
[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Notices]
[Pages 30727-30730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13059]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0366]


Food and Drug Administration Food Safety Modernization Act: Focus 
on Inspections and Compliance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``FDA Food Safety Modernization Act: Focus on 
Inspections and Compliance.'' The purpose of the public meeting is to 
provide interested persons an opportunity to discuss implementation of 
inspections and compliance under the recently enacted FDA Food Safety 
Modernization Act (FSMA). More specifically, the public will have an 
opportunity to provide information and share views that will inform 
FDA's

[[Page 30728]]

FSMA implementation strategies relative to enforcement authorities; 
frequency and targeting of facility inspections; manner of inspection 
in a preventive controls environment; and improving the reportable food 
registry (RFR).

DATES: See table 1 in the SUPPLEMENTARY INFORMATION section of this 
document.

FOR FURTHER INFORMATION CONTACT: Patricia M. Kuntze, Office of External 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 5322, Silver Spring, MD 20993, 301-796-8641, 
Patricia.Kuntze@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FSMA (Pub. L. 111-353) amends the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) to establish the foundation for a modernized, 
prevention-based food safety system. The legislation recognizes that 
inspection is an important means of assessing industry compliance with 
the law and holding industry accountable for their responsibility to 
produce a safe product. FDA will meet this expectation by:
     Using the new enforcement authorities granted by FSMA,
     Applying its inspection resources in a risk-based manner, 
and
     Adopting inspection approaches that promote the efficient 
and effective use of existing resources.
    Section 102 of FSMA, among other things, amends section 415 of the 
FD&C Act (21 U.S.C. 350d) for various purposes, including authorizing 
the Secretary of Health and Human Services to suspend registration of a 
facility if she determines that food manufactured, processed, packed, 
received, or held by the facility poses a reasonable probability of 
serious adverse health consequences or death and the facility either 
created, caused, or was otherwise responsible for that reasonable 
probability or knew of, or had reason to know of, such reasonable 
probability and packed, received, or held the food. A facility that is 
under suspension is prohibited from introducing food into commerce in 
the United States.
    Section 201 of FSMA, among other things, creates a new section 421 
of the FD&C Act (21 U.S.C. 350j) that establishes a mandated inspection 
frequency, based on risk, for food facilities that are required to 
register under section 415 of the FD&C Act and requires the frequency 
of inspection of such facilities to increase immediately. All high-risk 
domestic facilities must be inspected within 5 years of FSMA's 
enactment and no less than every 3 years thereafter. Non-high-risk 
domestic facilities must be inspected within 7 years of FSMA's 
enactment and no less than every 5 years thereafter. Within 1 year of 
FSMA's enactment, the law directs FDA to inspect at least 600 foreign 
facilities and to double those inspections every year for the next 5 
years.
    Section 206 of FSMA creates a new section 423 of the FD&C Act (21 
U.S.C. 3501) to provide FDA with mandatory recall authority for foods 
other than infant formula. This authority applies when FDA determines 
that there is a reasonable probability that an article of food is 
adulterated under section 402 of the FD&C Act (21 U.S.C. 342) or 
misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) and 
the use of or exposure to such article of food will cause serious 
adverse health consequences or death to humans or animals.
    Section 207 of FSMA amends section 304(h)(1)(A) of the FD&C Act (21 
U.S.C. 334(h)(1)(A)) to provide FDA with a more flexible standard for 
administratively detaining human and animal food products that are 
potentially in violation of the FD&C Act. Under the new law, FDA may 
administratively detain food if FDA has reason to believe that the food 
is adulterated or misbranded. Administrative detention is the procedure 
FDA uses to keep suspect food from being moved.
    Section 211 of FSMA amends section 417 of the FD&C Act (21 U.S.C. 
350f), among other things, to require FDA to publish, on the Web, an 
easily printable one page summary of certain consumer-oriented 
information regarding certain reportable foods, including information 
necessary to enable a consumer to accurately identify whether the 
consumer is in possession of the reportable food. Grocery stores that 
sold a reportable food that is the subject of a summary posting and 
that are part of a chain of establishments with 15 or more physical 
locations will be required to prominently display such summary or the 
information from such summary via at least one of the methods to be 
identified by FDA within 24 hours after FDA publishes the summary.

