105490 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Proposed Rules 

performance, with possible impact with 

terrain or obstacle. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Requirements 

Except as specified in paragraph (h) of this 

AD: Comply with all required actions and 

compliance times specified in, and in 

accordance with, European Union Aviation 

Safety Agency (EASA) AD 2024–0137, dated 

July 11, 2024 (EASA AD 2024–0137). 

(h) Exceptions to EASA AD 2024–0137 

(1) Where EASA AD 2024–0137 refers to its 

effective date, this AD requires using the 

effective date of this AD. 

(2) This AD does not adopt the ‘‘Remarks’’ 

section of EASA AD 2024–0137. 

(3) Where paragraph (2) of EASA AD 2024– 

0137 specifies corrective actions if ‘‘any 

discrepancy, as defined in the SB, is 

detected,’’ for this AD, replace that text with 

‘‘any corrosion, crack, dent, nick, 

deformation, or measurement not within 

specified dimensions of the SB is detected.’’ 

(4) Where paragraph (3) of EASA AD 2024– 

0137 specifies additional actions if ‘‘any 

discrepancy is detected,’’ for this AD, replace 

that text with ‘‘any discrepancy, which 

includes corrosion, cracks, dents, nicks, and 

deformation, is detected.’’ 

(5) Paragraph (4) of EASA AD 2024–0137 

specifies to report inspection results to 

Deutsche Aircraft GmbH within a certain 

compliance time. For this AD, report 

inspection results at the applicable time 

specified in paragraph (h)(5)(i) or (ii) of this 

AD. 

(i) If the inspection was done on or after 

the effective date of this AD: Submit the 

report within 30 days after the inspection. 

(ii) If the inspection was done before the 

effective date of this AD: Submit the report 

within 30 days after the effective date of this 

AD. 

(i) Additional AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Validation Branch, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or 

responsible Flight Standards Office, as 

appropriate. If sending information directly 

to the manager of the International Validation 

Branch, send it to the attention of the person 

identified in paragraph (j) of this AD and 

email to: AMOC@faa.gov. Before using any 

approved AMOC, notify your appropriate 

principal inspector, or lacking a principal 

inspector, the manager of the responsible 

Flight Standards Office. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain instructions 

from a manufacturer, the instructions must 

be accomplished using a method approved 

by the Manager, International Validation 

Branch, FAA; or EASA; or Deutsche Aircraft 

GmbH’s EASA Design Organization Approval 

(DOA). If approved by the DOA, the approval 

must include the DOA-authorized signature. 

(j) Additional Information 

For more information about this AD, 

contact Joe Salameh, Aviation Safety 

Engineer, FAA, 1600 Stewart Avenue, Suite 

410, Westbury, NY 11590; phone: 206–231– 

3536; email: joe.salameh@faa.gov. 

(k) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

the material listed in this paragraph under 5 

U.S.C. 552(a) and 1 CFR part 51. 

(2) You must use this material as 

applicable to do the actions required by this 

AD, unless this AD specifies otherwise. 

(i) European Union Aviation Safety Agency 

(EASA) AD 2024–0137, dated July 12, 2024. 

(ii) [Reserved] 

(3) For EASA material identified in this 

AD, contact EASA, Konrad-Adenauer-Ufer 3, 

50668 Cologne, Germany; telephone +49 221 

8999 000; email ADs@easa.europa.eu; 

website easa.europa.eu. You may find this 

material on the EASA website at 

ad.easa.europa.eu. 

(4) You may view this material at the FAA, 

Airworthiness Products Section, Operational 

Safety Branch, 2200 South 216th St., Des 

Moines, WA. For information on the 

availability of this material at the FAA, call 

206–231–3195. 

(5) You may view this material at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, 

visit www.archives.gov/federal-register/cfr/ 

ibr-locations or email fr.inspection@nara.gov. 

Issued on December 19, 2024. 

Victor Wicklund, 

Deputy Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2024–30763 Filed 12–26–24; 8:45 am] 

BILLING CODE 4910–13–P 

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 TalcContaining Cosmetic Products 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Proposed rule. 

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: 


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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Proposed Rules 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), 

QuestionsAboutMoCRA@fda.hhs.gov. 

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, PRAStaff@fda.hhs.gov. 

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 § 730.3(a)) 

B. What definitions apply to this section? 

(Proposed § 730.3(b)) 

C. What test methods must you use? 

(Proposed § 730.3(c)) 

D. How does one determine if a sample has 

tested positive for asbestos? (Proposed 

§ 730.3(d)) 

E. Is there an alternative to performing 

finished product testing for detecting 

and identifying asbestos in a talccontaining cosmetic product? (Proposed 

§ 730.3(e)) 

F. How frequently must tests be 

performed? (Proposed § 730.3(f)) 

G. Proposed Records/Record Retention 

Requirements (Proposed § 730.3(g)) 

H. Proposed Enforcement Provisions 

(Proposed § 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 talccontaining cosmetic products that 

contain asbestos. We specifically invite 

comment on existing industry practices 

and the utility of this approach. 


