Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Availability, 38438-38439 [E9-18453]

Download as PDF 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INFORMATION: sroberts on DSKD5P82C1PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance entitled ‘‘Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons.’’ This draft guidance covers melons that are grown and harvested for fresh market (i.e., fresh, unprocessed form) or for ‘‘fresh-cut/value-added products’’ (i.e., minimally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 The term ‘‘melons’’ as used in this draft guidance includes raw agricultural commodities and fresh-cut/value-added products derived from cantaloupe (also known as muskmelons), honeydew, watermelon, and variety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 This draft guidance is based primarily on melon industry guidelines issued in 2005 (Ref. 1), along with agency experience and information from other recent public and private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 FDA is issuing this draft guidance as Level 1 draft guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on the microbiological hazards presented by fresh and fresh-cut melons and the recommended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
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