Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc; Public Meeting; Request for Comments

 
CONTENT
Federal Register, Volume 85 Issue 7 (Friday, January 10, 2020)
[Federal Register Volume 85, Number 7 (Friday, January 10, 2020)]
[Notices]
[Pages 1317-1320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00259]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0025]
Testing Methods for Asbestos in Talc and Cosmetic Products
Containing Talc; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
public meeting entitled ``Testing Methods for Asbestos in Talc and
Cosmetic Products Containing Talc.'' The purpose of the public meeting
is to discuss and obtain scientific information on topics related to
testing methodologies, terminology, and criteria that can be applied to
characterize and measure asbestos and other potentially harmful
elongate mineral particles (EMPs) that may be present as contaminants
in talc and cosmetic products manufactured using talc as an ingredient.
DATES: The public meeting will be held on February 4, 2020, from 8:30
a.m. to 5 p.m. Eastern Time, or until after the last public commenter
has spoken, whichever occurs first. Submit requests to make oral
presentations and comments at the public meeting by January 17, 2020.
Electronic or written comments on this meeting will be accepted until
March 4, 2020. See the SUPPLEMENTARY INFORMATION section of this
document for information about early registration, requesting special
accommodations due to disability, and other information regarding
meeting participation.
ADDRESSES: The public meeting will be held at the Food and Drug
Administration, White Oak Campus, 10903 New Hampshire Ave., Building 31
Conference Center, The Great Room (Rm. 1503), Silver Spring, MD 20993.
Entrance for the public meeting participants (non-FDA employees) is
through Building 1, where routine security check procedures will be
performed. For parking and security information, please refer to
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2020-N-0025. The docket will close on March 4,
2020. Submit either electronic or written comments on or before March
4, 2020. The electronic filing system will accept comments until 11:59
p.m. Eastern Time at the end of March 4, 2020. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date. Please note that late,
untimely filed comments will not be considered.
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 below (see ``Written/Paper Submissions'' and
``Instructions'').
Written/Paper Submissions
    Submit written/paper submissions as follows:
     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-2020-N-0025 for ``Testing Methods for Asbestos in Talc and Cosmetic
Products Containing Talc.'' 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.
     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.'' We will review
this copy, including the claimed confidential information, in our
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 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.
FOR FURTHER INFORMATION CONTACT: Denise Hodge, Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5001
Campus Dr. (HFS-125), College Park, MD 20740,
[[Page 1318]]
301-796-7739, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
    Talc is used in a wide variety of consumer products, including
cosmetics. Talc is mined as a naturally occurring hydrous magnesium
silicate and may be contaminated with asbestos fibers due to the
proximity of asbestos to talc deposits. Asbestos is a known human
carcinogen, and its health risks are well documented. Inhalation of
asbestos is a safety concern because it can cause the formation of
scar-like tissue in the lung, resulting in asbestosis, or it may lead
to the development of lung cancers and malignant mesothelioma.
    In 1976, the cosmetics industry implemented voluntary asbestos
testing of talc raw materials using the Cosmetic, Toiletry, and
Fragrance Association (CTFA) J4-1 (Ref. 1) method in response to test
results indicating asbestos to be present. Talc suppliers to the
pharmaceutical industry use a similar method to certify that talc meets
the United States Pharmacopeia's (USP's) requirement for ``Absence of
Asbestos'' (Ref. 2). To date, both methods, which rely on the use of x
ray diffraction (XRD) or infrared (IR) spectroscopy followed by
polarized light microscopy (PLM) only if XRD or IR is positive for
amphibole or serpentine minerals in talc, remain standard test methods
despite long-recognized shortcomings in specificity and sensitivity
compared with electron microscopy-based methods. In 2010, FDA asked the
USP to consider revising the current tests for asbestos in talc to
ensure adequate specificity, and, in 2014, the Talc USP expert panel
recommended an update of the Talc USP monograph to require an electron
microscopy method for the measurement of asbestos in talc (Refs. 3 and
4). Recent testing of cosmetics by private laboratories \1\ using
transmission electron microscopy (TEM) has revealed the presence of
asbestos fibers in samples that had negative findings for the same
products using polarized light microscopy, thus highlighting the
shortcomings of optical microscopy methods.
