FDA Updates

 

 

FDA Resources and Updates

 

 FDA Resources

  As of early 2022, the FDA has released two proposed rules and one act that will be implemented in the coming years. To best prepare for these regulations, the FDA has provided several resources, including web pages, fact sheets, and public meetings, to assist stakeholders with understanding these     requirements. Below is a compiled list of these FDA created resources. 

 

FASTER Act

FDA Updates

To receive email updates from the FDA, visit: http://go.fda.gov/subscriptionmanagement

 

2023

January

 

New- Resources for Food Producers in Areas Impacted by Recent Storm Related Flooding

January 25, 2023: Recent storms impacting the West Coast have caused significant flooding with the potential to impact agriculture in the state of California. The FDA would like to remind food producers of their online resource page intended to help food producers impacted by flooding and severe weather events. The page includes information about federal and state resources available to those who may be  handling foods after experiencing a severe weather incident. This resource page also includes state contact information for the FDA’s Office of Regulatory Affairs (ORA) Emergency Response Coordinators and a list of FDA resources to help industry evaluate the safety of flood affected food crops for human consumption and information on reconditioning adulterated crops into animal food. The flooding resource page can be reviewed here

 

New- Update on the 2022 FDA Food Code

January 20, 2023: The 2022 edition of the FDA Food Code has been re-released. There were several formatting errors identified that resulted from incorporation of new formatting in the Food Code and the 508-compliance process. For additional information, visit https://www.fda.gov/foodcode

 

New- Food Traceability Final Rule - Translations Now Available

January 19, 2023: Today, the FDA posted translated materials for the FSMA final rule on food traceability in five languages: Indonesian, Simplified Chinese, Spanish, Thai and Vietnamese. The translated materials include the codified rule, FAQs, the Food Traceability List and additional resources.

 

New- FDA Launches ‘Dataverse’ Series with Video on 21 Forward

January 18, 2023: The FDA has launched the first in a planned series of videos called “Into the Dataverse,” part of the agency’s commitment to delivering trusted technology and data solutions. The first video provides an overview of 21 Forward, a data analytics tool that makes the food supply chain more transparent to the FDA, enabling us to anticipate potential problems and manage those risks before they have real-world implications. The video can be viewed here

 

New- FDA Releases Fact Sheet, Reminds Produce Stakeholders of Upcoming End of Intended Enforcement Discretion Period for Harvest and Post-Harvest Agricultural Water

January 13, 2023: The intended enforcement discretion period for the harvest and post-harvest agricultural water provisions for covered produce (other than sprouts) in the Produce Safety Rule ends on January 26, 2023 for all businesses other than small and very small businesses. To help prepare growers, the FDA has released a fact sheet with questions and answers on the requirements. The factsheet can be viewed here

 
New- FDA and Stop Foodborne Illness to Co-Host Webinar on Food Safety Culture Learning and Training

January 10, 2023: Today, the FDA announced the sixth in the ongoing series of webinars exploring food safety culture will take place on January 25, 2023, from 12:00 to 1:00 pm ET.  The webinar series Collaborating on Culture in the New Era of Smarter Food Safety is in partnership with Stop Foodborne Illness, a non-profit public health organization. The upcoming webinar “Food Safety Culture Learning: It's more than checking the boxes”, will focus on how food safety culture relates to training and education. To learn more about this webinar series and to listen to recordings, visit Collaborating on Culture in the New Era of Smarter Food Safety. Webinar registration can be found here

 

New- FDA Updates Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water

January 6, 2023: The FDA has worked with the EPA to update the protocol to remove Listeria monocytogenes from the organism test panel. This change is being made because pilot studies have found that sanitizer treatments that will likely be effective for E. coli and Salmonella may be different from those that are most effective for L. monocytogenes. This is likely due to the physical characteristics of E. coli and Salmonella being distinctly different from those of L. monocytogenes. In light of recent outbreaks of Shiga toxin-producing E. coli (STEC) and Salmonella linked to produce, FDA and EPA agreed and decided to move forward with removing L. monocytogenes from the panel. We expect that doing so will facilitate the registration of antimicrobial treatments against STECs (and other E. coli) and Salmonella in pre-harvest agricultural water, the availability of which will be a significant resource for farms to protect their crops against these pathogens. Companies may opt to continue testing against L. monocytogenes for inclusion in their registration with EPA. The full constituent update can be reviewed here

 

 

2022

DECEMBER

 

FDA Releases 2022 Food Code

December 28, 2022: Today, the FDA issued the 2022 edition of the FDA Food Code, which provides guidance to state and local authorities and retailers to help mitigate foodborne illness risks at retail and provide a uniform set of national standards for retail food safety. The 2022 edition commemorates 30 years of the FDA Food Code in its current format. It represents the FDA's best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service. The 2022 edition of the Food Code can be viewed here

 

Web Pages Feature New Era of Smarter Food Safety Core Elements

December 19, 2022: The FDA’s New Era of Smarter Food Safety has four priority areas, called Core Elements. They cover the range of technologies, analytics, business models, modernization and values that are the New Era’s building blocks. Each Core Element is now featured separately on a web page that highlights its initiatives and links to other New Era resources. The new pages are:

 

VQIP Application Set to Open January 1, 2023

December 19, 2022: On January 1, 2023, the FDA will open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year (FY) 2024. VQIP is a voluntary fee-based program that provides importers, who achieve and maintain control over the safety and security of their supply chains, the benefits of expedited review and importation of human and animal foods into the United States. To participate in VQIP, food importers must meet certain eligibility requirements, including ensuring that the facilities of their foreign suppliers are certified through the FDA’s Accredited Third-Party Certification Program. The portal will close May 31, 2023.

 

FDA Reminds Manufacturers of Effective Date for Sesame as a Major Food Allergen

December 15, 2022: The FDA is reminding manufacturers that effective January 1, 2023, foods containing sesame will be subject to specific food allergen regulatory requirements, including labeling and manufacturing requirements. Sesame is joining the list of major food allergens defined in the law as the result of the FASTER Act, which was signed into law April 23, 2021. Sesame joins eight other major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. FDA reminds consumers that foods already in interstate commerce before 2023, including those on retail shelves, do not need to be removed from the marketplace or relabeled to declare sesame as an allergen.  So depending on shelf life, some food products may not have allergen labeling for sesame on the effective date.  Consumers should check with the manufacturer if they are not sure whether a food product contains sesame.

 

Registration Now Open for the 8th National Consumer Food Safety Education Conference

December 14, 2022: Registration is open for the eighth national Consumer Food Safety Education Conference (CFSEC 2023). Hosted by the non-profit Partnership for Food Safety Education, the conference, The Future of Food Safety: Everyone Has a Seat at the Table, will be held March 1-3 in Arlington VA. CFSEC 2023 will equip an expected 400 health and food safety educators from all sectors for the future of food safety education and orient educators to national goals such as Healthy People 2030 and the Core Element 4.3 of the New Era of Smarter Food Safety Blueprint. Early Bird registration discounts are available until January 1 to all attendees. You can register for the conference here

 
Advancing Food Safety Culture as Science Not a Slogan: A Systematic Literature Review

December 12, 2022: Today, the FDA released a systematic review of the scientific literature on food safety culture (FSC) as a foundation for the FDA’s work on food safety culture with industry, consumers and within the agency. A total of 79 articles met eligibility criteria for the review and are included in this analysis. The FDA conducted the literature review to better understand the latest science of FSC, including how it is defined, how it is developed and maintained by various organizations, and how it is assessed or measured. While food safety culture is defined in various ways in the literature, the review identified the most frequently cited definition of FSC as the aggregation of the prevailing, relatively constant, learned, shared attitudes, values and beliefs contributing to the hygiene behaviors used within a particular food handling environment (Griffith, Livesey, and Clayton 2010). The literature review also identified numerous key determinants that contribute to an FSC, as well as challenges and barriers to establishing and maintaining a strong and effective FSC. The FDA will use this research to inform its continued efforts in support of food safety culture. We encourage stakeholders and regulated industries to foster a robust food safety culture across the food system. To view the literature review, please click here

 

FDA Highlights Best Practices on Food Safety for Online Delivery Services

December 9, 2022: The FDA, in coordination with the USDA and the CDC, collaborated with the Conference of Food Protection (CFP) to release food safety best practices for third-party delivery services. These recommendations focus on key parameters companies should consider when delivering food to consumers. The best practices document identifies mitigating measures to potential food safety vulnerabilities, including those that may arise in the “last mile” of delivery. This document provides food safety best practices that include preventive controls, mechanisms to assess risk, recommendations for proper packaging, temperature control, physical and chemical contamination control, and allergen control. The food safety best practices document can be viewed here

 

Now Available: FSMA Food Traceability Final Rule Webinar Recording and Presentation Slides

December 9, 2022: The webinar recording and presentation slides for the FSMA Food Traceability Final Rule Webinar on the recently released Food Traceability final rule issued under the FDA Food Safety Modernization Act (FSMA) are now available. The webinar was held on Wednesday, December 7, 2022. During the webinar, the FDA provided an overview of the final rule, including the foods and entities covered by the rule, explained the exemptions from the rule, and discussed the recordkeeping requirements of the rule.  The FDA answered pre-submitted questions and took questions during the webinar.

NOVEMBER

 
New- FDA Issues Guidances on Food Allergen Labeling Requirements

November 29, 2022: Today, the FDA issued two guidance documents about food allergen labeling requirements to help the food industry meet the requirements to list any major food allergen on the labels of FDA-regulated foods. Food labels are a powerful tool to help protect consumers with food allergies. Consumers can avoid ingredients they may be allergic or sensitive to in a food by looking for specific allergen labeling and reading the ingredient list. One of the guidance documents is a draft guidance titled Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry. This draft guidance updates the previous edition (Edition 4) with new and revised questions and answers related to the labeling of food allergens, including requirements in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). Comments about the draft guidance can be submitted up to 60 days of publication of the notice in the Federal Register announcing the availability of the draft guidance. Submit comments electronically on www.regulations.gov. The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition (Edition 4) that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

 

 

FDA to Hold Webinar on the Food Traceability Final Rule

November 17, 2022: The FDA will hold an informational webinar on Wednesday, December 7, 2022, from 1:00 pm - 5:00 pm (ET) on the recently released Food Traceability final rule issued under FSMA. The final rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths. During the webinar, the FDA will provide an overview of the final rule, including the foods and entities covered by the rule, explain the exemptions from the rule, and discuss the recordkeeping requirements of the rule.  The FDA will answer pre-submitted questions and take questions during the webinar. You can register for the webinar here: register for the webinar! The webinar will be recorded and posted to the meeting page.

You may submit a question in advance when registering. You may also submit your question to FSMA204Traceability@fda.hhs.gov

 

FDA Announces the Final Rule for Food Traceability Under FSMA

November 15, 2022: Today, the FDA issued a final rule on food traceability designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths. Foods subject to the final rule requirements appear on the Food Traceability List (FTL). The FTL includes fresh cut fruits and vegetables, shell eggs, and nut butters, as well as certain fresh fruits, fresh vegetables, ready-to-eat deli salads, cheeses, and seafood products. At the core of the final rule is a requirement that persons who manufacture, process, pack or hold food on the FTL maintain records including Key Data Elements related to Critical Tracking Events. The final rule provides full and partial exemptions for some entities and foods, such as certain small producers, small retail food establishments and restaurants, farms that sell food directly to consumers, and foods that receive certain types of processing, among others. The final rule can be reviewed here

 

Manufactured Food Regulatory Program Standards 2022 Updates

November 1, 2022: The FDA has issued revised food safety standards for state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods. These regulatory program standards, known as the Manufactured Food Regulatory Program Standards, were first issued by the agency in May 2007. The 2022 changes include updates to defined terms, new job aides, as well as updates to the current standards. Additional information on the 2022 updates, including a downloadable copy of the updated standards, Summary of Changes, and updated Fact Sheet and Informational Brochure, are available at Manufactured Food Regulatory Program Standards (MFRP).

 

 

OCTOBER

 
How Does the FDA Respond to Foodborne Outbreaks?

October 26, 2022: Every year, the FDA responds to dozens of foodborne outbreaks, but what does that mean? What are the steps the FDA and other public health agencies take to protect public health during a foodborne illness outbreak? In this video, the FDA describes the often complex web of steps taken by the agency along with the CDC and local, state, and international public health authorities to respond to outbreaks in FDA regulated food products. The video explores how the CDC works with public health authorities to learn more about what might be making consumers sick, and then if an FDA regulated food product is identified, how the FDA investigates the cause of the outbreak and work with industry to remove any potentially contaminated product from store shelves.

 
Welcome 2022/2023 VQIP Participants

October 25, 2022: The 2022/2023 benefit year begins October 1, 2022, for participants in the Voluntary Qualified Importer Program (VQIP) under FSMA. VQIP is a voluntary fee-based program that provides importers who achieve and maintain control over the safety and security of their supply chains, expedited review and importation of human and animal foods into the United States. To participate in VQIP, food importers must meet certain eligibility requirements, including ensuring that the facilities of their foreign suppliers are certified through the FDA’s Accredited Third-Party Certification Program.

 

National Advisory Committee on Microbiological Criteria for Foods Announces Public Meeting to Discuss Cronobacter

October 21, 2022: On November 15, 2022, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will hold a virtual public meeting of the full Committee. The Committee will discuss adding a work charge being advanced by the FDA on Cronobacter spp. in powdered infant formula. The Committee will also discuss updates under the Cyclospora cayetanensis subcommittee and vote on adopting the following report: “Enhancing Salmonella Control in Poultry Products.” The charge being advanced by FDA to the NACMCF is intended to help us gain scientific insight about some of the questions regarding Cronobacter infections including recommendations for how public health authorities can better protect public health; and recommendations for food safety management practices that the food industry can implement to enhance the safety of powdered infant formula. 

