AFDO STRIVES TO PROTECT PUBLIC HEALTH...
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Salmonella Cases Linked to Onions Increase to Nearly 900
A salmonella outbreak linked to onions has expanded to 43 states and Canada, prompting a recall from a producer in California and various grocery chains, health officials said. Grocery chains, including Publix and Giant Eagle, have recalled onions supplied by Thomson International and products that may contain the onions.
As of Sunday, there had been 640 reported salmonella cases, including 85 hospitalizations, tied to the outbreak, the Food and Drug Administration said. Many of the reported cases were in the Western states of Utah (90); Oregon (85); California (76); and Montana (52). There have also been 41 cases reported in Illinois. Read the New York Times story here.
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Coronavirus (COVID-19) Update
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
• As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to one company for selling fraudulent COVID-19 related products. The company, Vapore, LLC, dba Mypurmist, sells Mypurmist with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requested that Vapore, LLC, immediately cease selling this unapproved and unauthorized product. Consumers concerned about COVID-19 should consult with their health care provider.
• Testing updates:
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FDA Issues Final Guidance for Industry on Action Level for Inorganic Arsenic in Infant Rice Cereals
the U.S. Food and Drug Administration issued guidance finalizing the 2016 draft guidance for inorganic arsenic in infant rice cereals and identifying the agency’s intended sampling and enforcement approach. The guidance identifies an action level of 100 micrograms per kilogram (µg/kg) or 100 parts per billion (ppb) which protects public health by reducing infants’ dietary exposure to inorganic arsenic and is achievable by industry. The FDA is taking this action because exposure to inorganic arsenic is associated with neurodevelopmental effects. Read more.... |
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AFDO Executive Director, Steven Mandernach, Featured on Food Safety Matters Podcast
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!
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AFDO Released a Request for Information (RFI) for the System for Agriculture, Food, Health, E-inspections and Registration (SAFHER) Platform
 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.
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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.
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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
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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....
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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.: |
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“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.... |
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Did You Miss Them? IFPTI Fellows Presentations Now Available On Demand
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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 Lopez, New York State Department of Agriculture and Markets, Cold Brew Coffee Regulations and Policies
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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
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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
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Division Chief, Environmental Public Health - Tulsa
Reporting to the Executive Director and serving as an integral member of the senior leadership team, the Environmental Public Health Division Chief will be primarily responsible for the direction, operation, budget, development and implementation of policies and procedures that relate to the Environmental Health Division. Assists staff in the education and regulatory activities involved with food and institutional facilities, public bathing places, lodging, vector control, occupied housing, nuisance abatement and premise sanitation and water quality laboratory activities. Coordinates the Division’s activities with federal, state, and local agencies, community and civic leaders.
Read more and/or apply.... |
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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.... |
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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
- August 25-27
- September 8-10
- October 13-15
- November 3-5
Click here to access the schedule of online PCQI Courses
- ONLINE Foreign Supplier Verification Courses (FSVP-QI) Courses
- August 11 -12
- September 22-23
- October 20-21
- November 17-18
Click here to access the schedule of online FSVP-QI courses
- Intentional Adulteration Vulnerability Qualified Individuals (IAVA-QI) Courses
- Singapore: November, 9 2021
Click here to access the schedule of IAVA-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
August 3 - 4, 2020
August 5 - 6, 2020
August 7, 2020
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