[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8086-8087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3409]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0085]


Preventive Controls for Fresh Produce; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
opening of a docket to obtain information about current practices and 
conditions for the production and packing of fresh produce. FDA is 
establishing this docket in order to provide an opportunity for 
interested parties to provide information and share views that will 
inform the development of safety standards for fresh produce at the 
farm and packing house and strategies and cooperative efforts to ensure 
compliance.

DATES: Submit electronic or written comments by May 24, 2010.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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 20740-3835, 301-436-2024.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 19, 2009, President Barack Obama established a new Food 
Safety Working Group (FSWG), chaired by the Secretaries of the 
Department of Health and Human Services and the Department of 
Agriculture. In announcing creation of the FSWG, the President said the 
group would advise him on how to upgrade U.S. food safety laws for the 
21st century, foster coordination of food safety efforts throughout the 
Government, and ensure laws are being adequately enforced to keep the 
American people safe from foodborne illness (Ref. 1).
    On July 1, 2009, the FSWG recommended a new public health-focused 
approach to food safety based on three core principles: (1) 
Prioritizing prevention; (2) strengthening surveillance and 
enforcement; and (3) improving response and recovery (Ref. 1). The FSWG 
announced steps to be taken by FDA and other Federal agencies to 
achieve these goals.
    With regard to fresh produce, the FSWG announced that FDA would 
issue ``commodity-specific draft guidance on preventive controls that 
industry can implement to reduce the risk of microbial contamination in 
the production and distribution of tomatoes, melons, and leafy greens'' 
(Ref. 1). The FSWG also announced that FDA, over the next 2 years, 
would ``seek public comment and work to require adoption of these 
approaches through regulation'' (Ref. 1).
    On August 3, 2009, FDA made available draft guidances to industry 
for leafy greens, melons, and tomatoes (Refs. 3 through 5). FDA is now 
establishing a docket in order to provide an opportunity for interested 
parties to provide information and share views that will inform the 
development of: (1) Safety standards for fresh produce at the farm and 
packing house and (2) strategies and cooperative efforts to ensure 
compliance.

II. Request for Comments and Information

    We are requesting comments that will inform the development of: (1) 
Safety standards for fresh produce at the farm and packing house and 
(2) strategies and cooperative efforts to ensure compliance. In 
particular, we welcome input on any of these general categories:
    <bullet> Role of the good agricultural practice guidelines entitled 
``Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and 
Vegetables'' (GAPs Guide, Ref. 6);
    <bullet> Standards for domestic and foreign growers and packers;
    <bullet> Identification and prioritization of risk factors;
    <bullet> Environmental assessment of hazards and possible pathways 
of contamination;
    <bullet> The impact of scale of growing operations on the nature 
and degree of possible food safety hazards;
    <bullet> Methods to tailor preventive controls to particular 
hazards and conditions affecting an operation;
    <bullet> Possible approaches to tailoring preventive controls to 
the scale of an operation so that the controls achieve an appropriate 
level of food safety protection and are feasible for a wide range of 
large and small operations;
    <bullet> Coordination of produce food safety practices and 
sustainable and/or organic production methods;
    <bullet> Coordination of produce food safety practices and 
environmental and/or conservation goals or practices;
    <bullet> Coordination of produce food safety practices and Federal, 
State, local and tribal government statutes and regulations;
    <bullet> Microbial testing;
    <bullet> Post-harvest operations and the role of the current good 
manufacturing practices in 21 CFR part 110;
    <bullet> Records and other documentation that would be useful to 
industry and regulators in ensuring the safety of fresh produce; and
    <bullet> Strategies to enhance compliance.
    The agency will consider information submitted to the docket in 
developing safety standards for fresh produce. Comments previously 
submitted to the Division of Dockets Management for the following 
dockets will also be considered by FDA and do not need to be 
resubmitted:
    <bullet> ``Draft Guidance for Industry: Guide to Minimize Microbial 
Food Safety Hazards of Tomatoes; Availability'' (74 FR 38438, August 3, 
2009; Docket No. FDA-2009-D-0346);
    <bullet> ``Draft Guidance for Industry: Guide to Minimize Microbial 
Food Safety Hazards of Melons'' (74 FR 38437, August 3, 2009; Docket 
No. FDA-2009-D-0347);
    <bullet> ``Draft Guidance for Industry: Guide to Minimize Microbial 
Food Safety Hazards of Leafy Greens; Availability'' (74 FR 38439, 
August 3, 2009; Docket No. FDA-2009-D-0348); and

[[Page 8087]]

    <bullet> ``Guide to Minimize Microbial Food Safety Hazards for 
Fresh Fruits and Vegetables; Request for Comments and for Scientific 
Data and Information'' (73 FR 51306, September 2, 2008; Docket No. FDA-
2008-N-0455).

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this docket. 
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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. References

    FDA has placed the following references on display in FDA's 
Division of Dockets Management (see ADDRESSES). You may see them 
between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the 
Web site addresses, but FDA is not responsible for any subsequent 
changes to Web sites after this document publishes in the Federal 
Register.)
    1. Food Safety Working Group, ``Food Safety Working Group: Key 
Findings'' (July 1, 2009), Available at http://www.foodsafetyworkinggroup.gov/ContentKeyFindings/HomeKeyFindings.htm, 
Accessed and printed on January 11, 2010.
    2. Food Safety Working Group, ``President's Food Safety Working 
Group: Delivering Results,'' Available at http://www.foodsafetyworkinggroup.gov/FSWG_Fact_Sheet.pdf, Accessed and 
printed on January 11, 2010.
    3. FDA, ``Draft Guidance for Industry: Guide to Minimize Microbial 
Food Safety Hazards of Tomatoes; Availability'' (74 FR 38438, August 3, 
2009).
    4. FDA, ``Draft Guidance for Industry: Guide to Minimize Microbial 
Food Safety Hazards of Melons'' (74 FR 38437, August 3, 2009).
    5. FDA, ``Draft Guidance for Industry: Guide to Minimize Microbial 
Food Safety Hazards of Leafy Greens; Availability'' (74 FR 38439, 
August 3, 2009).
    6. FDA, ``Guidance for Industry: Guide to Minimize Microbial Food 
Safety Hazards for Fresh Fruits and Vegetables,'' October 26, 1998, 
Available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm064574.htm.

    Dated: February 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3409 Filed 2-18-10; 11:15 am]
BILLING CODE 4160-01-S