Meeting Date: Tuesday, November 15, 2022, from 10:00 a.m. to 12:00 p.m. ET.
Comments should be submitted electronically to docket number FSIS-2022-0031 on or before November 15, 2022.

Registration: The meeting will be held virtually using Zoom. Attendees must pre-register to receive a join link, dial-in number, access code, and unique Attendee ID for the event. Attendees who express interest in delivering comments during the meeting must register by November 8, 2022. USDA’s FSIS will do its best to accommodate all registered persons who request to provide oral comments. Attendees that do not plan to speak at the public meeting may register at any time up to the day of the meeting.

 

FDA Issues Guidance on Refusal of Inspection by a Foreign Food Establishment or Foreign Government

October 20, 2022: Today, the FDA issued guidance that describes the actions, behaviors, and statements by a foreign food establishment or foreign government that the FDA considers to be a refusal of an FDA inspection. To view the guidance, please visit this resource

 

Now Available: Small Entity Compliance Guide for Laboratory Accreditation for Analyses of Foods Program

October 19, 2022: Small Entity Compliance Guide (SECG) is now available for the Laboratory Accreditation for Analyses of Foods (LAAF) program. To review the guide, please click here

 

TechTalk Podcast on Data Exchange

October 13, 2022: Episode 4 of the New Era of Smarter Food Safety TechTalk Podcast is now live. “Data Exchange in the New Era of Smarter Food Safety” explores the platform created by FDA’s Office of Regulatory Affairs to securely share information between the agency and its regulatory partners at the state and local levels. Listen to Episode 4 and view podcast transcript here

 

FDA and Stop Foodborne Illness to Co-Host 5th Food Safety Culture Webinar

October 7, 2022: The FDA and Stop Foodborne Illness are announcing a fifth webinar in their collaborative series that explores food safety culture. The fifth webinar, called “Rewards and Recognition Programs,” will take place on October 26, 2022, from 12:00 p.m. to 1:00 p.m. ET.  Guest speakers will span the food system and share their experiences in establishing rewards programs that drive positive food safety culture. Webinar registration can be found here. 

 
FDA to Hold Webinar on the New Laboratory Accreditation for Analyses of Foods (LAAF) Program

October 6, 2022: The FDA will be holding an informational webinar on Thursday, October 27, 2022, from 1:00 pm-2:30 pm (ET) on the new Laboratory Accreditation for Analyses of Foods (LAAF) program, which establishes a laboratory accreditation program for the testing of food in certain circumstances. The LAAF final rule was published on December 3, 2021. Under the LAAF program, FDA will recognize accreditation bodies (ABs) that will accredit laboratories to the standards established in the final rule (referred to as LAAF-accredited laboratories). During the webinar, FDA will provide an overview of the program and aspects of its implementation most relevant to accreditation bodies and laboratories that may be interested in participating. FDA will both answer pre-submitted questions and take questions during the October 27 webinar. To register for the webinar, please visit the registration website. 

 

FDA and CDC Partner to Reduce Foodborne Illness in Retail and Foodservice Establishments

October 4, 2022: The FDA and the Centers for Disease Control and Prevention (CDC) have entered into a Memorandum of Understanding (MOU) to strengthen food safety in retail environments. The goal of the renewed partnership between the FDA and the CDC is to help reduce the occurrence of foodborne illness in retail and foodservice establishments. The MOU can be reviewed here

 

SEPTEMBER 

 

FDA Reminds Human and Animal Food Facilities to Register or Renew Registration between October 1 and December 31, 2022

September 30, 2022: Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2022. The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2022. There is no fee associated with registration or renewal. Owners, operators, or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver that allows for paper submission.

 

FDA’s Fourth TechTalk Podcast Will Focus on Data Exchange with State and Local Partners

September 29, 2022: On October 12, 2022, the FDA will air the fourth New Era of Smarter Food Safety TechTalk Podcast, a series that focuses on the development and use of new technologies to accelerate prevention of food safety problems and speed responses to foodborne-illness outbreaks. TechTalk features leaders in FDA, other government agencies, and the private sector who share their unique experiences and insights. Entitled “Data Exchange in the New Era of Smarter Food Safety,” this fourth podcast will explore the platform created by FDA’s Office of Regulatory Affairs (ORA) to securely share information between the agency and its regulatory partners at the state and local levels. For more information about how to listen on October 12, 2022, and submit questions in advance for consideration by the panelists, visit: TechTalk Podcast Episode 4: Data Exchange in the New Era of Smarter Food Safety

 

FDA Releases Overview of Activities Underway to Enhance the Safety of Imported Produce

September 27, 2022: Today the FDA released its Activities to Enhance the Safety of Imported Producewhich provides an overview of the work underway to advance the safety of produce imported into the United States. This overview follows the 2019 release of the Strategy for the Safety of Imported Food (Import Strategy) which described the agency’s comprehensive approach to enhancing the safety of food imported into the United States. The overview can be reviewed here

 

FDA Releases Food Safety Prevention Strategies

September 26, 2022: The FDA is taking further action to help prevent outbreaks of foodborne illnesses associated with certain foods through the development of food safety prevention strategies. When a foodborne illness outbreak occurs, the FDA, through its Coordinated Outbreak Response and Evaluation (CORE) Network and federal, state, local, territorial, tribal, and international public health partners, as appropriate, work together to determine what food may have caused the outbreak and how it became contaminated. After the outbreak investigation ends, the information learned can be used to contribute to a food safety prevention strategy for that food. While the agency is working with industry, state, international and other partners on the development of several food safety prevention strategies, the FDA is releasing the following first two strategies (see below).

 

Risk Assessment of Norovirus Transmission in Food Establishments 2nd Manuscript

September 20, 2022: FDA has completed a research study entitled, Evaluation of the Impact of Compliance with Mitigation Strategies and Frequency of Restaurants Surface Cleaning and Sanitizing on Control of Norovirus Transmission from Ill Food Employees Using and Existing Quantitative Risk Assessment Model which  focused on identifying strategies to reduce the risk of norovirus from consumption of foods prepared in food establishments. This study evaluated more than 60 scenarios examining the impact of implementation of and compliance with recommendations contained in the FDA Food Code. Key findings from this study can be found in a factsheet and the manuscript is available via open access at Risk Assessment of Norovirus Transmission in Food Establishments.

 

FDA Announces Targeted Sampling, Additional Efforts to Enhance the Safety of Leafy Greens

September 8, 2022: The FDA is committed to enhancing the safety of leafy greens through continued implementation of the Leafy Greens STEC Action Plan (LGAP). As part of this effort the FDA is announcing targeted sampling of leafy greens grown on farms and ranches during the fall 2022 harvest season in the Salinas Valley region of California, releasing results from a 2021 sampling assignment, and providing an update on other work under the action plan. During the fall 2022 harvest season the FDA plans to collect about 240 lettuce samples at farms/ranches in the Salinas Valley. These farms/ranches were identified by traceback investigations in recent years as being potentially associated with a foodborne illness outbreak in which lettuce or leafy greens were the likely or suspect food vehicle. The FDA also may collect environmental samples such as water, soil, and scat, as appropriate, based on observations made at the time of sampling and a farm/ranch’s past inspection history. All samples will be tested for Salmonella spp. and E. coli O157:H7 and sampling will begin in mid-September 2022 and run through October 2022.

In 2021, the FDA conducted a different leafy greens sampling assignment and is releasing a summary report of the results. As part of this assignment, the agency collected lettuce from commercial coolers in the Salinas Valley growing area in California and tested samples for E. coli O157:H7 and Salmonella spp. between May and November of last year. The report describes the agency’s detection of Salmonella enterica in one green leaf sample and STEC in two other samples. In all cases, potentially contaminated product was destroyed and follow-up inspections were conducted.

Additional information on the progress being made on the action plan can be found on the Leafy Greens STEC Action Plan website.

 

September 2022 is the 24th National Food Safety Education Month

September 1, 2022: For 24 years, National Food Safety Education Month has provided 30 days for health educators at the national, state, and local levels to focus attention on the fundamentals of buying, storing, preparing, and serving food as safely as possible. While the United States has one of the safest food supplies in the world, every year an estimated one in six Americans gets foodborne illness. FDA offers Food Safety Education Month resources all year round for consumers and educators on a variety of subjects, including learning who is most at risk for foodborne illnesses and how to avoid food waste while maintaining food safety.

 

AUGUST

FDA Releases Spanish and English Paper-Based Versions of the Agricultural Water Assessment Builder Tool

August 11, 2022: The FDA has released paper-based versions of its agricultural water assessment builder tool in both English and Spanish. The agricultural water assessment builder was released in March 2022 as a user-friendly, online tool to help farms understand the proposed requirements for an agricultural water assessment in the Agricultural Water Proposed Rule. The paper-based versions of the tool will make the content more accessible to a broader array of users. Use of the online tool, and its paper-based companions, is optional.

The FDA also welcomes feedback on the online and paper-based versions of the tool, such as suggestions related to the tool’s functionality and useability. Feedback on the tool can be sent here.

 

JULY

2022 FDA Retail Food Protection Seminar

July 26, 2022: FDA has announced that registration is now open for the 2022 FDA Retail Food Protection Seminar. The Seminar will be held September 19-22, 2022 and registration is free. This event is open to all interested in retail food safety, including all state, local, territorial and tribal regulators, standardized officers, industry and academia. To register, please click here

 

Webinar on Food Facility Registration (FFR), Biennial Renewal, and Unique Facility Identifiers (UFI)

July 26, 2022:  The FDA will present a webinar for stakeholders on August 11, 2022, at 1pm EST, to discuss Food Facility Registration, Biennial Renewal (FFR), and obtaining an acceptable Unique Facility Identifier (UFI).  U.S. and foreign human and animal food facilities that are required to register with the FDA must renew their registration this year between October 1 and December 31, 2022. Registration closes on August 10th. To register, please click here

 

Retail Food Safety Regulatory Training Needs Assessment

July 26, 2022: The Food and Drug Administration (FDA) supports retail regulatory partners in a variety of ways including training and education.  As part of an FDA Grant,  the National Environmental Health Association is conducting a comprehensive assessment to identify retail food safety regulatory training and resource needs across the nation. Please consider taking this 20-minute, anonymous survey, to help FDA/NEHA to assess and improve training and resources available for this essential profession. Learn more and take the online survey by clicking here.

This needs assessment is only for regulatory professionals who work in retail food as part of their role.  Professionals who do not perform retail food duties will be redirected to exit the survey. In addition, professionals whose primary positions are in food industry or academia will be redirected to exit the survey.

 

FDA Shares Updates on Cyclospora Prevention and Research Efforts

July 25, 2022: Today, the FDA released new updates detailing the agency’s Cyclospora prevention and research efforts. In 2021, the FDA released its Cyclospora Prevention, Response and Research Action Plan. The action plan was developed by the agency’s Cyclospora Task Force and details the FDA’s strategy for reducing the public health burden of foodborne cyclosporiasis in the United States. It also defines the agency’s priorities for Cyclospora food safety research and supports ongoing efforts to combat foodborne illness in alignment with the New Era of Smarter Food Safety initiative

Since releasing the Cyclospora action plan, the FDA has:

  • Collaborated with the National Advisory Committee on Microbiological Criteria for Foods to develop a charge document to help the FDA guide prioritization of Cyclospora research and propose novel food safety research projects in collaboration with stakeholders.
  • Implemented a genotyping approach for C. cayetanensis in environmental and food samples based on the same method published by the Centers for Disease Control and Prevention (CDC).
  • Implemented a distance learning plan and delivered a series of Cyclospora methodology training webinars on the Bacteriological Analytical Manual (BAM) Chapter 19b - Detection of Cyclospora cayetanensis in Fresh Produce using a real-time PCR-analytical method in Spanish to regulatory lab personnel at food safety authorities in Mexico through the FDA-SENASICA-Cofepris Food Safety Partnership.  
  • Collaborated with the CDC to publish an article in Food Safety Magazine summarizing the data on all cyclosporiasis outbreaks from 2013 to 2020.
  • Delivered eight webinars directed to the fresh produce industry, regulators, and other stakeholders for Cyclospora outreach and educational purposes.
  • Completed a microbial survey of fresh herbs that included over 800 samples tested for C. cayetanensis.

Visit Cyclospora Prevention, Response and Research Action Plan to see a full listing of the task force’s latest accomplishments and their current Cyclospora prevention and research efforts along with an updated factsheet on Cyclosporiasis and Fresh Produce.

 

FDA Works to Enhance the Safety of Berries

July 22, 2022: Consistent with the FDA’s commitment to enhance produce safety, the FDA is developing a food safety prevention strategy to enhance the safety of fresh and frozen berries. The strategy is being developed in response to a history of hepatitis A (HAV) and norovirus (NoV) outbreaks linked to the consumption of both fresh and frozen berries. Much like ongoing prevention work for other commodities, such as leafy greens, tahini, and imported specialty mushrooms, the food safety prevention strategy for berries will be informed by the findings of surveillance sampling.  In August, the FDA plans to resume an assignment to collect and test frozen berries that it paused at the start of the COVID-19 pandemic. The assignment seeks to estimate the prevalence of HAV and NoV in frozen strawberries, raspberries and blackberries and help the FDA identify sites where practices or conditions may exist that constitute safety vulnerabilities. To date, the FDA has collected and tested more than 1,100 samples under this assignment and plans to collect and test about 427 more to meet the assignment’s public health goals. The agency does not plan to collect or test any additional frozen strawberries as we have already met our collection target for that commodity.

