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Dear International Colleague,
The Office of Global Policy and Strategy (OGPS) would like to to share with you the FDA Center for Food Safety and Nutrition's (CFSAN) Update for October 21, 2020:
The International Food Safety and Nutrition (IFSN) Update is a quarterly summation of key, public information recently released by the U.S. Food and Drug Administration (FDA), for international stakeholder awareness. Please contact Jeffrey.Read@fda.hhs.gov and Joanna.Brown1@fda.hhs.gov directly with any questions.
INTERNATIONAL FOOD SAFETY AND NUTRITION UPDATE October 21, 2020
Food Safety and the Coronavirus Disease (Covid-19)
October 21, 2020
The following are just a few resources available to all stakeholders on Coronavirus Disease 2019 (COVID-19) and food safety.
For the full set of information, visit FDA's Coronavirus Disease 2019 (COVID-19) main page.
What’s New
Factsheets
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FDA to Hold Webinar on the First 100 Days: New Era of Smarter Food Safety
October 14, 2020
Please join FDA for 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.
You will hear about:
- The people at FDA who are leading this effort, their vision for achieving the goals set forth in the blueprint, and an inside look at how they are doing that.
- The milestones/achievements of the first 100 days since the blueprint was issued
- Key next steps and priorities for the next two years – and beyond
- Our plans to engage with stakeholders
Remarks provided by:
- Frank Yiannas, Deputy Commissioner for Food Policy and Response, FDA
- Leaders of the Core Element teams:
- Core Element 1: Tech Enabled Traceability
- Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response
- Core Element 3: New Business Models and Retail Modernization
- Core Element 4: Food Safety Culture
There will be an opportunity to ask questions. 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.
Additional Information:
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FDA Sampling Fresh Herbs, Guacamole and Processed Avocado
October 9, 2020
As of March 31, 2020, the agency had collected and tested 1,272 samples of fresh herbs (759 domestic and 513 imported). The agency plans to collect 1,600 fresh herbs samples (761 domestic, and 839 of international origin) under this assignment.
Of the fresh herb samples, 15 tested positive for Salmonella (6 domestic, 9 import), and 10 tested positive for Shiga-toxin producing E. coli (STEC) (5 domestic, 5 import). Further study showed that only one of the domestic STEC positive samples was pathogenic, and that all others did not have the potential to cause severe illness. The FDA did not detect E. coli O157:H7 in any of the fresh herb samples. In July 2018, the FDA also began testing its fresh herb samples for Cyclospora cayetanensis given that Cyclospora-related illnesses typically occur during the summer. The agency detected Cyclospora in 17 of the 691 fresh herbs samples tested (5 domestic, 12 import).
The current fresh herbs sampling assignment is on pause while travel restrictions and social distancing measures make it temporarily impractical to continue most surveillance sampling work. The assignment is expected to resume when it is safe to do so, and an analysis of the data and final report will be provided at the conclusion of the study.
The FDA concluded its collection of processed avocado and guacamole samples with the close of fiscal year 2019. The agency has recently begun its analysis of the processed avocado and guacamole samples and the results will be published in the final report.
For more information:
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FDA Releases Continuing Medical Education Videos on the New Nutrition Facts Label
October 8, 2020
Today, the U.S. Food and Drug Administration (FDA), in collaboration with the American Academy of Pediatrics (AAP) and the American Medical Association (AMA), announced continuing medical education (CME) videos for pediatricians and other physicians, as well as other healthcare professionals on the new Nutrition Facts label. The videos provide information on using the new label to help patients understand the changes to the label and make informed dietary choices.
Although we know that physicians are well aware of the key importance of nutrition in health and disease prevention, FDA wants to ensure that they are familiar with the role the Nutrition Facts label can play in helping patients make healthy food choices. The CME videos are designed to educate physicians on the new label and provide strategies about how to counsel patients to use the label to make informed food choices that support a healthy diet. Specifically, these videos review the various components of the label and teach healthcare professionals how to best educate patients on how to use each component.
To view the CME videos, visit FDA’s Healthcare Professionals website. The videos and companion patient educational materials are available to all healthcare professionals. The CME videos are also available on PediaLink, the AAP Online Learning Center, and the AMA Ed HubTM, where interested physicians can access these activities at no cost and can earn 1 AMA PRA Category 1 CreditTM.
To learn more about the new Nutrition Facts label, visit www.fda.gov/NewNutritionFactsLabel.
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FDA and Mexico Sign Statement of Intent Forging Food Safety Partnership
October 5, 2020
Today, the U.S. Food and Drug Administration (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.
