AFDO STRIVES TO PROTECT PUBLIC HEALTH...
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FDA and CDC Investigate Outbreak of Cyclospora in Bagged Salads
The FDA, along with CDC and state and local partners are investigating a multistate outbreak of Cyclospora infections potentially linked to ALDI, Hy-Vee, and Jewel-Osco grocery store brand “garden salads” containing iceberg lettuce, red cabbage, and carrots. This applies only to the store brand salads labeled as “garden salads” and not for other types of store brand packaged salads sold at these retailers. In an announcement on June 19th, the FDA and CDC were recommending that consumers should not eat, and restaurants and retailers should not sell or serve all ALDI Little Salad Bar Brand Garden Salad sold in Iowa, Illinois, Minnesota, and Missouri, all Hy-Vee Brand Garden Salad sold in Iowa, Illinois, Kansas, Minnesota, Missouri, and Nebraska, and Jewel-Osco Signature Farms Brand Garden Salad sold in Illinois. Read the FDA release here.
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Rapid Growth in Food Deliveries Means Regulators Must Clarify Safety Responsibilities
According to The Pew Charitable Trusts’ safe food project, even before the COVID-19 pandemic, food delivery and e-commerce services were rapidly increasing in popularity. Concerns about virus exposure risks have accelerated this trend; deliveries from restaurants and grocery stores—many facilitated by third-party companies such as DoorDash, GrubHub, or Instacart—have soared, and companies that ship meal kits to consumers have reported rising sales. Read more from the Pew Charitable Trust here.
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OTED Virtual Instructor Led Training (vILT) message to States
We at the U.S. Food and Drug Administration, Office of Regulatory Affairs, Office of Training Education and Development (OTED) are pleased to inform you that we are actively working with our subject matter experts and course instructors to transition courses that we previously offered as a face to face classroom experience as virtual instructor led training (known as vILT). See hyperlinked video here for additional context. Introduction to Virtual Instructor Led Training video (7:34 min.)
For the remainder of FY 20 and for FY 21 we will deliver training as vILT. This redeployment of our efforts has impacted our course schedule; however, we are doing our best to meet the needs of our students.
The table provided with this message lists the vILT course offerings through the end of FY 20.
We will issue course announcements in the same manner as before. OTED course announcements will include actual dates and times for vILT course offerings. We will add more course offerings as courses become available to be offered via vILT.
The OTED Training Schedule & Catalog can be found online at https://www.fda.gov/training-and-continuing-education/office-training-education-and-development-oted/oted-training-schedule-catalog.
Thank you for your patience during this transition as we work to develop virtual instructor led training.
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Release of CIFOR Guidelines 3rd edition
On World Food Safety Day, June 7, 2020, the third edition CIFOR Guidelines for Foodborne Disease Outbreak Response was published on the CIFOR website! Due to the impact of COVID-19 response, CIFOR leadership approved the soft launch and promotion of the online version in favor of saving the larger promotions and printed release for the fall of 2020.
The Guidelines incorporate significant changes in the foodborne disease surveillance and outbreak investigation framework since the second edition of the Guidelines was published. The third edition highlights:
· The implementation of whole genome sequencing, advanced molecular detection and culture-independent diagnostic tests
- The integration of consumer complaint systems with pathogen-specific surveillance
- The importance of sub-cluster investigations and epidemiologic tracebacks
- The importance of environmental assessments
- The importance of after-action reviews
- More coordinated inclusion of communications sections.
- Elimination of CIFOR metrics and better referencing of existing program metrics.
The third edition can be accessed here: https://cifor.us/products/guidelines.
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Registration Open for AFDO Virtual Annual Education Conference June 29, 2020
COVID-19 may have canceled the in-person meeting of the AFDO Annual Education Conference but you won't to miss the virtual meeting of the Association the afternoon of Monday, June 29. Sessions will include CBD & Cannabis: An FDA Perspective, presented by Sharon Mayl, Senior Advisor for Policy, U.S. Food and Drug Administration and Cassandra Taylor, Ph.D.,Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
More information about the sessions will be released this week -- watch your email.
