ``Test for Asbestos'' to 
account for residual limitations in sensitivity and specificity. In 
addition, the proposal aims to improve the analytical approach by 
deleting the optional IR test, improving the XRD test to deal with 
interference that hinders detection of serpentine, and improving the 
optical microscopy test to require the use of polarized light for the 
detection and identification of asbestos.
    Lastly, USP's proposed protocol will require the analyst to use 
PLM, even if the XRD test is negative. To accommodate this proposal to 
amend the Talc USP monograph, USP has issued two new General Chapters. 
General Chapter <901> (Ref. 40) describes the analytical procedures for 
XRD and PLM in detail and a complementary General Information Chapter 
<1901> (Ref. 41) includes images of chrysotile and tremolite asbestos 
detected by PLM. Additionally, in the briefing to <901>, USP proposes 
that a third talc expert panel be convened to develop an electron 
microscopy test method to complement the PLM method, which promises to 
improve the sensitivity and specificity of the protocol for asbestos 
even further. However, as noted above, despite demonstrated 
improvements in sensitivity and specificity, the capability for 
detection and identification of asbestos in talc used to manufacture 
cosmetic products using the XRD and PLM techniques described in 
chapters <901> and <1901> (i.e., without using TEM/EDS/SAED) remains 
limited.
    FDA is proposing to require the use of TEM/EDS/SAED in addition to 
PLM with dispersion staining because many of the particles of 
chrysotile and asbestiform amphibole minerals that might be found in 
raw material talc and talc-containing cosmetic products are not 
detectable by PLM. Electron microscopy, including transmission electron 
microscopy (TEM/EDS/SAED) and scanning electron microscopy (SEM/EDS), 
overcomes the resolution limitations of PLM and has the ability to 
detect extremely small asbestos fibers. The minimum fiber width that 
can be routinely characterized by TEM/EDS/SAED is on the order of 0.04 
[mu]m, corresponding to the typical width of single chrysotile fibrils. 
SEM/EDS can be a complementary approach to TEM/EDS/SAED to provide 
additional information on amphibole mineral particle morphology. 
However, due to its limitations with respect to obtaining high-quality 
SAED patterns helpful to identify chrysotile and amphibole minerals, 
SEM/EDS can only be regarded as a complementary technique but not as a 
substitute for TEM/EDS/SAED. To have a comprehensive assessment, the 
IWGACP had advised that the development of a standardized approach 
should include both optical and electron microscopy. FDA's proposal to 
require manufacturers of talc-containing cosmetic products to test for 
asbestos using PLM (optical microscopy) and TEM/EDS/SAED (electron 
microscopy) is therefore aligned with IWGACP scientific opinions no. 1 
and no. 3 on testing approach (Ref. 22).
    Since 2019, FDA's contract laboratory has tested more than 200 
samples of talc-containing cosmetic products using a TEM/EDS/SAED 
method that can reliably detect a single asbestos fiber in a sample 
aliquot, providing the confidence needed in the method proposed. All 
laboratory reports representing testing of samples of cosmetic products 
by FDA's contract laboratory from 2019-2023 are posted on the FDA 
website (https://www.fda.gov/news-events/fda-brief/fda-brief-fda-releases-final-report-talc-containing-cosmetic-products-tested-asbestos). These reports provided an estimated limit of detection as 
the smallest single asbestos fiber that can be detected and identified 
by TEM/EDS/SAED, and provide an estimated limit of quantification by 
TEM/EDS/SAED as four such fibers.
    The limit of detection and limit of quantification calculation is 
dependent upon the amount of sample viewed by the analyst on a TEM 
grid, which is based on the method of sample preparation. Recognizing 
that laboratories may prepare samples for TEM/EDS/SAED differently 
depending on the type of sample, we propose to require that, when 
testing talc or talc-containing cosmetics for asbestos, at least 0.1 
micrograms of talc or talc-containing cosmetic product be viewed on a 
TEM grid on which the sample is uniformly distributed. Based on our 
discussions with our own and other contract testing labs, we believe 
this requirement would be consistent with general practice by asbestos 
testing laboratories expert in TEM/EDS/SAED microscopy and would help 
ensure consistency across laboratories.
    The testing of over 200 samples by FDA's contract laboratory 
established the TEM/EDS/SAED method's sensitivity to detect one 
asbestos particle (i.e., fiber) per 0.1 micrograms of talc. Further, 
under our proposed requirement to analyze at least 0.1 micrograms of 
the sample, detection of a single asbestos fiber corresponds to an 
estimated 10\7\ fibers per gram of talc or talc-containing cosmetic 
product, representing approximately 10-5 percent of asbestos 
by weight (Ref. 19). Therefore, we believe that the limit of detection 
of a single asbestos fiber in a sample is the appropriate basis for 
determining if a sample should be regarded to be positive for asbestos. 
When testing for asbestos in talc or a talc-containing cosmetic 
product, suitable negative controls (use of laboratory blanks) can 
provide assurance that a single asbestos fiber detected is a true 
positive finding.
    We note that FDA has used the limit of quantification as the basis 
for determining that a sample is positive. However, based on FDA's 
historical testing data and our current better understanding of the 
sensitivity, accuracy, and precision of the methods discussed above, we 
are proposing to use the limit of detection corresponding to detection 
of a single asbestos fiber as the basis for a positive sample. We 
request comment on this proposed requirement.
    FDA acknowledges that there may be significant challenges in 
developing reference materials for the identification of asbestos in 
talc and talc-containing cosmetics. FDA finds that printed images or 
drawings depicting morphology of asbestos fibers and bundles, appearing 
in certain published asbestos testing standards, especially those 
written to address situations in which asbestos is known to be present, 
provide useful visual aids for comparison. For example, ISO 22262-
1:2012(E) specifies methodology for using PLM to detect and identify 
asbestos added to fabricate commercial bulk materials such as 
fireproofing and thermal insulation (see Annex A). With respect to 
asbestos morphology, Annex D in ISO 22262-1:2012(E) (Ref. 31) appears 
to contain useful PLM images of chrysotile and asbestiform amphiboles. 
ISO 13012:2019(E) specifies a TEM/EDS/SAED method for the determination 
of airborne asbestos fibers and structures in a wide range of ambient 
air situations, including the interior atmospheres of buildings 
undergoing removal of previously installed asbestos insulation. Figure 
C.1

