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Cannabis Quality Considerations for Research Guidance for Industry

This draft guidance provides FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. With this draft guidance, FDA intends to respond to questions raised by stakeholders, including some raised during a public hearing held last year.

The draft guidance covers topics such as sources of cannabis, information on quality considerations and background on calculating percent delta-9-tetrahydrocannabinol (THC) to provide clarity in response to a recent legislative change related to hemp. Finally, the draft guidance introduces key FDA regulatory concepts to stakeholders who may be less familiar with FDA, or our authorities, than other drug developers. 
Submit Comments

McEntire Promoted at United Fresh Produce

Last Thursday, United Fresh Produce Association announced the promotion of Dr. Jennifer McEntire to the position of Senior Vice President, Food Safety & Technology. Dr. McEntire joined the association four years ago, bringing her extensive background in food safety, regulatory issues, and association management to the United Fresh Team.  Read more here.

Fairs Find Ways to Promote Local Agriculture Despite Cancellations

There are many food safety risks associated with fairs and carnivals; mobile and temporary vendors can lack clean workstations, there aren’t always sinks for employees to wash their hands or even gloves for employees to use when handling food, and vendors might not have refrigeration on-site for raw ingredients or precooked foods. Read the story in Food Safety News.

Podcast: Food Repackaging More Critical and Doable in COVID-19 Crisis

This week's AFDO Podcast addresses the impact of COVID-19 on bulk repackaging events that have become even more critical during the pandemic.We visited virtually with Topher Philgreen with Something to Eat in the Kansas City area, about adjustments that have allowed repackaging events to continue to support at risk families. 

Last year the Association of Food & Drug Officials (AFDO) pubished the Bulk Repacking of Non-Ready-to-Eat Dry Product for Charitable Distribution guide, providing a simplified set of standard operating practices designed to provide safe packing conditions. This guide is available at www.afdo.org/publications . 
 
A Conversation with Topher Philgreen, Something to Eat, about Bulking Food Repacking During COVID-19  Check out Philgreen'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. 

2020 Food Safety Summit Goes 100% Virtual

 
BNP Media has announced that the 2020 Food Safety Summit will be a virtual experience instead of an in-person event. The Summit team is working closely with the Educational Advisory Board to offer an in-depth conference program offering real world business solutions for today and planning for tomorrow. The virtual Summit will feature the world's leading authorities examining the most up-to-date innovations in the food industry. The education program, access to participating exhibitors, and networking opportunities will be live online from Monday, October 19 - Thursday, October 22. To register to attend visit www.foodsafetysummit.comRead more about the decision here. 

 

Happiness Is a Safe Meal

BAC Fighters, put your skills to the test! Take your best main dish — the one everyone requests — and enter it in the 30-Minute Meals Safe Recipe Contest
 
It's easy to enter:
 
  1. Use the Safe Recipe Style Guide to write your recipe instructions.
  2. Prepare your dish and take a high-quality photo.
  3. Submit your entry online.
 
Winning entries will help create an online cookbook full of delicious, safe recipes launching in September.
 
Early Bird Entries received TODAY will be entered into a drawing to win a $10 Amazon Gift Card!
 
Contest deadline is Monday, August 17. You may enter up to two recipes per household.
 
This contest is part of our commitment to make every recipe a safe one. Good luck!
Enter the Contest

Time to Build Your Safe Recipe!

You’re invited to join us for the first-ever virtual cooking event Ready, Set, Cook it Safe! on Thursday, Sept. 24 at 5 p.m. Eastern, benefiting the Partnership for Food Safety Education’s efforts to help families stay healthy by practicing safe food handling. 

