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Rports/Notices/News Releases

April 24, 2013

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

FDA Extends Public Comment Period 120 Days for Proposed Rules on Preventive Controls for Human Food, Produce Safety, and Draft Qualitative Risk Assessment

On April 24, FDA issued Federal Register notices to extend the comment periods on the proposed rules for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (the Preventive Controls proposed rule) and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety proposed rule) until September 16, 2013. 

These proposals, originally published in the Federal Register for public comment on January 16, 2013, are the first of five proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The other three proposed rules, Preventive Controls for Animal Food; Foreign Supplier Verification Program (FSVP); and Accreditation of Third Party Auditors, are under review.

The Agency granted the extension of the comment period based on formal, written requests from many interested persons and groups that indicated more time was needed to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues in the two proposed rules.

The comment period is being extended for 120 days for the Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm, as well as for the information collection provisions for the preventive controls and the produce safety proposed rules.

FDA invites interested persons to submit comments by September 16, 2013. 

Upcoming Meetings/Events

May 22, 2013

DEPARTMENT OF AGRICULTURE/Department of Health and Human Services

Food Safety and Inspection Service/Food and Drug Administration

Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens: Notice of a Public Meeting

ACTION: Notice of public meeting.

SUMMARY: The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration/Center for Food Safety and Applied Nutrition (FDA/CFSAN) are holding a public meeting on May 22, 2013, to present the background, approach, scope, and findings of the draft ``Interagency Risk Assessment--L. monocytogenes in Retail Delicatessens.'' The purpose of this draft quantitative risk assessment (QRA) is to evaluate the public health impact of changes in retail delicatessen (deli) practices and potential interventions to reduce or prevent L. monocytogenes contamination in ready-to-eat (RTE) foods that are sliced, prepared, or packaged in retail facilities. FSIS and FDA invite
interested individuals, organizations, and other stakeholders to participate in the meeting and to provide comments on the draft QRA.

DATES: The public meeting will be held on May 22, 2013 from 8:45 a.m. to 4:15 p.m. EDT. Submit either electronic or written comments to FSIS
June 24, 2013.
A copy of the agenda will be made available for viewing prior to the meeting on FSIS's Web site at www.fsis.usda.gov/News/Meetings_&_Events/.

ADDRESSES: The meeting will be held in Washington, DC, on May 22, 2013, in the USDA Jefferson Auditorium (South Building), 1400 Independence Avenue SW., Washington, DC 20250. Attendees must provide a photo ID to enter the building. The Jefferson Auditorium is located between Wings 5 and 6 in the South Building. Attendees should enter the building via Wing 5 or 7 on 14th Street and Independence Avenue SW. After 9:30 a.m., attendees should enter the building via the Wing 1 entrance.
Registration: Registration will begin at 8:15 a.m. Pre-registration for this meeting is encouraged. To pre-register, access the FSIS Web site, http://www.fsis.usda.gov/News/Meetings_&_Events/.
Contact Joan Lindenberger for more information on logistics at (202) 720-0284.

Food Safety

April 29, 2013

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Joint Food and Drug Administration/Health Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft “Joint Food and Drug Administration/Health Canada--Sant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis From Soft-Ripened Cheese Consumption in the United States and Canada.” This draft Quantitative Risk Assessment (the draft QRA) includes an Interpretative Summary, a Technical Report, with Appendixes, and a risk assessment model. The purpose of the draft QRA is to evaluate the effect of factors such as the microbiological status of milk, the impact of cheese manufacturing steps, and conditions during distribution and storage on the overall risk of invasive listeriosis to the consumer in the United States or Canada of soft-ripened cheese. The draft QRA makes it possible to evaluate the effectiveness of some process changes and intervention strategies in reducing the risk of listeriosis. We are making the draft QRA available for public comment.
DATES: Submit either electronic or written comments on the draft QRA by April 29, 2013.
ADDRESSES: Submit electronic comments to http://www.regulations.gov. Submit written comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Sherri Dennis, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1914.
Link:  http://www.gpo.gov/fdsys/pkg/FR-2013-02-11/html/2013-02960.htm

May 6, 2013

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
Food Ingredients and Sources of Radiation Listed and Approved for Use in the Production of Meat and Poultry Products
ACTION: Final rule.
SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the Federal meat and poultry products inspection regulations to remove sodium benzoate, sodium propionate, and benzoic acid from the list of substances that the regulations prohibit for use in meat or poultry products. New uses of these substances in meat or poultry products will continue to be approved by the Food and Drug Administration (FDA) for safety and by FSIS for suitability. FSIS will add approved uses of these substances to the list of approved substances contained in the Agency’s directive system.
DATES: Effective May 6, 2013.
FOR FURTHER INFORMATION CONTACT: Charles Williams, Director, Policy Issuances Division, Office of Policy and Program Development, FSIS, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250-3700, (202) 720-5627.
Link:  http://www.gpo.gov/fdsys/pkg/FR-2013-03-07/html/2013-05341.htm

