This draft guidance provides FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived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 With this draft guidance, FDA intends to respond to questions raised by stakeholders, including some raised during a public hearing held last year.

The draft guidance covers topics such as sources of cannabis, information on quality considerations and background on calculating percent delta-9-tetrahydrocannabinol (THC) to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 Finally, the draft guidance introduces key FDA regulatory concepts to stakeholders who may be less familiar with FDA, or our authorities, than other drug developers.

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) published 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. 

AFDO Executive Director Steven Mandernach was featured on the Food Safety Matters Podcast this week discussing the release of FDA’s New Era of Smarter Food Safety Blueprint.   The podcast can be accessed here and also includes a new update and extensive discussion on finding and destroying Listeria (https://www.foodsafetymagazine.com/podcast/ep-76-joe-stout-seek-destroy-listeria-foxhole/ )

Mandernach was also featured in the Ovation Up podcast discussing 5 tips on sanitation and navigating the new normal with retail foods with COVID-19. Check it out! 

On July 27, 2020, AFDO released a Request for Information (RFI) for the System for Agriculture, Food, Health, E-inspections and Registration (SAFHER) platform. This RFI will assist AFDO and states in validating the proposed requirements and architecture of the new platform as well as possibly challenge the concepts described. A key objective is for the RFI to help with narrowing down the core and state costs for this platform. Since the RFI is not a procurement opportunity, IT vendors were provided high level requirements but not all of the almost 700 requirements were listed in the document. 
 
The RFI submission process will close on August 24th, 2020 at 5 PM ET York, PA time. The hope is to have enough feedback on the platform to develop a more in-depth Request for Proposal (RFP) to officially procure a vendor to develop and implement SAFHER. 
 
The RFI and Cost Estimation sheet are both listed on the AFDO website. A comprehensive list of vendors was contacted about the release of the RFI and we look forward to reading their responses. 

A new training module on AAFCO's 2018 resource GOOD Test Portions is now available. This presentation provides audio instruction on key messages from GOOD Test Portions, including the importance of establishing sample quality criteria, choosing the correct sampling tool and making inferences. A transcript is also available.

AOAC INTERNATIONAL (AOAC) announces the availability of the following draft Standard Method Performance Requirements®(SMPRs®) for public comment:

• Mycotoxin Screening Technique in Cannabis plant material and cannabis derivatives
• Detection of Shiga toxin-producing Escherichia coli in Cannabis and Cannabis Product

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 the outcomes of FSIS outbreak investigations, please visit https://www.fsis.usda.gov/OutbreakOutcomes.

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

The EPA-approved protocol can be used to evaluate the effectiveness of treatments in reducing microbial contamination in agricultural water.

Today, the U.S. Food and Drug Administration 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.

The announcement was made during a webinar on the FDA's 2020 Leafy Green STEC Action Plan.

"This new protocol is a huge milestone for produce safety and for the Leafy Green Action Plan released by the FDA earlier this year. Working together, the FDA and EPA have supported the development of this protocol that may ultimately help farmers address contamination issues in their water sources and protect consumers from foodborne illness," said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas. "We must all work together to help ensure the safety of produce to consumers across the country. We will continue to work with our partners in industry, government and academia on this and other longer-term studies on the ecology of human pathogens in specific growing regions, and new efforts as part of the New Era of Smarter Food Safety Initiative." 

"Thanks to the strong partnership between EPA and the FDA, we can now unleash the innovation needed to develop treatment products for the agricultural water used to irrigate our nation's leafy greens," said Alexandra Dapolito Dunn, assistant administrator of EPA's Office of Chemical Safety and Pollution Prevention. "We look forward to working with pesticide product manufacturers, innovators, and farmers on this important development that will help protect public health and our environment."

EPA's approval of this protocol allows for companies to develop data on the effectiveness of their products in inactivating foodborne bacteria, such as E. coli or Salmonella, in preharvest agricultural water. Companies may use the data developed to support registration of new treatment products, or amendments to current products' labels, for use against microbial contamination in preharvest agricultural water.

Recent outbreaks of foodborne illness associated with the consumption of romaine lettuce and other leafy greens have highlighted the need for a viable option for treating agricultural water against foodborne pathogens. While farmers are not required to treat their agricultural water, these treatments could be a valuable tool to help farmers protect the safety of their produce. There currently are no registered antimicrobial treatment products that are authorized for use on agricultural fields, or for treatment of irrigation water systems or ponds. This protocol is an important step toward addressing this lack of available treatments for preharvest agricultural water.  

Teams of FDA experts have been working collaboratively with partners in the public and private sectors to help protect agricultural water from the many ways it can be contaminated in the environment or from unsanitary practices on a farm. This effort has included hundreds of farm visits over the past few years. In addition, the FDA intends to release a proposed rule in late 2020, to revise certain agricultural water requirements in the Produce Safety Rule and to address practical implementation challenges while protecting public health. The development and approval of this treatment protocol is one of several steps the agency has taken or intends to take to help improve produce safety, such as through the Leafy Green Action Plan and the New Era of Smarter Food Safety initiative.

Additional Resources:
 
• Efficacy Protocol for Reduction of Foodborne Bacteria in Preharvest Agricultural Water 
• New Era of Smarter Food Safety Initiative 
• Leafy Green STEC Action Plan
 

FDA Announces Outbreak Investigation of Salmonella Newport: Red Onions (July 2020

The FDA, along with CDC and state and local partners, is investigating a multistate outbreak of Salmonella Newport infections. FDA’s traceback investigation is ongoing but has identified Thomson International, Inc. of Bakersfield, CA as a likely source of potentially contaminated red onions. Although the investigation has determined that red onions are the likely source of this outbreak, Thomson International, Inc. has notified FDA that it will be recalling all varieties of onions that could have come in contact with potentially contaminated red onions, due to the risk of cross-contamination. This recall would include red, white, yellow, and sweet onions from Thomson International, Inc. Recall information will be made public as soon as it is available from Thomson International, Inc.

