Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance, 30727-30730 [2011-13059]
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Federal Register / Vol. 76, No. 102 / Thursday, May 26, 2011 / Notices
labeling statements on food packages
may affect how consumers perceive a
product or a label, which may in turn
affect their dietary choices. Results of
the study will not be used to develop
population estimates.
To help design and refine the
questionnaire, FDA plans to conduct
cognitive interviews by screening 72
panelists in order to obtain 9
participants in the interviews. Each
screening is expected to take 5 minutes
(0.083 hour) and each cognitive
interview is expected to take one hour.
The total for cognitive interview
activities is 15 hours (6 hours + 9
hours). Subsequently, we plan to
conduct pretests of the questionnaire
before it is administered in the study.
We expect that 1,600 invitations, each
taking 2 minutes (0.033 hour), will need
to be sent to panelists to have 200 of
them complete a 15-minute (0.25 hour)
pretest. The total for the pretest
activities is 103 hours (53 hours + 50
hours). For the survey, we estimate that
21,600 invitations, each taking 2
minutes (0.033 hour) to complete, will
need to be sent to the consumer panel
to have 2,700 of its members complete
a 15-minute (0.25 hour) questionnaire.
The total for the survey activities is
1,388 hours (713 hours + 675 hours).
Thus, the total estimated burden is
1,506 hours. FDA’s burden estimate is
based on prior experience with research
that is similar to this proposed study.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses
per
respondent
Average
burden
per response
(in hours) 2
Total annual
responses
Total hours
Cognitive interview screener ................................................
Cognitive interview ...............................................................
Pretest invitation ..................................................................
Pretest ..................................................................................
Survey invitation ...................................................................
Survey ..................................................................................
72
9
1,600
200
21,600
2,700
1
1
1
1
1
1
72
9
1,600
200
21,600
2,700
5/60
1
2/60
15/60
2/60
15/60
6
9
53
50
713
675
Total ..............................................................................
........................
........................
........................
........................
1,506
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
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II. References
The following references are on
display in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20857, under
Docket No. FDA–2011–N–0320 and may
be seen by interested persons between
9 a.m. and 4 p.m., Monday through
Friday. We have verified all Web site
addresses, but we are not responsible for
any subsequent changes to the Web sites
after this document publishes in the
Federal Register.
1. U.S. Food and Drug Administration,
‘‘Claims That Can Be Made for
Conventional Foods and Dietary
Supplements,’’ September 2003,
available at https://www.fda.gov/Food/
LabelingNutrition/LabelClaims/
ucm111447.htm.
2. Cleveland, L. E., A.J. Moshfegh, A.M.
Albertson, and J.D. Goldman, ‘‘Dietary
intake of whole grains,’’ Journal of the
American College of Nutrition, 19, 331S–
338S, 2000.
3. Kantor, L. S., J.N. Variyam, J.E. Allshouse,
J.J. Putnam, and B.H. Lin, ‘‘Choose a
variety of grains daily, especially whole
grains: A challenge for consumers,’’
Journal of Nutrition, 131, 473S–486S,
2001.
4. U.S. Department of Agriculture and U.S.
Department of Health and Human
Services. ‘‘Executive Summary of Dietary
Guidelines for Americans, 2010,’’
January 2011, available at https://
www.cnpp.usda.gov/Publications/
DietaryGuidelines/2010/PolicyDoc/
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ExecSumm.pdf.
5. Supermarket News, ‘‘Report: Whole Grains
Gain Momentum,’’ September 2010,
available at https://
supermarketnews.com/news/whole_
grains_0917/#.
¨
¨
6. Arvola, A., L.Lahteenmaki, M. Dean, M.
Vassallo, M. Winkelmann, E. Claupein,
A. Saba, and R. Shepherd, ‘‘Consumers’
beliefs about whole and refined grain
products in the UK, Italy and Finland,’’
Journal of Cereal Science, 46, 197–206,
2007.
7. Kantor, L. S., J.N. Variyam, J.E. Allshouse,
J.J. Putnam, and B.H.Lin, ‘‘Choose a
variety of grains daily, especially whole
grains: A challenge for consumers,’’
Journal of Nutrition, 131, 473S–486S,
2001.
8. Marquart, L., K.L. Wiemer, J.M. Jones, and
B.Jacob, ‘‘Whole grain health claims in
the U.S.A. and other efforts to increase
whole-grain consumption,’’ Proceedings
of the Nutrition Society, 62, 151–159,
2003.
9. Drichoutis, A.C., P. Lazaridis, and R.M.
Nayga, ‘‘Consumers’ Use of Nutritional
Labels: A Review of Research Studies
and Issues,’’ Academy of Marketing
Science Review, 2006(9), 2006.