Historically, the FDA and its regulatory counterparts in Mexico have worked collaboratively in both countries due to the high volume of food trade across the border. About a third of all imported food into the United States is from Mexico and 60% of all imported produce is from Mexico.
The goal of the Food Safety Partnership is to strengthen collaboration on four priority areas agreed upon by all three agencies to better protect public health across the border:
- Outbreak response
- Laboratory collaboration
- Prevention
- Outreach and training
The Food Safety Partnership aligns with the aims of the FDA’s New Era of Smarter Food Safety Blueprint, announced earlier this summer, with its approach to food safety through the Blueprint’s four core elements of tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and business modernization and food safety culture.
For more information
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FDA to Hold Public Meetings to Discuss the Requirements for Additional Traceability Records for Certain Foods: Proposed Rule
October 2, 2020
The U.S. Food and Drug Administration (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. The times for each meeting have been adjusted to provide persons in different regions of the country an opportunity to comment.
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. For general questions about the meetings, contact Juanita Yates, FDA, Center for Food Safety and Applied Nutrition, e-mail: Juanita.Yates@fda.hhs.gov.
For additional information, see the Federal Register Notice announcing the meetings and the Meeting Page to register.
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FDA and USDA Sign MOU to Facilitate U.S. Dairy Exports
October 1, 2020
The U.S. Food and Drug Administration and the United States Department of Agriculture (USDA) have signed a Memorandum of Understanding (MOU) that will enable the agencies to take a concerted, modern approach to support the export of U.S. milk and milk products worldwide.
The United States exports $6 billion worth of milk and milk products annually. In their respective roles of food safety, marketing and trade facilitation, FDA and USDA have complimentary programs to support the exportation of these products from the United States. Increasingly, U.S. dairy exporters face challenges in the global marketplace from trade partners requiring additional information and assurances. This has resulted in the need for an increased level of coordination by regulators to help address requests and to facilitate trade of safe and wholesome products from the U.S.
This MOU outlines an effective and efficient framework to leverage the collective strengths of FDA and USDA.
The FDA is responsible for ensuring that milk and milk products are safe and wholesome as labeled through enforcement of the Federal Food, Drug and Cosmetic Act (FD&C). This is accomplished, in part, by inspecting the production, processing, and distribution of foods and examining samples to ensure compliance with the FDA’s statutory requirements. In addition, the FDA engages with international regulators and stakeholders regarding the safety of U.S. milk and milk products. The FDA will continue in its role as competent authority, engaging directly with foreign authorities as needed on food safety matters, and providing oversight to more than 6,000 firms that produce dairy products.
The USDA, through its dairy grading service, is the lead agency on issuing dairy sanitary certificates, coordinating interagency collaboration related to U.S. exports of milk and milk products, and negotiating with foreign countries on certifications to meet their importing requirements.
Through this MOU, the FDA and USDA remain committed to facilitating the efficient exporting of milk and milk products.
For more information
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FDA Releases New “Feed Your Mind” Consumer Education Materials
September 29, 2020
Today, the U.S. Food and Drug Administration (FDA) has posted additional “Feed Your Mind” consumer education materials. Developed in partnership with the U.S. Department of Agriculture and the Environmental Protection Agency and launched earlier this year, “Feed Your Mind” is a consumer education initiative to provide science-based information on genetically engineered foods, commonly called GMOs or genetically modified organisms.
The new materials include:
As part of the initiative, the Science and Our Food Supply: Exploring Food Agriculture and Biotechnology high school curriculum is available for the 2020-2021 school year. This supplementary curriculum includes science-based lesson plans to introduce an in-depth understanding of the science behind genetically engineered plants.
Funding for “Feed Your Mind” was provided by Congress in the Consolidated Appropriations Act of 2017 to conduct “consumer outreach and education regarding agricultural biotechnology and biotechnology derived food products and animal feed, including through publication and distribution of science-based educational information on the environmental, nutritional, food safety, economic, and humanitarian impacts of such biotechnology, food products, and feed.” Additional funds were provided through 2018 and 2019 Appropriations bills.
For More Information
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FDA Finalizes First Food Safety Equivalence Determination - Resumption of Shellfish Trade with Spain and Netherlands
September 23, 2020
Today, the U.S. Food and Drug Administration (FDA) and the European Commission (EC), have taken important steps to open the market for the sale of molluscan shellfish, including oysters, clams, mussels and scallops, from both the United States and the European Union to their consumers. Initially, certain firms in Washington and Massachusetts will have access to the EU market. U.S. firms in other states soon will have an opportunity to be considered, using a streamlined process established by FDA and the EC.