The investigation is ongoing to determine the source of contamination and if additional products are linked to illness. Additional information will be provided as it becomes available.

Recommendations
Advice for consumers, restaurants, and retailers: Consumers, restaurants, and retailers should not eat, sell, or serve red, white, yellow, or sweet onions from Thomson International, Inc. or products containing such onions. If you cannot tell if your onion is from Thomson International Inc., or your food product contains such onions, you should not eat, sell, or serve it, and should throw it out.

FDA recommends that anyone who received or suspects having received onions from Thomson International, Inc. use extra vigilance in cleaning and sanitizing any surfaces and containers that may have come in contact with these products to reduce the risk of cross-contamination. This includes cutting boards, slicers, countertops, refrigerators, and storage bins.

Consumers who have symptoms of Salmonella infection should contact their health care provider. Most people with salmonellosis develop diarrhea, fever, and abdominal cramps. More severe cases of salmonellosis may include a high fever, aches, headaches, lethargy, a rash, blood in the urine or stool, and in some cases may become fatal.

Suppliers and Distributors: Suppliers, distributors and others in the supply chain should not use, ship or sell red, white, yellow, or sweet onions from Thomson International, Inc. or food products containing such onions. Suppliers and distributors that re-package raw onions should use extra vigilance in cleaning any surfaces and storage areas that may have come into contact with onions from Thomson International, Inc. If there has been potential cross contamination or mixing of onions from other sources with onions from Thomson International, Inc., suppliers and distributors should discard all comingled and potentially cross-contaminated product.

 Investigation Update
July 31, 2020
The FDA, along with CDC and state and local partners, is investigating a multistate outbreak of Salmonella Newport infections. The Public Health Agency of Canada is also investigating an outbreak of Salmonella Newport illnesses that have a genetic fingerprint closely related to the U.S. outbreak.

Investigators in the U.S. and Canada have been collaborating to identify the source of this outbreak. On July 30, 2020, Canadian health officials announced that they had determined red onions from the U.S. to be the potential source of the Canadian outbreak. The Canadian investigation has also prompted a recall (External Website Disclaimer) by the Canadian Food Inspection Agency.

Building on this information, and on epidemiologic information on the U.S. outbreak from CDC, the FDA’s traceback investigation was able to identify Thomson International, Inc. as a likely source of contaminated red onions in the U.S.

Product Recall
Thomson International, Inc. has notified FDA that it will be recalling all varieties of onions that could have come in contact with potentially contaminated red onions, due to the risk of cross-contamination. This recall would include red, white, yellow, and sweet onions from Thomson International, Inc. Recall information will be made public as soon as it is available from Thomson International, Inc.

View the entire announcement on the outbreak investigation

Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products 

Agency Urges Consumers, Health Care Professionals Not to Use Certain Products, Citing Serious Adverse Events and Death

The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has also taken additional action to help prevent certain hand sanitizers from entering the United States by placing them on an import alert. The FDA is proactively working with manufacturers to recall products and is encouraging retailers to remove products from store shelves and online marketplaces. As part of these actions, a warning letter has been issued to Eskbiochem S.A. de C.V. regarding the distribution of products labeled as manufactured at its facilities with undeclared methanol, misleading claims –including incorrectly stating that FDA approved these products—and improper manufacturing practices. 

Read more....

FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging

Today, the U.S. Food and Drug Administration is announcing that the manufacturers of certain per- and polyfluoroalkyl substances (PFAS) used for grease-proofing in paper and paperboard for food packaging (for example, as coatings on some fast-food wrappers, to-go boxes, and pizza boxes) have voluntarily agreed to phase-out their sales of these substances for use as food contact substances in the United States. This action follows new analyses of data that raised questions about potential human health risks from chronic dietary exposure – findings that warrant further study. This phase-out balances uncertainty about the potential for public health risks with minimizing potential market disruptions to food packaging supply chains during the COVID-19 public health emergency.

Earlier this year, FDA scientists published their analyses of studies on certain PFAS used in food packaging. Their analyses of data from rodent studies raised questions about a subset of short-chain PFAS that contains 6:2 fluorotelomer alcohol (6:2 FTOH) because of evidence of biopersistence of 6:2 FTOH. While the findings were from studies in rodents, and at higher doses than we would expect in humans, the data suggest the potential of 6:2 FTOH to also persist in humans from chronic dietary exposure. Further scientific studies are needed to better understand the potential human health risks from dietary exposure to food contact substances that contain 6:2 FTOH. Read more....

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

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. 

Did You Miss Them?  IFPTI Fellows Presentations Now Available On Demand

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 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

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

2020 Food Safety Summit Goes 100% Virtual

Division Chief, Environmental Public Health - Tulsa

Food Safety Job - Virginia 

Preventive Controls for Human Foods and Foreign Supplier Verification Programs 

EAS Consulting Group Training 

The Food Safety Doctor LLC 

• ONLINE Preventive Controls for Human Foods (PCQI) Courses
  • August 4-06
  • August 25-27
  • September 8-10
  • October 13-15
  • November 3-5

• ONLINE Foreign Supplier Verification Courses (FSVP-QI) Courses
  • August 11 -12
  • September 22-23
  • October 20-21
  • November 17-18

• Intentional Adulteration Vulnerability Qualified Individuals (IAVA-QI) Courses
  • Singapore:  November, 9 2021

Click here to access the schedule of IAVA-QI courses

Laws and Regulations Committee Update

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