Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Availability, 38439-38440 [E9-18451]
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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
harvesting, packing, processing, and
distribution of tomatoes, along with
retail and food service preparation.
Such tomatoes may be grown and
harvested either from an open field or
a greenhouse; they may be packed or
repacked either for the fresh market or
for ‘‘fresh-cut/value-added processing’’
(i.e., minimally processed, such as by
slicing or dicing, and then bagged or
prepackaged); and then shipped either
to food service operations or retail
establishments where they are offered
for sale to the consumer. The use of the
term ‘‘tomatoes’’ in this document
includes raw agricultural commodities
and fresh-cut/value-added products.
This draft guidance is based primarily
on tomato industry guidelines issued in
July 2008 (Ref. 1), along with agency
experience and information from other
recent public and private programs.
FDA is issuing this draft guidance as
Level 1 draft guidance consistent with
FDA’s good guidance practices
regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent
the agency’s current thinking on the
microbiological hazards that may result
in contamination of fresh and fresh-cut
tomatoes and the recommended control
measures for such hazards in the
growing, harvesting, packing,
processing, and distribution of
tomatoes, along with retail and food
service preparation. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
sroberts on DSKD5P82C1PROD with NOTICES
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to publish notice in the
Federal Register soliciting public
comment on each proposed collection of
information before submitting the
collection to OMB for approval. To
comply with this requirement, FDA will
publish a 60-day notice on the proposed
collection of information in a future
issue of the Federal Register.
VerDate Nov<24>2008
16:05 Jul 31, 2009
Jkt 217001
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The draft
guidance and received comments may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov.
V. References
The following reference has been
placed on display in the Division of
Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. North American Tomato Trade
Workgroup and United Fresh Produce
Association. ‘‘Commodity Specific Food
Safety Guidelines for the Fresh Tomato
Supply Chain.’’ 2d ed., July 2008. Accessed
online at https://www.fda.gov/Food/
FoodSafety/Product-SpecificInformation/
FruitsVegetablesJuices/GuidanceCompliance
RegulatoryInformation/ucm171695.htm.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18453 Filed 7–31–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0348]
Draft Guidance for Industry: Guide to
Minimize Microbial Food Safety
Hazards of Leafy Greens; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Guidance for Industry: Guide to
Minimize Microbial Food Safety
Hazards of Leafy Greens.’’ This draft
guidance is intended to cover the entire
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
38439
leafy greens supply chain, both
domestic firms and foreign firms
exporting leafy greens products into the
United States, to enhance the safety of
leafy greens by recommending practices
to minimize microbial food safety
hazards and to prevent microbial
contamination. This draft guidance,
when finalized, will supplement
existing FDA guidances, including the
1998 ‘‘Guidance to Industry: Guide to
Minimize Microbial Food Safety
Hazards for Fresh Fruits and
Vegetables,’’ which applies to fresh
produce commodities, and the 2008
‘‘Guidance to Industry: Guide to
Minimize Microbial Food Safety
Hazards of Fresh-cut Fruits and
Vegetables,’’ which applies to fresh-cut
produce.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by October 2, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Food Safety (HFS–317), Center
for Food Safety and Applied Nutrition,
5100 Paint Branch Pkwy., College Park,
MD 20740. Send one self-addressed
adhesive label to assist that office in
processing your request, or fax your
request to 301–436–2651. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Amy Green, Center for Food Safety and
Applied Nutrition (HFS–317), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–2025.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance entitled ‘‘Guidance for
Industry: Guide to Minimize Microbial
Food Safety Hazards of Leafy Greens.’’
This draft guidance covers leafy greens
that are grown and harvested then
packed or cooled for fresh market or for
‘‘fresh-cut/value-added processing’’ (i.e.,
minimally processed, such as chopped
or shredded, moved through a series of
washes, and then bagged or
prepackaged), shipped to food service or
retail establishments, and offered for
E:\FR\FM\03AUN1.SGM
03AUN1
38440
Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
sroberts on DSKD5P82C1PROD with NOTICES
sale to the consumer. The term ‘‘leafy
greens’’ as used in this draft guidance
includes raw agricultural commodities
and fresh-cut/value-added products.
