Salmonella and Paypas

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Status: In Progress  |  Genre: Non-Fiction  |  House: Booksie Classic

Submitted: September 05, 2019

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Submitted: September 05, 2019



Salmonella and Paypas



Statement calling on all sectors of the papaya industry to improve practices to better protect consumers

For Immediate Release:

August 26, 2019

Statement From:

Acting Commissioner of Food and Drugs - Food and Drug Administration

Norman E. "Ned" Sharpless MD

Deputy Commissioner for Food Policy and Response - Food and Drug Administration

Frank Yiannas

Every day Americans enjoy an abundant food supply that is among the safest in the world. The U.S. Food and Drug Administration works tirelessly to ensure that foods available to consumers, whether they are produced domestically or abroad, meet the FDA’s food safety requirements and that we are using all available tools to ensure compliance.

As demand and tastes continue to drive change in the market, consumers’ desire for a variety of products available year-round have increased the number of imported foods offered for sale in the U.S. To keep up with this trend, we have doubled down on our efforts to ensure the safety of imported food. This includes issuing a new Strategy for the Safety of Imported Food and requesting new funding from Congress to support our efforts.

While we continue to focus on shifting our work upholding food safety from response to prevention, we know that there are times where we will still need to respond to problems when they arise, including outbreaks of foodborne illness. This is especially important when we see recurrent patterns of illness associated with particular commodities. For example, fresh papayas. This commodity is most often eaten raw, without cooking or processing to eliminate microbial hazards; and therefore, the way they are grown, harvested, packed, held, processed and distributed is crucial to minimizing the risk of contamination with human pathogens.

Unfortunately, since 2011, American consumers have been exposed to eight outbreaks caused by Salmonella serotypes linked to imported, fresh papaya. And, just this June we started an investigation into an outbreak of Salmonella Uganda illnesses tied to the consumption of whole, fresh papaya imported from Mexico. While the 2019 outbreak is ongoing, the first seven outbreaks accounted for almost 500 reported cases of illness, more than 100 hospitalizations, and two deaths.

This trend has to stop. The pattern of recurrent outbreaks we have observed since 2011, including the 2019 illnesses, have involved Salmonella infections traced back to, or are suspected of being associated with, papaya grown in Mexico. The recurring nature of these outbreaks is a clear indication that more must be done within all sectors of the papaya industry to protect its customers and to meet its legal obligations. This includes growers, importers and even retailers that can and must do more.

This is why today we have issued a letter calling on all sectors of the papaya industry to take actions to prevent these outbreaks in the future. We are urging growers, packers, shippers and retailers in the papaya industry to review their operations and make all necessary changes to strengthen public health safeguards.

Our letter calls on the papaya industry to assess the factors that make their crops vulnerable to contamination. If a foodborne pathogen is identified in the crop or growing environment, a root cause analysis should be performed to determine the likely source of contamination. Procedures and practices that minimize that contamination must be implemented.

We are strongly encouraging the papaya industry to examine the use and monitoring of water used to grow, spray (pesticides, fungicides), move, rinse or wax crops to identify and minimize risks from potential hazards. All sectors of the industry should adopt tools and practices needed to enhance traceability since papayas are a perishable commodity, to more rapidly facilitate the tracking of involved product to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions.

And finally, they should fund and actively engage in food safety research to identify the potential sources and routes of contamination by microbial pathogens and develop data-driven and risk-based preventive controls.

In response to this most recent Salmonella Uganda outbreak, the FDA deployed an inspection team to the packing house and farm that was linked to the contaminated papayas via trace back and epidemiological evidence. The findings of those visits will be made public when their investigation is complete. We have also increased sampling and screening of papayas at the border. In addition, the FDA is actively collaborating with our counterparts in the Mexican government regarding this current outbreak through the agency’s Latin America Office to determine ways to further our collaborative prevention efforts.

The U.S. Federal Food, Drug, and Cosmetic Act prohibits food producers from introducing, or delivering for introduction, into interstate commerce adulterated foods (meaning foods that are potentially harmful to consumers). Additionally, there are new requirements under the FDA Food Safety Modernization Act (FSMA). The Produce Safety Rule under FSMA sets science- and risk-based minimum standards for domestic and foreign farms for the safe growing, harvesting, packing and holding of covered produce, which includes papayas. Another FSMA rule, the Foreign Supplier verification Program (FSVP) makes importers responsible for verifying that the foods they bring into the U.S., including papayas, have been produced in a manner that meets applicable U.S. safety standards. 

We take our responsibility to protect public health very seriously and will continue to use all of our regulatory authorities and enforcement tools available to do so. So, today we issued a warning letter to a papaya importer, Agroson’s LLC, following an FDA investigation at the facility in conjunction with the current outbreak. This investigation uncovered significant violations of the Federal Food, Drug, and Cosmetic Act. Rest assured that the FDA will continue to strengthen safeguards and prevent contaminated papayas from being imported into the U.S. Our efforts also include education, outreach, training and research activities designed to support farmers’ efforts to keep their crops safe for consumers.