Register Now

FSIS Posts After-Action Review Report for Foodborne E. coli O157:H7 Outbreak 

FSIS has posted on its website an after-action review report for the investigation of a 2019 outbreak of E. coli O157:H7 illnesses associated with ground beef. Public health officials in Oregon and Washington states, the Centers for Disease Control and Prevention (CDC), and FSIS investigated an outbreak of five confirmed E. coli O157:H7 illnesses linked to ground beef produced by multiple retailers. The findings of this outbreak investigation highlight the need for continued illness-prevention efforts in three areas: (1) Retailers and official establishments that grind beef are required to maintain complete and accurate grinding records (9 CFR 320.1(b)(4)); (2) retailers and FSIS-regulated establishments that produce beef should address the risk of E. coli O157:H7, including taking steps to ensure that beef is being used as intended; and (3) consumers should fully cook ground beef.
 
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-ecoli-ground-beef-2019.
 
The purpose of FSIS outbreak investigation after-action review reports is to share lessons learned with industry and public health partners 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.

FDA In Brief: FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research

The following quote is attributed to FDA Principal Deputy Commissioner Amy Abernethy M.D., Ph.D.:
 
“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area.
 
“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis. The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.
 
“The agency is committed to supporting the development of these new drugs through the investigational new drug, drug review and drug approval processes – and one key element of this support involves development of guidance, like this one.” Read more....

 IFPTI Fellows Presentations Wrap Up on July 31, 2020 

There is one Friday left. Join IFPTI Fellowship Cohort VIII members as they present their research project presentations. 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.  

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 the remaining session below.

IFPTI COHORT PRESENTATIONS Friday, July 31

In case you missed them -- the IFPTI sessions are available as a recording.  

Now you can watch at your convenience! 

July 17, 2020 Presenters

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 LopezNew York State Department of Agriculture and MarketsCold Brew Coffee Regulations and Policies

View July 17th Recording Here

July 24, 2020 Presenters

Melanie Marquez, Minnesota Department of Agriculture, Consumer Perceptions on the Impact of Pet Food on Human Health

Charlotte Detmer, Illinois Department of AgricultureA 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 AgricultureRelationships Between Violative Conditions Observed at Medicated Feed Manufacturers Inspected by the Minnesota Department of Agriculture; Commercial Feed Program

View July 24th Recording Here

Allergen Removal and Transfer Using Wiping and Cleaning Methods in Retail Food Establishments

The FDA is announcing the publication of the manuscript Allergen Removal and Transfer with Wiping and Cleaning Methods Used in Retail and Food Service Establishments.
    
The FDA conducted a study to investigate the impact of existing recommendations for wiping and cleaning food-contact surfaces on removal and transfer of food allergens. This study investigated:

  1. allergen removal from surfaces by wiping with paper wipes, terry cloths and alcohol/quaternary ammonium chloride (quat) sanitizing wipes;
  2. cleaning of allergen-contaminated surfaces using a wash-rinse-sanitize-air dry procedure; and
  3. allergen transfer from contaminated wipes to multiple surfaces.  

Food-contact surfaces (stainless steel, textured plastic and maple wood) were contaminated with peanut-, milk- and egg-containing foods, and subjected to various wiping and cleaning procedures.
   
FDA has developed a Fact Sheet with the study’s key findings.
A copy of the full article is available via open access in the Journal of Food Protection

Upcoming AFDO Professional Development Webinars: 

AFDO Professional Development Series Part 2: Food Delivery The Good, The Bad, And The Ugly!!! What You Need To Know!

Session Introduction – Traci (Slowinski) Michelson, Senior Manager, QA & Food Safety for Brinker International

Ice Breaker and Intro Polls – Tara (Paster) Cammarata, President & CEO of Paster Training, Inc.

Expert Panel:

  • Dilshika Wijesekera, Director, Food Safety and Regulatory Compliance at Instacart
  • Helen Kor, Sr Director, Regulatory Affairs for Blue Apron
  • Anthony Affray, Director, Global Product/Food Safety and Compliance at Amazon
See the detailed agenda here.