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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 talccontaining cosmetics from fewer recalls. 

We quantify costs to talc suppliers and 

to cosmetics manufacturers to read and 

understand the rule and to test talc for 

asbestos. We estimate that the 

annualized monetized benefits over 10 

years would range from $0.00 million to 

$1.39 million at a 7 percent discount 

rate, with a primary estimate of $0.06 

million, and from $0.00 million to $1.39 

million at a 3 percent discount rate, 

with a primary estimate of $0.06 

million. The annualized costs would 

range from $1.29 million to $6.78 

million at a 7 percent discount rate, 

with a primary estimate of $3.54 

million, and from $1.30 million to $6.78 

million at a 3 percent discount rate, 

with a primary estimate of $3.55 

million. 

II. Table of Abbreviations/Commonly 

Used Acronyms in This Document 

Abbreviation/ 

acronym What it means 

APA ............. Administrative Procedure Act. 

CTFA .......... Cosmetic, Toiletry, and Fragrance 

Association. 

EDS ............ Energy Dispersive Spectroscopy. 

EO ............... Executive Order. 

EPA ............. Environmental Protection Agency. 

FD&C Act .... Federal Food, Drug, and Cosmetic 

Act. 

IEC .............. International Electrotechnical Commission. 

IR ................ Infrared Spectroscopy. 

ISO .............. International Organization for Standardization. 

IWGACP ..... Interagency Working Group on Asbestos in Consumer Products. 

MoCRA ....... Modernization of Cosmetics Regulation Act of 2022. 

OIRA ........... Office of Information and Regulatory 

Affairs. 

OMB ............ Office of Management and Budget. 

PLM ............ Polarized Light Microscopy. 

SAED .......... Selected Area Electron Diffraction. 

SEM ............ Scanning Electron Microscope. 

TEM ............ Transmission Electron Microscope. 

USP ............ U.S. Pharmacopeia. 

XRD ............ X-Ray Diffraction. 

III. Background 

A. Introduction 

MoCRA, enacted on December 29, 

2022, requires the promulgation of 

proposed and final regulations to 

establish and require standardized 

testing methods for detecting and 

identifying asbestos in talc-containing 

cosmetic products. 

B. Need for the Regulation 

Talc is used in various cosmetic 

products. Talc is mined as a naturally 

occurring hydrous magnesium silicate. 

Asbestos is found in the same rock types 

that host talc deposits (Refs. 1, 2) and so 

may be found in commercial talc mines 

and may be inseparable from talc in the 

mining process. As a result, talc used in 

cosmetic products sometimes contains 

asbestos fibers from serpentine or 

amphibole minerals present in 

proximity to talc deposits (Refs. 3, 4). 

Asbestos is a known human 

carcinogen, and its health risks are welldocumented (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 talccontaining 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/cosmeticsrecalls-alerts/fda-advises-consumersstop-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 talccontaining 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 


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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Proposed Rules 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 talccontaining 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 talccontaining 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 peerreviewed (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: 

customerservice@iso.org; 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/ 


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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 talccontaining 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 talccontaining 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 talccontaining 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 


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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 § 730.3 entitled ‘‘Testing 

Methods for Detecting and Identifying 

Asbestos in Talc-Containing Cosmetic 

Products’’ would require testing of talccontaining 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 § 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 § 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 talccontaining 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 § 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/ 


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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 talccontaining 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 falsenegative 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. 


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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 mm, 

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/fdabrief-fda-releases-final-report-talccontaining-cosmetic-products-testedasbestos). 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 talccontaining cosmetics for asbestos, at 

least 0.1 micrograms of talc or talccontaining 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 107 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 


khammond on DSK9W7S144PROD with PROPOSALS
105498 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Proposed Rules 

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 § 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 

§ 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 talccontaining cosmetic product? (Proposed 

§ 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 § 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 § 730.3(f)) 

We propose, at a minimum, that a 

manufacturer test a representative 

sample of each batch or lot of each talccontaining cosmetic product or talc 

ingredient for asbestos in accordance 

with § 730.3(c). If a manufacturer relies 

on the supplier’s certificate of analysis 

in accordance with § 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 § 730.3(c). 

G. Proposed Records/Record Retention 

Requirements (Proposed § 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 § 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 § 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. 


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1From 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. 

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. 

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 talccontaining 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] 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(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 ..................