The session begins at 1 p.m. EDT.
Register for Monday's session here.
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Save-the-Date: Managing Retail Food Operations
During and After a Pandemic Save
The National Environmental Health Association (NEHA), the National Association of City and County Health Officials
(NACCHO), the Association of Food and Drug Officials (AFDO) and the Partnership for Food Protection (PFP) are pleased to cohost this ninety-minute webinar to discuss lessons learned, best practices implemented, and continuing challenges to conducting retail food inspections during pandemic events. Speakers from FDA, local, and state food programs will share their perspectives and take questions from the audience. We look forward to this opportunity to share information across
the public health community.
Date: July 16, 2020
Time: 12:30PM ET
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White House Office Reviewing FDA Cannabis Guidance
An office that serves President Donald Trump is reviewing a draft cannabis guidance document from FDA—possibly signaling progress in the public health agency’s examination of whether and how to regulate the market for CBD in dietary supplements and other products, though some advocacy groups expressed skepticism that the document is related to the latter issues.
The document, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” is pending before the White House’s Office of Management and Budget (OMB). OMB received the document May 28, approximately one year after FDA held a widely publicized public meeting about products containing cannabis. Read the full article...
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Learn While Supporting the IFPTI Fellows July 17, 24 and 31, 2020
Join IFPTI Fellowship Cohort VIII members as they present their research project presentations over three Fridays in July. These presentations are the culmination of a unique, year-long program for food protection professionals who want to make a positive impact on the profession through association membership, advocacy, and applied leadership.This program takes a multifaceted approach incorporating three on-location week-long sessions, periodic webinars, and a mentor-guided research project. This program is guided by recognized leaders in food protection and focuses on the areas of professional skills, program management, and applied leadership. Learn more about the Fellowship program by listening to this week's AAFDO podcast below.
July 17, 2020 1 p.m. EDT
Summer Williams, Florida Department of Agriculture and Consumer Services, Specialized Tools Used by State Food Protection Regulatory Agencies During Response to Natural Disasters
Laura Wildey, National Environmental Health Association: formerly District of Columbia Department of Health, Challenges and Practices Associated with the Implementation and Enforcement of Cannabis-infused Food Product Regulations
Joshua Lopez, New York State Department of Agriculture and Markets, Cold Brew Coffee Regulations and Policies
July 24, 2020 1 p.m. EDT
Melanie Marquez, Minnesota Department of Agriculture, Consumer Perceptions on the Impact of Pet Food on Human Health
Charlotte Detmer, Illinois Department of Agriculture, A retrospective study of farm use of insecticides containing piperonyl butoxide prior to violative residue levels detected in livestock carcasses sampled for the fiscal years 2017-2019 FSIS National Residue Program
Robert Leuer, Minnesota Department of Agriculture, Relationships Between Violative Conditions Observed at Medicated Feed Manufacturers Inspected by the Minnesota Department of Agriculture; Commercial Feed Program
July 31, 2020 1 p.m. EDT
Kathleen Close, FDA, Evaluation of Performance Factors Rated “Needs Improvement” From Field Inspection Audits
Leonid Levchenko, New York State Department of Agriculture and Markets, Major Food Safety Challenges Associated with Retail Sushi Operations
Michael Otzelberger, City of Milwaukee Health Department, Food Safety Risk Factors at the City of Milwaukee, WI, Temporary Events
Rhiannon Pomerville, Health Department of Northwest Michigan, Identifying Post-Standardization Performance Challenges of Food Sanitarians within Michigan’s Local Health Departments
Register for one or all three below.
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Podcast: IFPTI Fellowship Program Offers Opportunities, Leadership Skills
Last week the AFDO Podcast introduced you to IFPTI. A few weeks before the COVID-19 crisis hit, we interviewed Jerry Wojtala, Executive Director of International Food Protection Training Institute or IFPTI to learn more about the Institute in addition to the IFPTI Fellowship program. The Fellowships are a unique, year-long program for food protection professionals who want to make a positive impact on the profession through association membership, advocacy, and applied leadership. This program takes a multifaceted approach incorporating three on-location week-long sessions, periodic webinars, and a mentor-guided research project. This year those poster sessions will be done virtually -- more information is above. For more about the Fellowship program and how to apply, check out Wojtala's video and audio interviews here.
