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U.S. Department of Health and Human Services

Food

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FSMA Progress Reports

The FDA intends to provide regular updates to inform the public and Congress on its progress in implementing the FDA Food Safety Modernization Act (FSMA). This summary does not reference all actions taken by FDA. For a summary of accomplishments during the first year, see FSMA One-Year Progress Report.

For additional information, see the Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)

Stay connected with FSMA E-mail updates! 


2013 Progress Reports (Print-friendly downloads of the 2013 Progress Reports are also available)

2012 Progress Reports

2011 Progress Reports


January 2013

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.

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 2013

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.  

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 2013

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.

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 2013

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 2013

FDA Announces the 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 2013

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 2013

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 2013

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 2013

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 2013

FDA Holds Public Meeting on Import Proposed Rules
FDA held a public meeting on proposed rules on Foreign Supplier Verification Programs and the Accreditation of Third Party Auditors/Certification Bodies on October 22 and 23 in Long Beach, CA. Due to the lapse in federal funding, FDA had to cancel the public meeting scheduled for October 10 and 11, 2013 in Miami, FL and was unable to reschedule it.

FDA Releases Proposed Rule for Preventive Controls for Food for Animals
On October 29, the FDA published the proposed rule for the Preventive Controls for Food for Animals. Under the proposed rule, facilities that manufacture, process, pack, or hold food for animals would be required to adhere to current good manufacturing practices and to implement hazard analysis and risk-based preventive controls.
 

November 2013

FDA Holds Public Meetings on Food for Animals
FDA held public meetings on the Proposed Rule to Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals on November 21 in College Park, MD and on November 25 in Chicago, IL. .

FDA Extends Comment Period for the Environmental Impact Statement for the Produce Safety Rule
On November 18, the FDA published the extended comment period on the scope of issues FDA should include in the Environmental Impact Statement for the proposed Produce Safety Rule.

FDA Extends Comment Period for the Proposed Rule on Produce Safety and Preventive Controls for Human Food
On November 15, FDA announced in a FSMA listserv that it would provide an additional seven days for comments on both the proposed rule on Produce Safety and Preventive Controls for Human Food due to technical difficulties on Regulations.gov. The Federal Register notices announcing the extension of the comment periods to November 22 published on November 20.

FDA Extends the Comment Period on Proposed Import Rules
On November 20, the FDA published a notice extending the comment periods until January 27, 2014 for the proposed rules on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals and the Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications. In addition, the FDA also noted that the comment periods for the information collection provisions related to these rules would also be extended to January 27, 2014.

FDA Releases Report on the Food Emergency Response Network
FDA posted The Second Biennial Report to Congress on the Food Emergency Response Network, required by Section 202(b) of the FSMA and signed by the Secretary on November 8.

FDA Releases Report to Congress on Food Facilities, Food Imports and FDA Foreign Offices
FDA posted the 2013 Annual Report to Congress regarding Food Facilities, Food Imports, and FDA Foreign Offices, which was signed by the Secretary on November 15.

 

December 2013

FDA Releases Statement on Re-proposing Parts of Produce, Preventive Controls for Humans Proposed Rules
On December 19, FDA released a statement by Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, on FDA’s intention to re-propose certain sections of the proposed rules on produce safety and preventive controls for human food. This decision was based on discussions with farmers, the research community, and other input the Agency received during 2013.

FDA Proposes New Food Defense Rule to Address Intentional Adulteration of Food
On December 24, FDA published a proposed a rule that would require the largest food businesses in the U.S. and abroad to take steps to prevent facilities from being the target of intentional attempts to contaminate the food supply. The proposed rule will be open for comment until March 31, 2014 and a public meeting will be held February 20, 2014 in College Park.

 

Download the 2013 Progress Reports

January - March 2013 (PDF: 178KB)

April - June 2013 (PDF: 162KB)

July - September (PDF: 283KB)

October - December (PDF: 268KB)