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TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF THE PROPOSED RULE—Continued 

[millions of dollars] 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

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-fdaregulations. 

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 talccontaining 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 talccontaining 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: 


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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

(hours) 

Total hours 

730; recordkeeping of tests for asbestos in talc-containing 

cosmetic products including certificate of analysis .......... 801 17.43 13,961 18 251,298 

1There 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 × 

17.43 records/manufacturer = 13,961.43, 

rounded to 13,961 records; 13,961 × 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 TalcMagnesite 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%20

is%20also%20present%20in,deep%20

to%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/. 


khammond on DSK9W7S144PROD with PROPOSALS
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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-ReportSeries/Iarc-Monographs-On-TheIdentification-Of-Carcinogenic-HazardsTo-Humans/Arsenic-Metals-Fibres-AndDusts-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/defaultsource/chemical-safety/asbestos/ 

asbestos--hazards-and-safe-practice-forclear-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/astmebooks/book/2238/chapter-abstract/ 

27896558/Comparing-Historical-andRecent-Accelerated?

redirectedFrom=fulltext. 

18. * FDA. ‘‘Talc.’’ Previous Activity—FDA’s 

Talc Survey of 2009–2010. Available at: 

https://www.fda.gov/cosmetics/cosmeticingredients/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/fdabrief/fda-brief-fda-releases-final-reporttalc-containing-cosmetic-productstested-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-MilletteGeneralReference-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/FDA2020-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-scientificinformation-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-methodsasbestos-/talc-and-cosmetic-productscontaining-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/OFR02-458-508.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-nitr20200731 (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/PMC660

3445/ (accessed December 11, 2024). 

38. USP–NF ‘‘Talc.’’ Absence of Asbestos 

Test Method, Official May 1, 2022. 


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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Proposed Rules 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-fdaregulations. 

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 

§§ 730.1–730.2 [Reserved] 

§ 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 talccontaining 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 


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105504 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Proposed Rules 

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 talccontaining 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: DMSInbox@

fda.hhs.gov. For information on the 

availability of this material at NARA, 

visit www.archives.gov/federal-register/ 

cfr/ibr-locations or email fr.inspection@

nara.gov. 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: customerservice@

iso.org; 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. 

§§ 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 

DEPARTMENT OF LABOR 

Employment and Training 

Administration 

29 CFR Parts 29 and 30 

[Docket No. ETA–2023–0004] 

RIN 1205–AC13 

National Apprenticeship System 

Enhancements; Withdrawal 

AGENCY: Employment and Training 

Administration, Labor. 

ACTION: Withdrawal of proposed rule 

and termination of rulemaking 

proceeding. 

SUMMARY: The Department of Labor (the 

Department) is withdrawing its notice of 

proposed rulemaking (NPRM or 

proposed rule), which proposed to 

revise the Federal regulations 

implementing the National 

Apprenticeship Act of 1937 (NAA). 

DATES: The Department is withdrawing 

the proposed rule published on January 

17, 2024 (89 FR 3118), as of December 

27, 2024. 

ADDRESSES: The docket is available at 

https://www.regulations.gov—Docket 

No. ETA–2023–0004. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Paczynski, Administrator, 

Office of Policy Development and 

Research, U.S. Department of Labor, 

Employment and Training 

Administration, 200 Constitution 

Avenue NW, Room N–5641, 

Washington, DC 20210, Telephone: 

202–693–3700 (voice) (this is not a tollfree number). For persons with a 

hearing or speech disability who need 

assistance to use the telephone system, 

please dial 711 to access 

telecommunications relay services. 

SUPPLEMENTARY INFORMATION: 

Background 

The NAA (29 U.S.C. 50) authorizes 

the Secretary of the Department of Labor 

(the Secretary) to ‘‘formulate and 

promote the furtherance of labor 

standards necessary to safeguard the 

welfare of apprentices, to extend the 

application of such standards by 

encouraging the inclusion thereof in 

contracts of apprenticeship, to bring 

together employers and labor for the 

formulation of programs of 

apprenticeship, [and] to cooperate with 

State agencies engaged in the 

formulation and promotion of standards 

of apprenticeship.’’ Under this 

authority, the Department established 

the registered apprenticeship program. 

The Department set forth labor 

standards designed to facilitate these 

statutory directives through its 

implementing regulations at 29 CFR part 

29. Those regulations prescribe 

minimum quality and content 

requirements with respect to a 

program’s standards of apprenticeship 

and its apprenticeship agreements; 

establish procedures concerning the 

registration, cancellation, and 

deregistration of apprenticeship 

programs; and set forth a mechanism for 

the recognition of State Apprenticeship 

Agencies (SAAs) as Registration 

Agencies authorized to register and 


khammond on DSK9W7S144PROD with PROPOSALS