Friday, February 23, 2018

FDA Release Initial Pathogen Survey Results for Herbs and Guacamole

FDA is in the process of conducting a survey of microbiological pathogens on fresh cilantro, parsley and basil, as well as processed avocado and guacamole.  While FDA has only sampled less a small percentage of the samples they plan to get (less than 12% or so of total samples planned), they do have some results for samples taken as of 1/1/18.

Fresh herbs
35 domestic samples - None of the domestic samples tested positive for Salmonella, or E. coli STED
104 import samples - 4 tested positive for Salmonella, 3 tested positive for Shiga toxin-producing E. coli, and none tested positive for E. coli 0157:H7.
(It is important to point out that most of the outbreaks associated with these items - 7 of 9 - have been due to Cyclospora.  FDA indicated that they will survey for Cyclospora in the summer months when there is a higher tendency for this to be an issue.

Proccessed avocado/guacamole
58 domestic samples - 3 tested positive for Listeria monocytogenes
49 import samples - 1 tested positive for Listeria monocytogenes.

Not much to worry about when eating your chips and dip at happy hour.....

Constituent Update
https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm597356.htm
FDA Sampling Fresh Herbs, Guacamole and Processed Avocado
February 23, 2018

In its continued efforts to protect consumers and ensure food safety, the U.S. Food and Drug Administration has begun testing fresh cilantro, parsley and basil, as well as processed avocado and guacamole, for certain microbial contaminants. These two large-scale sampling assignments will help the FDA assess the rates of bacterial contamination in these commodities, as well as help to identify possible common factors among the positive samples.

The FDA plans to collect 1,600 samples for each assignment. As of January 1, 2018, the agency had collected 35 domestic samples (4.6 percent) and 104 import samples (12.4 percent) of the total for fresh herbs. None of the domestic samples tested positive. Of the 104 import samples tested, 4 tested positive for Salmonella, 3 tested positive for Shiga toxin-producing E. coli, and none tested positive for E. coli 0157:H7.

As of January 1, 2018, the agency had collected 58 domestic samples (7.3 percent) and 49 import samples (6.1 percent) of the totals for processed avocado/guacamole. Of the 58 domestic samples tested, 3 tested positive for Listeria monocytogenes. Of the 49 imported samples, 1 tested positive for Listeria monocytogenes. It is important to note that no conclusions about overall contamination rates can be made until all of the data are collected, validated and analyzed.

If samples are found to be positive for microbial hazards, the FDA will pursue an appropriate regulatory and enforcement option, which may include encouraging a voluntary recall, ordering a mandatory recall, ordering administrative detention to prevent food from being distributed, issuing public warnings to alert consumers to the potential danger, or, in the case of imported products, refusing their entry into the United States and subjecting future shipments to an import alert. In the case of the positive samples identified in the first quarter of data collection, imported products capable of causing disease were prevented from entry into the United States and domestic products were voluntarily recalled.

The agency chose to sample fresh herbs because they are typically eaten without having undergone a ‘kill step,’ such as cooking, to reduce or eliminate bacteria. These herbs are also often eaten as part of multi-ingredient foods, and thus people may not report having eaten them when they become ill.

From 1996 to 2015, the FDA reported nine foodborne outbreaks linked to basil, parsley and cilantro, which resulted in 2,699 illnesses and 84 hospitalizations. Of the nine outbreaks, seven were attributed to Cyclospora cayetanensis; one was attributed to E. coli O157:H7; and one was attributed to Shigella sonnei. The FDA is seeking to obtain baseline estimates of the prevalence of Salmonella and Shiga toxin-producing E. coli (STEC) in cilantro, basil and parsley. The agency also intends to test for Cyclospora cayetanensis during the summer months, when Cyclospora-related illnesses typically occur.

The agency chose to sample processed avocado because avocados have a high moisture content and a non-acidic pH level, conditions that can support the growth of harmful bacteria. Processed avocado products, including avocado that is fresh cut, refrigerated and frozen, may be packaged and eaten without having undergone a ‘kill step’ prior to consumption. According to the Centers for Disease Control and Prevention, there were 12 outbreaks of foodborne illness related to avocado, avocado products or guacamole products from 2005 to 2015. Of those 12 outbreaks, nine involved Salmonella and three involved E. coli, resulting in 525 illnesses and 23 hospitalizations. Though no Listeria outbreaks were reported in connection with avocados from 2005 to 2015, a recent sampling assignment by the FDA detected Listeria monocytogenes in samples collected from the fruit’s pulp and skin. The agency is seeking data on the prevalence of Salmonella and Listeria monocytogenes in processed avocado and processed avocado products.