Examples of leafy greens include iceberg
lettuce, romaine lettuce, leaf lettuce,
butter lettuce, baby leaf lettuce
(immature lettuce or leafy greens),
escarole, endive, spring mix, spinach,
cabbage, kale, arugula, and chard. Leafy
greens do not include herbs such as
cilantro and parsley.
This draft guidance is based primarily
on leafy greens industry guidelines
issued in 2006 (Ref. 1), along with
agency experience and information from
other recent public and private
programs. The leafy greens industry has
since updated and supplemented its
2006 guidelines with additional
recommendations on the production
and harvest of leafy greens that include
quantitative metrics and measures to
assist industry in implementing the
guidelines (Ref. 2). This draft guidance
does not include these more specific
and quantitative metrics and measures.
We are considering the extent to which
more specific measures, including
metrics, should be utilized to help
verify the implementation and efficacy
of the Federal recommendations and
industry practices. We are also
evaluating the extent to which metrics
can be applied to diverse geographic
areas within the United States and
internationally. FDA invites comment
on whether such information should be
incorporated into the guidance, when
finalized.
FDA is issuing this draft guidance as
Level 1 draft guidance consistent with
FDA’s good guidance practices
regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent
the agency’s current thinking on the
microbiological hazards presented by
fresh and fresh-cut leafy greens products
and the recommended control measures
for such hazards in production and
harvesting, postharvest operations,
processing, distribution, and retail and
food service handling of such produce.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
VerDate Nov<24>2008
16:05 Jul 31, 2009
Jkt 217001
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to publish notice in the
Federal Register soliciting public
comment on each proposed collection of
information before submitting the
collection to OMB for approval. To
comply with this requirement, FDA will
publish a 60-day notice on the proposed
collection of information in a future
issue of the Federal Register.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The draft
guidance and received comments may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov.
V. References
The following references have been
placed on display in the Division of
Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Gorny, J., et al., editors, ‘‘Commodity
Specific Food Safety Guidelines for the
Lettuce and Leafy Greens Supply Chain’’ (1st
ed.); International Fresh-cut Produce
Association, Produce Marketing Association,
United Fresh Fruit and Vegetable
Association, Western Growers Association;
April 25, 2006. Accessed online at https://
www.fda.gov/Food/FoodSafety/ProductSpecificInformation/FruitsVegetablesJuices/
GuidanceComplianceRegulatoryInformation/
ucm168630.htm.
2. See ‘‘Commodity Specific Food Safety
Guidelines for the Production and Harvest of
Lettuce and Leafy Greens’’; Produce
Marketing Association, United Fresh Fruit
and Vegetable Association, and Western
Growers Association; last revised June 13,
2008. Accessed online at https://
www.caleafygreens.ca.gov/trade/documents/
LGMAAcceptedGAPs06.13.08.pdf. (FDA has
verified the Web site address, but FDA is not
responsible for any subsequent changes to
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
the Web site after this document publishes in
the Federal Register.)
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18451 Filed 7–31–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Treatment of Cancer Using Metal
Coordinating Compounds That Kill
Multi-Drug Resistant Cancer Cells
Description of Invention: One of the
major hindrances to successful cancer
chemotherapy is the development of
multi-drug resistance (MDR) in cancer
cells. MDR is frequently caused by the
increased expression or activity of ABC
transporter proteins in response to the
toxic agents used in chemotherapy.
Research has generally been directed to
overcoming MDR by inhibiting the
activity of ABC transporters. However,
compounds that inhibit ABC transporter
activity often elicit strong and
undesirable side-effects, restricting their
usefulness as therapeutics.