Although today’s actions focus on the papaya industry, recurring outbreaks taking place with any commodity are unacceptable from a public health perspective. We know that more must be done by industry as repeated illness outbreaks are a threat to public health. In such situations, it is incumbent upon all sectors of the industry to work together to investigate the cause, review food safety procedures and practices, and take action to prevent further outbreaks.

We must take collective steps to eliminate the threat that recurring outbreaks pose to consumers and look forward to working with the papaya industry as well as all food producers to ensure that America’s food supply remains among the safest in the world.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Outbreak Investigation of Salmonella Uganda Likely Linked to Whole, Fresh Papayas, June 2019

Agroson’s LLC refuses to voluntarily recall; FDA urges avoidance of Cavi Brand papayas

July 19, 2019

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC), and state and local partners, are investigating a multistate outbreak of Salmonella Uganda illnesses likely linked to Cavi Brand whole, fresh papayas.

The FDA has asked Agroson’s LLC, the exclusive distributor of this brand, to conduct a voluntary recall of Cavi brand papayas. Agroson's LLC refused to initiate a recall. FDA contacted wholesale customers of Agroson’s LLC to ensure the fruit was no longer available for sale, has been discarded, or not further processed or frozen.  FDA is doing this to protect consumers as it pursues additional protective and regulatory actions.



For Consumers, Restaurants, and Retailers:

Consumers in all states should not eat any Cavi brand whole, fresh papayas and should throw them away. If consumers are unable to determine the brand of papayas, the product should be thrown away. Retailers, restaurants, and other food service providers in all states should not serve or sell whole, fresh papayas under the Cavi brand, which are distributed by Agroson’s LLC.

Consumers no longer need to avoid whole, fresh papayas, with the exception of Cavi brand papayas.

For Restaurants, Retailers, Importers, Suppliers, and Distributors in All States:

The FDA strongly advises importers, suppliers, and distributors, as well as restaurants, retailers, and other food service providers from all states to not sell or distribute whole, fresh papayas from Agroson’s LLC that are labeled under the Cavi brand.

Based on this new information, the hold FDA advised on June 28, 2019 for all imported Mexican papayas is no longer necessary.

Distributors don’t need to withhold Mexican papayas from distribution, with the exception of the Cavi brand.

Case Counts

Total Illnesses: 71
Hospitalizations: 27
Deaths: 0
Last illness onset: June 16, 2019
States with Cases: CT (14), FL (1), MA (5), NJ (18), NY (27), PA (4), RI (1), TX (1)




Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on a new strategy to advance FDA’s food safety mission and modernize oversight of imported food

For Immediate Release:

February 25, 2019

Statement From:

American consumers expect a diverse, robust and fresh food supply that’s affordable and safe all year round. Since not all food products can be produced solely by domestic facilities, to help meet these demands, the U.S. imports about 15 percent of its overall food supply from more than 200 countries or territories representing about 125,000 international food facilities and farms. Over the past 15 years alone, we’ve seen a trend of rising imported foods. Other countries now supply about 32 percent of the fresh vegetables, 55 percent of the fresh fruit and 94 percent of the seafood that Americans enjoy.

Even though we’ve seen an increase in imported foods, the safety of food products available to American consumers hasn’t waned thanks to the important roles that the U.S. Food and Drug Administration, the food industry and our regulatory counterparts around the world play in addressing the safety of imported human and animal foods. Whether produced domestically or abroad, a critical part of the FDA’s job is making sure all foods sold to American consumers meet U.S. food safety standards. This is especially important given the globalization of the food supply and steps the food industry has taken to meet consumer demands. The result is more complex supply chains and increased specialization, where a single manufacturer responsible for a single ingredient could find it in many different finished products.

We work hard every day to ensure that the U.S. food supply remains among the safest in the world. One of the greatest advancements in our ability to better safeguard our food supply, has been the implementation of the FDA Food Safety Modernization Act (FSMA), which gave the FDA additional authority over importers and food producers sending products to the U.S. market and provided support for a level playing field between domestic and international producers. Optimizing our FSMA implementation activities, as well as our longstanding tools and authorities, will provide for an even more comprehensive approach to help ensure imported food safety.

Today, we’re taking an important, new step to communicate how the FDA intends to use our modern toolkit by introducing a new, comprehensive, imported food safety strategy to address these challenges and opportunities. Our new strategy is designed to meet four important goals: preventing food safety problems in the foreign supply chain prior to entry into the U.S.; effectively detecting and refusing entry of unsafe foods at U.S. borders; responding quickly when the FDA learns of unsafe imported foods; and measuring our progress to ensure that our imported food safety program remains effective and efficient.