 

FDA Proposes Compliance Date Extension for Pre-Harvest Agricultural Water Requirements

July 18, 2022: Today the FDA issued a supplemental notice of proposed rulemaking to extend the compliance dates for the pre-harvest agricultural water provisions as outlined in the recent 2021 agricultural water proposed rule. The 2021 agricultural water proposed rule, if finalized, will require farms to conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. The FDA is now proposing extended compliance dates for those proposed pre-harvest requirements and is also providing clarifying information about the enforcement discretion policy for the harvest and post-harvest agricultural water requirements.

The supplemental rulemaking proposes to establish the following compliance dates for the pre-harvest agricultural water requirements for covered produce other than sprouts:

  • 2 years and 9 months after the effective date of a final rule for very small businesses;
  • 1 year and 9 months after the effective date of a final rule for small businesses; and
  • 9 months after the effective date of a final rule for all other businesses.

Compliance Dates for Harvest and Post-Harvest Agricultural Water Requirements- The 2021 pre-harvest agricultural water proposed rule did not propose substantive changes to the harvest and post-harvest agricultural water requirements in the Produce Safety Rule; however, the FDA recognizes that prior to the proposal, stakeholders did not have clarity on whether FDA might propose to change the harvest and post-harvest agricultural water requirements. In addition, the FDA recognizes that adequate training and technical assistance are needed to fully recognize the benefits of the harvest and post-harvest requirements. Therefore, we intend to continue enforcement discretion for the harvest and post-harvest agricultural water requirements of the Produce Safety regulation until the following dates:

  • January 26, 2025, for very small businesses;
  • January 26, 2024, for small businesses; and
  • January 26, 2023, for all other businesses.

FDA is reopening the comment period only with respect to the proposed compliance dates for the pre-harvest agricultural water provisions until September 19, 2022. Comments should be submitted to docket FDA-2021-N-0471 on Regulations.gov. 

 

FDA and Stop Foodborne Illness to Co-Host 4th Food Safety Culture Webinar

July 18, 2022: The FDA and Stop Foodborne Illness, a non-profit public health organization, are announcing a fourth webinar in their collaborative series that explores food safety culture. The fourth webinar, called “What More Do You Want to Know About Food Safety Culture?,” will be broadcast live from the International Association for Food Protection 2022 Annual Meeting on August 3, 2022, from 12:15 p.m. to 1:15 p.m. ET. Speakers and attendees will engage in a question-and-answer session on an array of food safety culture topics. Registration is available for both in-person and virtual attendance. Please click here to register for the session. 

 

Today is the Second Anniversary of the New Era of Smarter Food Safety Blueprint

July 13, 2022: Today, July 13, 2022, is the second anniversary of the release of the New Era of Smarter Food Safety Blueprint, which outlines FDA's commitment to continuous modernization to address the ever changing food system and potential challenges ahead. FDA’s New Era of Smarter Food Safety is leveraging technology and other tools and approaches to create a safer and more digital, traceable food system. The ultimate goal is to bend the curve of foodborne illness in this country by reducing the number of illnesses, so that consumers can live better lives. For more information on the New Era of Smarter Food Safety initiative, please click here

 

 

JUNE

 

FDA Releases Update of 2022 Priority Guidance Topic for Foods Program

June 30, 2022: Today, the FDA CFSAN and OFPR released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2022. The list updates the guidance agenda released in January 2022 and focuses on Level 1 draft and final guidances. Since the release of the agenda in January 2022, the FDA has issued the following guidances that were on the list:

Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA - 2021-N-0553.

 
Important 30-Day Notice for FSVP Importers RE: “UNK”

June 22, 2022: Beginning July 24, 2022, the entity identification code “UNK” will no longer be accepted in the Entity Number field by U.S. Customs and Border Protection (CBP). Consistent with 21 CFR 1.509(a), FSVP importers will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. To learn more about DUNS number, please review this constituent update

 

FDA releases updated sections to the “Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition”

June 2022: The FDA is announcing the availability of specific chapters, appendices and addenda of the “Fish and Fishery Products Hazards and Controls Guidance, June 2022 Edition.” The FDA has determined specific chapters, appendices, and addenda of the guidance would be updated with the availability of new science. This update includes:

  • Table of Contents
  • Chapter 9: Environmental Chemical Contaminants Including Pesticides

Updates may be accessed through the FDA’s Seafood website at www.fda.gov/seafood or the Fish and Fishery Products Hazards and Controls Guidance Page at Fish and Fishery Products Hazards and Controls.

 

FDA Retail Program Standards Self Assessment / Verification Audit Courses Available Online

June 15, 2022: The FDA just announced the availability of the FDA Retail Food Program Standards Self-Assessment/Verification Audit Courses! As part of the FDA’s commitment to provide training to those individuals conducting self-assessments and verification audits of the FDA Retail Food Program Standards, they will be offering online self-guided courses. Visit the Voluntary National Retail Food Regulatory Program Standards page for more information.

 

Adoption of the FDA Food Code by State and Territorial Authorities Responsible of the Oversight of Foodservice and/or Retail Food Stores – December 31, 2021

June 14, 2022: The Food Code is a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. It represents FDA's best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service. The Food Code is offered for adoption by local, state, and federal governmental jurisdictions for administration by the various departments, agencies, bureaus, divisions, and other units within each jurisdiction that have been delegated compliance responsibilities for food service, retail food stores, or food vending operations. Information regarding adoption of the FDA Food Code is communicated in the report entitled, Adoption of the FDA Food Code by State and Territorial Authorities Responsible of the Oversight of Foodservice and Retail Food Stores – December 31, 2021. The 2021 report can be viewed here

 
FDA Marks World Food Safety Day 2022

June 7, 2022: Today, June 7, is World Food Safety Day and this year’s theme is “Safer Food, Better Health.” The World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations facilitate this observance each year to make people aware of food safety issues, help prevent foodborne illness, consider collaborative approaches, and promote solutions.  A World Food Safety Day page on fda.gov offers ways to participate in this global effort as well as information on how to protect yourself and your family from foodborne disease. For more information on the event, please visit foodsafety.whohealthtalks.org

 
FDA Releases New Resource Page for Human and Animal Food Producers Affected by Flooding and Severe Weather Incidents

June 6, 2022: Today, the FDA released a new online resource page for human and animal food producers affected by flooding and severe weather incidents such as hurricanes or tropical storms. This new page will help food producers identify some of the federal and state resources available to those who may be harvesting, mixing, storing, or distributing grains and other foods after experiencing a severe weather incident. This resource page also includes state contact information for the FDA’s Office of Regulatory Affairs (ORA) Emergency Response Coordinators and a list of FDA resources to help industry evaluate the safety of flood affected food crops for human consumption and information on reconditioning adulterated crops into animal food. To view the new resource page, please click here. 

 

FDA Posts Answers to Frequently Asked Questions for the FSMA Lab Accreditation for Analyses of Foods Final Rule

June 2, 2022: Today, the FDA posted clarifying FAQs for stakeholders for the FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF). LAAF establishes a laboratory accreditation program for the testing of food in certain circumstances. Under the LAAF program, FDA will recognize accreditation bodies that will accredit laboratories to the standards established in the final rule (referred to as LAAF-accredited laboratories). These FAQs provide examples of the testing covered by the LAAF final rule; information on the directed food laboratory order, a new tool being implemented in the LAAF rule; and a reminder that LAAF-accredited laboratories are not required to provide FDA with results of tests that are not covered by the LAAF final rule.

 

MAY

 

FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase U.S. Supply

May 26, 2022: Today, the FDA is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. This type of specialized medical infant formula is currently in short supply in the U.S. To read the full press release, please click here

 

FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Juice

May 24, 2022: Please join the FDA for a webinar on Tuesday, June 14, 2022, at 1:00 pm (ET) to discuss the recent draft guidance on lead action levels for juice. The draft guidance, titled “Action Levels for Lead in Juice; Draft Guidance for Industry,” issued in April provides action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends. During the webinar the FDA will provide an overview of the draft guidance and additional information, as well as answer stakeholder questions. To register for the webinar and to submit a question or brief comment related to this guidance in advance, please visit the registration page. Questions or comments must be submitted by Tuesday, May 31, 2022.

 
Continuing the Conversation: FDA’s Foodborne Outbreak Response Improvement Plan

May 23, 2022: On April 13, 2022, the FDA hosted a webinar to hear stakeholders’ questions about FDA’s Foodborne Outbreak Response Improvement Plan announced on December 9, 2021. More than 1,700 people registered from 45 countries, and more than 2,200 have watched the webinar video since then. Webinar panelists and other FDA experts on food safety have provided answers to additional questions submitted in advance by registrants or posed during the webinar. In addition to general questions, others focus on the specific priority areas identified in the plan: tech-enabled product traceback, root cause investigations, analysis and dissemination of outbreak data, and operational improvements.

 

FDA to Hold Webinar on the Guidance for Industry on Infant Formula Enforcement Discretion Policy

May 18, 2022: The FDA will host an industry webinar on Friday, May 20th at 11 AM EST to provide an overview and answer questions on the recently released guidance to infant formula manufacturers regarding temporary exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula. The webinar will be recorded and posted to this event page.

 

FDA Updates Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water

May 17, 2022: Two updates have been made since we first released the protocol in July 2020. In the most recent update, (April 2022), the FDA again worked with the EPA to amend the contact time in the protocol, changing it from a maximum of 1-minute to “up to 5 minutes.” This change is being made to meet the current need scientifically and practically. These changes are reflected in the Efficacy Protocol and U.S. Environmental Protection Agency Protocol Review

 

FDA Issues Final Guidance for Seeds Used for Sprouting

May 13, 2022: Today the FDA issued a final guidance titled “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting: Guidance for Industry.” This guidance outlines FDA’s serious concerns over foodborne illness outbreaks associated with the consumption of raw and lightly-cooked sprouts and provides firms with recommended steps to prevent adulteration throughout the production chain of seed for sprouting. The Produce Safety Rule (PSR) includes sprout-specific requirements for sprout growers. However, FDA does not consider seed for sprouting to be covered produce under the PSR. Therefore, the growing, conditioning, and distribution of seed for sprouting is not subject to PSR requirements. Although seed used for sprouting is not covered by the PSR, the FDA does consider seed used for sprouting to be food. To review this guidance, please click here

 

April

 

FDA Issues the Accredited Third-Party Certification Program: Questions and Answers: Draft Guidance for Industry

April 28, 2022: Today, the FDA has announced the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry.  The final rule for Accredited Third-Party Certification was issued in 2015 under FSMA. The rule establishes a voluntary program, known as the Accredited Third-Party Certification Program (also referred to as the Third-Party Program), in which the FDA recognizes accreditation bodies that have the responsibility of accrediting third-party certification bodies. To review the new draft guidance, please click here

 

FDA Issues Updated Guidance on Compliance and Date for Providing an Acceptable Unique Facility Identifier (DUNS number) for the Foreign Supplier Verification Programs

April 27, 2022: Today, the FDA issued an updated guidance for industry, Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation. The updated guidance replaces the temporary policy put in place with the March 2018 guidance of the same name, by stating that beginning on July 24, 2022 the use of the entity identification code “UNK” will no longer be an option when filing an entry with U.S. Customs and Border Protection. The guidance provides information to human and animal food importers on requirements under the Foreign Supplier Verification Programs for Food Importers (FSVP) regulation. To review the updated guidance, please click here

 

FDA and Stop Foodborne Illness to Co-Host Third Food Safety Culture Webinar

April 27, 2022: The FDA and Stop Foodborne Illness, a non-profit public health organization, are announcing a third webinar in their collaborative series that explores food safety culture. The third webinar is called “Building a Coalition of Food Safety Culture Champions Across Your Organization.” It will take place on May 18, 2022, at 12:30-1:30 PM EST. To learn more about the webinar and register, please click here

 

FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

April 18, 2022: Today, the FDA issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the U.S (non-listed food allergens). To review the draft guidance, please click here. Comments on this draft guidance can be submitted through August 17th, 2022. Cooments can be submitted by clicking this link

 

FDA and USDA Scientists Research Seasonal Effects Linked to E.coli Outbreaks in Bagged Romaine

April 18, 2022: Scientists from FDA CFSAN and the USDA ARS have been working collaboratively to understand the seasonal effects and other factors that may be contributing to outbreaks of E.coli O157:H7 linked to bagged romaine lettuce. In a study recently published in the BMC Environmental MicrobiomeFDA and USDA scientists presented findings which reveal that season, and lettuce shelf life, can influence the bacterial communities and behavior of E. coli O157:H7 on cut lettuce stored in modified atmosphere packaging. The scientists found that E. coli O157:H7 survived significantly better in cold-stored packaged romaine harvested in the fall than on the same varieties harvested in late spring. The research team also demonstrated that the microbiome present on bagged romaine differed by season, lettuce deterioration state, and whether the survival of E. coli O157:H7 on the lettuce was high or low. For example, the team found that E.coli O157:H7 survived better in lettuce that was harvested in the fall than lettuce harvested in the spring during cold storage. To review the publication, please click here

 

FDA Webinar Focuses on Foodborne Outbreak Response Improvement Plan

April 14, 2022: The recording is now available for the webinar that FDA held on April 13, 2022 on the Foodborne Outbreak Response Improvement Plan that the agency released in early December 2021. More than 1,600 people from 45 countries registered for the webinar. During the webinar, Deputy FDA Commissioner Frank Yiannas and FDA experts across the agency’s human foods program answered questions from stakeholders about the plan with the goal of raising awareness, enhancing understanding, and building support. To watch the recording, please click here.