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    \1\ See AMA testing results at FDA's Investigation of Reports of
Asbestos Contamination in Cosmetics 2017-2019 tab at https://www.fda.gov/cosmetics/cosmetic-ingredients/talc.
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    FDA monitors for asbestos in talc-containing cosmetic products,
including directing its sampling of products toward confirming reports
from various laboratories that have reported asbestos using electron
microscopy. For example, in 2010, shortly after reports of asbestos
contaminated talc-containing products in Asia, FDA surveyed 34 cosmetic
products,\2\ including body powders, face powders, foundation, eye
shadow, blush, and samples from four major talc suppliers and found no
asbestos contamination using the most sensitive techniques available.
FDA's survey was limited in scope but served to provide data from
testing using TEM, currently regarded by many experts as the most
reliable technique for detecting asbestos fibers (see Ref. 4). In July
2017, FDA began investigating reports of asbestos contamination of
cosmetic products that contained talc, presumably originating from talc
that was used as an ingredient in the cosmetic products. In 2019, FDA
surveyed 50 talc-containing cosmetic products. In March, June, August,
and October 2019, FDA confirmed the presence of chrysotile and/or
tremolite asbestos in several cosmetic products, which were voluntarily
recalled by the companies. The use of TEM was critical in detecting
asbestos in these cosmetic products.
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    \2\ https://www.fda.gov/cosmetics/cosmetic-ingredients/talc.
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    Even when using the most sensitive electron microscopy methods,
laboratories testing the same product may reach different conclusions
about the presence of asbestos. These differences may be attributed to
a lack of a uniform standard for testing which provides unambiguous
guidelines for identifying and counting asbestos fibers. Thus, at FDA's
request, on November 28, 2018, the Joint Institute for Food Safety and
Applied Nutrition (JIFSAN) convened an ``Asbestos in Talc'' symposium
to provide a forum for experts in asbestos mineral analysis,
academicians, and government officials to share knowledge and
experience.\3\ The discussions focused on the toolbox of available
testing methods for analysis of asbestos in talc and talc-containing
cosmetic products, criteria used for asbestos fiber identification and
counting in current published methods, and how analytical microscopy
data might be interpreted in making decisions about the suitability of
cosmetic products found to contain asbestos and other potentially
harmful mineral particles.
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    \3\ https://jifsan.umd.edu/events/2018-asbestos-in-talc-symposium.
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    During the fall of 2018, FDA formed an interagency working group on
asbestos in consumer products (IWGACP). The IWGACP consists of 38
subject matter experts from the following U.S. federal agencies: FDA,
National Institute for Occupational Safety and Health (NIOSH), National
Institutes of Health/National Institute of Environmental Health
Sciences, Occupational Safety and Health Administration, Environmental
Protection Agency, Consumer Product Safety Commission, National
Institute of Standards and Technology, and Department of Interior's
U.S. Geological Survey. The IWGACP was asked to support the development
of standardized testing methods for asbestos and other mineral
particles of concern that could potentially affect consumer product
safety. The IWGACP was tasked to address terminology and definitions of
asbestos and other EMPs of health concern in talc and talc-containing
consumer products, recommend methodological improvements for measuring
asbestos in talc and talc-containing consumer products, and recommend
laboratory reporting standards for testing talc and talc-containing
consumer products. The IWGACP is also addressing issues regarding
asbestos contamination in talc-containing cosmetic products, the
presumptive source of asbestos, as well as scientific and technical
information shared at the JIFSAN Symposium and how that information
could be used by different government agencies. The IWGACP is comprised
of three subgroups formed to address the following topics: (1)
Terminology and definitions of asbestos and other EMPs of health
concern in talc; (2) development of a robust analytical protocol for
detecting asbestos and other EMPs of health concern in talc and
consumer products containing talc; and (3) data reporting and analysis.
II. Purpose of the Public Meeting
    FDA is interested in obtaining information to further the
development of standardized testing methods to improve sensitivity,
consistency, and inter-laboratory concurrence of asbestos testing of
talc used in cosmetic products and of talc-containing cosmetic
products. Toward this end, at the public meeting, IWGACP members will
present preliminary recommendations (summarized in section IV.C) on
testing methods, including criteria to be used for asbestos fiber
identification and counting. We will also seek additional information
on these topics at the meeting. We do not intend for this meeting to
produce any decisions or new positions on specific regulatory
questions. However, we expect this meeting to be an important step in
our continued efforts to gather information, including data to improve
the consistency in terminology, analytical protocols, and data
reporting for
[[Page 1319]]
asbestos and other potentially harmful mineral particles that may be
present as contaminants in talc and cosmetic products containing talc
and provide information that can be used for future discussions on
health effects.