[[Page 105498]]

in Annex C in ISO 10312:2019(E) (Ref. 32) appears to contain useful 
depictions of the morphology of asbestos detected and identified by 
TEM/EDS/SAED. Therefore, FDA is proposing to require the use of these 
images to assist the analyst in detecting and identifying asbestos.

D. How does one determine if a sample has tested positive for asbestos? 
(Proposed Sec.  730.3(d))

    We propose to require manufacturers to test for asbestos using both 
PLM and TEM/EDS/SAED. If asbestos is detected using either method, then 
the sample would be required to be regarded as positive for asbestos. 
As explained above, we are proposing that the limit of detection of 
asbestos would be the basis for determining that a sample has tested 
positive. Thus, we propose that if any asbestos is detected when the 
sample is tested as required in Sec.  730.3(c), the sample must be 
regarded as positive for asbestos.

E. Is there an alternative to performing finished product testing for 
detecting and identifying asbestos in a talc-containing cosmetic 
product? (Proposed Sec.  730.3(e))

    We propose to provide manufacturers flexibility to test the talc or 
rely on a certificate of analysis from the talc supplier, prior to 
using the talc in the manufacture of a talc-containing cosmetic 
product. We are proposing that a manufacturer relying on such a 
certificate would satisfy the testing requirements of the rule. If a 
manufacturer chooses to rely on a talc certificate of analysis, they 
must qualify the supplier by establishing and maintaining the 
reliability of the supplier's certificate of analysis through 
verification of the results of the supplier's tests for asbestos in 
accordance with Sec.  730.3(f). Testing of the talc intended to be used 
as a cosmetic ingredient can help prevent the manufacturing of cosmetic 
products that contain asbestos. Thus, FDA is providing talc-containing 
cosmetic product manufacturers with a flexible and efficacious approach 
to testing that will enable them to comply with the proposed 
requirements and minimize the likelihood that their talc-containing 
cosmetic products will contain asbestos.

F. How frequently must tests be performed? (Proposed Sec.  730.3(f))

    We propose, at a minimum, that a manufacturer test a representative 
sample of each batch or lot of each talc-containing cosmetic product or 
talc ingredient for asbestos in accordance with Sec.  730.3(c). If a 
manufacturer relies on the supplier's certificate of analysis in 
accordance with Sec.  730.3(e), a manufacturer must at least, upon 
receipt of the supplier's initial certificate of analysis and 
subsequently annually thereafter, verify the reliability of the 
reported asbestos test results based on testing by the manufacturer or 
another laboratory as required in Sec.  730.3(c).

G. Proposed Records/Record Retention Requirements (Proposed Sec.  
730.3(g))

    The record requirements section would establish certain 
requirements for manufacturers to keep records of testing for asbestos 
that show test data, including raw data, and to describe in detail how 
samples were tested. Raw data would include microscopy images, spectra, 
diffraction patterns and bench sheets that are used by the manufacturer 
or another asbestos testing lab in accordance with standardized methods 
the manufacturer or testing lab follow and the manufacturer or the 
testing lab's requirements for quality assurance. If the manufacturer 
chooses to rely on a certificate of analysis for the talc supplier, 
records must include any certificate of analysis received from the 
supplier for testing of the talc used to make the finished product, and 
documentation of how the manufacturer qualified the supplier by 
establishing and maintaining the reliability of the supplier's 
certificate of analysis through verification of the results of the 
supplier's tests for asbestos in accordance with Sec.  730.3(f).
    This section would also require that records be made available 
within 1 business day, upon request, to an authorized FDA 
representative for inspection and copying and that they be written in 
English or an English translation be made available upon request. 
Records that would be required under this section must be retained for 
a period of 3 years after the date such record was created. FDA is 
soliciting comment on whether the timeframe for manufacturers to retain 
the records under this section is sufficient for FDA to ensure 
compliance with the rule, including specific comment on the length of 
time between when talc used in cosmetic products is tested and when 
such cosmetic products reach consumers, and specific comment on the 
length of time consumers retain or use their cosmetic products. FDA 
generally verifies compliance with recordkeeping requirements during 
inspections. Thus, the timeframe for recordkeeping is based upon 
consideration of the estimated inspection timeframe. FDA monitors for 
asbestos in talc-containing cosmetic products by sampling a relatively 
small number of products annually, and conducts ``for cause'' 
inspections. Thus, FDA estimates a period of up to 3 years from the 
time the record was created to when FDA may request the record.
    Records would be retained either as originals or as true copies 
such as photocopies, microfilm, microfiche, or other reproductions that 
preserve the content and meaning of the data, including associated 
metadata and audit trails. Electronic records would be required to 
comply with 21 CFR part 11. Where reduction techniques are used, 
suitable reader, computer, and copying equipment should be readily 
accessible to FDA during an inspection. Documents and records that can 
be immediately retrieved from another location as originals or true 
copies, including by computer or other electronic means, would meet the 
requirement to make these records available to FDA. We also propose to 
require that records be sent electronically, or through another 
delivery method that delivers the records within 1 business day, to FDA 
upon request, rather than provide such records at the place of 
business. We believe that remote access by FDA would be relatively less 
burdensome on manufacturers compared to an FDA visit to a 
manufacturer's place of business.