Today, the FDA announced its first-ever equivalence determination with a notice in the Federal Register. The equivalence determination will enable Spain and the Netherlands to export raw bivalve molluscan shellfish to the United States. Specifically, FDA’s equivalence determination finds that the adoption and implementation by Spain and the Netherlands of the European Union’s (EU’s) system of food safety control measures for raw bivalve molluscan shellfish, along with their application of additional measures specifically adopted for export to the United States, provides at least the same level of sanitary protection as comparable food safety measures in the United States and is therefore equivalent. The FDA and the EU have not allowed the import of raw molluscan shellfish from each other since 2010.
Today’s equivalence determination finalizes the proposed determination that FDA published a notice in the Federal Register on March 9, 2018. In response to that notice, the FDA received approximately 25 comments, most of which generally supported the proposed equivalence determination and the technical basis for the FDA’s conclusion.
FDA will host a Webinar with the Interstate Shellfish Sanitation Conference for the shellfish industry and state shellfish control authorities on-or-about October 1, 2020. Details will be posted on Workshops, Meetings & Webinars on Food and Dietary Supplements.
For more information
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FDA Announces FSMA Food Traceability Proposed Rule, A Major Milestone in the New Era of Smarter Food Safety
September 21, 2020
Today, the U.S. Food and Drug Administration (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.
The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). If finalized, the proposal would standardize the data elements and information firms must establish and maintain, and the information they would need to send to the next entity in the supply chain to facilitate rapid and accurate traceability. While limited to only certain foods, this proposal lays the foundation for a standardized approach to traceability recordkeeping, paving the way for industry to adopt, harmonize, and leverage more digital traceability systems in the future. Where possible, FDA has drawn on existing consensus standards that industry members may already be using.
Existing FDA regulations require much of the food industry to establish and maintain records to identify the immediate previous sources and the immediate subsequent recipients of foods (commonly referred to as “one-up, one-back” recordkeeping). These requirements form a baseline for traceability recordkeeping, but they provide limited information to effectively and rapidly link shipments of food through each point in the supply chain. This -- and the fact that recordkeeping systems can be largely paper-based and lack a universal lexicon throughout industry-- can make it difficult to trace a product to its original source when necessary.
As a result, many foodborne illness outbreak investigations have been slowed, resulting in more illnesses and economic loss. Improved traceability, as envisioned by the proposed rule, would allow the FDA to more quickly identify the source of a contaminated product, reduce the scope of product recalls, and conduct more timely root-cause investigations to learn more about how contamination occurred in order to prevent future outbreaks.
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. For each CTE, entities would be required to establish and maintain records containing Key Data Elements (KDEs). Examples of KDEs include the traceability lot code, the date the product was received, the date the product was shipped, and a product description. The traceability lot code is an important KDE throughout the supply chain intended to establish critical linkages that will help to facilitate rapid traceback and traceforward investigations during foodborne illness outbreaks and recall events. In addition, those subject to the rule would also be required to create and maintain records related to their internal traceability program, which would help regulators better understand a firm’s recordkeeping practices and traceability operations.
The proposed rule would require records to be maintained as either electronic, original paper records, or true copies. In addition, the proposal states that in the event of a foodborne illness outbreak, a product recall, or other threat to public health, the FDA could require that firms submit, within 24 hours, an electronic sortable spreadsheet containing relevant traceability information for specific foods and date ranges. More generally, the FDA encourages all food businesses to maintain their traceability records electronically whenever possible, to expedite the identification of traceability information when needed to address threats to public health.
The requirements of the proposed rule would only apply to foods that are on the FTL, which includes foods that have listed foods as ingredients. The proposed rule includes several exemptions, including that the additional traceability records would not be required after a kill-step (a process that significantly minimizes pathogens in a food) is applied to a food, but documentation of the kill-step application would have to be established and maintained.
The proposed rule and draft Food Traceability List are available for public comment for a 120 days from the date of publication. The FDA will also be holding three public meetings during the public comment period. Information about the public meetings will be provided in a forthcoming announcement.
For More Information
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FDA Holds Webinar to Discuss Leafy Greens Action Plan
July 30, 2020
The FDA held 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.
FDA provided an overview of the Leafy Greens Action Plan, provided an update on key activities and addressed external stakeholder engagement activities associated with the plan and how stakeholders can engage in this process.
Featured speakers included Deputy Commissioner for Food Policy and Response Frank Yiannas, Dr. Steve Musser, Deputy Director for Scientific Operations, Center for Food Safety & Applied Nutrition, Natalie Krout-Greenberg, Director, Division of Inspection Services Division at the California Department of Food & Agriculture and Dr. Jennifer McEntire, Senior Vice President of Food Safety & Technology at United Fresh Produce Association.
Meeting Recording
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Next IFSN Update: January 15, 2020
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