
[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67461-67463]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28238]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0770]


Cosmetic Microbiological Safety Issues; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments and opening of a 
docket.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Cosmetic Microbiological Safety Issues.'' The 
purpose of the public meeting is to provide stakeholders an opportunity 
to present information regarding cosmetic microbiological safety and to 
suggest areas for the possible development of FDA guidance documents. 
FDA is seeking information regarding microbiological testing of 
cosmetics; types of preservative systems and how to test their 
efficacy; the identity and prevalence of microorganisms, including 
antibiotic-resistant strains, that pose specific health risks in 
finished products; routes of exposure to microorganisms and the 
corresponding infective doses; product and packaging characteristics 
that affect microbial growth and risk of infection; particular 
subpopulations that may be at greater risk of infection when using 
different cosmetic products; the occurrence of adverse events 
associated with microbial contamination of cosmetics; and any other 
issues relevant to the microbiological safety of cosmetics.

DATES: Submit either electronic or written comments to FDA's Division 
of Dockets Management by January 30, 2012. See also ``How to 
Participate in the Meeting'' in the SUPPLEMENTARY INFORMATION section 
of this document for important meeting registration deadlines.

ADDRESSES: See Table 1 of this document for meeting location and other 
information regarding registration for this meeting.

FOR FURTHER INFORMATION CONTACT: For questions about registering for 
the meeting, to register orally, or to submit a notice of participation 
by mail, fax, or email: Courtney Treece, Planning Professionals, Ltd., 
1210 W. McDermott, suite 111, Allen, TX 75013, (704) 258-4983. Fax: 
(469) 854-6992, ctreece@planningprofessionals.com.

    For questions about the meeting, to request an opportunity to make 
public comments, to submit the full text, comprehensive outline, or 
summary of an oral presentation, or to request special accommodations 
due to a disability: Juanita Yates, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, (240) 402-1731, 
Juanita.Yates@fda.hhs.gov.


SUPPLEMENTARY INFORMATION: 

I. Background

    FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 301 et seq.) and, for products marketed 
on a retail basis to consumers, under the Fair Packaging and Labeling 
Act (FPLA) (15 U.S.C. 1451 et seq.). The law requires that cosmetics be 
neither adulterated under section 601 of the FD&C Act (21 U.S.C. 361) 
nor misbranded under section 602 of the FD&C Act (21 U.S.C. 362). That 
is, they must be safe for consumers under labeled or customary 
conditions of use and they must be properly labeled. FDA has issued 
regulations addressing certain aspects of cosmetic safety and labeling 
(see 21 CFR parts 700, 701, and 740). FDA has also issued guidance 
regarding certain aspects of cosmetic safety and labeling, including 
the ``Good Manufacturing Practice (GMP) Guidelines/Inspection 
Checklist'' (available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm), 
the ``Cosmetic Labeling Manual'' (available at http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/default.htm), and other cosmetic guidance documents (available at 
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm).
    FDA has not yet issued specific guidance regarding cosmetic 
microbiological safety. FDA has presented its preferred laboratory 
procedures for microbiological analyses of foods and cosmetics in its 
Bacteriological Analytical Manual (BAM). Chapter 23 of the BAM concerns 
microbiological methods for cosmetics (available at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm073598.htm).

[[Page 67462]]

    Microbial contamination of cosmetic products is of concern to FDA 
because of the potential for serious adverse events. Cosmetics intended 
to be used in the area of the eye are of particular concern. Eye-area 
cosmetics that contain pathogenic microorganisms have the potential to 
cause serious eye infections which can, in some cases, result in 
partial or total loss of vision. In addition, contaminated alcohol-free 
mouthwash has caused outbreaks of serious bacterial illness among 
hospitalized patients. Other microbially contaminated cosmetic product 
types, such as skin lotions, also have the potential to cause 
significant irritation or infection.
    A variety of factors can affect the microbiological safety of 
cosmetic products. Microbial contaminants can be introduced during 
manufacturing, packaging, or repacking. Microbial growth can be 
supported by certain product characteristics, such as high water 
content. Microorganisms can also be introduced by consumers during use. 
Certain forms of cosmetic product packaging may serve to limit or 
prevent the introduction of microorganisms. Preservative systems are 
intended to protect consumers from microorganisms introduced during 
manufacturing and while using a product, but inadequate preservative 
systems may fail to do so. Some microorganisms are known to be 
pathogenic, that is, they are capable of causing injury or illness, 
while others are not. Certain microorganisms may pose little risk to 
most consumers, but may pose significant risks to vulnerable consumers, 
such as those with compromised immune systems.
    FDA believes that guidance on factors and practices to promote the 
microbiological safety of cosmetics would benefit consumers and 
industry. FDA is contemplating developing such guidance and is seeking 
information about microbiological safety of cosmetics. This public 
meeting is intended to provide stakeholders the opportunity to present 
information regarding microbiological testing of cosmetics; types of 
preservative systems and how to test their efficacy; the identity and 
prevalence of microorganisms, including antibiotic-resistant strains, 
that pose specific health risks in finished products; routes of 
exposure to microorganisms and the corresponding infective doses; 
product and packaging characteristics that affect microbial growth and 
risk of infection; particular subpopulations that may be at greater 
risk of infection when using different cosmetic products; the 
occurrence of adverse events associated with microbial contamination of 
cosmetics; and any other issues relevant to the microbiological safety 
of cosmetics.