 

FDA Issues Final Guidance for Industry on Reconditioning Fish and Fishery Products by Segregation 

April 13, 2022: Today the FDA issued a final guidance titled “Reconditioning Fish and Fishery Products by Segregation: Guidance for Industry.” 

The final guidance:

  • Clarifies the steps that owners of fish and fishery products, or their representatives, can take to segregate non-violative products from products adulterated with pathogens, unlawful animal drugs, scombrotoxin (histamine) or decomposition, to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act.    
  • Recommends information that industry should include in reconditioning by segregation proposals. 
  • Provides uniform guidance and greater transparency to industry and stakeholders on how the FDA evaluates these proposals.

The public may submit electronic or written comments related to this final guidance at any time. Public comments can be submitted electronically to www.regulations.gov using Docket ID: FDA-2019-D-3324.

 

MARCH

 

FDA Launches Agricultural Water Assessment Builder to Help Farms Understand Agricultural Water Proposed Rule Requirements

March 21, 2022: The FDA released a new user-friendly online Agricultural Water Assessment Builder to help farms understand the proposed requirements for an agricultural water assessment in the Agricultural Water Proposed Rule.  Use of the tool is optional. If finalized, the proposed rule would require farms to conduct systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. The assessment would include an evaluation of the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land, and other relevant factors, such as the results of optional testing. Covered farms would be required to conduct pre-harvest agricultural water assessments annually, and whenever a significant change occurs that affects the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto produce or food contact surfaces. The Agricultural Water Assessment Builder prompts users to answer questions and/or fill in information specific to their farms. Information entered into the tool is not shared with the FDA and will not be saved. However, users have the opportunity save or print the information they provide to their local computers. To learn more about the AWA builder, please click here

 

FDA’s Third TechTalk Podcast Focuses on Artificial Intelligence

March 21, 2022: Today, FDA posted the third episode of their quarterly podcast series called TechTalk that focuses on the development and use of new technologies to strengthen the ability of FDA, regulated industry, and others to accelerate prevention, speed outbreak response, and more swiftly adapt to crises that could affect the food supply. The podcast, “Artificial Intelligence in the New Era of Smarter Food Safety,” features leaders in FDA and the private sector who share their unique experiences and insights on the opportunities that AI offers to help protect consumers from food safety issues. You can listen to the episode in the link provided in text.

 

FDA Releases Summary Report on Multi-year Processed Avocado and Guacamole Sampling Assignment

March 16, 2022: Today the FDA released findings from a sampling assignment that collected and tested processed avocado and guacamole from November 2017 to September 2019. The assignment sought to estimate the prevalence of Salmonella spp. and Listeria monocytogenes in processed avocado and guacamole as part of the FDA’s ongoing effort to proactively ensure food safety and prevent contaminated food from reaching consumers. During the assignment the FDA collected and tested a total of 887 samples of both domestic and imported processed avocado and guacamole. The agency detected Salmonella spp. in two samples, which were later determined to be distinct samples of the same brand of domestically manufactured guacamole. The FDA detected Listeria monocytogenes in 15 samples. Following whole genome sequencing conducted on the pathogens detected, the agency determined in the case of each positive that either there was no linkage to any clinical illnesses or that the available epidemiological information was inconclusive with respect to the food or other vehicle involved in the illnesses. To view the report, please click here

 

FDA Reopens the Comment Period on Draft Compliance Policy Guide for Decomposition and Histamine in Scombrotoxin (Histamine)-forming Fish and Fishery Products

March 14, 2022: The FDA is reopening the comment period for the draft Compliance Policy Guide (CPG) entitled “Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine” that was published on December 27, 2021 (86 FR 73295). This draft CPG, when finalized, will assist the FDA in addressing adulteration associated with decomposition and histamine identified during surveillance sampling and testing. The FDA is reopening the comment period to allow additional time for stakeholders to develop and submit data, other information, and comments for the draft CPG. The new comment period will close on April 13, 2022. To submit comments electronically to the docket, visit Docket No. FDA-2021-D-0367.

 

FDA Issues Guidance on Enforcement Discretion Policies for Certain FSMA Regulations

March 11, 2022: Today the FDA issued guidance on its intent not to enforce certain provisions of five rules that implement the Food Safety Modernization Act (FSMA). As FDA began implementation of these rules, they received questions and comments from stakeholders regarding specific provisions. In certain situations the FDA has determined it is appropriate to take time to consider options, including rulemaking, to address concerns raised by stakeholders, while continuing to protect public health. As FDA works on solutions, the agency does not intend to enforce these provisions as they currently apply to entities or activities addressed in the guidance.

The enforcement discretion policies announced today are specific to provisions in the following rules:

  • Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Animal Food
  • Foreign Supplier Verification Program,
  • Produce Safety
  • Intentional Adulteration

In many instances, this guidance builds upon previously announced enforcement policies. To view more on the extension of enforcement discretion, please click here

 

FDA’s Third TechTalk Podcast Will Be on Artificial Intelligence

March 7, 2022: On Monday, March 21, 2022, FDA will air the third in a new quarterly podcast series that focuses on the development and use of new technologies to accelerate prevention of food safety problems and speed responses to foodborne-illness outbreaks. Entitled “Artificial Intelligence in the New Era of Smarter Food Safety,” this podcast will explore the potential of artificial intelligence (AI) to transform food safety. Discussion will center on the opportunities that AI offers to help protect consumers from food safety issues, potential uses of AI that food producers could consider, and what’s on the horizon for AI in FDA’s New Era of Smarter Food Safety.  

For more information about how to listen on March 21 and submit questions in advance for consideration by the panelists, visit the TechTalk podcast page

 

FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

March 3, 2022: Today, the FDA finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public’s exposure to risk. To view the guidance, please click here

 

January

 

FDA Releases List of Priority Guidance Topics for Foods Program

January 31, 2022: Today, the FDA’s Center for Food Safety and Applied Nutrition and Office of Food Policy and Response released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months. The agency anticipates it will publish many of these documents by January 2023. The list is an update on the guidance agenda released in June 2021 and focuses on Level 1 draft and final guidances. The list of guidance topics can be reviewed here

 
FASTER Act Video for Food Industry and Other Stakeholders

January 31, 2022: The FDA released a new video that provides an overview of the 2021 Food Allergy Safety, Treatment, Education, and Research (FASTER) Act. The FASTER Act, among other things, adds sesame to the list of major food allergens effective January 1, 2023. The video includes basic information about the FASTER Act and helps answer frequently asked questions the FDA has received from the food industry and other stakeholders. The video can be viewed at the link within the text. 

 

FDA and Stop Foodborne Illness to Co-Host Second Food Safety Culture Webinar

January 27, 2022: The FDA and Stop Foodborne Illness, a non-profit public health organization, are announcing a second webinar in their collaborative series that explores food safety culture. The second webinar is called “Making Leaders Risk Aware and Push to Reduce Risk” and it will take place on February 16, 2022 from 12:30 to 1:15 p.m. ET. The webinar will feature Nancy Wilson, Director of Quality Assurance, Risk Management and Safety at Wawa, and Randall Huffman, Chief Food Safety and Sustainability Officer at Maple Leaf Foods. The webinar is part of the webinar series entitled “Collaborating on Culture in the New Era of Smarter Food Safety”. The series will engage experts from the public and private sectors in a collaborative exchange of ideas and experiences related to the importance of a robust food safety culture in helping to ensure safe food production.  To register for the webinar, please click here

 

FDA Reminds Produce Stakeholders of Prior Statement Regarding Enforcement Discretion for Agricultural Water Compliance Dates

January 26, 2022: The FDA wants to remind produce stakeholders that the Agency previously announced its intention to exercise enforcement discretion for all of the agricultural water requirements for covered produce (other than sprouts). This includes exercising enforcement discretion related to the January 26, 2022 compliance date for the pre-harvest, harvest and post-harvest agricultural water requirements in the FSMA Produce Safety Rule for the large covered farms. The enforcement discretion plans were announced in the recently issued agricultural water proposed rule. At that time, the FDA also announced that they would pursue a targeted compliance date rulemaking for these requirements. During these rulemakings, covered farms should implement good agricultural practices to maintain and protect the quality of their water sources.

 

Now Available: At-a-Glance Fact Sheet for FSMA Laboratory Accreditation for Analyses of Foods Program

January 25, 2022: Today, the FDA posted an At-a-Glance Fact Sheet (pdf) to assist stakeholders with information about the FSMA Final Rule on Laboratory Accreditation for Analyses of Foods (LAAF). To view the fact sheet and learn mopre about the final rule, please visit the links in the text. 

 

FDA Updates Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act

January 21, 2022: The FDA has updated the Guidance for Industry: Seafood HACCP and the Food Safety Modernization Act (FMSA) document to explain the connection between the FDA FSMA regulations and pre-FMSA regulation. To view the updated guidance, please click on the link provided in the text above. 

 

FDA Issues Draft Compliance Policy Guide for Decomposition and Histamine in Scombrotoxin (Histamine)-forming Fish and Fishery Products

January 19, 2022: The FDA is issuing a draft Compliance Policy Guide (CPG) that revises the current CPG Sec. 540.525 on decomposition and histamine in fish and fishery products. This draft CPG provides guidance to assist the FDA in addressing adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing. The draft CPG also increases consumer protections related to histamine poisoning by lowering the levels of histamine in fish at which the FDA indicates that it may take action. To view the draft guide, please click on the link provided in the text. 

 

FDA to Hold Public Meetings to Discuss Proposed Changes to Agricultural Water Requirements in the Produce Safety Rule

January 6, 2022: The FDA will be holding two virtual public meetings on the recently released proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” The purpose of the public meetings is to discuss the proposed rule and are intended to facilitate and support the public's evaluation and commenting process on the proposed rule. The public meetings will be held according to the schedule below. 

First Virtual Public Meeting
February 14, 2022
11:45 am - 7:45 pm EST

Second Virtual Public Meeting
February 25, 2022
8:45 am - 4:45 pm EST  

Registration is required to attend the virtual meetings. To register, please visit the FDA Meetings page. 

 

The FDA’s Faster and Easier Reportable Food Registry Process Will Lead to Better Data and a Safer Food Supply

January 5, 2022: The FDA has published a new, interactive public data dashboard that allows anyone to view historical data (September 2009-2019) from the Reportable Food Registry (RFR), an essential tool that the food industry uses to alert the FDA of a dangerous food product. The new dashboard, which will be updated annually, makes it faster and easier to get better data from the RFR compared to the past. The RFR program helps FDA's state and local partners better determine when to issue health alerts, take steps to remove harmful food from the market, and target enforcement efforts, such as sampling assignments. To interact with the new dashboard, please click here

December 

 
FDA Issues Draft Compliance Policy Guide for Decomposition and Histamine in Scombrotoxin (Histamine)-forming Fish and Fishery Products

December 23, 2021: The FDA has issued a draft Compliance Policy Guide (CPG) that revises the current CPG Sec. 540.525 on decomposition and histamine in fish and fishery products. This draft guide provides guidance to assist the FDA in addressing adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing. The draft guide also increases consumer protections related to histamine poisoning by lowering the levels of histamine in fish at which the FDA indicates that it may take action. To view the guide, please click here

 

FDA Updates Guidances that Explain Certain Exemptions from FSMA

December 21, 2021: The FDA has updated three guidance documents for food producers covered by the FDA’s regulations for Juice Hazard Analysis and Critical Control Point (HACCP)Seafood HACCP, and Low-Acid Canned Foods to explain the connection between the FDA Food Safety Modernization Act (FSMA) regulations and pre-FSMA regulations.  The updated information can be viewed in the links provided above. 

 

FDA Releases Plan, Independent Review to Improve Foodborne Outbreak Response

December 9, 2021: Today, the FDA released the Foodborne Outbreak Response Improvement Plan to enhance the speed, effectiveness, coordination, and communication of investigations into outbreaks of foodborne illness. The goal is to improve FDA's ability to identify the sources and causes of foodborne illness outbreaks. These improvements will help to reduce the number of foodborne outbreaks that go unsolved and ultimately bend the curve of foodborne illness in this country. To view the plan, please click here

 

FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule

December 2, 2021: Today, the FDA published a proposed rule that would revise subpart E of the FDA FSMA Produce Safety Rule to change certain pre-harvest agricultural water requirements for covered produce other than sprouts. Under this proposal, farms would be required to conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. The assessment would include an evaluation of the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land, and other relevant factors, such as the results of optional testing. For more information, please visit the FSMA Proposed Rule on Agricultural Water webpage and the Federal Register proposed rule webpage. 

 

FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods

December 1, 2021: Today, the FDA issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as required by the FDA Food Safety Modernization Act (FSMA). Under the LAAF program, the FDA will recognize accreditation bodies (ABs) that will accredit food testing laboratories to standards established in the final rule (referred to as LAAF-accredited laboratories). The final rule outlines eligibility requirements that ABs and laboratories will need to satisfy to participate in the program, as well as procedures for how the FDA will manage and oversee the program. To view the final rule, please click here

 

October

FY 2019 Pesticide Report: Consistent with Trends Over the Past 8 Years, Pesticide Residue Levels Remain Low

October 20, 2021: The FDA has issued its annual Pesticide Residue Monitoring Program Report for FY 2019. They tested for 812 pesticides and industrial chemicals across 4,692 total samples and the majority of samples had pesticide residues below the limits (known as “tolerances”) set by the U.S. Environmental Protection Agency (EPA). These results are consistent with the trend of low levels of pesticide residue violations over the past 8 years. To view the entire report, please click here

 

Release of 2019 Annual Report on the Sources of Foodborne Illness by the Interagency Food Safety Analytics Collaboration

October 15, 2021: In an ongoing effort to understand sources of foodborne illness in the U.S., the Interagency Food Safety Analytics Collaboration (IFSAC) collects and analyzes foodborne illness outbreak data for four pathogens - Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter - and specific foods and food categories that are responsible for foodborne illnesses in the U.S. The data are analyzed by calendar year and released in an annual report. The CDC estimates that, together, these four pathogens cause nearly two million cases of foodborne illnesses in the U.S. each year. IFSAC’s newest annual report, “Foodborne illness source attribution estimates for 2019 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States,” is now available and can be viewed here.