H. Proposed Enforcement Provisions (Proposed Sec.  730.3(h), (i), and 
(j))

    Manufacturers would be required to keep testing records, including 
any certificates of analysis and qualification and verification 
documentation, for 3 years after the record was created. Manufacturers 
would be required to provide these records to us, including 
electronically, within 1 business day upon request. Failure to test for 
asbestos in a talc-containing cosmetic product or to maintain testing 
records would render the product adulterated under section 601(c) of 
the FD&C Act. Further, if asbestos is present in a talc-containing 
cosmetic product, or in talc used in a cosmetic product, that cosmetic 
product is adulterated under section 601(a) of the FD&C Act. Likewise, 
if asbestos is present in talc intended for use in a cosmetic, that 
talc is adulterated under section 601(a) of the FD&C Act. Finally, 
confirmation of asbestos presence, for example through testing 
conducted on behalf of FDA, similarly means the talc or talc-containing 
cosmetic product tested is adulterated under section 601(a) of the FD&C 
Act. It is a prohibited act under section 301(a) of the FD&C Act to 
introduce or deliver for introduction an adulterated cosmetic into 
interstate commerce.

[[Page 105499]]

VI. Proposed Effective Date

    We propose that any final rule that may be issued based on this 
proposal become effective 30 days after the date of publication of the 
final rule in the Federal Register.

VII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order (E.O.) 12866, E.O. 13563, E.O. 14094, the Regulatory Flexibility 
Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4).
    E.O.s 12866, 13563, and 14094 direct us to assess all benefits, 
costs, and transfers of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). Rules are ``significant'' under E.O. 12866, section 3(f)(1) 
(as amended by E.O. 14094), if they ``have an annual effect on the 
economy of $200 million or more (adjusted every 3 years by the 
Administrator of the Office of Information and Regulatory Affairs 
(OIRA) for changes in gross domestic product); or adversely affect in a 
material way the economy, a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local, territorial, or tribal governments or communities.'' OIRA has 
determined that this proposed rule is not a significant regulatory 
action under E.O. 12866, section 3(f)(1).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the proposed rule would impose small costs on 
affected firms, relative to annual revenue, we propose to certify that 
the proposed rule will not have a significant economic impact on a 
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes estimates of 
anticipated impacts, before proposing ``any rule that includes any 
Federal mandate that may result in the expenditure by State, local, and 
Tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The 2023 threshold after adjustment for inflation is $183 
million, using the most current (2023) Implicit Price Deflator for the 
Gross Domestic Product. This proposed rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    The proposed rule, if finalized, would require testing of talc-
containing cosmetic products using standardized testing method(s) to 
detect and identify asbestos that may be present as a contaminant in 
talc. We summarize the benefits, costs, and transfers of the proposed 
rule in table 1.
    The benefits of the proposed rule include potential public health 
benefits from fewer asbestos exposures. To the extent the proposed rule 
would reduce exposures to asbestos, health benefits would include fewer 
asbestos-related illnesses, such as mesothelioma, lung cancer, larynx 
cancer, and ovarian cancer. We lack data to quantify these public 
health benefits, so we instead discuss them qualitatively. Benefits 
would also include cost savings to manufacturers of talc-containing 
cosmetics from fewer recalls each year. At a 7 percent discount rate, 
the present value of monetized benefits over 10 years would range from 
$0.00 million to $10.42 million, with a primary estimate of $0.48 
million.\1\ At a 3 percent discount rate, the present value of 
monetized benefits over 10 years would range from $0.00 million to 
$12.25 million, with a primary estimate of $0.56 million. Annualized 
monetized benefits over 10 years would range from $0.00 million to 
$1.39 million at a 7 percent discount rate, with a primary estimate of 
$0.06 million, and from $0.00 million to $1.39 million at a 3 percent 
discount rate, with a primary estimate of $0.06 million.
---------------------------------------------------------------------------

    \1\ From the Office of Management and Budget's Circular A-4, the 
``ending point for your analysis should be far enough in the future 
to encompass, to the extent feasible, all the important benefits and 
costs likely to result from all regulatory alternatives being 
assessed.'' We estimate that this proposed rule would have one-time 
costs immediately following the publication of the rule, then 
recurring benefits and costs following the effective date of the 
proposed rule. We therefore choose a 10-year time horizon to 
encompass all important benefits and costs.
---------------------------------------------------------------------------

    The costs of the proposed rule include monetized costs to read and 
understand the rule, monetized asbestos testing costs, and monetized 
costs of subsequent testing conducted on new batches of talc when an 
initial sample of talc tests positive for asbestos. We expect that talc 
producers, talc suppliers, and manufacturers of talc-containing 
cosmetics would all read and understand the rule. Also, we assume that 
all manufacturers of talc-containing cosmetics would rely on 
certificates of analysis from talc suppliers to comply with asbestos 
testing requirements in the proposed rule. As a result, talc suppliers 
would incur costs to regularly test lots or batches of talc for 
asbestos, and manufacturers of talc-containing cosmetics would incur 
costs to maintain qualified talc-suppliers. At a 7 percent discount 
rate, the present value of monetized costs over 10 years would range 
from $9.72 million to $50.97 million, with a primary estimate of $26.58 
million. At a 3 percent discount rate, the present value of monetized 
costs over 10 years would range from $11.41 million to $59.85 million, 
with a primary estimate of $31.20 million. Annualized monetized costs 
over 10 years would range from $1.29 million to $6.78 million at a 7 
percent discount rate, with a primary estimate of $6.78 million, and 
from $1.30 million to $6.81 million at a 3 percent discount rate, with 
a primary estimate of $3.55 million.
    We request both comment and data on the assumptions underlying our 
analysis.

