Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Availability, 38438-38439 [E9-18453]
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38438
Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
Safety and Applied Nutrition (HFS–
317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–1111.
SUPPLEMENTARY INFORMATION:
sroberts on DSKD5P82C1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance entitled ‘‘Guidance for
Industry: Guide to Minimize Microbial
Food Safety Hazards of Melons.’’ This
draft guidance covers melons that are
grown and harvested for fresh market
(i.e., fresh, unprocessed form) or for
‘‘fresh-cut/value-added products’’ (i.e.,
minimally processed, such as trimmed,
peeled, sliced or diced, and then bagged
or prepackaged), cooled, shipped to
retail, wholesale or for processing, and
offered for sale to the consumer. The
term ‘‘melons’’ as used in this draft
guidance includes raw agricultural
commodities and fresh-cut/value-added
products derived from cantaloupe (also
known as muskmelons), honeydew,
watermelon, and variety melons (e.g.,
‘‘Canary,’’ ‘‘Crenshaw,’’ and ‘‘Galia’’).
This draft guidance is based primarily
on melon industry guidelines issued in
2005 (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FDA is issuing this draft guidance as
Level 1 draft guidance consistent with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 The draft
guidance, when finalized, will represent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 presented by
fresh and fresh-cut melons 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
VerDate Nov<24>2008
16:05 Jul 31, 2009
Jkt 217001
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 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. Fleming, P., Pool, W., and Gorny, J.,
editors; ‘‘Commodity Specific Food Safety
Guidelines for the Melon Supply Chain’’ (1st
ed.); Produce Marketing Association and
United Fresh Produce Association; November
7, 2005. Accessed online at https://
www.fda.gov/Food/FoodSafety/ProductSpecificInformation/FruitsVegetablesJuices/
GuidanceComplianceRegulatoryInformation/
ucm168609.htm.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18452 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–0346]
Draft Guidance for Industry: Guide to
Minimize Microbial Food Safety
Hazards of Tomatoes; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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 Tomatoes.’’ This guidance is
intended to cover the entire tomato
supply chain, both domestic firms and
foreign firms exporting tomatoes into
the United States, to enhance the safety
of tomatoes 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 for Industry: Guide to
Minimize Microbial Food Safety
Hazards for Fresh Fruits and
Vegetables,’’ which applies to fresh
produce commodities, and the 2008
‘‘Guidance for 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:
Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS–
317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–2024.
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 Tomatoes.’’ This
draft guidance covers the growing,
E:\FR\FM\03AUN1.SGM
03AUN1
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
Agencies
[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Pages 38438-38439]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18453]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0346]
Draft Guidance for Industry: Guide to Minimize Microbial Food
Safety Hazards of Tomatoes; 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 Tomatoes.'' This
guidance is intended to cover the entire tomato supply chain, both
domestic firms and foreign firms exporting tomatoes into the United
States, to enhance the safety of tomatoes 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 for Industry:
Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables,'' which applies to fresh produce commodities, and the 2008
``Guidance for 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: Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2024.
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 Tomatoes.'' This draft guidance covers the growing,
[[Page 38439]]
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.
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 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/GuidanceComplianceRegulatoryInformation/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