II. Purpose and Format of the Meeting

    If you wish to attend and/or present at the meeting scheduled for 
June 6, 2011, please register by e-mail to http://www.blsmeetings.net/FDAInspection&Compliance by May 31, 2011. FDA is holding the public 
meeting to receive input from the public to inform FDA's implementation 
of the FSMA provisions identified previously in this document.
    In general, the meeting format will include introductory 
presentations by FDA. 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, participating in a total of 
three 75-minute breakout sessions on the provisions discussed at the 
meeting, and submitting written comments to the docket(s) within 30 
days after this meeting. Participants can select up to three of the 
following four breakout sessions: Enforcement authorities, frequency 
and targeting of facility inspections, manner of inspection in a 
preventive controls environment, and improving the RFR.
    FDA requests comment on the following questions in the break-out 
sessions:

1. Enforcement Authorities

     How do you suggest FDA employ the use of its revised 
administrative detention authority in a preventive controls 
environment?
     State regulators--can you provide examples where you have 
recently used your embargo/detention authorities? Can you describe 
examples where States have used embargo in situations where the subject 
food was produced contrary to established food safety preventive 
control standards; for instance, contrary to those standards defined 
under the juice or seafood Hazard Analysis and Critical Control Points 
rules?
     How do you see FDA implementing food facility registration 
suspension, and under what circumstances should FDA use its suspension 
authority? Under what circumstances should FDA use its mandatory food 
recall authority? Under what circumstances do you envision FDA using 
food facility registration suspension in conjunction with ordering a 
mandatory food recall?

2. Frequency and Targeting of Facility Inspections

     What data sources are available that could assist with the 
designation of high risk/non-high risk facility inventories? What data 
sources could assist with targeting foreign firms for inspection?
     What criteria should FDA consider when defining its high 
risk and non-high risk facility inventories? If the criteria you 
suggest require use of data that FDA does not currently collect or 
otherwise possess, how should FDA acquire that information?
     How should FDA evaluate or ``weigh'' the criteria to 
determine risk?

[[Page 30729]]

What factor(s) should be considered the most important and should this 
vary depending on the circumstances?

3. Manner of Inspection in a Preventive Controls Environment

     What inspection approaches could FDA use to satisfy the 
domestic and foreign inspection frequency mandates, including by 
working with State and local governments?
     What inspection tools (e.g., new technologies) could FDA 
use to meet the domestic and foreign inspection frequency mandates?
     How might FDA use firms' written preventive control plans 
that will be required in the future under section 103 of FSMA, or 
information from those plans, to prioritize FDA's work and develop 
inspectional strategies?
     How should FDA work with foreign governments with respect 
to inspections of those food facilities in their countries that offer 
food products for import to the United States?

4. Improving the RFR

     What information is necessary to enable a consumer to 
accurately identify whether the consumer is in possession of a 
reportable food?
     What methods could best be used by grocery stores to 
inform consumers of information to enable them to identify whether they 
possess a reportable food?
     Are there other approaches to getting key information in 
the hands of consumers in real time that FDA should also consider 
pursuing?
     Who should FDA consider to be a grocery store subject to 
the consumer notification requirement in section 417(h) of the FD&C 
Act?
     What methods are grocery stores currently using to provide 
notice of food recalls to consumers?
    There will be an interactive Web cast; see section III of this 
document. If you would like to participate at the meeting via the Web 
cast, please register at http://www.blsmeetings.net/FDAInspection&Compliance. In order to provide Web cast participants 
with information before and after the meeting, we request attendees 
provide their name, their affiliation, and e-mail when registering. It 
is recommended that attendees via Web cast test their Internet 
connection to confirm access of the Web cast prior to the meeting. To 
test this connection, visit http://fda.yorkcast.com/webcast/Catalog/catalogs/default.aspx and click on ``CDRH Television Tutorial and 
Firewall Test.''

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, either onsite or by Web cast, including those 
requesting an opportunity to make an oral presentation during the time 
allotted for public comment at the meeting, 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 anticipates that there will be several opportunities to 
speak in breakout sessions and an interactive Web cast will also be 
available for stakeholders who are not onsite.
    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. 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. Onsite 
registration will be accepted after all pre-registered attendees are 
seated. Table 1 of this document provides information on participating 
in the meeting and on submitting comments to the docket (see table 2 of 
this document for a list of docket numbers and corresponding sections 
of FSMA).