 

FDA Encourages Food and Agriculture Workers to Get Vaccinated Against Flu and COVID-19

October 14, 2021: The FDA encourages food and agricultural workers to protect themselves by getting an annual flu vaccination and a COVID-19 vaccination. Throughout the pandemic, millions of workers on the front lines of processing, preparing, selling, and delivering food for humans and animals have remained steadfast and on the job. Right now, the best protection for these workers, their family, their workplace(s), and their community, is to get vaccinated against both the seasonal flu and COVID-19. CDC recommends that adults and children 6 months of age and older get a flu vaccine by the end of October, ideally before flu activity starts. To learn more about how and where to get a flu shot, contact your doctor or employer and visit: www.cdc.gov/flu. When an essential worker is vaccinated against the flu and COVID-19, they protect themselves, their families, co-workers, and their communities. Healthy workers help to ensure the availability of a safe and nutritious food supply. For more information, please visit: www.cdc.gov/flu or www.vaccines.gov

 

FDA Releases Report on Findings from Sampling of Romaine Lettuce in Yuma, AZ

October 7, 2021: The FDA is releasing the findings of a sampling assignment in which they collected and tested romaine lettuce from commercial coolers in Yuma County, Arizona during February and March 2021. The agency tested the lettuce for Shiga toxin-producing Escherichia coli (STEC) and Salmonella spp. This assignment was part of the FDA’s ongoing surveillance following multistate E. coli O157:H7 outbreaks of foodborne illness in recent years linked to or potentially linked to romaine lettuce. To read the report, please click here

 

FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and Wisconsin

October 7, 2021: Today, the FDA announced that California, Florida, Utah and Wisconsin have entered into domestic mutual reliance agreements with the agency. These Mutual Reliance agreements facilitate a coordinated effort between the FDA and individual states with goals to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight and increase public health protection by focusing on areas of higher risk. The FDA will collaborate with partner states on data sharing, risk prioritization, inspections, outbreak investigations, development and monitoring of key metrics and laboratory capacity, among many other key focus areas. To read more about the Mutual Reliance agreements, please click here

 

FDA Assesses Impact of Whole Genome Sequencing Program

October 6, 2021: The FDA published a study on the effectiveness of the GenomeTrakr Whole Genome Sequencing (WGS) Network, a scientific tool that helps the FDA detect, investigate and limit the spread of foodborne illness outbreaks linked to FDA-regulated foods. The FDA estimates that the program was likely cost effective in its second year of implementation and at current funding levels, the program is generating $100 million to $450 million in net annual health benefits. To read the study, please click here

 
Voluntary Qualified Importer Program Update

October 1, 2021: Today, the benefit year begins for participants in the Voluntary Qualified Importer Program (VQIP) under the FDA Food Safety Modernization Act. VQIP is a voluntary fee-based program that provides importers who achieve and maintain control over the safety and security of their supply chains, expedited review and importation of human and animal foods into the United States. To learn more about this program, please click here

 

September

Webinar To Showcase the Winners of FDA’s Food Traceability Challenge

September 23, 2021: The FDA is hosting a Low- or No-Cost Tech-Enabled Traceability Challenge Webinar on Tuesday, September 28, 2021 from 11 a.m. to 1 p.m. ET. The 12 winners of the FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge will present their solutions and take questions during a live Q&A session. The winning teams represent the U.S., Canada, and New Zealand. Questions can be sent to SmarterFoodSafety@fda.hhs.gov. After the webinar broadcasts, a recording will be available. Learn more about the winners and watch the videos they submitted on FDA’s Food Traceability Challenge page.

 

FDA Selects Winners for Low- or No-Cost Food Traceability Challenge; Plans Webinar to Showcase Solutions

September 13, 2021: Today, the FDA announced the 12 winners of the FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge. From the time the challenge was launched on June 1, 2021 until the submission window closed on July 30, 2021, there were 90 submissions, with the winning teams representing the U.S., Canada, and New Zealand. The primary goal of this challenge has been to encourage stakeholders, including technology providers, public health advocates, entrepreneurs, and innovators from all disciplines to develop traceability hardware, software, or data analytics platforms that are low-cost or no-cost to the end user. To learn more about the winners and watch the videos they submitted on FDA’s Food Traceability Challenge page.

 

FSMA's Produce Safety Rule Now Available in Korean and Japanese

September 10, 2021: The FDA is pleased to announce that the Food Safety Modernization Act Produce Safety Rule (PSR) is now available in Korean and Japanese. The PSR is also available in Spanish, Chinese and Portuguese.The translations of the PSR can be found on the FSMA Final Rule on Produce Safety webpage.

 

FDA Hosts New Era of Smarter Food Safety Summit on E-Commerce

September 3, 2021: Today, the FDA issued a Federal Register Notice to formally announce a three-day public meeting to discuss the safety of foods sold online and delivered directly to consumers.The FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers will take place virtually October 19-21, 2021. The summit is designed to help the agency improve its understanding of how human and animal foods are sold through Business to Consumer (or B2C for short) e-commerce models across the U.S. and globally. The blueprint goal is to convene a summit to identify courses of action to address potential food safety vulnerabilities, including those that may arise in the “last mile” of delivery. The FDA intends to use what we learn during the public meeting, and from comments submitted to the Federal Register, to help determine what actions, if any, may be needed to keep consumers safe.

During the three-day event, there will be opportunities for public comment each day. Participants who wish to speak during the public comment sessions must register as indicated in the Federal Register Notice by October 8, 2021. In addition, FDA will open a public docket to receive additional comments about these topics. Public comments can be submitted electronically to www.regulations.gov using Docket ID: FDA-2021-N-0929 now through November 20, 2021.

There is no cost to attend the summit, but registration is required. Register for this event here

 

August

FDA to Hold Retail Food Protection Seminar

August 31, 2021: Registration is open for the 2021 FDA Retail Food Protection Seminar, which will be held September 13-16, 2021. Registration for the virtual event is free and open to all interested in retail food safety, including state, local, territorial, and tribal regulators, industry, and academia. The seminar will include region-specific breakout sessions, as well as workshops on funding opportunities. The event is being conducted in partnership with the Association of Food and Drug Officials. To register and learn more, please click here.

 

The Food Safety Partnership Between the U.S. and Mexico Reports Progress at First Annual Meeting

August 23, 2021: The FDA reported continuing progress to ensure the safety of food imported from Mexico at the virtual annual meeting of the FDA-SENASICA-Cofepris Food Safety Partnership (FSP), held on August 20, 2021.  The FDA has launched a new Web page, which includes resources in both English and Spanish, to communicate the progress of the FSP to stakeholders. To view this page, please click here.

 

FDA’s Second TechTalk Podcast Focuses on Whole Genome Sequencing

August 11, 2021: Today, FDA posted the second TechTalk podcast episode that focuses on the development and use of new technologies to strengthen the ability of FDA, regulated industry, and others to accelerate prevention, speed outbreak response, and more swiftly adapt to crises that could affect the food supply. The podcast, “Whole Genome Sequencing in the New Era of Smarter Food Safety,” features food safety and public health experts in the Association of Public Health Laboratories, Western Growers, and the New York State Department of Health, which is responsible for public health in the nation’s fourth most populous state.To listen, please click here

 

Microbiological Surveillance Sampling: FY21 Collection and Testing of Lettuce Grown in Salinas Valley, CA

August 2, 2021: Today, the FDA updated its sampling assignment for collecting and testing lettuce grown in Salinas Valley, California from commercial coolers that service the Salinas Valley area. To review the updated assignment, please click here

 

July

New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers

July 29, 2021: The FDA will host a virtual summit October 19-21, 2021, to convene industry and consumer experts, government officials, stakeholders and other interested parties for a discussion and exchange of perspectives about the safety of human and animal foods produced, manufactured, sold, and delivered directly to consumers through e-commerce. Summit participants will discuss the regulatory framework that apply to these foods and ways to strengthen food safety. More specifics, including information on how to register for the summit will follow in the Federal Register and on the FDA website

 

FDA Announces FY2022 User Fee Rates for the Voluntary Qualified Importer Program and the Accredited Third-Party Certification Program

July 27, 2021: The FDA is announcing the fiscal year 2022 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP), and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP). The user fee rates are authorized by the FDA FSMA and allow the agency to assess and collect fees to cover the FDA’s cost of administering these programs. The FY2022 VQIP user fee rate will be effective on August 1, 2021 and supports program benefits from October 1, 2021 through September 30, 2022. Currently, the agency is not offering an adjusted fee for small businesses. Approved VQIP applicants must pay the user fee before October 1, 2021 to begin receiving benefits for the 2022 fiscal year.  

 

FDA and USDA Collaborate to Present Webinars on FSMA Produce Safety Rule to Produce Exporters in Latin America

July 9, 2021: Throughout July and August, the FDA will offer webinars followed by live Q&A sessions on the Produce Safety Rule (PSR) and the Foreign Supplier Verification Program (FSVP) for stakeholders in Latin America. A list of webinar dates and times, languages spoken for these webinars, and webinar registration can be found here

 

FDA Issues Industry Guidance on Oversight of Food Products Covered by Systems Recognition Arrangements

July 9, 2021: Today, the FDA issued the draft FDA Oversight of Food Products Covered by Systems Recognition Arrangements: Guidance for Food and Drug Administration Staff that addresses how the agency plans to adjust its regulatory oversight activities for covered foods imported from countries that have been determined to produce similar food safety outcomes through an FDA assessment. To learn more about the draft guidance or to submit questions related to the guidance, please click here

 

FDA Releases Cyclospora Prevention, Response and Research Action Plan

July 1, 2021: Today, the FDA released a Cyclospora Prevention, Response and Research Action Plan that outlines FDA’s strategy for reducing the public health burden of foodborne cyclosporiasis in the United States caused by Cyclospora cayetanensis in both domestically grown and imported produce. To view the action plan, please click here

 

June

FDA Releases List of Guidance Topics for Foods Program

June 29, 2021: Today, the FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months. The agency anticipates it will publish many of these documents by June 2022. The list focuses on Level 1 draft and final guidances. To view the priority list, please click here

 

Adoption of the FDA Food Code by State and Territorial Authorities Responsible of the Oversight of Foodservice and Retail Food Stores – December 31, 2020

June 24, 2021: The FDA Food Code is a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. It represents FDA's best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service. The FDA Food Code is offered for adoption by local, state, and federal governmental jurisdictions for administration by the various departments, agencies, bureaus, divisions, and other units within each jurisdiction that have been delegated compliance responsibilities for food service, retail food stores, or food vending operations. Information regarding adoption of the FDA Food Code is communicated in the report entitled, Adoption of the FDA Food Code by State and Territorial Authorities Responsible of the Oversight of Foodservice and Retail Food Stores – December 31, 2020. To view the report, please click here

 

FDA Releases Updated Chapters and Appendices to the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition

June 17, 2021: The FDA has announced the availability of specific chapters, appendices and addenda of the “Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition” now dated June 2021.

This update includes:

Chapter 3: Potential Species-Related and Process-Related Hazards

Chapter 11: Aquaculture Drugs

Appendix 1: Forms

Appendix 2: Product Flow Diagram – Example

Appendix 3: Critical Control Point Decision Tree

Appendix 5: FDA and EPA Safety Levels in Regulations and Guidance

Appendix 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products

Appendix 11: Approved Aquaculture Drugs

Appendix 12: Unapproved Aquaculture Drugs

Addendum 1: Fish and Fishery Products (21 CFR 123) and Control of Communicable Diseases (21 CFR 1240.60)

Addendum 2: current Good Manufacturing Practices (cGMPs)

The modifications can be reviewed through the “Guidance to Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition – June 2021” section of the guidance document. Updates may be accessed through the FDA’s Seafood website or the Fish and Fishery Products Hazards and Controls Guidance Page.

 

FDA Releases Investigation Findings Following Summer 2020 Outbreak Linked to Peaches

June 11, 2021: The FDA has released a report on its investigation of the Salmonella Enteritidis outbreak in peaches. The FDA and multiple state and federal partners investigated an outbreak of Salmonella Enteritidis infections that were linked to the consumption of peaches during the summer of 2020. In total, the outbreak caused 101 reported illnesses across 17 states, including 28 hospitalizations. This appears to be the first time a Salmonella outbreak has been linked to peaches. The FDA conducted this investigation in conjunction with the U.S. CDC, state partners, and Canadian public health officials between August and October 2020. The epidemiological and traceback investigation determined that peaches packed or supplied by a large grower/producer were the likely source of the outbreak. To learn more about the outbreak and/or review the report, please click here

 

Vaccinating Migrant/Migratory and Seasonal Food and Agriculture Workers

June 1, 2021: As the vaccine supply increases, the FDA encourages the leadership and management of food facilities to support migrant/migratory and seasonal food and agriculture workers vaccinations. When an essential worker gets a COVID-19 vaccine, they protect themselves, their families, co-workers, and their communities. Healthy workers help to ensure the availability of a safe and plentiful food supply. See CDC’s Guide to Vaccinating Workers: Vaccinating Migrant/Migratory and Seasonal Food and Agriculture Workers.

