[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
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Abbreviation/acronym What it means
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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.
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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