                  Table 1--Information on Participation in the Meeting and Submitting Comments
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                                                                             Address
                                     Date        Electronic address      (nonelectronic)      Other information
----------------------------------------------------------------------------------------------------------------
Date of Public Meeting.......  June 6, 2011, 9  ....................  FDA White Oak         Registration begins
                                a.m. to 5:30                           Campus, The Great     at 7:30 a.m.
                                p.m..                                  Room, Bldg. 31, rm.
                                                                       1503, 10903 New
                                                                       Hampshire Ave.,
                                                                       Silver Spring, MD
                                                                       20993.
Web cast Registration........  Ongoing........  http://                                     ....................
                                                 www.blsmeetings.net/
                                                 FDAInspection&Compl
                                                 iance.
                                                It is recommended
                                                 that attendees via
                                                 Webcast test their
                                                 Internet connection
                                                 to confirm access
                                                 to the Webcast
                                                 prior to the
                                                 meeting. To test
                                                 this connection,
                                                 visit http://fda.yorkcast.com/webcast/Catalog/catalogs/default.aspx and
                                                 click on ``CDRH
                                                 Television Tutorial
                                                 and Firewall Test''.
Advance Registration.........  By May 31, 2011  http://               ....................  Registration to
                                                 www.blsmeetings.net/                        attend the meeting
                                                 FDAInspection&Compl                         will also be
                                                 iance.                                      accepted onsite on
                                                                                             the day of the
                                                                                             meeting, as space
                                                                                             permits.
                                                                                             Registration
                                                                                             information may be
                                                                                             posted without
                                                                                             change to http://www.regulations.gov
                                                                                             , including any
                                                                                             personal
                                                                                             information
                                                                                             provided.

[[Page 30730]]

 
Request special                By May 31, 2011  ....................  Patricia M. Kuntze,   ....................
 accommodations due to                                                 301-796-8641, e-
 disability.                                                           mail:
                                                                       Patricia.Kuntze@fda.hhs.gov.
Make a request for oral        By May 31, 2011  http://               ....................  Written material
 presentation.                                   www.blsmeetings.net/                        associated with an
                                                 FDAInspection&Compl                         oral presentation
                                                 iance.                                      should be submitted
                                                                                             in Microsoft
                                                                                             PowerPoint,
                                                                                             Microsoft Word, or
                                                                                             Adobe Portable
                                                                                             Document Format and
                                                                                             may be posted
                                                                                             without change to
                                                                                             http://www.regulations.gov
                                                                                             , including any
                                                                                             personal
                                                                                             information
                                                                                             provided.
Provide a brief description    By May 31, 2011  http://               ....................  All comments must
 of the oral presentation and                    www.blsmeetings.net/                        include the Agency
 any written material for the                    FDAInspection&Compl                         name and the docket
 presentation.                                   iance.                                      number
                                                                                             corresponding with
                                                                                             the section of FSMA
                                                                                             on which you are
                                                                                             commenting (see
                                                                                             table 2 of this
                                                                                             document for a list
                                                                                             of docket numbers
                                                                                             and corresponding
                                                                                             sections of FSMA).
                                                                                             All received
                                                                                             comments may be
                                                                                             posted without
                                                                                             change to http://www.regulations.gov
                                                                                             , including any
                                                                                             personal
                                                                                             information
                                                                                             provided.
Submit electronic or written   Submit comments  Federal eRulemaking   FAX: 301-827-6870.    FDA encourages the
 comments.                      by July 6,       Portal: http://       Mail/Hand delivery/   submission of
                                2011.            www.regulations.gov   Courier (for paper,   electronic comments
                                                 . Follow the          disk, or CD-ROM       by using the
                                                 instructions for      submissions):         Federal eRulemaking
                                                 submitting comments.  Division of Dockets   Portal. For
                                                                       Management (HFA-      additional
                                                                       305), Food and Drug   information on
                                                                       Administration,       submitting
                                                                       5630 Fishers Lane,    comments, see
                                                                       rm. 1061,             section IV of this
                                                                       Rockville, MD 20852.  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.

                                 Table 2
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     Section of FSMA              Topic                Docket No.
------------------------------------------------------------------------
102.....................  Registration of Food  FDA-2011-N-0390
                           Facilities--Suspens
                           ion of Registration.
201.....................  Targeting of          FDA-2011-N-0391
                           Inspection
                           Resources for
                           Domestic Facilities
                           and Foreign
                           Facilities--Identif
                           ication and
                           Inspection of
                           Facilities.
206.....................  Mandatory Recall      FDA-2011-N-0392
                           Authority.
207.....................  Administrative        FDA-2011-N-0393
                           Detention of Food.
211.....................  Improving the         FDA-2011-N-0394
                           Reportable Food
                           Registry.
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    Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

V. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov and http://www.fda.gov/Food/FoodSafety/FSMA/default.htm. It may 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 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., Rockville, MD 20857.

    Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13059 Filed 5-25-11; 8:45 am]
BILLING CODE 4160-01-P