 

FDA Launches Challenge to Spur Development of Affordable Traceability Tools as Part of Broader Food Safety Efforts

June 1, 2021: Today, the FDA launched a challenge to spur the development of affordable, tech-enabled traceability tools to help protect people and animals from contaminated foods by enabling the rapid identification of their sources and helping remove them from the marketplace as quickly as possible. The FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge advances a goal set forth in the New Era of Smarter Food Safety blueprint, to encourage the development of creative financial models for low- to no-cost traceability solutions that would enable food producers of all sizes to participate in a scalable, cost-effective way.

Through this challenge, the agency is asking food technology solution providers, public health advocates, entrepreneurs and innovators across the human and animal food supply chain to present food traceability solutions that utilize economic models that are affordable, with costs that are proportional to the benefits received and can scale to encourage widespread adoption. The FDA will accept submissions from June 1 through July 30 and intends to announce up to 12 winners at the end of the challenge. No cash prizes will be awarded, but the winners will have the opportunity to present their work publicly in a webinar planned for September and their videos will be posted for public viewing. The challenge is being overseen by the FDA’s Office of Food Policy and Response and administered by PrecisionFDA. For more information on how to join the challenge, visit the registration page.

 

May

FDA Releases Results of FY20-FY21 Romaine Lettuce Sampling Assignment

May 25, 2021: The FDA released the findings of a sampling assignment that tested raw agricultural commodity romaine lettuce mostly at facilities and on farms in the Salinas, California, and Yuma, Arizona growing regions for the presence of pathogens that have been linked to outbreaks of foodborne illness.

The assignment to detect pathogenic Escherichia coli (specifically, Shiga toxin-producing E. coli or STEC) and Salmonella spp began in November 2019 and ended in December 2020, after a pause in sample collection and testing from March through October 2020 due to the COVID-19 pandemic. The FDA did not detect any pathogens during the assignment. To view the report, please click here

 

FDA Seeks Innovative Food Traceability Tools and Opens a Dialogue on Advancing Food Safety with Technology

May 18, 2021: On June 1, the FDA will launch The FDA New Era of Smarter Food Safety Low or No-Cost Tech-enabled Traceability Challenge, asking stakeholders, including technology providers, entrepreneurs, and innovators, to develop traceability tools that can be implemented in a scalable, cost-effective way for food operations of all sizes. The Low- or No-Cost Tech-enabled Traceability Challenge is being overseen by the FDA’s Office of Food Policy and Response and administered by precisionFDA, which convenes community challenges and app-a-thons that galvanize dialogue and scientific discovery around technologies. 

The challenge will invite submissions for tech-enabled solutions that address traceability needs and challenges faced by primary producers (such as entities involved in farming, fishing, and animal agriculture), importers, manufacturers and processers, distributors, and retailers and foodservice. There is a pre-registration web page that will be updated on June 1 at 8 a.m. ET with all the information needed to participate in the challenge until the submission window closes on July 30 at 5 p.m. ET. Up to 12 winners will be announced at the completion of the challenge.

While there is no cash prize, the challenge winners will gain significant visibility, including an opportunity to present their entry in a public forum hosted by the FDA. The food industry will gain new insights into how to solve traceability challenges, and the FDA will open the door to a conversation about finding new ways to overcome obstacles in the road to farm-to-fork traceability.

 

FDA Issues Report Highlighting Salmonella Outbreak in Red Onions

May 13, 2021: The FDA has released a report on its investigation of the Salmonella Newport outbreak that caused more than 1,600 reported illnesses in the U.S. and Canada between June and October 2020. The FDA worked with the U.S. Centers for Disease Control and Prevention (CDC), state partners, and Canadian officials (Public Health Agency of Canada and Canadian Food Inspection Agency) to investigate the outbreak, which was linked through epidemiology and traceback to whole red onions supplied by Thomson International Inc., headquartered in Bakersfield (Southern San Joaquin Valley) with additional operations in Holtville (Imperial Valley), California. The outbreak is the largest Salmonella foodborne illness outbreak in over a decade. The report released today includes an overview of the traceback investigation, subsequent on-site interviews, visual observations of the growing fields, and environmental sampling, and various factors that potentially contributed to the contamination of red onions with Salmonella. To view the report, please click here

 

Voluntary Qualified Importer Program portal will close May 31, 2021

May 12, 2021: The Voluntary Qualified Importer Program (VQIP) application portal for fiscal year 2022 benefits will close on May 31, 2021. VQIP is a voluntary fee-based program for importers who achieve and maintain control over the safety and security of their supply chains. VQIP participants enjoy the benefits of expedited review and importation of human and animal foods into the U.S. To participate in VQIP, food importers must meet certain eligibility requirements, including ensuring that the facilities of their foreign suppliers are certified through the FDA’s Accredited Third-Party Certification Program, part of the FSMA. Certification bodies conduct food safety audits of foreign facilities and farms, and issue the certifications that importers need to participate in VQIP. Importers have until May 31,2021 at 11:59 pm EST to submit their online application to participate in VQIP for FY2022 benefits, beginning October 1, 2021. If you have already submitted an application, you may check the status at https://www.access.fda.gov/

 

FDA to Implement Sampling Effort for Lettuce Grown in Salinas Valley, California

May 11, 2021: The FDA will be collecting and testing samples of lettuce grown in California’s Salinas Valley from local commercial coolers from May through November 2021. The agency will test the samples for Shiga toxin-producing Escherichia coli (STEC), including E. coli O157:H7, and Salmonella spp. as part of ongoing surveillance efforts following reoccurring outbreaks linked to this region, including most recently in the fall of 2020.

The FDA assignment will direct sampling to be conducted at commercial cooling and cold storage facilities where field heat is removed from harvested lettuce and where product is cold-stored before processing. Sampling may include pre-cooled product (preferred) or post-cooled product. Sample collection at commercial coolers helps the FDA efficiently obtain samples from multiple farms at centralized locations and facilitates prompt traceback and follow-up if contamination is detected.

The agency plans to collect and test a total of approximately 500 post-harvest samples of iceberg, leaf and romaine lettuce. Each sample will consist of 10 subsamples, each made up of one head of lettuce (trimmed, cored and possibly wrapped), or in the case of romaine lettuce, loose leaves or one package of hearts.  FDA laboratories will conduct all testing.

The FDA will take extra precautions to help ensure the safety of agency investigators and firm employees during the COVID-19 pandemic. FDA investigators will preannounce their visits to firms per the Agency’s COVID-19 safety practices. They will be outfitted with personal protective equipment and will carry out their work while adhering to local, state and applicable CDC guidance.

 

FDA Opens Industry Portal for FSVP Records Submission

May 10, 2021: Today, the FDA opened the FSVP Importer Portal for FSVP Records Submission for importers of human and animal and human food into the U.S. The FDA established the Portal to serve as a dedicated, streamlined way for importers to submit FSVP records electronically to the FDA, if they choose. 

The FDA Foreign Supplier Verification Programs for Food Importers (FSVP), requires importers to perform certain risk-based activities to verify that their foreign suppliers are producing food in accordance with U.S. food safety standards. The FDA typically conducts inspections of FSVP records at an importer’s place of business. However, if requested in writing by the FDA, the FSVP regulation requires importers to provide FSVP records to the agency electronically, or through another means that delivers the records promptly.  Importers with an active FDA Account ID and password can access the Portal on the FDA’s Unified Registration and Listing System (FURLS) page. 

 

FDA Releases Report on Foodborne Illness Risk Factors in Delis

May 7, 2021: The FDA has released its report on a study of foodborne illness risk factors in retail food store deli departments. This study is part of a 10-year initiative that examines when foodborne illness risk factors, such as employees practicing poor personal hygiene, and food safety practices, like improper handwashing, occur; and their relationship to Food Safety Management Systems (FSMS) and Certified Food Protection Managers (CFPM). To view the report, please click here. For questions, please contact the FDA National Retail Food Team at retailfoodpolicyteam@fda.hhs.gov.

 

Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

May 5, 2021: Today, the FDA issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.

In March 2020, the FDA announced that it was temporarily postponing all domestic and foreign routine surveillance facility inspections, while continuing mission critical inspections when possible. Beginning the week of July 20, 2020, the FDA began to work toward resuming prioritized domestic inspections using its COVID-19 Advisory Rating system. The report outlines inspections that the agency was unable to complete during the past year due to travel restrictions or inability to ensure the safety of our workforce or the workforces the agency regulates. The report also outlines the number of mission-critical inspections the agency completed during that time including the response to foodborne disease outbreaks or other food safety risks such as undeclared allergens.

Additionally, the report outlines the FDA’s continued successful use of alternative tools and approaches where inspections were or are not currently feasible, including remote interactive evaluations (e.g., remote livestreaming video of operations, teleconferences or screen sharing), record requests and leveraging information from trusted regulatory partners.

The report further outlines the ongoing steps the agency is taking in order to resume standard operational levels of inspection activities, including how it intends to prioritize domestic and foreign inspections that were not performed during the pandemic. The plan highlights a variety of possible scenarios given the continued uncertainty of the trajectory of the ongoing pandemic. Inspections considered critical to the FDA’s mission will remain the primary focus. When planning routine surveillance inspections, the agency will prioritize higher-risk establishments. Therefore, a longer interval between inspections will occur for the less high-risk facilities as the FDA adjusts to the impact of the COVID-19 pandemic. This means that postponed inspections will be prioritized based on risk and conducted over a longer period of time, ultimately increasing the amount of time between inspections of certain lower-risk facilities.

 

April

FDA Begins New Era of Smarter Food Safety TechTalk Podcast

April 15, 2021: On Thursday, April 29, 2021, FDA is launching the first in a new quarterly podcast series that focuses on the development and use of new technologies to strengthen the ability of FDA, regulated industry, and others to accelerate prevention, speed up outbreak response, and more swiftly adapt to crises that could affect the human and animal food supply. Each quarter they will examine a different aspect of the Core Elements in the New Era of Smarter Food Safety Blueprint for which there are novel technological approaches and solutions.The podcast will be hosted by FDA and feature top experts involved in food safety and technology. The goal is to discuss current and emerging technologies and solutions, with all their opportunities and challenges, and explore how they may facilitate and enhance food safety.The first episode is about Tech-enabled Traceability in the New Era of Smarter Food Safety. Registration is not required but questions can be emailed in advance at SmarterFoodSafety@fda.hhs.gov. Questions submitted by April 22, 2021 may be considered by the panelists. To learn more about the podcast, please click here to visit their website.

 
FDA Takes Two Important Steps to Advance the Safety of Leafy Greens

April 6, 2021: Today, the U.S. FDA is taking two important steps to advance the safety of leafy greens. The first is the release of a report on the investigation into the Fall 2020 outbreak of E. coli O157:H7 illnesses linked to the consumption of leafy greens. The report describes findings from the investigation, as well as trends key to understanding leafy greens outbreaks linked to the California Central Coast growing region (encompassing the Salinas Valley and Santa Maria growing areas) that have occurred every fall since 2017. In addition, the FDA is also releasing an updated version of the Leafy Green Shiga-toxin producing E. coli (STEC) Action Plan, reaffirming the need for collaborative action to improve the safety of leafy greens, and building on the work accomplished in 2020. To review the report, please click here. To view the Leafy Green Shiga-toxin producing E. coli Action Plan, please click here

 

March

FSMA's Produce Safety Rule Now Available in Chinese, Portuguese and Spanish

March 10, 2021: The FDA is pleased to announce that the Food Safety Modernization Act Produce Safety Rule (PSR) is now available in Chinese and Portuguese. The PSR was previously translated into Spanish. In conjunction, the Produce Safety Alliance, an FDA-funded produce safety training partner, is publishing a grower curriculum for farmers in Chinese and will soon finalize the curricula in Portuguese. The translations of the PSR can be found on the FSMA Web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety.

Additional information/links: PSA Grower Curricula in Chinese

 

February

FDA Shares Resources for the Food and Agriculture Sector about COVID-19 Vaccination

February 24, 2021: Today the FDA published a new web page, COVID-19 Vaccination & the Food and Agriculture Sector, to share information and resources to help employers in the Food and Agriculture sector communicate about COVID-19 vaccination to their workforce.

The page includes links to information about:

  • The safety and effectiveness of COVID-19 vaccines authorized for emergency use by the FDAand fact sheets in more than 25 languages
  • A CDC tool kit in different languages with key messages to reach essential workers about COVID-19 vaccination  
  • Information about the availability of vaccines in your community

As the COVID-19 vaccine supply increases, the FDA hopes these resources will help leadership and management of food and agriculture operations support worker vaccination. 

 

FDA Publishes Materials from Food Traceability Public Meetings, including Supply Chain Example

February 12, 2021: The FDA recently held a series of three virtual public meetings in 2020 to discuss the recently released Food Traceability Proposed Rule. The purpose of the public meetings was to discuss the proposed rule, and to support the public's evaluation and commenting process on the proposed rule. Following each of the public meetings the FDA posted a video recording and transcript on our public meeting webpage. The FDA is now publishing the remaining materials discussed at the meetings, the six slide presentations. 

The supply chain example discussed during the public meetings was of a salad kit prepared with cherry tomatoes, iceberg lettuce, and other foods, focused on the tomato grower, salad kit maker, distributor, and retail store. At the public meetings, FDA explained that this is only one example and it does NOT represent the only way data could be kept and shared under the proposed requirements. 

FDA will carefully consider comments submitted to the public docket when drafting the final rule, which may differ from the proposed rule. Interested parties are encouraged to submit comments during the comment period, which has been extended until February 22, 2021. Comments can be submitted to regulations.gov, Docket ID: FDA-2014-N-0053. 