                                  Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
                                                                  [millions of dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Units
                                                                                  ------------------------------------
                   Category                      Primary       Low        High                               Period                  Notes
                                                estimate    estimate    estimate      Year      Discount     covered
                                                                                     dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized ($m/year)...........       $0.06       $0.00       $1.39        2023           7          10  .................................
                                                     0.06        0.00        1.39        2023           3          10  .................................
    Annualized Quantified....................  ..........  ..........  ..........        2023           7  ..........  .................................
                                               ..........  ..........  ..........        2023           3  ..........  .................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 105500]]

 
    Qualitative..............................           Benefits from reduced consumer exposure to asbestos.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($m/year)...........        3.54        1.29        6.78        2023           7          10  .................................
                                                     3.55        1.30        6.78        2023           3          10  .................................
    Annualized Quantified....................  ..........  ..........  ..........  ..........  ..........  ..........  .................................
    Qualitative..............................  ..........  ..........  ..........  ..........  ..........  ..........  .................................
Transfers:
    Federal Annualized Monetized ($m/year)...  ..........  ..........  ..........  ..........  ..........  ..........  .................................
                                              ----------------------------------------------------------------------------------------------------------
                                               From:
                                               To:
                                              ----------------------------------------------------------------------------------------------------------
    Other Annualized Monetized ($m/year).....  ..........  ..........  ..........  ..........  ..........  ..........  .................................
                                              ----------------------------------------------------------------------------------------------------------
                                               From:
                                               To:
                                              ----------------------------------------------------------------------------------------------------------
Effects:
    State, Local, or Tribal Government: None............................................................................................................
    Small Business: Not significant.....................................................................................................................
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a Preliminary Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. The full preliminary 
analysis of economic impacts is available in the docket for this 
proposed rule (Ref. 42) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the OMB under the PRA (44 U.S.C. 3501-3521). 
The title, description, and respondent description of these provisions 
are shown in the following paragraphs with an estimate of the annual 
recordkeeping burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on these topics: (1) whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Recordkeeping of Tests for Asbestos in Talc-Containing 
Cosmetic Products.
    Description of Respondents: The respondents to this information 
collection are manufacturers of a talc-containing cosmetic products 
marketed in the United States.
    Description: The proposed rule would add 21 CFR part 730 to 
subchapter G to require manufacturers of a talc-containing cosmetic 
product to make and keep written records of testing for asbestos to 
verify that talc-containing cosmetic products comply with requirements 
of the FD&C Act. Examples of these records include test data including 
raw data, detail of how samples of the talc-containing cosmetic product 
or talc used in the product were tested, the test method used, the 
result of the test, and if applicable, a supplier's certificate of 
analysis. Raw data must include microscopy images, spectra, diffraction 
patterns, and bench sheets. If a manufacturer relied on a supplier's 
certificate of analysis from a qualified talc supplier, records must 
include any certificate of analysis received from the supplier for 
testing of the talc used to make the finished product, and 
documentation of how a manufacturer qualified the supplier by 
establishing and maintaining the reliability of the supplier's 
certificate of analysis through verification of the results of the 
supplier's tests for asbestos.
    Manufacturers must provide these records upon request from FDA for 
inspection and copying. Upon request, manufacturers must provide to FDA 
within a reasonable time an English translation of records maintained 
in a language other than English. If requested in writing by FDA, a 
manufacturer must send records electronically, or through another means 
that delivers the records within 1 business day, rather than making the 
records available for review at their place of business.
    We estimate the recordkeeping burden of this collection of 
information as follows:

[[Page 105501]]



                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Average  burden
                                                                        Number of        Number of       Total annual         per
                       21 CFR part; activity                          recordkeepers     records per        records       recordkeeping     Total hours
                                                                                        recordkeeper                        (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
730; recordkeeping of tests for asbestos in talc-containing                     801            17.43           13,961               18          251,298
 cosmetic products including certificate of analysis...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimates in table 2 are consistent with the analysis in table 
5 of the Preliminary Regulatory Impact Analysis (Ref. 42). In table 5 
of the Preliminary Regulatory Impact Analysis, FDA estimates that there 
are 801 manufacturers and 13,961 products adjusted for private label 
products. For the purpose of this analysis, we are assuming that each 
batch of talc or lot of talc will supply a cosmetic product for 1 year, 
or that each batch or lot of talc-containing cosmetic product will be 1 
year's supply of cosmetic product. Each batch or lot of talc or 
product, as applicable, must have a record of testing for asbestos. 
With 13,961 products, we estimate that each batch or lot of talc or 
product, as applicable, will be tested annually, creating 13,961 
records. With this estimation, we calculate that each of the 801 
manufacturers will create and maintain 17.43 (17-18) records. We 
estimate that creating and maintaining such records takes about 18 
hours, based on FDA's experience with retail sampling of talc-
containing cosmetic products for the presence of asbestos. Thus, we 
calculate the total burden will be 251,298 hours (801 manufacturers x 
17.43 records/manufacturer = 13,961.43, rounded to 13,961 records; 
13,961 x 18 hours).
    To ensure that comments on information collection are received, OMB 
recommends that comments be submitted at https://www.reginfo.gov/public/do/PRAMain (see ADDRESSES). Find this particular information 
collection by selecting ``Currently Under Review--Open for Public 
Comments'' or by using the search function. The title of this proposed 
collection is ``Testing Methods for Detecting and Identifying Asbestos 
in Talc-Containing Cosmetic Products.''
    In compliance with the PRA (44 U.S.C. 3407(d)), we have submitted 
the information collection provisions of this proposed rule to OMB for 
review. These information collection requirements will not be effective 
until FDA publishes a final rule, OMB approves the information 
collection requirements, and the rule goes into effect. FDA will 
announce OMB approval of these requirements in the Federal Register.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13132. We have determined that the 
proposed rule does not contain policies that have substantial direct 
effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the E.O. and, consequently, a 
federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in E.O. 13175. We have tentatively determined that 
the rule does not contain policies that would have a substantial direct 
effect on one or more Indian Tribes, on the relationship between the 
Federal Government and Indian Tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian Tribes. 
The Agency solicits comments from tribal officials on any potential 
impact on Indian Tribes from this proposed action.

