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Food Safety Modernization Act (FSMA) 2013 Year in Review

Food Safety Modernization Act (FSMA)
2013 Year in Review: Presented by Mi-Jack Systems and Technologies

January

FDA Announces Two Proposed Rules for Public Comment
On January 4, FDA announced and on January 16 published for public comment a proposed rule on preventive controls for human food and a proposed rule on standards for produce safety.

The following resources were published relating to the two proposed rules:

FDA Issues New FAQs Concerning Food Facility Registration Renewal
On January 18, FDA added two new FAQs concerning the renewal process for food facility registration. The questions pertain to accessing the system and retaining access to historical information.

FDA Announces Public Meetings on Proposed FSMA Rules
On January 30, FDA announced a series of three public meetings concerning the FSMA Proposed Rules for Produce Safety Standards and Preventive Controls for Human Food.

 

February                      

FDA Announces Final Rule on Administrative Detention of Food
On February 4, FDA announced a final rule Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption amending the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. This action makes the criteria consistent with changes to the Federal Food, Drug, and Cosmetic Act under FSMA. The final rule adopts the interim final rule, “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption,” published in May 2011, without change. Website Disclaimer

FDA Issues Reminder on Comment Period Deadline for Draft Qualitative Risk Assessment under Proposed Rule on Preventive Controls for Human Food
On February 13, FDA issued a reminder about the February 15 deadline for comments on “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 purpose of the draft risk assessment is to provide a science-based risk analysis of those activity/food combinations that could be considered low risk.

FDA Extends Comment Period for Information Collection Provisions of Two Proposed FSMA Rules
On February 15, FDA announced the extension of the comment period to May 16 for the information collection provisions associated with the proposed FSMA rules on produce safety standards and preventive controls for human food.

FDA Releases International Capacity-Building Plan
On February 28, FDA released a plan, which outlines goals, objectives, and key actions that will provide a strategic framework for the FDA in setting priorities and managing international food safety capacity-building programs.

FDA Holds First Public Meeting on FSMA Proposed Rules
On February 28 and March 1 in Washington, D.C., FDA held the first of three public meetings on the proposed rule for preventive controls for human food and the proposed rule for produce safety standards.

 March

FDA Seeking Input on Product Tracing Pilot Report
On March 4, FDA called for public comment on a report from the Institute of Food Technologists (IFT) entitled “Pilot Projects for Improving Product Tracing along the Food Supply System.” The comments are to be considered by FDA in the development of recommendations in a report to Congress.

FDA Releases Guidance for Industry on Administrative Detention
On March 7, FDA released revised guidance on administrative detention entitled “Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide.”

FDA Holds Second Public Meeting on FSMA Proposed Rules
On March 11 and 12, in Chicago, Illinois, FDA held the second of three public meetings to receive comment on the proposed rule for preventive controls in human food and the proposed rule for produce safety standards.

Comment Period Extended for Draft Risk Assessment
On March 12, FDA reopened 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.
” Based on three requests for a deadline extension, FDA reopened the comment period until May 16, 2013.(Website Disclaimer)

Corrections to Proposed Rules
On March 19, FDA corrected technical errors to the proposed rules for Preventive Controls for Human Food and Standards for Produce Safety, originally published on January 16, 2013.

Frequently Asked Questions Concerning the Proposed Rules for Preventive Controls and Produce Safety
On March 26, FDA released an expanded list of questions and answers on the Preventive Controls Proposed Rule and the Produce Safety Proposed Rule.

FDA Holds Final Public Meeting on FSMA Proposed Rules
On March 27 and 28, in Portland, Oregon, FDA held the third in a series of public meetings to receive comment on the proposed rule for preventive controls for human food and the proposed rule for produce safety.

 April

FDA Extends Comment Period for Pilot Projects Report
On April 1, FDA announced that the comment period for the report “Pilot Projects for Improving Product Tracing Along the Food Supply System” was extended to July 3, 2013.

 

Guidance for FDA Staff on Food Facility Registration – Human and Animal Food – Now Available
On April 5, FDA announced the availability of the “Draft Compliance Policy Guide (CPG) Food Facility Registration – Human and Animal Food.” When finalized, the draft will replace “Compliance Policy Guide Section 110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.” This document provides guidance for FDA staff on food facility registration under section 415 of the Food, Drug, and Cosmetic Act, including: the requirement that certain food facilities register with FDA; the requirement that registered facilities renew their registrations with FDA biennially; and FDA’s authority to suspend a food facility’s registration.

FDA Releases Vulnerability Assessment
On April 9, FDA published “Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types.” The study utilized the results from 25 vulnerability assessments, conducted by FDA over several years on more than 50 products or processes, to determine if a potential “threshold” score for the implementation of mitigation strategies could be identified.