You can access the AFDO podcast catalog at the following links. Videos can be found at https://afdo.podbean.com/ and audio podcasts at https://afdoaudio.podbean.com/. Or download the AFDO app (IT'S FREE) so you can listen or watch on the go. The app is available for iPhone and Android.
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FDA Extends Comment Period for Third Installment of the Draft Guidance for the Intentional Adulteration Rule
The U.S. Food and Drug Administration is extending the comment period for the third installment of the draft guidance designed to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule under the FDA Food Safety Modernization Act (FSMA).
The Agency released the third installment of the draft guidance in February 2020. Since that time, FDA has received a request for extension to allow stakeholders sufficient time to provide comprehensive feedback. The comment period will be extended until August 14, 2020.
This last installment of the IA rule draft guidance adds to the previously published revised draft guidance. Chapters in the last installment cover topics focusing on food defense corrective actions, food defense verification, reanalysis of food defense plans, and recordkeeping; it 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.
Comments can be submitted electronically via Regulations.gov to docket FDA-2018-D-1398
For More Information
Food Safety Preventive Controls Alliance (FSPCA) Training Materials and Courses
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Call for AFDO Committee Charges for 2020/2021
AFDO is looking for recommendations for 2020/20201 committee charges. If you have any suggestions, please submit your recommendations by Friday, June 19, 2020.
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Food Safety Oversight Strengthened by Root Cause Analysis
Governments around the globe are observing the second annual World Food Safety Day on this Sunday, June 7 to promote collective and individual actions to ensure a safe food supply. To mark the occasion, The Pew Charitable Trusts spoke with three veteran public health officials who have encouraged the use of root cause analysis (RCA) to improve food safety. Included is AFDO's Executive Director Steven Mandernach. Read more here....
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FSIS Posts After-Action Review Report for Foodborne Listeria Monocytogenes Outbreak
FSIS has posted on its website an after-action review report for the investigation of a 2017–2018 outbreak of Listeria monocytogenes illnesses associated with ready-to-eat, country-cured ham. During April–November 2018, public health officials from Virginia, North Carolina, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and FSIS investigated an outbreak of four reported L. monocytogenes illnesses linked to ready-to-eat country-cured ham manufactured at an FSIS-regulated establishment.
This was the first reported multistate outbreak of listeriosis associated with an FSIS-regulated product since 2005. Whole genome sequencing (WGS) was instrumental in detecting this outbreak and determining its source. The investigation revealed that production practices may have led to cross-contamination and that the cooking of the product may have been insufficient to address L. monocytogenes.
In response to this outbreak, FSIS plans to update Directive 10,240.4, Verification Activities for the Listeria monocytogenes Regulation and the Ready-to-Eat (RTE) Sampling Program. Additionally, FSIS added a related study to its Food Safety Research Priorities on the FSIS website and plans to update its “Appendix A” cooking guidance in 2020.
To view the full report, please visit https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/foodborne-outbreak-investigation/outbreak-lm-ham-2018.
The purpose of FSIS after-action review reports is to share lessons learned with industry and public health partners from outbreak investigations to help prevent illness and improve response. To view additional reports and learn more about outcomes of FSIS outbreak investigations, please visit https://www.fsis.usda.gov/OutbreakOutcomes.
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IAFP Explores Food Safety Culture in Series of Webinars With Expert Panels
Anyone interested in the culture of food safety is invited to attend a series of free webinars with panels of international presenters and organized by the International Association for Food Protection.
The non-profit group has thousands of members worldwide, including government leaders and employees, academics, industry representatives and others interested in food safety.
The free webinar sessions are free and open to the public, but registration is required.