II. Purpose and Format of the Meeting

    If you wish to present at the meeting scheduled for November 30, 
2011, please register at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm by November 10, 2011. If you 
wish to attend the meeting but not give a presentation, please register 
at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm by November 21, 2011. FDA is holding the public meeting on 
cosmetic microbiological safety issues to receive input from the public 
to support the development of guidance. The meeting format will include 
introductory presentations by FDA, followed by the opportunity for 
stakeholders to make presentations or offer remarks. Listening to our 
stakeholders is the primary purpose of this meeting. In order to meet 
this goal, FDA will provide multiple opportunities for individuals to 
actively express their views by making presentations at the meeting and 
submitting written comments to FDA's Division of Dockets Management 
within 60 days of this meeting.

III. How To Participate in the Meeting

    Stakeholders will have an opportunity to provide oral comments. Due 
to limited space and time, FDA encourages all persons who wish to 
attend the meeting to register in advance. Interested persons and 
organizations who desire an opportunity to make an oral presentation 
during the time allotted for public comment at the meeting, are 
encouraged to register in advance and to provide the specific topic or 
issue to be addressed and the approximate desired length of their 
presentation. Depending on the number of requests for such oral 
presentations, there may be a need to limit the time of each oral 
presentation (e.g., 3 minutes each). If time permits, individuals or 
organizations that did not register in advance may be granted the 
opportunity for such an oral presentation. FDA would like to maximize 
the number of stakeholders who make a presentation at the meeting and 
will do our best to accommodate all persons who wish to make a 
presentation or express their views at the meeting. FDA encourages 
persons and groups who have similar interests to consolidate their 
information for presentation through a single representative. After 
reviewing the presentation requests, FDA will notify each participant 
before the meeting of the amount of time available and the approximate 
time their presentation is scheduled to begin. Stakeholders will also 
have an opportunity to submit electronic or written comments to the 
docket following the meeting, but no later than January 30, 2012.
    There is no fee to register for the public meeting and registration 
will be on a first-come, first-served basis. Early registration is 
recommended because seating is limited.
    Table 1 of this document provides information on participating in 
the meeting and on submitting comments to the docket.

                 Table 1--Information on Participation in the Meeting and on Submitting Comments
----------------------------------------------------------------------------------------------------------------
                                                        Electronic       Address  (non-
                                        Date             address          electronic)        Other information
----------------------------------------------------------------------------------------------------------------
Date of Public Meeting.........  November 30,       Individuals who    L'Enfant Plaza     Registration begins at
                                  2011, from 9       wish to            Hotel, 480         8 a.m.
                                  a.m. to 5:30       participate in     L'Enfant Plaza
                                  p.m. EST.          person are asked   Southwest,
                                                     to pre-register    Washington, DC,
                                                     at http://         20024-2253.
                                                     www.fda.gov/Food/
                                                     NewsEvents/
                                                     WorkshopsMeeting
                                                     sConferences/
                                                     default.htm.
Advance Registration...........  Register by        http://            FDA encourages     Registration to attend
                                  November 21,       www.fda.gov/Food/  the use of         the meeting will also
                                  2011.              NewsEvents/        electronic         be accepted onsite on
                                                     WorkshopsMeeting   registration if    the day of the
                                                     sConferences/      possible.          meeting, as space
                                                     default.htm.                          permits. Registration
                                                                                           information may be
                                                                                           posted without change
                                                                                           to http://www.regulations.gov
                                                                                           including any
                                                                                           personal information
                                                                                           provided.
Request special accommodations   Register by        Juanita Yates, e-  Juanita Yates,     ......................
 due to disability.               November 21,       mail:              240-402-1731.
                                  2011.              Juanita.Yates@fda.hhs.gov.