FDA Announces Comment Period Extensions
On April 24, FDA issued Federal Register notices to extend the comment periods to September 16, 2013 for two proposed rules and a draft qualitative risk assessment:

 May

FDA Announces Availability of Meeting Transcripts
On May 8, FDA announced the availability of transcripts from the FSMA Public Meeting held February 28, 2013 in Washington, DC concerning proposed rules for Preventive Controls in Human Food and Produce Safety Standards.

New FAQs Available
On May 16, FDA announced publication of new questions & answers concerning the Proposed Rule for Preventive Controls as it relates to Dairy Products Produced under the Pasteurized Milk Ordinance. See additional information on the Proposed Rule for Preventive Controls.

FDA Announces the Availability of Meeting Transcripts
On May 22, FDA announced the availability of transcripts from the FSMA Public Meeting held March 11, 2013 in Chicago, IL concerning proposed rules for Preventive Controls in Human Food and Produce Safety Standards.

 

FDA Report Submitted to Congress
On May 23, FDA announced the availability of the report “Building Domestic Capacity to Implement the FDA Food Safety and Modernization Act (FSMA)” required by Section 110(a)(1) of FSMA. This section of the Act requires that the Department of Health and Human Services Secretary submit to Congress a comprehensive report that identifies programs and practices intended to promote the safety of the U.S. food supply.

FDA Issues Final Rule
On May 30, FDA issued a final rule that adopts the interim final rule issued May 5, 2011, “Information Required in Prior Notice of Imported Food.” It requires an additional element of information in a prior notice of imported food, specifically that a person submitting prior notice of imported food must report the name of any country that has refused entry of that product. See more on Imports Under the FSMA

June

FDA Announces the Availability of Meeting Transcripts
On June 17, FDA announced the availability of transcripts from the FSMA Public Meeting held March 27, 2013 in Portland, OR, concerning proposed rules for Preventive Controls in Human Food and Produce Safety Standards.

 July

FDA Introduces Redesigned FSMA Website
On July 15, FDA announced a redesigned FSMA website, with easier navigation and additional materials to help farmers learn about the proposed safety rule.

FDA Releases Proposed Rules to Ensure Safety of Imported Food: Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors/Certification Bodies
On July 26, FDA released the Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors/Certification Bodies proposed rules, required under the FDA FSMA. Under the new proposed rules, U.S. importers would need to verify that their suppliers are meeting U.S. food safety requirements. In addition, FDA would establish a program for accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities and the foods they produce for both humans and animals.

August

FDA Announces the Fiscal Year 2014 Fee Rates
On August 1, FDA announced the Fiscal Year (FY) 2014 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA FSMA. See more on Fees Under the FSMA

 

FDA Extends Comment Period
On August 8, FDA announced that the comment period for the proposed rules on Preventive Controls for Human Foods and Standards for Produce Safety would be extended for 60 days until November 15, 2013, the second and final extension of the comment period for these two proposed rules.

FDA Announces New Blog
On August 12, FDA announced “On the Road With Mike Taylor: Touring the Pacific Northwest,” a new blog that describes his tour of Idaho, Oregon and Washington to discuss the proposed produce safety rule with farmers, state officials and others involved in agriculture.

FDA Announces Days Two and Three of New Blog
On August 15, FDA announced the new posts, “On the Road With Mike Taylor: Frank Talk in Farm Country,” and “On the Road With Mike Taylor: Families and Partnerships” on a new blog that continues with his tour of Idaho, Oregon and Washington to discuss the proposed produce safety rule with farmers, state officials and others involved in
agriculture.

FDA Announces a Public Meeting on Two Proposed Rules under FSMA to Strengthen the Oversight of Imported Foods
On August 15, FDA announced a public meeting to be held September 19-20, 2013 in Washington, D.C. on the FSMA: Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies. This was the first in a series of three public meetings FDA planned to hold on these FSMA proposed rules.

FDA To Prepare Environmental Impact Statement on Proposed Produce Rule
On August 16, FDA announced its intent to prepare an Environmental Impact Statement (EIS) that will evaluate the potential environmental effects of the proposed rule for produce safety.

FDA Releases Presentation on Import Safety
On August 19, FDA released a presentation, Proposed Rules to Help Ensure the Safety of Imported Food, to provide an overview of the Proposed Regulations for Foreign Supplier Verification Programs (FSVPs) and the Proposed Rule for Accreditation of Third-Party Auditors.

September

FDA Publishes “Frequently Asked Questions” on Systems Recognition
On September 5, FDA published a “Frequently Asked Questions” document that describes a new activity that the Agency has been developing and piloting over the past few years called Systems Recognition. While not a FSMA provision, systems recognition is part of FDA’s broader toolbox for import safety and is referenced in the recently published Proposed Rule for Foreign Supplier Verification Programs (FSVPs) under FSMA.