The series begins May 26 and wraps up on July 22. Check out all of the webinars in the series
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AFDOSS Mary Logan Scholarship
The AFDOSS Board regrets to announce the cancellation of the 2020 Fall Conference scheduled for September in Gatlinburg. Some of the affiliate’s annual activities will continue as planned (see below about the Mary Logan scholarship), while others will be on hold until next year. Please mark your calendars now for the AFDOSS AEC 2021 in Asheville, North Carolina (Sept. 12-15, 2021; the Crowne Plaza in Asheville is booked!), and there is a contract to return to the Park Vista Doubletree in Gatlinburg in Sept. 2022.
As of this month, AFDOSS has opened the 2020-2021 Mary Logan Scholarship Application process, with applications accepted through July 15. Once the Scholarship Committee has reviewed applications and determined if there is an appropriate candidate to select, the $4,500 annual scholarship award will be awarded for the 2020-2021 school year. More details can be found here, and the new online scholarship application is available here: https://forms.gle/hw5PtC8AmwSJQ6M59 (please share with potential applicants you know in the SE region!).
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FDA Continues to Answer COVID-19 Questions & Update Documents
The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) continue to released responses for questions of interest to AFDO members regarding COVID-19. These answers can be found here.
It's important to check back frequently for the latest as well as visit the AFDO COVID-19 Resource Page.
This is in addition to updating its COVID-19 Frequently Asked Questions page to include guidance regarding food products. Real time updates of the FDA's Food Safety and the Coronavirus Disease 2019 (COVID-19) page can be found at https://www.fda.gov/food/food-safety-during-emergencies/food-safety-and-coronavirus-disease-2019-covid-19. Updates are dated so you are able to tell what information has been added each time.
As part of the AFDO commitment to providing information and resources to members and the those we serve, we continue to add resources to the COVID-19 Resource Page. We continue to offer links to information that has been developed by our partnerships and other subject matter experts. If you identify resources that should be considered or your organization develops some of your own that can be shared with other members, please email them or the link to bbenschoter@afdo.org. We appreciate everyone who helps us be more prepared.
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FDA Publishes Report with Key Investigation Findings From 2019 Outbreaks Associated with Leafy Greens
Today, the U.S. Food and Drug Administration published the findings of an investigation into the contamination of romaine lettuce implicated in three outbreaks of E. coli O157:H7 during the Fall of 2019.
Late last year the FDA, the Centers for Disease Control and Prevention and state partners investigated the contamination of romaine lettuce with several strains of E. coli O157:H7 that resulted in three outbreaks of foodborne illness traced back to the Salinas Valley growing region in California. These outbreaks -- two multi-state and one single-state beginning in September and ending in December 2019 -- collectively resulted in 188 people falling ill.
Please see below for further information,
Constituent Update,
https://www.fda.gov/food/cfsan-constituent-updates/fda-publishes-report-key-investigation-findings-2019-outbreaks-associated-leafy-greens
Statement,
https://www.fda.gov/news-events/press-announcements/fda-releases-report-investigation-fall-2019-outbreaks-illnesses-tied-romaine-lettuce
Investigation Report,
https://www.fda.gov/food/outbreaks-foodborne-illness/factors-potentially-contributing-contamination-romaine-lettuce-implicated-three-outbreaks-e-coli
The investigation was conducted at several farms identified in the outbreak traceback, as well as at other businesses and public access areas and resulted in several key findings:
- Each of these three outbreaks, identified in the report as Outbreaks A, B and C was caused by distinctly different strains of E. coli O157:H7 as determined by whole genome sequencing (WGS) analysis;
- Traceback investigations of multiple illness sub-clusters and supply chain information identified a common grower with multiple ranches/fields which supplied romaine lettuce during the timeframe of interest to multiple business entities associated with all three outbreaks.