XII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. Although FDA verified the website addresses 
in this document, please note that websites are subject to change over 
time.

1. *Robinson, G.R., Jr., B.S. Van Gosen, and N.K. Foley, 
``Ultramafic-hosted Talc-Magnesite deposits''. U.S. Geological 
Survey presentation at 42nd Forum on the Geology of Industrial 
Minerals, May 7-13, 2006, in Asheville, NC (USA). Available at: 
https://pubs.usgs.gov/of/2006/1229/of2006-1229.pdf (accessed 
December 11, 2024).
2. *``Where is Asbestos Found?'' Agency for Toxic Substances and 
Disease Registry web page on Naturally Occurring Asbestos. Available 
at: https://archive.cdc.gov/www_atsdr_cdc_gov/csem/asbestos/
where_is_asbestos_found.html#:~:text=Asbestos%20is%20also%20present%2
0in,deep%20to%20be%20disturbed%20easily (accessed December 11, 
2024).
3. *Virta, R.L., ``Asbestos: Geology, Mineralogy, Mining and 
Uses.''. U.S. Geological Survey Report No. 02-149, 2002. Available 
at: https://pubs.usgs.gov/of/2002/of02-149/of02-149.pdf (accessed 
December 11, 2024).
4. Segrave, A.M., 2021. ``Overview of the Geology of Cosmetic Talc 
Formation and Morphology of Amphiboles''. ASTM Selected Technical 
Papers No. 1632, Asbestos and Other Elongate Mineral Particles. J. 
R. Millette and J. S. Webber. Available at: Overview of the Geology 
of Cosmetic Talc Formation and Morphology of Amphiboles  
Asbestos and Other Elongate Mineral Particles--New and Continuing 
Challenges in the 21st Century  ASTM eBooks  ASME 
Digital Collection.
5. * National Toxicology Program, 2021. ``Asbestos.''. In: Report on 
Carcinogens. Fifteenth Edition. U.S. Department of Health and Human 
Services, Public Health Service, National Toxicology Program. 
Available at: https://ntp.niehs.nih.gov/ntp/roc/content/profiles/asbestos.pdf (accessed December 11, 2024).
6. * ``Toxicological Review of Libby Amphibole Asbestos, 
Environmental Protection Agency (EPA) Integrated Risk Information 
System (IRIS) EPA/635/R-11/002F,'' 2014. Available at: https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/1026tr.pdf (accessed December 11, 2024).
7. * Filetti, V, E. Vitale, G. Broggi, et al. ``Update of In-Vitro, 
In-Vivo and Ex-Vivo Fluoro-edenite Effects on Malignant 
Mesothelioma: A Systematic Review (Review)'', Biomedical Reports, 
13(6):60, December 2020. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC7605121/.

[[Page 105502]]