 

FDA Announces Two Additional Public Meetings on Major FSMA Proposed Rules
On September 17, FDA announced two additional public meetings on the FSMA Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies. These meetings are the second and third in a series of meetings announced in the August 16, 2013 Federal Register Notice and on FDA’s FSMA website.

FDA Releases Agenda for Upcoming FSMA Public Meeting
On September 18, FDA released the agenda for the FSMA Public Meeting Concerning Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies to be held in Washington, DC on September 19-20, 2013.

October

Public Meeting Cancelled due to lapse in Federal Funding
Updated October 7, 2013, the meeting was originally scheduled for October 10-11, 2013FSMA Public Meeting Concerning the Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies - Miami, FL

FDA Launches Twitter feed on FSMA and other food issues
Updated October 18, 2013https://twitter.com/FDAfood @FDAfood twitter account

FSMA Public Meeting Concerning Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies - Long Beach, CA
October 22-23, 2013

FDA releases the Preventive Controls for Food for Animals proposed rule.
October 25:  Proposed Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

November

Jan-Sept, 2013 FSMA Progress Reports
November 1, 2013, new reports summarizing actions taken by FDA to implement the Food Safety Modernization Act (FSMA) are now available. Visit FSMA Progress Reports to view these and all progress reports. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm255893.htm?source​=govdelivery&utm_medium=email&utm_source=govdelivery

Advance Notice of 60-day Comment Period Extension
November 4, 2013, FDA will soon announce a 60-day extension of the comment period on proposed rules for Foreign Supplier Verification Programs for Importers of Food for Humans and Animals and Accreditation of Third-Party Auditors/Certification bodies to Conduct Food Safety Audits to Issue Certifications.  The current comment period for both proposed rules is scheduled to end November 26, 2013.  Details to follow. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm

Proposed Rule for Preventive Controls for Food for Animals (PPT, 2.5MB)Updated November 4, 2013, a power point presentation on the Proposed Rule for Preventive Controls for Food for Animals is now available.

Meeting Videos Available - Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies, Sept Washington, DC
November 7, 2012 http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm364950.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Translations of key material concerning FSMA proposed rules are now available.-  New Translated Material

FDA releases the Preventive Controls for Food for Animals proposed rule3. Under the new proposed rule, facilities that manufacture, process, pack, or hold food for animals would be required to adhere to current good manufacturing practices and implement hazard analysis and risk-based preventive controls. FDA will hold 3 public meetings4 on the proposed rule.

Meeting Materials Available
November 13, 2013, the agenda for the upcoming FSMA Public Meeting Proposed Rule to Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, to be held in College Park, MD, is now available. Visit the meeting page to view the agenda and additional information.

Public Meeting Concerning the Proposed Rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals - College Park, MD3
November 21, 2013

FDA Extends Public Comment Period on both the proposed rule on produce safety and preventive controls for human food to November 22, 2013

·         We are very interested in your comments and have made every effort to encourage input since they were first published in January 2013.  Our efforts include extending the comment period twice, holding three public meetings, and visiting farms across the country. 

·         That is why we are concerned about the intermittent technical difficulties that have occurred in November with the website http://www.r​egulations.gov, which have prevented some people from submitting comments.  We know that these difficulties are inconvenient and very frustrating.

·         For that reason, to ensure that everyone has the opportunity to comment, FDA is providing more time for comments on both the proposed rule on produce safety and preventive controls for human food for an additional 7 days.  This means that the close of the comment period, which was scheduled for today, November 15, will now be November 22.

·         We are expediting publication of a notice in the Federal Register.   You can continue to submit your comments at http://www.regulations.gov.  

  • We appreciate your patience and look forward to receiving your comments. For more information on FDA's Food Safety Modernization Act, visit http://www.fda.gov/fsma.

FDA extends Comment Period on notice to determine scope for Environmental Impact Statement on the proposed Produce Safety Rule until March 15, 2014.
The U.S. Food and Drug Administration (FDA) is extending the comment period for the “Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption,” which appeared in the August 19, 2013 Federal Register. Comments on the scope of issues FDA should include in the Environmental Impact Statement may be submitted until March 15, 2014. Comments were originally due by November 15, 2013.  http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm375072.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Public Meeting Concerning the Proposed Rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
-Chicago, IL

November 25, 2013

Biennial Report to Congress on the Food Emergency Response Network - 20133
November 2013

2013 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices2
November 2013

 

December

Public Meeting Concerning the Proposed Rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals – Sacramento, CA

December 6, 2013

 

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