- The same strain of E. coli O157:H7 that caused Outbreak A was found in two different brands of fresh-cut salads containing romaine lettuce in 2019;
- This same outbreak strain of E. coli O157:H7 in Outbreak A was detected in a fecal--soil composite sample taken from a cattle grate on public land less than two miles upslope from a produce farm with multiple fields tied to the outbreaks by the traceback investigations;
- Other strains of Shiga toxin-producing E.coli (STEC), while not linked to any of the outbreaks, were found in closer proximity to where romaine lettuce crops were grown, including two samples from a border area of a farm immediately next to cattle grazing land in the hills above leafy greens fields and two samples from on-farm water drainage basins.
The FDA considers adjacent or nearby land use for cattle grazing as the most likely contributing factor associated with these three outbreaks. While the agency could not confirm a definitive source or route(s) of contamination of the romaine fields, the agency considers indirect transmission of fecal material from adjacent and nearby lands from water run-off, wind, animals or vehicles to the romaine fields, or to the agricultural water sources used to grow the romaine, as possible routes of contamination.
These findings, together with the findings from earlier leafy greens outbreaks, suggest that a potential contributing factor has been the proximity of cattle—a persistent source of E. coli O157:H7 and other STEC—to the produce fields identified in traceback investigations. These key findings reinforce our concern about the possible impacts of nearby and adjacent land use on the safety of leafy green crops and further underscore the importance of implementing appropriate risk-based preventive measures to reduce the potential for contamination of leafy greens.
Because of the reoccurring nature of outbreaks associated with leafy greens, the FDA recently released a 2020 Leafy Greens STEC Action Plan, which outlines a three-pronged approach for tackling this problem. It describes the FDA’s plans for working with industry, federal partners, state and local regulators, academia and others to address the safety of leafy greens by advancing work in three areas: prevention, response, and addressing knowledge gaps.
Food safety is a shared responsibility that involves food producers, distributors, manufacturers, retailers, and regulators. FDA is committed to working with these stakeholders to implement this action plan to ensure that America’s food supply remains among the safest in the world.
For More Information
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Virginia - Manufactured Food Regulatory Program Standards Coordinator
The Virginia Department of Agriculture and Consumer Services is seeking a qualified Manufactured Food Regulatory Program Standards Coordinator with the Food Safety Program. The successful candidate will be responsible for planning, coordinating and executing all activities under the Manufactured Food Regulatory Program Standards (MFRPS) FDA Cooperative Agreement; ensuring the Program’s conformance with all of the MFRPS; performing audits of inspections and compliance activities to ensure uniform and consistent application of all laws, regulations, policies and procedures; supervising staff and coordinating training so that program infrastructure improvements are developed; and preparing budgets and financial reports to ensure resources and spending are within the budget limits of the MFRPS grant. This position requires that the incumbent be able to respond to emergency situations and other possible situations during both traditional and non-traditional hours. This is a restricted position that has been developed as part of a Cooperative Agreement with the Food and Drug Administration and will last until June 30, 2023; however, the cooperative agreement has the potential for continuation. Read more and/or apply...
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Other Training Opportunities
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Preventive Controls for Human Foods and Foreign Supplier Verification Programs
Intentional Adulteration Conducting Vulnerability Assessments (IAVA) – 1 Day
Course Information/Schedule Page
Preventive Controls for Human Foods Course (PCQI) – 3 Day
Course Information/Schedule Page
Preventive Controls for Human Foods Course (PCQI) Blended Course Part 2 – NEW
Course Information/Schedule Page
Foreign Supplier Verification Programs Course (FSVP) – 2 Day
Course Information/Schedule Page
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The Food Safety Doctor LLC
Promoting Public Health and Food Safety through Training and FSMA Awareness
While sheltering in place, The Food Safety Doctor LLC is offering
- ONLINE Preventive Controls for Human Foods (PCQI) Courses
- July 21 – 23
- September 8-9
- October 13-15
- ONLINE Foreign Supplier Verification Courses (FSVP-QI) Courses
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Laws and Regulations Committee Updates
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Laws and Regulations Committee Update
A collection of current food, drug, device, and consumer product regulatory issues and news
June 12 - 15, 2020
June 16 - 17, 2020
June 18 - 19, 2020
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