III. Participating in the Public Meeting
    Registration: To register to attend the public meeting on ``Testing
Methods for Asbestos in Talc and Cosmetic Products Containing Talc,''
either in person or by webcast, please register at https://www.fda.gov/cosmetics/cosmetics-news-events/meetings-conferences-workshops-cosmetics by January 28, 2020, at 11:59 p.m. Eastern Time. Please
provide complete contact information for each attendee, including name,
title, affiliation, and email and whether you want to attend in person
or by webcast. The FDA Conference Center at the White Oak location is a
Federal facility with security procedures and limited seating.
Attendance will be free and based on space and availability. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted for
in-person attendance. If time and space permit, onsite registration on
the day of the public meeting will be provided beginning at 7:30 a.m.
We will inform registrants if registration closes before the day of the
public meeting. Persons attending this meeting are advised that FDA is
not responsible for providing access to electrical outlets. FDA will
make every effort to accommodate persons with physical disabilities or
special needs. If you need special accommodations due to a disability,
please contact Denise Hodge (see FOR FURTHER INFORMATION CONTACT) no
later than January 17, 2020.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to make a formal presentation (with up to five
slides) or present oral comments during the public comment session
(with no slides), and you may indicate which topic(s) you would like to
address. Oral presentations can only be made in person at the meeting.
FDA will do its best to accommodate requests to make public
presentations. We seek a broad representation of ideas and issues
presented at the meeting. We urge individuals and organizations with
common interests to consolidate or coordinate their presentations and
request time for a joint presentation. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each presentation is to begin and
will select and notify participants by January 21, 2020. All requests
to make oral presentations must be received by January 17, 2020, 11:59
p.m. Eastern time. Typically, presentations are between 3 and 5
minutes. If selected for a formal oral presentation (with slides), each
presenter must submit an electronic copy of their presentation
(PowerPoint or PDF) to [email protected] on or before January 28,
2020. Those who are not giving electronic presentations are encouraged
to submit a single slide (PowerPoint or PDF) with their name,
affiliation, and topic. No commercial or promotional material will be
permitted to be presented or distributed at the public meeting. Persons
notified that they will be presenters are encouraged to arrive early
and check in at the onsite registration table to confirm their
designated presentation times. Actual presentation times may vary based
on how the meeting progresses in real time. An agenda for the public
meeting and any other background materials will be made available at
least 5 days before the meeting at https://www.fda.gov/cosmetics/cosmetics-news-events/meetings-conferences-workshops-cosmetics. Those
without internet or email access can register and/or request to
participate by contacting Denise Hodge (see FOR FURTHER INFORMATION
CONTACT) no later than January 17, 2020.
    Transcripts: A transcript of the public meeting will be made
available as soon as feasible. It will be accessible at
www.regulations.gov and https://www.fda.gov/cosmetics/cosmetics-news-events/meetings-conferences-workshops-cosmetics. It may be viewed at
the Dockets Management Staff (see ADDRESSES). A transcript will also be
made available in either hardcopy or on CD-ROM, in response to a
Freedom of Information Act request. A Freedom of Information Act
request may be submitted by visiting https://www.accessdata.fda.gov/scripts/foi/foirequest/requestform.cfm or by submitting an email
request to [email protected].
IV. Issues for Consideration and Request for Information
    We encourage public comments and presentations at the public
meeting. In submitting information to the docket, please provide
available references for the information.
A. Testing Methodologies and Criteria
    As previously discussed, laboratories may reach different
conclusions as to whether asbestos and other potentially harmful EMPs
are present when testing consumer products. We are seeking scientific
information on the following topics related to testing methodologies
and criteria that can be applied to characterize and measure asbestos
and other potentially harmful EMPs present as contaminants in talc and
cosmetic products manufactured using talc as an ingredient. We invite
comments on the following:
    1. The sensitivity of PLM as a test method, including whether the
test method can lead to a false negative result for asbestos particles.
    2. The sensitivity of TEM as a test method, including the ability
of the test method to identify asbestos particles in comparison to PLM.