To achieve our first goal of preventing imported safety problems prior to entry into the U.S., we’ll take new steps to continue to ensure that food offered for import meets the same standards as domestically produced food. One of our tools to achieve this goal is onsite inspections of foreign food facilities. These valuable inspections are resource-intensive, so our strategy will involve a more modern focus on tools for risk-informed prioritization of firms for inspection. Our decisions will be informed by an increasing amount of data and information from other oversight activities and partners. To that end, we also recently began inspections for the FDA’s Foreign Supplier Verification program (FSVP) rule. This program requires importers to verify that their suppliers are meeting U.S. food safety standards. Some key requirements under this rule include obligating U.S.-based importers to conduct hazard analyses, perform evaluations of the risk of the food and foreign suppliers, and conduct safety verification activities based on the identified hazards, including the use of third-party audits as appropriate.

In addition, the FDA’s launch of the Accredited Third Party Certification program will aid the agency in meeting our goal of preventing imported food safety problems prior to entry into the U.S. This program provides a framework for audits of foreign food facilities to verify compliance with U.S. food safety standards, which can be used by importers to establish eligibility in the Voluntary Qualified Importer Program (VOIP). The VQIP offers importers expedited review and entry of their food based on the safety assurances that the audits provide. The program also provides the FDA with additional data and intelligence that will help us plan oversight activities based on a more accurate assessment of risk. 

To advance our focus on preventive measures, the FDA’s new strategy also outlines how we’ll utilize a systems recognition program. Under this program we recognize that certain countries’ food safety systems and oversight activities provide comparable levels of public health protection to ours. In turn, these countries adopt a similar reliance on our systems and oversight activities. By relying on the activities of these reputable foreign regulatory programs, the FDA can avoid conducting separate inspectional oversight activities that are already by these foreign regulators with strong regulatory systems that are a part of the systems recognition program. By leveraging partnerships between the U.S. and other countries with very strong food safety systems through our systems recognition program, we’re able to prioritize our inspection and border screening activities on foods imported from higher-risk areas. In turn, we’re better positioned to verify the safety of food products presented for import. So far, Canada, New Zealand and Australia have been assessed and recognized as comparable under the systems recognition program. In addition, we’re currently working with the European Union on a mutual assessment.

While we work to prevent problematic foreign food from reaching the U.S., we’re equally focused on our second goal -- detecting and refusing unsafe products -- by updating our import screening and review processes at the U.S. border. The FDA is charged with examining foods offered for import into the U.S., including high-risk foods. To accomplish this complex task, the FDA utilizes its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). This is an automated import screening tool that helps us to identify high-risk shipments of food offered for import. As part of our new strategy, the FDA intends to optimize this tool by incorporating new sources of data from foreign supplier verification programs, voluntary importer incentive programs, accredited third-party auditors, foreign regulatory authorities and domestic supply chain activities. This will allow us to form a more complete picture of the risk of imported food in a new era of smarter food safety. By enhancing our access to various data streams, we’ll be better positioned to catch issues with imported foods before they are made available in the U.S. marketplace.

As we implement our first two goals, we must remain wise to the fact that, despite our best efforts to prevent and stop unsafe food from entering the U.S., it’s impossible to completely stop all unsafe food products before they hit our market. That’s why our third goal is focused on enhancing our ability to swiftly respond to unsafe imported food. To meet this goal, our new strategy describes how the FDA will use data from multiple sources to optimize use of physical examination and to develop strategic and targeted surveillance sampling that targets the highest-risk products for sampling assignments. This approach allows regular monitoring and surveillance of imported products, facilitates targeted assignments to collect data that informs oversight activities, and assists with verification of other related programs. We’ll also continue our work with state and other partners to determine how we can improve testing methodologies and tools used to determine admissibility of food offered for import. Further, we’ll capitalize on opportunities for improving the efficiency of our response to food safety incidents, for example by using mandatory recall authority, import alerts and improved information sharing with our regulatory partners as appropriate.

Our final goal is to ensure that our import program remains effective and efficient and adopts modern tools to advance these purposes. We’ll be developing an improved global inventory of food facilities and farms to help optimize the FDA’s resource allocation for imported food safety oversight to areas of higher risk and help us strategically employ the full range of our regulatory tools as effectively as possible. To make our imported food safety program as efficient as possible, we’ll assess our performance of imported food safety activities and take additional steps to improve our performance based on those assessments. We’re already in the process of developing performance measures and outcome indicators for imported food safety and intend to publish our measures and non-confidential data about imported food, foreign suppliers, FSVP importers and other importers to the public as it becomes available.

Overall, our modern strategy is designed to leverage our different authorities and tools to provide a multi-layered, data-driven, smarter approach to imported food safety. We recognize that the FDA plays an important oversight role in securing consumer safety. We’re fully committed to keeping our food safety mission robust and highly effective in this increasingly complex and global food landscape.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



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