Preventive Controls for Fresh Produce; Request for Comments, 8086-8087 [2010-3409]

Download as PDF 8086 Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 / Notices early stage human embryos, up to and including the blastocyst stage, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.’’ This proposed change in no way alters the rigorous ethical standards set forth in the Guidelines. DATES: Written comments on this proposed change must be received by NIH on or before March 25, 2010 in order to be considered. ADDRESSES: Public comments may be may be entered at: https:// hescregapp.od.nih.gov/comments/ add.htm. Comments may also be mailed to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland 20892–7997. Comments will be made publicly available. Personally identifiable information (except for organizational affiliations) will be removed prior to making comments publicly available. Dated: February 16, 2010. Francis S. Collins, Director, National Institutes of Health. [FR Doc. 2010–3527 Filed 2–19–10; 4:15 pm] BILLING CODE 4140–01–P 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. mstockstill on DSKH9S0YB1PROD with NOTICES ACTION: Notice; request for comments. 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 https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug VerDate Nov<24>2008 16:25 Feb 22, 2010 Jkt 220001 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 healthfocused 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 cooperative efforts to ensure compliance. In particular, we welcome input on any of these general categories: • Role of the good agricultural practice guidelines entitled ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables’’ (GAPs Guide, Ref. 6); • Standards for domestic and foreign growers and packers; • Identification and prioritization of risk factors; • Environmental assessment of hazards and possible pathways of contamination; • The impact of scale of growing operations on the nature and degree of possible food safety hazards; • Methods to tailor preventive controls to particular hazards and conditions affecting an operation; • 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; • Coordination of produce food safety practices and sustainable and/or organic production methods; • Coordination of produce food safety practices and environmental and/or conservation goals or practices; • Coordination of produce food safety practices and Federal, State, local and tribal government statutes and regulations; • Microbial testing; • Post-harvest operations and the role of the current good manufacturing practices in 21 CFR part 110; • Records and other documentation that would be useful to industry and regulators in ensuring the safety of fresh produce; and • 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: • ‘‘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); • ‘‘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); • ‘‘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 E:\FR\FM\23FEN1.SGM 23FEN1 Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 / Notices • ‘‘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 mstockstill on DSKH9S0YB1PROD with NOTICES 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 https:// www.foodsafetyworkinggroup.gov/ ContentKeyFindings/HomeKey Findings.htm, Accessed and printed on January 11, 2010. 2. Food Safety Working Group, ‘‘President’s Food Safety Working Group: Delivering Results,’’ Available at https://www.foodsafetyworking group.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 https://www.fda.gov/Food/Guidance ComplianceRegulatoryInformation/ 16:25 Feb 22, 2010 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 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. VerDate Nov<24>2008 GuidanceDocuments/ProduceandPlan Products/ucm064574.htm. Jkt 220001 DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket No. DHS–2010–0009] DHS Data Privacy and Integrity Advisory Committee Privacy Office, DHS. Notice of Federal Advisory Committee Meeting. AGENCY: ACTION: SUMMARY: The DHS Data Privacy and Integrity Advisory Committee will meet on March 18, 2010, in Washington, DC. The meeting will be open to the public. DATES: The DHS Data Privacy and Integrity Advisory Committee will meet on Thursday, March 18, 2010, from 8:30 a.m. to 1 p.m. Please note that the meeting may end early if the Committee has completed its business. ADDRESSES: The meeting will be held at the US Citizenship and Immigration Services Tomich Center, 111 Massachusetts Ave, NW., (corner of New Jersey Avenue) Washington, DC 20529. Written materials, requests to make oral presentations, and requests to have a copy of your materials distributed to each member of the Committee prior to the meeting should be sent to Martha K. Landesberg, Executive Director, DHS Data Privacy and Integrity Advisory Committee, by March 11, 2010. Persons who wish to submit comments and who are not able to attend or speak at the meeting may submit comments at any time. All submissions must include the Docket Number (DHS–2010–0009) and may be submitted by any one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • E-mail: PrivacyCommittee@dhs.gov. Include the Docket Number (DHS– 2010–0009) in the subject line of the message. • Fax: (703) 483–2999. • Mail: Martha K. Landesberg, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Washington, DC 20528. Instructions: All submissions must include the words ‘‘Department of PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 8087 Homeland Security Data Privacy and Integrity Advisory Committee’’ and the Docket Number (DHS–2010–0009). Comments will be posted without alteration at https://www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received by the DHS Data Privacy and Integrity Advisory Committee, go to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Martha K. Landesberg, Executive Director, DHS Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Washington, DC 20528, by telephone (703) 235–0780, by fax (703) 235–0442, or by e-mail to PrivacyCommittee@dhs.gov. SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. App. (Pub. L. 92–463). During the meeting, the Chief Privacy Officer will provide the DHS Data Privacy and Integrity Advisory Committee an update on the activities of the DHS Privacy Office. The Committee will also hear presentations on the Department’s cyber security efforts. In addition, the Committee’s subcommittees will discuss their ongoing work. The agenda will be posted in advance of the meeting on the Committee’s Web site at https:// www.dhs.gov/privacy. Please note that the meeting may end early if all business is completed. If you wish to attend the meeting, please plan to arrive at the Tomich Center by 8:15 a.m., to allow extra time to be processed through security, and bring a photo ID. The DHS Privacy Office encourages you to register for the meeting in advance by contacting Martha K. Landesberg, Executive Director, DHS Data Privacy and Integrity Advisory Committee, at PrivacyCommittee@dhs.gov. Advance registration is voluntary. The Privacy Act Statement below explains how DHS uses the registration information you may provide and how you may access or correct information retained by DHS, if any. At the discretion of the Chair, members of the public may make brief (i.e., no more than three minutes) oral presentations from 12 p.m. to 12:30 p.m. If you would like to make an oral presentation at the meeting, we request that you register in advance or sign up on the day of the meeting. The names and affiliations, if any, of individuals who address the Committee are included in the public record of the meeting. If you wish to provide written materials to be distributed to each E:\FR\FM\23FEN1.SGM 23FEN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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:
     Role of the good agricultural practice guidelines entitled 
``Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and 
Vegetables'' (GAPs Guide, Ref. 6);
     Standards for domestic and foreign growers and packers;
     Identification and prioritization of risk factors;
     Environmental assessment of hazards and possible pathways 
of contamination;
     The impact of scale of growing operations on the nature 
and degree of possible food safety hazards;
     Methods to tailor preventive controls to particular 
hazards and conditions affecting an operation;
     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;
     Coordination of produce food safety practices and 
sustainable and/or organic production methods;
     Coordination of produce food safety practices and 
environmental and/or conservation goals or practices;
     Coordination of produce food safety practices and Federal, 
State, local and tribal government statutes and regulations;
     Microbial testing;
     Post-harvest operations and the role of the current good 
manufacturing practices in 21 CFR part 110;
     Records and other documentation that would be useful to 
industry and regulators in ensuring the safety of fresh produce; and
     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:
     ``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);
     ``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);
     ``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]]

     ``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 https://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 https://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 https://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
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