8. * ``Toxicological Profile for Asbestos'', 2001. Agency for Toxic 
Substances and Disease Registry of the U.S. Department of Health and 
Human Services Centers for Disease Control. https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=30&tid=4 (accessed December 11, 
2024).
9. * ``Arsenic, Metals, Fibres, and Dusts--Volume 100C, A Review of 
Human Carcinogens--Asbestos (Chrysotile, Amosite, Crocidolite, 
Tremolite, Actinolite, and Anthophyllite),'' pp. 219-309, 2012. 
International Agency for Research on Cancer (IARC). Lyon, France. 
Available at: https://publications.iarc.fr/Book-And-Report-Series/Iarc-Monographs-On-The-Identification-Of-Carcinogenic-Hazards-To-Humans/Arsenic-Metals-Fibres-And-Dusts-2012 (accessed December 11, 
2024).
10. ``Asbestos--Selected Cancers'', National Academies of Science 
and Medicine Consensus Study Report, 2006. Available at: https://nap.nationalacademies.org/catalog/11665/asbestos-selected-cancers 
(accessed December 11, 2024).
11. * ``Asbestos--Overview'' Occupational Safety and Health 
Administration (https://www.osha.gov/asbestos).
12. * ``Asbestos--Hazards and Safe Practice for Clear-Up After 
Tsunami''. World Health Organization Regional Office of Southeast 
Asia. May 3, 2006. Available at: https://www.who.int/docs/default-
source/chemical-safety/asbestos/asbestos_hazards-and-safe-practice-
for-clear-up-after-tsunami.pdf (accessed December 11, 2024).
13. * Interagency Workgroup for Asbestos in Consumer Products 
(IWGACP), January 13, 2022. ``Appendices to White Paper: IWGACP 
Scientific Opinions on Testing Methods for Asbestos in Cosmetics 
Products Containing Talc.'' Available at: https://www.regulations.gov/document/FDA-2020-N-0025-0054 (accessed December 
11, 2024).
14. * Cook, P.M., and G.F. Olson. ``Ingested Mineral Fibers: 
Elimination in Human Urine,'' Science, 204: 195-198, 1979.Available 
at: https://www.ncbi.nlm.nih.gov/pubmed/219478 (accessed December 
11, 2024).
15. Heller, D.S., R.E. Gordon, C. Westhoff, and S. Gerber. 
``Asbestos Exposure and Ovarian Fiber Burden,'' American Journal of 
Industrial Medicine, 29: 435-439, 1996. Available at: https://www.ncbi.nlm.nih.gov/pubmed/8732916.
16. Suzuki, Y. and N. Kohyama. ``Translocation of Inhaled Asbestos 
Fibers from the Lung to Other Tissues'', American Journal of 
Industrial Medicine, 19: 701-704, 1991.Available at: https://www.ncbi.nlm.nih.gov/pubmed/1882849.
17. Fitzgerald, S.M., ``Comparing Historical and Recent Accelerated 
Concerns Regarding Asbestos in Talc,'' 2021. ASTM Selected Technical 
Papers Series, No. 1632, Asbestos and Other Elongate Mineral 
Particles. J.R. Millette and J.S. Webber, ed. Available at: https://asmedigitalcollection.asme.org/astm-ebooks/book/2238/chapter-abstract/27896558/Comparing-Historical-and-Recent-Accelerated?redirectedFrom=fulltext.
18. * FDA. ``Talc.'' Previous Activity--FDA's Talc Survey of 2009-
2010. Available at: https://www.fda.gov/cosmetics/cosmetic-ingredients/talc#64f0201d159f9 (accessed December 11, 2024).
19. * FDA. ``FDA In Brief: FDA Releases Final Report of Talc-
containing Cosmetic Products Tested for Asbestos.'' Available at: 
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-releases-final-report-talc-containing-cosmetic-products-tested-asbestos 
(accessed December 11, 2024).
20. * Millette, J.R. ``Procedure for the Analysis of Talc for 
Asbestos.'' The Microscope, 63(1), pp. 11-20, 2015. Available at: 
https://jifsan.umd.edu/files/wordpress/wp-content/uploads/2018/11/Asbestos-2018-Millette-GeneralReference-4.pdf (accessed 12/11/2024).
21. * Block, L.H., D. Beckers, J. Ferret, et al. ``Stimuli to the 
Revision Process, Modernization of Asbestos Testing in USP Talc,'' 
USP-PF 40(4), pp. 455-472, 2014. Available at: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/pf-legacy-pdf/pf-2014_vol-40.pdf (accessed December 11, 2024).
22. * Interagency Workgroup for Asbestos in Consumer Products 
(IWGACP), January 13, 2022. ``White Paper: IWGACP Scientific 
Opinions on Testing Methods for Asbestos in Cosmetic Products 
Containing Talc.'' Available at: https://www.regulations.gov/document/FDA-2020-N-0025-0053 (accessed December 11, 2024).
23. * FDA. ``Peer Review Report External Peer Review Comment and FDA 
Responses'' 2024. Available at: https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews.
24. * FDA. ``Public Meeting on Testing Methods for Asbestos in Talc 
and Cosmetic Products Containing Talc''. Available at: https://www.fda.gov/cosmetics/cosmetics-news-events//public-meeting-testing-methods-asbestos-/talc-and-cosmetic-products-containing-talc-02042020 (accessed December 11, 2024).
25. Miller, E., E.M. Beckett, D. Cheatham, et al. ``A Review of the 
Mesotheliogenic Potency of Cleavage Fragments Found in Talc,'' 
Toxicology and Industrial Health, 40(7): 398-424, 2024. Available 
at: https://journals.sagepub.com/doi/abs/10.1177/07482337241246924.
26. * Lowers, H. and G. Meeker, 2002, ``Tabulation of Asbestos 
Related Terminology.'' Available at: https://pubs.usgs.gov/of/2002/ofr-02-458/OFR-02-458-508.pdf (accessed December 11, 2024).
27. * Campbell, W.J., R.L. Blake, L.L. Brown, et al., 1977, 
``Selected Silicate Minerals and Their Asbestiform Varieties,'' U.S. 
Bureau of Mines (Department of the Interior) Information Circular 
8751. #18--Selected Silicate Minerals and Their Asbestiform 
Varieties. Available at: https://babel.hathitrust.org/cgi/pt?id=mdp.39015078453563&view=2up&seq=1 (accessed December 11, 
2024).
28. * Van Gosen, B.S., H.A. Lowers, and S.J. Sutley, 2004. ``A USGS 
Study of Talc Deposits and Associated Amphibole Asbestos Within 
Mined Deposits of the Southern Death Valley Region, California.'' 
U.S. Geological Survey Open-File Report 2004-1092. Available at: 
https://pubs.usgs.gov/of/2004/1092/ (accessed December 11, 2024).
29. * Baumann, F., J.-P. Ambrosi, M. Carbone. ``Asbestos Is Not Just 
Asbestos: An Unrecognised Health Hazard.'' The Lancet. Oncology, 
14(7): 576-578, 2013. Available at: https://pubmed.ncbi.nlm.nih.gov/23725699/ (accessed December 11, 2024).
30. * National Institute for Occupational Safety and Health (NIOSH), 
2011. Asbestos Fibers and Other Elongate Mineral Particles: State of 
the Science and Roadmap for Research. In Current Intelligence 
Bulletin 62. Department of Health and Human Services. Centers for 
Disease Control and Prevention. Publication No. 2011-159. April. 
Available at: https://www.cdc.gov/niosh/docs/2011-159/pdfs/2011-159.pdf (accessed December 11, 2024).
31. ISO 22262-1:2012--Air quality--Bulk materials--Part 1: Sampling 
and qualitative determination of asbestos in commercial bulk 
materials. Annex D (pp. 43-51).
32. ISO 10312:2019--Ambient air--Determination of asbestos fibres--
Direct transfer transmission electron microscopy method. Annex C 
(pp. 34-36).
33. * International Mineralogical Association. Amphibole Supergroup: 
Mineral information, data and localities. Available at: https://www.mindat.org/min-207.html (accessed December 11, 2024).
34. * CIR Expert Panel Meeting March 18-19, 2013, See Safety 
Assessment of Talc as Used in Cosmetics, CTFA Method J4-1 (1976) 
``Asbestiform Amphibole Minerals in Cosmetic Talc,'' pp. 66-82. 
Available at: https://www.cir-safety.org/sites/default/files/032013_web_w2.pdf) (accessed December 11, 2024).
35. * USP-NF Compendial Notices, Intent to Revise Talc USP Monograph 
Asbestos Test Method, July 31, 2020; updated December 18, 2020. 
Available at: https://www.uspnf.com/notices/talc-nitr-20200731 
(accessed December 11, 2024).
36. ISO/IEC Guide 2:2004 ``Standardization and related activities--
General vocabulary.'' ISO/IEC. November 2004.
37. * Rosner, D, G. Markowitz, and M. Chowkwanyun, July 2019. 
``Nondetected: The Politics of Measurement of Asbestos in Talc, 
1971-1976,'' American Journal of Public Health Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC6603445/ (accessed December 11, 
2024).
38. USP-NF ``Talc.'' Absence of Asbestos Test Method, Official May 
1, 2022.