 

FDA Announces New Sampling Plan for Romaine Grown in the Yuma, Arizona Growing Region

February 5, 2021: The FDA is launching an assignment to collect romaine lettuce samples from commercial coolers in the Yuma County, Arizona growing region during the current harvest season. The samples will be tested for Shiga toxin-producing Escherichia coli (STEC) and Salmonella spp. as part of ongoing surveillance efforts following the spring 2018 multistate E. coli O157:H7 outbreak of foodborne illness linked to romaine lettuce from the Yuma agricultural region. Salmonella spp. also commonly causes foodborne illness outbreaks in the United States which have at times been linked to romaine lettuce consumption.

The FDA plans to begin collecting samples of romaine lettuce from commercial coolers in February and intends to continue sampling through the end of the romaine harvest season in Yuma. The FDA assignment will focus on commercial cooler and cold storage facilities where field heat is removed from harvested romaine and where product is cold stored before processing and shipment. The focus on these sites enables the FDA to efficiently collect samples from multiple farms at centralized locations, following a similar model used during an assignment conducted in FY19.

To learn more about the sampling plan, please click here

 

January

FDA Adds Clarifying Descriptions to the Food Traceability List; Publishes FAQ on Food Traceability Proposed Rule

January 12, 2021: The FDA has made two updates to its materials for stakeholders regarding the Food Traceability Proposed Rule. First, the agency has made clarifying edits to the Food Traceability List (FTL), which lists the foods for which the additional traceability recordkeeping requirements in the proposed rule would apply. The edits to certain commodity descriptions were made for clarity and do not reflect a change in which foods are on the FTL. All of the specific edits are described in a memo titled “Food Traceability List for ‘Requirements for Additional Traceability Records for Certain Foods’ Proposed Rule- Clarified Language.”

Second, the FDA has published an FAQ, addressing questions that the agency has received about the proposed rule (e.g. during the public meetings, through the FSMA Technical Assistance Network, and during other outreach engagements) to assist stakeholders who are considering providing feedback during the comment period, which has been extended until February 22, 2021. Comments can be submitted at regulations.gov, Docket ID: FDA-2014-N-0053. 

VQIP Application Portal Now Open for FY 2022

December 23, 2020: On January 1, 2021, the FDA will open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year 2022. VQIP is a voluntary fee-based program that provides importers, who achieve and maintain control over the safety and security of their supply chains, the benefits of expedited review and importation of human and animal foods into the United States. To participate in VQIP, food importers must meet certain eligibility requirements, including ensuring that the facilities of their foreign suppliers are certified through the FDA’s Accredited Third-Party Certification Program. Certification bodies conduct food safety audits of foreign facilities and farms, and issue the certifications that importers need to participate in VQIP. If you are an importer interested in applying for VQIP benefits during fiscal year 2022, the portal will be open through May 31, 2021

 

FDA Extends Period Before It Will Begin to Consider Comments on Draft Guidance for Industry on Voluntary Disclosure of Sesame When Added as Flavoring or Spice

December 23, 2020: The FDA is extending for 45 days the period before it will begin to consider comments on its draft guidance regarding voluntary disclosure of sesame as an allergen.  Comments should be submitted before February 25, 2021 to ensure that FDA considers them before beginning work on the final guidance. 

 

FDA Extends the Comment Period for the Food Traceability Proposed Rule and the Information Collection Provisions

December 17, 2020: The FDA is extending the comment period for the proposed rule entitled “Requirements for Additional Traceability Records for Certain Foods” and reopening the comment period for the information collection provisions until February 22, 2021. The FDA previously signaled its intention to extend the comment period for the information collection provisions after hearing concerns from several stakeholders that more time was needed to adequately review and analyze those provisions with consideration to the entire proposed rule. The announcement today formally reopens and extends the comment period for the information collection provisions and extends the comment period for the entire rule.

 

CORE Outbreak Investigation Table Issued

November 18, 2020: The FDA has issued the Coordinated Outbreak Response and Evaluation (CORE) Investigation Table. This new tool will share information on FDA foodborne illness outbreak investigations, even in their early stages and as soon as FDA begins its response to the outbreak. It will give consumers early awareness of developing multistate outbreaks that are occurring across the United States. The FDA’s CORE team will use this new Investigation Table to communicate about outbreaks from beginning to end. This table will be updated once a week. It will include all outbreaks for which a CORE Response Team is coordinating an active investigation. This table will be rolled out as a 6-month pilot, during which the Agency is interested in receiving feedback and after which FDA may adjust the table, if needed.

 

FDA Signals that it Intends to Extend Comment Period for the Food Traceability Information Collections Provisions

November 18, 2020: During the second public meeting to discuss the proposed traceability rule, the FDA expressed their intent to extend the comment period for the information collection provisions that is set to close on November 23rd. FDA also is considering whether to provide any extension of the comment period for the proposed rule. After hearing concerns from several stakeholders that more time is needed to adequately review and analyze the information collection provisions with consideration to the entire proposed rule, the agency intends to formally announce an extension to the comment period for these provisions in a forthcoming notice in the Federal Register. Some stakeholders also have asked the FDA to extend the comment period for the proposed rule, which is currently slated to close on January 21, 2021.  Any extension of the proposed rule comment period would be announced through a notice in the Federal Register and issuance of a Constituent Update.

 

FDA Issues Draft Guidance for Industry on Voluntary Disclosure of Sesame When Added as Flavoring or Spice

November 10, 2020: Today, the FDA issued a draft guidance for voluntary sesame labeling to encourage manufacturers to clearly declare sesame in the ingredient list, when it is used as a “flavoring” or “spice” or when the common or usual name (such as tahini) does not specify sesame. This voluntary labeling guidance to industry aims to help consumers who are allergic or sensitive to sesame to avoid these products. Sesame is not one of the eight major food allergens required by the 2004 Food Allergen Labeling and Consumer Protection Act (FALCPA) to be included in specific allergen labeling, but in most cases, it does have to appear in the ingredient statement. An exception is when sesame is part of a flavoring or spice. In those cases, it may be declared as simply “spice” or “flavor” on the label without requiring “sesame” to be included, so its presence may not be obvious to consumers. To learn more about the recommended voluntary labeling and draft guidance for industry, please click here. Comments for this draft guidance are being accepted through January 11, 2021. 

 

FDA Extends Comment Deadline to Submit Information on Expansion of the Rarely Consumed Raw List for Uncommonly Consumed Produce

November 6, 2020: The FDA issued a Request for Information (RFI) in August 2020 to open a docket for data and information related to produce known to have no or low reported consumption. The Agency plans to use the data and information to consider whether any of these produce commodities should be added to the “rarely consumed raw” (RCR) list and thereby exempt from the Produce Safety rule. The items currently on the exhaustive RCR list are not subject to the requirements in the Produce Safety rule. The FDA is now extending the comment period for stakeholders to submit the requested information for an additional 60 days, through January 8, 2021. The FDA invites those with data, information, and/or comments regarding U.S. consumption patterns of those commodities with no or low reported consumption to submit such information to the agency through the RFI docket.

 

FDA Releases Additional Resources Related to the Food Traceability Proposed Rule

November 5, 2020: Recently the FDA released a proposed rule to establish additional traceability recordkeeping requirements for certain foods. This Food Traceability rule is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FSMA. To assist stakeholders in understanding this new proposal, the FDA is making a number of additional resources available.

The first resource is a tool designed to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability List. In the tool users can learn more about the methods and criteria used to score commodity-hazard pairs, and the results of that scoring which was used to determine which foods to include on the Food Traceability List (FTL).

The FDA has also released a pre-recorded webinar featuring Deputy Commissioner for Food Policy and Response Frank Yiannas, and Angela Fields, a traceability subject matter expert with FDA’s Coordinated Outbreak Response and Evaluation Network. During the presentation they discuss the benefits of the proposed rule, who would be subject to the rule, what the proposed key requirements are, exemptions and more.

In addition, the FDA has also made a number of other materials available including a “who is subject to the rule?” flowchart and a key terms glossary.

The FDA will be holding a series of virtual public meetings to discuss the proposed rule on November 18th and December 2nd. For those interested in attending, please visit the FDA's meeting page to learn more information and to register.

 

FDA Launches Voluntary Pilot Program to Evaluate Third-Party Food Safety Standards, Meeting Another Milestone in the New Era of Smarter Food Safety

October 23, 2020: The FDA is launching a voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations under FSMA - the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules. This pilot program will help both FDA and industry better understand how to determine whether these standards align with FDA regulations, a goal that is consistent with the New Era of Smarter Food Safety Blueprint. As part of the pilot, the FDA plans to select and assess up to five third-party food safety standards for alignment with the requirements in the PC Human Food and/or Produce Safety rules. The pilot will evaluate the resources required to review and assess third-party standards for alignment with the PC Human Food and Produce Safety rules, the ability of the pilot participants to provide adequate information to enable FDA to make a determination of alignment, and whether FDA audit comparison templates, are helpful in making alignment determinations. To learn more about the pilot program and how to apply, please click here

 

FDA establishes U.S. Agent Voluntary Identification System for Food Facilities

October 16, 2020: The FDA has issued guidance establishing a U.S. Agent Voluntary Identification System (VIS) for food facility registration. The VIS is intended to be used in conjunction with the Food Facility Registration Module (FFRM) to streamline and expedite the U.S. agent verification process. The guidance document provides additional information about the VIS process through questions and answers.  More information about food facility registration can be found at Registration of Food Facilities and Other Submissions.

 

FDA establishes U.S. Agent Voluntary Identification System for Food Facilities

October 14, 2020: The FDA will be hosting a webinar on Monday, October 26, 2020 from 3 to 4 p.m. on the highlights of the first 100 days since FDA issued its blueprint for the New Era of Smarter Food Safety. During this one-hour webinar, Deputy Commissioner Frank Yiannas and leaders of the four Core Elements of the blueprint will discuss the new approach FDA is taking to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system. There will be an opportunity to ask questions and the webinar will be recorded and posted to the FDA website. Registration is required; please register at your earliest convenience as space will be limited. Registration will close on Thursday, October 22, 2020 at 5 pm ET.  To register, please use this link.

 

FDA Updates Health and Personal Hygiene Handbook for Food Employees

October 7, 2020: The FDA has released an updated version of the Employee Health and Personal Hygiene Handbook for retail food managers and food employees. The handbook includes best practices and behaviors that can help prevent food employees from spreading bacteria and viruses, such as Salmonella and norovirus, that cause foodborne illness. This handbook has been revised to include updates from the 2017 Food Code. While the Food Code does not address respiratory illness, such as COVID19, the Employee Health section emphasizes long-standing public health principles for preventing disease transmission – hand washing; excluding ill employees from the workplace, prohibiting bare-hand contact with ready-to-eat foods; and reporting of illness and symptoms, among others. Along with several updates to the text, including procedures on how to respond to vomiting or diarrheal events, the handbook also highlights effective interventions to prevent the transmission of foodborne viruses and bacteria on food and food-contact surfaces. For more information, see Retail Food Protection: Employee Health and Personal Hygiene Handbook.

 

FDA and Mexico Sign Statement of Intent Forging Food Safety Partnership

October 5, 2020: Today, the FDA held a ceremony commemorating the signing of a Statement of Intent (SOI) that enhances the Food Safety Partnership between the United States and Mexico. The SOI broadens and strengthens the scope of the existing Produce Safety Partnership SOI, signed in 2014. Now referred to as the Food Safety Partnership, this partnership is expanded from produce to include all human food regulated by the FDA. The partnership between the FDA, the National Service of Agro-Alimentary Public Health Safety and Quality (SENASICA) and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), embraces the use of new and emerging technologies to strengthen the Participants’ respective technical and predictive capabilities; leverages food safety programs at SENASICA and COFEPRIS and their work with local industry; and further enhances collaborations with other key partners in the United States and Mexico, among others. To learn more about the new Food Safety Partnership, please click here

 

FDA to Hold Public Meetings to Discuss the Requirements for Additional Traceability Records for Certain Foods: Proposed Rule

October 2, 2020: The FDA will be holding a series of three virtual one-day public meetings to discuss the recently released proposed rule “Requirements for Additional Traceability Records for Certain Foods.” The purpose of the public meetings is to discuss the proposed rule, which was issued under the FDA Food Safety Modernization Act. These public meetings are intended to facilitate and support the public's evaluation and commenting process on the proposed rule.

The public meetings will be held according to the schedule below. For additional information, see the Federal Register Notice announcing the meetings and the Meeting Page to register.

First Virtual Public Meeting - November 6, 2020, 8:30 a.m. – 4:30 p.m. EST

Second Virtual Public Meeting- November 18, 2020, 9:30 a.m. – 5:30 p.m. EST

Third Virtual Public Meeting- December 2, 2020, 11:30 a.m. – 7:30 p.m. EST

Registration is required to attend one of the virtual meetings. Space is limited so please register early.