[[Page 67463]]

 
Make a request for oral          Submit a request   http://            .................  Requests made on the
 presentation.                    by November 10,    www.fda.gov/Food/                     day of the meeting to
                                  2011.              NewsEvents/                           make an oral
                                                     WorkshopsMeeting                      presentation will be
                                                     sConferences/                         granted as time
                                                     default.htm.                          permits. Information
                                                                                           on requests to make
                                                                                           an oral presentation
                                                                                           may be posted without
                                                                                           change to http://www.regulations.gov,
                                                                                           including any
                                                                                           personal information
                                                                                           provided.
Provide a brief description of   By November 21,    http://            .................  Written material
 the oral presentation and any    2011.              www.fda.gov/Food/                     associated with an
 written material for the                            NewsEvents/                           oral presentation
 presentation.                                       WorkshopsMeeting                      should be submitted
                                                     sConferences/                         in Microsoft
                                                     default.htm.                          PowerPoint, Microsoft
                                                                                           Word, or Adobe
                                                                                           Portable Document
                                                                                           Format (PDF) and may
                                                                                           be posted without
                                                                                           change to http://www.regulations.gov,
                                                                                           including any
                                                                                           personal information
                                                                                           provided.
Submit electronic or written     Submit comments    Federal            Fax: 301-827-      All comments must
 comments.                        by January 30,     eRulemaking        6870, Mail/Hand    include the Agency
                                  2012.              Portal: http://    delivery/Courier   name and the docket
                                                     www.regulations.   (for paper,        number corresponding
                                                     gov. Follow the    disk, or CD-ROM    to the Cosmetic
                                                     instructions for   submissions):      Microbiological
                                                     submitting         Division of        Safety Issues; Public
                                                     comments.          Dockets            Meeting. All received
                                                                        Management (HFA-   comments may be
                                                                        305), Food and     posted without change
                                                                        Drug               to http://
                                                                        Administration,    www.regulations.gov,
                                                                        5630 Fishers       including any
                                                                        Lane, rm. 1061,    personal information
                                                                        Rockville, MD      provided. FDA
                                                                        20852.             encourages the
                                                                                           submission of
                                                                                           electronic comments
                                                                                           by using the Federal
                                                                                           eRulemaking Portal.
                                                                                           For additional
                                                                                           information on
                                                                                           submitting comments,
                                                                                           see the ``Comments''
                                                                                           heading of the
                                                                                           SUPPLEMENTARY
                                                                                           INFORMATION section
                                                                                           of this document.
----------------------------------------------------------------------------------------------------------------

IV. Comments

    Regardless of attendance at the public meeting, interested persons 
may submit to the Division of Dockets management (see Table 1 of this 
document) either electronic or written comments for consideration at or 
after the meeting in addition to, or in place of, a request for an 
opportunity to make an oral presentation. It is only necessary to send 
one set of comments. It is no longer necessary to send two copies of 
mailed comments. Identify comments with the docket number found in 
brackets in the heading of this document. Received comments may be 
viewed in the Division of Dockets Management at the address provided in 
Table 1 of this document between 9 a.m. and 4 p.m., Monday through 
Friday.

V. References

    We have placed hard copies of the following references on display 
in the Division of Dockets Management (see ADDRESSES). You may view 
them between 9 a.m. and 4 p.m., Monday through Friday. (FDA has 
verified the Web site addresses, but FDA is not responsible for any 
subsequent changes to Web sites after this document publishes in the 
Federal Register.)
    1. FDA, ``Good Manufacturing Practice (GMP) Guidelines/Inspection 
Checklist,'' available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm.
    2. FDA, ``Cosmetic Labeling Manual,'' available at http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/default.htm.
    3. FDA, ``Guidance Documents,'' available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm.
    4. FDA, Bacteriological Analytical Manual, chapter 23, 
``Microbiological Methods for Cosmetics,'' available at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm073598.htm.

VI. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov and at FDA's Web site 
under ``Cosmetics.'' It may also be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. A transcript will also be available in 
either hardcopy or on CD-ROM, after the submission of a Freedom of 
Information request. Written requests are to be sent to Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: October 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28238 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P