10. Willis, Josephine M., and K.G. Grunert,
‘‘A Review of Research on Consumer
Response to Nutrition Information on
Food Packaging,’’ 2007.
11. Kellogg Co. ‘‘A Survey of Consumers’
Whole Grain & Fiber Consumption
Behaviors, and the Perception of Whole
Grain Foods as a Source of Dietary
Fiber,’’ 2010. FDA Docket No. 2006–D–
0298, July 2010, available at https://
www.regulations.gov/
#!documentDetail;D=FDA-2006-D-0298-
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0016.
Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13060 Filed 5–25–11; 8:45 am]
BILLING CODE 4160–01–P
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.
Notice of public meeting;
request for comments.
ACTION:
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
SUMMARY:
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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
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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 consumeroriented 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
https://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
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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 nonhigh 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?
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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
https://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 https://
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, firstserved 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
Electronic address
Address (nonelectronic)
Other information
Date of Public
Meeting.
June 6, 2011,
9 a.m. to 5:30
p.m..
......................................................
FDA White Oak Campus, The
Great Room, Bldg. 31, rm.
1503, 10903 New Hampshire
Ave., Silver Spring, MD 20993.
Registration begins at 7:30 a.m.
Web cast Registration.
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Date
Ongoing ............
Advance Registration.
By May 31,
2011.
https://www.blsmeetings.net/FDA
Inspection&Compliance.
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 https://fda.yorkcast.
com/webcast/Catalog/catalogs/
default.aspx and click on
‘‘CDRH Television Tutorial and
Firewall Test’’.
https://www.blsmeetings.net/
FDAInspection&Compliance.
......................................................
Registration to attend the meeting will also be accepted onsite
on the day of the meeting, as
space permits. Registration information may be posted without
change
to
https://
www.regulations.gov, including
any personal information provided.
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Federal Register / Vol. 76, No. 102 / Thursday, May 26, 2011 / Notices
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND SUBMITTING COMMENTS—Continued
Date
Electronic address
Address (nonelectronic)
Other information
Request special
accommodations due to disability.
Make a request
for oral presentation.
By May 31,
2011.
......................................................
Patricia M. Kuntze, 301–796–
8641, e-mail: Patricia.Kuntze@
fda.hhs.gov.
By May 31,
2011.
https://www.blsmeetings.net/
FDAInspection&Compliance.
......................................................
Provide a brief
description of
the oral presentation and any
written material
for the presentation.
By May 31,
2011.
https://www.blsmeetings.net/
FDAInspection&Compliance.
......................................................
Submit electronic
or written comments.
Submit comments by July
6, 2011.
Federal eRulemaking Portal:
https://www.regulations.gov. Follow the instructions for submitting comments.
FAX: 301–827–6870. Mail/Hand
delivery/Courier (for paper,
disk, or CD–ROM submissions): Division of Dockets
Management (HFA–305), Food
and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
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
Written material associated with
an oral presentation should be
submitted
in
Microsoft
PowerPoint, Microsoft Word, or
Adobe Portable Document Format and may be posted without
change
to
https://
www.regulations.gov, including
any personal information provided.
All comments must include the
Agency name and the docket
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
https://www.regulations.gov, including any personal information provided.
FDA encourages the submission
of electronic comments by
using the Federal eRulemaking
Portal. For additional information on submitting comments,
see section IV of this document.
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
Section of FSMA
Topic
Docket No.
102 ..........................
201 ..........................
Registration of Food Facilities—Suspension of Registration .................................................................
Targeting of Inspection Resources for Domestic Facilities and Foreign Facilities—Identification and
Inspection of Facilities.
Mandatory Recall Authority ....................................................................................................................
Administrative Detention of Food ...........................................................................................................
Improving the Reportable Food Registry ...............................................................................................
FDA–2011–N–0390
FDA–2011–N–0391
206 ..........................
207 ..........................
211 ..........................
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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 https://www.regulations.gov
and https://www.fda.gov/Food/
FoodSafety/FSMA/default.htm. It may
be viewed at the Division of Dockets
Management (HFA–305), Food and Drug
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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.
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FDA–2011–N–0392
FDA–2011–N–0393
FDA–2011–N–0394
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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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
----------------------------------------------------------------------------------------------------------------
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........ https:// ....................
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 https://fda.yorkcast.com/webcast/Catalog/catalogs/default.aspx and
click on ``CDRH
Television Tutorial
and Firewall Test''.
Advance Registration......... By May 31, 2011 https:// .................... 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 https://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 https:// .................... 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
https://www.regulations.gov
, including any
personal
information
provided.
Provide a brief description By May 31, 2011 https:// .................... 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 https://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: https:// 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
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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 https://www.regulations.gov and https://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