Date: July 28, 2020
Time: 2:00PM - 3:30PM EDT

 
Register Now

FDA Continues to Answer COVID-19 Questions 



The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) continue to release 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-19Updates 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 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 Updates 

Seafood Guidance developed by the CDC and OSHA, in consultation with the FDA

Seafood processing worksites (i.e., factories that are located in plants onshore and in vessels offshore) are a component of the critical infrastructure within the Food and Agriculture Sectorexternal icon. CDC’s Critical Infrastructure Guidance advises that critical infrastructure workers may be permitted to continue work following potential exposure to SARS-CoV-2, the virus that causes COVID-19, provided they remain asymptomatic, they have not had a positive test result for COVID-19, and additional precautions are implemented to protect them and the community. Facilities that are not part of the critical food and agriculture sector should follow the CDC Public Health Recommendations for Community-Related Exposure following workers’ potential exposure to SARS-CoV-2.
 
Please see below for further information,
https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-seafood-processing.html

FDA Redoubles Call to Action for Papaya Industry to Keep Consumers Safe from Foodborne Illness

Today, the U.S. Food and Drug Administration issued a second letter to papaya growers, harvesters, packers, distributors, exporters, importers and retailers outlining a series of steps that can be taken to prevent recurring outbreaks of Salmonella linked to papayas.
 
Please see below for further information,
 
https://www.fda.gov/food/cfsan-constituent-updates/fda-redoubles-call-action-papaya-industry-keep-consumers-safe-foodborne-illness
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Job Opportunities 

Food Safety Job - Virginia 

The Virginia Department of Agriculture and Consumer Services is seeking a Manufactured Food Specialist within the agency’s Food Safety Program. This position ensures that food products and dietary supplements in Virginia are safe by providing guidance and technical advice to consumers and the food industry. The successful candidate will assist the Manufactured Food Regulatory Program Standards (MFRPS) Coordinator with conformance and maintenance of all MFRP Standards. Duties include assisting the MFRPS Coordinator to ensure that all of the outcomes and deliverables specified in the MFRPS FDA Cooperative Agreement are adhered to and met; working with home based food manufacturing operations and small food producers to address issues in labeling, processing, and general food safety; gathering information necessary to conduct the facility inspections; and evaluating the condition of food manufacturing facilities relative to food safety. Additional duties include conducting audits of inspection reports and of sample collection forms; preparing various reports and documents; maintaining an assortment of files and records; and coordinating outreach efforts in order to protect public health and educate industry partners. 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 July 30, 2023; however, the cooperative agreement has the potential for continuation.
 
Read more and/or apply....

Food Safety Job - Virginia 

The Virginia Department of Agriculture and Consumer Services is seeking a self-motivated person to become part of our Food Safety team. This position is responsible for the evaluation of food processes and the enforcement of the Virginia Food Laws and related federal and state regulations. Duties include evaluating the condition of food processing facilities relative to food safety and food defense; assisting new and existing food processing technologies and food labeling at manufacturing operations and retail food establishments; investigating complaints; conducting foodborne illness investigations; collecting official samples of food and food related products; reviewing new food business proposals and assisting in the development of safe food processes; and evaluating and interpreting nutritional related claims for foods and dietary supplements.
 
The selected individual will establish and work from a home office under the guidance and direction of a regional field office and will be required to live in or convenient to the assigned territory. The home office must have reliable access to a network for mobile communications. The work territory includes Newport News, Hampton, and York County. The use of a state vehicle will be provided for business use only.

 
Read more and/or apply....

Other Training Opportunities

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
 

EAS Consulting Group Training 


EAS Consulting Group Offers Complimentary Webinar Best Practices for Food Manufacturers, Restaurants and Food Distributors During the COVID-19 Pandemic – Conducted in Spanish

Low Acid Canned Food and Acidified Foods Current Topics for the Food Industry
July 28, 2020

Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar
September 29-30, 2020 • Dallas, TX

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  
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Laws and Regulations Committee Updates 

Laws and Regulations Committee Update

A collection of current food, drug, device, and consumer product regulatory issues and news


July 20 - 21, 2020
July 22 - 23, 2020
July 24, 2020
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Copyright © 2020 Association of Food and Drug Officials, All rights reserved.


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