    3. Criteria for identification of the specified asbestos minerals,
noting that different minerals with the same chemical composition can
exist in samples.
B. Research Needs To Promote the Reliability of Analytical Methods
    The IWGACP identified the following as areas for directing efforts
to promote reliability of the analytical methods for asbestos and other
EMPs of health concern in talc and talc-containing consumer products.
We invite such information to be presented during the public comment
section of the meeting:
    1. Validation of analytical methods (XRD, PLM, TEM) specific to
talc and cosmetic products containing talc that minimize false positive
and false negative results.
    2. Research and validation of methods of sampling that maximize
sample representativeness and minimize error and false positives and
false negatives.
    3. Research on methods for sample preparation, in particular
treatment (e.g., ``concentration methods'') that improves sensitivity
while leaving covered minerals unchanged with respect to identity and
dimensions.
    4. Development of talc-specific reference standards with known
concentrations of specific EMPs that can be used to assess laboratory
and analyst proficiency, increase inter-laboratory concurrence in
method validation, minimize reporting errors, and potentially provide
for improved reliability of quantitative analysis.
C. IWGACP's Preliminary Recommendations
    We invite comments related to the following preliminary
recommendations from the IWGACP:
    1. Adoption of the term EMP as ``any mineral particle with a
minimum aspect ratio of 3:1'', consistent with how this term is defined
in NIOSH Bulletin 62 (Ref. 5).
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    2. Testing laboratories should report all EMPs having length >=0.5
micrometers (500 nanometers (nm)).
    3. Test methods should specify reportable EMPs identified as
amphibole or chrysotile particles as covered minerals.
    4. Test methods should include the counting and reporting of
covered EMPs as a function of sample mass. In counting, guidelines such
as ISO 10312, ``Ambient air--Determination of asbestos fibres--Direct
transfer transmission electronic microscopy method'' (Ref. 6), classify
primary and secondary structures. Individual fibers in secondary
structures can be counted recording the dimensions of each fiber.
    5. Use of TEM at nominally 20,000 x magnification, in addition to
PLM, to resolve the issues of sensitivity that cause reporting of false
negatives for covered EMPs. Use of TEM with energy dispersive x ray
spectroscopy and selected area electron diffraction analyses may
reliably detect and identify chrysotile and asbestiform and non-
asbestiform amphibole minerals, including EMPs whose narrowest width is
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. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
1. The Cosmetic, Toiletry and Fragrance Association, Inc. (CTFA)
1990. Method, J 4-1, ``Asbestiform Amphibole Minerals in Cosmetic
Talc'' in Compendium of Cosmetic Ingredient Composition:
Specifications Personal Care Products Council, Washington DC (1976)
(revised in 1990). See http://www.asbestosandtalc.com/EMP%20Detection%20Limits%20ASTM/PCPC000960.pdf.
2. USP, Revision Bulletin, ``Talc,'' dated August 1, 2011, at page
2. See https://www.usp.org/sites/default/files/usp/document/harmonization/excipients/m80360talc.pdf.
*3. Woodcock, J. (2010). Letter to Roger L. Williams, CEO of USP
(October 12, 2010). See https://www.usp.org/sites/default/files/usp/document/get-involved/monograph-modernization/2010-10-12-letter-from-dr-janet-woodcock.pdf.
4. Block L.H., D. Beckers, J. Ferret, G.P. Meeker, et al. (2014).
``Stimuli to the Revision Process, Modernization of Asbestos Testing
in USP Talc,'' USP-PF 40(4).
*5. NIOSH 2011. ``Asbestos Fibers and Other Elongate Mineral
Particles: State of the Science and Roadmap for Research,'' Current
Intelligence Bulletin 62. Department of Health and Human Services.
Centers for Disease Control and Prevention. National Institute for
Occupational Safety and Health. Publication No. 2011-159 (March
2011). https://www.cdc.gov/niosh/docs/2011-159/pdfs/2011-159.pdf.
6. International Organization for Standardization, ``ISO
10312:2019(en) Ambient air--Determination of asbestos fibres--Direct
transfer transmission electron microscopy method.'' See https://www.iso.org/obp/ui/#iso:std:iso:10312:ed-2:v1:en.
    Dated: January 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00259 Filed 1-9-20; 8:45 am]
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