The assignments are anticipated to last 18 months. The agency will post results on a quarterly basis and also post a comprehensive report once sampling and analysis is complete.


https://www.fda.gov/Food/ComplianceEnforcement/Sampling/ucm590449.htm
Microbiological Surveillance Sampling: FY18-19 Fresh Herbs (Cilantro, Basil & Parsley) and Processed Avocado and Guacamole Assignments

Microbiological Surveillance Sampling

•Fresh Herbs (Cilantro, Parsley & Basil)

•Processed Avocado & Guacamole

•Questions and Answers

•Results as of 1/1/2018

•Additional Information

Fresh Herbs (Cilantro, Parsley & Basil)
Fresh cilantro, parsley and basil are typically eaten without having undergone a ‘kill step,’ such as cooking, to reduce or eliminate bacteria. These herbs are grown low to the ground and therefore are susceptible to contamination (e.g., from irrigation water splashing off the soil).

From 1996 to 2015, the FDA reported nine outbreaks linked to basil, parsley, and cilantro, which resulted in 2,699 illnesses and 84 hospitalizations. Four of the outbreaks were linked to basil, three to cilantro, and two to parsley. Of those same nine outbreaks, seven were attributed to Cyclospora cayetanensis; one was attributed to E. coli O157:H7; and one was attributed to Shigella sonnei. The FDA is seeking to obtain baseline estimates of the prevalence of Salmonella and Shiga toxin-producing E. coli (STEC) in cilantro, basil and parsley. The agency also intends to test for Cyclospora cayetanensis during the later portion of the assignment so that it can focus its resources on that pathogen during the summer months, when Cyclospora-related illnesses typically occur.

Processed Avocado & Guacamole

Avocados have a high lipid and moisture content, low carbohydrates, and non-acidic pH level, which can make them a favorable growth medium for harmful bacteria. Processed avocado products, including avocado that is fresh cut, refrigerated and frozen, may be packaged and eaten without having undergone a ‘kill step’ prior to consumption. In addition, processing fresh produce into fresh-cut products increases the risk of bacterial growth by breaking the fruit’s skin and allowing for the spread and potential growth of any pathogens that may be present.

According to the Centers for Disease Control and Prevention, there were 12 outbreaks of foodborne illness related to avocado, avocado products or guacamole products from 2005 to 2015. Of those 12 outbreaks, nine involved Salmonella and three involved E. coli, resulting in 525 illnesses and 23 hospitalizations in all. Though no Listeria outbreaks were reported in connection with avocados from 2005 to 2015, a recent sampling assignment by the FDA detected Listeria monocytogenes in samples collected from the fruit’s pulp and skin. The agency is seeking data on the prevalence of Salmonella and Listeria monocytogenes in processed avocado and processed avocado products.

Questions and Answers

When will the FDA collect samples?

The FDA began collecting samples of these commodities in October 2017 and plans to continue its collection until it has met its target of 1,600 samples for each assignment. The sample collections are anticipated to take 18 months. Sampling will occur primarily Monday through Thursday, throughout the year.

Where will the samples be collected from?

The FDA will collect samples of imported fresh cilantro, parsley and basil from ports of entry, importer warehouses, or other storage facilities where foreign goods are cleared for entry into the country, and domestic samples from packers (including post-harvest products in packinghouses on farms), wholesalers, distributors/warehouses and retail locations. Retail samples will be collected from dealer storage (i.e., prior to consumer handling).

The FDA will collect samples of imported processed avocado and guacamole from ports of entry, importer warehouses, or other storage facilities, and domestic samples from processors, distributors, and retail locations.

What exactly do you plan to collect?

For fresh herbs, the FDA plans to collect fresh, raw parsley, cilantro and basil. The agency does not plan to collect frozen, chopped, or dried herbs, or fresh herbs indicated as intended for processing.

The FDA plans to collect processed avocado, including fresh cut, pureed, refrigerated and frozen product, as well as frozen avocado pulp with additives, and guacamole. The agency does not plan to collect whole avocados (intact, with skin). The FDA will not collect samples from farms or growers, product indicated as intended for beverage(s), or product indicated to have undergone a pathogen reduction step, such as pasteurization.