[[Page 105503]]

39. * USP-NF Compendial Notices, ``Talc, <901> Detection of Asbestos 
in Pharmaceutical Talc, <1901> Theory and Practice of Asbestos 
Detection in Pharmaceutical Talc,'' May 2023. Available at: https://www.uspnf.com/notices/talc-official-dates-20230601 (accessed 
December 11, 2024).
40. * USP-NF Compendial Notices, ``General Chapter Prospectus: <901> 
Detection of Asbestos in Pharmaceutical Talc,'' posted April 2021; 
updated August 2021. USP-NF. Available at: https://www.uspnf.com/notices/gc-901-prospectus-20210430 (accessed December 11, 2024).
41. * USP-NF Compendial Notices, ``General Chapter Prospectus: 
<1901> Theory and Practice of Asbestos Detection in Pharmaceutical 
Talc,'' posted April 2021; updated August 2021. USP-NF. Available 
at: https://www.uspnf.com/notices/gc-1901-prospectus-20210430 
(accessed December 11, 2024).
42. * FDA. Preliminary Regulatory Impact Analysis; Initial 
Regulatory Flexibility Analysis; Unfunded Mandates Reform Act 
Analysis; Testing Methods for Detecting and Identifying Asbestos in 
Talc-Containing Cosmetic Products; Proposed Rule. Available at: 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

List of Subjects in 21 CFR Part 730

    Cosmetics, Incorporation by reference, Recording and recordkeeping 
requirements, Testing.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, FDA 
proposes to amend chapter I of title 21 of the Code of Federal 
Regulations by adding part 730 to subchapter G to read as follows:

PART 730--REQUIREMENTS FOR TALC-CONTAINING COSMETIC PRODUCTS

Subpart A--Testing Methods
Sec.
730.1-730.2 [Reserved]
730.3 Testing methods for detecting and identifying asbestos in 
talc-containing cosmetic products.
730.4-730.100 [Reserved]
Subparts B through K [Reserved]

    Authority:  21 U.S.C. 321, 331, 352, 355, 361, 362, 371, 374; 
sec. 3505, Pub. L. 117-328, 136 Stat. 4459.

Subpart A--Testing Methods


Sec. Sec.  730.1-730.2  [Reserved]


Sec.  730.3  Testing methods for detecting and identifying asbestos in 
talc-containing cosmetic products.

    (a) Who is subject to this section? You are subject to this section 
if you manufacture a talc-containing cosmetic product.
    (b) What definitions apply to this section? For purposes of this 
section:
    (1) Asbestos means amosite, chrysotile, crocidolite; asbestiform 
tremolite, actinolite, anthophyllite, winchite, and richterite; and 
other asbestiform amphibole minerals.
    (2) Representative sample means a sample that consists of a number 
of units that are drawn based on rational criteria, such as random 
sampling, and intended to ensure that the sample accurately portrays 
the material being sampled.
    (c) What test methods must you use? (1) You must use an analytical 
approach that includes both Polarized Light Microscopy (PLM) (with 
dispersion staining), and Transmission Electron Microscopy (TEM)/Energy 
Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction 
(SAED). You must conduct the tests on either a representative sample of 
each batch or lot of the talc-containing cosmetic product or on a 
representative sample of each batch or lot of the talc ingredient that 
will be incorporated into the talc-containing cosmetic product.
    (i) Use of PLM method. Detecting and identifying asbestos must be 
based on comparison of optical crystallographic properties (i.e., color 
and pleochroism, refractive indices, birefringence, extinction 
characteristics and sign of elongation) and particle morphology with 
data for and images of asbestos in Annex D of ISO 22262-1:2012(E). 
Images of asbestos from ISO 22262-1:2012(E) (Annex D) for PLM analysis 
of asbestos must be used as visual aids to assist the analyst.
    (ii) Use of TEM/EDS/SAED method. You must examine an area 
containing at least 0.1 micrograms of talc on a TEM grid on which the 
sample is uniformly distributed. Detecting and identifying asbestos 
must be based on comparison of elemental composition, crystal structure 
of particles, and particle morphology with data for and images of 
asbestos in Figure C.1 in Annex C of ISO 10312:2019(E). Images of 
asbestos from ISO 10312:2019(E) (Figure C.1 in Annex C) must be used as 
visual aids to assist the analyst.
    (2) [Reserved]
    (d) How does one determine if a sample has tested positive for 
asbestos? If asbestos is detected based on use of PLM or based on the 
use of TEM/EDS/SAED as required in paragraph (c) of this section, the 
sample must be regarded as positive for asbestos and therefore asbestos 
must be regarded as present in the material represented by that sample.
    (e) Is there an alternative to performing finished product testing 
for detecting and identifying asbestos in your talc-containing cosmetic 
product? If you manufacture a talc-containing cosmetic product and do 
not perform testing for detecting and identifying asbestos in your 
talc-containing cosmetic product before you release the product, all 
the talc in your product must have been tested in accordance with 
paragraph (c) of this section prior to using the talc in the 
manufacture of a talc-containing cosmetic product. You may rely on a 
certificate of analysis from the supplier of the talc ingredient if you 
qualify the supplier by establishing and maintaining the reliability of 
the supplier's certificate of analysis through verification of the 
results of the supplier's tests for asbestos in accordance with 
paragraph (f) of this section. The certificate of analysis must at 
minimum state that:
    (1) The supplier uses an analytical approach that includes both PLM 
and TEM/EDS/SAED as described in paragraph (c) of this section; and
    (2) The certificate of analysis is specific to the talc purchased 
by the manufacturer, including identification of a lot or batch number 
for the talc being tested, the date or date range when the test(s) were 
performed, and the results of each test.
    (f) How frequently must tests be performed? At a minimum, you must 
test a representative sample of each batch or lot of each talc-
containing cosmetic product or talc ingredient for asbestos in 
accordance with paragraph (c) of this section. If you rely on the 
supplier's certificate of analysis in accordance with paragraph (e) of 
this section, you must at least upon receipt of the supplier's initial 
certificate of analysis and subsequently annually thereafter verify the 
reliability of the reported asbestos test results based on testing by 
you or another laboratory as required in paragraph (c).
    (g) What records must be kept? You must keep records of testing for 
asbestos that show test data, including raw data. The record must 
describe in detail how samples of the product or talc used in your 
product were tested, the test method used, and the result of the test. 
Raw data must include microscopy images, spectra, diffraction patterns 
and bench sheets. If you rely on a supplier's certificate of analysis, 
records must include any certificate of analysis received from the 
supplier for testing of the talc used to make the finished product, and 
documentation of how you qualified the supplier by establishing and 
maintaining the reliability of the supplier's certificate of analysis 
through verification of the results of the supplier's tests for 
asbestos in