May 13, 2013

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket; Extension of Comment Period
ACTION: Notice; extension of comment period.
SUMMARY: The Food and Drug Administration (FDA or we) is extending to May 13, 2013, the comment period for the notice entitled “Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket,” that appeared in the Federal Register of December 14, 2012 (77 FR 74485). In that document, we requested comments relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens as defined in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The document requested comments (including data) that we can use to design and carry out a quantitative risk assessment for establishing regulatory thresholds for major food allergens. We are extending the comment period in response to a request from an industry association.
DATES: Submit either electronic or written comments by May 13, 2013.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-N-0711, by any of the following methods: Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.  Submit written submissions in the following way: Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA-2012-N-0711. FOR FURTHER INFORMATION CONTACT: Steven M. Gendel, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1056.
Link:  http://www.gpo.gov/fdsys/pkg/FR-2013-02-04/html/2013-02319.htm

May 21, 2013

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Flavored Milk; Petition to Amend the Standard of Identity for Milk and 17 Additional Dairy Products
ACTION: Notice; request for comments, data, and information.
SUMMARY: The Food and Drug Administration (FDA) is announcing that the International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) have filed a petition requesting that the Agency amend the standard of identity for milk and 17 other dairy products to provide for the use of any safe and suitable sweetener as an optional ingredient. FDA is issuing this notice to request comments, data, and information about the issues presented in the petition.
DATES: Submit either written or electronic comments by May 21, 2013.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-P-0147 by any of the following methods: Submit electronic comments in the following way: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Submit written submissions in the following ways: Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and docket number for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided.
FOR FURTHER INFORMATION CONTACT: Daniel Y. Reese, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.
Link:  http://www.gpo.gov/fdsys/pkg/FR-2013-02-20/html/2013-03835.htm

July 3, 2013

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Extension of Comment Period
ACTION: Notice; extension of comment period.
SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled “Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food” that appeared in the Federal Register of March 5, 2013 (78 FR 14309). In the notice, FDA requested comments on the findings and recommendations contained in the Institute of Food Technologists (IFT) report to FDA and the submission of information relevant to improving product tracing. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
DATES: Submit either electronic or written comments by July 3, 2013.
ADDRESSES: You may submit comments and information, identified by Docket No. FDA-2012-N-1153, by any of the following methods: Submit electronic comments and information in the following way: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments and information. Submit written submissions in the following way: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Sherri A. McGarry, Office of Foods, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1212, Silver Spring, MD 20903, 301-796-3851.
Link:  http://www.gpo.gov/fdsys/pkg/FR-2013-04-02/html/2013-07580.htm

September 16, 2013

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Period for Information Collection Provisions
ACTION: Proposed rule; extension of comment period for information collection provisions.
SUMMARY: The Food and Drug Administration (FDA or “we”) is extending the comment period for the information collection related to the proposed rule on “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
DATES: The comment period for the proposed rule published January 16, 2013 (78 FR 3646), is extended. Submit either electronic or written comments by September 16, 2013.
ADDRESSES: To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the title “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.”
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Picard Dr., PI50-400T, Rockville, MD 20850, Domini.Bean@fda.hhs.gov.
Link:  http://www.gpo.gov/fdsys/pkg/FR-2013-02-19/html/2013-03732.htm

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Period for Information Collection Provisions
ACTION: Proposed rule; extension of comment period for information collection provisions.
SUMMARY: The Food and Drug Administration (FDA or “we”) is extending the comment period for the information collection provisions of the proposed rule on “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
DATES: The comment period for the proposed rule published January 16, 2013 (78 FR 3504), is extended. Submit either electronic or written comments by September 16, 2013.
ADDRESSES: To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the title “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.”
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Picard Dr., PI50-400T, Rockville, MD 20850, Domini.Bean@fda.hhs.gov.
Link:  http://www.gpo.gov/fdsys/pkg/FR-2013-02-19/html/2013-03778.htm

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability; Reopening of the Comment Period
ACTION: Notification; reopening of the comment period.
SUMMARY: The Food and Drug Administration (FDA or “we”) is extending the comment period for a document entitled “Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” (the draft RA) that we made available for public comment in the Federal Register of January 16, 2013.
DATES: Submit either electronic or written comments by September 16, 2013.
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: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740, 240-402-2166.
Link:  http://www.gpo.gov/fdsys/pkg/FR-2013-03-13/html/2013-05730.htm

To submit comments electronically visit:

1. Comment on the Produce Safety Proposed Rule
2. Comment on the Preventive Controls Proposed Rule
3. Comment on the Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations: Activities Outside the Farm Definition Conducted in a Facility Co-Located on a Farm

For more information on submitting comments to the docket, please see Comment on Proposed Regulations and Submit Petitions.

Regulations Under OMB Review