What will the FDA test for?

The FDA is testing both fresh herbs (cilantro, basil and parsley) and processed avocado and guacamole for Salmonella. The agency also plans to test fresh herbs for Shiga toxin producing E. coli and processed avocado and guacamole for Listeria monocytogenes. The agency will conduct whole genome sequence testing on any samples that test positive to obtain the genetic ‘fingerprint’ of the pathogen, and will add this information to the databases used to match human illnesses with potential food sources. The agency also intends to test for Cyclospora cayetanensis during the summer months, when Cyclospora-related illnesses typically occur.

Will the FDA provide pre-notification to facilities where it plans to conduct sampling?

Per standard FDA practice, the agency will not provide pre-notification to firms prior to collecting samples, except if the sample collection is to occur at a packinghouse located on a farm. (All fresh herb sample collection is to occur after the produce has been harvested.) When a member of the FDA field staff is planning to collect fresh herb samples from an on-farm packinghouse, the agency employee will call the farm at least 24 hours in advance to notify the owners or operators. Sampling is a routine and critical activity that the FDA is authorized to conduct as part of its charge to ensure the safety of the food supply.

What happens when the FDA finds a positive sample?

The FDA has the authority to take action when a sample tests positive for a pathogen. This can include placing a firm on import alert, overseeing a recall, or issuing public warnings. In all cases, the FDA will communicate with the responsible entity and carry out follow-up activities, such as further sampling or inspection, as necessary.

What should I expect when the FDA collects samples?

See detailed information on what to expect when the FDA collects samples.

Will the FDA publish the test results? If so, how often?

The FDA plans to publish the test results on a quarterly basis. Check here as they will be posted at the bottom of this page.

What is the FDA doing to minimize the impact of its sampling on trade and commerce?

The FDA is sensitive to the concerns of both domestic firms and importers and will provide analytical results to importers as soon as they are available. Domestic firms that indicate they will hold a sampled lot pending the receipt of analytical results also will receive the results as soon as they are available. For perishable products, initial results are typically available three to five business days after the laboratory’s receipt of the samples. Samples that initially appear positive typically take an additional six to eight days to confirm, depending on the pathogen.

Results as of 1/1/2018

The FDA began collecting and testing fresh herbs (cilantro, parsley and basil) and processed avocado and guacamole in October 2017. These two assignments are anticipated to last about 18 months. The information that follows presents the laboratory results through December 31, 2017 as interim figures subject to potential revision. The FDA will publish summary reports of its results (to include final figures and breakdowns of its findings) once the assignments have been completed. People who wish to see an example report on the FDA’s food product surveillance sampling can view the agency’s report on its sampling of sprouts.

The sampling design for each food represents what U.S. consumers are likely to find in the marketplace with respect to product origin (i.e., domestic vs. import). Accordingly, the FDA has considered the volume of the target food that is imported and produced domestically, and which countries produce and export the food to the United States. The FDA may adjust the number of samples to be collected or the collection timeline based on factors that the agency may encounter during the assignments.

In the event that samples are found to be positive for microbial hazards, the FDA will consider regulatory and enforcement options, which include: encouraging a voluntary recall, ordering a mandatory recall, ordering administrative detention to prevent food from being distributed, issuing public warnings to alert consumers to the potential danger, and in the case of imported products, refusing their entry into the country and subjecting future shipments to an import alert. The agency ll detail any enforcement action it takes in its summary report(s).

Fresh Herbs Results as of 1/1/2018

The FDA plans to collect 1,600 fresh herbs samples (761 domestic, and 839 of international origin) under this assignment. As of January 1, 2018, the agency had collected 35 domestic samples (4.6 percent) and 104 import samples (12.4 percent) of the totals. The following figures summarize the interim sampling results. As the testing is still underway, no conclusions can be drawn at this time.

Fresh Herbs Bar Charts












Processed Avocado and Guacamole Results as of 1/1/2018

The FDA plans to collect 1,600 processed avocado and guacamole samples (800 domestic, and 800 of international origin) under this assignment. As of January 1, 2018, the agency had collected 58 domestic samples (7.3 percent) and 49 import samples (6.1 percent) of the totals. The following figures summarize the interim sampling results. As the testing is still underway, no conclusions can be drawn at this time.

Avocado and Guacamole Bar Charts

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