[[Page 105504]]

accordance with paragraph (f) of this section. You must keep such 
records for, at a minimum, 3 years after the date such record was 
created. You must make all records required under this subpart 
available within 1 business day to an authorized FDA representative, 
upon request, for inspection and copying. Upon FDA request, you must 
provide within a reasonable time an English translation of records 
maintained in a language other than English.
    (1) Records must be kept as original records, as true copies (such 
as photocopies or other accurate reproductions of the original 
records), or as electronic records.
    (2) Electronic records must comply with part 11 of this chapter.
    (3) Documents and records must be retrieved as originals or true 
copies, and available for copying by FDA, including by computer or 
other electronic means, using equipment readily accessible to FDA 
during an inspection. If requested in writing by FDA, you must send 
records electronically, or through another means that delivers the 
records within 1 business day, rather than making the records available 
for review at your place of business.
    (h) What consequences result from failing to test talc ingredients 
or talc-containing product for asbestos or failing to rely on and 
verify a certificate of analysis from the talc ingredient supplier? 
Failure of a manufacturer to test a talc ingredient or a talc-
containing product in compliance with paragraph (c) of this section 
renders the product adulterated under section 601(c) of the Federal 
Food, Drug, and Cosmetic Act.
    (i) What consequences result from failing to comply with the 
recordkeeping requirements? Failure of a manufacturer to operate in 
compliance with the requirements of paragraph (g) of this section 
renders the cosmetic product adulterated under section 601(c) of the 
Federal Food, Drug, and Cosmetic Act.
    (j) What consequences result from the presence of asbestos in a 
talc-containing cosmetic product, or in talc used in that cosmetic 
product, or from the presence of asbestos in talc intended for use in 
cosmetics? If asbestos is present in a talc-containing cosmetic product 
or in talc used in that cosmetic product, that cosmetic product is 
adulterated under section 601(a) of the Federal Food, Drug, and 
Cosmetic Act. If asbestos is present in talc intended for use in a 
cosmetic, that talc is adulterated under section 601(a) of the Federal 
Food, Drug, and Cosmetic Act.
    (k) Incorporation by reference. Material listed in this paragraph 
(k) is incorporated by reference into this section with approval of the 
Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 
51. All approved material is available for inspection at the Food and 
Drug Administration and at the National Archives and Records 
Administration (NARA). Contact the Food and Drug Administration between 
9 a.m. and 4 p.m. Monday through Friday at: Dockets Management Staff, 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852; phone: 240-402-7500; email: [email protected]. 
For information on the availability of this material at NARA, visit 
www.archives.gov/federal-register/cfr/ibr-locations or email 
[email protected]. The material may be obtained from The 
International Organization for Standardization (ISO), BIBC II, Chemin 
de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; phone: +41-
22-749-01-11; email: [email protected]; website: https://www.iso.org/store.html.
    (1) ISO 22262-1:2012(E), ``Air quality--Bulk materials--Part 1: 
Sampling and qualitative determination of asbestos in commercial bulk 
materials,'' Annex D, Asbestos identification by PLM and dispersion 
staining in commercial materials, First edition, July 1, 2012.
    (2) ISO 10312:2019(E), ``Ambient air--Determination of asbestos 
fibres--Direct transfer transmission electron microscopy method,'' 
Annex C, Structure counting criteria, Figure C.1, Second edition, 
October 10, 2019.


Sec. Sec.  730.4-730.100  [Reserved]

Subparts B Through K [Reserved]

    Dated: December 17, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-30544 Filed 12-26-24; 8:45 am]
BILLING CODE 4164-01-P`