In an alternative approach to reducing
the debilitating effects of MDR during
cancer therapy, scientists at the NIH
have identified a family of compounds
E:\FR\FM\03AUN1.SGM
03AUN1
Agencies
[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Pages 38439-38440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18451]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0348]
Draft Guidance for Industry: Guide to Minimize Microbial Food
Safety Hazards of Leafy Greens; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Guide to Minimize Microbial Food Safety Hazards of Leafy Greens.'' This
draft guidance is intended to cover the entire leafy greens supply
chain, both domestic firms and foreign firms exporting leafy greens
products into the United States, to enhance the safety of leafy greens
by recommending practices to minimize microbial food safety hazards and
to prevent microbial contamination. This draft guidance, when
finalized, will supplement existing FDA guidances, including the 1998
``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards
for Fresh Fruits and Vegetables,'' which applies to fresh produce
commodities, and the 2008 ``Guidance to Industry: Guide to Minimize
Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,''
which applies to fresh-cut produce.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 2, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Food Safety (HFS-317), Center for Food Safety
and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-436-2651. Submit
written comments on the draft guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Amy Green, Center for Food Safety and
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 301-436-2025.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Guide to Minimize Microbial Food Safety
Hazards of Leafy Greens.'' This draft guidance covers leafy greens that
are grown and harvested then packed or cooled for fresh market or for
``fresh-cut/value-added processing'' (i.e., minimally processed, such
as chopped or shredded, moved through a series of washes, and then
bagged or prepackaged), shipped to food service or retail
establishments, and offered for
[[Page 38440]]
sale to the consumer. The term ``leafy greens'' as used in this draft
guidance includes raw agricultural commodities and fresh-cut/value-
added products. Examples of leafy greens include iceberg lettuce,
romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce
(immature lettuce or leafy greens), escarole, endive, spring mix,
spinach, cabbage, kale, arugula, and chard. Leafy greens do not include
herbs such as cilantro and parsley.
This draft guidance is based primarily on leafy greens industry
guidelines issued in 2006 (Ref. 1), along with agency experience and
information from other recent public and private programs. The leafy
greens industry has since updated and supplemented its 2006 guidelines
with additional recommendations on the production and harvest of leafy
greens that include quantitative metrics and measures to assist
industry in implementing the guidelines (Ref. 2). This draft guidance
does not include these more specific and quantitative metrics and
measures. We are considering the extent to which more specific
measures, including metrics, should be utilized to help verify the
implementation and efficacy of the Federal recommendations and industry
practices. We are also evaluating the extent to which metrics can be
applied to diverse geographic areas within the United States and
internationally. FDA invites comment on whether such information should
be incorporated into the guidance, when finalized.
FDA is issuing this draft guidance as Level 1 draft guidance
consistent with FDA's good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent the
agency's current thinking on the microbiological hazards presented by
fresh and fresh-cut leafy greens products and the recommended control
measures for such hazards in production and harvesting, postharvest
operations, processing, distribution, and retail and food service
handling of such produce. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to publish
notice in the Federal Register soliciting public comment on each
proposed collection of information before submitting the collection to
OMB for approval. To comply with this requirement, FDA will publish a
60-day notice on the proposed collection of information in a future
issue of the Federal Register.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The draft guidance and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov.
V. References
The following references have been placed on display in the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852 and may be seen by interested persons between 9 a.m. and 4
p.m., Monday through Friday.
1. Gorny, J., et al., editors, ``Commodity Specific Food Safety
Guidelines for the Lettuce and Leafy Greens Supply Chain'' (1st
ed.); International Fresh-cut Produce Association, Produce Marketing
Association, United Fresh Fruit and Vegetable Association, Western
Growers Association; April 25, 2006. Accessed online at https://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/GuidanceComplianceRegulatoryInformation/ucm168630.htm.
2. See ``Commodity Specific Food Safety Guidelines for the
Production and Harvest of Lettuce and Leafy Greens''; Produce
Marketing Association, United Fresh Fruit and Vegetable Association,
and Western Growers Association; last revised June 13, 2008.
Accessed online at https://www.caleafygreens.ca.gov/trade/documents/LGMAAcceptedGAPs06.13.08.pdf. (FDA has verified the Web site
address, but FDA is not responsible for any subsequent changes to
the Web site after this document publishes in the Federal Register.)
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18451 Filed 7-31-09; 8:45 am]
BILLING CODE 4160-01-S