 

FDA Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety

September 21, 2020: Today, the FDA announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. The FDA also published a draft “Food Traceability List,” which describes the foods that would be subject to the proposed requirements. The list includes leafy greens, fresh cut fruits and vegetables, some types of fish, shell eggs, nut butters, and more. At the heart of the proposal is a requirement for those who manufacture, process, pack, or hold a food on the Food Traceability List (FTL) to establish and maintain records associated with specific Critical Tracking Events (CTEs): growing, receiving, transforming, creating, and shipping. To read the proposed rule, please click here. A constituent update on this proposed rule can be accessed here

 

Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic

August 19, 2020: The FDA and OSHA are providing this checklist for FDA-regulated human and animal food operations to use when assessing operations during the COVID-19 pandemic, especially when re-starting  operations after a shut down or when reassessing operations because of changes due to the COVID-19 public health emergency caused by the virus SARS-CoV-2. Some or all of this checklist may be useful to persons growing, harvesting, packing, manufacturing, processing, or holding human and animal food regulated by FDA. This includes produce, seafood, milk, eggs, grains, game meat, and other raw materials or ingredients, as well as their resulting human or animal food products.To view the press release, please click here. To access the checklist, please follow this link: https://www.fda.gov/media/141141/download 

 
FDA Requests Information on Expansion of the Rarely Consumed Raw List for Uncommonly Consumed Produce

August 6, 2020: Today, the FDA issued a Request for Information (RFI) to open a docket for data and information related to produce that has been known to have no or low reported consumption. The Agency will use the data and information to consider whether any of these produce commodities should be added to the “rarely consumed raw” (RCR) list and thereby exempt from the Produce Safety rule. The items currently on the exhaustive RCR list are not subject to the requirements in the Produce Safety rule. Beginning on Monday, August 10th, the FDA will be collecting information from the public for 90 days and invites those with data, information, and/or comments on consumption of produce that is rarely consumed raw to submit it through the Request for Information (RFI) docket. To access the docket, please use this link: https://www.federalregister.gov/documents/2020/08/10/2020-16800/request-for-information-consumption-of-certain-uncommon-produce-commodities-in-the-united-states

 

FDA Announces New Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water

July 30, 2020: The FDA has announced a new protocol for the development and registration of antimicrobial treatments for preharvest agricultural water, such as the water used in farm irrigation systems. The protocol was developed through a collaboration with the U.S. Environmental Protection Agency. Companies can now use data developed under this protocol to support the EPA registration of products that can treat agricultural water against foodborne bacteria, which could provide farmers with a useful tool to help protect the safety of produce intended for consumers, like romaine lettuce and other leafy greens. To read more about this announcement and the efficacy protocol, please click here

 

FDA Announces FY2021 Fee Rates for Voluntary Qualified Importer Program and Third-Party Certification Program

July 30, 2020: The FDA is announcing the fiscal year (FY) 2021 fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP), and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP). The FSMA FY2021 VQIP user fee rate will be effective on August 1, 2020 and supports program benefits from October 1, 2020 through September 30, 2021. Currently, the agency is not offering an adjusted fee for small businesses. Approved VQIP applicants need to pay the user fee before October 1, 2020 to begin receiving benefits for the 2021 fiscal year. To view the fee rate, please click here

 

The U.S. Food and Drug Administration announced today the re-release of Decoding the Food Code: Information to Assist the User

July 30, 2020: The Food Code and this Decoding the Food Code: Information to Assist the User training module are resources for protecting public health and ensuring food is unadulterated and safe when it is offered to the consumer at retail and in food service establishments. This online training module was designed to help our stakeholders, including all levels of government and industry, understand the structure, nomenclature, and conventions of the Food Code. To view the module, please click here.

 

Food Safety and the Coronavirus Disease Questions and Answers for Industry

July 29, 2020: Today, the FDA updated its “Food Safety and the Coronavirus Disease” webpage of Questions and Answers (Q&A). The Center for Food Safety and Nutrition added a new Q&A item, titled “What do U.S. exporters of FDA-regulated food products need to consider related to COVID-19?”. To read this update, please click here

 

FDA to Hold Webinar Discussion on Leafy Greens Action Plan

July 23, 2020: The FDA will be hosting a webinar on Thursday, July 30, 2020 from 2-3pm EST to discuss the 2020 Leafy Greens STEC Action Plan. The action plan, which was released in March, outlines steps the agency plans to take this year to advance the safety of leafy greens. To read the full update and register for the webinar, please click here

 

Inspections of Small Businesses under the FSMA Intentional Adulteration Rule to Begin March 2021

July 15, 2020: Today, the FDA announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will begin in March 2021. For more information about the IA rule, please click here. For more information about food defense plans, the upcoming compliance date, draft guidance, and other resources are available in an updated conversation piece featuring FDA food defense experts Ryan Newkirk and Jon Woody.

 

FDA Announces the New Era of Smarter Food Safety Blueprint

July 13, 2020: Today the FDA annouced the release of the New Era of Smarter Food Safety blueprint. The New Era of Smarter Food Safety represents a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system. To learn more about the blueprint, please visit the FDA's New Era of Smarter Food Safety webpage

 

Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency

June 4, 2020: The FDA has updated this temporary policy that was issued in March 2020. To view this update, please click here

 

Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency

May 27, 2020: A guidance document for voluntarily notifying FDA-regulated establishments (i.e., human food facilities and farms) of temporary closures and reductions in operation has been released. This guidance also details how to request help from FDA on issues that may affect continuity of operations. To view this guidance, please click here.  

 

FDA Extends Comment Period for Third Installment of the Draft Guidance for the Intentional Adulteration Rule

May 27, 2020: The comment period for the 3rd installment of the draft guidance for the Intentional Adulteration rule has been extended until August 14, 2020. Chapters in the last installment cover topics including food defense corrective actions, food defense verification, reanalysis of food defense plans, and recordkeeping. This section also includes appendices on FDA’s online Mitigation Strategies Database and how a business can determine if it is a small or very small business under the rule. To submit comments, please visit Regulations.gov and comment under docket FDA-2018-D-1398. 

 

FDA Provides Flexibility to Farms Regarding Eligibility for the Qualified Exemption Under the Produce Safety Rule 

May 22, 2020: The FDA has announced that it will provide flexibility on qualified exemptions under the Produce Safety Rule during COVID-19. To read more on this temporary policy, visit: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-during-covid-19-public-health-emergency-regarding-qualified-exemption-standards?utm_campaign=FoodCOVID_Produce_05222020&utm_medium=email&utm_source=Eloqua

 

FDA Extends Application Period for Voluntary Qualified Importer Program to July 31

May 22, 2020- The FDA will be extending the application period for importers to submit their notice of participation and completed application for the Voluntary Qualified Importer Program (VQIP) for FY 2021. To read more on this extension, please click here

 

FDA and USDA Release Recommendations for those in the Food and Agriculture Sector Experiencing Shortages of PPE, Cloth Face Coverings, Disinfectants, and Sanitation Supplies

May 22, 2020- The FDA and USDA have released recommendations to help address shortages of PPE, face coverings, disinfectants, and sanitation supplies in the food and agriculture industry during the COVID-19 pandemic. To read these recommendations, please click here

 

FDA Announces Temporary Flexibility Policy Regarding Certain Labeling Requirements for Foods for Humans During COVID-19 Pandemic

May 22, 2020- The FDA has issued a guidance document to provide temporary flexibility in food labeling requirements to manufacturers and vending maching operators. To read this policy, please click here

 

FDA Publishes Investigation Findings

May 21, 2020: The FDA has published their findings of an investigation into the contamination of romaine lettuce implicated in three outbreaks of E. coli O157:H7 during the Fall of 2019.

 
FDA Update- Produce Safety Rule Translation

May 13, 2020: The FDA has released a Spanish translation of the codified text of the Produce Safety Rule.

 

Produce Safety Press Release

January 6, 2020: The FDA has released an article that emphasizes the importance of produce safety standards 

FDA Update- Enforcement Discretion Policy for Co-Manufacturers under FSMA

November 6, 2019: The FDA has released an update on continuing the enforcement discretion policy for co-manufacturers under the Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs. 

 
FDA Report on Cucumbers

Fall 2019: The FDA has released a report on microbiological surveillance sampling of cucumbers from FY16-17. 

 
PCHF Draft Guidance - Chapter 14 Recall Plans

Fall 2019: The FDA has released the 14th chapter of the draft guidance document for FSMA’s final rule on Preventive Controls for Human Food. This chapter focuses on what is required in the recall plan and resources to assist with preparing the recall plan.

 
FDA Launches the FDA-TRACK: Food Safety Dashboard to track FSMA Progress

September 30, 2019: The FDA has established the FDA-TRACK: Food Safety Dashboard to track the impact, meaure the progress, and assist with implementation of the seven rules that make up FSMA. 

 
Guidance for Industry - Evaluating Alternate Curricula for the Produce Safety Rule 

June 2019: The FDA has provided guidance on what farms should consider when choosing Produce Safety Rule (PSR) training and what educators should consider when creating or evaluating alternate curricula related to the PSR. 

 
Draft Guidance for Industry - Number of Employees for the Purpose of Small Business Definition

June 2019: The FDA has provided guidance for the industry to assist with determining the number of employees for the "small business" definition for Current Good Manufacturing Practices (CGMPs) and FSMA’s Preventive Controls for Animal Food rule and Preventive Controls for Human Food rule. 

Guidance for Industry - Questions and Answers Regarding Mandatory Food Recalls

November 2018: The FDA has released a guidance document related to common questions and answers regarding mandatory food recalls for FSMA. 

 
Draft Guidance for Industry - Food Facility Registration

August 2018: The FDA has developed a guidance document to answer frequently asked questions related to food facility registration requirements for Current Good Manufacturing Practices (CGMPs) and FSMA’s Preventive Controls for Animal Food rule and Preventive Controls for Human Food rule.  

2017

FSMA Compliance Dates

October 23, 2017: The FDA has created a webpage that outlines the compliance dates for each FSMA rule for each facility type.

 

FDA Guidance Documents to help companies with FSMA Compliance

October 19, 2017: The FDA has released two guidance documents intended to help companies come into compliance with FSMA’s Preventive Controls for Animal Food rule and Preventive Controls for Human Food rule. The first document provides companies producing food intended for animal consumption help with ensuring that they are meeting Current Good Manufacturing Practices (CGMPs). The second document explains possible “solely engaged” exemptions for operations that store or transport raw agricultural commodities.


FDA Fact Sheet

September 19, 2017: FDA Commissioner addresses state agriculture commissioners; announces new steps to enhance collaboration with states and ensure farmers are prepared for FSMA. Included in the announcement are: a proposed extension for agricultural water compliance dates; equivalent testing methods for agricultural water; extension of compliance dates for produce farm inspections; training opportunities for producers and regulators.

 

New Steps to Enhance Collaboration With States

September 12, 2017: FDA Commissioner addresses state agriculture commissioners; announces new steps to enhance collaboration with states and ensure farmers are prepared for FSMA. Included in the announcement are: a proposed extension for agricultural water compliance dates; equivalent testing methods for agricultural water; extension of compliance dates for produce farm inspections; training opportunities for producers and regulators.

 

Produce Safety Rule Guidance for Small Businesses 

September 5, 2017: The FDA has released a guidance document designed to help small businesses come into compliance with FSMA’s Produce Safety Rule. This guidance document is part of the FDA’s Small Entity Compliance Guides (SECGs), which seek to help small businesses meet federal standards.

 

PCHF Draft Guidance - Chapter 6 on Heat Treatment

August 30, 2017: The FDA has released the sixth chapter of the draft guidance document for FSMA’s final rule on Preventive Controls for Human Food. This chapter focuses on how to establish a heat treatment method to prevent contamination by disease-causing bacteria.

 

Intenational Adulteration Rule - Guidance for Small Businesses

August 24, 2017: The FDA has released a guide document designed to help small businesses come into compliance with FSMA’s Mitigation Strategies to Protect Food Against Intentional Adulteration rule.

 

FDA's Food Safety Plan Builder

August 22, 2017: The FDA has launched a new software tool, called the Food Safety Plan Builder, to help companies create a food safety plan for their facility that follows FSMA’s Preventive Controls for Human Food rule. This free software application was designed to help smaller businesses that may have limited resources, but can be useful for any sized operation.

 

Guidance Document on Sanitary Transportation - Waivers to the Rule

August 14, 2017: The FDA has released a guidance document for FSMA’s Sanitary Transportation of Human and Animal Food Rule. This guidance document specifically explains the three waivers to the rule, which were originally announced in April.

 

FSMA and Low-Acid Canned Foods, Juice and Seafood

August 7, 2017: FDA has released three new guidelines to help producers already following the FDA’s regulations for low-acid canned foods and juice or seafood HACCP figure out how FSMA affects them.

 

FDA Commissioner Scott Gotlieb's Statement on CAP 

July 19, 2017: FDA commissioner, Scott Gotlieb, released a statement about the $30.9 million the FDA is distributing between 43 states to help implement the produce safety rule. This comes as part of the State Produce Implementation Cooperative Agreement Program (CAP).

 

Three Waivers to FSMA Sanitary Transportation Rule

April 5, 2017: The FDA has announced that there will be three waivers to FSMA’s Sanitary Transportation of Human and Animal Food Rule. These waivers will be offered to businesses whose operations are already following regulations from federal, state, or local entities.

 

FDA Announces Simplification of Ag Water Standards in Produce Safety Rule 

March 20, 2017: The FDA is looking into ways to simplify the standards for agricultural water set by FSMA’s Produce Safety Rule. Feedback the FDA has received shows that some of these standards are too complex to understand and implement effectively. Due to this, the FDA is seeking to simplify the microbial quality and testing requirements of the Produce Safety Rule, while still protecting public health.

 

Produce Safety Rule Guidance for Sprout Growers

January 19, 2017: The FDA has released a draft guidance document to help sprout operations comply with FSMA’s Produce Safety Rule.

 

2016

Guidance on Farms and Facilities Classification 

August 24, 2016: The FDA has released draft guidance documents for FSMA’s Preventive Controls for Animal Food and to help with the classification of activities for farms and facilities. These topics are covered in three draft guidance documents covering: Current Good Manufacturing Practice requirements for animals, human food by-products for use as animal food, and the classification of activities as harvesting, packing, holding, or manufacturing/processing for farms and facilities.