Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Availability, 38439-38440 [E9-18451]

Download as PDF 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 This draft guidance is based primarily on tomato industry guidelines issued in July 2008 (Ref. 1), along with agency experience and information from other recent public and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 FDA is issuing this draft guidance as Level 1 draft guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on the microbiological hazards that may result in contamination of fresh and fresh-cut tomatoes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
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